Single Use Sanitary Products

W. L. Gore & Associates, Inc., is a worldwide presence, providing diverse, high-performance solutions in pharmaceutical, consumer, industrial, electronic, medical and surgical markets. As a business initiative within the Enterprise, Gore PharmBIO Products develops high-performance, technology-driven products and applications to better serve the global pharmaceutical and bioprocess markets.

Contact NWFS to discuss our full like of Gore PharmBio products or
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Making Virtual Reality
The GORE™ STA-PURESM Bioprocess Configurator is an easy-to-use, interactive tool that enables users to work via the web to design and build customized fluid assemblies. Benefits of the GORE™ STA-PURESM Bioprocess Configurator :

• Allows you to work independently to modify designs or interact directly with Gore engineers and authorized distributors
• Provides a flexible design mechanism via a drag-and-drop interface
• Reduces engineering design cycles and simplifies request for quote (RFQ) processes through an electronic approval system
• Enables 24-hours per day, 7-days per week design capabilities

Visit www.Gore.com for more information on the GORE™ STA-PURESM Bioprocess Configurator. For additional questions, contact NWFS today to learn more!

Aseptic Single-Use Sampling Systems for Bioprocess Fluids
Liquid sampling in pharmaceutical manufacturing can be complicated, time-consuming and highly dependant on the skill of the operator. Now there is a more convenient way to accomplish this critical operation. The GORE™ STA-PURE™ Fluid Sampling System for single-use aseptic applications is a fully disposable system for biopharmaceutical fluid sampling. It is delivered as a preassembled, pre-sterilized, closed system that incorporates an intuitive lever-valve actuator. A wide variety of options allow you to customize the device to fit your application.

Benefits of the GORE™ STA-PURE™ Fluid Sampling System

• Improves operator safety and delivery of fragile cell media via its needle-free, smooth fluid transport valves
• Maximizes operator efficiency by eliminating assembly time and cleaning costs
• Connects to standard vessel ports and works with existing equipment
• Allows for increased versatility through a modular design and full range of optional peripherals
• Enables multiple but discrete aseptic sampling from a single vessel port with an option of single and five-valve devices
• Ability to fit any process protocol (CIP/SIP-compatible, customized configurations and collection container options)

The GORE™ STA-PURE™ Fluid Sampling System provides quick validation and implementation with the use of USP Class VI materials and complete engineering and microbial test packages. These systems are safe, easy to use and adaptable to virtually any sampling protocol.

Typical Applications

• Monitoring cell count and development
• Sampling for pH, purity and ingredient concentration
• QC retains or sterile transfer
• Small volume (10 mililiter) to large volume (1 liter) sampling

Gore offers a family of thermoplastic elastomer (TPE) tubing products to meet a variety of different pharmaceutical and bioprocess applications. TPE’s are ideally suited for weldable applications, as well as high-purity fluid transfer. Overmolded and stainless steel end connectors can also be integrated into any of the GORE™ TPE Products for added processing versatility.

GORE™ TPE Tubing for Peristaltic Pump Applications  – Series AMP

High-Purity Extended Life Peristaltic Pumping
GORE™ TPE Tubing for Peristaltic Pump Applications (Series AMP) is specifically designed for use in high-purity applications that require extended life peristaltic pumping. This opaque tubing is soft and flexible, thermally weldable, heat sealable and has a broad range of chemical compatibility. GORE™ TPE Tubing for Peristaltic Pump Applications is a specialty thermoplastic elastomer designed to meet the needs of biotech and pharmaceutical processes.

Benefits of GORE™ TPE Tubing – Series AMP

• Offers mechanical properties superior to other thermoplastic elastomers
• Provides good flexibility to meet a variety of processing challenges
• Enables enhanced peristaltic pump life over competitive thermoplastic elastomer products
• Meets specific process connection requirements with compatible stainless steel and non-metallic molded end connections
• Offers versatility in processing with the ability to customize tubing lengths

Typical Applications

• Peristaltic pumps
• Media processing
• Standard fluid transfer
• Cell harvesting/filtration

GORE™ TPE Tubing for Weldable Bioprocess Applications– Series GF

Ultra-Pure, Thermally Weldable and Sealable Tubing
GORE™ TPE Tubing for Weldable Bioprocess Applications (Series GF) is constructed of a proprietary thermoplastic elastomer material specifically formulated for use in high-purity pharmaceutical and bioprocess applications. This clear tubing is thermally weldable, heat sealable and has increased performance in higher temperature steam sterilization. Using GORE™ TPE Tubing is ideal for high purity fluid transfer and peristaltic pumping.

Benefits of GORE™ TPE Tubing – Series GF

• Offers improved peristaltic pump life over other weldable and sealable tubing
• Lowers the risk of contamination through reduced extractables
• Increases process yield through low preservative absorption
• Allows for higher temperature steam sterilization over other weldable and sealable tubing
• Provides easy visibility of liquids through naturally clear tubing construction

Typical Applications

• Pharmaceutical and biotech processing
• Peristaltic pump and fluid transfer
• Filling operations
• Laboratory use
• Upstream processing

GORE™ Silicone Tubing

High-Purity Tubing for Fluid Transfer and Peristaltic Pump Operations

GORE™ Silicone Tubing is offered in a variety of different options including standard, pump, and extended life pump tubing. These products have been specifically formulated for use with sensitive media found in pharmaceutical and biotech processing. Designed to meet a range of performance requirements, GORE™ Silicone Tubing is ideal for extended-life pumping and in applications demanding ultimate purity in fluid transfer and peristaltic pump operations. All tubing products are fully traceable from start to finish.

Benefits of GORE™ Silicone Tubing

• Offers superior performance over peroxide-cured silicone in high-purity fluid transfer and pump applications
• Imparts no odors or taste to transported fluids due to ultra-pure biopharmaceutical grade silicone
• Allows for tubing resilience and adaptability within processes because of excellent tubing flexibility and pumpability
• Provides easy visibility of fluid transport due to naturally clear tubing
• Enables identification and differentiation of fluid transfer paths with custom coding and printing options
• Offers versatility in processing with the ability to customize tubing lengths
• Meets specific process connection requirements with compatible reusable and integrated non-metallic molded connectors

Typical Applications

• Pharmaceutical and biotech processing
• Ultra-pure fluid transfer
• Peristaltic pumping
• Filling operations
• Laboratory use
• Media processing

GORE™ Reinforced Silicone Hose

Ultra-Pure Fluid Transfer for High Pressure and Vacuum Applications

GORE™ Reinforced Silicone Hose is offered with a variety of different options including wire, fabric, double-braid and single-braid reinforcement for enhanced performance in high pressure and vacuum applications. All GORE™ Reinforced Silicone Hose products are manufactured with an inner layer of platinum-cured silicone for ultra-pure fluid transfer. Engineered with superior flexibility, these products allow for excellent hose resilience and bend radius. To meet a diverse range of application needs, GORE™ Reinforced Silicone Hose is constructed to prevent kinking and compression and can withstand temperature and pressure extremes. All hose products are carefully controlled and fully traceable throughout the manufacturing process.

Benefits of GORE™ Reinforced Silicone Hose

• Provides extremely high pressure and vacuum ratings due to reinforced hose constructions
• Allows for hose resilience and adaptability within processes because of excellent flexibility and bend radius
• Offers versatility in processing with the ability to customize hose lengths
• Meets connection requirements with reusable and integrated stainless steel and molded-end connections
• Enables identification and differentiation of fluid transfer paths with custom color-coding, including colored braid striping as well as molded and printed labels
• Imparts no odors or taste to transported fluids due to an inner diameter of ultra-pure platinum-cured silicone

Typical Applications

• Pharmaceutical and biotech processing
• High volume ultra-pure fluid transfer
• Purification processes
• High pressure and bulk liquid transfers
• Load cells
• Skid transfer
• Process lines

The GORE™ Single-Use Valve for steam-in-place applications provides positive flow control in pharmaceutical and biotherapeutic fluid dispensing applications, where high purity is required. It is ideally suited for barb-fitting or silicone-molded connection to disposable fluid transport systems. When used as the primary connection interface between a vessel port and a closed, pre-sterilized disposable assembly, it enables the assembly to remain aseptic throughout the connection, SIP, and fluid transfer processes. The unique platinum-cured silicone valve body liner creates a continuous, seamless, single-material contact surface for high value fluids. The liner's one-piece molded construction extends from the device face as a sealing gasket for sanitary end fittings and has a 0.25" (6 mm) ID tube extending from the valve body to enable easy connection to disposable assemblies. With higher flow rates than alternative valves, delivery time is minimized.

Benefits of the GORE™ Single-Use Valve

• Minimizes the risk of cross-contamination via a single-use preassembled system
• Reduces the risk of particle entrapment through unique crevice-free design
• Simplifies connection to standard sanitary end connections by eliminating the need for seals, o-rings or gaskets
• Enables higher flow rates than alternative single-use valves
• Provides an aseptic seal when in the closed position
• Allows for confident control of flow and shut-off with easy on/off knob

Typical Applications

• Single-use or disposable bioprocesses
• Sample collection
• Sterile transfers
• Product and media storage
• Tank connections - 0.625" ID sanitary connection

The GORE™ STA-PURE™ Gasket for Sanitary Fittings seals critical bioprocesses and enables pure processing. Commercially available in the Summer of 2009, this new product is constructed of a 100% patent pending ePTFE, can withstand up to 500 SIP cycles, and is designed to meet the new ASME BPE equipment seal standards for sanitary gaskets. It features full supply chain and lot traceability and has a low stress-to-seal design, does not require re-torque and ensures minimal gasket intrusion. The GORE™ STA-PURE™ Gasket for Sanitary Fittings can be used universally and integrated into a variety of different systems which allows for standardized operations, reduced inventory and improved purchasing efficiency.

Benefits of the GORE™ Gasket for Sanitary Fittings

• Ensure system reliability and safety with a low stress-to-seal design
• Provide superior dimensional stability and crush resistance through a patent pending 100% ePTFE microstructure
• Resist intrusion into process stream
• Enable clean processing with low particulation/spallation and leachable/extractable profiles
• Offer durable construction to withstand repeated CIP/SIP cycling
• Provide supply chain integrity and lot-to-lot traceability

Typical Applications

• Pharmaceutical and bioprocessing
• Water systems
• Ultra-pure fluid transfer
• Media processing