RUBBER FAB’S SANITARY GASKET GUIDELINESliterature.puertoricosupplier.com/026/US25411.pdfSteam trap mini orifice plates are an alternative to standard steam trap technology. Tabs

• Tuf-Flex® is the world’s first unitized gasket, setting newstandards for purity, performance and flexibility. A Tuf-Flex®

Gasket’s contact surface is PTFE unitized to an EPDMrubber inner core. This totally bonded construction pro-vides a PTFE gasket with the mechanical characteristics,including memory, of an elastomer gasket. Designed tomeet critical requirements in biopharmaceutical, ultra-pure water, WFI (water for injection) and difficult food and beverage processing.

• Food-Flex™ is setting new standards for purity and performance for the food and beverage industries. Food-Flex™ will not absorb product, thus eliminating flavortransfer and reducing the need for costly gasket changeouts. A contact surface of PTFE unitized to a Buna rubber innercore provides a PTFE gasket with the inert, non-stick char-acteristics and memory of an elastomer gasket without pigmentation or spalling. Unlike standard PTFE gaskets,once clamped (30 in./lb), Food-Flex™eliminates leaks in ∆T situations and out performs all standard elastomericgaskets by providing 2-6x extended service life.

• Tuf-Steel® is composed of a unique 50/50 blend of non-pig-mented PTFE and 316L passivated and atomized stainlesssteel. Testing and seven years of documented applica-tion usage has demonstrated that Tuf-Steel® is the choicefor perfect surface performance, outstanding durability

and extended service life in both SIP (steam in place) andWFI (water for injection) applications. Tuf-Steel® is idealfor sanitary steam pipe connections in extreme tempera-tures ranging from -100°F to 500°F. The superiorstrength of Tuf-Steel® eliminates creep and cold flowproviding a leak-free seal and preventing maintenanceproblems and system downtime.

• PTFE is the material of choice whenever low temperature flexibility or gasket memory is not required and can remainin service for longer periods of time in both water andsteam applications. PTFE is not recommended with largetemperature variations due to creep and cold flow. PTFE hasminimal extractables, has a low absorption rate and excel-lent resistance to process fluids.

• Platinum Cured Silicone is the material of choice in sanitary water systems when PTFE is not feasible due toseverely misaligned fittings, or if the cost of high pressureclamps does not outweigh the benefits of PTFE (extendedservice life). See literature RF-170 for more information.

• FKM Fluoroelastomer and EPDM compounds are speci-fied by many of our process equipment manufacturers.They are generally suitable for these applications, however,service life must be considered and a preventative mainte-nance program be implemented to mitigate degradation.

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

Gasket Continuous Intermittent Pure Pure Process Process Process Temp.Steam Steam Water Water Fluids Fluids Fluids Variable Range

Comments Ambient Hot Ambient Hot (<0’C->100’C)

Tuf-Flex®/Ansi-Flex™ 1 1 1 1 1 1 1 -100°F toMaintains seal with wide temperature variations. Has extended service life.* 350°F

Food-Flex™ X 2 1 2 1 2 2 -30°F toMaintains seal. No pigmentation or spalling. Has extended service life.* 250°F

Tuf-Steel® 1 1 1 1 1 1 1 -100°F toMaintains seal with wide temperature variations. Has extended service life.* 500°F

HPV 1 1 1 1 1 1 1 See ElastomerEPDM, FKM, Silicone† of choice

PTFE 1 1 1 1 1 1 3 -100°F toWide temperature variations and may cause leakage at ∆T. 500°F

Silicone (platinum) 2 2 2 2 2 2 1 -40°F toVery 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 toLow pressure steam only. 300°F

* Application dependent. † 100 SIP steam cycle tested.

R U B B E R F A B ’ S S A N I T A R Y G A S K E T G U I D E L I N E S

Smart Gaskets®

The Rubber Fab Smart Gasket® value is proven when validating sterility in a high-purity pharmaceutical system. A standard sanitary flange utilizing the Smart Gasket® Thermocouple Gasketobtains the critical thermal mappinginformation needed during the valida-tion process. Meter fluids in yourprocess system using a peristalticpump or withdraw samples throughour luer lock valve or syringe. Then,utilize Rubber Fab’s Spore Trap Gasketto securely retain spore test strips.

AVAILABLE SIZES:

1/2" - 4" (excluding 2-1/2")AVAILABLE PORTS:

Thermocouple Gasket: 1-4 portsSpore Trap Gasket: 1 port

BiologicalIndicator

Rubber Fab’s Biological Indicator Gasketenables the use of a self-contained bio-logical indicator in sanitary processlines. This unique Smart Gasket® permitseither top loading or inline positioningof an EZTest® biological indicatorand/or a temperature probe. The greatadvantage of a self-contained biologicalindicator over the traditional spore stripin glassine is the time saved when con-firming spore kill. Results are easilyobtained in only 24 hours (versus thefive to seven days required with a sporestrip) and without problematic labora-tory transfer. Feel secure knowing thatthe biological indicator will not be lostdown stream in the process. This fail-safe Rubber Fab Smart Gasket® holds the indicator in place for easy retrieval.

AVAILABLE SIZES:

3/4" - 2"AVAILABLE PORTS:

1 port in sizes 1", 1-1/2", 2"N/A in 3/4"

Patent 6,927,058

Orifice Plates

Our innovative Orifice Plate line includesa complete selection of solid 316LStainless Steel, in standard TC or tabbedTC styles, that can be custom drilled with an eccentric or concentric bore.Steam trap mini orifice plates are analternative to standard steam traptechnology. Tabs help to acknowledgethat an orifice plate is “in line” and canbe laser engraved to indicate the holediameter, gasket size or user specifiedinformation. A major safety consider-ation! Rubber Fab’s Orifice Plates canadvance your system’s performance,adjust flow rates, balance backflowand equalize back pressure during SIPprocedures; achievable benefits whilemaintaining sanitary conditions.

AVAILABLE ELASTOMERS:

Buna, EPDM, FKM Fluoroelastomer,SiliconeAVAILABLE FLUOROPOLYMERS:

PTFE, Tuf-Steel®

AVAILABLE SIZES:

1/2" - 4" Consult factory for 6" and over ALSO AVAILABLE :

Slotted Clamps for Tabbed style orifice platesAVAILABLE SERVICES:

ElectropolishingPassivationLaser Engraving

Visit www.rubberfab.com for additional information.Please refer to Rubber Fab literature #RF-100.

Visit www.rubberfab.com for additional information. Please refer to Rubber Fab literature #RF-185.

Visit www.rubberfab.com for additional information.Please refer to Rubber Fab literature #RF-130.

Screen Gaskets

Rubber Fab manufactures fluid condi-tioning screen gaskets in 10 micronthrough 4 mesh. Screen gaskets provideprefiltration for critical membrane filters, coalescence of water vaporfrom process exhaust lines, particulateremoval before fill and finish, liquidgassing or degassing, sparging, chro-matography purification and more.

Screen Gaskets:• Perforated plate fluid conditioning

gaskets • Removable styles: perforated plate

gaskets, rigid screens, orifice plates • Sock designs • Filter cloth• Custom Hastelloy C276 screens • New hygienic screens specifically

designed for ultimate cleanability


Buna, EPDM, FKM Fluoroelastomer, SiliconeAVAILABLE FLUOROPOLYMERS:

PTFE, Tuf-Steel®

AVAILABLE SIZES:

1/2" - 6" Consult factory for sizes over 6"Consult factory for custom meshesAVAILABLE SERVICES:

ElectropolishingPassivationLaser Engraving

StandardGaskets

Gauge GuardIsolator Gaskets

All Rubber Fab standard Tri-Clamp® sanitarygaskets are molded from FDA compliantcompounds and have passed 3A testing.Rubber Fab’s 1/2" - 4" Type I EPDM, FKMFluoroelastomer, Silicone and PTFE Tri-Clamp® gaskets have passed U.S.P. ClassVI testing and are molded in the U.S.A.AVAILABLE ELASTOMERS:

Buna, EPDM, FKM Fluoroelastomer, Platinum & Peroxide-Cured Silicone,Perfluoroelastomer (Perlast®)AVAILABLE FLUOROPOLYMERS:

PTFE, Tuf-Steel®, Tuf-Flex®, Food-Flex™

AVAILABLE SIZES:

1/2" - 12"Now Available: DIN/ISO Gaskets Type II

Please refer to Rubber Fab literature #RF-145.




The Gauge Guard Isolator Gasket protectsexpensive diaphragm and instrumentsfrom damage without affecting per-formance. By combining a Rubber Fabsanitary gasket with a thin membrane, the Gauge Guard Isolator Gasket isolatesCIP and corrosive solutions frominstrumentation, a necessary and cost-effective step in assuring long life and accurate results. Failure to use a gauge guard gasket can voidinstrument and gauge warranties.Gauge Guard Isolator Gaskets are AnimalDerived Ingredient Free (ADI) and availablein Metal Detectable elastomers.

Laser Engraved

Laser Engraved Gaskets insure permanentbatch and lot traceability. Engravingremains readable throughout the servicelife of the gasket. Compound type and/orspecial application markings can also beengraved by request.

NOTE:

Consult factory for spacing and size limitations.

Metal DetectableElastomersMetal detectables can eliminate productrecall, lower product loss and decreasethe risk of elastomers consumed in afinished product. Gaskets manufacturedwith our FDA approved metal fillerinsures a worn off piece of elastomermaterial migrating through your systemwill be detected and rejected by an in-line metal detector or removed by amag bar. Searching for and locating frag-mented rubber parts has traditionally beena costly, time consuming and inconclu-sive process requiring expensive x-rayequipment, manual observation and anextensive maintenance program. Notlocating a worn and lost rubber piececan have an even costlier outcome! Meets USDA Hazard Analysisand Critical Control Points.


Buna, EPDM, Silicone, FKMFluoroelastomer, PTFEAVAILABLE PRODUCTS:

Gaskets, Valve Stems, Check Balls, QuadRings, Heat Sealing Bars, Sheet, Extrusions,Hoses, Utensils, O-Rings

Please refer to Rubber Fab literature #RF-196.

AntimicrobialAll Rubber Fab elastomer products can bemanufactured with an antimicrobial addi-tive that provides continuous protectionagainst microbial growth. The additiveforms an integral part of the rubber com-pound and is durable, non-leaching andprevents microorganisms from feedingon important rubber components andforming mildew, slime, foul odors andsimilar forms of process contamination.

Meets USDA Hazard Analysis and Critical Control Points, USP Class VI and NSF 51.

Tuf-Steel®

The original Tuf-Steel® gasket, a RubberFab market innovation, is composed of aunique 50/50 blend of non-pigmented PTFEand 316L passivated and atomized stain-less steel. Testing and seven years ofdocumented application usage hasdemonstrated that Tuf-Steel® is the choicefor perfect surface performance, out-standing durability and extended servicelife in both SIP (steam in place) and WFI(water for injection) applications. Tuf-Steel® is ideal for sanitary steam pipeconnections in extreme temperature appli-cations, such as frier and hot oil appli-cations, with temperatures ranging from -100°F up to 500°F. The superiorstrength of Tuf-Steel® eliminates creepand cold flow providing a leak-free seal.Plus, Tuf-Steel® works with the Torque-Rite® Perfect Surface Gasket System elimi-nating the potential for bacterial entrap-ment problems caused by over-tighteningor under-tightening a sanitary gasket.AVAILABLE SIZES:

1/2" - 12" TUF-STEEL® SHEET AVAILABLE:

1/16" & 1/8" thick25" x 48" square

ALSO AVAILABLE:

Ansi-Flange in 1/8" thick Tuf-Steel material

ControlledCompression

The Controlled Compression Gasket(CCG) and the HPV Gasket cannot beover-tightened! The CCG is composed of aRubber Fab elastomer with a ring of ultem®

vulcanized inside the gasket. This non-compressible ring controls clamp com-pression to exactly the correct amount,allowing the properly positioned gasket to make a perfect surface I.D. seal withthe ferrules.

The HPV Gasket is a ring of perforatedstainless steel totally and permanentlyencapsulated in an elastomeric gasket.The locked stainless steel ring elimi-nates the gasket’s ability to stretch,creep or cold flow while preventingtears, rips and I.D. intrusion. The HPVGasket works with high pressure clamps.100 SIP steam cycle tested.


CCG: EPDM, FKM Fluoroelastomer, SiliconeHPV: Silicone, EPDM, FKMAVAILABLE SIZES:

CCG: 1" - 3" HPV: 1/2" - 4"

Patent 6,857,638




Tuf-Flex® Food-Flex™ Ansi-Flex™150#

Ansi FlangeGasket

Tuf-Flex®, the ultimate pharmaceuticalsanitary gasket, is setting new standardsfor purity, performance, flexibility andis the world’s first unitized gasket. A Tuf-Flex® gasket’s contact surface is PTFEunitized to an EPDM rubber inner core.This totally bonded construction pro-vides the inert, non-stick benefits of PTFEwith the memory of an elastomeric gasketwithout fear or risk of pigmentation or spalling. Designed to meet criticalrequirements in biopharmaceutical, ultra-pure water, WFI (water for injection) and difficult aseptic processing applications.Tuf-Flex’s® extended service life out per-forms other gaskets while eliminatingcostly process interruptions. Achieve higherperformance under SIP/CIP conditions.

AVAILABLE SIZES:

1/2" - 4" TUF-FLEX® SHEET AVAILABLE:

1/16" & 1/8" thick13-3/4"x13-3/4"square

Food-Flex™, the next generation in unitizedgasket technology, was designed specifi-cally for purity and performance in critical food and beverage applications. A Food-Flex™ Gasket’s contact surface isPTFE unitized to a Buna rubber innercore. This totally bonded construction provides a PTFE gasket with the inert, non-stick characteristics and memory ofan elastomer gasket without pigmentationor spalling. Food-Flex™ will not absorbproduct, thus eliminating flavor transfer and reducing need for costly gasket change-outs. Unlike standard PTFE gaskets, onceclamped (30 in./lb), Food-Flex™ eliminatesleaks in ∆T situations and resists all CIP(Clean in Place) media. Food-Flex™ outperforms all standard elastomeric gas-kets by providing 2-6x extended servicelife and helps eliminate costly processinterruptions in food and beverage pro-duction. Food-Flex™ is suitable for use inhomogenizers, carbo coolers, filtrationhousings and pasteurizers. Meets FDA, 3A and USDA requirements.

AVAILABLE SIZES:

1/2" - 4"

An Ansi-Flex™150# Ansi Flange Gasket’scontact surface is a layer of PTFE unit-ized to an EPDM rubber inner core. This totally bonded construction providesa PTFE gasket with the mechanical charac-teristics, including memory, of an elas-tomer gasket with exceptional steamresistance. An Ansi-Flex™ 150# Ansi FlangeGasket is ideal for applications, such asPVC piping and glass lining piping,where low seating stress is required. TheAnsi-Flex™150# Ansi Flange Gasket hassuperior and extended service life overstandard flange gaskets. Achieve higherperformance under SIP/CIP conditions.AVAILABLE SIZES:

1/2" - 12" ALSO AVAILABLE:

Ansi-Flange in 1/8" thick Tuf-Steel material



For additional information, please refer to Rubber Fab literature #RF-650.

Type I Type IIIGaskets Envelope Gaskets TUF-FLEX

Torque-Rite®

For Standard Gasket and Specialty Gasket

Applications


Patent 6,082,941

Torque-Rite®

provides exacttorque for

rupture disks and sensory alert disk

applications.

Compression control is easy! Torque-Rite®

allows you to control compression andexpansion while maintaining constantinch/pounds force insuring a Perfect Surface I.D.Torque-Rite® eliminates sanitary problems associated with over- or under-tightening a gasket. When tightened, the Torque-Rite’s® self-limiting internalmechanism will make an audible “click” signaling the user that they havereached proper inch/pounds force. If further tightening is attempted, there will be more “clicks” but no additional application of force on the gasket (if emergency conditions arise, the Torque-Rite® has a built-in manual override feature).

In applications where exact torque values are mandatory for properoperation, such as rupture disks and sensory alert disks, Torque-Rite®

will quickly and easily provide the required torque. Because Torque-Rite® doesnot require any special tools or training, exact torque is reached fasterand on the first try! See below for rupture disk torque requirements.

AVAILABLE:

30 in/lbs for all elastomers, Tuf-Flex® and Food-Flex™

50 in/lbs for PTFE and Tuf-Steel®

AVAILABLE FOR RUPTURE DISKS:

40 in/lbs for 1.5" Rupture Disks50 in/lbs for 2" Rupture Disks60 in/lbs for 3" Rupture Disks

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Hose, Hose Assemblies,Tubing, Fittings and Adapters

Rubber Fab PresentsAntimicrobial Hose & Metal Detectable Hose

High Purity Platinum Silicone Hose, Tubing, Sanitary Molded EndsPTFE & FEP Lined Smooth Bore & Convoluted Hose

Metal HoseFDA Rubber Hose

FDA PVC Hose, Tubing, Sanitary Molded EndsSight Gauges: PTFE & Polysulfone

Fittings & Adapters: 316L, Special Alloys & Non Metallic

ANIMAL DERIVED INGREDIENT FREE

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Sanitary DiffuserGasket

V2B Vent Gasket

View Port

Diffuser aeration systems provideincreased oxygen content to high purity water systems. Diffusers can alsobe used to diffuse digester gases suchas hydrogen sulfide and sulphur dioxide; to introduce ozone for oxidizing anddestroying bacterial and organic chemicalcontaminants, also for carbon dioxideinjection for carbonization and ph adjustment.


EPDM, FKM Fluoroelastomer, SiliconeAVAILABLE SIZES:

1/2" - 3" Consult factory for other sizesAVAILABLE MICRON:

1/2 - 2 micron2 micron is standard stock, all other micron are custom

The Rubber Fab V2B Vent Gasket providesvacuum and pressure relief for pharmaceu-tical and food/beverage processingtank venting when airborne particulateremoval is required. A 200 mesh screencombined with a 14 mesh screen of sin-tered construction creates a cost effectivealternative to expensive vacuum breakersand venting systems.

The V2B System is attached/connected usinga standard sanitary clamp to a sanitarytank port, the same way a standard vacuumbreaker in installed. Installation can behorizontal, vertical or in single or multi-ple port configurations (i.e. manifolds)without special fabrication or expensivetooling. The V2B screen will fit perfectlyinto the I.D. of a sanitary pipe and can beused for inflow fluid conditioning filtration.

The Rubber Fab View Port has been engineered to meet your process andsafety needs. The View Port’s sanitaryone-piece window construction exceedsconventional tempered glass windows inperformance and safety. The simpleinstallation makes for easy cleaning.Works with standard Tri-Clamp ferruleconnections under positive or negativepressure. View Port is pretested for highimpact strength and thermal shock.View Port is 3A approved and has FactoryMutual Electrical Certification.

AVAILABLE MATERIAL:

Hastelloy C

ALSO AVAILABLE:

Hastelloy C22, C276

AVAILABLE SIZES:

1-1/2", 2", 2-1/2", 3", 4", 6", 8"



Visit www.rubberfab.com for additional information. Please refer to Rubber Fab literature #RF-500-6.

Rubber Fab Technologies GroupLimecrest Road

P.O. Box 626 • Andover, NJ 07821phone: 973-579-2959 fax: 973-579-7275

www.rubberfab.com

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Rubber Fab Technologies Group is a member of:Smart Gasket®, Tuf-Steel®, Tuf-Flex® and Torque-Rite® are registered trademarks of Rubber Fab Technologies Group.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.Elastoguard® is a registered trademark of Milliken & Co. Perlast® is a registered trademark of Perlast, Ltd.

Get the information you need and more at www.rubberfab.comRubber Fab Technologies Group, a Material Science Company, is a leading innovator of high quality hygienic seals, sanitary gaskets,

hose assemblies, valve, pump and filler machine components in a wide range of high purity elastomer materials. For additional information, contact Rubber Fab at 973-579-2959.

Rubber Fab Gaskets Meet the MostStringent Standards For Purity• U.S. Pharmacopeia Class VI Certification*

• Cytotoxicity Criteria*

• Title 21 CFR 177.2600 and 177.1550

• USDA and 3-A Sanitary Standards

• Current Good Manufacturing Practices (CGMP)

• ASME-BPE Standards

• ISO 9001:2000 and QS-9000:1998

• European Pharmacopeia 3.1.9*

• Animal Derived Ingredient Free*

• Gaskets are made in the U.S.A.* Buna does not pass U.S. Pharmacopeia Class VI Certification

and Cytotoxicity and is not ADI free.

ISPE

Documents

RUBBER FAB’S SANITARY GASKET GUIDELINESliterature.puertoricosupplier.com/026/US25411.pdfSteam trap mini orifice plates are an alternative to standard steam trap technology. Tabs