Sanitary Seals


Patent #6,927,058
Biological Indicator Gaskets

We are proud to introduce a new technology that enables the use of a self contained biological indicator in sanitary process lines. This unique Rubber Fab Smart Gasket® permits either top loading or inline positioning of the EZTest® self contained biological indicator and/or temperature probe. The great advantage of a self contained biological indicator over the traditional spore strip in glassine is the time saved when confirming spore kill. Results are easily obtained in only 24 hours (versus the 5 to 7 days required with a spore strip).

You can feel secure knowing that the biological indicator will not be lost down stream in the process. The fail-safe Rubber Fab Smart Gasket® holds the indicator in place for easy retrieval. Available for 3/4'', 1.0'', 1.5'' and 2.0'' Sanitary, Tri-Clamp® process lines.

EZTest®

  • U.S. Pharmacopeia
  • ISO 11138
  • European Norm 866

 

Meets High Pharmaceutical Standards:

  • U.S. Pharmacopeia Class VI Certification
  • CFR Title 21 Section 177.2600
  • Certification: Lot and Batch
  • USDA Standards
  • Current Good Manufacturing Practices (CGMP)
  • Cytotoxicity Criteria
  • Traceability: Lot and Batch
  • ASME-BPE Standards
  • 3-A Sanitary Standards

 


Patent #6,867,638
Compression Control Gaskets

The Controlled Compression Gasket cannot be over-tightened! The CCG is composed of the elastomer of your choice with a ring of ultem® vulcanized inside the seal from the ring O.D. to the locating ring. This non-compressible polymer controls clamp compression to exactly the correct amount, allowing the properly positioned seal to make a perfect surface I.D. with the ferrules. No intrusion of the hygienic seal in the product flow is possible.

Controlled Compression Gaskets

  • Hygienic seal meets ASME-BPE intrusion requirement of ± .020.
  •  Works with virtually any manufacturer’s ferrules, fittings, clamps or combination thereof.
  • No torque requirement. Tighten until it stops (we suggest wetting the gasket with isopropyl alcohol during installation to insure uniform compression, especially the 1" CCG).
  • The CCG hygienic seal will allow for slight misalignment and ferrule face anomalies.
  • Available in EPDM, FKM and silicone.
  • Can be tabbed for traceability or non-tabbed with laser engraved
  • FDA compliant, 3A and Class VI tested.
  • First major gasket design patent issued in the last 60 years.
  • 1" to 3" sizes available (excluding 2.5").

 

Meets the Stringent Standards For Purity:

  • U.S. Pharmacopeia Class VI Certification
  • Cytotoxicity Criteria
  • USDA and 3-A Sanitary Standards
  • Current Good Manufacturing Practices (CGMP)
  • ASME-BPE Standards
  • Animal Derived Ingredient Free
  • Title 21 CFR 177.2600

 

Food-Flex Gaskets

Introducing a technologically advanced new sanitary seal, FOOD-FLEX. This revolutionary new sanitary seal from Rubber Fab Technologies Group is the world’s only unitized gasket, setting new standards for purity, performance and flexibility. Specifically designed for purity and performance in critical food and beverage applications. A FOOD-FLEX gasket's contact surface is PTFE unitized to a Buna rubber inner core.

Applications include: Homogenizers, Carbo Coolers, Filtration Housings and Pasteurizers.

Achieve higher performance under CIP Conditions

  • Uniting the flexibility of an elastomer with the chemical resistance of PTFE.
  • Seats perfectly.
  • Superior resistance to cold flow and creep.
  • Minimal thermal expansion.
  • Outstanding service life.
  • Exceptional flexibility.

FOOD-FLEX Meets Stringent Standards:

  • Title 21 CFR 177.2600 and Title CFR 177.1550
  • Current Good Manufacturing Practices (CGMP)
  • USDA and 3-A Sanitary Standards
  • ASME-BPE Standards

 

Platinum Silicone Gasket

High purity platinum cured silicone hygienic seals are the ideal choice for use in production facilities of fine pharmaceutical, biotechnology, high-purity water, injectables, food and beverage products. Rubber Fab’s platinum cured silicone seals withstand temperature extremes, radiation, corona, moisture and steam. Due to its smooth finish, platinum cured silicone resists product adhesion. These odorless, tasteless, non-toxic seals maintain product integrity and can be autoclaved, irradiated and gas sterilized. And because there is no Benzoic Acid residue, Rubber Fab’s platinum cured silicone hygienic seals provide you with the ultimate, high pure, contact surface.

The Choice is "Clear"

  • Odorless
  • Non-toxic
  • No reversion
  • Smooth Bore
  • Tasteless
  • Non-pyrogenic
  • No Benzoic Acid
  • Non leaching
  • No plasticizers
  • No pigmentation
  • SIP up to 30 psi @123°C
  • Superior tear resistance
  • High/low temperature range: -100°F to 450°F
  • Eliminates particulates

Meets High Pharmaceutical Standards:

  • U.S. Pharmacopeia Class VI Certification
  • CFR Title 21 Section 177.2600
  • ASME-BPE Standards
  • USDA Standards
  • Current Good Manufacturing Practices (CGMP)
  • Cytotoxicity Criteria
  • Traceability: Lot and Batch
  • Certification: Lot and Batch
  • 3-A Sanitary Standards

 

Screen TC Gaskets

If elimination of particulates are critical to the CGMP in your injectable filled product, chromatography, columns, upstream particulate removal, downstream, filtration, consider Rubber Fab Technologies Group’s Fluid Conditioning technology. Rubber Fab’s sanitary Fluid Conditioning Seals are designed to be interchangeable with standard sanitary clamp gaskets and are available in the USP Class VI elastomer of your choice, in a variety of mesh sizes, 21 micron through 4 mesh.

Range of Particulate Elimination
Fluid conditioning hygienic seals provide for the most comprehensive range of stainless steel mesh and filter cloth which provide for particulate elimination to protect fill and finish sterile products.

Meets High Pharmaceutical Standards:

  • U.S. Pharmacopeia Class VI Certification
  • Title 21 CFR 177.2600
  • USDA Sanitary Standards
  • ASME-BPE Standards
  • Cytotoxicity Criteria
  • Title 21 CFR 177.1550
  • Current Good Manufacturing Practices (CGMP)
  • Animal Derived Ingredient Free

* Buna-N does not pass U.S. Pharmacopeia Class VI Certification and Cytotoxicity and is not an ADI Free elastomer.

 

Sock Screen TC Gaskets

The extended sock shaped mesh gasket offers up to 300% more open area for 300% more soil collection capability than conventional screens. They provide greater flow for situations where a large amount of particulates are involved. Due to the large capacity and open screen area, sock screens require less service, therefore, reducing down time and costly changeouts, a major consideration with inline pharmaceutical processing. Applications include: Tank to Tank Transfer, Inline Fluid Conditioning and Pump Protection. Sock designs are inserted into the I.D. of your stainless steel tubing and provide filtration for a greater soil retention.

  • Available in 10 mesh to 325 mesh with standard 16 mesh and 20 mesh in stock.
  • Available electropolished.
  • Durable 316 SS with the elastomer of choice: EPDM, FKM, Silicone, Buna.

Meets High Pharmaceutical Standards:

  • U.S. Pharmacopeia Class VI
  • Title 21 CFR 177.2600
  • Current Good Manufacturing Practices (CGMP)
  • Animal Derived Ingredient Free
  • Cytotoxicity Criteria
  • USDA Sanitary Standards
  • ASME-BPE Standards

* Buna does not meet USP Class VI and is not ADI Free.

 

Tuf-Flex Gaskets

STI offers Tuf-Flex Gaskets by Rubber Fab - designed to meet critical requirements in pharmaceutical, biotechnology, ultra-pure water, WFI (water-for-injection) and difficult food and beverage processing.

Tuf-Flex, the revolutionary new hygienic seal from Rubber Fab Technologies Group, is the world’s only unitized seal setting new standards for purity, performance and flexibility. Designed to meet critical requirements in pharmaceutical, biotechnology, ultra-pure water, WFI (water-for-injection) and difficult food and beverage processing, Tuf-Flex outperforms other hygienic seals while eliminating costly process interruptions.

Performance Based on a Revolutionary Composition A Tuf-Flex hygienic seal’s contact surface is a layer of PTFE grafted to an EPDM rubber inner core. This totally bonded construction provides an exceptionally pure and incredibly flexible seal. By grafting the elastomer with a layer of PTFE, Tuf-Flex will behave like an elastomer but will prevent the product contamination, service interruptions and clean-up costs associated with elastomer seals.

Achieve higher performance under SIP/CIP Conditions

  • Uniting the flexibility of an elastomer with the chemical resistance of PTFE
  • Superior resistance to cold flow and creep
  • Minimal thermal expansion
  • Seats perfectly
  • Outstanding service life
  • Exceptional flexibility

Tuf-Flex® Meets Stringent Standards:

  • U.S. Pharmacopeia Class VI Certification
  • Title 21 CFR 177.2600
  • USDA and 3-A Sanitary Standards
  • ASME-BPE Standards
  • Cytotoxicity Criteria
  • Title CFR 177.1550
  • Current Good Manufacturing Practices (CGMP)
  • Animal Derived Ingredient Free

 

Tuf-Steel Gaskets

Composed of a unique proprietary blend of non-pigmented PTFE and 316L passivated and atomized Stainless Steel, you can bet on any Tuf-Steel® seal for leak-proof performance and outstanding durability. There is no beating the Tuf-Steel family in SIP, WFI and hot oil applications because Tuf-Steel® maintains seal integrity in applications with large temperature variations. With a 500 steam cycle guarantee, this metal detectable gasket will easily out perform any elastomeric or perfluoroelastomer gasket and will remain in service for extended periods of time. It is the material of choice when chemical and heat resistance are required. Minimum creep and cold flow, non-stick, ultra-low absorption, no pigmentation and it will not revert. This gasket is tough!

PTFE and Stainless Steel Tuf-Steel® Offers Rugged Composition for Demanding Steam Environments

  • Non-stick surfaces
  • Non-pigmented
  • I.D. Pharmaceutical finish
  • Stainless Steel and PTFE blend
  • Passivated to eliminate rouging
  • Type I Standard, Screen and Orifice Plate gaskets available

The original Tuf-Steel® gasket, a Rubber Fab product innovation, is the strongest gasket in the pharmaceutical, biotech, food and beverage industries. Whatever your application, there’s a gasket in the Tuf-Steel® family ready to do the job. Tuf-Steel® is ideal for extreme temperatures applications, such as steam, hot oil and friers, where temperatures range from -350°F to 550°F. Unlike traditional solid PTFE and PTFE envelope style gaskets, Tuf-Steel® does not revert, eliminating creep and cold flow, resulting in a leak free seal. Because the superior strength and chemical resistance of Tuf-Steel® allows it to go the distance without leaking, it significantly reduces maintenance and system downtime by staying in place when cleaning and validating a system. Testing and a decade of documented application usage has demonstrated that Tuf-Steel® is the choice for perfect surface performance, outstanding durability and extended service life in both SIP (steam in place) and WFI (water for injection) applications.

Tuf-Steel® Holds Up Under Rigorous Conditions and Delivers Leak-Proof Performance

  • 100 CIP/SIP cycles guaranteed
  • No obstruction of flow
  • Superior creep resistance
  • Excellent chemical resistance
  • Excellent expansion/contraction stability with minimal thermal expansion
  • Stops leaks when correctly torqued (50 in./lbs. with Torque-Rite Model TR-50)
  • No gasket extrusion into the sanitary tube I.D.
  • Maintains sealing stability in ΔT processes

 

Flanged Sanitary Gaskets

Flanged sanitary gaskets are used in processing pipeline systems for the food, dairy, beverage, pharmaceutical and biotech industries. These gaskets have an outer lip that holds onto the ferrule for easier assembly.

Flanged sanitary gaskets are manufactured from EPDM, Viton®, Buna-N, and Silicone and Fluoropolymer (PTFE). All compounds are FDA compliant. Most compound formulations are also available USDA, 3-A and USP Class VI compliant.

 

Part # Material
Call Buna-N
Call Viton® / FKM
Call EPDM
Call Solid Fluoropolymer (PTFE)
Call Silicone - White Peroxide Cured
Call Silicone - Clear Platinum Cured

 

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