Ta I tinu

Specilication
Manual
Fifth Edition
Ta I tinu
Specilication
Manual
Fifth Edition
Introduction

The first edition of the Tableting Specification Manual, • Understand tooling dimensions, including toler-
published in 1971, offered the first industry-wide speci- ances and clearances, and the puipose of tooling
fications for tablet tooling. The specifications, which specifications .
were developed under the direction of the Industrial • Understand the factors that affect tablet design and
Pharmaceutical Technology (IPT) section of APhA's how to use this knowledge to create optimal tablet
Academy of Pharmaceutical Sciences, are often designs
referred to as the "IPT standards." Because the IPT sec- • Understand the properties of the various types of
tion no longer exists, APhA and the Steering,<;:ommit- tool steels and how the compression forces to
tee introduced the term "TSM standards" in the fourth which they are subjected affect the life cycle of
edition. Linking the catchphrase with the abbreviation tooling
of the Tableting Specification Manual rather than a • Determine the maximum punch tip forces for con-
specialty group, should provide a more stable point of cave capsule, oval, and compound-cup oval tooling,
reference. as well as those forces for 30° F.F.B.E. tooling
• Lengthen the service life of tooling by reducing
premature wear and excessive breakage
• Determine the causes of common tablet and tooling
Objectives problems, and implement methods to reduce or
eliminate the problems by selecting the appropriate
The fifth edition of the manual continues to provide tooling options
comprehensive information on specifications and quali- • Interchange tooling appropriately between different
ty control programs for tablet tooling. The scope of the makes and models of tablet presses
fifth edition has been broadened to offer more • Order tooling from multiple suppliers
information on tooling options, tablet design, and • Avoid the costly work stoppages and poor-quality
maximum punch tip compression forces. In addition, a tablets that can result from using poor-quality
few specifications have been revised. These punches or misusing good-quality tooling
enhancements are highlighted in the following
discussions of sections 2, 3, and 4, respectively.

The information in this edition should aid all personnel Section Topics and
involved in tablet design, tablet manufacturing, tooling Guidelines
manufacturing, and press manufacturing to
• Communicate clearly about the basic and special
features of production tooling, as well as the basic This manual offers basic information for personnel new
components and operations of a tablet press to the industry, specifications for tooling requirements
• Communicate clearly about the basic configura- and design options, technical information on tablet
tions and design considerations of tablets design and tool steels, detailed information on
• Understand the advantages of using presses that are procuring and maintaining tooling, and guides for
compatible with TSM specifications troubleshooting production problems. A summary of
• Implement methods to ensure standardization of the topics in each section is presented here so that
tooling readers can quickly identify their areas of interest. New
or revised information is also highlighted.
Depending on their information needs, purchasers of
the fifth edition also have ready access to guidelines
that will help them to

©American Pharmaceutical Association xi

 • Measure a tool selected to replace a discarded one Cleaning Tooling
to ensure a proper fit with the remaining tools in
that set. All tooling should meet TSM specifica- Punches and dies removed from the press should be
tions. cleaned and inspected before any maintenance is per-
• Periodically inspect tooling and document the formed. An ultrasonic bath is ideal for cleaning tooling.
results as specified earlier in the discussion of "Ini- If another system is used, the liquid cleaner should be
tial Inspection of Tooling." nontoxic and should not cause rust. After cleaning, tool-
ing must be handled carefully to prevent moisture from
the operator's fingers remaining on the tooling and
causing rust.
Punch and Die Maintenance
This section describes all aspects of punch and die
Proper maintenance is the most important factor in maintenance; however, only the operations that bring
maximizing the life of punches and dies. Maintaining tooling to an acceptable running condition should be
tooling also minimizes many compression problems performed. Because the operations are abrasive in
such as variations in tablet weight and thickness, and nature, excessive or unnecessary maintenance will
picking, sticking, or capping of tablets. The cost of reduce tooling life. After all repair work is done, tooling
maintenance equipment and the time spent in maintain- should be cleaned again by the described method.
ing tooling will be amply recovered by the savings real-
ized in prolonged tooling life and reduced incidence of
problems during tablet production. Safety Procedures

The person responsible for tooling maintenance must be Before proceeding with the actual maintenance of tool-
conscientious, adaptable, and, most importantly, fully ing, the following safety procedures should be noted.
trained in the techniques of handling and polishing tool- • DO wear safety glasses at all times.
ing. A person with basic mechanical knowledge is ideal • DO maintenance procedures in good lighting.
for the job; however, previous engineering knowledge is • DO the work according to the maintenance manual
not essential. and training that have been provided.
• DO protect yourself from sharp punch edges and
The following instructions for maintaining punches and keyway slots.
dies cover the most common polishing techniques; the • DO use all provided safety guards.
supporting illustrations apply mainly to B- and D-type • DO secure loose clothing, hair, and jewelry.
tooling. These techniques along with the appropriate • DO ensure that tools are securely and squarely
modifications to equipment, if required, can be applied clamped before turning on a machine.
to other tooling types. • DO use cotton wool to clean rotating punches.
• DO NOT leave chuck keys in a motorized chuck.
A record of the polishing of tooling and inspection of • DO NOT apply excessive pressure to polishing
tooling dimensions is an excellent aid in determining bobs; slipping may occur.
when to purchase backup sets of tooling, thereby reduc- • DO NOT use cloths to wipe punches clean while
ing the risk of downtime in tablet production. (See Fig- punches are rotating.
ure 39 on page 87, "Punch and Die Inspection Sheet.") • DO NOT use a chuck without the guard in place.
• DO NOT wear gloves when operating moving com-
ponents.
Although the techniques for punch and die mainte-
nance described in this manual have been used suc-
cessfully, the TSM Committee has no control over Typical Maintenance Equipment
their application and. therefore, cannot accept lia-
bility arising from their use. The following equipment is used for general cleaning
and polishing of tooling and for tooling repairs, such as
removing burrs, chips, and bruises.

©American Pharmaceutical Association 89

 A motorized polishing chuck with a magnetic brake is A flexible-drive polishing unit is used with a motorized
used for general cleaning and polishing of plain con- polishing chuck to polish plain concave punches, large
cave punches and for cleaning of die bores (see Illustra- F.F.B.E. punches, and die bores (see Illustration 3). The
tion 1). The motor is fitted with a backplate and a 5- flexible-drive unit has a motor, handpiece, and stand
inch, standard three-jaw chuck, which is gear scrolled from which the unit is suspended.
and self-centering.
An air-driven hand-held polisher is an alternative to the
Illustration 1
flexible-drive polishing unit. The hand-help polisher
requires an air supply of 80 psi/6 bar.
MOTORIZED
POLISHING
CHUCK
Maintenance Materials

The following materials are commonly used in main-

taining and handling punches and dies. Variations of
listed materials may also be considered.

Illustration 2
Materials used with motorized polishing chucks and
flexible-drive polishing units include:
TWO-SPEED,
DOUBLE-ENDED
MOTOR • Radius gauges (inch and/or metric sizes)
• Felt bobs (various sizes)
• Nylon brushes
• Diamond-polishing compound (grades from 0-2
microns to 8-12 microns)

Materials used with double-ended polishing motors

Collet-type lathes are also very effective for cleaning include:
and polishing tooling.
• Nylon brushes (wheel-type or pencil-type)
A two-speed, double-ended motor is used to polish and • 2-inch brass brushes (wheel-type)
debur F.F.B.E., shaped, and embossed punch tips, • Polishing paste or compounds
including the breaklines (see Illustration 2). The motor
can be supplied with two standard adapters for nylon Additional materials used in the maintenance and han-
brushes and an adapter for a brass-wheel type brush. dling of punches and dies include:

Illustration 3 • Lapping sticks (various sizes)

FLEXIBLE-
• Cotton wool
DRIVE • Self-adhesive, fine emery sheet (600-grit)
POLISHING • Self-adhesive, fine emery sheet (320-grit)
UNIT • Medium emery cloth strip (180-grit)
• Coarse emery cloth strip (80-grit)
• Scotchbrite sheet
• Arkansas stone
• Magnifying glass
• V blocks
• Corrugated PVC strips
• Length gauge

90 © American Pharmaceutical Association

Handling Punches Measuring Punches

The most important factor in tooling maintenance is Maintaining working lengths of punches within a speci-
appreciating the delicate nature of punch tips. Although fied range is critical to avoiding problems in tablet pro-
a punch tip is designed to withstand several tons of duction. Excessive deviations from TSM standards for
pressure in a press, it is very easily damaged by the tip-to-barrel concentricity, tip sizes, and tip radii can
slightest contact with a hard surface. Therefore, a punch result in damaged tooling and poor-quality tablets.
tip should never come in contact with ( 1) any part of
another punch, whether in the press, on a bench, or in Checking tooling dimensions is recommended as part
storage; (2) any part of the press; (3) any metal tools or of routine maintenance procedures. The following
equipment such as a vice, polishing unit, etc.; and equipment used to check these dimensions is shown in
(4) any part of a metal storage container. Illustrations 5 and 6:
• Comparator
Many punches and dies are damaged beyond repair • Pointed brass anvil
each year by mechanical damage (e.g., bruising and • Ball anvil
chipping) while they are out of the press. This unneces- • Length gauge
sarily high cost could be reduced, or even eliminated, if • Appropriate punch holder (B- or D-type)
the maintenance operator imagines the punch tips to be • Vertically held V block, used in place of a punch
made of glass and treats them accordingly. Using strips holder (see Illustration 8)
of corrugated PVC sheets, of the type used for roofing • Micrometer (see Illustration 9)
materials, to segregate punches during handling and • "Go-No Go" Gauge (see Illustration 10)
maintenance prevents them from rolling into each other
or off the bench (see Illustration 4). The PVC strips are
Illustrations 5 and 6
5.06 inches [130 millimeters] wide and have a 1.19-
inch [30-millimeter] profile. Using racks or storage
boxes can also reduce damage. INDICATOR

(5)

Illustration 4
PUNCHES

~
PUNCH
HOLDER

BASE

COMPARATOR AND PUNCH HOLDER

CORRUGATED PVC STRIP

~~::::;:::=~LIFTING
LEVER
INSET DIAL
(6)

Maintenance personnel should be discouraged from

wiping punch tip faces with their fingers. Finger-
BALL ANVIL POINTED BRASS
prints on clean punches often cause corrosion, ANVIL
which is very difficult to remove. DIAL INDICATER

©American Pharmaceutical Association 91

 Setting Up the Comparator Measuring Working Length

The comparator is used to measure overall length, 1. Place punch in holder with head in recessed end and
working length, and tip-to-barrel concentricity of a tip pointing up (see Illustration 7).
punch. An optical comparator with overlays can also be 2. Place holder on base of comparator; depress lifting
used to check head profiles, tip profiles, and overall lever to raise anvil; and slide punch and holder
length. The described steps for setting up the compara- under the anvil.
tor should be followed carefully. 3. Lower the anvil carefully onto the punch face and
find the deepest point by moving the punch and
1. Fit appropriate anvil into dial indicator on the com- holder around until the dial indicator shows the
parator. minimum reading.
NOTE: The pointed brass anvil is used for p,qnches 4. Subtract this minimum reading from the measured
with embossing or bisect lines and for punches with overall length and compare the difference to the the-
small tips and deep concavities. The ball anvil is oretical or calculated cup depth. If the punch meets
used for flat and plain concave punches (see Illus- TSM standards, the difference in lengths should
tration 6). closely approximate the cup depth.

2. Place the length gauge on the comparator base

under the dial indicator anvil, while depressing the Illustration 7
lifting lever.
3. Move the dial indicator unit on the pillar until it
makes contact with the length gauge. COMPARATOR
AND PUNCH
4. Continue to move the indicator until the pointer has HOLDER
made a sufficient revolution of the dial to measure
the appropriate depth of the punch concavity or
bevel; then set the indicator to zero.
PUNCH
NOTE: The number of revolutions of the pointer HOLDER
will be shown on the small inset dial (see Illustra-
tion 6).
BASE
5. Remove length gauge.

The working length is the most critical punch

Measuring Overall Length dimension because it controls tablet weight and
thickness. The working lengths of all punches in a set
1. Place punch in holder with tip in recessed end and must be within ±.001 inch [±.025 millimeter] of each
head pointing up. other. If the punches do not meet this standard due to
2. Place holder on base of comparator; depress lifting wear, reworking, etc., the working lengths should be
lever to raise anvil; and slide punch and holder adjusted according to the instructions given in
under the anvil. "Maintaining Accurate Punch Lengths" on page 97.
3. Lower the anvil carefully onto the head flat and
record the indicator reading.
Measuring Cup Depths
The overall length is not critical because wear of the tip
edges only marginally affects variations in tablet 1. Obtain the theoretical depth of the cup from the
weight. Also, embossing and breaklines, which pro- tooling drawing, or calculate the depth using the
trude· above the tip surface, can affect the measurement formula for cup depths.
of overall length. 2. To find the actual cup depth, subtract the measured
working length from the measured overall length.

92 ©American Pharmaceutical Association

 NOTE: Again, the cup depth is not a critical dimen-
Measuring Punch Barrel Diameters
sion with regard to controlling tablet weight.
1. Measure barrel diameter with a micrometer.
2. Check the tolerances shown on tooling drawings or
Measuring Tip-to-Barrel Concentricity relevant tolerance charts (see Figures 8-11, pages
23-26) to determine if the diameters meet specifica-
1. Set up the comparator with a ball anvil and tions.
V block.
2. Place V block on comparator base; place punch in
V block with the outside edge of the punch tip or Illustration 9
tip straight under the indicator anvil to ensure suffi-
cient register on the dial (see Illustration 8).
3. Carefully rotate the punch and note pointer deflec-
tion, which should not exceed .001 inch [ .(Y25 mil-
limeter] T.I.R.
NOTE: T.I.R., or total indicator reading, is the dif-
ference between the highest and lowest readings
taken during one rotation of the punch. Eccentricity,
or deviation from T.I.R, that exceeds .001 inch
[.025 millimeter] is excessive and could be caused
by poorly manufactured tools, mishandling of tools, CHECKING PUNCH TIP DIAMETER
or excessive compression force applied to tools in WITH A MICROMETER
the press.

Illustration 8 Measuring Punch Tip Diameters

1. Measure tip diameters with a micrometer (see Illus-

tration 9).
COMPARATOR VEE
BLOCK AND PUNCH 2. Check the tolerances shown on tooling drawings or
FOR CONCENTRICITY relevant tolerance charts (see Figures 8-11, pages
CHECK 23-26) to determine if the diameters meet spedfica-
tions.

© American Pharmaceutical Association 93

 Checking Radii of Concave Punches Inspecting Punches

• Using radius gauges that are thin steel templates After tools have been removed from the press and
and contain a range of internal and external radii, cleaned to remove all granulation and oil, they should
check the radius of punch faces. When the gauge is be inspected to determine their condition before any
compared to the punch face, there should be a good maintenance is considered.
match of radii.

Inspecting Punch Tips

Checking Punch Head and Neck Profile
I. Use a magnifying glass to inspect the outside of tip
I. Using a "go-no go" gauge (see Illustration 10), edges for bruising (see Illustration 11). A toolmak-
check the punch head first by passing it through the er's microscope can also be used.
"go" end; then check that the head does not pass
through the "qo go" end.
Illustration 11
NOTE: An alternative method is to use an optical MAGNIFYING GLASS
comparator.

Illustration 10

HEAD PROFILE AND NECK GO-NO GO GAGE

2. Check tip edges for raised burrs by visually inspect-

NOGO ing the tip edge and/or by drawing a finger nail
0 across the tip edge (see Illustration 12). Be careful
HEAD GAGE not to leave finger prints on the punch.

0
GO
Illustration 12
THE FINGER NAIL TEST

HEADGAGE

2. Reject any punch that cannot pass through the "go"

end or that passes through the "no go" end.

NOTE: The same gauge can be used for punch

heads that have the same specifications, but are used
in different presses.
3. Visually inspect tip straights for scoring.

94 © American Pharmaceutical Association

Inspecting Punch Faces 1. Pay close attention to the press's lubrication, clean-
liness (particularly punch guides), and applied pres-
1. Use a magnifying glass to inspect punch faces for sure; head wear is usually caused by one or a com-
abrasion. bination of these factors~ In some cases, head wear
2. Visually inspect punch faces for corrosion. is caused by excessive tablet ejection pressure.

NOTE: If lubricant becomes contaminated with the

Inspecting Punch Bodies granulation or powder, its lubricating properties are
destroyed and excessive wear will result.
1. Use a magnifying glass to check for scoring or
binding on punch barrels or stems. 2. If punches are not free to move under their own
2. Visually inspect punch bodies for corrosion. weight in the punch guides with the antiturning
device loosened, remove punches and then clean
guides thoroughly with a stiff turret brush. Return
Inspecting Punch Heads punches to cleaned guides.
3. If head wear is severe, steel has been removed from
1. Use a magnifying glass or toolmaker's microscope the punches and probably deposited in the press, in
to inspect punch heads for any signs of damage (see cam tracks, or on the pressure rollers. Check press
Illustration 13). cams and pressure rollers before the press is used
again. If the steel particles are rolled under pressure
into the punch heads, further damage is inevitable.
Illustration 13 NOTE: Tools are subjected to very high pressures: a
load of several tons in point contact with the punch

,,,
;---........
B head is normal during tablet compression .

I I

l
/
Punch Repairs
I\__ A
l -- I Common maintenance procedures for punches include
repairing damaged heads, repairing chipped or bruised
tip edges, removing burrs from inside punch tips, and
polishing punches. Only trained personnel should per-
2. Check under the head for irregular or excessive form the following procedures.
wear of the inside head angle (see Illustration 13A).
3. Check the top of the head, head flat, and outside
head radius or angle for irregular or excessive wear Repairing Punch Heads
(see Illustration 13B).
1. Set up equipment: motorized polishing chuck, 80-
These are the most common forms of head damage. If and 180-grit emery cloth, and cotton wool.
either type of damage is present, problems with the 2. Set punch in polishing chuck with the head protrud-
press are indicated. ing. Take care to prevent damage to punch tip.
3. Tum on polishing chuck.
4. Holding an 80-grit emery cloth in the fingers, wipe
Inspecting Presses over the damaged portions of the punch head. Apply
firm pressure until all marks are removed. Or if the
Performing the following press checks should deter- head is severely damaged, apply pressure until the
mine the cause of damage to punches. marks are smooth to the touch.
5. Polish punch head with an 180-grit emery cloth.
6. Clean punch head with cotton wool.

©American Pharmaceutical Association 95

 7. Be sure to clean the equipment to prevent coarse 7. Do not remove any more metal than is absolutely
emery grit from interfering with the fine polishing necessary to eliminate the damage. Only burrs or
of the punches. metal raised above the level of the surrounding sur-
face can be removed; any dents or chips can only be
disguised.
Repairing Chipped or Bruised Tip Edges 8. Clean the tip edge by wiping with cotton wool.
9. Check the amount of metal removed by again mea-
I. Measure the tip diameter with a micrometer. suring the tip diameter ·with the micrometer.
2. Set up equipment: motorized polishing chuck; cot-
ton wool; and a 600-grit, self-adhesive emery sheet NOTE: A technique of applying the emery stick
applied to a hard flat surface, such as a 12-millime- alternately with an Arkansas stone is often effective
ter wide, hardwood lapping stick (see Illustration in repairing tip edges.
14). ''!

3. Set the punch in the polishing chuck with the tip

protruding. Removing Burrs Inside Tip Edges

1. Set up equipment: motorized polishing chuck,

Illustration 14
Arkansas stone, and cotton wool.
EMERY STICK 2. If a burr is raised inside the punch tip (see Illustra-
600 GRIT EMERY tion 16A) remove it with an Arkansas stone held
against the rotating tip (see Illustration 16B and C).

Illustration 16
LAPPING STICK
BURR

4. Tum on motor.
5. Very carefully apply the emery sheet to the outside
diameter of the punch tip, making sure the surface
of the emery sheet is parallel to the side of the tip.
Move the emery stick back and forth (see Illustra-
ARKANSAS STONE
tion 15A).
6. Do not allow more than one-fourth of the emery
stick to protrude beyond the end of the tip (see
Illustration 15B ), or rounding of the tip will occur.

Illustration 15

~
3. If the tip has a breakline or other embossing that
bJ ,,~
prevents this operation from being carried out with
the punch rotating, carefully move the stone by
EMERY A~ PUNCH TIP
hand around the tip edge of a stationary punch.
4. Ensure that the stone does not touch any part of the
STICK
I punch face other than the extreme edge. Take partic-

r---J r ular care with embossed punches.

5. Clean tip edge with cotton wool.

96 ©American Pharmaceutical Association

Maintaining Accurate Punch Lengths very high degree of accuracy and can tolerate only very
slight wear before causing excessive "flash" or "collar-
1. From a set of punches that need reworking of head ing" of tablets. This excessive material left on the edges
flats, select the punch that has the shortest working of tablets results from rounding of the tip edge, which
length. creates a space between the tip and the die.
2. Using this length as a standard, remove sufficient
material with a surface grinder from the head flats Because all polishing operations abrade the surface,
of the remaining punches to bring the working polishing must be kept to a minimum. The four most
lengths of all the punches to within ±.001 inch common errors in polishing punches are:
[±.025 millimeter] of the TSM specification.
• Rounding of the outside diameter of the tip (see
NOTE: Using a surface grinder is a skilled opera- Illustration 18A)
tion and should be done by an experienced operator • Rounding of the edge of the tip face (see Illustra-
who is aware of the delicate nature of tablet punch- tion 18B)
es. Consult your tooling supplier about the maxi- • Distortion of the tip face (see Illustration 18C)
mum reduction in punch head thickness. • Distortion of embossing (see Illustration 18D

3. Mark reworked punches as such and store them sep- Illustration 18

arately from other sets of punches.
4. If only one or two punches in a set are badly worn,
replace them with the spare punches. Measure and,
if necessary, standardize the replacement punches.
5. If many of the punches are worn, rework the head
flats of all the worn punches.
6. Check the diameter of head flats on punches that
underwent surface grinding. The head flat diameters
must be smaller than the neck diameter or breakage
under pressure is likely (see Illustration 17).
7. If the punches do not meet the minimum length,
replace them.
8. Polish the reworked punch heads

Polishing Compounds
Illustration 17
Various grades of diamond paste or milder abrasive
-
MAX
- compounds are used to polish punch tips (see Table 18
.._ on page 98). These compounds are very abrasive, par-
I --- I ticularly the coarser diamond pastes. Unless used very
..... v
sparingly, excessive removal of metal will occur with
subsequent reduction of punch life.
I _~_J

Polishing Tools

Polishing of Punches One of the most important points of polishing punch

tips is ensuring that the polishing tools (brushes or
Punch tips can be completely spoiled by excessive or bobs) are of a size and form appropriate to the tip being
improper polishing that can remove the knife edge of polished.
punch tips in seconds. Each punch tip is machined to a

©American Pharmaceutical Association 97

..
Polishing Brushes are used for all small F.F.B.E., Felt Bobs are used for plain concave and large F.F.B.E.
shaped, and embossed punch tips, including the break- punch tips. For plain concave tips, the end of the bob
line. A nylon wheel brush, similar to the type used in should be spherical and have_ the same radius as the tip
dental work, is recommended; the brush diameter concave (see Illustration 21A). The diameter of the bob
should not exceed .91 inch [23 millimeters] (see Illus- end should be smaller than the punch tip diameter (see
tration 19). Alternatively, a pencil brush can be used in
a handpiece (see Illustration 20). A pencil brush is rec-
Illustration 21B). ~
ommended when a mirror surface finish is needed to For large F.F.B.E. tips, t~e bob's radius should be ~
prevent granulation from sticking inside the embossing slightly smaller than that of the punch tip (see Illustra- i
of a punch face. tion 21C); the bob's diameter should be approximately
two-thirds the diameter of the punch face (see Illustra-
tion 21D). =
i
Illustrations 19 and 20

Illustration 21
B D
=
!!
(19)
NYLON BRUSH M I:
(EMBOSSED TIPS)

- !=:
(20)
ii

I ii
ii

=
!I
TABLE 18. POLISHING COMPOUNDS AND TOOLS
=
ii
USE TOOL COMPOUND

Cleaning and polishing embossed, shaped, Nylon brush Mild abrasive compound
and small F.F.B.E. tips with good surface finish

Polishing embossed, shaped, and small F.F.B.E. Nylon brush Diamond paste ( 0-2 microns)
tips with deteriorating surface finish

Final polishing of plain round (concave or convex) Felt bob Diamond paste (0-2 microns)
and large F.F.B.E. tips with good surface finish

1. Separate felt bobs and nylon brushes should be kept for each grade of polishing compound.
2. When punch tips are severely deteriorated, it may be necessary to use a 14-micron diamond paste with either a felt bob
or nylon brush. To give the final required high polish, a final polishing with a 3-micron diamond paste is recommended.
3. _Coarse emery grit should not be allowed to contaminate the felt bob or polishing compounds.

98 © American Pharmaceutical Association

 Section 1: "Guidelines tor Using (see Table 2) to reflect differences between Ameri-
This Manual" can and European presses
• Addition of drawings to Figure 20, showing
Section 1 provides basic information about tablet man- screwed-in Woodruff keys
ufacturing, tablet tooling, and tooling specifications, • Revision to Tables 4 and 5 showing updated infor-
including the rationale for standardization of tools. mation on Kilian presses ~
Specifically, these guidelines define tooling terminolo- • Updated tooling interchangeability tables (see
gy, discuss the most common punches and dies, com- Tables 6-9) ~
pare round and shaped tablet tooling, explain the func-
tions of the various positions on a rotary press, explain
~
the concepts of clearances, tolerances, and reference
dimensions, explain how to interpret specification
Section 3: "Tablet Design"
=
drawings, and explain the problems associate<j with Section 3 defines tablet terminology and provides sup-
=
nonconformance of tooling to TSM specifications porting illustrations, identifies the factors that affect
tablet design, provides guidelines for optimal tablet =
New information to this section include the following
revisions to figures:
design, and provides sample designs for bold and
numeral characters. =
• Addition of Table 1 showing direction of rotation
=
of major manufacturers' presses
• Revision of punch barrel diameter for B2-type
lower punches (see Figures 2 and 21)
Revision to this section encompasses an expanded
discussion of tablet bisects, including
• Guidelines for determining which punch face
=
should bear the bisect
• The appropriate cup depths on which to base bisect
=
depths =
Section 2: "TSM Tooling Specifications
=
and Design Options"

Section 2 contains the specification drawings for

Section 4: "Tool Steels, Compression
Forces, and Fatigue Failure"
=
=
punches and dies, optional designs for punch tips and
dies, and tooling interchangeability tables. Revisions or
additions to this section include:
Section 4 provides information on the types of tool
steels and their uses, maximum punch tip compression -
iiiii

iiiii

--
iii
forces for round tooling based on finite element analy-
• Expanded discussion of working length, overall ses, a calculation method for determining maximum iiiii
length, and cup depth, which specifies how to mea- punch tip forces for shaped tooling, and fatigue failure
iii
sure working lengths of upper and lower punches of punch tip supported by a fatigue curve.
• Correction to Figure 5 concerning the measurement
of working length Revisions to this section include
=
• New subsection Tooling Design Options, which
discusses
- domed punch heads
• Noting that the force ratings for concave tooling, as
calculated, also apply to 408 steels
=
-mirror-finished punch heads
-punch key types and positions
• In Table 15, giving the formulas for converting
kilonewton ratings to metric tons and to kilograms
=
!
-short upper-punch tip straights • In Table 15, changing the compression force for
-punch-barrel chamfers F.F.B.E. punches with a tip diameter of 1/4 inch
!:
-punch-barrel flutes
-lined dies
[6.35 millimeters] from 12.5 kilonewtons to 12.0
kilonewtons =
• Revision to Figures 6 and 7, indicating that the
TSM and Japan Norm domed punch heads have the
• In Table 16, changing the shape factor value .209 to
.205.
=
same specifications
• Revision to maximum tablet size for round tablets
• Providing equations for calculating shape factors and
maximum punch tip forces for 30° F.F.B.E. tooling
=
E:
xii © American Pharmaceutical Association ~
..
Polishing Brushes are used for all small F.F.B.E., Felt Bobs are used for plain concave and large F.F.B.E.
shaped, and embossed punch tips, including the break.- punch tips. For plain concave tips, the end of the bob
line. A nylon wheel brush, similar to the type used in should be spherical and have the same radius as the tip
dental work, is recommended; the brush diameter concave (see Illustration 21A). The diameter of the bob
should not exceed .91 inch [23 millimeters] (see Illus- end should be smaller than the punch tip diameter (see
tration 19). Alternatively, a pencil brush can be used in
a handpiece (see Illustration 20). A pencil brush is rec-
Illustration 21B). ~
ommended when a mirror surface finish is needed to For large F.F.B.E. tips, the bob's radius should be ~
prevent granulation from sticking inside the embossing slightly smaller than that of the punch tip (see Illustra- i
of a punch face. tion 21C); the bob's diameter should be approximately

Illustrations 19 and 20
two-thirds the diameter of the punch face (see Illustra-
tion 21D). =
i
Illustration 21
B D
=
!I
(19)
NYLON BRUSH M I:
(EMBOSSED TIPS)
s:
(20) =
I =
=
=
II
TABLE 18. POLISHING COMPOUNDS AND TOOLS
=
ii
USE TOOL COMPOUND

Cleaning and polishing embossed, shaped, Nylon brush Mild abrasive compound
and small F.F.B.E. tips with good surface finish

Polishing embossed, shaped, and small F.F.B.E. Nylon brush Diamond paste ( 0-2 microns)
tips with deteriorating surface finish

Final polishing of plain round (concave or convex) Felt bob Diamond paste (0-2 microns)
and large F.F.B.E. tips with good surface finish

1. Separate felt bobs and nylon brushes should be kept for each grade of polishing compound.
2. When punch tips are severely deteriorated, it may be necessary to use a 14-micron diamond paste with either a felt bob
or nylon brush. To give the final required high polish, a final polishing with a 3-micron diamond paste is recommended.
3. .Coarse emery grit should not be allowed to contaminate the felt bob or polishing compounds.

98 © American Pharmaceutical Association

Felt bobs should be shaped with a file as the bob is Polishing of Plain Tip Faces is done with a motorized
rotated in the polishing handpiece. The bob and punch polishing chuck and a flexible-drive polishing unit, or
tip radii must match exactly, or the punch tip will be with an air-driven hand-held polisher.
distorted. A radius gauge should be used to obtain the
exact radius. 1. Be sure any bruises or chips in the tip edge have
been dealt with before polishing the tool.
2. Be sure safety guard is in place.
3. Set the punch in the polishing unit with the tip pro-
Using Polishing Equipment truding.
4. Fit a bob into the handpiece.
Polishing equipment for tablet tooling includes a 5. Apply a small quantity of polishing compound to
(1) polishing unit with motor and handpiece, (2) motor- the bob.
ized polishing chuck, and (3) two-speed double-ended 6. Tum on the unit to begin rotation of the punch.
motor. 7. Tum on the handpiece.
8. During the operation, keep elbows and forearms
Polishing of Punch Barrels is usually done with a firmly on the bench top or some other rigid support
motorized chuck to remove corrosion or discoloration to maintain control of the polishing tool. Always
from punch bodies and to polish punch tips and heads. use the protective fences to prevent injury to hands.
9. Apply the end of a rotating bob to the punch face,
1. Set the punch in the chuck with the tip and half of making sure the punch is rotating in the opposite
the barrel protruding. If the tool is a shaped punch, direction of the bob. Move the handpiece from side
remove the key. to side, pivoting away from the punch face (see
2. Tum on the motor to rotate the punch. Illustration 22).
3. Lightly polish the punch barrel with a Scotchbrite
sheet. If the punch is severely corroded, use a 600-
grit emery sheet.
Illustration 22
4. Polish only to the point of removing the corrosion
or discoloration. Further polishing could reduce the FELT BOB
barrel diameter.
5. To polish tip diameter, hold a 600-grit, emery lap-
ping stick parallel to the punch tip and apply pres-
sure carefully. Move the emery stick back and forth
across the tip to avoid rounding of the tip edge.
6. Tum off motor; remove punch; and push a wad of
clean cotton wool into the chuck to protect the
punch tip from being damaged by the contact with
\...- - ../

the backplate. Reverse the position of the punch so

that the head is protruding from the chuck.
7. Using a Scotchbrite sheet, lightly polish the remain- 10. Wipe the punch face and inspect it. If the desired
der of the punch barrel. finish has not been achieved, repeat the operation.
8. To polish punch heads, use a 180-grit emery sheet. 11. After polishing is completed, check the working
Avoid excessive polishing of the dwell flat, which length of the punches. If the punch lengths do not
could reduce the punch length. fall within ±.001 inch [.025 millimeter] of the
length of the reference punch, rectify the problem
(see "Maintaining Accurate Punch Lengths").

©American Pharmaceutical Association 99

 Illustration 23 shows the operator's view of this polish-
Illustration 24
ing method; the arrows indicate the pivoting of the pol-
ishing tool from side to side. An alternative method is FELT BOBS
to mount the bob on a fixed-drive chuck while holding
the punch in the hand.

Illustration 23

PUNCH TIP'

\ Polishing of Plain F.F.B.E. Tip Facesis a similar opera-

tion to that for plain concave tips, with the exception

\
\
that the bob should be dressed flat with a chamfer (see
Illustration 25).
--
iii

Illustration 25
\
\

=l [j
The bob radius must fit the radius of the concave punch

-
tip (see Illustration 24A). An oversized bob with an
~
incorrect radius (see Illustration 24B) can cause severe
wear of the punch tip edge (see Illustration 24C). Con- 1. Follow steps 1-8 for polishing plain concave tips.
versely, if the bob is undersized, it will not polish 2. Apply the end of the felt bob to the tip face, keeping
around the tip edge and might distort the face (see Illus-
tration 24D).
the flat end of the bob parallel with the flat surface
of the punch face. Move the bob from side to side
across the punch face (see Illustration 26).
-
~

An internal radius gauge can be used to check the bob

radius. If the bob radius is too small, it should be
increased by removing material from the center of the Illustration 26
convex. If the radius is too large, it should be reduced
by removing material from the outer edge of the
convex.

-
~

100 ©American Pharmaceutical Association I

NOTE: The bevel on the edge of the bob should be NOTE: Experience will aid in determining the time
smaller than the bevel on the punch face; otherwise, required to polish a tool; an experienced operator can
wear of the tip edge will occur. polish a complete set of tools in a very short time.

Polishing of Embossed Punches requires different Illustration 28

equipment and polishing tools.

1. Be sure any bruises or chips in the tip edge have

been dealt with before polishing the tool. A
2. Set up equipment: double-ended polishing motor,
nylon brushes, polishing compound, and polishing
fluid.
3. Turn on motor.
CORRECT
4. Apply a small quantity of polishing compound to @ t
the punch tip face.
5. Hold the punch in the hand as shown in Illustration B
27, supporting the punch in the left hand and rotat-
ing the punch against the brush with the right hand.

Illustration 27
INCORRECT

Die Maintenance

The following measurements and inspections of dies

should be performed upon initial receipt of a set of tool-
ing, and as part of the routine maintenance of dies.

6. Carefully rotate the tip, applying very light pressure Die Measurements
(i.e., do not flatten nylon brushes against the tip).
7. Avoid polishing the outside edges of the punch tips, Die Height is measured with a micrometer (see Illustra-
especially when the tips have a blended land (see tion 29). An alternative method is to use a comparator
Illustration 28A); otherwise, problems with tablet with a ball anvil on the dial indicator.
production will occur.
8. Make sure the bristles of the brush move from
inside the cup to the outside edge (see Illustration Illustration 29
28B), never from the outside edge into the cup (see
Illustration 28C).
9. If the polishing compound becomes dry and sticks
to the tip face, moisten the compound with polish-
ing fluid.
·10. Clean the tip face.
11. Inspect the finish. If acceptable, go on to the next
punch; if not, repeat the operation.

©American Pharmaceutical Association 101

NOTE: The bevel on the edge of the bob should be NOTE: Experience will aid in determining the time
smaller than the bevel on the punch face; otherwise, required to polish a tool; an experienced operator can
wear of the tip edge will occur. polish a complete set of tools in a very short time.

Polishing of Embossed Punches requires different Illustration 28

equipment and polishing tools.

1. Be sure any bruises or chips in the tip edge have

been dealt with before polishing the tool. A
2. Set up equipment: double-ended polishing motor,
nylon brushes, polishing compound, and polishing
fluid.
3. Turn on motor. ' ~
CORRECT
4. Apply a small quantity of polishing compound to @ t
the punch tip face.
5. Hold the punch in the hand as shown in Illustration B
27, supporting the punch in the left hand and rotat-
ing the punch against the brush with the right hand.

l/lustration 27
INCORRECT

Die Maintenance

The following measurements and inspections of dies

should be performed upon initial receipt of a set of tool-
ing, and as part of the routine maintenance of dies.

6. Carefully rotate the tip, applying very light pressure Die Measurements
(i.e., do not flatten nylon brushes against the tip).
7. Avoid polishing the outside edges of the punch tips, Die Height is measured with a micrometer (see Illustra-
especially when the tips have a blended land (see tion 29). An alternative method is to use a comparator
Illustration 28A); otherwise, problems with tablet with a ball anvil on the dial indicator.
production will occur.
8. Make sure the bristles of the brush move from
inside the cup to the outside edge (see Illustration Illustration 29
28B), never from the outside edge into the cup (see
Illustration 28C).
9. If the polishing compound becomes dry and sticks
to the tip face, moisten the compound with polish-
ing fluid.
10. Clean the tip face.
11. Inspect the finish. If acceptable, go on to the next
punch; if not, repeat the operation.

© American Pharmaceutical Association 101

 Die O.D. is measured with a micrometer (see Illustration Shaped Die Bores are measured with a micrometer; the
30). major and minor axes are measured with this gauge. An
optical comparator with accurately drawn overlays is
then used to check the configuration of the bore.
Illustration 30

NOTE: An alternative method to checking shaped die

bores is to insert the punch tip- into the bore.

Concentricity of Round Die Bores is measured with a

comparator. The die is placed in a V block and the ball
anvil of the dial indicator is lowered into the die bore
(see Illustration 32). The die is then rotated by hand
until the total deflection of the dial indicator is
Round Die Bores are measured by passing the bore observed. The deflection, or T.I.R., should not exceed
through the "go end" of the appropriate "go-no go" .001 inch [.025 millimeter].
plug gauge (see Illustration 31). If the bore is the cor-
rect size, the "go" end will pass through the bore,
whereas the "no go" end will not. A micrometer can Illustration 32
also be used to measure round die bores.

Illustration 31

Die Inspection

Before any repairs are made, the dies should be inspect-

ed for (1) compression rings in the bores, (2) wear or
binding in the bores, (3) corrosion, and (4) burrs or
NOTE: More sophisticated methods, such as air gaug- bruising on the O.D.
ing or a spring-loaded probe attached to a measuring
scale, are available for measuring round die bores.

102 © American Pharmaceutical Association

Die Repairs Storage at Tooling

Repairs to dies should be kept to a minimum because Tooling must be stored carefully to prevent corrosion.
any polishing of the die bore will result in an increased Of the several storage methods, one method is to store
clearance between a punch tip and the die bore. Distor- tooling in a cabinet; another is to store tooling in spe-
tion of the die bore can also occur. Under normal work- cially designed plastic storage boxes. ·These storage
ing conditions, wiping the die bore and the O.D. with a containers allow transport 9f the tooling with minimum
clean cloth should be sufficient. handling. Further, operators should wear cotton gloves
to handle tools. Applying a light coating of a thin, non-
Under extreme conditions, and only as a last resort, die toxic lubricant will protect tooling from rust. If punches
bores may be polished. If polishing is warranted, the and dies have been stored for long periods between use,
following method is recommended. they should be inspected periodically to ensure corro-
1. Set up equipment: motorized polishing chuck, flexi- sion is not occurring.
ble polishing unit with handpiece, felt bobs, dia-
mond paste, and polishing fluid.
2. Make sure the felt bob is slightly smaller than the
die bore. If necessary, abrade the bob with a clean Useful Hints
emery cloth to a size slightly less than the punch tip
diameter. The bob's O.D. should be slightly smaller • Use spare punches frequently to maintain punch
than the die' s inner diameter. length compatibility.
3. Put felt bob into polishing handpiece. • Do not polish chrome-plated tooling because the
4. Position die in the polishing chuck so that the chuck chromium will be removed.
grips the die O.D. and the die rotates true. • Design a safe and practical storage system that will
5. Smear diamond paste on felt bob and moisten the extend tooling life.
compound slightly with polishing fluid. • Design a compact and user-friendly layout for the
6. Tum on both units. punch and die room.
7. Insert rotating felt bob into die bore; using light • Use a custom-designed cart, rack, or tray (with sep-
pressure, move the bob back and forth. arations that prevent punches from moving) to
8. Do not allow the bob to protrude more than a quar- carry tooling from storage to the press.
ter of its length from the end of the die bore; other- • To avoid shortages, keep an inventory record of
wise, the bore size will increase rapidly at each end consumables such as diamond paste, polishing
of the die. Also, do not polish the center of the bore bobs and brushes, etc.
excessively; this could cause barrel-shaped bores
and lead to problems with tablet ejection. The procedures described in this section for cleaning,
9. Remove the die from the chuck, and clean the bore repairing, and polishing punches and dies are part of a
with cotton wool. general maintenance program. Following these proce-
10. Inspect the finish. If unsatisfactory, repeat the oper- dures will help to prolong tooling life and avoid pro-
ation. duction problems. If such problems do occur, the trou-
bleshooting tables in Section 6 list corrective actions for
the most common tablet and tooling problems.

©American Pharmaceutical Association 103

 SECTION 6
Troubleshooting Tablet
Production Problems
Problems encountered during tablet production may be uct at the lowest overall cost. The designer must consid-
caused by deficiencies in the granulation, the tablet er the practicality of manufacturing tooling to exact
press, or the compaction tooling. Many times, a defi- specifications, as well as the needs of production, pack-
ciency in one component leads to improper functioning aging, and marketing personnel.
of and/or damage to the other components. A·third of
all production problems are caused or made worse by Quality of tooling is far more important than the price.
ignoring three basic rules: Failed tooling can result in hundreds to thousands of
dollars lost by a product not being available for the
• Keep compression pressure as low as possible. market, the labor expended in the remanufacturing of
• Clean and lubricate the machine properly. an unmarketable product, and/or the labor expended in
• Keep punches and dies in good condition. reworking of poor-quality tablets.

Adhering to the third rule requires paying attention to The number of tablets that the tools will produce during
the factors that can affect the service life of punches: their useful life and the resultant tooling costs per tablet
will be a function of the tooling design, the tool steel
• Product corrosion and hardness selected, and the quality of the tooling
• Excessive compression force (overloading) maintenance program. The time required to implement
• Cam wear on punch heads the tooling for a new tablet design will be a function of
• Damage caused by improper handling or acciden- the correctness and completeness of the information
tally running punches together in the press supplied to the tooling supplier.
• Insufficient land size
• Internal punch defects Tooling suppliers have gained a wealth of experience in
• Excessive hardness of punch tips dealing with many compressing problems. Tooling
• Excessively deep cup depth users should not hesitate to contact their supplier if the
• Worn compression rollers need arises. The suppliers will be pleased to help when-
• Worn cam tracks ever they can in the solution of any tablet compressing
• No lubrication of compression rollers problem.
• Poorly lubricated granulation
• A malfunction of the automatic system that oils Of the two troubleshooting guides that follow, Table 19
punches describes common production problems with tablet
quality; Table 20 (pages 112-116) deals with the most
common tooling problems that occur during tablet pro-
duction.
Advantages of Quality
Tooling
Tablet Problems
Careful consideration and implementation of the many
factors involved in a good, workable tooling program The impact of distributing tablets of poor quality is not
will reap benefits in many ways. A well thought-out limited merely to a diminished corporate image. If a
design is necessary to produce the highest quality prod- poor-quality tablet provides an improper dosage

©American Pharmaceutical Association 105

 SECTION 6
Troubleshooting Tablet
Production Problems
Problems encountered during tablet production may be uct at the lowest overall cost. The designer must consid-
caused by deficiencies in the granulation, the tablet er the practicality of manufacturing tooling to exact
press, or the compaction tooling. Many times, a defi- specifications, as well as the needs of production, pack-
ciency in one component leads to improper functioning aging, and marketing personnel.
of and/or damage to the other components. A·third of
all production problems are caused or made worse by Quality of tooling is far more important than the price.
ignoring three basic rules: Failed tooling can result in hundreds to thousands of
dollars lost by a product not being available for the
• Keep compression pressure as low as possible. market, the labor expended in the remanufacturing of
• Clean and lubricate the machine properly. an unmarketable product, and/or the labor expended in
• Keep punches and dies in good condition. reworking of poor-quality tablets.

Adhering to the third rule requires paying attention to The number of tablets that the tools will produce during
the factors that can affect the service life of punches: their useful life and the resultant tooling costs per tablet
will be a function of the tooling design, the tool steel
• Product corrosion and hardness selected, and the quality of the tooling
• Excessive compression force (overloading) maintenance program. The time required to implement
• Cam wear on punch heads the tooling for a new tablet design will be a function of
• Damage caused by improper handling or acciden- the correctness and completeness of the information
tally running punches together in the press supplied to the tooling supplier.
• Insufficient land size
• Internal punch defects Tooling suppliers have gained a wealth of experience in
• Excessive hardness of punch tips dealing with many compressing problems. Tooling
• Excessively deep cup depth users should not hesitate to contact their supplier if the
• Worn compression rollers need arises. The suppliers will be pleased to help when-
• Worn cam tracks ever they can in the solution of any tablet compressing
• No lubrication of compression rollers problem.
• Poorly lubricated granulation
• A malfunction of the automatic system that oils Of the two troubleshooting guides that follow, Table 19
punches describes common production problems with tablet
quality; Table 20 (pages 112-116) deals with the most
common tooling problems that occur during tablet pro-
duction.
Advantages of Quality
Tooling
Tablet Problems
Careful consideration and implementation of the many
factors involved in a good, workable tooling program The impact of distributing tablets of poor quality is not
will reap benefits in many ways. A well thought-out limited merely to a diminished corporate image. If a
design is necessary to produce the highest quality prod- poor-quality tablet provides an improper dosage

©American Pharmaceutical Association 105

 amount, the well-being of those who purchase the prod- presses to manufacture high-quality tablets. The follow-
uct can be affected. The importance of producing a ing troubleshooting guide to tablet problems is an
high-quality product cannot be overemphasized: the excellent resource for determining the source of and
tablet manufacturer's livelihood depends on the compa- correcting the most common problems related to tablet
ny's commitment to using high-quality tooling and quality.

TABLE 19. PRODUCTION PROBLEMS WITH TABLET QUALITY

TABLET PROBLEM POSSIBLE CAUSE(S)/CORRECTIVE ACTION($)

A. Nonuniform tablet weight 1. Erratic punch flight =

CHECK: FOR/ACTION
a. Free movement of punch barrels in guides (Guides must be clean and =
250.00mg
well lubricated.)
b. Excessive press vibration
c. Worn or loose weight-adjustment ramp
d. Proper operation of lower-punch control devices
••
e. Limit cam on weight-adjustment head missing, worn, or incorrectly
fitted
=
=
f. Check dust seals
g. Check that antiturning device is set correctly
h. Reduce press speed
fl
2. Granulation lost or gained after proper filling of die
CHECK FOR/ACTION
a. Tail over die missing or not lying flat on die table
ii
b. Recirculation band leaking
c. Excessive vacuum pressure, or nozzle improperly located
ii
3. Feeders starved or choked
=
=
CHECK FOR/ACTION
a. Incorrect setting of hopper spout adjustment
b. Granulation bridging in hopper
c.
d.
Wrong fill cam in use
Excessive recirculation of granulation =
ii
4. Dies not filling
CHECK FOR/ACTION ii
a. Excessive press speed
b. See A3 and AS
c. Check speed or shape of feeder paddle
a
5. Lower punch pulled down before die is filled
Sii
CHECK FOR/ACTION
a. Inadequate recirculation of granulation =
6.
b. Recirculation scraper missing or bent

Poor scrape-off of granulation

CHECK FOR/ACTION
=
a
a. Scraper blade bent, worn, or not lying flat; bad spring action

7. Nonuniform punch length

a
CHECK FOR/ACTION ii

•
a. Check that working length is within ±.001 inch [.025 millimeter] of TSM
243.75mg specification

8. Projection of die(s) above die table

CHECK FOR/ACTION
a. Clean die pocket or check die dimension

106 © American Pharmaceutical Association

.~--

4'-'"* §r,~"'"~-,{'1>'i "'\' ',yi'k:""~ ~~ "', c+0~"" "';sM"" ";,,~~.lt71 ""

F.! '0 ~ "' ;; ~ <' { ''ICY
0
,P-. ~ f ~ '" , "'\xRif;·v.'$4"' 'Pkftu ~ ¢.11 • ~®h ~'Sil~ 1faA'.~\·~
Section 5: "Tooling Procurement, Section 6: "Troubleshooting Tablet
Inspection, and Maintenance" Production Problems"

Section 5 provides a template for a standard operating Section 6 is the most comprehensive troubleshooting
procedures program. Instructions for setting up a tablet guide to tablet compressing problems available to tablet
and tooling directory are supported by forms for obtain- manufacturers. The preventative and corrective measures
ing approval of tooling drawings, as well as forms for presented in this section include basic rules for avoiding
ordering, inspecting, disbursing, and repairing tooling. production problems, factors that affect punch life, the
This section also provides comprehensive guidelines for possible causes and corrective actions for common tablet
maintaining tools. and tooling problems, and a method of determining wear
of turret guideways by measuring punch tip deflection.

The publisher and the steering committee will continue

to track technological advances in the tablet manufacturing
industry and identify emerging topics of interest. Readers
are also invited to participate in this quest to identify new
information needs. Suggested topics should be sent to the
Tableting Specification Manual; Books and Electronic
Products Department; American Pharmaceutical
Association; 2215 Constitution Avenue, NW;
Washington, DC 20037. E-mail suggestions can be sent
to [email protected].

© American Pharmaceutical Association xiii

 TABLE 19. PRODUCTION PROBLEMS WITH TABLET QUALITY (CONT.)

TABLET PROBLEM POSSIBLE CAUSE(S)/CORRECTIVE ACTION(S)

A. Nonuniform tablet weight 9. Automatic weight-control system not working correctly

(continued) CHECK FOR/ACTION
a. Check that system's settings and operation are correct; see
manufacturer's handbook ·

10. Wide variation in thickness of lower punch heads

CHECK FOR/ACTION
a. Check that head thickness of lower punches is within ±.010 inch [.025
millimeter] of TSM specification

B. Nonuniform tablet thickness 1. Nonuniform tablet weight

CHECK FOR/ACTION
(Not pictured) a. See A

2. Bouncing of pressure rollers

CHECK FOR/ACTION
a. Improper setting for overload release
b. Press operating near maximum density point of granulation; increase
thickness and/or reduce weight within allowable tablet tolerances
c. Pressure rollers not moving freely; punch faces in poor condition
d. Air trapped in hydraulic overload system
e. Worn pivot pins on roller carriers

3. Nonuniform punch lengths

CHECK FOR/ACTION
a. Check that working length is within ±.001 inch [.025 millimeter] of TSM
specification

c. Nonuniform tablet density 1. Nonuniform tablet weight and thickness

(triability) CHECK FOR/ACTION
a. See A and B
b. See capping in G

2. Unequal distribution of granulation in die bores

CHECK FOR/ACTION
a. Stratification or separation of granulation in hopper
b. Excessive recirculation (This causes classification of granulation
because only finer mesh material escapes the rotary feeders.)

3. Particle segregation or stratification in hopper

CHECK FOR/ACTION
a. Reduce variations in particle size; reduce machine vibration; reduce
machine speed

4. Low moisture content

CHECK FOR/ACTION
a. Add moisture to aid bonding

D. Excessive vibration of press 1. Worn drive belt

CHECK FOR/ACTION
(Not pictured) a. Inspect drive belt

2. Mismatched punch lengths

CHECK FOR/ACTION
a. See A-7

©American Pharmaceutical Association 107

 TABLE 19. PRODUCTION PROBLEMS WITH TABLET QUALITY' (CONT.)

TABLET PROBLEM POSSIBLE CAUSE(S)/CORRECTIVE ACTION($)

D. Excessive vibration of press 3. Press operating near maximum density point of gtanulation

~
(continued) CHECK FOR/ACTION

•
a. Increase tablet thickness and/or reduce its weight within allowable
(Not pictured) tablet tolerances

4. High ejection pressure

CHEC~FOR/ACTION II

5.
a. Worn ejection cam
b. Add more lubrication to granulation, or taper dies
c. Barrel-shaped die bores

Improper pressure-release setting

•
ii

-
ii
CHECK FOR/ACTION
a. Increase pressure to the tooling's limit
iiii
E. Dirt in product (black 1. Dust, dirt, or press lubrication in the granulation
specks) CHECK FOR/ACTION iiiil
iiii
a. Clean press more frequently
(Not pictured) b. Excessive or wrong press lubrication
c. Use proper punch dust cups and keyway fillers
ii
d. Rubbing of feeder components
e. Punch-to-die binding iii
F. Excessive loss of 1. Incorrect fit of feeder to die table iii
granulation CHECK FOR/ACTION

(Not pictured)
a. Feeder base set incorrectly (i.e, too high or not level)
b. Bottom of feeder pans worn due to previous incorrect settings; relap
pans, if necessary
=
=
2. Incorrect action of recirculation band
CHECK FOR/ACTION
ii
a. Gaps between band's bottom edge and die table
b. Binding in mounting screw
=
3.
c. Inadequate pressure on hold-down spring

Insufficient scraping of die table

CHECK FOR/ACTION
=
ill
a. Worn or binding scraper blade
b. Outboard scraper edge allowing granulation to escape SI
4. Granulation lost from die prior to upper punch entry ii
CHECK FOR/ACTION
a. Tail over die not lying flat on table

5. Granulation lost at compression point

=
CHECK FOR/ACTION ==
6.
a. Compression occurring too high in the die
b. Excessive suction or misdirected exhaust nozzle

Excessive sifting
=
=
CHECK FOR/ACTION
a. Excessive clearance between lower punch tip and die bore ii
b. Excessive fine particles in the granulation
c. Tapered dies installed upside down

108 © American Pharmaceutical Association

 TABLE 19. PRODUCTION PROBLEMS WITH TABLET QUALITY (CONT.)

TABLET PROBLEM POSSIBLE CAUSE(S)/CORRECTIVE ACTION($)

G. Capping and lamination 1. Air entrapment

CHECK FOR/ACTION
a. Compress granulation higher in the die
b. Reduce press speed
c. Precompress granulation
d. Reduce quantity of fine particles in the granulation
e. Reduce cup depth on punches
f. J:aper dies
g. Ensure that punch-to-die clearance is correct

2. Excessive pressure
CHECK FOR/ACTION
a. Reduce tablet weight and/or increase its thickness within allowable
tolerances
b. Adjust pressure

3. Ringed or barrel-shaped die bore

CHECK FOR/ACTION
a. Reverse dies
b. Hone or lap bores
c. Compress granulation higher in the die

4. Too rapid expansion of tablet upon ejection

CHECK FOR/ACTION
a. Taper dies

5. Weak granulation
CHECK FOR/ACTION
a. Increase quantity of binder; use stronger binder

6. Excessively dry granulation

CHECK FOR/ACTION
a. Increase level of lubricant

7. Excessive lubrication of granulation

CHECK FOR/ACTION
a. Decrease level of lubricant; blend all ingredients fully before adding
lubricant

8. Punch cavity too deep

CHECK FOR/ACTION
a. Use punches with less concave depth

9. Punch tips worn or burred

CHECK FOR/ACTION
a. Refurbish or replace punches

10. Lower punch set too low at tablet take-off (Reworking or refurbishing
punches can cause this.)
CHECK FOR/ACTION
a. Set lower punch tip flush with top of die

11. Tablet take-off bar set too high

CHECK FOR/ACTION
a. Adjust take-off bar

© American Pharmaceutical Association 109

 TABLE 19. PRODUCTION PROBLEMS WITH TABLET QUALITY (CONT.)

TABLET PROBLEM POSSIBLE CAUSE(S)/CORRECTIVE ACTION(S)

H. Picking and sticking 1. Excessive moisture

CHECK FOR/ACTION
a. Check moisture content of granulation
b. Check room humidity

2. Punch face condition

CHECK FOR/ACTION
a. Pits'On punch faces and/or improper draft on embossing; try
repolishing punch faces
b. Try chrome-plating punch faces

3. Insufficient compaction force

CHECK FOR/ACTION
a. Increase tablet weight and/or reduce its thickness within allowable
tolerances

4. Inadequate lubrication of granulation

CHECK FOR/ACTION
a. Check and/or adjust level of lubricant used

5. Poor embossing design

CHECK FOR/ACTION
a. Redesign embossing per TSM guidelines, or consult tooling supplier

I. Mottled or marked tablets 1. Contamination of granulation, usually by grease or oil

CHECK FOR/ACTION
a. Check oil seals on upper punch guides
b. Reduce lubrication of upper punches to an acceptable level
c. Fit oil/dust cups to upper punches

2. Contamination of granulation from chutes, feed hoppers, take-off bar, or

rubbing together of feed paddles
CHECK FOR/ACTION
a. Clean and reset components correctly .
i

3. High moisture content of granulation

CHECK FOR/ACTION
a. Re-dry granulation

4. Oversized granulation particles

CHECK FOR/ACTION
a. Reduce particle size

J. Indistinct breakline or 1. Incorrect embossing design

embossing CHECK FOR/ACTION
a. Redesign embossing per TSM guidelines, or consult tooling supplier ii
ii
2. Worn punch tips
ii
CHECK FOR/ACTION ii
a. Replace punches

3. Excessively coarse granulation

•!iii

,l
CHECK FOR/ACTION
a. Reduce particle size

© American Pharmaceutical Association I

110
 TABLE 19. PRODUCTION PROBLEMS WITH TABLET QUALITY (CONT.)

TABLET PROBLEM POSSIBLE CAUSE(S)/CORRECTIVE ACTION($)

J. Indistinct breakline or 4. Inadequate binder

embossing CHECK FOR/ACTION
(continued) a. Increase binder strength

5. Picking
CHECK FOR/ACTION
a. Compress granulation at a lower pressure

K. Double impression of 1. Rotatitm of punches

embossing CHECK FOR/ACTION
a. Adjust antiturning device
b. Use keyed punches

L. Chipping or splitting 1. Poor surface finish on punch tips; worn punches and dies
CHECK FOR/ACTION
a. Polish punch tips; replace punches and dies

2. Poor tooling design (e.g., sharp embossing or bisect lines)

CHECK FOR/ACTION
a. Polish punch tips; replace punches and dies

M. Splitting of layered tablet 1. Excessive pressure

CHECK FOR/ACTION
a. Decrease pressure
2. Excessive lubrication of granulation
CHECK FOR/ACTION
a. Reduce amount of lubricant

NOTE: Table reprinted with permission from Pharmaceutical Dosage Forms, Vol. 2, 2nd. ed. New York: Marcel
Dekker, Inc.; 1989: 603-607.

© American Pharmaceutical Association 111

 Tooling Problems
Most tablet manufacturers face the expensive problem able causes given, and, when possible, corrective
of damaged tooling during some stage of tablet produc- actions suggested. If the problem cannot be rectified,
tion. Often, the problem could easily be avoided by suggestions to prevent recurrence of the problem are
using the press correctly. If left unchecked, the damage given.
could result in the cost of a new set of tools or even
major repairs to the press. To help readers isolate the problem, illustrations show-
ing the likely damage accompany the description of all
Table 20 is a troubleshooting guide to the tooling prob- but two problems. However, to aid clarity, the damage
lems most commonly encountered during tablet pro- shown is exaggerated; the actual damage will be far
duction. Each problem is described, details of the prob- less pronounced.

TABLE 20. PRODUCTION PROBLEMS WITH TOOLING

TOOLING CORRECTIVE
PROBLEM CAUSE(S) ACTION(S) COMMENTS

(1) 1. Excessive hard- None: discard tool; Tools should always

The tip has cracked ness for applica- consult tooling be run at the minimum
across the face of the tion. Excessive manufacturer. pressure required to
concave and then bro- pressure. achieve a satisfactory
ken away. tablet.

(2) 2. See cause for 1. See action for 1. A crack will always
The tip has cracked follow the line of least
and broken away along resistance, which may
the angle between the be the sharp angle
bevel and tip face. between the punch
face and the
embossing.

(3) 3. Excessive hard- See action for 1. See comments for 2.

The tip has cracked ness. Areas of con-
and broken away along centrated stress
the angle between a near breakline or
breakline and a con- on embossing (i.e.,
cave tip face. abrupt change of
surface contour).
Excessive pres-
sure.

(4) 4. See cause for 3. See action for 1. See comments for 2.
The tip has cracked
and broken away along
the embossed lettering.

112 © American Pharmaceutical Association

 TABLE 20. PRODUCTION PROBLEMS WITH TOOLING (CONT.)

TOOLING CORRECTIVE
PROBLEM CAUSE(S) ACTION(S) COMMENTS

(5) 5. Normal die wear Examine dies with mag- If allowed to go too far,
This die shows a typi- caused by continu- nifying glass and moni- the die wear can lead
cal wear pattern in the ous pressure at the tor tablet ejection .. to ejection problems
bore. compression area When possible, com- and other problems
in the bore. press tablets in different associated with punch
areas of the die to tightness. If a known
spread wear, and abrasive granulation is
reverse the die when to be compressed, the
one end is worn. Check tooling manufacturer
that correct steel was can possibly offer a
chosen. If wear is a more wear-resistant
serious problem, con- material for tooling.
sult tooling manufac-
turer.
Careful examination of
(6) 6. Mishandling of Carefully remove dam- this type of damage
The edge of the tip has punch (punch has age by blending and will reveal clues to its
been damaged outside collided with or polishing. Exercise cause. (a) If the
the press. been dropped onto extreme care when damage has caused
a hard surface). handling tools; the tips the tip to spread
Accidental damage are very fragile. Train beyond its diameter,
occurred during fit- personnel to handle the damage most
ting of punches to tools properly. likely occurred out of
the press. the press. (b) The
texture of the surface
causing the damage
will be transferred to
the damaged part.

In some presses, if
(7) 7. Contact between Carefully remove dents tools are run or even
The punches have met upper and lower by blending and polish- turned without
in the press; damage punches in the ing. Do not run the granulation, the
occurred where the press. press without granula- punches can meet,
opposing punch has a tion at setup; manually causing damage.
break/ine. turn over the dies until
all are filled with granu-
lation.

See comments for 7.

(8) 8. See cause for 7. See action for 7.
Again, the punches
have met in the press,
but the opposing punch
has no breakline.

This type of damage

(9) 9. Excessive pressure In the early stages can be checked by
Pressure has started to (first stage for before working length is measuring the tip
spread the punch tip; upper and lower affected, punch damage diameter at the
working length may not punch). can be removed by extreme edge and at
yet be affected. The blending or polishing. the lower end. If these
spreading will probably Check all punch lengths dimensions vary,
occur on both upper before reusing the set; damage has occurred.
and lower punches. other punches may have
been damaged. Rolling the punch

©American Pharmaceutical Association 113

 TABLE 20. PRODUCTION PROBLEMS WITH TOOLING {CONT.)

TOOLING CORRECTIVE
PROBLEM CAUSE(S) ACTION($) COMMENTS

(10) 10. Excessive pressure None: the final stage barrel ori a flat surface
Lower punch is over- (final stage for of over-pressure can- is a simple way to
pressured to the point lower punch). not be rectified; the , check for this type of
where the stem is dis- punch is permanently damage: the punch tip
torted and the working distorted. will be seen to rotate
length is reduced. out of true.

See comments for 10.

(11) 11. Excessive pressure See action for 10.
Excessive pressure will (final stage for
have the same effect upper punch).
on the upper punch as
on the lower; see (10).

If not tackled early,

(12) 12. Excessive pressure Reduce pressure; this type of damage
The head flat has worn and damaged or replace lubricant; repair can lead to serious
to the point where frag- worn pressure pressure roller. Spalling wear and damage to
ments of metal are roller. Foreign mat- of the head deposits the tools and the
being removed from ter between pres- metal particles in the press.
the punch head. sure roller and press:
punch head. clean press through-
out. Consult tooling
manufacturer.
Many tooling problems
(13) 13. Tightness of the If possible, polish are caused by
Scoring of the punch punch barrel in the punch to restore origi- tightness; marking of
barrel is caused by a turret leading to nal condition. Check the barrel is a definite
lack of lubrication possible scoring that guides are clear of indication of trouble. If
and/or the presence of and pick up of granulation and metal the lubrication
foreign matter in the metal, which leads particles. Pay particular becomes
punch guides. to increased tight- attention to the punch contaminated with the
ness. Poor lubrica- sockets in the turret. granulation, its
tion. Check working length lubricating properties
before reworking are destroyed and
punch. Ensure that the excessive wear
lubrication system is occurs.
clean, correct, and
operative.

Press damage is
(14) 14. Excessive pres- Check that head flat is possible.
The punch is not rotat- sure. Lack of lubri- not too small to achieve
ing, and the pressure cation. Tight punch- satisfactory dwell time
roller may be running es or pressure during compression.
tight, causing wearing rollers. Check underside of
of the head in only one head for damage. If
spot. (Shaped punches warranted, polish head.
do not rotate.) Resolve pressure prob-
lem; ensure that punch
and pressure roller can
move freely; ensure
adequate lubrication.

114 ©American Pharmaceutical Association

• "
~ ',', ' '1 !,~, :~,:~;,,, ;;~ :'~,,;,,,'' ' ,, ; ' ~ ',,' J'
 TABLE 20. PRODUCTION PROBLEMS WITH TOOLING (CONT.)

TOOLING CORRECTIVE
PROBLEM CAUSE(S) ACTION(S) COMMENTS

(15) 15. A rotating punch is Polish head or increase If the head flat is too
The ejection cam is running very tight size of head flat. Ensure small, the compression
causing wear on the on ejection, caus- that punches can oper- force is concentrated
lower punch head. ing a radial pattern ate freely at all times. on a small area and
of wear. Insufficient Resolve ejection prob- ultimately will cause the
head flat. Exces- lem; to ease ejection center of the head to
sive pressure. loads, taper dies. fail. Tooling is subjected
Damaged, bruised, Always use minimum to continuous high
or scored compres- pressure needed to pressure and eventually
sion roller. compress tablets. the structure of the
Ensure that surface of steel will break down. If
compression roller is punches are tight,
clean and free of burrs unnecessary pressure
or bruising. Check cam is applied to tooling,
for excessive wear; cams, and compression
clean and remove any rollers. If not corrected,
metallic particles from damage to punch
the cam track and pres- heads or compression
sure rollers. rollers will transfer
rapidly to all the
punches in the press.

The top of the punch

(16) 16. Punch has become None: discard the head may also be
Tight punches have tight in the die or punch. Determine damaged. This kind of
,'_caused excessive wear press turret due to cause and ensure that damage leaves metal
to the inside head lack of lubrication. replacement punch particles in the press.
angle. (Damage to Incorrect cam moves freely (i.e.,
press cams is likely.) angle on punch punch should fall freely
heads. Bruised or under its own weight
scored press when antiturning device
cams. is loosened). Clean the
press to remove metal
particles. Ensure that
punch guides are clean
and correct lubrication
is applied. Check that
cam angle is compati-
ble with the press
cams. Inspect cams for
bruises and scores; if
needed, repolish or
replace cams.

See comments for 16.

(17) 17. This problem is None: discard the
This damage is similar similar to 16, but punch. Determine With unenclosed
to (16), but the punch the punch is not cause of problem, and
was not allowed to rotating due to the ensure that replace-
rotate, resulting in part use of a keyed mentpunchisloose
of the head breaking punch or tightening (i.e., punch should fall
off. in the turret. freely under its own
weight when the anti-
turning device is loos-
ened). Clean the press
to remove metal parti-
cles.

© American Pharmaceutical Association 115

 TABLE 20. PRODUCTION PROBLEMS WITH TOOLING (CONT.)

TOOLING CORRECTIVE
PROBLEM CAUSE($) ACTION($) COMMENTS

(18) 18. Upper punch is Discard tool; monitor presses,· the broken
The punch barrel has possibly being pre- condition of tooling at part may be ejected
snapped in the press. vented from enter- all times to avoid tigl;lt- from the press with
ing the die due to ness and excessive considerable force,
tip breakage (see pressure. endangering
1, 2, 3 or 4); the personnel and
head then strikes equipment.
part of the punch
guide system and
'~
breaks the barrel.
Excessive tight-
ness.

g (19)
The punch snapped in
the press, but this time
the head has broken
off.
19. Due to wear and
refurbishing, head
flat has become
larger than the neck
diameter. When
compression force
None: discard tool and
monitor the condition of
tools in use, especially
after refurbishing.
Ensure that all metal
fragments are removed
Severe damage to the
press is almost
certain.

is applied, the from the press.

punch is unsupport-
ed at the neck and
breakage results.

(20) 20. Misalignment of Ensure that internal

Burrs are present punch tips in die chamfer of die bores is
inside the punch tip bore. Worn punch sufficient. Check for
(clawing). guides or die sock- wear and rectify; check
ets. Eccentricity of concentricity of punch
(Not pictured) punch tips to punch tips. Ensure that tip-to-
body. Extrusion of die bore clearance is
product between correct. Increase land or
punch tips and die flat on tip edge; ensure
bores. Excessive that land is blended.
feather edge on
punch tips, espe-
cially deep concave
cups.

(21) 21. Compression of an Ensure that the correct

The surface finish of abrasive or corro- steel has been chosen.
the punch face is dete- sive granulation. Check for sufficient
riorated (i.e., pitted or lubrication of the gran-
discolored). ulation.

(Not pictured)

NOTE: Reprinted with permission from Tooling Problems, Holland Educational Series, No. 4. Nottingham, England:
I Holland Limited; 1988.

116 ©American Pharmaceutical Association

 SECTION 1
Guidelines for Using This Manual
Special Notice to Readers: Unless otherwise indi- "lifting" cam (upper punches).
cated, figures and text illustrations in the manual
are not drawn to scale. Further, unless otherwise Head O.D.: The outside diameter (0.D.) of the punch
indicated, the dimensions listed in figures and head extends the effective area of contact between the
tables are given first in inches, followed by the cam and both the inside head angle and outside head
equivalent millimeters in brackets. angle/radius.

Neck: The relieved area between the head and barrel,

The first step in learning any industry is mastering its which provides clearance for the cams.
terminology. With this in mind, the Steering Committee
has adopted a list of standard, industry-accepted terms Barrel (Shank): The area between the neck and stem;
for tablet manufacturing. An understanding of these the barrel's surface is controlled by the turret punch
terms will provide a foundation on which persons new guides to ensure the punch's alignment with the die.
to the industry can build a working knowledge of the
basic tablet categories, tooling types, press operations, Barrel-to-Neck-Radius: The area at the junction of the
and tooling specification drawings. For those who have barrel and neck, which provides a smooth transition
industry experience, the information in this section from the barrel to the neck.
could be a useful reference for ensuring clear communi-
cation between production staff, tablet designers, tool- Barrel-to-Neck Chamfer: The beveled area located
ing suppliers, and press manufacturers. between the barrel and barrel-to-neck radius. The cham-
fer can reduce wear of punch guides.

Stem: The area of the punch opposite the head, begin-

Tooling Terminology ning at the tip and extending to the point where the full
diameter of the barrel begins. If a chamfer is present
The following definitions of the standard terminology (see definitions for barrel-to-neck chamfer and barre/-
for tooling (punches and dies) are illustrated in Figure 1 to-stem chamfer), the barrel usually reaches its full
on page 3. diameter just above the chamfer.

Tip: The end of the punch that is compatible with the

Punch Terminology die bore. The tip determines the size, shape, profile, and
identification of the tablet.
Head: The end of the punch that guides it through the
press's cam track. Cup: The depression or cavity in the tip. Its depth
measurement does not include identification embossing
Head Flat (Dwell Flat): The flat area of the head that or debossing.
receives the full force of the compression rollers.
Land: The area between the edge of the punch cup and
Outside Head Angle/Radius: The area of the head the outside diameter of the punch tip.
that is in contact with the press cams and has the initial
contact with pressure rollers. Tip Straight: The area of the tip length that extends
from the end of the tip to the tip relief.
Inside Head Angle: The area of the head that is in
contact with the "pull-down" cam (lower punches) and Tip Length: The straight portion of the stem that is

© American Pharmaceutical Association 1

Turret Guideway Wear punches impact the chamfer harder. Excessive deflec-
tions and high impact forces can ultimately lead to
dents in the land or a curling in of punch tips. Serious
Turret guideways for upper punches are sized suffi- damage to inside head angles can also occur as the
ciently larger than the punch barrels to allow free smooth movement of punches thro1:.1gh lifting and low-
movement of the punches and provide adequate room ering cams becomes increasingly difficult.
for lubrication. The resultant clearance also gives rise to
an angular end play, which causes the punch tip to be Wear in turret guideways is not uniform throughout the
slightly off center relative to the die bore as the punch length of the guideway. Loads from the cams and com-
enters the die. Figure 41 depicts this phenomenon. pression rollers force the punch barrels to the backside
of the guideway at the head end and toward the leading
When using punches that meet TSM tolerances in new side at the tip end. The net effect is an egg-shaped
turrets, tip deflection can be as much as ±.003 inch wear pattern at the tops and bottoms of the guideways
(.076 millimeter], depending upon the press make. Die with very little wear occurring in between. Because of
bore chamfers ensure that the punch tips are guided into the wear pattern, establishing a specification as to
the die without causing damage to the tooling. As the when a turret is worn cannot be based on measure-
turret guideways wear, tip deflection increases and the ments of guideway bore diameters.

Punch tip deflection, however, is a good indicator of

FIGURE 41. PUNCH guideway wear. The procedure for measuring tip
deflections is as follows:
TIP DEFLECTION
1. Cover the die pocket in the station that is to be
measured with a thin strip of metal. A blank die
can also be used.
2. Insert a punch and let it rest on the metal strip or
blank die.
3. Set up a surface gauge indicator so that circumfer-
ential tip movement can be measured.
4. Tilt the punch back and forth at the head end and
measure the T.l.R. at the tip.

Maximum recommended tip deflections may vary

according to the press manufacturer, type of tooling
(i.e., round or shaped), and press speed. As a general
guideline, a maximum range of .012 to .014 inch [.304
to .356 millimeter] T.l.R. can be used. Noticeable
punch tip damage and inside head angle wear should
also be considered as indications to replace a turret.

The Tableting Specification Steering Committee

expresses its deepest appreciation to I. Holland
Limited and Thomas. Engineering Inc.. for sharing
TIP DEFLECTION with the Committee and users of this manual the
valuable information contained in the troubleshoot-
USING PUNCH TIP DEFLECTION
AS AN INDICATOR OF WEAR ing tables. This generous contribution of time and
IN TURRET GUIDEWAYS materials will help users of tableting tools to
increase the service life of their tools and avoid
DWG. NO. TSM-N41 costly work stoppages.

© American Pharmaceutical Association 117

 effective inside the die bore. On lower punches, the tip Taper: A gradual increase in the size of the die bore
length allows vertical movement within the die bore for that extends from the point of compaction to the mouth
the metering and compression of granulation, and ejec- of the bore. Tapering of the bore assists in ejecting the
tion of the tablet. tablets (see Figure 17, page 32).

Barrel-to-Stem Radius: The area at the junction of Die Groove: The groove around the periphery of the
the barrel and stem, which provides a smooth transition die, which allows the die to be fixed in the press.
from the tip length to the barrel.
Die Protection Shoulder or Radius: The undercut or
Barrel-to-Stem Chamfer: The beveled area located rounded area, respectively, between the die groove and
between the barrel and barrel-to-stem radius. The O.D. Either of these features can be added to prevent
chamfer allows the punches to be inserted through tur- damage to die pockets during installation of dies in the
ret guide seals. press.

Relief (Undercut): The area of increased mechanical Lined (Insert) Dies: Dies fitted with a liner or insert
clearance between the stem and the die bore. The sharp made from a much harder, more wear-resistant material
edge between the tip straight and the undercut area acts such as tungsten carbide or a ceramic (see Figure 18,
to clean the die. page 33).

Working Length: The length of the punch from the

bottom of the cup to the head flat. The working lengths General Tooling Terminology
of the upper and lower punches control tablet thickness
and weight. Tooling: A collective term that refers to an upper
punch, a lower punch, and a die as a unit. For example,
Overall Length: The total punch length as measured the term tooling maintenance means the concept per-
from the head flat to the end of the tip. tains to all three tools.

Key: A structure that projects above the barrel's sur- Dwell Time: The length of time the head flat is in con-
face and prevents rotational movement of the punches, tact with the main compression roller. During this inter-
thus ensuring their alignment to shaped or multi-bored val, the tablet is undergoing full compression.
dies.
Tolerance: The authorized deviation from a tooling
Keying Angle: The relationship of the punch key to dimension measurement. The deviation allows for prac-
the tablet shape. The key's position is influenced by the ticality of manufacture.
tablet shape, take-off angle, and turret rotation.
T.I.R.: The total indicator reading obtained when mea-
suring certain tooling dimensions with a comparator.
=
Die Terminology

Die O.D.: The outside diameter of the die, which is

compatible with the die pockets in the press.
The T.l.R. is the difference between the highest and
lowest readings noted on the indicator dial during one
complete rotation of the punch or die. =
=
Die Height (Depth): The overall height of the die.
Clearance: The difference in size between interacting
parts, which creates a working space between the parts
and allows for their correct and free movement.
=
=
Die Bore: The cavity where the tablet is made. The
cavity's shape and size determine the same for the
tablet.
Abrasion: The premature wear of contact surfaces.

Corrosion: A chemical reaction of contact surfaces,

=
=
Chamfer: Entry angle on the die bore. which causes pitting and discoloration.

2 ©American Pharmaceutical Association

 ...

FIGURE 1. PUNCH AND DIE TERMINOLOGY

,,,,-;.LAND
I" '\
I I

CUP ~ / UPPER
·~ ../

r DEPTH
TIP
FACE
I ,""-'<
/
/ \
- OR -

....--i-:r.t~ ~,J- , BL~NDED LAND

PUNCH
.-4'
\
,
:
,'
~
,
SECONDARY

1
' KEY__..........
KEY SLOT
(OPTIONAL)

I \

~) 'V
STEM
(TIP TO FULL BARREL)
BARREL-TO-STEM
CHAMFER
(OPTIONAL)

BORE

DIE

TIP STRAIGHT

N-KEY
1 / ORIENTATION
~---I ANGLE

I
I
OVERALL
LENGTH WORKING
UPPER PUNCH FACE
KEY POSITION LENGTH
BARREL

LOWER
PUNCH

HEADO.D. ~~MHEADFLAT
OUTSIDE H E A D _ / - - - - - - - - - - - - - ,
ANGLE DWG. NO.
TSM-N1

©American Pharmaceutical Association 3

 Hardening: A process of heating steel at high temper- Convex tablets can be further categorized according to
atures to transform it from a soft (annealed) condition their cup depth. Figure 23 on page 48 shows convex
to a hard condition. tablets with shallow, standard, deep, extra-deep, and
modified-ball cup depths. Flat-faced tablets can be fur-
Tempering: A process of reheating and cooling steel ther categorized as flat-faced plain, flat-faced bevel-
that follows the hardening process. Tempering toughens edged, and flat-faced radius-edged (see Figure 25, page
the steel and reduces its hardness. 51).

Rockwell Hardness: A measurement of the hardness

of steel. The Rockwell C scale is customarily used for Shaped Tablets
measuring tool steels.
Tablets that have geometric configurations other than
those listed for rounds are referred to as shapes (see
=
ii
iiiil

Figure 25). Figure 24 on page 49 uses three common

Tablet Manufacturing geometric configurations to illustrate the terminology
for shaped tablets. To produce a tablet with a particular Ii
iiiiiil
Producing a tablet with a unique design often increases configuration, the tablet shape is reproduced in the tool-
a product's recognition among consumers. Although ing used to manufacture the tablets. Before the method
tablets can be produced in a variety of shapes and sizes, of reproduction can be discussed, a thorough under- Ii
iiil
limitations as to their configuration do exist. The limit- standing of tablet tooling is required.
ing factors are usually related to characteristics of the

-
iii
iiiiil
tooling and the press used to produce the tablets. Some
categories of tablets are easier to manufacture and com- Modern Tablet Tooling iiiil
prise the majority of tablets on store shelves. iii
The function of tablet tooling is to produce tablets with iiill

predetermined physical characteristics, such as shape,

Tablet Categories thickness, weight, and hardness. To achieve this, the die
cavity, or bore, is filled with a granulation or powder to
The definitions of tablet terminology, which are based a depth that is determined by the position of the lower
iiil
on the geometric properties of the most common tablet punch. The lower punch's position determines the iiil

shapes, are placed in Section 3, "Tablet Design," for amount of granulation used in each tablet. The upper iiil
iiiiiill
that reason. For the scope of this section, the reader punch tip is then guided into the bore and force is
needs only to know that tablets are broadly categorized applied to the punch heads, thereby compressing the
as either "rounds" or "shapes." To provide illustrative material into a tablet. The tablet's shape is determined
examples of the tablet categories, figures in section 3 by the configuration of the die bore and the punch tips.
are cross-referenced in the following text. The tablet's thickness and hardness are determined by
the amount of compression force applied to the punch
heads, whereas its weight is determined by the amount
Round Tablets of granulation loaded into the die before compression.

Round tablets include primarily convex and flat-faced The basic design of tablet punches and dies used in
tablets (see Figure 22, page 46). Frequently, industry rotary tablet presses has changed very little since these
people use the term concave to describe both the con- presses were first marketed in the late 1800's. Only
cave surface of a punch cup and the surface of the tablet minor changes, such as refinements to the head and tip
produced. Technically, the punch cup is usually a con- radius, tighter tolerances, and higher surface finishes,
cavity and therefore produces a tablet with a convex have been made. In the U.S. tablet industry, three types
surface; however, convex cups that produce concave of punches and three types of dies are used predomi-
tablets do exist. nantly in production presses to produce large quantities
of tablets for market distribution.

4 © American Pharmaceutical Association

Punches Dies

Punches are classified according to their overall length, Dies are classified according to their outside diameters
barrel diameter, and the O.D. of the punch head. These (see Figure 2).
dimensions, as well as the other specifications for tablet
tooling, are nominal: that is, each dimension has a spec- The .945 Die, as the name indicates,. has an O.D. of
ified measurement, but its actual measurement after the .945 inch [24.003 millimeters]. This size die can be
tool is produced may vary from its specification. The used with B- and B2-type punches. The die is common-
allowable variance from a nominal dimension, called its ly referred to as a "BB die."
tolerance range, is discussed later in this section under
''Tooling Specifications." The 1 3/16 Die has an O.D. of 1.1875 inches [30.162
millimeters] and can also be used with B- and B2-type
The punches most commonly used in production press- punches. This die is commonly referred to as a "B die."
es are the B-type and D-type punches (see Figure 2,
page 6). B2-type punches are used predominantly in a The "D" Die, which has an O.D. of 1.500 inches [38.10
few older models of presses that are no longer being millimeters], is used with D-type punches.
manufactured. During the research stage of a new tablet
design, F-type punches and dies (not pictured) and a
single-station laboratory press are used to determine the Comparison of Shaped and Round Tooling
approximate amount of compression force and granula-
tion needed to produce a tablet with the desired physi- Not surprisingly, punches and dies used to manufacture
cal characteristics. round tablets are often called "round tooling," and
punches and dies used to manufacture shaped tablets
B· Type Punches have a reference overall length of are called "shaped tooling." After the geometric config-
5.250 inches [133.35 millimeters] and a head O.D. of 1 uration of a tablet has been determined by the designer,
inch [25.40 millimeters]. These dimensions are the the desired configuration is reproduced in the punch
same for the upper and lower punches. Although the tips and die bores.
barrel diameter of a B-type punch is often said to be 3/4
inch [19.05 millimeters], the upper punch has a speci- The upper punch for a shaped tablet has a device called
fied barrel diameter of .7480 inch [19.00 millimeters]; a key that is inserted into a slot in the barrel and projects
the lower punch has a specified value of .7450 inch above the barrel's surface (see Figure 1 on page 3). The
[18.92 millimeters]. key prevents the punch from rotating as it is lifted verti-
cally from the die bore so that the punch can re-enter the
B2-Type Punches also have a barrel diameter of die bore at the proper alignment. Because round config-
approximately 3/4 inch [19.05 millimeters] and a head urations are usually unaffected by rotation of the upper
O.D. of 1 inch [25.40 millimeters]; however, the overall punches, round punches seldom require a key. However,
lengths of the upper and lower punches differ. The if a round lower punch is embossed, a key is sometimes
upper punch is 5.250 inches [133.35 millimeters] long, used to prevent punch rotation and possible distortion of
whereas the lower punch is 3.562 inches [90.475 mil- the embossing during tablet ejection.
limeters] long.
Regardless of the tablet shape and the type of tooling
D·Type Punches have the same reference overall used, the basic press operations are the same.
length as B-type punches (5.250 inches [133.35 mil-
limeters]), but the head 0.D. of D-type punches is
1.250 inches [31.75 millimeters]. Again, D-type punch- Rotary Tablet Presses
es are often said to have a barrel diameter of 1 inch
[25.40 millimeters]; however, the specified barrel diam- Major advancements in the tablet industry have
eters are .9980 inch [25.35 millimeters] for the upper occurred with new models of rotary tablet presses: their
punches and .9950 inch [25.27 millimeters] for the speed has increased; a precompression stage has been
lower punches. added to the production cycle; and, in some presses,

©American Pharmaceutical Association 5

 FIGURE 2. TSM PRODUCTION TOOLING
1.250 --l~~~--,­
[31.75]

0.748 5.250 5.250

[19.00] [133.35] [133.35]

I
8-TYPE UPPER PUNCH D-TYPE UPPER PUNCH
0.945 1.875 1.500
[24.003] [30.162] [38.10]

-1 b_ -1 b_ I ti
m:J 0.875
t:t1j [22.225]
~ 0.875
tt1j [22.225]
~
Ct:1:j
0.937
[23.812]

.945 D1ET 1 3/16 DIET "D" DIEf

0.995
[25.27]
5.250 5.250
[133.35] [133.35]
SEE FOOTNOTE 3.562
[90.475]

1.250 -<~~i::::._L
[31.75] .
D-TYPE LOWER PUNCH
DIE GAUGE
(SCALE 1:1)

1.1875 1.500
[30.162] [38.10]

.945 DIE 1 3 16 DIE "D" DIE

NOTE: FOR SPECIFIC PRESS MODELS, CONTACT TABLET PRESS
MANUFACTURER FOR THE BARREL DIAMETER. SEE ALSO DWG. NO.
TABLE 9 PAGE 42. TSM-N2

6 ©American Pharmaceutical Association

computer technology automatically adjusts the powder TABLE 1. ROTATION DIRECTION OF TABLET PRESSES
fill mechanism for lower punches to maintain the
proper tablet weight. The engineering of these presses PRESS TYPE DIRECTION OF ROTATION

was designed around the basic configuration of TSM

tooling to ensure that tablet manufacturers could
CAD MACH cw
COURTOY ccw
continue to use their existing inventory of tooling. All HATA ccw
presses have designated positions at which certain steps FETIE ccw
in the production of a tablet occur. The following KIKUSUI ccw
description of these positions is supported by Figures 3 KILIAN ccw
and 4 on pages 8 and 9. These figures show the KORSCH ccw
production cycle of a press that rotates
MAN ESTY cw
RIVA cw
counterclockwise. Table 1 lists the direction of rotation STOKES CCW (Gem Series);
for presses of major manufacturers. CW (all other models\
VECTOR ccw
NOTE: CW=CLOCKWISE; CCW=COUNTERWISE
Fill Position (Die Fill)

At the fill position, the lower punch is pulled down by die, thus determining the final weight of the tablet.
the fill cam as the die is passing under the feed frame. Increasing the highest vertical position of this cam will
The pulling down of the lower punch creates a slight expel more powder, resulting in a lighter tablet; like-
vacuum and a void in the die bore. Initially, the com- wise, decreasing the cam's highest vertical position will
bined effect of the vacuum and the void allows loose expel less powder, resulting in a heavier tablet. On
powder to flow into the die bore. As the die continues manual presses, a manual handwheel controls the posi-
its pass under the feed frame, the powder continues to tion of the weight adjustment cam; on automated press-
flow into the bore under the force of gravity. The pow- es, a computer-controlled feedback loop sets the cam's
der can be brought over the die by either a gravity feed- position.
er as just described (material flows without a mechani-
cal aid) or by a mechanical feeder (material is actively
pushed over the die by rotating paddles). Pull-Down Position

Typically, the position of the fill cam remains fixed for Newer press models have a pull-down position, which
the entire production run and can only be readjusted or allows the lower punch to be pulled down slightly so
changed manually. Keeping the fill cam at a fixed posi- that the top of the powder column in the die bore is
tion allows each die to be filled with the same amount below the surface of the die table. Simultaneously, the
of powder. After the die bore has been filled, the lower upper punch is lowered by the lowering segment of the
punch is transferred to the weight-adjustment cam. upper cam track. The lowering of the powder column
prevents any powder from being blown out of the die as
the upper punch enters the die bore, thus preventing
Weight·Adjustment Position variations in tablet weight. When the upper punch
enters the die, precompression begins.
The weight-adjustment cam next raises the lower
punch, which pushes excess powder out of the filled
die. After the die leaves the area of the feed frame, a Precompression Position
spring-loaded, knife-edged blade scrapes the surface of
the die and removes any excess powder. During precompression, loose powder is consolidated
in the die by the removal of any air trapped in the pow-
The highest vertical position reached by the weight- der column and by the physical orientation of the pow-
adjustment cam regulates the amount of powder der particles. Typically, precompression forces tend to
expelled and the amount of powder remaining in the be less than the main compression forces. In presses

© American Pharmaceutical Association 7

Tableting
Specification
Manual
Fifth Edition

(Previously referred to as the /PT

Standard Specifications for Tableting Tools)

APhA
American Pharmaceutical Association
Washington, DC
Tableting
Specification
Manual
Fifth Edition

(Previously referred to as the /PT

Standard Specifications for Tableting Tools)

APhA
American Pharmaceutical Association
Washington, DC
00

FIGURE 3. ROTARY TABLET PRESS CYCLE

MAIN
START OF CYCLE 1-
z PRECOMPRESSION COMPRESSION
z 3:
z wz oz -- Zz
t-~O oo oo
__J (/)
_Jo
0
1- I
(.!)
_-,(I)
woo
(1)1-
::>- __J 1-
__J (/) 0 1-1-
(.)-
w(/)

~L
l.J....0... 3: 4:0...
::::) 0
a...a... Qi -,0
WO...

1-- lo- 1-- ~ ~ ...__

...__ ...__ ...__ ...__

D' t t ,.....
~
~

._.
//:/}}:j=>bytq·~R:)/:/:/:/:\\\)~SCRAPER ._.
-
I lW lMJ lMJ lMJ lftJ ITTl
"l

4=iJ LMJ
<- '- '- '- '--
- yjj
'--' '--'

r--_ g

© FILL WEIGHT EJECTION

)>
3
Cl>
CAM ADJUSTMENT
CAM
0 CAM
~·
a
:::i

~
a
3 DIRECTION OF ROTATION
0
•
@
c:
R'
Q_
I
)>

"'"'0
Q.
9. I IDWG. NO.
TSM-N3
g·

Jrin 1m 1111 1r1 &1111 &\111 11• lllft am ll1I 111 m 1111 o JW HI Jll mm n Bl D .JI . ... u _... •• •• - .m ,
@
)>
3
§· FIGURE 4. TOP VIEW OF TABLET PRESS CYCLE
:::>
~
Q
3
@ MAIN COMPRESSION - - - - -----;----.......,,.._-MAIN COMPRESSION
c: ROLLER POSITION
a_
~a· 0 0
8'
:::>

DIRECTION
0 PRE COMPRESSION
OF ROLLER
ROTATION

EJECTION PRECOMPRESSION
POSITION POSITION

TABLET TAKE-OFF
BAR
PULL DOWN
POSITION

D . ....... .
. ·o·· ·o······
. .
. . ..

FILL
START OF POSITION WEIGHT ADJUSTMENT
CYCLE POSITION
DWG. NO.
TSM-N4

"°
 where the fill cam can be automatically adjusted, the other dimensional specifications that affect the proper
precompression position can be monitored for automat- manufacturing and operation of tablet tooling.
ic control of tablet weight. The "tablet" formed at this
step is now ready for main compression.
Clearances iiill
iii!
Main Compression Position If tablet tools are to work properly, there must be
enough space between interacting parts to allow them ~

..=...
I

The main compression step gives a tablet its final char- to function without making forced contact. This work-
acteristics. The final tablet thickness is determined by ing space is called clearance. For example, punch tips
iiill
the distance between the punch rollers, which deter- must be allowed to enter and leave the die bore without
mines the distance between the punch tips. Again, in making forced contact with the die bore wall. The iiill
some presses, the main compression position ,c;.an be amount of clearance between interacting parts is affect-
...
-=
monitored for automatic weight control. ed by the tolerance range of tooling dimensions. iiiill

iiiiiiil
Tablet Ejection and Take-Off Position Tolerances

Before reaching the full ejection position, the upper

punch is lifted out of the die bore while the lower
Producing tooling that match specifications exactly
would be accomplished only at great expense to tooling --
iiiiiiil

-
punch is being pushed up by the ejection cam, thereby manufacturers and ultimately to the companies that pur- iiiiiiil
pushing the tablet out of the die. At the full ejection chase the tooling. For that reason, tolerances, or allow-
position, a tablet take-off bar located above the die able deviations, have been established for tooling speci- ....
table guides the tablet off the table. fications. These permissible deviations from specified
...
-=
iiill
dimensions, established in cooperation with leading
The successful completion of each stage of tablet pro- tooling and press manufacturers, ensure that tools can i iil
duction depends on how well the tablet tools work with be purchased at a reasonable price and that they will
each other and within the tablet press. Making sure that operate properly in the press to produce good-quality
tooling and presses conform to TSM specifications can tablets. jiiil
eliminate many production problems. Understanding iiiil

specification drawings is critical in determining if a tool Specifically, a tolerance is given as a range with an
conforms to TSM specifications. upper limit that determines how much a dimension can
=
be exceeded and a lower limit that determines how
much a dimension can be reduced. For example, a tool-
ing dimension that has the specification 1 1/32 [26.19
=
=
Tooling Specifications millimeters] inches ±1132 inch [.794 millimeter] can

A tool that conforms to specifications has been

machined to meet specific dimensions within a desig-
vary from a high value of 1 1/16 inches [26.99 millime-
ters] to a low value of 1 inch [25.40 millimeters] and
still be considered to meet specifications.
=
=
nated range called a tolerance range. Dimensions have
been specified for all components of the punches and The tolerance range for a particular specification imme- =
dies shown in Figure 1 (see page 3). The specifications
drawings for standard punches and dies (Figures 8-11
diately follows the dimensional value. The range is
given either as a number preceded by a plus and minus =
and 14-16; pages 23-26, 29-31) list these dimensions
first in inches, followed by the equivalent millimeters
placed in brackets. For specifications of radii, an R fol-
sign(±) or a set of numbers, one of which is preceded
by a plus sign, the other by a minus sign. If a tolerance
range is not listed next to the dimensional value, the
=
=
low.s the measurement. If the specification is a refer-
ence dimension, the abbreviation REF. follows the mea-
appropriate tolerances can be found in the block located
in the lower right comer of each specification drawing.
=
=:
surement. An explanation of reference dimensions fol- For dimensions given as a fraction, the appropriate tol-
lows the discussions of tolerances and clearances-two erance range is the value labeled as "fractional." The
~
10 © American Pharmaceutical Association e:
same rule applies to dimensions given as decimals and correlating differences in die specifications.
angles.
Figures 6 and 7 on pages 21 and 22 give detailed illus-
The tolerance block also lists the acceptable tolerances trations of the dimensional and configurational differ-
for concentricity of die bores, punch tips, and punch ences of angled and domed punch heads. Angled punch
heads. Concentricity refers to the placement of one heads have an outside head angle, whereas domed
tooling element in the center of another larger element heads have a radius. Domed heads, which were devel-
(i.e., the two tooling elements share the same axis). The oped by European tooling manufacturers, increase the
tolerance is given as a T.l.R., or total indicator reading. dwell time during the tablet compression stage.
Indicator readings measure the form or location of one
surface with respect to another. The surface relation-
ships of concern here are the die bore to the O.D.; the
punch head to the barrel; and the punch tip to the barrel.
The instrument used to measure concentricity, called a Standardization-Its Purpose
comparator, has a readout dial that indicates any devia- and Advantages
tions in concentricity as measured by a pointer attached
to the dial. The T.l.R. is the difference between the
highest and lowest readings recorded during one com- Since the first edition of the Tableting Specification
plete rotation of a punch or die. Manual was published almost a quarter of a century
ago, many U.S. tablet press manufacturers have volun-
tarily redesigned their presses to conform with the spec-
Reference Dimension ifications. International press manufacturers are also
realizing the economic advantages of making their
A reference dimension is derived from, or is the result presses compatible with TSM tooling. Tablet manufac-
of, other toleranced dimensions that are machined first. turers, especially those with international production
For example, the die groove diameter for a .945-inch facilities, have compelling reasons for preferring press-
[24.003 millimeters] die is given as a reference value of es that meet TSM standards.
27/32 inch [21.43 millimeters] ±.015 inch [.381 mil-
limeter] (see Figure 14, page 29). When making this
die, the die groove width (114 inch [6.35 millimeters] Advantages of Standardized Tooling
±.015 inch [.381 millimeter]) and the protection radius
(3/16 inch [4.76 millimeters] ±.015 inch [.381 millime- Standardizing tablet tooling offers the following eco-
ter]) are machined, or "worked to," first. When these nomic and procedural advantages:
dimensions have been achieved within their specified
tolerance ranges, the resultant die groove diameter • A uniform quality of tooling can be achieved.
should fall near its reference dimension. • Tooling suppliers can produce tooling more
economically by standardizing their fabrication
equipment and manufacturing procedures, and by
Comparison of U.S. and International producing batch quantities of frequently ordered
Tooling Specifications tooling.
• Tooling suppliers can fulfill orders faster by carry-
Presently, there are three major "standards" of tooling ing an inventory of standard sizes of round tooling.
on the international market: the U.S. TSM, the Euro- • Procedures for purchasing tooling can be simpli-
Standard, and the Japan Norm. As shown in Figure 21 fied.
on page 44, the most significant differences in punch • Tablet manufacturers can use tooling interchange-
specifications are those for barrel diameter, overall ably in presses purchased from different manufac-
punch length, shape of the top of the punch head turers.
(domed versus angled), and inner head angle. Also • Tablet manufacturers can reduce their tooling
shown for the three standards of B-type tools are the inventory.

©American Pharmaceutical Association 11

 • Tablet manufacturers can use standard inspection Problems of Nonconformance to
equipment and validation procedures. Specifications
• Multinational pharmaceutical companies can inter-
change tools and discuss tooling technicalities on Using tools that do not conform to dimensional specifi-
the same level. cations can affect tablet quality, press performance, and
• Press manufacturers can be sure that their machines tablet production rate. Nonconformance of tooling to
will perform well with standard TSM tooling. specifications can also (1) reduce the life of punches,
(2) impair the efficient operation of machinery, and
(3) cause severe damage to tools and presses.

The remaining sections of this manual provide the nec-

essary information to determine whether a new tool
conforms to TSM specifications. The reader will also
find detailed guidelines on tablet design, standard oper-
ating procedures for procuring and inspecting tooling,
and step-by-step instructions for maintaining tools-an
important function in protecting tooling and presses.

aiiiil

iiil
iii

iii
iii

iii
iii

iii
ii

iiiiii
iii

;;
iii

© American Pharmaceutical Association

12
 SECTION 2
TSM Tooling Specifications and
Design Options
The detailed drawings of punches and dies contained in A dimension, usually without tolerance, used for
this section represent the bulk of the TSM specifica- information purpose only. It is considered
tions. Although the nominal dimensions shown on these auxiliary information and does not govern
drawings have remained basically unchanged over the production or inspection operations. A reference
years, the tolerances for these dimensions and, surface dimension is a repeat of a dimension or is derived
finishes of the tooling have changed, to some degree, as from other values shown on the drawing or on
the equipment used to manufacture the tooling has related drawings.2
improved. In some cases, the tolerances are based strict-
ly on what is reasonably achievable using the existing The O.L. of a common punch consists of two
equipment. In most cases, however, the tolerances are toleranced dimensions (except for flat-faced tip
the result of careful consideration of what limits pro- configurations): the W.L. dimension, with a tolerance of
vide users with satisfactory tooling performance and ±.001 inch [ ±.025 millimeter] and the cup depth, with
also allow suppliers to provide tooling at a reasonable a tolerance of ±.003 inch [ ±.075 millimeter].
cost. Combining these two tolerances yields a possible
variation of ±.004 inch [ ±.10 millimeter] for the
O.L.1

Effect of Tooling Dimensions The major concern with cup depth and W.L. is to
on Tablet Manufacturing maintain consistency within a set of lower and upper
punches.' The most critical of the two dimensions is the
working length (W.L.), or the length from head flat to
The proper interaction between tools and the presses on bottom of cup (L.B.C.). Variations in the W.L. of lower
which they are installed is the crux of determining the punches translate directly into variations in tablet
appropriate dimensions and tolerances for tablet tool- weight. The effect of the tolerance range for working
ing. Understanding how individual tooling dimensions length on the tablet weight can be as little as a fraction
affect the tablet manufacturing process is essential to of a percent for large tablets and as large as 2% for very
appreciating the need for standardized dimensions and small tablets.
tolerances.
In presses that compress tablets to a constant thickness,
variations in W.L. will also cause proportionate variations
Cup Depth, Overall Length, and in tablet thickness. Electronic weight-monitoring devices
Working Length (force and thickness types) are affected by punch length;
the effect is more pronounced when the device is used to
reject individual tablets of nonuniform weight than when
used for actual weight control.
Cup depth, overall length (0.L.), and working length
(W.L.) are the most critical dimensions in any tooling The W.L. of a new punch is measured directly, using a
program (see Figure 5, page 14): They relate directly to pointed indicator tip that is positioned as closely to the
final tablet thickness, weight, and hardness. The O.L. is center of the punch cup as possible. If the variation in
a reference dimension and therefore does not have a length throughout the set is within the tolerance range,
specified tolerance.' A reference dimension is defined the W.L. need not be measured at the exact center of the
by the Machinery 's Handbook as: punch cup, as long as each punch is measured at the

©American Pharmaceutical Association 13

 FIGURE 5. OVERALL AND WORKING
LENGTHS
LAND --ll-- ~
I

CUP DEPTHT

~
'

5.250 REF.
[133.35]
± .001 [ .025]

/
I
........... '
.- I
~

OVERALL LENGTH WORKING LENGTH •

iiil

EQUALS REFERENCE LENGTH 5.250

[133.35] AFTER APPLICATION OF A LAND
ONE PUNCH IN A SET SERVES AS A DA TUM. THE
VARIATION WITHIN THE COMPLETE SET FROM THE
DATUM'S WORKING LENGTH SHOULD NOT EXCEED A
RANGE OF .002 [ .05] T.l.R. (I.E., ± .001 [ .025].
--
i ii

i ii

Ii
iii

IN CASE OF EMBOSSING, BISECTS, ETC., THE WORKING

LENGTH SHOULD BE MEASURED AS CLOSELY AS POSSIBLE
TO THE CENTER OF THE TIP FACE. -
iii

iiii
iii

DWG. NO. TSM-N5

14 @American Pharmaceutical Association

same location. If embossing or a bisect is present, the Head Flat Diameter
indicator tip is positioned between the embossing

,
characters or bedside the bisect.

The common practice of reworking head flats on

The diameter of the punch head flat and the turret speed
of the press determine the amount of time the tablet
material undergoes maximum compression. The time of
punches throughout the useful life of a set of tooling maximum compression, often referred to as
can result in working lengths that vary considerably dwell time, directly affects the tablet hardness.
from the tooling's initial values. Aside from having to
change the height of the tablet ejection cam, a decrease The TSM specifications for the head flats of B- and D-
in W.L. is of little consequence, as long as the variation type tooling are .500 inch [12.70 millimeters] and .750
in length throughout the set remains within the inch [19.05 millimeters], respectively. These dimen-
tolerance range. sions refer to the head flat diameter before the 5/16-
inch [7.94-millirneter] blend radius is added between
The W.L. needs to be inspected as a single dimension the outside head angle and the head flat. The specifica-
and preferably for consistency within the given tion is based on the "preblended" dimension, rather
tolerance-not for a number obtained by subtracting than the actual finished dimension, because of the diffi-
the cup depth from the O.L. A set of punches should be culty in measuring exactly where the blend radius ends
separated into uppers and lowers and inspected for and the head flat starts. These preblended dimensions
variances in the W.L. tolerance range. For example, all are often designated as "over sharp comers (OSC)."
upper punches are checked for consistency, followed by
a check of all lower punches. As long as both upper and For B-type punches, the head flat is approximately .367
lower punches fall within the desired tolerance range, inch [9.32 millimeters] after the blend radius is applied
tablet thickness, hardness, and weight will be (see Figure 6, page 21). Similarly, for a D-type punch,
consistent.' the head flat is approximately .611 inch [15.52 millime-
ters] after the blend radius is applied (see Figure 7,
Although the cup depth is not responsible for tablet page 22).
thickness, it should be confirmed within the given
tolerance to maintain overall tablet consistency. The
cup depth should also be inspected as a single Tip Straight
dimension.'
Tip straights, a standard feature on lower punches, can
also be applied to upper punches. This relieved area at
Head Thickness the tip of the punch guides the punch in the die, and
provides a tight fit between the punch and die to prevent
On many tablet presses, the thickness of lower punch the loss of fine granulation particles from the die bore.
heads plays an important role in maintaining consistent
tablet weight and/or limiting the upward flight of the
punches at the point of final weight adjustment and Punch Tip Undercut
tablet ejection.
The stern area of lower punches is usually undercut to
Although the tolerance on punch head thickness is allow free movement of the punch tip in the die bore;
±.010 inch [±.25 millimeter], the deviation throughout a the undercut reduces the chance of a punch tip binding
new set of tooling is usually much less than the toler- in the die bore. The undercut, or relief, forms a sharp
ance range. Punch heads, particularly the inside head comer at the back edge of the tip straight; this comer
angles, are the most commonly reworked area on tablet can scrape film off the die wall as the lower punch
tooling. When punch heads are reworked, maintaining a moves up and down in the die. An undercut can also be
uniform punch head thickness throughout the set should added to upper punches to improve retention of dust
be the primary concern. cups.

©American Pharmaceutical Association 15

 Revised Tooling Tooling Interchangeability Tables
Specifications Tablet press manufacturers were also asked to review
Tables 6 through 9 (see pages 39 through 43). Several
A few tooling specifications were revised to accommo- new press models were added to these tables; a few dis-
date variability in tooling dimensions among tablet continued models were deleted. Some corrections to
presses. Further, new press models and their tooling tooling dimensions for existing presses were also made.
requirements were added. Finally, a method for calcu-
lating shape factors and maximum compression forces
for 30° F.F.B.E. tooling has been added. Punch Tip Compression Forces

Even tooling manufactured according to TSM standards

Barrel Diameter of 82· Type Lower can be damaged if the maximum compression force is
Punches not set and maintained during a press run. The fourth
edition provided methods for determining the punch tip
Among presses currently available, the barrel diameter force ratings for concave tooling. This new edition pro-
of B2-type lower punches can range from .745 [18.92] vides a method for calculating these ratings for 30°
to .748 [19.00]. Rather than give a range for the specifi- F.F.B.E. tooling. (See pages 80-81 in section 4.) Read-
cation,. the steering committee decided to refer readers ers should also note that one shape factor for concave
to their press manufacturer for the appropriate barrel tooling was revised (see Table 16, page 78): the new
diameter of this type of punch. This change is noted on value of .205 replaces the shape factor .209.
Figures 2 (see page 6) and 21 (see page 44). Readers
can also check Table 9 on page 42 to see whether their
press model is listed. This table lists tooling specifica-
tions for special rotary presses. Tooling Design Options
Tablet presses introduced during the 1980s run at high-
Maximum Tablet Size for Round Tablets er speeds, are more automated, and are more precise. Ii
iiil
Most press manufacturers ensured these presses were
iii
In the fourth edition, the maximum tablet size for round compatible with standard tooling. For certain tableted iii

tablets was given as 1 [25]. European tooling manufac- products, though, the use of standard tooling on some iii
iii
turers still consider this specification correct for Euro- presses makes it difficult to maintain the speeds and
pean tablet presses. However, some members of the accuracy the presses were engineered to achieve. At
steering committee thought 7/8 [22] was the most that point, tooling options should be considered; how-
appropriate dimension for American presses. Table 2 ever, tooling options must be distinguished from tooling
(page 34) lists both values but notes that, when 1 [25] requirements. Some tooling features might be consid-
tablets are manufactured, a special tool may be required ered optional for certain presses but required for others. •
iii

to extract the dies from some presses. The press manufacturer must supply specifications for Iii
iii
tooling options needed to obtain peak performance
from a press. The following tooling options can benefit Ii
ii

Available Key Space both high-speed and standard presses.I

Tablet press manufacturers were asked to review Tables I

ii
4 and 5 (page 38) as part of the updating of the manual. Punch-Barrel Chamfers
As a result, Kilian changed the minimum key extension
dimension (X min) from 1.024 [26.009] to 1.417 Punch-barrel chamfers are required on punches used
[35.992]. This change reduced the available key space with presses fitted with rubber or plastic guide seals.
on Kilian presses with upper punch seals to 0.985 The barrel charnfer has an advantage over the common
[25.019]. break edge for these press models. A barrel chamfer on
the head end of the punch (barrel-to-neck chamfer) can
i
16 © American Pharmaceutical Association
reduce wear of the punch guides caused from the Mirror-Finished Heads
punches being cocked from the torque of rotation as the
punch travels vertically in the guides.I (See Figure 1, Punches with optional mirror-finished heads are espe-
page 3.) cially beneficial for high-speed tablet presses that use
heavy metal cams composed of bronze or bronze alloys.
The absence of a chamfer on the tip end of the punch These metals eliminate premature head wear and pro-
(barrel-to-stem chamfer) can make installing punches long tool life, but they can also contaminate lubrication,
difficult. If a punch is forced past the seal, the seal can turning it to a black, dark green color. The contamina-
be damaged, resulting in seepage of lubrication from tion occurs when punch heads wear_ away the cam
the upper-punch guides and subsequent contamination metal. The typical finish of a punch head is done with
of the granulation. Damaged lower guide seals can fine emery or fine abrasive pads. This finish leaves fine
allow granulation to seep into the lower-punch guides radial lines on the contact surfaces of the heads, which
and mix with the lubrication, causing tight punches and have a filing effect on the softer cams, causing discol-
possibly press seizure.' oration of the lubrication and premature cam wear.
Using a soft cotton wheel and fine polishing compound
to polish the punch heads to a mirror finish helps to
Domed Punch Heads keep the lubrication cleaner and prolongs cam life.'

A domed punch head is an option for the TSM and

Japan Norm punch head configurations. This configura- Short Upper-Punch Tip Straights
tion is compatible with American TSM cams and is
acceptable for both the upper and lower punch. Domed A short upper-punch tip straight is a tooling option pri-
punch heads have the same top head radius and head marily for tablet presses with lubrication seals. In some
flat as that of the Eurostandard head. Figures 6 and 7 presses, the lower section of the upper-punch guides
(see pages 21 and 22) show the differences between the and the upper section of the lower-punch guides are fit-
TSM, TSM and Japan Norm domed, and the European ted with these seals. The seals serve to keep the lubrica-
head configurations.'[Note: Dimensions for the Japan tion and product granulation separated. However, the
Norm domed head are the same as those for the TSM punch seals are effective only if they maintain a seal
domed head.] around the upper- and lower-punch barrels. If the
upper-punch tip is too long, it can be pulled up past the
Pitting of the head (referred to technically as "surface- seal, allowing seepage of lubrication. This seepage can
origin fatigue" ) is identified by voids in the head flat. cause product contamination and usually shows up on
This type of premature failure is more common with the the tablet as black specks.I Table 4 (see page 38) shows
TSM standard head style. The failure is caused primari- the most common presses fitted with upper-guide seals
ly by the application of extreme compression forces, and their punch tip length requirements.
creating enormous stress at the 5/16-inch [7 .94- mil-
limeter] top head radius. The impact of heavy forces at
high speeds has a work-hardening effect, contributing Key Types and Positions
to the pitting of the head flat. This form of pitting is
detrimental to the life of the punches and pressure Fitting optional keys to shaped punches, and in some
rollers.' cases to round punches, can prevent punch rotation.
Rotation of shaped punches can result in misalignment
The area of concern is the 5116-inch [7.94-millimeter] of the punch tip and die bore, damaging both the tool-
radius between the head flat and the outside head angle. ing and the press. Such rotation on a round punch can
This radius is required for the standard American punch cause double debossed images and misplacement of
head. The domed head reduces the stress placed on bisects or debossing. Lower guide key slots are an
punches with the smaller 5/16-inch radius upon initial option for most presses and must be specified when a
contact with the pressure roller.I press is ordered. Existing presses would require modifi-
cation to accept keyed lower punches.

©American Pharmaceutical Association 17

Linda L. Young
Managing Editor
Mary Jane Hickey
Interior Design
Mary Burns
Cover Design
Glen Ebey, Trevor Higgins, Bill Hnatuk,
Richard Kirk, Dale Natoli, Paul Schaa
C.A.D. Illustrations and Tables

© 200 I by the American Pharmaceutical Association

© 1995, 1990, 1981, 1971
Published by the American Pharmaceutical Association
2215 Constitution Avenue, NW
Washington, DC 20037-2985
www.aphanet.org
To comment on this book by e-mail, send your message to the publisher at [email protected].
All rights reserved
Printed in the United States of America
Notice of Copyright: No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or
by any mean-electronic, mechanical, photocopying, recording, or otherwise- without written permission from the publisher
(with the exception of certain forms on which permission to copy is stated thereon).

Notice of Liability: The publisher and the Tableting Specification Steering Committee have made every effort to ensure the
accuracy and completeness of the information in this publication. However, the publisher, steering committee members, edi-
tors, contributors, and reviewers cannot be held responsible for the continued currency of the information, any inadvertent
errors or omissions, or the application of this information. Therefore, the named parties shall have no liability to any person or
entity with regard to claims, loss, or damage caused or alleged to be caused, directly or indirectly, by the use of information
contained herein.

Library of Congress Cataloging-in-Publication Data

Tableting specification manual : previously referred to as the IPT standard specifications for tableting tools.-5th ed.
p. ;cm.
ISBN 1-58212-005-6 (paperbound : spiral)
1. Tablets (Medicine)-Standards-United States. 2. Tableting-Standards-United States.
I. American Pharmaceutical Association. Tableting Specification Steering Committee.
[DNLM: 1. Equipment and Supplies-standards. 2. Tablets. 3. Technology,
Pharmaceutical-instrumentation. QV 26Tl13 2000]
RS201.T2 A46 2000
615'.43-dc21
99-052558

How to Order This Book

By phone: 800-878-0729 (802-862-0095 from outside the United States)
VISA®, MasterCard®, and American Express® cards accepted.
Linda L. Young
Managing Editor
Mary Jane Hickey
Interior Design
Mary Burns
Cover Design
Glen Ebey, Trevor Higgins, Bill Hnatuk,
Richard Kirk, Dale Natoli, Paul Schaa
C.A.D. Illustrations and Tables

© 200 I by the American Pharmaceutical Association

© 1995, 1990, 1981, 1971
Published by the American Pharmaceutical Association
2215 Constitution Avenue, NW
Washington, DC 20037-2985
www.aphanet.org
To comment on this book by e-mail, send your message to the publisher at [email protected].
All rights reserved
Printed in the United States of America
Notice of Copyright: No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or
by any mean-electronic, mechanical, photocopying, recording, or otherwise- without written permission from the publisher
(with the exception of certain forms on which permission to copy is stated thereon).

Notice of Liability: The publisher and the Tableting Specification Steering Committee have made every effort to ensure the
accuracy and completeness of the information in this publication. However, the publisher, steering committee members, edi-
tors, contributors, and reviewers cannot be held responsible for the continued currency of the information, any inadvertent
errors or omissions, or the application of this information. Therefore, the named parties shall have no liability to any person or
entity with regard to claims, loss, or damage caused or alleged to be caused, directly or indirectly, by the use of information
contained herein.

Library of Congress Cataloging-in-Publication Data

Tableting specification manual : previously referred to as the IPT standard specifications for tableting tools.-5th ed.
p. ;cm.
ISBN 1-58212-005-6 (paperbound : spiral)
1. Tablets (Medicine)-Standards-United States. 2. Tableting-Standards-United States.
I. American Pharmaceutical Association. Tableting Specification Steering Committee.
[DNLM: 1. Equipment and Supplies-standards. 2. Tablets. 3. Technology,
Pharmaceutical-instrumentation. QV 26Tl13 2000]
RS201.T2 A46 2000
615'.43-dc21
99-052558

How to Order This Book

By phone: 800-878-0729 (802-862-0095 from outside the United States)
VISA®, MasterCard®, and American Express® cards accepted.
 Two key configurations are available: the standard punch rotates. Flutes are recommended for extreme
Woodruff key, sometimes referred to as the pressed-in cases such as punches that hang up or stick in the guide-
key, and the fixed parallel or flat key, often referred to ways. Punches that show extreme premature wear or
as the European key (see Figure 20, page 37). 1 The gauging on the back angles ·of the heads can be good
Woodruff key is available in two styles, standard and candidates for fluting. In these instances, effectiveness
Hi-Pro. The latter has a tab on each side of the exposed of the guide seals is lost, causing shifting of granulation
top section and rests on the barrel to keep it secure by and seepage of lubrication. When barrel flutes are used
eliminating the rocking action common to the standard on presses with punch retainers, the lower punch retain-
Woodruff key. To obtain maximum security for high- ers should be removed for tound tooling because of the
speed presses, the Woodruff key should be fastened into punch rotation. For shaped tooling, the radial location
the barrel using screws.I of the flutes is critical; the flutes should be positioned
so as not to interfere with the retainers.
The fixed parallel key is a longer flat key, either 1
[25.40 millimeters] or 1 114 inches [31.75 millilfl.eters]
in length. It is not pressed into position but rests in a Lined (Insert} Dies
milled slot and is screwed into position.I
Dies are usually manufactured from D-3 steel. Although
The axial and radial position of a key is critical to this steel grade does not provide toughness, it is superi-
obtain maximum press performance. Unfortunately no or for wear. Dies are not subjected to the same pressures
standard has been established for upper guide key slots or shock as the punches, and therefore can be manufac-
due to the particular requirements of the many styles of tured from a larger selection of materials. 1
tablet presses. Table 4 also shows the most common
presses with upper punch seals and their key axial posi- The most common die used in compression of abrasive
tion. If a key is placed too low or extends too long on or corrosive formulations is the carbide-lined die. A
the barrel, it can interfere with the upper punch guide steel sleeve, which provides a cushion for the brittle
seal and cause damage and/or seepage of lubrication, carbide, is heat shrunk onto the insert die. Although car-
resulting in product contamination. If the key is placed bide dies cost more, they offer the advantages of superi-
too high on the barrel, it can travel out of the key slot at or die wear and tablet quality; die life is also easily
the top of the punch guide, possibly causing severe increased by 10 times in most cases. 1
damage to the punches and press.1
Because the carbide die is much harder, it is more brit-
The radial location is important to the take-off position tle and subject to fracturing under excessively heavy
of the tablet at the ejection cycle. If the radial position loading. If the carbide liner is too thin at its narrowest
is incorrect, it can cause the tablets to chip and/or pile point, it can fracture due to die lock pressure and stress-
up at the tablet take-off bar, requiring slower press es of compression. This is also true for the steel sleeve.
speeds.1 The tooling manufacturer should be consulted to deter-
mine whether a tablet size is acceptable for a carbide
liner. 1
Punch Barrel Flutes
When inserting carbide dies into the die pocket, a die-
Barrel flutes are an option for upper and lower punches; driving rod fitted with a nylon tip should be used to pre-
however, they are used most often on lower punches. vent carbide fracturing. Die lock pressure should also
As shown on Figure 13 (see page 28), the vertical be reduced by 10%.1
grooves are machined in to the length of the punch bar-
rels. The grooves serve to reduce the amount of bearing Ceramic-lined dies are becoming more widely used as
surface to help eliminate friction, thereby allowing the tougher grades become available. The most common
punch to move easier in the guideway. On a punch with ceramic grade used in compression dies is currently
a round tip configuration, the grooves can also help PSZ (partially stabilized zirconia). Dies lined with PSZ
scrape granulation form the punch guide as the lower have the same general wear characteristics and require

18 ©American Pharmaceutical Association

the same precautions as carbide-lined dies, but PSZ- If international press manufacturers incorporate stan-
lined dies have an advantage in reducing the friction dard TSM configurations (with some options) in their
coefficient during the fill and ejection cycles. The press designs, these presses will provide maximum
ceramic liner, which is commonly a light cream or tablet output and trouble-free operation while using
white color, is quickly gaining popularity over carbide.' TSM tooling.

TSM Compatibility of References

International Presses
1. Swarbrick J, Boylan JC, eds. Thermal Analysis of
Drugs and Drug Products to Unit Processes in
The attempts of press manufacturers in Japan, European Pharmacy: Fundamentals. Volume 15 of
countries, and other countries to make their newer press Encyclopedia of Pharmaceutical Technology. New
models compatible with TSM tooling have not always York: Marcel Dekker: 1997; 168-175, 183, 184,
been successful. Some of the newer international press- 186-188.
es advertised as being compatible with TSM tooling
can operate with this tooling in place, but not at the 2. Amiss J, ed. Machinery's Handbook New York:
maximum efficiency rate achieved in U.S. presses. Fig- Industrial Press; 1992.
ure 21 on page 44 shows the differences in specifica-
tions for TSM, European, and Japanese tooling.

© American Pharmaceutical Association 19

 Section 2: Tooling Specification Figures and Tables

Punch Figures
Figure 6 Common Head Configurations of B-Type Punches 21
Figure 7 Common Head Configurations of D-Type Punches ..................................................... ~ 22
Figure 8 Standard B-Type Upper Punch ............................................................................. . 23
Figure 9 Standard B-Type Lower Punch 24
Figure 10 Standard D-Type Upper Punch 25
Figure 11 Standard D-Type Lower Punch
., 26
Figure 12 Special Punch Tip Options ................................................................................... . 27
Figure 13 Special Punch Barrel Options 28

Die Figures
Figure 14 Standard .945 Die ............................................................................................... . 29
Figure 15 Standard 1 3/16 Die ............................................................................................ . 30
Figure 16 Standard "D" Die 31
Figure 17 Tapered Dies and Die Groove Reliefs .................................................................... . 32
Figure 18 Lined Dies ........................................................................................................ . 33

Clearances and Maximum Tablet Sizes

Figure 19 Punch and Die Clearances . . . .. .. . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . .. . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Shaped Punch Tip Clearances . .. . . . . .. . .. . .. . .. . .. . .. . .. . . . . . . . . .. . . . .. . .. . . .. . . . .. . . . . .. .. . . . .. .. . . . .. .. . . 34
Table 2 Maximum Tablet Sizes for Standard Dies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Table 3 Standard Clearances for Normal Application of Round Tooling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Punch Keys
Figure 20 Common Configurations and Dimensions for Punch Keys . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Table4 Available Key Space and Maximum Stem Lengths . .. . . . . . . . . . .. .. . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Table 5 Punch Key Lengths and Available Key Space . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 iii
iii

i
ii!
Tooling Interchangeability
i
Table 6 Interchangeable Tooling for Rotary Tablet Presses: i
3/4" Punch Barrel and .945" Die . .. . . . . . . . .. . . . . . . . . . . .. . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . 39
Table 7 Interchangeable Tooling for Rotary Tablet Presses:
3/4" Punch Barrel and 1.1875" Die ........................................................................... 40
Table 8 Interchangeable Tooling for Rotary Tablet Presses:
1" Punch Barrel and 1.500" Die . . .. . . . . . . . . . . . . . . . .. . .. . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . 41
Table 9 Interchangeable Tooling for Special Rotary Tablet Presses 42

Comparison of International Tooling

Figure 21 Comparison of TSM and International B-Type Tooling . . . . . . . . . . . . . . . . . . . . . . .. . .. . . . . . . . . . . . . . . . . . . . . . . . . 44

20 © American Pharmaceutical Association

 FIGURE 6. COMMON HEAD CONFIGURATIONS
OF B-TYPE PUNCHES
11
(3/4 [19 mm] DIAMETER BARREL)

.406

(10.31)
-1i--·-F------
~T
c~3~~~]----~---i
------

·rfL ~--, -- ~-----i-3--

•NOTE: THE .367-INCH HEAD FLAT RESULTS FROM BLENDING
5/1 6 R ';( A 1/2-INCH HEAD FLAT WITH THE 5/16-INCH RADIUS.
7 94 4
C· l STANDARD TSM HEAD P-ROFILE

5.250
.400 [133.35]
L [10.16]
.125 i-
[3.18] '!\'
l_
.375
[9.53]
t
5
(,~.8:J TSM AND JAPAN NORM DOMED HEAD PROFILE

i - - - - - - - - - 5.260
.125 [133.60]
[3.178]

c0:¥1- ---- ~-----t:3--

sr,~.a:1 x) EUROPEAN HEAD PROFILE
-l i==.358
[9.09]

DWG. NO. TSM-N6

©American Pharmaceutical Association 21

 FIGURE 7. COMMON HEAD CONFIGURATIONS
OF D-TYPE PUNCHES
(1'' [25.4 mm] DIAMETER BARREL)
5.250 - - - - - - - - i
[133.35]

.611 * ''
[15.52]

5/ 1 6 R
[7.94]
t
J\:N01£:

25
THE .611-INCH HEAD FLAT RESULTS FROM BLENDING A
3/4-INCH HEAD FLAT WITH THE 5/16-INCH RADIUS.

• STANDARD TSM HEAD PROFILE

- - - - - - - - 5.250 - - - - - - -
[133.35]

.625
[15.88]

I
5/8 R
[15.88] V30·1-
1TSM AND JAPAN NORM DOMED HEAD PROFILE

- - - - - - - 5.260 - - - - - - -
.358 [133.60]
. 1 25 i- [9.09]
[3.18]

J_
.625
[15.88]

t
5/8 R y30 _1 EUROPEAN HEAD PROFILE
[15.88] ~ ...----------·
DWG. NO. TSM-N7

22 @American Pharmaceutical Association

@
)>.
3

!· FIGURE 8. STANDARD B-TYPE UPPER PUNCH 11

~
a
(3/4 [19 mm] DIAMETER BARREL)
3
a
@
c:
[ 1 - - - - - - - 5.250 REf. ~ 33.3!5) SEE NOTE 7 - - - - - - - .

~cs- 15 1 -- .:t..001 [ _ _ .:t.o.02s] • 11--- ± .003 [ _ ± 0.076]

6'
::i

•
f.
500 +.000
-.0.301
+o ool
-1 6 ± .32
- [23.81 .:t.O. 79]

24·
• 7 480 + · 0000

[ 19 . 00
-.00051
+o.oool
- 0 · 013J
~ rm- \
I
11

I
UNDERCUT DIAMETER
(OPTIONAL)
SEE DRAWING TSM-N12
.30° OPTIONAL
C 2 70
•
SEE NOTE 5
-o:78J
1
.32 [o. 79]

~ E~GE
BREAK SHARP

-
64
[1.19] R
15
\I I
~ 1~ -~~ 4.76 ~~. ;:JR
I I I.;
+l [

+
+.000
1.000_.
015
/i __....--5MIRROR
MICROINCH OR
FINISH
r . +o.ool - -- -- _ +.0000 [+o.oool ROUND
L25t40 -0.38J t -.0005 -0.013j TIPS
f +. 0000 [ +o.oool SHAPED
+. 000 - •0008 -o.02oj TIPS
5 3 - .625 3
1S [7.94] R [2.38] R -.010 [4.76] (OPTIONAL)
32 16
.406 .:t..01 O [1!5.88 ~~:~~] VARIABLE (OPTIONAL) SEE NOTE 4
[10.31 .:l:0.25] I
~ L7.94J
16 r. 1 MIN •
NOTES:

1. WITH THE EXCEPTION OF SURFACE FINISHES, DIMENSIONS ARE GIVEN FIRST IN INCHES, .TJO MAX.f-- SEE NOTE 6
FOLLOWED BY THE EQUIVALENT MILLIMETERS IN BRACKETS.
[18.54.J
2. UNLESS OTHERWISE INDICATED, SURFACE FINISHES ARE 20 MICROINCH [ .508 MICRON] ALL
OVER. THE TOLERANCE ON ALL FINISHES IS ± 5 MICROINCH [±.127 MICRON]. TOLERANCES
3. TIP FACE SHOULD BE SQUARE WITH BARREL WITHIN ± .003 [±.08] PER INCH OF TIP UNLESS OTHERWISE INDICATED
DIAMETER.
4. THE 20· BARREL CHAMFER, WHICH IS OPTIONAL AND OF VARIABLE SIZE, IS DESIGNED FOR FRACTIONAL +.015 [ .381]
PRESSES EQUIPPED WITH PUNCH SEALS. CONSULT YOUR PRESS SUPPLIER. DECIMAL ±.003 [ .076]
5. THE HEAD FLAT IS DIMENSIONED TO A SHARP CORNER BEFORE ITS JUNCTION WITH THE ANGULAR + C1-:-30'
OUTSIDE HEAD ANGLE IS BLENDED.
6. SOME PRESSES EQUIPPED WITH UPPER PUNCH SEALS MAY REQUIRE A STEM LENGTH THAT IS CONCENTRICITY T.l.R.=
LESS THAN THE .730 [18.54] MAXIMUM. IN SUCH CASES, CONSULT YOUR PRESS OR TIP TO BARREL .001 [ .025]
TOOLING SUPPLIER. BARREL TO HEAD .003 [ .076]
A REFERENCE DIMENSION IS USUALLY UNTOLERANCED. IT IS CONSIDERED AUXILIARY

.,.,,
w
L INFORMATION AND DOES NOT GOVERN PRODUCTION OR INSPECTION OPERATIONS. DWG. NO.
TSM-N8
~

FIGURE 9. STANDARD B-TYPE LOWER PUNCH 11

(3/4 [19 mm] DIAMETER BARREL)
i - - - - - - - 5.250 REF. ~ 33.35] SEE NOTE 7 - - - - - - '

±.001 [ _ _ ±0.0211] -----~ - .± .003 [__ .± 0.076]

15 1
1 6 .± 32 [23.81 ± 0.79]-1------1 +.0000
.7450 -.00051
.500 +.OOQ

~···· -O:o.~ ~
-.030 +oooo ~30° OPTIONAL
[12. 70 ~~:~~] 1
32 [o.79] ,\ I
\/Al 11 +ij [4. 76 + 3 ' 18 ] R

~ ~.10]
SEE NOTE 6 BREAK SHARP
EDGE 16 _ _!_
16 - 1 · 59

[;; R 15/ . MAX

•••. 5 MICROINCH
/),,--MIRROR OR
FINISH
t+.000
1.000 _.015
+ · 0000 [ +o.oool ROUND
r. +o.ool -.0005 -0.013j TIPS
L25.4o -o.3eJ - - -+.0000
~ t- . 0008 [+o.oool SHAPED

y,7. ~~g~g~
-0.020j TIPS
5
16 [7.94] R
3
[2.3sJ ; .s25 , 1 I
- -__;_
KEEP EDGE SHARP
(OPTIONAL) SEE NOTE 5

~
32
15.ss +o.ool 1
[ -0.25J '-----+--UNDERCUT DIAMETER
.406 ±.010
[10.31 ±0.25] VARIABLE ~Ii I (SEE NOTE 4)
3
1.000 +.oso
-.031
[25.40 +1.521
-0.79J
-1 1 6 [4.76]

@ NOTES:
)>
3
§·
1. WITH THE EXCEPTION OF SURFACE FINISHES, DIMENSIONS ARE GIVEN FIRST IN INCHES, FOLLOWED
BY THE EQUIVALENT MILLIMETERS IN BRACKETS.
TOLERANCES
UNLESS OTHERWISE INDICATED)
::i 2. UNLESS OTHERWISE INDICATED, SURFACE FINISHES ARE 20 MICROINCH [ .508 MICRON] ALL OVER.
~ THE TOLERANCE ON ALL FINISHES IS ± 5 MICRO INCH [ ± .127 MICRON]. FRACTIONAL ±.015 [ .381]
a
3 3. TIP FACE SHOULD BE SQUARE WITH BARREL WITHIN .:1:. .003 [ .:t. .081 PER INCH OF TIP DIAMETER. DECIMAL .003 [ .076] +
a 4. THE UNDERCUT DIAMETER FOR PUNCH TIP DIAMETERS OF 1/4 [6.35] OR GREATER IS -.020 ±.005 ANGULAR ±0'-30'

l
[-.51 ±.13]. FOR TIP DIAMETERS LESS THAN 1/~ [6.35],THE UNDERCUT DIAMETER IS DISCRETIONARY.
5. THE 20' BARREL CHAMFER, WHICH IS OPTIONAL AND OF VARIABLE SIZE, IS DESIGNED FOR CONCENTRICITY T.l.R.=
PRESSES EQUIPPED WITH PUNCH SEALS. CONSULT YOUR PRESS SUPPLIER. TIP TO BARREL .001 [ .025]
~ 6. THE HEAD FLAT IS DIMENSIONED TO A SHARP CORNER BEFORE ITS JUNCTION WITH THE BARREL TO HEAD .003 [ .076]
OUTSIDE HEAD ANGLE IS BLENDED.
§. 7. A REFERENCE DIMENSION IS USUALLY UNTOLERANCED. IT IS CONSIDERED AUXILIARY INFORMATION DWG. NO.
g" AND DOES NOT GOVERN PRODUCTION OR INSPECTION OPERATIONS. TSM-N9
@
)>
3
§·=> FIGURE 10. STANDARD D-TYPE UPPER PUNCH11

~
Q
(1 [25.4 mm] DIAMETER BARREL)
3
~ i - - - - - - - 5.250 REF. (133.315] SEE NOTE 7 ----__,~
~
[. 1 1 1
--
.9980 ~-~000
±.oo 1 C--±0.025] Ir - ± .oo3 [ _ ±
•· 0.076]
g: 32 ± 32 [26.19 .±0.79}-·
rt••.
. 0051 ~I I (OPTIONAL) UNDERCUT DIAMETER

~
.750 +.OOQ +o.oool - 12
-.030 25·~ 30
-o.013j SEE DRAWING TSM-N

[ 19.05 -0.76J
+o.ool
1 rrl aREAK SHARP II 30° 0PT10NAL
SEE NOTE 5 32 II . / " T
\ I 6ED3GE
' 4 B-i•] R j ,z: 1 \~ 3 +l
/lT 16 ~ [4.76 ~3.18]
;
- 18 1.09
R

+.000 _
J ~
_l,.........--5 MICROINCH OR
MIRROR FINISH
1.250-.015
- - - - ___. - ___...... .. - +. 0000 [ +o.oool ROUND
+o.ool -.0005 -0.013j TIPS
[ 31.75 -0.36J

.875 +.000
~2~ ~11
+l ~ f ~.OOOO [+o.oool

l~
SHAPED
-o.020J 1l'S
' 5 t
16 (7.94] R [2.36]
R -.010 \ 3
4 79
.0008

32 r22.22 +o.ool I 16 [ · ] (OPTIONAL)

t .
-0 215J ~ I (0
. P~ONAL) SEE NOTE 4

.406 ±.010
II I 16 MIN. [7.94 MINJ

[ 10.31 .±0.215] VARIABLE--l I

.730 MAX. SEE NOTE 6
NOTES:
[18.54]
,....-
1. WITH THE EXCEPTION OF SURFACE FINISHES, DIMENSIONS ARE GIVEN FIRST IN INCHES, FOLLOWED
BY THE EQUIVALENT MILLIMETERS IN BRACKETS.
TOLERANCES
UNLESS OTHERWISE INDICATED
2. UNLESS OTHERWISE INDICATED, SURFACE FINISHES ARE 20 MICROINCH [ .508 MICRON] ALL OVER.
THE TOLERANCE ON ALL FINISHES IS .± 5 MICRO INCH [ .± .127 MICRON]. FRACTIONAL ±.015 [ .381]
3. TIP FACE SHOULD BE SQUARE WITH BARREL WITHIN .± .003 [ .± .08] PER INCH OF TIP DIAMETER. DECIMAL + .003 [ .076]
4. THE 20· BARREL CHAMFER, WHICH IS OPTIONAL AND OF VARIABLE SIZE, IS DESIGNED FOR
PRESSES EQUIPPED WITH PUNCH SEALS. CONSULT YOUR PRESS SUPPLIER.
ANGULAR + 0'~30'
5. THE HEAD FLAT IS DIMENSIONED TO A SHARP CORNER BEFORE ITS JUNCTION WITH THE OUTSIDE CONCENTRICITY T.l.R.=
HEAD ANGLE IS BLENDED. TIP TO BARREL ;001 [ .025]
6. SOME PRESSES EQUIPPED WITH UPPER PUNCH SEALS MAY REQUIRE A LENGTH THAT IS LESS THAN BARREL TO HEAD .003 [ .076]
THE .730 [18.54] MAXIMUM. IN SUCH CASES, CONSULT YOUR PRESS OR TOOLING SUPPLIER.
7. A REFERENCE DIMENSION IS USUALLY UNTOLERANCED. IT IS CONSIDERED AUXILIARY INFORMATION DWG. NO.
AND DOES NOT GOVERN PRODUCTION OR INSPECTION OPERATIONS. TSM-N10
..,
"'
 <--""11

FIGURE 11. STANDARD D-TYPE LOWER PUNCH 11

(1 [25.4 mm] DIAMETER BARREL)

5.250REF. ~33.35] SEE NOTE 7~
.:1:..001 [ _ _ .:l:.0.025] - .± .003 [__ .± 0.076]
1 32
1 ±321 [26.19 .:1:.0.79] --+.0000 ~

-0.01~] l A\I /;J ~

.9950 -.0005 OPTIONAL
.750 +.OOQ_
-.030 3~
f1 9.05 +o.ool
L -o.1eJ 1
25·
[ ....,
+o.ooo 11 136 -
1
+- [ 4.76 +3.18
-1.59 l R

27' / 1,..,,---~IRROR
32
SEE NOTE 6

~ ~
BREAK SHARP 16 MICROINCH OR
/ 15

~ '~~
I
\\ II EDGE [1.19] R
MAX.
1
FINISH
ROUND
t +.000 I 64 . +.0000 [+0.000 TIPS
1.250-.015 / 'll- 5 -0,013
+o.ool -.000
[ 31.75 -0.38J +.0000 [+o.oool SHAPED
-.0008 -0.020j TIPS

-J/i L~
2~
5
16 (7. 9 4] R [2.311] R -----, \ LJr' II KEEP EDGE SHARP

J3o·r 32 .875 +.000

-.010 UNDERCUT
f . +o.ool DIAMETER
'\ f---;406 .:1:..010 l'.22 22 -o.25J (SEE NOTE 4)

--j I [ 10.31 .:1:.0.25]

1.000 +.060
-.015
rt••.40 .....
+0.79
J I• ..
16 [4.76]

@ NOTES:
§- 1. WITH THE EXCEPTION OF SURFACE FINISHES, DIMENSIONS ARE GIVEN FIRST IN INCHES, FOLLOWED TOLERANCES
UNLESS OTHERWISE INDICATED)
§· 2.
BY THE EQUIVALENT MILLIMETERS IN BRACKETS.
UNLESS OTHERWISE INDICATED, SURFACE FINISHES ARE 20 MICROINCH [ .508 MICRON] ALL OVER.
:::> FRACTIONAL ±.015 ( .381]
~ THE TOLERANCE ON ALL FINISHES IS .:1:. 5 MICRO INCH [ .:1:. .127 MICRON].
Q 3. TIP FACE SHOULD BE SQUARE WITH BARREL WITHIN .:1:. .003 [ .:1:. .08} PER INCH OF TIP DIAMETER. DECIMAL ±.003 1
( .076]
3Q 4. THE UNDERCUT DIAMETER FOR PUNCH TIP DIAMETERS OF 1/4 [6.35] OR GREATER IS -.020 ±.005 ANGULAR Q"-30 +
(-.51 ±.13l FOR TIP DIAMETERS LESS THAN 1/4 [6.35],THE UNDERCUT DIAMETER IS DISCRETIONARY.

lf 5.

6.
THE 20· BARREL CHAMFER, WHICH IS OPTIONAL AND OF VARIABLE SIZE, IS DESIGNED FOR
PRESSES EQUIPPED WITH PUNCH SEALS. CONSULT YOUR PRESS SUPPLIER.
THE HEAD FLAT IS DIMENSIONED TO A SHARP CORNER BEFORE ITS JUNCTION WITH THE
OUTSIDE HEAD ANGLE IS BLENDED.
CONCENTRICITY T.1.R.=
TIP TO BARREL
BARREL TO HEAD
:001
.003
[ .025]
[ .076]

§. 7. A REFERENCE DIMENSION IS USUALLY UNTOLERANCED. IT IS CONSIDERED AUXILIARY INFORMATION DWG. NO.

TSM-N11
g· AND DOES NOT GOVERN PRODUCTION OR INSPECTION OPERATIONS.
 FIGURE 12. SPECIAL PUNCH TIP OPTIONS

3/16 [4.76]

1- - - -.-~ UNDERCUT DIAMETER

BY .020 [.51] .± .005

UNDERCUT UPPER PUNCH TIP

UPPER PUNCH TIPS CAN BE MANUFACTURED TO INCLUDE THE SAME TYPE OF

UNDERCUT FOUND ON LOWER PUNCHES. UPPER PUNCH UNDERCUTS PROVIDE A
LIP FOR BETTER RETENTION OF DUST CUPS.

.015 R
[.38] .030

---- _ [ [.76]

BAKELITE RELIEF

SOME MATERIALS TEND TO LEAVE A THIN FILM ON DIE BORE SURF ACES. THIS
FILM CAN BUILD UP TO A POINT WHERE BINDING OCCURS BETWEEN THE LOWER
PUNCH TIPS AND DIE WALLS. BAKELITE RELIEFS PROVIDE A DEEPER,
SHARPER RELIEF THAN A STANDARD UNDERCUT, AS WELL AS AN ANGULAR
BACKDRAFT THAT HELPS KEEP DIE WALLS CLEAN.

DWG. NO. TS M - N 1 2

©American Pharmaceutical Association 27

Contents
List of Figures v

List of Tables vi
Acknowledgments ................................................................................... : . . . . . . . . . . . . . . . . . . . . . . . . vii
Preface .................................................................... ....................................................... ix
Introduction xi

SECTION 1: Guidelines for Using This Manual

Tooling Terminology 1
Tablet Manufacturing 4
Tooling Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Standardization: Its Purpose and Advantages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

SECTION 2: TSM Tooling Specifications and Design Options

Effect of Tooling Dimensions on Tablet Manufacturing . .............. .. . .. . . .. ... . . . . .. ... . ...... ...... ........... ... 13
Revised Tooling Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Tooling Design Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
TSM Compatibility of International Presses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Tooling Specification Figures and Tables (Index) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

SECTION 3: Tablet Design

Tablet Terminology ........................................................................................................ . 45

Tablet Identification 50
Tablet Printing .............................................................................................................. . 62
Tablet Detail Drawings .................................................................................................. . 65
Tablet Land ................................................................................................................. . 66

SECTION 4: Tool Steels, Compression Forces, and Fatigue Failure

Tool Steels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Chemical Composition of Steels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

©American Pharmaceutical Association iii

Contents
List of Figures v

List of Tables vi
Acknowledgments ................................................................................... : . . . . . . . . . . . . . . . . . . . . . . . . vii
Preface .................................................................... ....................................................... ix
Introduction xi

SECTION 1: Guidelines for Using This Manual

Tooling Terminology 1
Tablet Manufacturing 4
Tooling Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Standardization: Its Purpose and Advantages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

SECTION 2: TSM Tooling Specifications and Design Options

Effect of Tooling Dimensions on Tablet Manufacturing . .............. .. . .. . . .. ... . . . . .. ... . ...... ...... ........... ... 13
Revised Tooling Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Tooling Design Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
TSM Compatibility of International Presses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Tooling Specification Figures and Tables (Index) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

SECTION 3: Tablet Design

Tablet Terminology ........................................................................................................ . 45

Tablet Identification 50
Tablet Printing .............................................................................................................. . 62
Tablet Detail Drawings .................................................................................................. . 65
Tablet Land ................................................................................................................. . 66

SECTION 4: Tool Steels, Compression Forces, and Fatigue Failure

Tool Steels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Chemical Composition of Steels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

©American Pharmaceutical Association iii

- - - - - - -

FIGURE 13. SPECIAL PUNCH BARREL OPTIONS

DUST CUP

EUROPEAN DUST CUP RELIEF

(SEAL GROOVE)

A REUSABLE AND INTERCHANGEABLE DUST CUP, \\1-!ICH FITS IN A SPECIAL GROOVE MACHINED IN UPPER
PUNCH BARRELS, CAN BE SUPPLIED. THIS DUST CUP HAS A CIRCULAR HOLE SIZED TO MATCH THE GROOVE
DIAMETER, THUS ELI MINA TING THE NEED TO PUNCH HOLES IN THE DUST CUPS.

BARREL FLUTES

UPPER AND LOWER PUNCHES WITH RADIUSED GROOVES ON THE BARREL CAN BE SUPPLIED. THE
GROOVES AID IN KEEPING THE PUNCH GUIDEWA YS CLEAN. LOWER PUNCH RESTRAINING PLUGS
CANNOT BE USED WITH FLUTED LOWER PUNCHES.

DWG. NO.
TSM-N13

28 © American Pharmaceutical Association

©
)>
3
§· FIGURE 14. ST AND ARD .945 DIE 11
:>
3?-
0
( .945 [24.0 mm] DIAMETER)
3
a
~
[ .875 +.000
-.001
~ r22.225 -0.025J
+o.oool
8 t
iS"
g SEE DRAWING TSM-N17
FOR GROOVE OPTIONS
(SEE NOTE 5)
.4375 ±.00
[1 , ., , ± o., 3] SHARP EDGE
ENDS)

+0.0005 [
-0.0000
+0.0131
-o.oooJ t
27 .9450 +.0000
32 REF. -.0005
5
. . ll/.l:d--:=~~=:::l~==~--Jr22•4<1-
t . coo3 +o.oool
[21.43]
-0.013J

.01 5 ".005 J~
1~ R~
[o ..3e ±0.13]

[4.76]
41 [El •.30]

NOTES:

1. WITH THE EXCEPTION OF SURFACE FINISHES, DIMENSIONS ARE GIVEN

FIRST IN INCHES, FOLLOWED BY THE EQUIVALENT MILLIMETERS IN
TOLERANCES
UNLESS OTHERWISE INDlCA TED)
BRACKETS.
2. UNLESS OTHERWISE INDICATED, SURF ACE FINISHES ARE 20 MICROINCH FRACTIONAL +.015 [ .381]
[ .508 MICRON] ALL OVER. THE TOLERANCE ON ALL FINISHES IS ±5 MICRO- DECIMAL + .003 [ .076]
INCH [± .127 MICRON].
3. DIE FACES SHOULD BE SQUARE WITH O.D. WITHIN .001 [ .025] T.l.R.
ANGULAR + 0-30'
4. BARREL-SHAPED BORES ARE NOT RECOMMENDED. CONCENTRICITY T.l.R.::::;
5. DIE GROOVE OPTIONS ARE DESIGNED TO REDUCE THE OCCURRENCE BORE TO 0.0. .001 [ .025]
OF BURRS LEFT BY RETAINING SCREWS.
6. A REFERENCE DIMENSION IS USUALLY UNTOLERANCED. IT IS CONSIDERED AUXILIARY
DWG. NO.
INFORMATION AND DOES NOT GOVERN PRODUCTION OR INSPECTION OPERATIONS . TSM-N14
..,
"°
~
0

FIGURE 15. STANDARD 1 3/16 DIE 11

(1.1875 [30.162 mm] DIAMETER)

.875 +.000
-.001
[22.2 2 ~ +o.oool
-0.025J
SEE DRAWING TSM-N17
FOR GROOVE OPTIONS
.4375 ±.005 (SEE NOTE 5)
[11.11 ±0.13]
BREAK SHARP EDGE
(BOTH ENDS)
+0.0005 [ +0.0131
-0.0000 - o.oooJ
3 , . , 875 +.0000
132 REF. -.0005
[27.78]
t:r30.1 62 -0.01
+o.oool
3J

.015 ±.005
[o.38 ±o.1J]
3
16 (ue] R1 4l [6.30]

@)
)> NOTES:

I·
::i
1. WITH THE EXCEPTION OF SURFACE FINISHES, DIMENSIONS ARE GIVEN
FIRST IN INCHES, FOLLOWED BY THE EQUIVALENT MILLIMETERS IN
BRACKETS.
TOLERANCES
UNLESS OTHERWISE INDICATED
~
a 2. UNLESS OTHERWISE INDICATEO, SURFACE FINISHES ARE 20 MICROINCH FRACTIONAL +.015 [ .381]
3 [ .508 MICRON) ALL OVER. THE TOLERANCE ON ALL FINISHES IS ±5 MICRO- DECIMAL + .003 [ .076]
~ 3.
INCH (± .127 MICRON).
DIE FACES SHOULD BE SQUARE WITH O.D. WITHIN .001 [ .025] T.l.R.
ANGULAR + 0'-30'
~ 4. BARREL-SHAPED BORES ARE NOT RECOMMENDED. CONCENTRICITY T.l.R.=
5. DIE GROOVE OPTIONS ARE DESIGNED TO REDUCE THE OCCURRENCE BORE TO O.D. .001 [ .025]
~ OF BURRS LEFT BY RETAINING SCREWS.
§. 6. A REFERENCE DIMENSION IS USUALLY UNTOLERANCED. IT IS CONSIDERED AUXILIARY
DWG. NO.
g-· INFORMATION AND DOES NOT GOVERN PRODUCTION OR INSPECTION OPERATIONS. TSM-N15
@
)>
3
§· FIGURE 16. STANDARD "D" DIE 11
:::i

~
(1.500 [38.1 mm] DIAMETER)
0
3
~
~ I ... •I .9375 +.000
-.001

~
a·
+o. oool
tr23.812 -0.02!5J
~ SEE DRAWING TSM-N17
FOR GROOVE OPTIONS
.4688 :t..005---' i-/1 (SEE NOTE 5)
[11.91 :t.0.13] BREAK SHARP EDGE
(BOTH ENDS)
+0.0005 [ +0.0131
-0.0000 -o.oooJ

r ~
~
~
---r""" ~
~
13 1.5000 +.0000
'/~I
--n-w ~
I.
132 REF.
[3!5.72]
-.0005
r38.10 +o.oool
t -o.013J
~~
;;;;;,;_
l .::;
h ,j
/,

.015 :t..005-----'
[o.3e :t.0.13] I

R~
3
16 [4.76]

41 [e.3o]

NOTES:

1. WITH THE EXCEPTION OF SURF ACE FINISHES, DIMENSIONS ARE GIVEN

FIRST IN INCHES, FOLLOWED BY THE EQUIVALENT MILLIMETERS IN
TOLERANCES
UNLESS OTHERWISE INDICATED
BRACKETS.
2. UNLESS OTHERWISE INDICATED, SURFACE FINISHES ARE 20 MICROINCH FRACTIONAL ±.015 [ .381]
[ .508 MICRON] ALL OVER. THE TOLERANCE ON ALL FINISHES IS ±5 MICRO- DECIMAL ±.003 [ .076]
INCH [± .127 MICRON]. ±0'-30'
3. DIE FACES SHOULD BE SQUARE WITH O.D. WITHIN .001 [ .025] T.l.R.
ANGULAR
4. BARREL-SHAPED BORES ARE NOT RECOMMENDED. CONCENTRICITY T.l.R.=
5. DIE GROOVE OPTIONS ARE DESIGNED TO REDUCE THE OCCURRENCE BORE TO O.D. .001 [ .025]
OF BURRS LEFT BY RETAINING SCREWS.
6. A REFERENCE DIMENSION IS USUALLY UNTOLERANCED. IT IS CONSIDERED AUXILIARY
DWG. NO.
INFORMATION AND DOES NOT GOVERN PRODUCTION OR INSPECTION OPERATIONS. TSM-N16

-
w
 FIGURE 17. TAPERED DIES AND DIE
GROOVE RELIEFS
(SPECIAL DIE OPTIONS)
DIE BORE + .003
[.08]

3/16
[4.76]

TAPERED DIES
DIES WITH A TAPERED BORE ON ONE OR BOTH ENDS CAN BE SUPPLIED.
TAPERED BORES REDUCE THE FORCE WITH WHICH TABLETS ARE EJECTED. THEY
CAN ALSO PROVIDE A GRADUAL RELEASE OF INTERNAL STRESSES THAT CAN
CAUSE CAPPING OF TABLETS.

t-.02 REF.
I [.5oJ
/-----~
~ !

L .04 REF.
[1.0]

PROTECTION
SHOULDER

3/32 [2.38]
PROTECTION RADIUS
TYP.
/

DIE GROOVE RELIEFS

PROTECTION SHOULDERS OR RADII CAN BE ADDED TO DIE GROOVES TO
PREVENT SCORING OF DIE POCKETS CAUSED BY BURRS OR SHARP EDGES ON
THE DIE O.D.

DWG. NO. TS M - N 1 7

32 ©American Pharmaceutical Association

 FIGURE 18. LINED DIES
(SPECIAL DIE OPTIONS)

SHELL

LINED DIES

LINED DIES, COMMONLY CALLED INSERT DIES, ARE USED PRIMARILY TO

COMPRESS ABRASIVE AND /OR CORROSIVE MATERIALS. AL THOUGH LINED DIES
COST MORE, THEIR LONGER WORKING LIFE IS USUALLY WELL WORTH THE
ADDED COST.

LINED DIES CONSIST OF AN OUTER SHELL AND A LINER. THE MOST COMMON
LINING MATERIALS ARE TUNGSTEN CARBIDE AND INDUSTRIAL CERAMICS SUCH
AS ALUMINA AND PARTIALLY STABILIZED ZIRCONIA (PSZ).

THE OUTER SHELL PROTECTS THE HARDER, MORE BRITTLE LINER FROM
POSSIBLE FAILURE RELATED TO PRESSURE FROM THE DIE-LOCKING SCREW.

INSERT DIES MAY ALSO BE USED IN SITUATIONS WHERE DIE CRACKING

RESULTS FROM POINTED TABLET SHAPES. BECAUSE THE SHELL IS A HEAT-
SHRINK FIT OVER THE LINER, THE LINER IS PRESTRESSED IN COMPRESSION.
THIS PRECOMPRESSIVE STATE REDUCES THE LIKELIHOOD OF THE DIE
CRACKING DURING TABLET PRODUCTION.

DWG. NO.TSM-N 18

@ American Pharmaceutical Association 33

 FIGURE 19. Shaped Punch Tip
PUNCH AND DIE Clearances
CLEARANCES The TSM Committee developed the following standard
clearances for upper and lower punch tips of shaped tooling.

--i 1-.--uAXIMUM
I CLEARANCE

~g~~~iRE-1 r~g~~RAF~w DIE Shaped. Upper Punch Tip Clearance

PUNCH TIP BORE A nominal clearance of .0017 inch [.043 millimeter] is

~-MINIMUM recommended for all sizes of upper punch tips on shaped
CLEARANCE tooling.
,.__-~+---HIGH LIMIT
FOR TIP Allowing for the die bore tolerance of +.0005 inch [+.013
millimeter] and the shaped punch tip tolerance of -.0008
._--il-+-i-+----LOW LIMIT inch [-.020 millimeter] gives a maximum possible clear-
FOR TIP ance of .0030 inch [.076 millimeter] for shaped upper
punch tips. Therefore, the clearance range for upper
punch tips is .0017/.0030 inch [.043/.076 millimeter].

Shaped Lower Punch Tip Clearance

A nominal clearance of .0012 inch [.030 millimeter] is

recommended for all sizes of lower punch tips on shaped
.____-++---L0W LIMIT 1
tooling.
FOR DIE BORE Again, allowing for the die bore tolerance of +.0005 inch
HIGH LIMIT [+.013 millimeter] and the shaped punch tip tolerance of
- - - - - - F O R DIE BORE -.0008 inch [-.020 millimeter] gives a maximum possible
clearance of.0025 inch [.064 millimeter] for shaped lower
punch tips. Therefore, the clearance range for lower
punch tips is .0012/.0025 inch [.0301"064 millimeter].
DWG. NO.TSM-N 19

TABLE 2. MAXIMUM TABLET SIZES FOR STANDARD DIES

MAXIMUM TABLET SIZE

DIE SIZE (0.D.) DIE GROOVE ROUND TABLETS' SHAPED TABLETS 2
DIAMETER

.945 [24.0] .835 [21.43] 1/2[13] 9/16(14]

1.1875 [30.162] 1.077 [27.78] 5/8 [16] 3/4 [19]

American Presses: 7/8 [22]
1.500 [38.1] 1.390 [35.72] European presses: 1 [25]
1 [25]

1. FOR SOME PRESSES, MANUFACTURING OF 1[25) TABLETS MAY REQUIRE A SPECIAL DIE EXTRACTION TOOL. CONSULT YOUR PRESS
MANUFACTURER FOR MAXIMUM RECOMMENDED SIZE OF ROUND TABLETS.

2. POINTED TABLET SHAPES SHOULD HAVE A MINIMUM POINT RADIUS OF .04 [1 ]. (SEE THE DISCUSSION OF LINED DIES IN FIGURE 18, PAGE 33.)

3. THE PRESS MANUFACTURER'S RECOMMENDED TORQUE SETTING FOR TIGHTENING DIE LOCK SCREWS SHOULD ALWAYS BE USED.

34 © American Pharmaceutical Association

 FIGURE 19. Shaped Punch Tip
PUNCH AND DIE Clearances
CLEARANCES The TSM Committee developed the following standard
clearances for upper and lower punch tips of shaped tooling.

--i 1-..-uAXIMUM
I CLEARANCE

~g~~~cfr---1 r~g~iRAF~'if DIE

PUNCH TIP BORE
Shaped Upper Punch Tip Clearance

A nominal clearance of .0017 inch [.043 millimeter] is

~--ulNIMUM recommended for all sizes of upper punch tips on shaped
CLEARANCE tooling.
',
._-..-.i+---HIGH LIMIT
FOR TIP Allowing for the die bore tolerance of +.0005 inch [+.013
millimeter] and the shaped punch tip tolerance of -.0008
._--il-+-1-+----LOW LIMIT inch {-.020 millimeter] gives a maximum possible clear-
FOR TIP ance of .0030 inch [.076 millimeter] for shaped upper
punch tips. Therefore, the clearance range for upper
punch tips is .0017/.0030 inch [.043/.076 millimeter].

Shaped Lower Punch Tip Clearance

A nominal clearance of .0012 inch (.030 millimeter] is

recommended for all sizes of lower punch tips on shaped
tooling.
.__ _.-++---L0W LIMIT 1

FOR DIE BORE Again, allowing for the die bore tolerance of +.0005 inch
HIGH LIMIT [+.013 millimeter} and the shaped punch tip tolerance of
.__ _-+---FOR DIE BORE -.0008 inch[-.020 millimeter] gives a maximum possible
clearance of.0025 inch [.064 millimeter] for shaped lower
punch tips. Therefore, the clearance range for lower
punch tips is .0012/.0025 inch [.030/.064 millimeter].
DWG. NO.TSM-N 19

TABLE 2. MAXIMUM TABLET SIZES FOR STANDARD DIES

MAXIMUM TABLET SIZE

DIE SIZE (O.D.) DIE GROOVE ROUND TABLETS' SHAPED TABLETS 2
DIAMETER

.945 (24.0] .835 (21.43] 1/2(13] 9/16(14]

1.1875 (30.162] 1.077 (27.78] 5/8 (16] 3/4 (19]

American Presses: 7/8 [22]

1.500 (38.1] 1.390 (35.72] European presses: 1 [25]
1 (25]

1. FOR SOME PRESSES, MANUFACTURING OF 1(25) TABLETS MAY REQUIRE A SPECIAL DIE EXTRACTION TOOL. CONSULT YOUR PRESS
MANUFACTURER FOR MAXIMUM RECOMMENDED SIZE OF ROUND TABLETS.

2. POINTED TABLET SHAPES SHOULD HAVE A MINIMUM POINT RADIUS OF .04 [1 ). (SEE THE DISCUSSION OF LINED DIES IN FIGURE 18, PAGE 33.)

3. THE PRESS MANUFACTURER'S RECOMMENDED TORQUE SETTING FOR TIGHTENING DIE LOCK SCREWS SHOULD ALWAYS BE USED.

34 © American Pharmaceutical Association

 TABLE 3. STANDARD CLEARANCES FOR NORMAL APPLICATION OF ROUND TOOLING
UPPER PUNCH ACTUAL PUNCH TIP LOWER PUNCH
DIAMETER3
NOMINAL
TOOL STANDARD MINIMUM MAXIMUM UPPER LOWER STANDARD MINIMUM MAXIMUM
SIZE CLEARANCE CLEARANCE CLEARANCE4 CLEARANCE CLEARANCE. CLEARANCE4

1/8 .0015 .0015 .0025 .1235 .1240 .0010 .0010 .0020

[3.175] [.038] [.038] [.064] [3.137] [3.150] [.025] [.025] [.051]

5/32 .0015 .0015 .0025 .1548 .1553 .0010 .0010 .0020

[3.970] [.038] [.038] [.064] [3.932] [3.945] [.025] [.025] [.051]

3/16 .0015 .0015 .002§ .1860 .1865 .0010 .0010 .0020

[4.763] [.038] [.038] [.064] [4.724] [4.737] [.025] [.025] [.051]

7/32 .0016 .0016 .0026 .2171 .2177 .0010 .0010 .0020

[5.555] [.041] [.041] [.066] [5.514] [5.530] [.025] [.025] [.051]

1/4 .0016 .0016 .0026 .2484 .2489 .0011 .0011 .0021

[6.350] [.041] [.041] [.066] [6.309] [6.322] [.028] [.028] [.053]

9/32 .0017 .0017 .0027 .2795 .2801 .0011 .0011 .0021

[7.142] [.043] [.043] [.069] [7.099] [7.115] [.028] [.028] [.053]

5/16 .0017 .0017 .0027 .3108 .3114 .0011 .0011 .0021

[7.938] [.043] [.043] [.069] [7.894] [7.910] [.028] [.028] [.053]

11/32 .0018 .0018 .0028 .3419 .3425 .0012 .0012 .0022

[8.730] [.046] [.046] [.071] [8.684] [8.700] [.031] [.031] [.056]

3/8 .0018 .0018 .0028 .3732 .3738 .0012 .0012 .0022

[9.525] [.046] [.046] [.071] [9.479] [9.495] [.031] [.031] [.056]

13/32 .0019 .0019 .0029 .4043 .4050 .0012 .0012 .0022

[10.318] [.048] [.048] [.074] [10.269] [10.287] [.031] [.0.31] [.056]

7/16 .0019 .0019 .0029 .4356 .4362 .0013 .0013 .0023

[11.113] [.048] [.048] [.074] [11.064] [11.080] [.033] [.033] [.058]

15/32 .0020 .0020 .0030 .4667 .4674 .0013 .0013 .0023

[11.905] [.051] [.051] [.076] [11.854] [11.872] [.033] [.033] [.058]

1/2 .0020 .0020 .0030 .4980 .4987 .0013 .0013 .0023

[12.700] [.051] [.051] [.076] [12.649] [12.667] [.033] [.033] [.058]

17/32 .0021 .0021 .0031 .5291 .5298 .0014 .0014 .0024

[13.493] [.053] [.053] [.079] [13.439] [13.457] [.036] [.036] [.061]

9/16 .0022 .0022 .0032 .5603 .5611 .0014 .0014 .0024

[14.288] [.056) [.056] [.081] [14.232] [14.252] [.036] [.036] [.061]

NOTES:

1. DIMENSIONS ARE GIVEN FIRST IN INCHES, FOLLOWED BY THE EQUIVALENT MILLIMETERS IN BRACKETS.
, 2. DUE TO METRIC CONVERSIONS, A DISCREPANCY OF .00004 [.001] OCCURS FOR SOME DIMENSIONS.
3. THE TOLERANCE FOR ROUND PUNCH TIPS IS +.0000, -.0005 [[+.000, -.013].
4. MAXIMUM CLEARANCE OCCURS AT MAXIMUM DIE SIZE AND MINIMUM PUNCH TIP DIAMETER.

©American Pharmaceutical Association 35

 TABLE 3. STANDARD CLEARANCES FOR NORMAL APPLICATION OF ROUND TOOLING
(CONT.}
UPPER PUNCH ACTUAL PUNCH TIP LOWER PUNCH
DIAMETER3 '

NOMINAL
TOOL STANDARD MINIMUM MAXIMUM UPPER LOWER STANDARD MINIMUM MAXIMUM
SIZE CLEARANCE CLEARANCE CLEARANCE4 CLEARANCE CLEARANCE CL£ARANCE4

19/32 .0023 .0023 .0033 .5914 .5923 .0014 < .0014 .0024
[15.080] [.058] [.058] [.084] [15.022] [15.044] [.036] [.036] [.061]

5/8 .0024 .0024 .0034 .6226 .6235 .0015 .0015 .0025

[15.875] [.061] [.061] [.086] [15.814] [15.837] [.038] [.038] [.064]
-~
21/32 .0025 .0025 .0035 . .6537 .6542 .0020 .0020 .0030
[16.668] [.064] [.064] [.089] [16.604] [16.617] [.051] [.051] [.076]

11/16 .0025 .0025 .0035 .6850 .6855 .0020 0020 .0030

[17.463] [.064] [.064] [.089] [17.399] [17.412] (.051] [.051] [.076]

23/32 .0025 .0025 .0035 .7162 .7167 .0020 .0020 .0030

[18.255] [.064] [.064] [.089] [18.192] [18.204] [.051] [.051] [.076]

3/4 .0025 .0025 .0035 .7475 .7480 .0020 .0020 .0030

[19.050] [.064] [.064] [.089] [18.987] [18.999] [.051] [.051] [.076]

25/32 .0025 .0025 .0035 .7787 .7792 .0020 .0020 .0030

[19.843] [.064] [.064] [.089] [19.779] [19.792] [.051] [.051] [.076]

13/16 .0025 .0025 .0035 .8100 .8105 .0020 .0020 .0030

[20.638] [.064] [.064] [.089] [20.574] [20.587] [.051] [.051] [.076]

27/32 .0025 .0025 .0035 .8412 .8417 .0020 .0020 .0030

[21.430] [.064] [.064] [.089] [21.367] [21.379] [.051] [.051] [.076]

7/8 .0025 .0025 .0035 .8725 .8730 .0020 .0020 .0030

[22.225] [.064] [.064] [.089] [22.162] [22.174] [.051] [.051] [.076]

29/32
[23.018]

15/16
.0025
[.064]

.0025
.0025
[.064]

.0025
.0035
[.089]

.0035
.9037
[22.954]

.9350
.9042
[22.967]

.9355
.0020
(.051]

.0020
.0020
[.051]

.0020
.0030
[.076]

.0030
-
ii!i!

[23.813] [.064] [.064] [.089] [23.749] [23.762] [.051] [.051] [.076]

31/32 .0025 .0025 .0035 .9662 .9667 .0020 .0020 .0030

[24.605] [.064] [.064] [.089] [24.542] [24.554] [.051] [.051] [.076]

1 .0025 .0025 .0035 .9975 .9980 .0020 .0020 .0030

[25.400] [.064] [.064] [.089] [25.337] [25.349] [.051] [.051] [.076]

NOTES:

1. DIMENSIONS ARE GIVEN FIRST IN INCHES, FOLLOWED BY THE EQUIVALENT MILLIMETERS IN BRACKETS.
·2. DUE TO METRIC CONVERSIONS, A DISCREPANCY OF .00004 [.001] OCCURS FOR SOME DIMENSIONS.
3. THE TOLERANCE FOR ROUND PUNCH TIPS IS +.0000, -.0005 [[+.000, -.013].
4. MAXIMUM CLEARANCE OCCURS AT MAXIMUM DIE SIZE AND MINIMUM PUNCH TIP DIAMETER.

36 © American Pharmaceutical Association

 Hardness of Tool Steels . . . . . . . .. . . . . . . . .. . . . . . . . . . . . . . . . ... . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . .. . . . . . . . . . 74
Punch Tip Force Ratings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Fatigue Failure of Punch Tips 81

SECTION 5: Tooling Procurement, Inspection, and Maintenance

Standard Operating Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Punch and Die Maintenance . . . . . . .. . . .. . . . . . . . . . . .. .. . . . . . . . . . . . .. . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . .. . . . . . . .. .. . . . .. . . . .. 89

SECTION 6: Troubleshooting Tablet Production Problems

Advantages of Quality Tooling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Tablet Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Tooling Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Turret Guideway Wear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

APPENDIX

Tablet Press and Tooling Manufacturers and Distributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

iv © American Pharmaceutical Association

 Hardness of Tool Steels . . . . . . . .. . . . . . . . .. . . . . . . . . . . . . . . . ... . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . .. . . . . . . . . . 74
Punch Tip Force Ratings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Fatigue Failure of Punch Tips 81

SECTION 5: Tooling Procurement, Inspection, and Maintenance

Standard Operating Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Punch and Die Maintenance . . . . . . .. . . .. . . . . . . . . . . .. .. . . . . . . . . . . . .. . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . .. . . . . . . .. .. . . . .. . . . .. 89

SECTION 6: Troubleshooting Tablet Production Problems

Advantages of Quality Tooling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Tablet Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Tooling Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Turret Guideway Wear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

APPENDIX

Tablet Press and Tooling Manufacturers and Distributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

iv © American Pharmaceutical Association

 FIGURE 20. COMMON CONFIGURATIONS AND DIMENSIONS FOR PUNCH KEYS
.1860 :!: .0005 (KEY THICKNESS)
[4.724 :!:.013]

WOODRUFF KEY
(TOP VIEW)

OPTIONAL SCREW OPTIONAL SCREW

(COUNTER BORE ARRANGEMENT) (TWO KEY SLOT ARRANGEMENT)

STANDARD WOODRUFF KEY HI-PRO WOODRUFF KEY

(PROFILE) (PROFILE)

lr
SCREW

.1860 :!: .0005 (KEY IlllCKNESS)

[4.m !.01~

FIXED PARALLEL KEY

(TOP VIEW) (PUNCH + KEY HEIGHT)
3
28(60.33]~
.078
- 010
.;lL_ I
[1.98 -.25] rp -,,-i
E
- ;~
3
,

-
E$
1.000 [25.40] REF.

-
B = .826 +.000, -.010 [20.98 +.00, -.25]
D = 1.076 +.000, -.010 [27.33 +.00, -.25]
KEY DIMENSIONS FOR B
AND D TYPE PUNCHES
FIXED PARALLEL KEY (END VIEW)
(PROFILE)
NOTES:

1. KEY CONFIGURATIONS ARE TO BE USED AS A GUIDE ONLY.

2. THE DIMENSION FROM HEAD FLAT TO CENTER OF THE KEY APPLIES TO PRESSES THAT DO NOT REQUIRE
UPPER PUNCH SEALS. TABLES 4 AND 5 LIST MAXIMUM KEY EXTENSIONS FOR PRESSES THAT REQUIRE
UPPER SEALS.
3. THE FIXED PARALLEL KEY IS HELD IN PLACE BY A SCREW. ALL KEY TYPES CAN BE SUPPLIED WITH THIS
FEATURE.

DWG. NO.
TSM-N20

@American Pharmaceutical Association 37

r
TABLE 4. AVAILABLE KEY SPACE AND MAXIMUM STEM LENGTHS
(FOR PRESSES WITH UPPER PUNCH SEALS)

MINIMUM
KEY EXTENSION
DIMENSION
n: y
x
MIN.
~--'II
PRESS TYPE
COURTOY
X MIN.
1.800
. [45.720]
1.712
Y MAX.
2.950
• [74.930]
2.890
Z MAX.
.730
[18.542]
.630
MM: L HATA

FETlE
[43.485]
1.654
[73.406]
2.6n
[16.002]
.730
MAXIMUM [42.000] [68.000] [18.542]
KEY EXTENSION KIKUSUI .i/s N/S N/S
DIMENSION
KILIAN 1.417 2.402 .730
[3.599} f61.011] [18.542]
KORSCH 1.693 2.637 .630
MAXIMUM t [66.980]
STEM z [43.002] [16.002]
MAX. 1.687 2.687 .630
LENGTH MANESTY
[42.849] [68.250] [16.002]

1. THE MAXIMUM STEM LENGTH HAS BEEN ADJJSTED - .025 INCH TO ACCOMMOOAlE REWORKING OF HEAD FlATS MNG MAINlENANCE.
2. PRESSES lHAT DO NOT REQUIRE UPPER SEALS ARE CADMACH, STOKES. AND W:CTOR.
3. KEY PLACEMENT IS IMPORTANT IN PRra:NllNG DAMAGE TO SEALS AND CAMS.
4. N/S MEANS MANUFAClURER DID NOT SUPPLY DATA.

TABLE 5. PUNCH KEY LENGTHS AND AVAILABLE KEY SPACE

AXED-POSITION AVAILABLE KEY SPACE (LISTED BY MANUFAClURER)

KEYS
0.00 ~--..-.....----tt-----r-----r-----.------.,..----.,.----r---~~----t
~ ~ ~ ~ ~
ii
c 0 < :z
~I ii ~I ~, ~, ~I ~, ~I ~I HEAD FLAT
~I l ~t
2
t; _J_
1.000 ,- I -r--,-- __L I
I ---t---,--- 1.411- ---=+--~<F
I I 0.985 I I
2.000
2.375
2.50
:h1:j~
~
;k ;~ ~-~---
lKEY
·:_i: ,~;l•~I
_ 2.677 2.637 2.687
2.870 2.891 2.875
3.000 2.95 2.89

4.000
(STANDARD)
.7YJ MAX.
_:::!:::t=:_!_:~===::t:========:::!=::_!_:~-===
1. lHE lHREE BARS ON lHE FAR LffT REPRESENT AClUAL KEY LENGlHS FOR lHE FIXED-POSITION KEYS. .6YJ MAX. m
5.000 2. 1HE REMAINING BARS REPRESENT lHE SPACE AVAILABLE TO POSITION A KEY SO THAT IT \lilll NOT INTERFERE 'MTH
5.250.....__ _UPPER
__ (OPllaW.)lMAl!J
lHE PUNCH_ _EACH
SEALS. _KEY _SPACE
__ __
IS BASED _LIMITS
ON lHE _OF_ THE_ _ _PRESS.
RESPECTIVE _ _ _ _ _ _ _ _ _._..I._ _ _......

38 ©American Pharmaceutical Association

 TABLE 6. INTERCHANGEABLE TOOLING FOR ROTARY TABLET PRESSES
(3/4" PUNCH BARREL AND .945" DIE)

~HA
t d f~ .)4

t
E
F~ ~
ITTI H 61 G

cw
A ea c4-6 05-7 E F G. H3
INCHES 5.250 .748 2.500 35° .945 .875 5.250 .745
MILLIMETERS 133.35 19.00 63.50 35° 24.003 22.225 133.35 18.92

CADMACH COURTOY KIKUSUI KORSCH RIVA VECTOR

BBC-45 R1/2LAB0-22 GEMINI 867-67 PH230-20 BB-2-35 233-33
BBC4-45 R090-28 LIBRA 845-45 PH250-30 BB2G-35 241-41
K5500-55 R090M-28 LIBRA 849-49 PH300-43 HIDR0-35 241a-41
K6100-61 R100-36 OCTANS 845-45 PH800-77 PRECOM-35 242-41
R190-36 VIRGO 524-24 REVOLUTION-65 243-41
R200-65 244-41
R200M-65 247-41
R290-65 2400
R292-65

FETIE HATA KILIAN MAN ESTY STOKES

P-21/35 HT-AP22-SSU E150-32 l:j3B-23 RB-2-33 & 37
P-31/51 HT-AP65-3L LX-28 B4-30 BGEM PREMIERE 570-P <36)
P-1000/33 HT-AP71-3L RTS-32 BB3-23 BGEM SUPREME 571-S (50)
P-1200/30 HT-HX77-LDU RX-67 BB3B-33 39 & 45 BGENESIS 757 <63)
P-2080/43 HT-X29-SSll S100-22 BB4-39 & 45 9454-1 41)
P-2200/43 HT-X45-MSIJ S200-28 BETAPRESS-23 454-1-A
p .~nnn1r:;r:; HT Xh"-1 n11 C:::?l:;l'L-411 ELITE 450-55 & 61 513-2 (45)
P-31n111i:;i:; HT-X71-I n1 I T100-22 ELITE 800-69 & 75 540-41
p. _::;;iiii73 T?OO-?A EXCEi APRESS-55 & 61 "i"i1-1 (51)
PT?1011/.1~ T300-40 EXPRESS-30 "i5?-1 (51)
PT3090/73 T400-67 EXPRESS MKll-34 555-PACER (45)
1090 WIP/30 TX-40 LAYERPRESS-47 560-1 VERSA
NOVAPRFSS-"i"i & 61 "ih.1-1 (45)
NOVAPRl=C:::C::: ?-"i"i & n1 i:\hi:\-1 (f)5)
NOVAPRFSS nlAMnNn-55 R. 61 5hfl-~ (.15)

ROTAPRFSS MKI II llA-"i"i & n1 i:\.Rfl-1 (45)

RnTAPRFSS MKlll-hO R. 75 !'\Rh-? /"i1 l
ROTAPRFC:::S MKlll IV V OIAf\1101\ln-75 593. -1 (f)5)
UNIPRESS-30 & 34 610-1 <GTP) <65)
UNIPRESS DIAMOND-30 & 34 747-1 (65)

1. A KEY IS USUALLY NOT REQUIRED ON ROUND TOOLING.

2. SOME PRESSES MAY REQUIRE SCREWED-IN FEATHER KEYS. CONTACT PRESS MANUFACTURER
FOR RECOMMENDATIONS.
3. FOR MOST PRESSES, "B" AND "H" DIMENSIONS ARE ENGINEERED WITH TURRET BORE SIZE SET AT .7500 [19.05).
SOME FETIE PRESSES, HOWEVER, HAVE A TURRET BORE SIZE OF .7488-.7496 [19.02-19.04). CONTACT PRESS
MANUFACTURER FOR APPROPRIATE DIMENSIONS FOR FETIE PRESSES.
4. UNLESS OTHERWISE INDICATED, STOKES PRESSES HAVE A "C" DIMENSION OF 2.750 [69.85).
5. "C" AND "D" DIMENSIONS MAY NOT APPLY TO VECTOR (COLTON) PRESSES.
. 6. KILLIAN PRESSES HAVE A "C" DIMENSION OF 1.909 [48.5) AND A "D" DIMENSION OF 30° .
7. CONTACT MANUFACTURER FOR APPROPRIATE "D" DIMENSION FOR COURTOY, N.V. PRESSES.
8. THIS PRESS HAS A "C" DIMENSION OF 2.375 [60.325). THE STEM CANNOT EXCEED.630 [16.00).
9. THIS PRESS REQUIRES A NECKLESS PUNCH SHANK.

©American Pharmaceutical Association 39

 TABLE 7. INTERCHANGEABLE TOOLING FOR ROTARY TABLET PRESSES
(3/4" PUNCH BARREL AND 1.1875" DIE)
~ ~F~~
C__,,,A
~ d r1t E [ill H 61 G

d
INCHES
A
5.250
93
.748
c4-6
2.500
'
05-7
35°
E
1.1875
F
.875
G
5.250
H3
.745
MILLIMETERS 133.35 19.00 63.50 35° 30.162 22.225 133.35 18.92
CAO MACH COURTOY FETIE KIKUSUI KORSCH RIVA
BBC-27 R1/2LAB0-18 P-21/30 GEMINI 855-55 PH100-3 BB-2-27
BBC-35 R090-23 P-1000/28 LIBRA 836-36 PH10Q-6 BB2-33
BBC4-35 R090M-23 P-1200/24 OCTANS 836-36 PH230-17 HIDR0-27
DB-16 R100-30 P-2000/36• VIRGO 512-12 PH250-25 HIDR0-33
K4500-45 R100M-30 P-2100/36 VIRGO 519-19 PH300-36
R190-30 P-2200/36 PH800-65
R200-55 P-3000/45 REVOLUTION-55
R200M-55 P-3100/45
R290-55 P-3200/61
R292-55 PT2080/36
PT20QO/::ln
I"' I -~I 1~uio I
10QO WIP/?4
HATA KILIAN MAN ESTY STOKES VECTOR
HT-AP18-SSU E150-26 ATS-45 BB-2 <27) MAGNA-66
HT-55-3LS LX-23 B3B-16 BGEM PREMIERE 570-P (30) MEDALIST-1800
HT-X24-SSU RL-15 B4-16 & 25 BGEM SUPREME 571-S (42) 224-43
HT-X38-LDU RTS-26 BB3B 27 & 35 BGENESIS 757 51 \ 227-27
HT-X55-LDU RX-55 BB4-27 & 35 9454-2 (35) 232-33
HT-X61-LDU S100-18 BETAPRESS-16 454-2-A 233A-33
S200-23 ELITE 450-45 513-3 (35) 242-33 & 43
S250-32 ELITE 800-55 540-35 243-33
T100-18 EXCELAPRESS-45 541-1 (41) 247-33
T200-23 EXPRESS-25 552-2 (41) 1800
T300-32 EXPRESS MKI 1-27 555-2 PACER 35) 2216
T400-55 LAYERPRESS-39 560-2 VERSA 2247-33
TX-32 NOVAPRESS-45 564-2 (35)
NOVAPRESS 2-45 565-2 (53)
NOVAPRESS DIAMOND-45 566-2 (27\ a
ROTAPRESS MKI 11 llA-45
ROTAPRESS MKlll, IV, V DIA-
MOND-55
UNIPRESS-27
566-102 (35)
580-2 (35)
::its::i-1 (411
593-2 (53\
•
Ii:
UNIPRESS DIAMOND-27 690-2 (53)
747-2 (53) Ii:
1. A KEY IS USUALLY NOT REQUIRED ON ROUND TOOLING. I!

•'i
2. SOME PRESSES MAY REQUIRE SCREWED-IN FEATHER KEYS. CONTACT PRESS MANUFACTURER
FOR RECOMMENDATIONS.
3. FOR MOST PRESSES, "B" AND "H" DIMENSIONS ARE ENGINEERED WITH TURRET BORE SIZE SET AT .7500 [19.05]. SOME FETIE
PRESSES, HOWEVER, HAVE A TURRET BORE SIZE OF .7488-.7496 [19.02-19.04]. CONTACT PRESS MANUFACTURER FOR APPRO-
PRIATE DIMENSIONS FOR FETIE PRESSES.
4. UNLESS OTHERWISE INDICATED, STOKES PRESSES HAVE A "C" DIMENSION OF 2.750 [69.85].
5.
6.
"C" AND "D" DIMENSIONS MAY NOT APPLY TO VECTOR (COLTON) PRESSES.
KILIAN PRESSES HAVE A "C" DIMENSION OF 1.909 [48.5] AND A "D" DIMENSION OF 30°. 11
~
7. CONTACT MANUFACTURER FOR APPROPRIATE "D" DIMENSION FOR COURTOY, N.V. PRESSES.
8. THIS PRESS HAS A "C" DIMENSION OF 2.375 [60.325]. THE STEM CANNOT EXCEED .630 [16.00].
9. THIS PRESS REQUIRES A NECKLESS PUNCH SHANK.

40 © American Pharmaceutical Association

 TABLE 8. INTERCHANGEABLE TOOLING FOR ROTARY TABLET PRESSES
(1" PUNCH BARREL AND 1.500" DIE)

ffi=i C->I A
~ d ~~ f
_d f~ ~
t
E aTI H 61 G
a]
A 93 c4-6 05-6 E F G H3
INCHES 5.250 .998 2.500 35° 1.500 .9375 5.250 .995
MILLIMETERS 133.35 25.35 63.50 35° 38.10 23.812 133.35 25.27
'!'

CADMACH COURTOY KIKUSUI KORSCH RIVA VECTOR

nr.-16 R1/2 I AR-D GEMINI 1545-45 PH110-3 D-3-16 ?.:10-16
BRr.4-27 R09fl-18 HERCULES PH ?':t0-14 n-::i-?o 1fmo
K3700-37 R090M-18 1529-29 PH 250-20 DD-3-25
R100-24 PH 300-29 DD3G-25
R100M-24 PH 800-53 HIDR0-25
R190-24 REVOLUTION-45 PRECOM-25
R200-43
R200M-43
R290-43
R292-43

FITTE HATA KILIAN MAN ESTY STOKES

P-1000/22 HT-AP15-SSU E150-21 D3B-16 D-3 (16)
P-1200/20 HT-AP45-3L LX-19 D3RY-16 ?GEM PREMIERE 570-P (25\
P-2000/29 HT-X20-SSU RTS-20 D4-16 & 20 ?GEM SUPREME 571-S 134\
P-2100/29 HT-X32-MSU RTS-21 DRYCOTA 500-16 ?GENESIS 757 141 & 43\
P-2200/29 HT-X45-LDU RX-41 DRYCOTA 600-16 514-1 116
P-3000/37 HT-HX51LD-U RX-45 ELITE 450-37 515 (16\
P-3100/37 S100-14 ELITE 800-45 550-2 (16
P-3200/49 S200-19 EXCELAPRESS-37 610-3 GTP (41\
PT2080/29 S250-26 EXPRESS MKI 11-20
PT2090/29 T100-14 NOVAPRESS-37
PT3090/49 T200-19 ROTAPRESS MKl-29 & 37
1090 WIP/20 T300-26 ROTAPRESS MKll llA-37
T400-45 ROTAPRESS MKlll, IV,
TX-21 V DIAMOND-45
TX-26 UNIPRESS-20
UNIPRESS DIAMOND-20

1. A KEY IS USUALLY NOT REQUIRED ON ROUND TOOLING.

2. SOME PRESSES MAY REQUIRE SCREWED-IN FEATHER KEYS. CONTACT PRESS MANUFACTURER
FOR RECOMMENDATIONS.
3. FOR MOST PRESSES, "B" AND "H" DIMENSIONS ARE ENGINEERED WITH TURRET BORE SIZE SET AT 1.000 [25.40].
SOME FETIE PRESSES, HOWEVER, HAVE A TURRET BORE SIZE OF .9988-.9996 [25.37-25.39]. CONTACT PRESS
MANUFACTURER FOR APPROPRIATE DIMENSIONS FOR FETIE PRESSES.
4. UNLESS OTHERWISE INDICATED, STOKES PRESSES HAVE A "C" DIMENSION OF 2.750 [69.85].
5. "C" AND "D" DIMENSIONS MAY NOT APPLY TO VECTOR (COLTON) PRESSES.
6. KILIAN PRESSES HAVE A "C" DIMENSION OF 1.909 [48.5] AND A "D" DIMENSION OF 30°.
7. THIS PRESS HAS A "C" DIMENSION OF 2.375 [60.325]. THE STEM CANNOT EXCEED .630 [16.00].

©American Pharmaceutical Association 41

~

TABLE 9: INTERCHANGEABLE TOOLING FOR SPECIAL ROTARY TABLET PRESSES

~C_..A
t d f ~ t an b _0
E
F~ ~H ,
G

~
PRESS MODELS
KILIAN KOR SCH MAN ESTY STOKES VECTOR
A R c4 o4 E F G H
5PH 343-43 5.250 .748 2.500 35° .945 .975 5.250 .745
RT-16 68-2-16 & 512-1 5.250 .748 2.500 35° 1.1875 .875 3.562 .747
68-2 (22) 5.250 .748 2.500 35° .945 .875 3.562 .747
RT-DS-16 605-3 (15) 250-12 5.250 1.248 2.500 35° 2.000 1.250 5.250 1.245
6550-1 (15) 5.250 1.248 2.500 35° 2.00Q 1.250 5.250 1.245
6515-1 5.250 1.248 2.500 35° 2.000 1.250 5.250 1.245
204-4 5.250 .748 2.500 35° 1.1875 .875 3.562 .745
216-16 5.250 .748 2.500 35° 1.1875 .875 3.562 .745
246-41 5.250 .748 2.500 35° .945 .875 3.562 .745
DD-2 (23) 260-25 6.812 1.248 3.000 35° 2.125 1.500 8.812 1.245
516-1 6.812 1.248 3.000 35° 2.125 1.500 8.812 1.245
260-31 6.812 1.248 3.000 35° 1.750 1.500 8.812 1.245
260-33 6.812 .998 * * 1.500 1.500 8.812 .995
260-43 6.812 .998 * * 1.1875 1.500 8.812 .995
270-18 9.000 1.999 * * 3.624 2.500 9.000 1.998
270-25 9.000 1.999 * * 2.499 2.500 9.000 1.998
246 & 47-49 5.250 .748 * * 7.875 .8749 5.250 .747
© 516-2 (19) 6.812 1.623 3.000 35° 2.750 1.500 8.812 1.620
)>
3
517-1 7.250 1.248 3.125 35° 2.125 2.250 6.687 1.254
(I)
DDS-2 (23) 7.250 1.248 3.125 35° 2.125 2.250 6.687 1.254
8•
::i
517-2 7.250 1.623 3.125 35° 2.750 2.250 6.687 1.620
MAGNA-54 5.250 .998 2.500 35° 1.500 1.250 5.250 .995.
~ MAGNA-74 5.250 .748 2.500 35° 1.500 .9375 5.250 .745
3
Q
n 246-33 5.250 .748 2.500 35° 3.562 .945 5.250 .745
(I)
c 240-16 5.250 .998 2.500 35° 1.500 1.250 5.250 .995
[ 557-1 (23) 6.812 1.248 3.000 35° 2.125 2.250 8.812' 1.245
)> 557-2 (19) 6.812 1.623 3.000 35° 2.750 2.250 8.812 1.620
"'"'g
i:S"
6-
:::i

... m1 • • • • 111 • m mt 1111 1111 l11J m II JI JI !II JI Jll JI J11 _J111 _JI .,•., .... _..f -...'-d" •11 ,
@
):.
3 TABLE 9. INTERCHANGEABLE TOOLING FOR SPECIAL ROTARY TABLET PRESSES (CONT.)
§·
:J

~ _d Fr-~
d }1$' b1 d
Q G
3Q
@
c
R'
:;:
C-><A

f
E [ill H
Q__
):.
<.n
<.n
g
a· PRESS MODELS
6"
:J
KILIAN KORSCH MAN ESTY STOKES VECTOR
A B c4 o4 E F G H
DD-2 <31 l 6.812 .998 3.000 35° 1.500 1.250 8.812 .995
8328-1 6.062 1.123 3.000 35° 1.312 1.500 6.250 1.120
8533-45 6.062 1.123 3.000 35° 1.312 1.500 6.250 1.120
8533-4 (45) 6.062 1.123 3.000 35° t.312 1.500 6.250 1.120
8328-2 6.062 1.248 3.000 35° 1.625 1.500 6.250 1.245
8533-124 (33) 6.062 1.248 3.000 35° 1.625 1.500 6.250 1.245
8515-3 5.125 1.248 2.750 35° 2.000 1.687 5.375 1.245
D3B-23 D3-22 5.250 .998 2.750 35° 1.1875 .9375 5.250 .995
9DRYCOTA 700 & 900-23 5.260 .998 2.125 45°CW 1.1875 .9375 5.260 .995
9BICOTA-23 5.260 .998 2.125 45°CW 1.1875 .9375 5.260 .995
DELTAPRESS-23 5.250 .998 * 35° 1.1875 .875 5.250 .995
PRESCOTERIV 5.9055 1.2598 3.7795 35° 1.3780 .9921 6.1811 .9843
RU-ZS 5.9055 1.2598 3.7795 35° 1.3780 .9921 6.1811 .9843
RU-ZS-H 5.9055 1.2598 3.7795 35° 1.3780 .9921 6.1811 .9843
RU-3S 5.9055 1.2598 3.7795 35° 1.3780 .9921 6.1811 .9843
280-53 5.250 .9980 * * * * 5.250 .9960

1. UNLESS OTHERWISE INDICATED, DIMENSIONS ARE GIVEN IN INCHES.

2. A KEY IS USUALLY NOT REQUIRED ON ROUND TOOLING.
3. SOME PRESSES MAY REQUIRE SCREWED-IN FEATHER KEYS. CONTACT PRESS MANUFACTURER FOR RECOMMENDATIONS.
4. "C" AND "D" DIMENSIONS MAY NOT APPLY TO VECTOR (COLTON) PRESSES.
5. THIS PRESS HAS A "C" DIMENSION OF 2.750.
6. THIS PRESS CAN USE STANDARD TOOLING BUT RQUIRES A SPECIAL HEAD FOR OPTIMAL PERFORMANCE. CONTACT PRESS MANUFACTURER FOR
SPECIFICATIONS.
7. THIS PRESS REQUIRES A DIE WITH A PROTECTIVE SHOULDER.
8. THIS PRESS REQUIRES A NECKLESS PUNCH SHANK.
9. THIS PRESS USES EUROPEAN TOOLING.
* INFORMATION NOT SUPPLIED BY MANUFACTURER.

t
 t
FIGURE 21. COMPARISON OF TSM AND INTERNATIONAL B·TYPE TOOLING

24'
36" 17
1

J71
5.250
.748 5.250 [133.35]
[133.~] .748 .748
[19.00] [19.00] [19.00]

1-------1
r --,
.945 1.1875 .945 1.1875 .9~ 1.1875
Ipo.162J I ~
1131116211
~ ~ IJ30.162JI

§ft3 J rfflis1 t:=m:J Tn87s

f::t:ttj ~225] $ f rfflis1 -~- lrffl1s1 -Elfi lrffl1s1 -~ lrfflis1

@
!l~I
!
)>
3 SEE .745 5.250 .748 ! 5.260 .748 5.250
[18.92 [133.35] [19.00 I [133.60] [19.oo· [133.35]
§· FOOTNOTE

@
'.:)

~
3
c:
[
24'
J l__l J
16.00 R
~
§. NOTE: FOR SPECIFIC TABLET PRESS MODELS, CONTACT TABLET PRESS MANUFACTURER FOR THE BARREL DIAMETER. DWG. NO.
5'
'.:)
SEE ALSO TABLE 9, PAGE 42. TSM-N21

Jill. Jll~ JI II n II II Ill 111 Im lit1 D D II -~I •1•1 HIL....--.lll.9l-.ALIL....ll.IL...ILll ·~! ll.11 1111 I~! 1111 Alfi 1111 •11r J\I[ 1\1[ 1\1\ -;
 SECTION 3
Tablet Design
Producing a tablet that has a unique shape and/or tablet General Terminology
face design can significantly enhance a product's recog-
nition. The "uniqueness" of any design is limited by the Figures 22 and 24 on pages 46 and 49 illustrate the gen-
compression force required to produce the tablet, the eral terminology as it pertains to round and shaped
formulation's characteristics, the design's impact on tablets, respectively.
tooling performance, and the tablet's ability to with-
stand packaging and shipping processes. Although Tablet Face: The area within the tablet's periphery.
tablet shape is not the only factor to consider in the
design of a new tablet, the choice of geometric configu- Band: The area between the opposing cup profiles.
ration can affect the output of the tablet press and, with The die wall forms the tablet band.
some sharp-angled tablet configurations, possibly cause
damages to the punches, dies, and cams. Some other Cup: The depression, or concavity, at the end of a
effects of poor tablet design include the following: punch tip.

Cup Depth: The distance from the tablet's band to the

• Product becomes contaminated with metal from highest point, or apex, of the cup's radius, or three-
broken punch tips. dimensional contour.
• Broken punch tips produce deformed tablets, which
could be rejected by Quality Control. Cup Radius: A single arc generated from the tablet's
• Costly reworking of tablets occurs (tablets are centerline (midpoint) across the tablet's diameter, minor
ground up and reprocessed). axis, or major axis. The cup radius forms the cup's pro-
• Higher quantities of broken tablets are present in file. Round convex tablets usually have a single cup
waste output of sorter (tablets are not reprocessed). radius.
• Filled bottles contain broken tablets, which could
be rejected by Quality Control or, if distributed, Compound Cup: A cup design in which multiple radii
diminish corporate image. (arcs) are generated from the tablet's centerline across
• Labor costs are increased, which could result in the tablet's diameter, minor axis, or major axis. This
higher prices to users and affect the product's com- configuration, which increases the cup volume by main-
petitive position in the marketplace. taining a required cup depth and reducing the band
• Time is lost in distributing the product, which could thickness, is used for round and shaped tablets (see Fig-
delay introducing a new product or cause a pur- ure 22, Illus. B; and Figure 24, Illus. C.)
chaser to run out of an existing product.
• Some shaped tablets break easily when fed through Land: A narrow plane perpendicular to the tablet's
the printer, sorter, and/or tablet filler. band, which creates a junction between the band and
the cup radius.

Tablet Thickness: The combined height of the two

Tablet Terminology cups and the band determines the total thickness.

The basic construction of a round or shaped tablet is the Tablet Identification: Any logo, product or company
same; therefore, many of the terms used in describing name, identification code, or three-dimensional charac-
tablets apply to both tablet categories. Definitions for ter contours applied to a tablet's face by means of
general terminology are presented first, followed by the debossing or embossing. (See the discussion of ''Tablet
terms specific to round or shaped tablets. Identification" on pages 50-62 for more information.)

©American Pharmaceutical Association 45

 FIGURE 22. TERMINOLOGY FOR
ROUND TABLETS
f
OUTSIDE
DIAMElt:R
(O.D.)

!
MAJOR CUP ....:filL MIN. RADIUS
RADIUS
[.38]
LAND
MINOR CUP
SPHERICAL~ CUP RADIUS
CUP
CUP RADIU

~-'----'~BEVEL
I

ANGL.£
TABL.fT THICKNESS

CONVEX CUP FLAT-FACED

COMPOUND CUP BEVEL-EDGED
(ILLUS. A) (ILLUS. B) (ILLUS. C)

EMBOSSED DEBOSSED
TABLET TABL.£T

EMBOSSED DEBOSSED
TABLET TABLET
(ILLUS. D) (ILLUS. E)

PUNCH IS PUNCH IS
DEBOSSEO EMBOSSED

PUNCH TIP PUNCH TIP

fACE fACE

TABL.£T TABLET
FACE FACE

DWG. NO.
TSM-N22

46 ©American Pharmaceutical Association

List of Figures
Figure 1 Punch and Die Terminology .............................................................. . 3
Figure 2 TSM Production Tooling ................................................................. . 6
Figure 3 Rotary Tablet Press Cycle ........................................................... ·.... ~ .. 8
Figure 4 Top View of Tablet Press Cycle ........................................................... . 9
Figure 5 Overall and Working Lengths ........................................................•... 14
Figure 6 Common Head Configurations of B-Type Punches ................................... . 21
Figure 7 Common Head Configurations of D-Type Punches ................................... . 22
Figure 8 Standard B-Type Upper Punch ........................................................... . 23
Figure 9 Standard B-Type Lower Punch ........................................................... . 24
Figure 10 Standard D-Type Upper Punch ........................................................... . 25
Figure 11 Standard D-Type Lower Punch ........................................................... . 26
Figure 12 Special Punch Tip Options ................................................................. . 27
Figure 13 Special Punch Barrel Options ........................................................... . 28
Figure 14 Standard .945 Die .......................................................................... . 29
Figure 15 Standard 1 3/16 Die ....................................................................... . 30
Figure 16 Standard "D" Die .......................................................................... . 31
Figure 17 Tapered Dies and Die Groove Reliefs 32
Figure 18 Lined Dies ................................................................................... . 33
Figure 19 Punch and Die Clearances ................................................................. . 34
Figure 20 Common Configurations and Dimensions for Punch Keys .......................... . 37
Figure 21 Comparison of TSM and International B-Type Tooling ............................. . 44
Figure 22 Terminology for Round Tablets ........................................................... . 46
Figure 23 Profiles of Convex and F.F.B .E. Tablets .................................................. . 48
Figure 24 Terminology for Shaped Tablets ........................................................ . 49
Figure 25 Common Tablet Shapes .................................................................... . 51
Figure 26 Applying Tablet Identification to Punch Face ......................................... . 52
Figure 27 Guidelines for Film Coating .............................................................. . 52
Figure 28 Types of Bisect Lines ....................................................................... . 54
Figure 29 Maximum Identification Area for Round Tablets ...................................... . 57
Figure 30 Stroke Specifications and Stroke Distortion ............................................ . 58
Figure 31 Techniques To Prevent Picking in Pad Areas ............................................ . 60
Figure 32 Techniques To Prevent Picking in Peninsulas and Comers .......................... . 61
Figure 33 Sample Designs for Bold Characters ..................................................... . 63
Figure 34 Sample Design for Narrow Characters .................................................. . 64
Figure 35 Guidelines for Punch Tip Land ........................................................... . 67
Figure 36 Stress Versus Cycle Life for Tool Steel .................................................. . 82
Figure 37 Sample Tablet Tooling Approval Form .................................................. . 84
Figure 38 Quote/Order Form .......................................................................... . 85
Figure 39 Punch and Die Inspection Sheet ........................................................ . 87
Figure 40 Tablet Tooling Usage and Repair Card .................................................. . 88
Figure 41 Punch Tip Deflection ....................................................................... . 117

©American Pharmaceutical Association v

List of Figures
Figure 1 Punch and Die Terminology .............................................................. . 3
Figure 2 TSM Production Tooling ................................................................. . 6
Figure 3 Rotary Tablet Press Cycle ........................................................... ·.... ~ .. 8
Figure 4 Top View of Tablet Press Cycle ........................................................... . 9
Figure 5 Overall and Working Lengths ........................................................•... 14
Figure 6 Common Head Configurations of B-Type Punches ................................... . 21
Figure 7 Common Head Configurations of D-Type Punches ................................... . 22
Figure 8 Standard B-Type Upper Punch ........................................................... . 23
Figure 9 Standard B-Type Lower Punch ........................................................... . 24
Figure 10 Standard D-Type Upper Punch ........................................................... . 25
Figure 11 Standard D-Type Lower Punch ........................................................... . 26
Figure 12 Special Punch Tip Options ................................................................. . 27
Figure 13 Special Punch Barrel Options ........................................................... . 28
Figure 14 Standard .945 Die .......................................................................... . 29
Figure 15 Standard 1 3/16 Die ....................................................................... . 30
Figure 16 Standard "D" Die .......................................................................... . 31
Figure 17 Tapered Dies and Die Groove Reliefs 32
Figure 18 Lined Dies ................................................................................... . 33
Figure 19 Punch and Die Clearances ................................................................. . 34
Figure 20 Common Configurations and Dimensions for Punch Keys .......................... . 37
Figure 21 Comparison of TSM and International B-Type Tooling ............................. . 44
Figure 22 Terminology for Round Tablets ........................................................... . 46
Figure 23 Profiles of Convex and F.F.B .E. Tablets .................................................. . 48
Figure 24 Terminology for Shaped Tablets ........................................................ . 49
Figure 25 Common Tablet Shapes .................................................................... . 51
Figure 26 Applying Tablet Identification to Punch Face ......................................... . 52
Figure 27 Guidelines for Film Coating .............................................................. . 52
Figure 28 Types of Bisect Lines ....................................................................... . 54
Figure 29 Maximum Identification Area for Round Tablets ...................................... . 57
Figure 30 Stroke Specifications and Stroke Distortion ............................................ . 58
Figure 31 Techniques To Prevent Picking in Pad Areas ............................................ . 60
Figure 32 Techniques To Prevent Picking in Peninsulas and Comers .......................... . 61
Figure 33 Sample Designs for Bold Characters ..................................................... . 63
Figure 34 Sample Design for Narrow Characters .................................................. . 64
Figure 35 Guidelines for Punch Tip Land ........................................................... . 67
Figure 36 Stress Versus Cycle Life for Tool Steel .................................................. . 82
Figure 37 Sample Tablet Tooling Approval Form .................................................. . 84
Figure 38 Quote/Order Form .......................................................................... . 85
Figure 39 Punch and Die Inspection Sheet ........................................................ . 87
Figure 40 Tablet Tooling Usage and Repair Card .................................................. . 88
Figure 41 Punch Tip Deflection ....................................................................... . 117

©American Pharmaceutical Association v

Debossed: A tablet identification that is depressed in Figure 23 on page 48 shows the profiles of convex and
the tablet's surface, forming a groove or indented pock- F.F.B.E. tablets. Although tablets are often referred to
et. The resultant groove creates a shadowed pocket on as being a shallow concave, standard concave, deep
the tablet's surface, thus enhancing the tablet identifica- concave, etc., the term concave better describes the
tion. The punch tip face that produces a debossed tablet shape of a punch face. Tablets produced with these
is shown in Figure 22, Illus. D. punches usually have a convex surface ..

Embossed: The protrusion of a tablet identification

above the tablet's surface. Due to its exposure above the Shaped Tablet Terminology
tablet surface, an embossed identification is susceptible
to abrasion and chipping. However, if the embossing is Figure 24 on page 49 provides supporting illustrations
not raised sufficiently above the surface, the identifica- for the following terms.
tion will lack clarity. The type of punch tip .face that
produces an embossed tablet is shown in Figure 22, Major Axis: Length of a shaped tablet.
Illus. E.
Minor Axis: Width of a shaped tablet.
Tablet Printing: An optional method of applying an
identification, in which the identification is mechanical- End Radius: The radius located at either end of a cap-
ly printed on the tablet's surface with a liquid ink. (See sule-shaped tablet.
the discussion of "Tablet Printing" on pages 62 and 65
for more information.) Oval: Although an oval may resemble an elliptical
shape, it is formed using only two radii: the major side
radius and the minor end radius.
Round Tablet Terminology
Minor Axis Cup Radius: A single arc generated from
Outside Diameter (0.D.) with a Spherical Cup the tablet's centerline across the tablet's minor axis.
Radius: The length of a line segment passing from the This radius forms the minor axis cup profile.
centerline to any point on the tablet's periphery. A
spherical cup design is merely a chord segment of a Major Axis Cup Radius: A single arc generated from
spherical ball (see Figure 22, Illus. A). the tablet's centerline across the tablet's major axis.
This radius forms the major axis cup profile.
Flat-Faced Bevel-Edged (F.F.B.E.) Tablet: A tablet
configuration consisting of a cup, an angle between the
cup and tablet face, and, if required, a land. A 30° bevel
is preferred to maximize the strength of punch edges. NOTE: Geometrically shaped tablets such as trian-
When the bevel is first applied, its contact area with the gles, pentagons, octagons, and hexagons have cir-
tablet face is a sharp beveled edge. If the sharp edge cumscribed and inscribed circles, which determine
remains, a punch tip will fracture at this point. A mini- the tablet's size and configuration.
mum .015-inch [.381-millimeter] radius is recommend-
ed to remove the sharp edge (see Figure 22, Illus. C).

Flat-Faced Radius-Edged (F.F.R.E.) Tablet: A tablet Circumscribed Circle: The smallest circle that can be
configuration similar to F.F.B.E. consisting of a cup, a drawn around a geometric shape so that it intersects
radius between the cup and tablet face, and, if required, each comer of the inner figure. A circumscribed circle
a land. To ensure the strength of punch edges, the restricts the external boundaries of a given tablet shape.
radius from the tablet's periphery or land should not
exceed the comparable 30° bevel used for the F.F.B.E. Inscribed Circle: The largest circle that can be drawn
design. This limitation on the radius will reduce the flat inside a geometric shape so that their boundaries touch
area on the tablet's face, limiting the surface area avail- at as many points as possible. An inscribed circle
able for an identification. restricts the internal boundaries of a given tablet shape.

© American Pharmaceutical Association 47

 FIGURE 23. PROFILES OF CONVEX AND F.F.B.E. TABLETS

EXTRA-DEEP
[
SHALLOW
STANDARD

C_J STANDARD

;:
DEEP I:
E:
ii:
Er:
e:
EXTRA-DEEP
ii!:

==
.015 R FLAT-FACED
•
if:
BEVEL-EDGED
!:::
.;.,-------~-------- _ _j_ .,..___MO_D_IF_l_ED_B_A_LL--1 ii!:
" 30· I;
)'
[ ] I:
I:
FLAT-FACED I:
BEVEL-EDGED
&:::
I:
OWG. NO.
TSM-N23 I:
[;:
48 ©American Pharmaceutical Association
I:
 FIGURE 24. TERMINOLOGY FOR SHAPED TABLETS

END RADIUS

MINOR
AXIS
MINOR END
I MINOR RADIUS
MAJOR AXIS SIDE VIEW

BAND

MAJOR SIDE VIEW OVAL

(ILLUS. B)
CAPSULE
(ILLUS. A) CUPMAJOR
RADIUS ~
_ _

MINOR CUP
RADIUS
MINOR CUP RADIUS

COMPOUND CUP
(ILLUS. C)

CUP
NAnJRAL
EDGE

SPHERICAL+ CU?
CUP RADIUS RADIUS

.04 MIN. C
~RADIUS
HEXAGON-SHAPED SHERICAL
RADIUS WITH NATURAL EDGE
(ILLUS. D)

INSCRIBED CIRCLE 1/2 l.C.

TOTAL
CUP /--~~~

\-,__ ~·

BEVEL ~ I\ J
HEXAGON-SHAPED RADIUS CHORD
ANGLE --J '('" SEGMENT WITH SQUARE EDGE
HEXAGON-SHAPED (ILLUS. F)
CONVEX WITH BEVELED EDGE
(ILLUS. E)
DWG. NO.
TSM-N24

© American Pharmaceutical Association 49

 Comer Radius: The curvature used to eliminate sharp • Tablet coating
corners on peripheral surfaces where two lines or • Bisects or sc·ores
curves meet. A minimum recommended corner radius • Compressibility of formulations
is .04 inch [1.01 millimeter]. (See Figure 23, Illus. D.) • Maximum area available for the identification
• Complexity of the identification
Figure 25 shows the shapes most commonly used in • Location of the identification
tablet designs. • Techniques for preventing picking

Tablet Coating
Tablet Identification Film-Coated Tablets

The Food and Drug Administration (FDA) has ruled Film coating can affect the complexity, font style, and
that all human drug products in solid oral dosage form stroke specifications of a tablet identification. As a film
must bear a code (imprinted or otherwise applied) that coating adheres to a tablet's surface, the coating begins
identifies the drug product and the holder of the prod- to consume the stroke width and depth, which in tum
uct's approved application for marketing. (For the com- diminishes the clarity of the identification. The degree
plete ruling, see the Federal Register. Sep. 1993; 58 to which the clarity is affected depends on the method
(175): 47948.) The ruling gave manufacturers of phar- of application, and the percentage and type of coating
maceutical, nonprescription, biological, and homeo- applied.
pathic drugs who were not in full compliance with the
ruling at that time until September 13, 1995, to meet all For film-coated tablets the stroke width should equal
FDA requirements. 22-24% of the font's height. Stroke depths smaller than
.007 inch [.178 millimeter] are not recommended
Before an identification (code) is applied to a tablet's unless the tablet manufacturer can verify that smaller
face, the tablet's form (i.e., its geometric shape, con- stroke depths worked on film-coated tablets produced
tour, and identification) must first be transferred to the in the past. Stroke angles can vary from 35-45°, with
punch tip's face. Using the information on a tablet 35° and a .005- to .007-inch [.127-to .178-millimeter]
detail drawing, a toolmaker produces a metal fixture flat in the bottom of the stroke being the optimal design
called a hob, one end of which contains a reproduction (see Figure 27, page 52). If these parameters cannot be
of the tablet detail dimensions. By means of a hydraulic met, the following conditions may exist:
press, the hob is pushed into the soft steel of the punch
tip, thereby leaving a duplicate, opposing impression of • The designated cup depth is too large.
the tablet's form. Many restrictions on tablet identifica- • The tablet is too small for the number of digits
tions are due to the constraints related to manufacturing specified for engraving.
a hob. • The identification is located outside the maximum
identification area of the tablet face.
To deboss or transfer the tablet identification into the • The identification is too complex.
hob's surface, the toolmaker uses a tool that cuts a
groove or pocket, called a stroke, in the metal (see Fig-
ure 26, page 52). Although the cutting tool is not shown Uncoated Tablets
on the tablet detail drawing, a cross section of the
stroke with dimensional specifications is detailed, Because design specifications for uncoated tablets are
allowing the toolmaker to produce the correct cutting less restrictive, the tablet identification can be more
tool. complex. The specifications for uncoated tablets are as
follows:
The following factors can affect the optimal design of a • Stroke width is 18-20% of the font height.
tablet identification: • Stroke depth is 50% of stroke width, or no less than
.003 inch [.076 millimeter].

50 © American Pharmaceutical Association

 FIGURE 25. COMMON TABLET SHAPES
2 3 4

0
STANDARD CONVEX
~ 8 0
STANDARD CONVEX STANDARD CONVEX
8 ij
STANDA~D CONVEX
BISECT NOT FLUSH QUADRISECT FLUSH STRAIGHT- THRU BISECT
5 6 7 8

o~
COMPOUND CUP
00
CONVEX WITH BEVEL
o~
FLAT-FACED PLAIN
00
FLAT-FACED BEVEL-EDGED

eo
g 10

FLAT-FACED BEVEL-EDGED FLAT-FACED BEVEL-EDGED FLAT-FACED RADIUS-EDGED LOZENGE

BISECT QUADRISECT

CORE ROD TYPE CAPSULE MOD CAPSULE

MODIFIED BALL (HOLE IN CENTER)

BULLET ARROW HEAD TRIANGLE

22 23 24

ARC TRIANGLE
0 0 0 0
SQUARE PILLOW
(ARC SQAURE)
0
RECTANGLE

27 28

MODIFIED RECTANGLE DIAMOND

0 0 0
PENTAGON HEXAGON
©
29 30 31

0 ©
OCTAGON NATURAL
EDGE
VO D HEART HALF MOON
( "D"SHAPE) ALMOND

IDWG. NO.
TSM-N25

©American Pharmaceutical Association 51

 FIGURE 26. APPL YING TABLET IDENTIFICATION
TABLET DETAIL
TO PUNCH FACE
( TSM) (j] HARDENED

__
(
STEEL HOB

( _1_2~ )

PUNCH TIP FACE

AFTER PRESSING

SOFT STEEL
HOB ~----PUNCH BLANK
REPRODUCTION OF
TABLET DETAIL
DWG. NO. TSM-N26

FIGURE 27. GUIDELINES FOR FILM COATING

l-. 013 __L_ .
·1-~35·
.009
----STROKE
WIDTH AFTER
-r- FILM COATING
.007
FILM-
COATING
.003 STROKE
BEFORE COATING AFTER COATING .005 DEPTH

UNCOATED DESIGN FILM-COATED DESIGN

.018
35·

-r-
l
.007 LFILM
COATING

DWG. NO.
TSM-N27

52 @American Pharmaceutical Association

 • Stroke angle is 30-45°. bisect, can only be used on radiused cup designs. It has
• The minimum font height is .035 inch [.889 mil- an advantage over the standard bisect by allowing the
limeter] with a 30° stroke angle. consumer to better break the tablet into the prescribed
dosages. The cut-through bisect is wider at the center of
the tablet than the standard bisect is, which reduces the
Bisects and Scores available engraving space on the tablet. face. The height
of the cut-through bisect is generally the same as the
Applying a bisect or score to a tablet's surface creates a cup depth.I
stress line along which the tablet breaks easily. The
bisect types shown in Figure 28 on page 54 range from Bisects are often modified to meet specialized require-
the most functional bisect (the Type G, or pressure sen- ments. The most common modified bisect style is the
sitive bisect) to the least functional (the Type H, or par- partial bisect, which is used when the bisect interferes
tial bisect). ', with a code or logo on the tablet surface.I

The bisect's purpose-to produce a desired dosage All bisect specifications for concave tooling are based
amount of a tablet-is affected by the tablet's cup on the standard cup depths as shown in Table 12 (see
depth, band thickness, and hardness. Specifications for page 69). Bisects for F.F.B.E./F.F.R.E tooling, should
the bisect's size are determined by the tablet's size, the also be based on the cup depths shown in Table 12. The
tablet identification, and the bisect design. (See Table table presupposes that the bisect's line radius, or stress
10 on page 55 for standard bisect specifications.) line, is parallel to the cup surface, similar to the A, E,
B, and H bisects shown in Figure 28. If one of these
To avoid ejection problems with bisected tablets, the bisects is to be used with a nonstandard concave depth,
bisect should be placed on the upper punch when the the bisect's depth should equal 33% of the required cup
bisect's depth exceeds 40% of the cup depth, unless the depth.
tablets will contain a large quantity of embossed char-
acters. With bisected debossed tablets, the bisect height
on the punch is generally higher than the engraving; Formulation Compressibility
therefore, placing a bisect on a lower punch makes it
more difficult to scrape the tablet off the face of the During the compression stage of tablet production, a
punch at ejection.1 With bisected embossed tablets, formulation (granulation) may exhibit unusual charac-
however, placing embossed characters on the lower teristics. Common problems with formulation com-
punch may create more ejection problems than placing pressibility include:
the bisect there.
• The formulation is hard to compress; a higher ton-
The standard TSM bisect has two different configura- nage than normal is required.
tions for concave tablets, protruding and cut flush. The • A lower tonnage than normal is required to com-
protruding bisect style follows the curvature of a press the formulation.
radiused cup and extends past the tip edge of the punch. • The formulation sticks to the punch face.
This style helps break the tablet into equal parts • Abrasives are higher than normal.
because the extended bisect is pressed into the tablet
band. The protruding bisect may run into the tip edge of Any problems with formulation compressibility should
the lower punches if they become too close during the also be discussed with the tooling manufacturer.
compression cycle of the press. Running the bisect into
the lower punch edge leaves deep impressions in the Formulation characteristics can dictate the (1) stroke
lower tip edge while smashing and swelling the protru- specifications for the identification and (2) location of
sion of the bisect on the upper punch. For this reason, the identification on the tablet face. Taking formulation
the standard cut-flush bisect style has become more compressibility into consideration at the design stage
popular. 1 could prevent problems during tablet production.

A cut-through bisect, also known as a European style

©American Pharmaceutical Association 53

 FIGURE 28. TYPES OF BISECT LINES
FACE VIEW END VIEW SIDE VIEW
G)
PRESSURE
J_ .
SENSITIVE
BISECT §Lso%MAXOF
BAND THICKNESS
G TYPE
®
CUT
THROUGH
BISECT L 95% OF
CUP DEPTH
D TYPE
®
DECREASING
BISECT
BISECT
L 75% OF
CUP DEPTH
C TYPE RADIUS

©
STANDARD
PROTRUDING
BISECT

A TYPE
®
STANDARD
BISECT

E TYPE
®
SHORT
BISECT

B TYPE
®
PARTIAL
BISECT

H TYPE
NOTES.:
1. ALL BISECT LINES ARE BASED ON A 90" ANGLE.
2. AN UPPER PUNCH DESIGNATION IS SUGGESTED IF THE BISECT'S DEPTH CONSUMES A HIGH PERCENTAGE OF THE CUP,
OR IF THE BISECT PROTRUDES INTO THE TABLET'S BAND, AS IN BISECTS 1
AND 4. OTHER TYPES OF BISECTS MAY ALSO PROTRUDE INTO THE BAND TO DWG. NO. TSM-N 28
MAKE IT EASIER TO BREAK THE TABLET.

54 ©American Pharmaceutical Association

 TABLE 10. STANDARD BISECT SPECIFICATIONS

TABLET SIZE CONVEX & F.F.B.E.

INCH I MILLIMETER I w D
1/8 [ 3.175] .014 [ .356] .006 [ .152]
5/32 [ 3.9701 .016 [ .406] .007 [ .178]
3/16 [ 4.763] .018 [ .457] .008 [ .203]
7 /32 [ 5.555] .020 r .5081 .009 r .229J
1/4 [ 6.350] .022 [ .559] .010 [ .254]
9/32 7.142] .024 [ .610] .011 [ .279]
5/16 r 7.9381 .026 [ .660] .012 [ .305]
11/32 [ 8.730] .028 [ .711] .013 [ .330]
3/8 [ 9.525] .030 [ .762] .014 [ .356]
13/32 [10.318] .032 [ .813] .015 [ .381]
7/16 [11.113] .032 [ .813] .015 [ .381]
15/32 11.905] .032 [ .813] .015 [ .381]
1/2 12.700] .032 r .813J .015 r .3811
17/32 13.493] .032 [ .813] .015 [ .381]
9/16 14.288] .032 [ .813] .015 [ .381]
19/32 [15.080] .032 [ .813] .015 [ .381]
5/8 [15.875] .032 [ .813] .015 [ .381]
11 /16 [17.463] .040 [1.016] .019 [ .483]
3/4 [19.050] .040 [1.016] .019 [ .483]
13/16 20.638] .040 [1 .016] .019 r .4831
7/8 [22.225] .040 [1.016] .019 [ .483]
15/16 [23.813] .040 [1.016] .019 [ .483]
1 [25.4001 .o5o r1 .2701 .024 r .6101

1. ALL BISECTS SHOULD HAVE AN APPROPRIATE .002-INCH [.051-MILLIMETER] RADIUS AT THE BOTIOM OF THE
BISECT.
2. BISECT SPECIFICATIONS FOR CONCAVE TABLETS ARE BASED ON THE STANDARD CUP DEPTHS LISTED IN TABLE
12 (PAGE 69). FOR NONSTANDARD CUP DEPTHS, THE BISECT DEPTH SHOULD EQUAL 33% OF THE CUP DEPTH.
· 3. BISECT SPECIFICATIONS FOR F.F.B.E./F.F.R.E. TOOLING ARE BASED ON THE CUP DEPTHS LISTED IN TABLE 12.
4. BISECT SPECIFICATIONS FOR SHAPED TABLETS ARE DETERMINED BY CORRELATING THEIR MINOR AXIS
DIMENSION WITH THE APPROPRIATE TABLET SIZE DIMENSION IN THE TABLE.

© American Pharmaceutical Association 55

 Maximum Identification Area The maximum allowable percentage of distortion
equals stroke distortion divided by the required stroke
The maximum identification area is the percentage of depth multiplied by 100. The size of the identification
the tablet face that is available to produce the least dis- area should be chosen so that the stroke depth never
tortion of the stroke depth. The identification area dic- exceeds 30% of the required stroke depth for film-coat-
tates the dimensions of any debossing or embossing ed tablet designs, and 35% for uncoated .tablets. For
that will be applied to the tablet's surface. Figure 29 on shaped tablets, the minor axis cup radius and, when
page 57 shows the maximum identification area for the applicable, the major axis cup radius are used to deter-
various cup depths of round tablets as a circular dashed mine the maximum tablet identification area. Exceeding
line on each tablet's face. As a rule, the identification the recommended limits for stroke distortion can
area and the dimensions of an identification-in this adversely affect the clarity of the tablet identification.
case the letter A-decrease as the cup depth increases.
On F.F.B.E. tablets, the bevel angle intersects the
Three factors determine the maximum identification tablet's face and creates a sharp beveled edge. As
area: ( 1) the cup radius, (2) stroke specifications, and shown in Illustration 1, an identification character or
(3) stroke distortion. symbol should be positioned at least .006 inch [.152
millimeter] plus a stroke width from the beveled edge.

Cup Radius Illustration 1

The cup radius, which is used to generate the tablet's .006 [.152]
+STROKE WIDTH
contour, is dictated by the size of the tablet's periphery,
cup depth, presence of land, and cup design. As the cup
radius increases, the tablet face becomes flatter and the
maximum identification area increases.

Stroke Specifications
STROKE WIDTH

Stroke specifications consist of the stroke width, depth,

and angle, as well as the radius and break radius dimen-
sions (see Figure 30, Illus. A; page 58). A normal stroke Complexity of Identification
results when the cutting tool begins at the apex of the
cup radius and cuts a stroke depth and angle that are Unless modified or simplified, an identification
equal on each side of the stroke width (See Figure 30, designed primarily for advertising copy, letterhead, and
Illus. B). The earlier discussion of "Tablet Coating" on packaging may not be practical for tablet designs. The
pages 50 and 52 lists the optimal stroke specifications illustrations below show how a design can be simplified
for film-coated and uncoated tablets.
Illustration 2

Stroke Distortion
IMPRACTICAL FONT SIMPLIFIED
FOR TABLET DESIGNS FONT DESIGN
Stroke distortion results when a cut is made at a point
on the cup radius that produces a stroke depth and
angle that are not equal on each side of the stroke width
TSM
(see Figure 30, Illus. C). As shown in Illustration C, the
outsi(ie stroke depth is smaller than the inside stroke FULL
PARTIAL
RADIUS
RADIUS
depth; the amount of stroke distortion equals the nomi- DESIGN
DESIGN
nal inside stroke depth minus the outside stroke depth.

56 © American Pharmaceutical Association

 List of Tables
Rotation Direction of Tablet Presses ..................................................... . 7
Table 1
Table 2 Maximum Tablet Sizes for Standard Dies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . 34
Table 3 Standard Clearances for Normal Application of Round Tooling .............. .'.... ,. 35
Table 4 Available Key Space and Maximum Stern Lengths ...............-. ... .. .. .. . ... .. .....
Punch Key Lengths and Available Key Space ..........................................
.38
38
•
i ii

Table 5 iii
ii
Table 6 Interchangeable Tooling for Rotary Tablet Presses:
3/4" Punch Barrel and .945" Die . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 •
i ii

Table 7 Interchangeable Tooling for Rotary Tablet Presses:

3/4" Punch Barrel and 1.1875" Die .. ...... ..... ... . ... .. ... ... ... .. ... .. .. ...... ... ..... 40
Table 8 Interchangeable Tooling for Rotary Tablet Presses:
1" Punch Barrel and 1.500" Die . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
•
i ii

Table 9 Interchangeable Tooling for Special Rotary Tablet Presses . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Table 10 Standard Bisect Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 •
i ii

Table 11 Minimum Land Widths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 •

ii

Table 12 Punch Tip Tabulations ..................................................................... 69

Table 13 Chemical Composition of Tool Steels ................................................... 73
ii
Typical Hardness Readings for Tool Steels .. . ... . ... ... ... ..... ... .. ... .. .... ... .. ... .. 75 iii
Table 14
Table 15 Punch Tip Compression Forces for TSM Round Tooling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Table 16 Punch Tip Pressure Ratings Versus Shape Factors .................................... 78 Ii
iii
Table 17 Punch Tip Pressure Ratings Versus Cup Depth for 30° F.F.B.E. Tooling . . . . . . . . . . . . 80
Table 18 Polishing Compounds and Tools ························································· 98

Table 19 Production Problems with Tablet Quality ................................................ 106

Table 20 Production Problems with Tooling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

ii
iii

;
ii

!
•
;
ii

;
ii

;
ii

!
•

ii
i

© American Pharmaceutical Association

vi
 FIGURE 29. MAXIMUM IDENTIFICATION
AREA FOR ROUND TABLETS
STROKE
ANGLE

BREAK
RADIUS

STROKE MAX. 1.0. AREA = 93%

DEPTH SH ALLOW CON VEX

SEC. A-A OF SHALLOW

CONVEX TABLET

REQUIRED
STROKE WIDTH
MAX. 1.0. AREA = 86%
/ STANDARD CONVEX
/ BREAKOUT
/
I
DETAIL "B"
I
I

MAX. 1.0. AREA = 703

DEEP CONVEX

DETAIL B OF DEEP
CON VEX TAB LET
MAX. l.D. AREA = 45%
NOTES: EXTRA-DEEP CONVEX
1. DOTTED LINE ON FACE VIEWS INDICATES USABLE
SURFACE AREA FOR TABLET IDENTIFICATION.

2. ALL PERCENTAGES FOR MAXIMUM IDENTIFICATION

AREA ARE BASED ON A 30• STROKE ANGLE, .006
INCH STROKE DEPTH, AND NO LAND. INCREASING
THE STROKE ANGLE OR DESIGNATING A LAND WILL
DECREASE THE PERCENTAGE OF IDENTIFICATION
AREA. MAX. l.D. AREA = 353
MODIFIED BALL CONVEX
3. THE MAX. l.D. AREA FOR A SHALLOW CONVEX
TABLET IS SMALLER THAN THAT FOR A STANDARD CONVEX
TABLET BECAUSE THE STROKE DEPTH CANNOT EXCEED THE
DWG. NO.
CUP DEPTH AT THE TABLErs EDGE.
TSM-N29

@American Pharmaceutical Association 57

 FIGURE 30. STROKE SPECIFICATIONS
AND STROKE DISTORTION

HOB

(ILLUS. B)

l
OUTSIDE
INSIDE
STROKE DEPTH
STROKE DEPTH

HOB
(ILLUS. C) STROKE DISTORTION
NOTES:
1. NOMINAL STROKE DEPTH MINUS OUTSIDE STROKE DEPTH EQUALS STROKE DISTORTION.
2. · STROKE DISTORTION DIVIDED BY REQUIRED STROKE DEPTH EQUALS MAXIMUM DISTORTION:
303 MAX. DISTORTION FOR FILM-COATED DESIGNS; 353 MAX. DWG NO
DISTORTION FOR UNCOATED DESIGNS. . . TSM- N 30

58 ©American Pharmaceutical Association

by changing the font and applying radii on the corners. or increasing dwell time does not improve or eliminate
A tablet's dosage size and maximum identification area the problem, a soft zone is strongly indicated. Reducing
also determine the clarity of the final product's identifi- the cup depth is the next step in solving the problem;
cation. however, if this is not possible, moving the identifica-
tion away from the cup apex should be considered (see
Illustration 5).

Location of Identification If design restrictions, sue~

as numerous characters or a
cup depth category that provides a small identification
After establishing the maximum identification area, the area, cannot be changed, the following measures should
next step is to locate the required tablet identification be considered:
within the confined area. The number of characters, as
well as the cup depth and design, determines,the opti- • Use a 35° or greater stroke angle.
mal location for the identification. Depending on the • Increase the stroke break radius.
number of engraved characters, the identification may • Use techniques to prevent picking.
be restricted to only one location within the identifica-
tion area. Centering the identification horizontally Illustration 5
across the tablet's face can optimize the identification
size. Illustration 3, below, shows the largest optimal
identification size.

Illustration 3

Techniques To Prevent Picking

Techniques that prevent picking reduce the amount of

force needed to compress powder within small confined
areas of a tablet identification, referred to as pads or
In some circumstances, characters located in a poten- peninsulas. As a result, the incidence of granulation
tially soft zone of the tablet cup can result in picking or sticking to the punch faces is reduced.
sticking of the formulation to the punch face. When a
punch begins compressing a powder into a tablet form, Figure 31 on page 60 shows two techniques to prevent
the compression force is initially higher at the land. The picking in pad areas: (1) increasing the stroke break
dwell time and applied tonnage can affect the equal dis- radius around pads and (2) decreasing the pad depth. If
tribution of the compression force across the entire sur- the required cutter depth is less than .006 inch [.152
face of the cup. If the force is not distributed equally, a millimeter], the break radius on the pads can be
soft zone can occur on the face of tablets that have a increased 1.5 to 2 times the outside break radius. If the
cup depth category of deep, extra-deep, or modified cutter depth is .006 inch or greater, decreasing the
ball. The soft zone normally appears at the apex of the depth of pad areas by 25-50% and increasing the break
cup as capping, picking or sticking, or abnormal surface radius can also alleviate picking in pad areas.
abrasion (see Illustration 4). If reducing the press speed
Figure 32 on page 61 shows techniques to prevent pick-
ing in two other problem areas: peninsulas and corners.
Illustration 4
Tapering a peninsula by 25-50% of the total cut depth
PUNCH should alleviate picking in this type of confined area.
TIP
Generating a corner radius in all sharp corners elimi-
_.. ..._POTENTIAL nates compound angles, which should alleviate picking
SOFT ZONE
in these areas. The minimum value recommended for a
corner radius is .002 to .003 inch [.051 to .076 millime-

©American Pharmaceutical Association 59

 FIGURE 31. TECHNIQUES TO PREVENT
PICKING IN PAD AREAS
INCREASE BREAK RADIUS
LOWER & INCREASE
PAD AREAS BREAK RADIUS

DECREASE DEPTH OF
PAD AREAS AND
INCREASE BREAK INCREASE BREAK
RADIUS ON THE RADIUS
PAD 1.5-2 TIMES
THE OUTSID'E
BREAK RADIUS
PAD AREAS ARE
DECREASED 25-503 OF
THE TOTAL DEPTH OF
THE CUT

l
INCREASE THE BREAK RADIUS ON PADS IF THE DECREASE DEPTH OF PAD AREAS AND
REQUIRED CUTTER DEPTH IS LESS THAN .006 INCREASE BREAK RADIUS IF AND ONLY IF
INCH. THE CUTTER DEPTH IS .006 INCH OR GREATER.
EXAMPLES: EXAMPLES:

D D
TSM-N31

60 ©American Pharmaceutical Association

 FIGURE 32. TECHNIQUES TO PREVENT
PICKING IN PENINSULAS AND c·oRNERS
TAPER PENINSULAS USE CORNER R.ADll
CORNER
RADII
r-i--ir---- COMPOUND
ANGLE
SHARP

NOTE:
TAPER PENINSULAS 25-50%
OF THE TOTAL DEPTH OF
THE CUT.

NOTE:
AS LETTER HEIGHT INCREASES, THE CORNER RADIUS
INCREASES. MIN. CORNER RADIUS = .002/.003 INCH;
MAX. CORNER RADIUS = .004/.006 INCH.

EXAMPLES: EXAMPLES:

DWG. NO. TSM-N 32

©American Pharmaceutical Association 61

 ter]; the maximum recommended value is .004 to .006 shape of a capsule. In this printing process, the tablet is
inch [.102 to .152 millimeter]. rotated about its major axis as the characters are applied
to the tablet's surface (see Illustration 7). The size and
Although all of these techniques alleviate problems with number of characters are determined by the tablet's
picking and sticking, the lack of a stroke break radius is circumference.
a main contributor to the problems. As a rule, the desig-
nated stroke break radius should remove approximately
one-third of the stroke depth (see Illustration 6). linear Printing

Figures 33 and 34 on pages 63 and 64 show sample In linear printing, the tablet's major axis periphery and
designs of bold and narrow letters and numerals used
by some tooling manufacturers. These and other similar
fonts can reduce the incidence of picking and sticking.
(See Table 19 on page 110 for other factors that can
cause picking and sticking.) If these problems cannot
minor axis cup are aligned with the printing mecha-
nism. This alignment allows the identification to be
imprinted consistently across a major axis location (see
Illustration 8). Tablet orientation is critical to maintain-
ing a consistent placement of the identification on the
-
iiiiiiil

be resolved, printing the identification on the tablet tablet and to avoiding side printing, or printing on the
might be an option. tablet band (see Illustration 9).
Illustration 8
Illustration 6

~~
1/3
STROKEl
STROKE ~ DEPTH
BREAK RADIUS '-. ---*~ ( ) LINEAR PRINTING

STROKE
DEPTH

t Illustration 9

Tablet Printing ~~SAUGNED SIDE PRINTING

When an identification is mechanically printed on a

tablet's surface, the tablet is usually film coated. Of the The two major factors to consider in designing a tablet
two types of tablet printing, linear and radial, linear for linear printing are (1) cup radii and (2) tablet pro-
printing is the method used most often. portions.

Radial Printing Cup Radii

Radial printing, also called spin printing, can be used The cup radii, which are the major and minor axis radii,
only for caplet shapes that closely approximate the form the tablet's contour, or surface. The cup radii
should be as large as possible to reduce rocking of the
Illustration 7
Illustration 10
TABLET
CIRCUMFERENCE
LARGE SMALL CUP RADIUS e
~~ RADIUS ~
( §!

RADIAL
)

PRINTING
COMPOUND
CUP
OO TABLET
ROCKED
OVER ONTO
BAND

62 © American Pharmaceutical Association •m

 FIGURE 33. SAMPLE DESIGNS FOR
BOLD CHARACTERS
BOLD DESIGN

STANDARD DESIGN

DWG. NO. TSM-N 33

© American Pharmaceutical Association 63

 FIGURE 34. SAMPLE DESIGNS FOR NARROW CHARACTERS

BJ [ID ~ [Q) ~
~ ® ~ ~ J
~ [L ~ ~ @
~ @l ~ ~ Li
[ill 'VJ ~ ~ l?
g ~ ~ ~ ~
® IJ ® ®
DWG. NO.
TSM-N34

64 ©American Pharmaceutical Association

tablet in the printer's carrier pockets (see Illustration Tablet Detail Drawings
10). Because the minor axis controls the degree of rock-
ing, the size of the minor axis radius should be empha-
sized in the tablet design. Prior to manufacturing of any tooling, a detailed draw-
ing of the proposed tablets must be gen~rated. Whether
The cup radii will also affect the printing window. The creating a design for a new product or modifying the
size of the printing window determines the maximum design of an existing one, tooling manufacturers can aid
character size that can be printed on the tablet's surface. in preparing tablet drawings. A tablet detail drawing
Illustration 1lA shows that a large cup radius provides should contain the following basic information:
a wide printing window, whereas a medium cup radius
provides only a narrow printing window. On tablet • A face view with full dimensions of the tablet
drawings, an approximation of the printing window is periphery
usually shown on the face view as a phantom line (see • For round tablets, a single side view
Illustration 1lB). • For shaped tablets, side views of the major and
minor axes
Illustration 11 • Cup depth, land, and cup radius
PRINTING WINDOW
• For compound cup tablets, all radii locations
PRINTING WINDOW

A
©® B
\
If a tablet identification is present, the following infor-
mation is needed:

• Height, width, and spacing for each character

Tablet Proportions • Location of the identification relative to the
periphery's latitude and the centerline's longitude
A tablet's proportions can affect the degree to which • Details and notes for techniques to prevent picking
rocking occurs. To reduce tablet rocking, the difference • Stroke specifications
between the tablet's minor axis, or width, and the tablet
thickness should not be less than .060 inch [l.524 mil- Because drawings for most shaped tablets usually
limeters]; a difference range of .075-.090 inch [l.905 require at least three views, a B-size (11- by 17-inch)
to 2.286 millimeters] is preferable. Cup depth, which sheet is suggested. An A-size (8 1/2- by 11-inch) sheet
can also affect rocking, should be at least 24% of the is usually sufficient for the face and side views required
total tablet thickness (see Illustration 12). Both propor- on drawings of round tablets. (A detail drawing of each
tions must be met to prevent tablet rocking. If the stipu- side of the tablet printed on separate sheets is recom-
lated difference between the minor axis and tablet mended.) If a drawing's size is reduced for facsimile
thickness is met, but the cup depth is less than 24% transmission, the text should be checked again for legi-
of the tablet thickness, the resultant increase in band bility. Tablet drawings created on a B-size sheet usually
thickness may cause the tablet to rock onto its side. require a minimum text height of 1/8 inch [3.175 mil-
limeters].

If a tablet drawing lacks the required information and

Illustration 12
the tooling for the product is purchased later from a dif-
MINOR AXIS ferent vendor, an inconsistency in the product may
(WIDTH)
occur. The new vendor needs the following information
,... •1 fCUP24%
to ensure product consistency:
~f TlBLETTHICKNESS
~; • Tablet detail drawing for each side of the tablet
• For round tablets, samples of the upper and lower
punches
• For shaped tablets, sample punches and a sample die

©American Pharmaceutical Association 65

 FIGURE 35. GUIDELINES FOR PUNCH
TIP LAND

(ILLUS. A)

SHALLOW CUP NO LAND

SHARP TIP EDGE
FORCE
DEFORMED
TIP EDGE
CAN RESULT
LT\P
DEFLECTION
UNDER LOAD
DETAIL A
(ILLUS. B) (ILLUS. C)

SHARP CORNER
1· LAND ·1 STD. CONC.
CUP RADIUS
EXTRA DEEP
CUP RADIUS
PUNCH
PERIPHERY
(ILLUS. D)

LAND
BLENDED RADIUS
STD.
CUP
MEASURABLE
LAND SIZE EX.-DP.

EXTRA DEEP
KEEP OUTER CUP RADIUS
EDGE SHARP
PUNCH
PERIPHERY (ILLUS. E)

DWG. NO. TSM-N 35

© American Pharmaceutical Association 67

Acknowledgments
The American Pharmaceutical Association (APhA) wishes to acknowledge the individuals listed below for their assis-
tance in producing this new edition. Although space limitations prevent our listing each person's specific contribution,
we thank the steering committee for suggesting revisions and additions to the manual, and for diligently.participating in
numerous rounds of critiquing and refining the new material. We also thank the reviewers and contributors for providing
information about their tablet tooling or presses and/or for reviewing preliminary copy. T~e dedication of these individ-
uals to their industry and their generous contributions of time, knowledge, and materials have helped us tO again
improve the Tableting Specification Manual.

Tableting Specification Paul E. Schaa Fran Mallee

Steering Committee Members A.C. Compacting Presses Larry D. Guessford
North Brunswick, New Jersey Stokes
Robert Andrew Division of DT Industries
Glaxo Wellcome Inc. Sean Scully Bristol, Pennsylvania
Research Triangle Park Fette America
North Carolina Rockaway, New Jersey Pat Staley
Vector Corporation
GlenC. Ebey William D. Supplee Marion, Iowa
Thomas Engineering Inc. McNeil Consumer Products
Hoffman Estates, Illinois Company David Woodson
Fort Washington, Pennsylvania Fette America
Bill Froat Rockaway, New Jersey
Schering Plough Corporation
Kenilworth, New Jersey
Reviewers and Contributors
Trevor M. Higgins
I. Holland Limited Warren Albeck
Nottingham, England Elizabeth-Hata International, Inc.
North Huntington, Pennsylvania
Bill Hnatuk
Colorcon Gary K. Barnabas
West Point, Pennsylvania BWI Manesty
Merck & Company, Inc. (Retired) Liverpool, England

Richard Kirk Jeff Contreras

Elizabeth Carbide Die Company, Inc. Key International, Inc.
McKeesport, Pennsylvania Englishtown, New Jersey

Dale Natoli Sandra Lipke-Torkel

Natoli Engineering Company, Inc. Kilian & Company, Inc.
Chesterfield, Missouri Horsham, Pennsylvania

©American Pharmaceutical Association vii

 The actual width of a measurable land is affected by the
( l) size of the blended radius and (2) cup radius and TABLE 11. MINIMUM LAND WIDTHS
depth. Based on the same land requirements, Illustration
LAND WIDTHS
E shows the measurable land of two cup depth categories.
CUP DEPTH SHAPES ROUNDS
The standard cup depth has a larger measurable land. Dif-
ficulty in controlling how much material is removed, or SHALLOW REMOVE REMOVE
SHARP TIP SHARP TIP
blended, increases as the cup depth increases.
EDGE EDGE
STANDARD .004 [ :102] .003 [ .076]
DEEP .005 [ .127] .004 [ .102]

NOTE: The TSM Committee recommends that a EXTRA-DEEP .006[.152] .005 [ .127]
land be specified for all tablets or punches with a MOD. BALL .008 [ .203] .007 [ .178]
cup depth of standard or greater. , ,, F.F.B.E. .004[.102] .003 [ .076]

NOTE: VALUES PERTAIN TO MINIMUM LAND

WIDTHS BEFORE BLENDING.

68 © American Pharmaceutical Association

 TABLE 12. PUNCH TIP TABULATIONS

PUNCH
TIP DIA. -$it -$6 $6 $@ $@ ${}
INCHES SHALLOW STANDARD DEEP EXTRA-DEEP MOD. BALL FFBE/FFRE
[MIWMETERS] CUP DEPTH CUP DEPTH CUP DEPTH CUP DEPTH CUP DEPTH CUP DEPTH

1/8 [3.175] .005 [ .127] .017 [ .432] .024 [ .610] .030 [ .762] .040 [1.016] .007 [ .178]

5/32 [3.970] .007 [ .178] .021 [ .533] .030 [ .762] .036 [ .914] .049 [1.245] .008 [ .203]
,
3/16 [ 4.763] .008 [ .203] .026 [ .635] .036 [ .914] .042 [1.067] .059 [1.499] .009 [ .229]

7/32 [5.555] .009 [ .229] .029 [ .737] .042 [1.067] .048 [1.219] .069 [1.753] .010 [ .254]

1/4 [6.350] .010 [ .254] .031 [ .787] .045 [1.143] .050 [1.270] .079 [2.007] .011 [ .279]
9/32 [7.142] .012 [ .305] .033 [ .838] .046 [1.168] .054 [1.372] .089 [2.261] .012 [ .305]

5/16 [7.938] .013 [ .330] .034 [ .864] .047 [1.194] .060 [1.524] .099 [2.515] .013 [ .330]
11/32 [8.730] .014 [ .356] .035 [ .889] .049 [1.245] .066 [1.676] .109 [2.769] .014 [ .356]

3/8 [9.525] .016 [ .406] .036 [ .914] .050 [1.270] .072 [1.829] .119 [3.023] .015 [ .381]
13/32 [10.318] .017 [ .432] .038 [ .965] .052 [1.321] .078 [1.981] .128 [3.251] .016 [ .406]
7/16 [11.113] .018 [ .457] .040 [1.016] .054 [1.372] .084 [2.134] .133 [3.378] .016 [ .406]
15/32 [11.905] .020 [ .508] .041 [1.041] .056 [1.422] .090 [2.286] .148 [3.759] .016 [ .406]

1/2 [12.700] .021 [ .533] .043 [1.092] .059 [1.499] .095 [2.413] .158 [ 4.013] .016 [ .406]
17/32 [13.493] .022 [ .559] .045 [1.143] .061 [1.549] .101 [2.565] .168 [ 4.267] .016 [ .406]

9/16 [14.288] .024 [ .610] .046 [1.168] .063 [1.600] .107 [2.718] .178 [4.521] .016 [ .406]
19/32 [15.080] .025 [ .635] .048 [1.219] .066 [1.676] .113 [2.870] .188 [ 4.775] .016 [ .406]

5/8 [15.875] .026 [ .660] .050 [1.270] .068 [1.727] .119 [3.023] .198 [5.029] .016 [ .406]

11/16 [17.463] .029 [ .737] .054 [1.372] .073 [1.854] .131 [3.327] .217 [5.512] .020 [ .508]

3/4 [19.050] .031 [ .787] .058 [1.473] .078 [1.981] .143 [3.632] .237 [6.020] .020 [ .508]

13/16 [20.638] .034 [ .864] .061 [1.549] .083 [2.108] .155 [3.937] .257 [6.528] .020 [ .508]

7/8 [22.225] .037 [ .940] .065 [1.651] .089 [2.260] .167 [ 4.242] .277 [7.036] .020 [ .508]
15/16 [23.813] .039 [ .991] .069 [1.753] .094 [2.388] .179 [ 4.547] .296 [7.518] .020 [ .508]
1 [25.400] .042 [1.067] .073 [1.854] .099 [2.515] .191 [ 4.851] .316 [8.026] .025 [ .635]

NOTES:
1. DUE TO DEFORMATION FROM THE HOBBING PROCESS, LARGE F.F.B.E. AND F.F.R.E. PUNCH FACES MAY BE
SLIGHTLY CONVEX. AS A RESULT, THE WORKING LENGTH DIMENSION MAY VARY ACROSS THE PUNCH
FACES; THE VARIATION SHOULD BE CONSISTENT WITHIN A SET OF TOOLING.
2. TIP TABULATIONS FOR SHAPED PUNCHES ARE DETERMINED BY CORRELATING THEIR MINOR AXIS
DIMENSION WITH THE APPROPRIATE PUNCH TIP DIAMETER IN THIS TABLE.

©American Pharmaceutical Association 69

 SECTION 4
Tool Steels, Compression Forces,
and Fatigue Failure
Tool Steels Tungsten carbide, while not actually a steel, is extreme-
1y wear resistant and is commonly used to line dies.
Although punch tips can be manufactured from tung-
Toughness, resistance to wear and corrosion? .,strength, sten carbide, its use is restricted to applications where
and resistance to distortion and warping dufing heat tip fracture caused by high compression forces is not
treatment are the most important properties of a tool likely. Such punches are quite expensive and require
steel. These properties are determined by the steel's special setup and alignment procedures. The tooling
chemical composition and the conditions under which it supplier should be consulted about these procedures.
is manufactured. For purposes of comparison, the steels
used to manufacture tablet press tooling have been Ceramic materials, such as partially stabilized zirconia,
grouped in three categories: general-purpose, wear- can also be used as die liners. Due to their low coeffi-
resistant, and corrosion-resistant. cient of friction, these materials offer longer wear, high-
er corrosion resistance, and lower required force for
tablet ejection than do either steel or tungsten carbide
General-Purpose Steels liners.

Most tablet press punches are manufactured from S1,

S5, S7 or 408 (3% nickel) tool steel. The S series steels Corrosion-Resistant Steels
provide a good combination of toughness and wear
resistance, and have a proven record of performance in SI, S7, and 408 steels provide some protection against
tablet production. At one time, 408 or 3% nickel steel mildly corrosive materials; more severe corrosion prob-
was the industry standard because of its superior tough- lems demand the use of stainless steel (440C) tooling.
ness. However, the S grades, which have only a slight From the standpoint of wear, 440C falls between the S
loss in ductility as compared to 408 steel, offer much and D grades of tool steel. Because 440C has a low
improved wear characteristics and have all but replaced toughness rating (comparable to that of D3), the punch
408 as the preferred general-purpose steel for punches. must have a strong cup design to avoid problems with
tip fractures.

Wear-Resistant Steels
Refined Tool Steels
A2, D2, and D3 grades are high-carbon, high-chromi-
um steels used for their excellent wear resistance. One measure of a tool steel's quality is the rate of inclu-
Among all the steels commonly used for press tooling, sions. Inclusions are unwanted impurities or voids that
D3 has the highest wear resistance. Its low toughness are present to some degree in all steels. After heat treat-
rating, however, almost exclusively limits its use to ment, inclusions give rise to localized areas of stress
dies. D2 rates slightly lower in abrasion resistance than concentration where microscopic cracks can later devel-
does 03, but its increased toughness makes D2 suitable op. Remelting the original steel ingots in a vacuum-
for manufacturing punches, provided the cup design is tight shell allows the impurities, in the form of dis-
not too fragile. A2, which is a compromise between the solved gases, to be expelled from the shell. This process
general-purpose S grades and D2 in toughness and of "vacuum remelting" further reduces the level of
wear, can be used for punches and dies. impurities and improves the steel's quality. The perfor-
mance of tooling made from this remelted steel is sub-

© American Pharmaceutical Association 71

 sequently improved. When punch tip fracture is a prob- Conversely, a steel's ductility and weldability decrease
lem, tooling suppliers may recommend a remelted or as its carbon content increas~s. Ductility is the ease
premium grade of a particular steel as a means of elimi- with which metal flows during the high pressures of
nating the problem. compression. Carbon also has a moderate tendency to
segregate within the ingot. Because carbon has a signif-
icant effect on steel properties, its segregation is fre-
quently more important thap. the segregation of other
Chemical Composition elements in the steel.
of Steels
Manganese
Carbon and alloy steels-the two main categories of
steel-contain carbon, manganese, and usually silicon Manganese, which is present in all commercial steels,
in varying percentages; they can also contain copper contributes significantly-but to a lesser degree than
and boron as specified additions. To qualify as a carbon does carbon-to a steel's strength and hardness. The
steel, a steel's maximum concentrations of manganese, effectiveness of manganese depends largely on and is
silicon, and copper must not exceed 1.65%, .60%, and directly proportional to a steel's carbon content.
.60%, respectively. With the exception of boron and
deoxidizers, no other alloy element is intentionally Manganese has a greater ability than any of the com-
added. Alloy steels comprise those steel grades that monly used alloy elements to decrease the critical cool-
exceed the above limits, as well as any grade to which ing rate during hardening, thereby increasing a steel's
an element other than those previously mentioned is hardenability. This element is also an active deoxidizer
added to achieve a specific alloy effect. and shows less tendency to segregate within the ingot
than do most of the other elements. Manganese also
The effects of the following chemical elements on the improves a steel's surface quality because it tends to
properties of hot-rolled carbon and alloy bars are con- combine with sulfur, thereby minimizing the formation
sidered individually. In practice, the effect of a particu- of iron sulfide. Iron sulfide can cause hot-shortness
lar element often depends on the presence and quanti- (i.e., the susceptibility of a steel to crack and tear when
ties of other elements in the steel. For example, the total the ingot is rolled).
effect of a combination of elements on the hardness of a
steel is usually greater than the sum of their individual
effects. This interrelation should be considered when a Silicon
change in a specified analysis is being evaluated. (With
the exception of sulfur and phosphorous, Table 13 on Silicon is one of the principal deoxidizers used in man-
page 73 details the chemical composition of pharma- ufacturing carbon and alloy steels. Depending on the
ceutical tool steels.) steel type, the amount of silicon can vary up to .35%;
greater amounts are used in some steels (e.g., silico-
manganese steel). The combined effects of these two
Carbon elements produce steels with unusually high strength,
good ductility, and shock resistance (toughness) in the
Carbon is the principal hardening element in steel; each quenched and tempered conditions. At these larger con-
additional increment of carbon increases the hardness centrations, however, silicon has an adverse effect on
and tensile strength of steel in the as-rolled, or normal- machineability and increases the steel's susceptibility to
ized, condition. As carbon content exceeds approxi- decarburization (i.e., removal of carbon) and graphitiza-
mately .85%, the resultant increase in strength and tion (i.e., conversion into graphite).
hardness is proportionately less for each increment
added. Upon quenching, the maximum attainable hard-
ness also increases with increasing carbon; however, Chromium
the rate of increase is very small for carbon contents
above .60%. Chromium is used in constructional alloy steels primar-

72 © American Pharmaceutical Association

ily to increase harden-
a bi lit y, provide TABLE 13. CHEMICAL COMPOSITION OF TOOL STEELS
improved resistance to
abrasion, and promote PERCENTAGE OF CHEMICAL ELEMENTS
carburization. Chromi- CHEMICAL
ELEMENT 408 S1 SS S7 A2 02 03 440C 01
um is surpassed by
only manganese and CARBON .50 .40- .50- .45- .95- 1.40- 2.00- .95- .90
molybdenum in its .55 .65 .55 1.05 1.60 2.35 1.20
effect on hardenability. MANGANESE .50 .10- .60- .20- .00- .00- .00- .00- 1.20
A chromium content of .40 1.00 .80 1.00 .60 .60 1.00
3.99% has been estab- SILICON .25 .15- 1.75- .20- .00- .00- .00- .00- .40
lished as the maximum 1.20 2.25 1.00 .50 .60 .60 1.00
limit for constructional '!'
CHROMIUM .75 1.00- .00- 3.00- 4.75- 11.0- 11.0- 16.0- .50
alloy steels. Exceeding 1.80 .35 3.50 5.50 13.0 13.5 18.0
this limit for chromium
content puts a steel in VANADIUM .15- .00- .00- .15- .00- .00- .20
.30 .35 .35 .50 1.10 1.00
the heat-resisting or
stainless steel category. TUNGSTEN 1.50- .00- .20
3.00 1.00
Of the common alloy MOLYBDENUM .00- .20- 1.30- .90- .70- .00-
elements, chromium .50 1.35 1.80 1.40 1.20 .75
forms the most stable
NICKEL 3.00 .00-
carbide, which gives .50
high-carbon high-
chromium steels excep- COBALT .00-
1.00
tional wear resistance.
Because this carbide is
relatively stable at elevated temperatures, chromium is Tungsten
often added to steels used for high-temperature applica-
tions. Tungsten, another stabile carbide former, increases
wear resistance and red hardness (i.e., the ability to
retain hardness at elevated temperatures). Most tung-
Vanadium sten alloys are used for applications that require hard-
ness retention at elevated temperatures.
Vanadium improves the strength and toughness of ther-
mally treated steels, primarily by its ability to inhibit
grain growth over a fairly broad quenching range. This Molybdenum
element also forms strong, stable carbides. At contents
of .04% to .05%, vanadium increases the hardenability With the exception of manganese, molybdenum
of medium-carbon steels with a minimum effect upon exhibits a greater effect on hardenability for each unit
grain size. Above this content, insoluble carbides form, added than do the other common alloy elements.
and the hardenability effect per unit added decreases Because it is a nonoxidizing element, molybdenum is
with normal quenching temperature. However, increas- highly useful in melting steels when close control of
ing the austenitizing temperatures can increase the hardenability is desired. Molybdenum is unique in the
hardenability of a steel with these higher contents of degree to which it increases the high-temperature ten-
vanadium. Austenite is a solid solution of carbon and, sile and creep strengths of steel. Its use also reduces a
sometimes, other solutes that can occur as a constituent steel's susceptibility to temper brittleness.
of steel under certain conditions.

© American Pharmaceutical Association 73

 Nickel Punches that are F.F.B.E. or are deeper than the TSM
standard concave may require a different hardness for
Nickel is one of the fundamental alloy elements. When the fragile punch tip than is required for the head and
present in appreciable ·amounts, it improves toughness, barrel. Secondary tempering of punch tips made from
particularly at low temperatures; provides a simplified certain steels reduces the hardness of the tip and helps
and more economical thermal treatment; increases eliminate tip breakage during compression; In this
hardenability; and improves corrosion resistance. Its process, the punch tips are subjected to high tempera-
presence also reduces distortion of the steel during tures and then cooled slowly. Punches made from S7
quenching. and D2 steels do not require a second tempering to pro-
duce durable punch tips, whereas punches made from
Nickel lowers the critical temperatures of steel, widens S5 steel are routinely tempered a second time to reduce
the temperature range for effective quenching and tem- tip hardness.
pering, and retards the decomposition of austenite."'Fur-
ther, nickel does not form carbides or other compounds The hardness of punches and dies can be checked with
that might be difficult to dissolve during heating for a nondestructive tester such as the Rockwell Tester,
austenitizing. All of these factors contribute to easier which determines hardness by measuring the depth to
and more successful thermal treatment. Nickel's rela- which its steel or diamond points penetrate the surface
tive insensitivity to variations in quenching conditions of the tool steel. The Rockwell Tester has two scales, A
is insurance against costly failures to attain the desired and C, for measuring tool hardness. The A scale, which
properties, particularly when the furnace is not uses a minor weight load to penetrate the steel surface,
equipped for precision control. leaves a small indentation. This superficial testing
should be considered for checking fragile punch tips.
The more commonly used C scale penetrates the sur-
face more deeply, thereby giving a more accurate read-
Cobalt ing of the hardness under the surface. The resultant
raised surface around the indentation should be
Cobalt is used primarily to increase the red hardness of removed by blending or polishing the tool before it is
steel. D2 is the only tool steel that contains this alloy used in a press.
element.
Accurate measurements of the tip hardness for shaped
punches are very difficult to obtain due to the critical
alignment required between the punch supports and the
Sulfur and Phosphorous penetrator. Unless the tip has undergone secondary tem-
pering, only the hardness of the barrel needs to be mea-
Sulfur and phosphorous, which are present in almost all sured for shaped punches. Dirt, grease, scale, and burrs
steels, are considered to be impurities. Their concentra- on a tool surface can also alter the final hardness read-
tions in tool steel should not exceed .03% to .05%; ing. To achieve positive results, tooling surfaces should
greater concentrations will affect the strength of the be cleaned or smoothed before readings are taken.
steel.
Because of the limited surface area contact, the Rock-
well hardness measurements for diameters or curved
surfaces on tooling are lower than the actual hardness.
When checking punches with 3/4- [19.05-millimeter] or
Hardness of Tool Steels 1-inch [25.40-millimeter] barrel diameters, .5 points
should be added to the indicated hardness to obtain the
The abrasion resistance of a steel usually increases as actual hardness. Table 14 lists the typical hardness
its hardness increases; conversely, the steel's ductility ranges of pharmaceutical tool steels.
and toughness decrease. Tooling that exceeds the rec-
ommended hardness range may fracture during use,
whereas tooling that is too soft may wear rapidly.

74 © American Pharmaceutical Association

 TABLE 14. TYPICAL HARDNESS READINGS FOR TOOL STEELS
HARDNESS RANGES (Re)

ITEM 408 S1 S5 S7 A2 02 03 440C 01

PUNCH 48- 54- 50- 54- 58- 58- 58- 56- 55-
56 56 59 58 60 60 60 58 60

DIE 60- 62-· 56-

62 64 58

Punch Tip Force Ratings,, 15 (see page 76) were derived using a finite element
analysis (FEA) to model exact cup designs. From the
FEA of hundreds of capsules and ovals, a calculation
The question tablet manufacturers ask most frequently method for determining the force ratings of shaped
of tooling suppliers is, "How much tonnage [force] can tooling was derived. This method can also be used to
I use with this cup design without risking punch tip calculate tip force rating for nonstandard sizes of round
cracking?" Virtually every user of tablet presses has at tooling. Although the calculations required for capsules
one time or another been faced with problems related to and ovals take a little more time than simply looking up
punch tip fracture. The consequences of tool breakage the force rating in a table, the greater accuracy of the
go well beyond just the cost of replacing the tools. resultant force rating is well worth the investment.
Additional inspection procedures, rejected batches of
tablets, and operator and equipment safety concerns are The maximum recommended compression forces in
related issues. Two important steps in good tablet pro- this manual are based on the fatigue limit for S5 and
duction procedures are (1) knowing the force limits for 408 tool steels. These values may be increased by 10%
each set of tooling used in production operations and for S 1 or S7 steel; however, the values should be
(2) properly setting and maintaining that limit on the reduced by 15% for D2, D3, and 440C steels.
press overload mechanism.

Historically, most press suppliers and tooling manufac- Punch Tip Force Ratings tor Concave
turers developed their own charts and graphs for deter- Oval, Round, and Capsule-Shaped
mining the allowable compression force for various Tooling
punch tip designs. Initially, this information was limited
to round concave and F.F.B.E. tooling. As shaped tool- Because the cup's minor axis (width), major axis
ing became more prominent, techniques for translating (length), and configuration can vary greatly in capsule-
the data for round tooling to other configurations, such and oval-shaped tooling, the compression force rating
as capsules and ovals, were formulated. The resultant for this type of tooling cannot be covered by simple
punch tip pressure guides were, at best, only a rough charts. However, extensive analysis has shown that the
approximation of the force capacity for shaped punch- maximum allowable pressure (i.e., force per unit area)
es. Tooling users found the published figures to be too that can be exerted on the punch face for oval and cap-
conservative in many cases and too high in others. sule shapes is strongly related to a cup shape factor.
This factor is defined as the ratio of the cup depth to the
Today, advanced desktop computer hardware and minor axis dimension. The compression force rating is
sophisticated stress analysis software, which are capa- then computed by multiplying the allowable pressure
ble of modeling complex shapes, have enabled tooling associated with the calculated shape factor by the cross-
designers to calculate punch tip force ratings for all sectional area of the punch tip. Calculating compression
tablet shapes with a high degree of accuracy. The punch force ratings for shaped tooling comprises four major
tip force ratings for TSM round tooling listed in Table steps.

©American Pharmaceutical Association 75

 TABLE 15. PUNCH TIP COMPRESSION FORCES FOR TSM ROUND TOOLING
COMPRESSION FORCE BY CUP DEPTH (IN KILONEWTONS)

PUNCH SHALLOW STANDARD DEEP EXTRA-DEEP MODIFIED

TIPDIA. CONCAVE CONCAVE CONCAVE CONCAVE BALL F.F.B.E. F.F.R.E.

1/8 [3.175) 5.0 3.5 2.6 2.0 1.2 3.5 3.5

5/32 [3.970) 7.5 5.0 4.0 3.4 1.9 5.2 5.4

3/16 [4.763) 11.0 7.5 6.0 5.0 2.8 7.2 7.7

7/32 [5.555) 15.5 10.5 7.5 7.0 3.7 9.5 10.5

' '
1/4 [6.350) 20.0 14.0 10.5 10.0 4.8 12.0 13.7

9/32 [7.142) 25.0 18.0 15.0 13.0 6.0 14.5 17.3

5/16 [7.938) 31.0 23.0 19.5 16.0 7.5 17.5 21.0

11/32 [8.730) 38.0 29.0 24.0 19.5 9.0 21.0 26.0

3/8 [9.525) 45.0 36.0 30.0 23.0 11.0 24.0 31.0

13/32 [10.318) 53.0 42.0 36.0 27.0 13.0 27.0 36.0

7/16 [11.113) 61.0 49.0 43.0 32.0 16.5 31.0 42.0

15/32 [11.905) 70.0 58.0 50.0 36.0 17.0 36.0 48.0

1/2 [12.700) 80.0 66.0 57.0 42.0 19.5 41.0 54.0

17/32 [13.493) 91.0 75.0 65.0 47.0 22.0 46.0 61.0

9/16 [14.288) 100.0 85.0 74.0 53.0 25.0 52.0 69.0

19/32 [15.080) 113.0 95.0 83.0 59.0 27.0 58.0 77.0

5/8 [15.875) 125.0 106.0 93.0 65.0 30.0 64.0 85.0

11/16 [17.463) 151.0 129.0 114.0 79.0 37.0 68.0 103.0

3/4 [19.050] 181.0 154.0 137.0 94.0 44.0 81.0 122.0

13/16 [20.638] 211.0 182.0 162.0 110.0 51.0 95.0 144.0

7/8 [22.225) 245.0 212.0 188.0 128.0 59.0 110.0 167.0

15/16 [23.813) 281.0 244.0 218.0 146.0 68.0 127.0 191.0

1 [25.400) 320.0 278.0 249.0 166.0 77.0 144.0 217.0

1. THE GIVEN TIP DIAMETERS AND CUP DEPTHS (SHALLOW, STANDARD, ETC.) CORRESPOND TO THE TSM CONFIGURA-
TIONS IN TABLE 12 (SEE PAGE 69). FOR OTHER CUP DEPTHS AND TIP DIAMETERS, THE CALCULATION METHOD FOR
ROUNDS, OVALS, AND CAPSULES SHOULD BE USED.

2. THESE FIGURES SHOULD BE USED ONLY AS A GUIDE.

3. TO CONVERT THE Kl LON EWTON RATINGS TO U.S. TONS (2,000 LB), DIVIDE BY 8.896.

4. TO CONVERT THE Kl LON EWTON RATINGS TO METRIC TONS (2,205 LB), DIVIDE BY 9.808.

5. TO CONVERT THE Kl LON EWTON RATINGS TO KILOGRAMS, MULTIPLY BY 101.976.

6. EMBOSSING CAN GIVE RISE TO AREAS OF SIGNIFICANT STRESS CONCENTRATION ON A PUNCH FACE. IT IS SUGGEST-
ED THAT THE COMPRESSION FORCES BE REDUCED BY 20% (MULTIPLIED BY .80) FOR TOOLING WITH EMBOSSING.

76 © American Pharmaceutical Association

 Illustrations 1 and 2 Illustration 3

CAPSULE
OR ROUND OVAL OR ROUND WITH COMPOUND CUP

(1)

@---! 1ro ---L--..t

--, t[]) We

(2)
-L- _l 1ro
VI \-....., OVAL
I
'- \. /~
w

'
lIJ) Step 2: Determine the Maximum
'~ Allowable Pressure
Table 16 (see page 78) lists the allowable cup face pres-
Step 1: Calculate the Shape Factor sures for various shape factors. The maximum allow-
able pressure P is obtained by correlating the SF value
For rounds, capsules, and ovals with a single cup with the appropriate value for allowable pressure in
radius, the shape factor SF is found by dividing the cup Table 16. For cross-sectional areas given in inches, P is
depth D by the width W (see Illustrations 1and2). expressed as units of pounds per square inch (lb/in2).
Accordingly, for cross-sectional areas given in millime-
For ovals with a compound cup on the minor axis (see ters, P is expressed as units of kilonewtons per square
Illustration 3), the minor radius is used to determine the millimeter (kN/mm2).
equivalent cup depth De and width We. (A compound
cup is a cup design with two or more radii per axis.) As
indicated by the phantom circle on Illustration 3, this NOTE: This procedure can also be used to calcu-
procedure can also be used to determine De and We for late ·compression force ratings for round tooling not
rounds with a compound cup. These dimensions can be covered in Table 15.
determined graphically by extending the minor radius
until it intersects the plane of the land, as shown, and
then using a scale to measure De and We.
Step 3: Calculate the Punch Tip
If the location of the center of the minor radius is Cross-Sectional Area
known, De and We can also be calculated directly as
follows: Cross-sectional area A can be calculated using the for-
mulas listed below. Width W and length L dimensions
De =R-Y, should be given in inches or millimeters.
where R equals the cup radius, and Y equals the dis-
tance from the center of the minor radius to the land. For round tooling:
A= .785 (W2)
We=2X,
where X equals the distance from the center of the For capsule-shaped tooling:
minor radius to the outside edge of the tablet. A= .785 (W2) + W(L -W)

Dividing De by We gives the SF for this configuration. For oval-shaped tooling:

A= .785 WL

This formula yields exact values for round and capsule

shapes. The values calculated for ovals are an approxi-
mation and are usually within 5% of the true cross-sec-
tional area; any errors are on the conservative side (i.e.,

©American Pharmaceutical Association 77

 TABLE 16. PUNCH TIP PRESSURE RATINGS VERSUS SHAPE FACTORS
(FOR CONCAVE ROUND, CAPSULE, OVAL, AND COMPOUND-CUP OVAL
TOOLING)
SHAPE ALLOWABLE ALLOWABLE SHAPE ALLOWABLE ALLOWABLE
FACTOR PRESSURE PRESSURE FACTOR PRESSURE PRESSURE
(SF) (LB/IN 2) (kN/MM 2) (SF) (LB/IN2 ) (kN/MM2)

.000 110.000 .758 .175 51,400 .354

.005 108,000 .745 .180 50,300 .347
.010 105,500 .727 .185 49,200 .339
.015 103,000 .710 ,,_ .190 47,750 .329
.020 101,000 .696 .195 46,650 .322
.025 98,500 .679 .200 45,550 .314
.030 96,500 .665 .205 44,450 .306
.035 94,500 .652 .210 43,500 .300
.040 92,500 .638 .215 42,500 .293
.045 90,500 .624 .220 41,500 .286
.050 88,500 .610 .225 40,500 .279
.055 86,500 .596 .230 39,500 .272
.060 84,500 .583 .235 38,500 .265
.065 82,600 .569 .240 37,500 .259
.070 80,800 .557 .245 36,500 .252
.075 79,100 .545 .250 35,500 .245
.080 77,400 .534 .255 34,500 .238
.085 75,800 .523 .260 33,500 .231
.090 74,200 .512 .265 32,500 .224
.095 72,650 .501 .270 31,500 .217
.100 71,100 .490 .275 30,500 .210
.105 69,550 .480 .280 29,500 .203
.110 68,000 .469 .285 28,500 .196
.115 66,500 .458 .290 27,500 .190
.120 65000 .448 .295 26,500 .183
.125 63,600 .438 .300 25,500 .176
.130 62,300 .430 .305 24,500 .169
.135 61,000 .421 .310 23,500 .162
.140 59,700 .412 .315 22,500 .155
.145 58,400 .403 .320 21,500 .148
.150 57,100 .394 .325 20,500 .141
.155 55,900 .385 .330 19,500 .134
.160 54,700 .377 .335 18,500 .128
.165 53,600 .370 .340 17,500 .121
.170 52,500 .362 .345 16,500 .114
.350 15,500 .107

NO.TE: THESE FIGURES SHOULD BE USED ONLY AS A GUIDE.

78 ©American Pharmaceutical Association

Preface

he Tableting Specification Manual is the sole ref- to review the updated information. The major tablet press

T erence on U.S. manufacturing specifications for

tablets and tablet tooling. Some international
tablet tooling manufacturers have also adopted the speci-
manufacturers were also .asked to update thei~ press
models on the tooling interchangeability tables.

fications as industry standards. With each edition of the This review resulted in the following new information: a
manual, the publisher and the steering committee have few revised specifications, a comprehensive discussion of
striven to update tooling standards as the technology of tooling options and bisects, thoroughly updated tooling
tablet presses and tooling continues to evolve. In addi- interchangeability tables, and equations for calculating
tion, the fourth edition significantly expanded the sec- the punch tip compression forces for 30° flat-faced
tions on tooling inspection and maintenance, included bevel-edged (F.F.B.E.) tablets. (The "Introduction" dis-
the first section on tablet design, and added the first trou- cusses these elements in more detail.) These enhance-
bleshooting guides. ments reflect the mission of the publisher and the steer-
ing committee to maintain the manual as the complete
The steering committee for the fifth edition consists of guide to tooling design and specifications, tablet
representatives from tablet tooling companies, tablet press design, the appropriate compression forces for various
companies, and pharmaceutical companies. Members of types of tooling, and the proper maintenance of pur-
the committee were asked to identify whether new speci- chased tooling. All who have contributed to this and
fications were needed, which, if any, specifications need- past editions of the manual have helped to produce
ed fine tuning, and what new topics would be beneficial specifications that further standardize U.S. tablet tool-
to those who manufacture tablet tooling or presses and to ing and to compile guidelines for tablet design and
those who work in tablet production departments. The tooling maintenance that have universal application.
individuals listed in the "Acknowledgments" were invited
- The Tableting Specification Steering Committee

©American Pharmaceutical Association ix

calculated value is less than actual area). Exact values 3. Calculate punch tip cross-sectional area:
for ovals can be obtained from tooling suppliers. A =.785(W 2 ) + W(L - W)
A = .785(.2812) 2 + (.2812) (.6875 - .2812)
A= .176 in2
Step 4: Calculate the Compression Force Rating
4. Calculate compression force rating:.
The compression force rating F for the punch tip is now F=PXA
determined by multiplying the maximum allowable =
F = (43,000 lb/in2) (.116) 7,568 lb [34 kN]
pressure P by the cross-sectional area A.
The Compression Force for a Compound Cup
F (lb) =P (lb/in2) x A (in2), or (see Illustration 5) is calculated as follows.

F (kn) =P (kN/mm2) x A (mm2) 1. Calculate shape factor:

SF=De/We
NOTE: The calculated force ratings apply to S5 SF= .063/.188 =.335
and 408 steels. These values should be increased
by 10% for Sl or S7 steel and decreased by 15% For this cup configuration, We and De are determined
for D2. 03, and 440C steels. Further, embossing graphically by extending the minor radius R until it
can give rise to areas of significant stress concen- intersects the plane of the land; De and We are then
tration on the punch face. For engraved tooling,· the measured. If the location of the center of the minor cup
calculated force· ratings should be reduced by 20% radius relative to the outside edge of the tablet is
(multiplied by .80). known, the De and We can be calculated as follows:

De =R - Y =.093 - .030 = .063

We= 2X =2( .094) = .188
Sample Calculations of Compression SF= De/We= .063/.188 =.335
Force Ratings
2. Determine maximum allowable pressure:
The Compression Force for a Capsule-Shaped Cup Correlate the SF of .335 with its corresponding
(see Illustration 4) is calculated as follows. maximum allowable pressure in Table 16; in this
example, P equals 18,500 lb/in2•
Illustration 4
3. Calculate punch tip cross-sectional area:
CAPSULE
A= .785 (WL)
A= (.785) (.312) (.625) =.153 in2

4. Calculate compression force rating:

F=Px A
=
F (18,500 lb/in2) (.153 in2 ) =2,830 lb [13 kN]
Illustration 5
1. Calculate shape factor:
OVAL WITH COMPOUND CUP
SF=DIW ~030
SF= .060/.2812 = .213 r.093R

2. Determine maximum allowable pressure: .094

Correlate the SF of .213 with its corresponding .312
maximum allowable pressure in Table 16; in this
example, P equals 43,000 lb/in2 (value is interpo-
lated).

©American Pharmaceutical Association 79

 Punch Tip Compression Forces for 30° Step 1: Determine the Allowable Pressure
F.F.8.E. Oval, Round, and Capsule-
Shaped Tooling Use Table 17 to determine the cup face pressure for the
desired tablet cup depth. If tablet cross-sectional areas
The maximum allowable pressure for flat-faced bevel- will be calculated in units of square inch~s, select the
edged (F.F.B.E.) tooling is highly dependent upon the value of P expressed in units of pounds per square inch
bevel angle and cup depth and only marginally affected (lb/inZ). Accordingly, for cross-sectional areas given in
by the diameter or shape of the tooling. Standard square millimeters, select the value of P expressed in
F.F.B.E. tooling design incorporates a 30° bevel angle kilonewtons per square millimeter (kN/mm2).
and a .015-inch (.35-millimeter) blend radius between
the bevel and flat. (Refer to Figure 22, Illus. C on page
46 for F.F.B.E tablet terminology). Table 15 (page, 76) Step 2: Calculate the Punch Tip Cross-Sectional
lists the recommended force ratings for standard TSM Area
flat-faced bevel-edged round tooling.
Cross-sectional area A can be calculated using the for-
Compression force ratings for nonstandard sizes and mulas listed below. Width (W) and length (L) dimen-
shapes can be computed using the pressure versus cup sions (refer to Illustrations 1 and 2, page 75) should be
depth data contained in Table 17. It should be noted given in inches or millimeters.
that the tabulated values apply only to tooling that has a
30° bevel angle. Calculating compression force ratings For round tooling:
for round or shaped tooling comprises three steps. A= .785(W2)

TABLE 17. PUNCH TIP FORCE RATINGS VERSUS CUP DEPTH FOR 30° F.F.B.E. TOOLING
(FOR ROUND, CAPSULE, AND OVAL TOOLING)
CUP DEPTH (INCHES) ALLOWABLE ALLOWABLE
PRESSURE (LB/IN2) PRESSURE (kN/MM2)

.007 63,500 .438

.008 60,500 .417
.009 58,600 .404
.010 56,800 .392
.011 55,000 .379
.012 53,300 .368
.013 51,600 .356
.014 50,000 .345
.015 48,500 .334
.016 47,000 .324
.017 45,500 .314
.018 44,100 .304
.019 42,700 .294
.020 41,400 .285
.021 40,100 .276
.022 38,900 .268
.023 37,600 .259
.024 36,500 .252
.025 35,300 .243
NOTE: THESE FIGURES SHOULD BE USED ONLY AS A GUIDE

80 © American Pharmaceutical Association

For capsule-shaped tooling: mately 50% of the ultimate stress limit will usually
A = .785(W2) + W(L - W) allow an infinite number of loading events to take place
without failure occurring. The stress level that provides
For oval-shaped tooling: virtually indefinite life is known as the endurance, or
A= .785WL fatigue, limit of the material.

These formulas yield exact values for round and cap- Figure 36 on page 82 shows a generalized stress versus
sule shapes. The values for ovals are an approximation cycle-life curve for a high-strength tool steel. Close
and are usually within 5% of the true cross-sectional examination of the characteristic fatigue curves for fer-
area; any errors are on the conservative side (i.e., calcu- rous materials, such as tool steels, reveals several
lated value is less than actual area). Exact values for important points about fatigue failure. First, the
ovals can be obtained from tooling suppliers. endurance limit corresponds to a cycle life in the neigh-
borhood of one to four million loading cycles. Unless
the operating stress level is known in advance for a par-
Step 3: Calculate the Compression Force Rating ticular component, at least one million loading events
are needed to assess whether the design is adequate for
The compression force rating F for the punch tip is now the working environment. In the case of tablet tooling,
determined by multiplying the maximum allowable the quantity of tablets made during the research and
pressure P by the cross-sectional area A. development stages is rarely sufficient to meet this cri-
terion. As a result, problems associated with punch tip
F (lb)= P (lb/in2) x A (in2) breakage usually do not become apparent until long
after a product enters the manufacturing stage.
F (kN) =P (kN/mm2) x A (mm2)
Another point to consider from an analysis of fatigue
curves is the logarithmic relationship between stress
NOTE: The calculated force ratings apply to SS and cycle life. A 25% reduction in stress, for instance,
and 408 steels. These values should be increased by results in a tenfold increase in tooling life. Punch break-
10% for SI or 57 steel and decreased by 15% for age is usually the result of stress levels that exceed the
02, D3, and 440C steels. maximum allowable limit for infinite life by less than
Since the point of maximum stress on the surface 20%. For this reason, only relatively minor design
of the punch cup occurs in the .015-inch (.38-mil- changes to the punch cup are needed to eliminate
limeter) blend radius between the bevel and flat, fatigue failure.
embossing does not generally affect the force rat-
ing. Finally, fatigue damage is cumulative. When a part is
over-stressed, the microscopic damage inflicted reduces
the useful life of that part by a percentage approximate-
ly equal to the number of cycles accumulated at that
stress level divided by the predicted cycle life from the
fatigue curve. Intermittent periods of excessive stress
followed by long periods of stress levels below the
Fatigue Failure of Punch fatigue limit can extend the time to failure well beyond
Tips the range of one to four million cycles. This explains
why some tooling sets produce hundreds of millions of
tablets before the tools crack.
The failure of machine components subjected to repeat-
ed loading cycles is known as fatigue failure. At stress
levels close to the ultimate stress limit of a material,
fatigue failure may occur after only a few hundred
loading cycles. Conversely, stress levels below approxi-

©American Pharmaceutical Association 81

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82 ©American Pharmaceutical Association

 SECTION 5
Tooling Procurement, Inspection,
and Maintenance
No processes are more important to producing the The information for the upper and lower punches
desired quantity and quality of tablets than the proper should be placed on separate lines because the upper
procurement, inspection, and maintenance of tablet and lower faces of a tablet often carry different emboss-
tooling. Every tablet manufacturing division should ing. If the punch is not a B-type, this should also be
establish standard operating procedures (SOP)' for these noted in the directory. The directory is a ready source of
processes. information for the "Sample Tablet Tooling Approval
Form" (see Figure 37, page 84).

Standard Operating Control of Tooling Drawings

Procedures
A single group or department should be responsible for
maintaining master files and issuing copies of all tablet
The TSM Committee offers the following procedures as and tooling drawings. This group participates in the
a guide in setting up a SOP program and does not imply process of approving tooling drawings. Specific steps in
that any such program should consist of or be limited to the process include the following:
the information presented here. These guidelines can be
tailored to meet the needs of individual manufacturing • Establish a suggested procedure for approving
divisions. drawings that includes, at a minimum, review and
approval of all drawings by the production and
quality assurance departments, as well as the
Tablet and Tooling Directory appropriate engineering, marketing,. and regulatory
affairs departments.
A tablet and tooling directory should be developed, • Establish a master file that consists of the original
maintained, and made available to all personnel tablet, tooling, and/or hob drawings with the appro-
involved in decisions or procedures that affect tablet priate approval signatures.
manufacturing. Such a directory provides documenta- • Keep a listing of all copies of approved drawings in
tion control, serves as a communication aid, and is a satellite files. If the drawings are modified or elimi-
procurement reference. Specifically, the directory is a nated, copies of earlier drawings should be collect-
list of tablet products and the punches used to produce ed and destroyed.
them. The directory should include:

• Name of product Procurement of Tooling

• Product embossed code
• Product number Use of the "Quote/Order Form" (see Figure 38, page
• Tablet size (not thickness) and shape 85) for tooling will ensure that the essential items have
• Punch position (upper or lower) been specified on each purchase order. The purchase
• Punch embossing order should include, but not be limited to:
·• Tablet drawing number
• Tablet drawing revision number • Respective tablet/tooling drawing number(s) or hob
• Tooling supplier drawing number number(s)
• Directory revision date • Identification number(s) to be engraved/imprinted

©American Pharmaceutical Association 83

 FIGURE 37. SAMPLE TABLET TOOLING APPROVAL FORM

TO: MANUFACTURING AND/OR TECHNICAL SERVICE MANAGER(S) •iii

FROM: COMPANY OR INDIVIDUAL PRODUCT AND/OR TOOLING COORDINATOR

SUBJECT: TABLET TOOLING APPROVAL FOR PRODUCT(S)

iiil
~'_ _____,
iii
APPROVAL OF: DRAWING(S) I.___ _ ___. HOB(S)

TOOLING SUPPLIER: - - - - - - - - - - - PURCHASE ORDER: _ _ _ _ __

The following new tooling drawing(s) and hob(s) are approved:

PRODUCT STRENGTH, PUNCH USER SUPPLIER

SIZE&SHAPE EMBOSSING POSITION DRAWING NO. DRAWING NO.

X:XXXX, 50 MG. UPPER: ZZZ 102 B-NNNNN-R P-ABCW-EX

5116 DIA.

XXX:XX, 50 MG. LOWER: XX:XXX B-NNNNN-R P-ABCX-EX

5/16 DIA.

YYYYY, .5 GM. UPPER: ZZZ 501(S) B-NNNNN-R P-ABCY-EX

.281 x .718 CAPSULE

YYYYY, .5 GM. LOWER: YYYYY B-NNNNN-R P-ABCZ-EX

.281 x .718 CAPSULE

Title--------------------------

Phone No./FAX No.

----------------------
cc: Manufacturing Manager, Technical Service or Engineering Manager (if not listed above), Purchasing,
Tooling Procurement Initiator (if not listed above), Tooling Supplier

1. (S) means the tablet is scored.

2. The information in the table should be included in any notice of tooling approvals sent to the supplier.

84 ©American Pharmaceutical Association

 FIGURE 38. QUOTE/ORDER FORM
DATE _ _ _ _ _ _ P.O. NO.
r--- Standard 0
Company ----------------~ Required Date ------Shipping J___ Overnight 0
Address Press Model No. - - - - - - N o . of Stations

Tooling Size 0 B Size DD Size Oother _ _ __

User Contact Punch Mot. 0 Stand. 0 Prem. Oother _ _ __

Fax No. Die Mot. 0 Prem. 0 Lined W/C Oother _ _ __

Phone No.

Previous Order Ref. No. AvoHobntty Of Samples 0Tools 0 Owgs. DToblets

Upper Tablet Face Dwg. No. Lower Tablet Face Dwg. No.

Upper Punch (quantity) rice Lower Punch (quantity) Price

Tooling Replacement 0 New 0 Tooling Replacement 0 New 0

Embossed 0 ! Description Embossed 0 IDescription

Plain 0 Plain 0
Bisect Line 0 ._____________ _J Bisect Line 0 .____________ _J

Tablet Shape/Size (circle one)

SQUARE
OlHER

D
--l A~
B

A
DIM.A - - - - - DIM.B
Tablet Profile (circle one)
Flat Beveled
Edge ANGLE f--- rC
Convex Convex
Bevel
Compound
Cup
Flat
Faced LBall OTHER
cl ~I _t_ _C_ ~
T'
Cup Depth C=
I Tr:::-:Jt•::Z:•t~'~)
Land= _ _ _ Bevel Angle=
f§
Product Name Tool Marking Requirements

Existing
FHm-Cooted

Abrasive

DIE INFO.
0
0
0
New
Sticky
Corrosive
0
0
0

EXTRA OPTIONS
Punches
Dies

KEYS
Wi-0
T.S.M. Head D T.S.M. Semi-Domed
KEY ORIENTATION
D

Die Quantity Pollahed Heads 0 Chrome Tips 0 Woodruff 0

Die Size Tip Relief 0 Chrome Other 0
on Lower HI-Pro 0
.945 D
1.1875 0 Bakelite Relief 0 Parallel 0
on Lower
1.500 0 Tapered Dies_ Screw-in Key 0
DIE GROOVE PROTECTION
(+.003 on Dla.3/16 Deep) 0 Stand. 35"
Secondary Key Slot 0
RADIUS 0 SHOULDER 0 1 End_ 0 2 Ends_ 0 OolHER
(THIS FORM MAY BE COPIED)

© American Pharmaceutical Association 85

 on each tool (These numbers provide a method of Storage of Tooling
maintaining records.)
• Logo description and punch orientation, if applica- Each set of tooling should be identified and stored sepa-
ble rately in an environment that is controlled to prevent
• Punch and die size oxidation and subsequent rusting. See the discussion of
• Type of tooling design: TSM, European, etc. "Storage of Tooling," presented on the last page of this
• Steel type for punches and dies section.
• Make and model of tablet press
• Number of tooling stations on the tablet press (It is
recommended that the quantity on each order Disbursement and Usage of Tooling
include 10% or more extra punches and 5-10%
extra dies.) When disbursing a set of tooling, the following proce-
• Punch and die materials dures should be considered and documented according-
• Type of punch key, if applicable ly on a preprinted form, such as the sample form in
• Tooling options (i.e., chrome punch tips, tapered Figure 40 on page 88.
dies, etc.)
• Visually inspect the appropriate set of tooling to
ensure that the tooling is not damaged and that a
NOTE: Interchanging shaped punches and dies sufficient number of tools are available for the
made by different manufacturers is not a good prac- press in which they are to be used.
tice. If a punch is ordered for use with another man- • Examine the tools to ensure a proper fit between
ufacturer's die, the punch supplier will request a the upper and lower punches and the respective die.
sample of the die to check the fit ofthe tools. • Document the product name, strength, and code
number of the material to be compressed.
• Document the identification number of the press on
which the tools are to be used.
Initial Inspection of Tooling • Document the identification number(s) of the indi-
vidual batches that are compressed with the tool-
Upon receipt of a set of tablet tooling, the following ing.
inspection could be considered for all or a portion of • Calculate and document the current status of the
the tools received. The dimensions should be docu- standard that is used to determine the periodical
mented on a preprinted form, such as Figure 39. As part inspection of the tooling (i.e., number of batches,
of the routine maintenance of tooling, this inspection number of tablets produced, etc.).
should be repeated periodically and documented
accordingly.
Maintenance of Tooling
• Inspect the logo for accuracy, size, and, if applica-
ble, position. The following is a general list of the steps taken to
• Measure tooling according to the instructions in the maintain tooling. The discussion of "Punch and Die
discussions of "Measuring Punches" and "Die Maintenance" on the following pages gives step-by-step
Measurements" on pages 91-94 and 101-102, instructions for these important procedures.
respectively.
• Perform a hardness test on a percentage of the • Clean per approved procedures, and inspect for
punches and dies to ensure that the specified hard- wear or damage those tooling sets used in press
ness has been achieved. (See Table 14 and the dis- runs.
cussion of "Hardness of Tool Steels" on pages 74 • Refurbish worn or damaged tools per approved pro-
and 75.) cedures.
• Discard and document accordingly tools that are
worn or damaged beyond repair. Deface identifi-
able markings on any discarded tool.

86 © American Pharmaceutical Association

 FIGURE 39. PUNCH AND DIE INSPECTION SHEET
PRODUCT NUMBER I PRODUCT NAME I CODE

DWG. No. I UPPER PUNCH

EMBOSSING/BISECT DWG. No. I LOWER PUNCH
EMBOSSING/BISECT

TYPE OF 0 ROUND 0 ODDSHAPED 0 FLAT FACE BEVELED EDGE 0 FLAT FACE 0 CONCAVE 0 OTHER--....-----
TOOLING
TOOLING SUPPLIER I P.O. No. MACHINE TYPE USED ON TOOLING TYPE

I 0NEW
0 REPLACEMENT

HOB APPROVAL (NEW) UPPER LOWER APPROVALS/DATE

PUNCH TIP & IMAGE SLUG
VS DRAWING OR OVERLAY 0 ACCEPT 0 REJECT 0 ACCEPT 0 REJECT
TECH. SERVICE I MFTG

UPPER LOWER DIE

COMMENTS
ACC. REJ. ACC. REJ. ACC. REJ.
HARDNESS

Barrel 10%
EMBOSSING vs DRAWING
OR OVERLAY
100%
FACE & SURFACE DEFECTS

Nicks, pits, cracks 100%

WORKING LENGTH

Indicator 100%
OVERALL LENGTH

Indicator 100%
KEY FIT/KEY TO HEAD

Go/No Go 100%
TIP CONCENTRICITY

Indicator 100%
HEAD

Go/No Go 100%
PUNCH BARREL O.D.

Go/No Go 100%
PUNCH TIP SIZE

Micrometer 100%
TIP TO BARREL
Over all vs MAX.
w/or w/o Chamfer 100%

DIE DIE
DIES COMMENTS DIES COMMENTS
ACC. REJ. ACC. REJ.
O.D. 3/16' RADIUS ANO EDGE
Micrometer 100% PROTECTION

l.D. Punch Tip or

DIE CONCENTRICITY 0.0.
Bore Gage 100%
CHAMFER l.D. DIE SQUARENESS
Hand Comparator 100%

HEIGHT
Micrometer 100%
INSPECTOR I
DATE

TOOLING APPROVALS
MANUFACTURING QUALITY CONTROL (NEW) TECH. SERVICE (NEW)

(THIS FORM MAY BE COPIED)

©American Pharmaceutical Association 87

co
co
FIGURE 40. TABLET TOOLING USAGE AND REPAIR CARD
LOCATION
PRODUCT/STRENGTH DIE SIZE QUANTITY

PRODUCT No. SET No.

UPPER (UP) QUANTITY
DATE RECEIVED
LOWER (LP) QUANTITY CARD No.
VENDOR NAME

DRAWING No. TOP SHAPE TABLETS/BATCH

BOTTOM

ISSUES RETURNS DESTRUCTION

DATE BATCH MACHINE No. UP-LP-DIE ISSUED DATE UP-LP-DIE RETURN AUTH. DATE No./ DESTROY VERIFY REASON
TO BY BY TYPE BY BY COMMENTS

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