Expertise in Fluoropolymer Engineering Provides Unique Products for Biopharmaceutical Processing July 2008

Throughout its 50-year history, WL Gore & Associates has earned its reputation for providing innovative, high-value products such as GORE-TEX® outerwear, Elixir® guitar strings, and GORE-TEX® vascular grafts. Having invented expanded polytetrafluoroethylene (ePTFE), Gore offers an unparalleled level of technical knowledge and experience with this versatile material. This know-how starts with a deep scientific understanding of fluoropolymers, particularly PTFE processing and fluoropolymer development. Gore’s unique technical agility enables the development of a wide range of processes, products, and creative, reliable technologies.

Performance Characteristics

Gore’s configuration engineering of ePTFE and other materials can result in products that offer a wide range of performance characteristics, including biocompatibility, chemical and thermal resilience, low dielectric constant, antibacterial functionality, odor absorbency, radiation resistance, selective permeability, transparency/opacity, dimensional stability, varied hardness and stiffness, low/high surface energy, low/high abrasion resistance, nonpermeable barrier properties, controlled fluid delivery, and hydrophobicity.

Selected Gore Product Applications of ePTFE

Medical Implants: Because ePTFE is totally inert, Gore Medical Products are extremely biocompatible. The microporous structure of ePTFE can be engineered for a wide range of healing solutions, including synthetic blood vessels, patches for soft-tissue regeneration, and surgical sutures.

Gaskets and Sealants: Combined with its ability to withstand temperature extremes, ePTFE’s resistance to chemicals and abrasion makes it highly effective in the transport and sealing of industrial fluids.

Membrane Technology for Industry: Gore’s ePTFE membranes are engineered to unique microstructures that provide an array of high-efficiency filter media suitable for exposure to harsh chemicals or high temperatures. The pores in these membranes allow air to pass through while trapping particles as small as bacteria or viruses.

Advanced Dielectric Materials for Electronics: The inherently low loss and dielectric constant of ePTFE makes it an ideal insulation for wire and cable, allowing signals to travel at nearly the speed of light with minimum loss or disruption.

Gore PharmBIO Products

Based on this expertise, Gore has developed a family of products specifically for global pharmaceutical and biotechnology manufacturers. Gore PharmBIO products are innovative, nonreactive product contact components that control contamination and meet demanding process and packaging challenges. This product portfolio provides high-purity solutions for single-use components and for SIP/CIP applications as well as long-life, highly durable forms, and packaging solutions.

Single-Use Components

Gore single-use products include tubing, hoses, connectors, manifolds, sampling and collection systems, and custom-molded components manufactured in a newly constructed class 10,000 cleanroom operation. The GORE® aseptic sampling device comes as a fully disposable, pre-sterilized, and assembled, needle-free design. Custom components material capabilities include silicone, ePTFE, and various TPEs. We customize bioprocess assemblies using our online configuration tool. New to the market is a sanitary gasket made from 100% ePTFE, which has a low stress-to-seal design and resists creep and cold flow into process streams. Gore freeze-drying products are completely enclosed trays and containers designed to improve the lyophilization process while reducing product and freeze-dryer contamination risk.

Long-Life Highly Durable Products

Gore high-resilience tubing effectively resists the mechanical stress of peristaltic pumps. GORE® filtration products — including totally inert, FDA approved ePTFE membrane filters — help to optimize product collection of pharmaceutical dry powders as well as to help control dust emissions. For effective sealing in small-molecule API operations, Gore offers a variety of gaskets, packing materials, and diaphragms for vessels, pumps, valves, and piping systems. GORE® Microfiltration Media help pharmaceutical filter manufacturers engineer the highest performing and most reliable filters available.

Packaging Solutions

GORE™ membranes are used for sterile venting in some of the latest, most innovative pharmaceutical devices, blocking contamination including bacteria and viruses. They promote consistent sterile dosing — including those formulated to be preservative-free. Reliable venting components are simple to incorporate into multiple devices and packages including pumps, droppers, and squeeze bottles.