Specialty 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

 

Gauge Guard Isolator Gaskets

The Rubber Fab Gauge Guard Isolator gaskets protect expensive diaphragm and instruments from damage without affecting instrument performance. By combining a quality Rubber Fab sanitary gasket with a membrane, the Gauge Guard Isolator isolates hot or caustic saline solution from instrumentation. A necessary and cost effective step in assuring long life and accurate results from your instruments and gauges. As some manufacturers will suggest the use of a gauge guard gasket, others note that the failure to use a gauge guard gasket can void most instrument and gauge warranties.

All the Rubber Fab Benefits in a Gauge Guard Gasket

  • Gasket membrane protects instrumentation from caustic saline solutions.
  • Will not interfere with gauge operation or accuracy.
  • Works with most industry standard instruments.
  • Help extend the life of gauges.

Available in:

  • FKM Fluoroelastomer
  • EPDM
  • Platinum Silicone
  • 1/2" and 3/4" – .015 membrane thickness
  • Metal Detectable elastomers available

 

All Rubber Fab Gaskets Meet the Stringent Standards For Purity:

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

 

Gauge Guard Protector Gaskets

The Rubber Fab Gauge Guard Protector protects expensive, fragile gauge diaphragms and other similiar instruments from damage during calibration, routine maintenance and during autoclave procedures. Rubber Fab Gauge Guard Protectors are specially designed to snap onto a sanitary Tri-Clamp® connection, protecting the ferrule face from damage. The Gauge Guard Protector is available in 3/4", 1", 1-1/2" and 2" and is manufactured using U.S.P. Class VI Platinum Cured Silicone and 316 Stainless Steel. Combine the Gauge Guard Protector with a quality Rubber Fab Gauge Guard Isolator Gasket to achieve complete diaphragm protection! A necessary and cost effective step in assuring maximum service life and accurate results from your instruments and gauges! Gauge Guard Isolator Gaskets are manufactured using FDA, 3A, Class VI material and are available in platinum cured silicone, EPDM, FKM and Tuf-Steel®

 

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.

 

Smart Gasket / Thermocouples

Rubber Fab’s Smart Gasket’s® value is proven when validating sterility in a high-purity pharmaceutical system. Your standard sanitary flange utilizing the Smart Gasket® is used to obtain the critical thermal mapping information you need during the validation process.

Smart Gasket® easily installs between two sanitary standard flanges using the Rubber Fab sanitary Smart Clamp to secure the flanges. Our clamp provides up to four internal ports for accepting the Smart Gasket® thermocouple samples or accessories; i.e. ACC-T or K-199-S-Short Temperature Probe; ACC-T or K-199A-LLong Temperature Probe.

Choose between Rubber Fab’s Thermocouple Gasket (above) or select the Smart Gasket® Spore Trap (left) to securely retain spore challenge test strips. There is also a sampler device available that utilizes standard luer lock fittings. Meter fluids in your process system utilizing a peristaltic pump or withdraw samples utilizing our luer lock sampler and luer lock valve or syringe.

Benefits

  • Use temporarily or permanently without custom thermowells or expensive custom fittings
  • Easy to expand to multiple system sites
  • Sanitary without a dead leg

Meets High Pharmaceutical Standards:

  • Safe to use
  • Ease of installation
  • 1, 2, 3 and 4 internal ports available
  • Sensors seal with gasket compression
  • User friendly
  • Reusable

Smart Gasket® with Smart Clamp is available in 1/2", 3/4", 1", 1-1/2", 2", 3" and 4" sizes and fits standard Tri-Clover®, Top Line®, Waukesha® and G&H® sanitary flanges. Choose between USDA, FDA grade EPDM, platinum-cured silicone, FKM and other elastomers (consult factory for larger sizes).

 

SMART TRAKR™

The SMART TRAKR™ - T is a miniature, battery powered, stand alone, precision temperature recorder. The all-in-one compact, portable, easy to use device will measure and record up to 21,845 measurements per channel. The storage medium is non-volatile solid state memory, providing maximum data security even if the battery becomes discharged. The RTD sensor does not suffer from the cold-junction issues of the thermocouple nor the errors at high and low temperatures of the thermistor. The device can be started and stopped directly from your computer and its small size allows it to fit almost anywhere. The SMART TRAKR™ - T makes data retrieval quick and easy. Simply plug it into an empty COM or USB port and our user-friendly software does the rest.

The Rubber Fab Smart Gasket® value is proven when validating sterility in a high purity pharmaceutical system. A standard sanitary ferrule utilizing the Smart Gasket® Thermocouple Gasket obtains the critical thermal mapping information needed during validation, combined with Rubber Fab’s Smart Trakr™-T provides real time data transfer!

Applications include: Precision Temperature Recording, Biopharmaceutical, Food, Dairy and Beverage.

Features

  • N.I.S.T. traceable
  • Low cost
  • Reusable
  • Miniature size
  • Real-time operation
  • Programmable start time
  • User-friendly
  • CE compliant

 

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

 

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