Rubber Fab’s Sanitary Gasket Guidelines

• Tuf-Flex® is the world’s first unitized gasket, setting • PTFE is the material of choice whenever low temperature
new standards for purity, performance and flexibility. A flexibility or gasket memory is not required and can remain
Tuf-Flex® Gasket’s contact surface is PTFE unitized to an in service for longer periods of time in both water and
EPDM rubber inner core. This totally bonded construction steam applications. PTFE is not recommended with large
provides a PTFE gasket with the mechanical characteristics, temperature variations due to creep and cold flow. PTFE has
including memory, of an elastomer gasket. Designed to meet minimal extractables, has a low absorption rate and excellent
critical requirements in biopharmaceutical, ultra-pure water, resistance to process fluids.
WFI (water for injection) and difficult food and beverage • Platinum Cured Silicone is the material of choice
processing. in sanitary water systems when PTFE is not feasible due to
• Tuf-Steel® is composed of a unique 50/50 blend of non- severely misaligned fittings, or if the cost of high pressure
pigmented PTFE and 316L passivated and atomized stainless clamps does not outweigh the benefits of PTFE (extended
steel. Testing and seven years of documented service life). See Rubber Fab’s Platinum Silicone Hygienic
application usage has demonstrated that Tuf-Steel® is the Seal literature for more information.
choice for perfect surface performance, outstanding • FKM Fluoroelastomer and EPDM compounds are
durability and extended service life in both SIP (steam specified by many of our process equipment manufacturers.
in place) and WFI (water for injection) applications. Tuf-Steel® They are generally suitable for these applications, however,
is ideal for sanitary steam pipe connections in extreme service life must be considered and a preventative
temperatures ranging from -320°F to 550°F. The superior maintenance program be implemented to mitigate degradation.
strength of Tuf-Steel® eliminates creep and cold flow
providing a leak-free seal and preventing maintenance • Buna is the last choice in most applications due to
problems and system downtime. temperature limitations and does not pass U.S. Pharmacopeia
Class VI Certification and Cytotoxicity.

1 = Excellent 2 = Good 3 = Acceptable 4 = Marginal 5 = Poor 0 = Do Not Use

Gasket Continuous Intermittent Pure Pure Process Process Process Temp.
Comments Steam Steam Water Water Fluids Fluids Fluids Variable Range
Ambient Hot Ambient Hot (<0ºC - >100ºC)

Tuf-Flex®/Ansi-Flex 1 1 1 1 1 1 1 -20°F to
Maintains seal with wide temperature variations. Has extended service life.** 300°F
Tuf-Steel® 1 1 1 1 1 1 1 -320°F to
**
Maintains seal with wide temperature variations. Has extended service life. 550°F
PTFE 1 1 1 1 1 1 3 -100°F to
Wide temperature variations and may cause leakage at ∆T. 500°F
Silicone (platinum) 2 2 2 2 2 2 1 -40°F to
Very flexible low temperature. 450°F
FKM Fluoroelastomer 2 2 2 2 2 2 2 -30°F to
Acceptable for steam applications. 400°F
EPDM (peroxide cured) 3 3 3 3 3 3 3 -30°F to
Low pressure steam only. 300°F
Buna* 0 0 5 5 5 5 5 -30°F to
Not recommended for strong acids and ozone 200°F
*Buna does not pass U.S. Pharmacopeia Class VI Certification and Cytotoxicity and is not ADI free. ** Application dependent.
Smart Gaskets® Biological Orifice Plates
Indicator

The Rubber Fab Smart

Gasket® value is proven when Rubber Fab’s Biological Indicator Gasket enables Our innovative Orifice Plate line includes a R
validating sterility in a complete selection of solid 316L Stainless t
the use of a self-contained biological indicator
high-purity pharmaceutical m
in sanitary process lines. This unique Smart Steel, in standard or tabbed tri-clamp that
system. The Smart Gasket® e
Gasket® permits either top loading or inline can be custom drilled with an eccentric or
Thermocouple Gasket obtains p
positioning of an EZTest® biological indicator concentric bore. Vertical styles, which are
Y
the critical thermal map- and/or a temperature probe. The great funnel shaped for optimal vertical drainage, are
e
ping information needed advantage of a self-contained biological indicator also available. Steam trap mini orifice plates
v
during the validation process. over the traditional spore strip in glassine is the are an alternative to standard steam trap m
They can meter fluids in your process system time saved when confirming spore kill. technology. Tabs help to acknowledge that
A
using a peristaltic pump or withdraw samples an orifice plate is “in line” and can be laser E
Results are easily obtained in a few hours (versus
through our lure lock valve or syringe. The Smart engraved to indicate the hole diameter, gasket
several days required with a spore strip) and A
Gasket® requires a specifically designed thermocou- size or user specified information. A major P
without problematic laboratory transfer. Feel
ple clamp but easily installs in any standard sanitary safety consideration! Rubber Fab’s Orifice A
secure knowing that the biological indicator will
tri-clamp. Then, utilize Rubber Fab’s Spore Trap Plates can enhance your system’s performance, 1
not be lost down stream in the process. This fail- adjust flow rates, balance back flow C
Gasket to securely retain spore test strips.
safe Rubber Fab Smart Gasket® holds and equalize back pressure during SIP A
AVAILABLE SIZES: the indicator in place for easy retrieval. E
1/2" - 4" procedures; achievable benefits while maintaining P
Biological Indicator Gaskets require a specifically sanitary conditions. L
AVAILABLE PORTS:
Thermocouple Gasket: 1 - 4 ports
designed thermocouple clamp but easily install in AVAILABLE ELASTOMERS:

S
Spore Trap Gasket: 1 port any standard tri-clamp. EPDM, FKM Fluoroelastomer, Silicone, Buna*
(Elastomer replacement gaskets are available)
ACCESSORIES AVAILABLE: AVAILABLE SIZES: AVAILABLE FLUOROPOLYMERS:
Sampling/Injection Tube 3/4" – 2" T
PTFE, Tuf-Steel®
Hole Plug AVAILABLE PORTS:
t
AVAILABLE SIZES:
Stopcock 1 port in sizes 1", 1-1/2", 2" 1/2" – 4" c
Teflon Coated Wire Probe N/A in 3/4" Consult factory for 6" and over T
Kapton Coated Wire Probe l
ALSO AVAILABLE:
Thermometer For more information on Rubber Fab's Biological
Extension Lead - 3 ft & 6 ft
Slotted Clamps for Tabbed style orifice plates i
Indicator, please visit www.rubberfab.com.
Temperature Probes AVAILABLE SERVICES: m
Patent 6,927,058 Electropolishing
A
Passivation
E
Laser Engraving
A
E
Screen Gaskets Inline Strainers V2B Vent
& Overscreens Gasket

Rubber Fab’s fluid filtration screen gaskets provide

the most comprehensive range of stainless steel
The Rubber Fab V2B Vent Gasket provides vacuum
mesh and filter cloth which provide for particulate
elimination to protect fill and finish sterile and pressure relief for pharmaceutical and
Today’s processing pipe lines require strainers food/beverage processing tank venting when
products, spray balls and spray nozzles.
You can choose a screen gasket in a USP Class VI with an increased capacity to meet production airborne particulate removal is required. A
elastomer or Fluoroelastomer and are available in a needs of state-of-the-art Food, Beverage 200 mesh screen combined with a 14 mesh screen
variety of mesh sizes including 10 micron through 4 and Pharmaceutical manufacturing of sintered construction creates a cost effective
mesh. Custom screens are also available. facilities. Rubber Fab’s sanitary strainers and alternative to expensive vacuum breakers and
AVAILABLE ELASTOMERS: overscreens protect valuable processing venting systems.
EPDM, FKM Fluoroelastomer, Silicone, Buna* equipment (pumps, spray nozzles, needle valves, The V2B System is attached/connected the same way
AVAILABLE FLUOROPOLYMERS: heat exchangers and homogenizers) and have been a standard vacuum breaker in installed. Installation
PTFE, Tuf-Steel®
specifically designed to meet the most stringent can be horizontal, vertical or in single or
AVAILABLE SIZES:
1/2" – 6" (Consult factory for 6" and over)
process requirements. Our sanitary strainer multiple port configurations (i.e. manifolds)
Consult factory for custom meshes products are manufactured using 316L stainless without special fabrication or expensive tooling. The
AVAILABLE SERVICES: steel and are designed for maximum installation V2B screen will fit perfectly into the I.D. of a
Electropolishing flexibility, sanitary construction, and unrestricted sanitary pipe and can be used for inflow fluid
Passivation
flow. conditioning filtration.
Laser Engraving
AVAILABLE: AVAILABLE SIZES:

Sock Screens Inline Sanitary Strainers, Hi-Capacity Sanitary Strainers,

Side Inlet Sanitary Strainers and Custom Fabricated
Sanitary Strainers
1-1/2" – 6"

The extended sock shaped mesh gasket offers up

to 300% more open area for 300% more soil ALSO AVAILABLE:

collection capability than conventional screens. Wire mesh overscreens, hygienic overscreens, wedge
wire, disposable filter socks, wire and mesh basket
They provide greater flow for situations where a liners, 10 mesh to 200 mesh overscreen
large amount of particulates are involved. Available
in 10 mesh to 325 mesh with standard 10 & 16
mesh in stock.
AVAILABLE ELASTOMERS:
EPDM, FKM Fluoroelastomer, Silicone, Buna*
AVAILABLE SERVICES:
Electropolishing
Gauge Guard Tuf-Steel® Tuf-Flex®
Protector Internationa
Dairy Fitting
Also Availab
l
s
le!

The Gauge Guard Isolator and Protector Gaskets

protect expensive gauge diaphragms and
instruments from damage.
When moving, storing or being autoclaved, the
Gauge Guard Protector Gasket protects the
gauge’s fragile diaphragm from damage. Tuf-Flex®, the ultimate pharmaceutical
Tuf-Steel – the original metal detectable
®
sanitary gasket, is setting new standards for
The easy attach ring slips effortlessly onto the
and x-ray inspectable gasket, a Rubber purity, performance, flexibility and is the
gauge keeping the Protector Gasket ready for use.
Fab market innovation, is composed of a unique world’s first unitized gasket. A Tuf-Flex® gasket’s
AVAILABLE IN:
proprietary blend of non-pigmented PTFE and 316L contact surface is PTFE unitized to an EPDM rubber
Platinum Silicone only and Sizes 3/4" - 2"
(3/4" protectors can be used with 1/2" isolators) passivated and atomized stainless steel. Testing inner core. This totally bonded construction
and many years of documented application provides the inert, non-stick benefits of

Gauge Guard usage has demonstrated that Tuf-Steel is the

®
PTFE with the memory of an elastomeric
choice for perfect surface performance, gasket without fear or risk of pigmentation
Isolator Gasket outstanding durability, extended service life
and increased up-time in both SIP (steam in
or spalling. Designed to meet critical requirements
in biopharmaceutical, ultra-pure water, WFI (water
By combining a Rubber Fab sanitary place) and WFI (water for injection) applications. for injection) and difficult aseptic processing
gasket with a thin membrane, the Isolator Gasket Tuf-Steel is ideal for sanitary steam and extreme
®
applications. Tuf-Flex’s® extended service life
isolates CIP and corrosive solutions from temperature processes, specifically fryer and hot increases up-time by out performing other
instrumentation without affecting oil applications, with temperatures ranging from gaskets by eliminating costly process
performance, a necessary and cost-effective –320°F up to 550°F. The superior strength interruptions.
step in assuring long life and accurate results. of Tuf-Steel eliminates creep and cold flow
®

AVAILABLE IN:
providing a leak-free seal. Standard Envelope
Gasket Gasket Tuf-Flex®
Platinum Silicone, AVAILABLE SIZES:
PTFE, Tuf-Steel®, 1/2" – 12"
FKM and EPDM TUF-STEEL ®

TUF-STEEL® Type II Flan

AVAILABLE SHEET AVAILABLE: ged
SIZES: AVAILABLE!
1/16" & 1/8" thick
1/2" - 2" 12" x 12", 24" x 24",
Consult and 36" x 36"
Factory for
sizes per ALSO AVAILABLE:
material. Type II Flanged
DIN/ISO AVAILABLE SIZES:
Ansi Flange 1/8" thick 1/2" – 6"
X-Ray Inspectable TUF-FLEX® SHEET AVAILABLE:
150# Flanged Screen Gaskets 1/16" & 1/8" thick and
13-3/4" square
 Ansi-Flex 150# Detectomer ®
DIN/ISO
Ansi Flange METAL DETECTABLE AND
X-RAY INSPECTABLE PRODUCTS
Gasket

Rubber Fab’s DIN/ISO gaskets are manufactured in

Detectomer is a full line of metal detectable
® compliance with FDA, USP Class VI requirements
and x-ray inspectable products designed to to insure the highest purity sealing product
work with any existing conveyor, pipe line or free fall available worldwide. We offer the following line
detection system – sanitary gaskets, o-rings, sanitary of European standard sanitary gaskets DIN32676,
screens, sheet, rod, hose, tubing, extrusions, cam DIN11851, DIN11864, ISO1127, ISO2852,
An Ansi-Flex 150# Ansi Flange Gasket’s contact & groove gaskets camlock screen gaskets, scoops, SMS1149
and scrapers. Detectomer® products help eliminate
surface is PTFE unitized to an EPDM rubber
product recall, lower product loss and AVAILABLE ELASTOMERS:
inner core. This totally bonded construction decrease the risk of components consumed Platinum Silicone, FKM
provides a PTFE gasket with the mechanical Fluoroelastomer, EPDM, Buna*
in a finished product by insuring that a worn off
characteristics, including memory, of an elastomer piece of elastomer material migrating through AVAILABLE FLUOROPOLYMERS:
gasket with exceptional steam resistance. PTFE, Tuf-Steel®
your system will be detected and rejected
An Ansi-Flex 150# Ansi Flange Gasket is ideal for by an in-line x-ray system, metal detector or
applications, such as PVC piping and glass removed by a mag bar. Searching for and locating
lining piping, where low seating stress is required. fragmented component parts has traditionally been
The Ansi-Flex 150# Ansi Flange Gasket has superior a costly, time consuming and inconclusive
and extended service life over standard flange process. Not locating a worn and detached part
can have an even costlier outcome!
gaskets. Achieve higher performance under SIP/CIP
conditions. Meets USDA Hazard Analysis and
Critical Control Points.
AVAILABLE SIZES:
AVAILABLE ELASTOMERS:
1/2" – 12"
Consult factory for sizes over 12" EPDM, FKM Fluoroelastomer, Silicone, Buna*
AVAILABLE FLUOROPOLYMERS:
Tuf-Steel
®

AVAILABLE PRODUCTS: Lock & Label

Gaskets, Quad Rings, Heat Sealing Strips, Sheet, Lock & Label tags provide sanitary system
Extrusions, Hoses, Utensils, O-Rings safety, security and identification. When
ALSO AVAILABLE: properly installed, they cannot be opened, reducing
Ansi-Flange in 1/8" thick Tuf-Steel® material the risk of accidental steam or product release.
PLASTIC MATERIAL (METAL DETECTABLE ONLY): Lock & Label tags will work with most hinge
UHMW, Acetal clamps. Customer specified labeling is available.
SHEET MATERIAL AVAILABLE: AVAILABLE IN:
Polyurethane Blue, Green, Red, Yellow and White

Metal Detectable Patent # 7,390,580

Detectomer® Patent Pending 61/414,552
Rubber Fab has O-rings!
Rubber Fab offers a full line of AS 568 Dash Numbers, metric and specialty O-Ring sizes in
many materials including Detectomer® Metal Detectable and X-Ray Inspectable materials.
Our proprietary compounds are designed to perform in a wide range of applications
with varying chemical exposures, pressures and temperatures.

Products
• O-Rings
• O-Ring Kits
• O-Ring Cord

Materials Available
• Buna* • EPDM
• Silicone • PTFE
• FKM Fluoroelastomer • Tuf-Steel®

Available
AS 568 Dash Numbers and Metric O-Rings
available in:
• Standard
• FDA
• Class VI
• Detectomer® Metal Detectable/X-Ray Inspectable

O-Ring Cord
Vulcanize your own O-rings from our selection
of O-ring cord stock, offered in both inch or
metric sizes.

Materials Available
• Standard • FDA
• Class VI • Metal Detectable
• Detectomer Metal Detectable/X-Ray Inspectable
®

For cord diameters, please consult Rubber Fab’s o-ring department.

Standard Gaskets T

Rubber Fab standard Tri-Clamp® sanitary gaskets are

manufactured using FDA compliant compounds,
and according to CGMP guidelines. Our 1/2" – 4" T
Type I EPDM, FKM Fluoroelastomer, Silicone and PTFE, Tuf-Flex®, & a
Tuf-Steel® Tri-Clamp® gaskets are USP Class VI and FDA CFR 177.2600 & 177.1550 p
and ADI (Animal Derived Ingredient Free) certified. R
w
Rubber Fab offers a variety of: t
• APC • O-Rings m
• Bevel Seat • Perforated Plates t
• Camlock • Q-Line f
m
• Detectomer® Metal Detectable/ • Quad Rings
X-ray Inspectable f
• Schedule V r
• Diffuser • Screen r
• DIN/ISO • Smart Gaskets®
• Envelope • Tuf-Flex®
A
3
• Full Face Flange Gaskets 150# & 300# • Tuf-Steel® 5
• Gauge Guard • Tri-Clamp® Type I
• I-Line
T
• Tri-Clamp® Type II
• John Perry • V2B Vent Gasket
• Manway • Valve Body R
• Orifice Plates
a
In addition to standard gaskets Rubber Fab offers
A
custom Screen Gaskets, Custom Gaskets, and T
Custom Tooling. We also offer Sanitary Sheet
Material, profiles and cord in Class VI and FDA
compliant materials.
Torque-Rite Smart Clamp™ Services
®

For Standard Gasket and The “Half-Turn” Sanitary What really sets Rubber Fab apart from other
Specialty Gasket Applications Smart Clamp manufacturers are our value added services.
Coding & Labeling:
Time is money. Don't waste valuable time searching
for sanitary components in your process line.
“Identify” your system components using one of
Rubber Fab’s System Identification products.
K
C
I
L
Patent 6,082,941
C Laser Engraved
Torque-Rite allows you to control compression
®

Products & Bar

and expansion while maintaining constant inch/ Coding:
pounds force insuring a Perfect Surface I.D. Torque- Rubber Fab is proud to introduce the next generation of Gaskets, hose
Rite eliminates sanitary problems associated
®

sanitary hinge clamps – the one-piece, completely assemblies, stainless

with over- or under-tightening a gasket. When unitized Smart Clamp™. With features that include fittings & adapters
tightened, the Torque-Rite’s self-limiting internal
®

half-turn installation and faster uptime, the benefits of insure process line identification and provide
mechanism will make an audible “click” signaling Rubber Fab’s Smart Clamp™ far exceeds any other complete cradle to grave lot and batch traceability.
the user that they have reached proper inch/pounds sanitary clamp. Laser Engraved Products & Bar Coded
force. If further tightening is attempted, there will be • Dramatically increased uptime Collars present a sharp
more “clicks” but no additional application of • Supports ASME-BPE seal performance legible, professional
force on the gasket. Because Torque-Rite does not
®

• Half-turn installation image. Include your

require any special tools or training, exact torque is • Repetitive stress and ergonomic benefits company name,
reached faster and on the first try! •M  ultiple compression settings for sanitary gaskets, application-specific
no over or under tightening of gasket information such as
AVAILABLE:
30 in/lbs for all elastomers and Tuf-Flex ®
• Extends gasket's service life serial numbers or
50 in/lbs for PTFE and Tuf-Steel ®
•D  eeper clamp channel nests ferrules and evenly maintenance codes,
distributes force over the gasket's face and more. Use etched
• Single unitized unit - no additional parts collars to communicate your most critical
Torque Tee • T hreadless system minimizes soil and bacterial
entrapment
information. Part numbers, sizes, service dates, and
usage recommendations are just a few examples.
Rubber Fab’s Torque Tee and universal torque socket • Clamp hinge and locking arm will not collapse Tabbed Orifice
are designed to aid in clamp installation & removal. • Manufactured in 304 Stainless Steel Plate Gaskets:
Available with a family of components, the Torque • No tools required Tabs protrude from
Tee handle creates effective tightening leverage & • User-friendly clamp and can be
aids in reaching laser etched for easy
tight spaces. line identification.

AVAILABLE: NOTE: Consult factory

30 in/lbs, 40 in/lbs for spacing and size
& 50 in/lbs limitations on all etched
Consult factory for products.
other torques up to
80 in/lbs.
 Hose, Hose Assemblies, Tubing,
Fittings and Adapters
High Purity Platinum Silicone Hose, Tubing,
Sanitary Molded Ends
PTFE & FEP Lined Smooth Bore &
Convoluted Hose
Metal Hose
FDA Rubber Hose
FDA PVC Hose, Tubing,
Sanitary Molded Ends
Sight Gauges: PTFE & Polysulfone
Fittings & Adapters: 316L, Special Alloys &
Non Metallic
3A Standard Number 62-02

Standard Number 62-02

Rubber Fab Gaskets Meet

the Most Stringent Standards
For Purity
• U.S. Pharmacopeia Class VI Certification*
• Cytotoxicity Criteria* 26 Brookfield Drive • Sparta, NJ 07871
973-579-2959 Phone • 866-442-2959 Toll Free • 973-579-7275 Fax
• Title 21 CFR 177.2600 and 177.1550
[email protected]
• USDA and 3-A Sanitary Standards
• Current Good Manufacturing Practices (CGMP) www.rubberfab.com
• ASME-BPE Standards
• ISO 9001:2000 and QS-9000:1998
• Animal Derived Ingredient Free*
Rubber Fab is a member of:
* Buna does not pass U.S. Pharmacopeia Class VI Certification
and Cytotoxicity and is not ADI free.

Smart Gasket®, Tuf-Steel®, Tuf-Flex® and Torque-Rite® are

registered trademarks of Rubber Fab.
ISPE
Detectomer® is a trademark of Rubber Fab.
EZTest® is a registered trademark of SGM Biotech, Inc.
Tri-Clamp® is a registered trademark of The Ladish Company.
Ultem® is a registered trademark of GE.
Kalrez® is a registered trademark of Du Pont Performance
Elastomers LLC

© 2004-2016 Rubber Fab – rev. 01/17