H Y G I E N I C S E A L M AT E R I A L G U I D E L I N E S

This information has been carefully prepared to help in selecting the correct elastomer or
perfluorocarbon utilized in high purity sanitary hygienic seals where critical pure water,
process fluids (both ambient and hot), and SIP environments exist. The intention is to
consider the different uses, applications and conditions to determine the most favorable
hygienic seal material for each application.
The following criteria is used in determining correct hygienic seal materials;

U.S. Pharmacopeia Class VI Certification

Cytotoxicity Criteria

CFR Title 21 Section 177.1550

CFR Title 21 Section 177.2600

Traceability: Lot and Batch

Certification: Lot and Batch

ASME-BPE Standards

USDA Standards

3-A Sanitary Standards

Current Good Manufacturing Practices (CGMP)

Manufacturer data and specifications

Consultation with various pharmaceutical users

Animal Derived Ingredient Free

The gasket materials considered are Tuf-Steel (PTFE/Stainless Steel), Tuf-Flex, PTFE,
Silicone (platinum), FKM Fluoroelastomer, EPDM and Buna.
The 3 main goals are:
To protect products from contamination, spalling, particulates and TOCs resulting
from the use of improper hygienic seal material.
To protect facilities from unnecessary downtime associated with hygienic seal failure
and replacement from use of improper hygienic seal material.
To provide a standard of consistency for hygienic seal selection between multiple
facilities.
Most decisions driving seal type selection are based on chemistry, temperature, exposure
limits, USP, FDA qualifications, and curing methods. The following briefly addresses each
of these issues.

H Y G I E N I C S E A L M AT E R I A L G U I D E L I N E S

Exposure Limits
It is important to define the operating parameters of a new or existing processing sanitary
system. The user specifications for exposure limits and reactivity to process fluids are compared
with process operating parameters. All materials are acceptable for steam excluding Buna.
All materials should meet process fluid reactivity parameters. Even though all compound
exposure limits fall within operating parameters, the service life of some compounds will be
different under certain conditions. This must be considered when selecting a compound.

FDA and USP Qualifications

CFRs define the criteria for extractables and for compounds used in the manufacture of rubber
and plastic articles. The two applicable categories are; rubber articles (Buna, EPDM, FKM
Fluoroelastomer, Silicone) and perfluorocarbon resins (PTFE).
USP defines the criteria for testing biological reactivity and the amount/type of extractables.
The hygienic seals in service must meet USP Class VI specifications, and be manufactured
using the proper compounds as stated in the CFR, Title 21, Sections 177.1550 and 177.2600
respectively. Certificates are available from Rubber Fab Technologies Group verifying compliance with regulatory requirements, traceability lot and batch and certification lot and batch.
Note: Not all hygienic seals meet these requirements.

Curing Methods
Curing agents have an affect on the amount and type of extractables a material will emit.
Typically, the hygienic seal group in service uses three methods; sulfur cured*, peroxide cured
and platinum cured. When dealing with elastomers, peroxide cured is the most favorable
method. When dealing with silicone, platinum cured is the most favorable. All gaskets shall
be post cured. Using these methods minimize potential reactions with the respective process
fluid applications and can uphold pure water and process fluid standards.
* Sulfur cured elastomers can significantly alter a process fluids integrity and negatively
affect mammalian cell yields.
Note hygienic seal identification for curing methods. For example, EPDM: one green dot ( )
means sulfur cured and three green dots ( ) means peroxide cured.
RUBBER FAB EPDM HYGIENIC SEALS ARE ALL PEROXIDE CURED.

What Material(s) Can Be Used

By reviewing manufacturer data and compiling information regarding regulatory requirements,
it appears that any of the aforementioned compounds are suitable for both utility and process
equipment use. However, you must ensure that all hygienic seals and compounds meet the
CFR and USP requirements, and have a certificate to verify compliance.

H Y G I E N I C S E A L M AT E R I A L G U I D E L I N E S

What Material(s) Should Be Used

Tuf-Steel is the material of choice when purity, long service life performance, chemical
and heat resistance is required. Leak free when torqued correctly. Minimum creep and
cold flow. Non-stick, ultra-low absorption and no pigmentation. Maintains seal integrity in
applications where large temperature variations occur frequently. It can remain in service
for extended periods of time in both water and frequent SIP use. The Torque-Rite is
recommended for use with clamps (See Torque-Rite literature for complete details).

PTFE is the material of choice whenever low temperature flexibility or hygienic seal memory
is not required (not recommended where large temperature variations occur frequently,
leakage can occur). PTFE has almost no extractables, has a low absorption rate and
excellent resistance to process fluids. It can remain in service for longer periods of time
in both water and steam for continuous use, high pressure clamps are recommended to
prevent leakage resulting from temperature variations. A PTFE envelope hygienic seal with
an FKM Fluoroelastomer inner core should be used if slight misalignment is observed.

Platinum cured silicone is the material of choice in sanitary water systems when PTFE is
not feasible due to severely misaligned fittings, or if the cost of high pressure clamps does
not outweigh the benefits of PTFE (extended service life).

FKM Fluoroelastomer, EPDM and Buna compounds are specified by many of our process
equipment manufacturers. They are generally suitable for these applications, however,
service life must be considered and a preventative maintenance program be implemented
to mitigate degradation. They are not recommended for continuous use in SIP procedures.

Color coding - identification of hygienic seal materials

material

description

Tuf-Steel

no dot

Tuf-Flex

no dot

PTFE

no dot

PTFE Type 3 envelope seals

FKM Fluoroelastomer filler
EPDM filler

one white, one yellow dot

three green dots

FKM Fluoroelastomer

one white, one yellow dot

EPDM*
sulfur cured
peroxide cured*

one green dot

three green dots

Silicone
peroxide cured
platinum cured

one pink dot

no dot

Buna

one red dot

* All Rubber Fab EPDM hygienic seals are peroxide cured.

color code

H Y G I E N I C S E A L M AT E R I A L G U I D E L I N E S
1 = Excellent
Gasket

2 = Good
Continuous
Stream

3 = Acceptable
Intermittent
Steam

Process
Fluids
Ambient

Process
Fluids
Hot

X = Do Not Use
Temp.
Range

Tuf-Steel
1
1
1
1
1
1
Maintains seal with wide temperature variations. Has extended service life.*

-100F to
500F

1
1
1
1
1
1
Tuf-Flex
Maintains seal with wide temperature variations. Has extended service life.*

-100F to
350F

PTFE
1
1
1
1
Wide temperature variations and may cause leakage at T.

-100F to
500F

Silicone (platinum)
2
Very flexible low temperature.

-40F to
450F

FKM Fluoroelastomer
3
Acceptable for steam applications.

-30F to
400F

EPDM (peroxide cured)

3
Low pressure steam only.

-30F to
300 F

-30F to
200F

Buna
0
0
Not recommended for strong acids and ozone.

Pure
Water
Hot

5 = Poor

Process
Fluids Variable
(<0C->100C)

Comments

Pure
Water
Ambient

4 = Marginal

* Application dependent.

Tuf-Flex: Tuf-Flex is the worlds only

unitized gasket, setting new standards
for purity, performance and flexibility.
A Tuf-Flex Gaskets contact surface is
a layer of PTFE unitized to an EPDM
rubber inner core. This totally bonded
construction provides a PTFE gasket with
the mechanical characteristics, including
memory, of an elastomer gasket. Designed
to meet critical requirements in biopharmaceutical, ultra-pure water, WFI
(water for injection) and difficult food
and beverage processing, Tuf-Flex
out performs other gaskets while
eliminating costly process interruptions.
Achieve higher performance under
SIP/CIP conditions.
Tuf-Steel: A unique 50/50 blend of nonpigmented PTFE and 316L, water atomized and passivated, delivers leak-proof
performance. Tuf-Steel is the choice for
leak-proof, perfect surface performance
and outstanding durability in SIP
(steam in place) and WFI (water for
injection) applications. Tuf-Steel is ideal
for sanitary steam pipe connections
in extreme temperatures ranging from
-20F to 500F. The superior strength
of Tuf-Steel eliminates cold flow and
creep to prevent maintenance problems
and system downtime.

PTFE is the material of choice whenever

low temperature flexibility or gasket
memory is not required (not recommended
where large temperature variations occur
frequently, leakage can occur). PTFE
has almost no extractables, has a low
absorption rate and excellent resistance
to process fluids. It can remain in service
for longer periods of time in both water
and steam for continuous use, high pressure clamps are recommended to prevent
leakage resulting from temperature variations. PTFE envelope gaskets with a FKM
Fluoroelastomer inner core should be
used if slight misalignment is observed.
Platinum Cured Silicone is the material
of choice in sanitary water systems when
PTFE is not feasible due to severely
misaligned fittings, or if the cost of high
pressure clamps does not outweigh the
benefits of PTFE (extended service life).
FKM Fluoroelastomer and EPDM compounds are specified by many of our
process equipment manufacturers. They
are generally suitable for these applications,
however, service life must be considered
and a preventative maintenance program
be implemented to mitigate degradation.
They are acceptable, but not recommended
for continuous use in SIP procedures.

Buna is the last choice in most applications due to temperature limitations and
does not pass U.S. Pharmacopeia
Class VI Certification and Cytotoxicity.
This sheet indicates general preferences.
Unique applications may require further
considerations and analysis. When selecting hygienic seal materials it is important
to consider many factors: resistance to
heat, resistance to SIP, resistance to chemicals like; hydrocarbons, ethanol, ketones,
etc, tear strength, and flexibility. The
service life of a material depends on
the application. Many of the materials are
acceptable if the expected service life is
very short in duration, however, in extended exposure situations the material can
degrade quickly rendering it ineffective or
less desirable overall. This analysis was
intended for hygienic seal applications
specifically. Sanitary gasket applications
are inherently static and can be dynamic.
When different performance attributes are
a consideration in dynamic applications,
Tuf-Steel may be the material of choice.
Torque-Rite, Tuf-Flex, Tuf-Steel and ADI Free

are registered trademarks of Rubber Fab

Technologies Group.
Torque-Rite: United States Patent Number 6,082,941.

2004 Rubber Fab Technologies Group rev. 8/05 #RF-140