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Innovative GORE™ LYOGUARD® Vial Isolators Preserve, Protect, and Contain Freeze-Drying Products
Elkton, MD (June 22, 2009)–GORE™ LYOGUARD® Freeze-Drying Products, which recently celebrated a 10-year anniversary, has released an innovative product that preserves, protects, and contains the contents of vials during freeze-drying activities. GORE™ LYOGUARD® Vial Isolators are single-use devices that combine proven Gore technology with standard vials and stoppers for efficient freeze-drying while containing and protecting valuable product immediately after filling.
Made with Gore's unique expanded polytetrafluoroethylene (ePTFE) membrane, GORE™ LYOGUARD® Vial Isolators reduce product "fly-out" and product cross-contamination, while improving sterility in small-scale aseptic processing applications. This biocompatible membrane allows vapor to pass through the isolator, but its microstructure prevents contaminants from entering the vial. With this ePTFE membrane integrated into a molded housing that seals on a 20mm neck vial, the GORE™ LYOGUARD® Vial Isolator combines the protection of a "closed" system with the efficiency of an "open" system that is necessary for the lyophilization process.
Designed for R&D and early-phase clinical trials, GORE™ LYOGUARD® Vial Isolators offer process flexibility and the ability to bring products to market faster. According to Joe Brendle, global product manager for GORE™ LYOGUARD® Freeze-Drying Products, "GORE™ LYOGUARD® Vial Isolators offer customers more flexibility in terms of processing freeze-dried products in their current facility or with a contract research organization (CRO). Customers that choose to process in their current facilities can avoid capital equipment investments, while at the same time they can process freeze-dried products that may normally need to be outsourced. CROs that adopt GORE™ LYOGUARD® Vial Isolators are better able to assure customers that their products are not being cross-contaminated, and these isolators can help reduce cleaning and cleaning validation costs. Lastly, from an environmental health and safety perspective, GORE™ LYOGUARD® Vial Isolators can be used as part of an engineering control tool for handling uncharacterized or potent products."
GORE™ LYOGUARD® Freeze-Drying Products have been used globally in more than 250 new and existing applications and enable the aseptic transfer, containment, and processing of freeze-dried products in a variety of environments and freeze-drying equipment.
About W. L. Gore & Associates, Inc. and GORE™ PharmBIO Products
Gore is a world-renown manufacturer of thousands of advanced technology products and is perhaps best known as the inventors of ePTFE and the makers of GORE-TEX® fabric. With more than $2.5 billion in annual sales and 8,000 employees in 80 countries throughout the world, W. L. Gore & Associates, Inc., provides diverse, high-performance solutions in pharmaceutical, consumer, industrial, electronic, medical, and surgical markets.
As a business initiative within the Enterprise, Gore PharmBIO Products develops innovative, technology-driven products and applications to better serve the global pharmaceutical and bioprocess markets. W. L. Gore & Associates has cultivated a unique corporate culture, resulting in a high energy commitment to innovation and a passionate belief in making a difference. Gore PharmBIO Products supports the Enterprise's pledge to maintain product leadership and create dependable and reliable products and services for its customers. For more information about W. L. Gore & Associates, Inc. and Gore PharmBIO Products, call 1/800-368-GORE (4673), or visit gore.com/pharmbio.
Contact
Greg Apps
(410) 506-8783
gapps@wlgore.com
GORE, GORE-TEX, LYOGUARD, and design are registered trademarks of W. L. Gore & Associates, Inc.