News | March 28, 2008

Gore PharmBIO Products Introduces Industry-Leading New Product At INTERPHEX 2008

Gore PharmBIO Products has developed and assembled a unique set of innovative products to meet the diverse needs of the global pharmaceutical and bioprocess industries.

Launching at Interphex Philadelphia 2008 is another industry-leading product, the GORE Aseptic Sampling Device - the only fully disposable, completely assembled system for biopharmaceutical fluid sampling. It provides the simplest means for biopharmaceutical manufacturers to safely and cost-effectively monitor cell development as well as sample other critical fluids in their processes.

"Our customers identified a need in the marketplace and we responded with the first ready-to-use, safe and convenient sampling device," says Greg Tronto, Business Leader. "This is an example of Gore PharmBIO Products providing highperformance solutions to meet the growing needs of our global customers."

The GORE Aseptic Sampling Device is safe, disposable, easy to use and easy to validate requiring no assembly or pre-cleaning. Manufacturers benefit through advances in operational efficiency and operator safety, which combine to reduce risk to valuable product.

Sampling is a critical step in the production of high value products. The process can be complicated, time consuming and highly dependent on the skill of production personnel. Fully assembled and disposable, the GORE Aseptic Sampling Device eliminates the time and procedural risks of assembling and pre-cleaning devices. Delivered as a sterile closed system, it is aseptic throughout the sampling operation, providing unparalleled safety and protection for products and people. With customizable tubing, receptacle and access peripherals, it can be adapted to almost any protocol.

The GORE Aseptic Sampling Device also incorporates patent pending, leveractuated, hollow valve delivery paths to permit high flow rates for fast filling and low fluid shear. The safe needle-free design has no sharp parts that protrude from the device or into the vessel. Redundant fluid seals both in the device and at the separation site provide an extra measure of security.

According to Domenic Sciamanna, Product Specialist for Sampling and Collection, a number of features were designed into the device to accommodate a key customer need - ease of use. "Because the Gore solution is pre-assembled, pre-sterilized, pre-packaged and customizable, it arrives as a true ‘plug and play' device. You can simply remove the protective packaging and attach it to the vessel port prior to in-place cleaning and/or steaming procedures. That minimizes training, validation times and contamination risks for many customers, while improving aseptic assurance and operator efficiency."

Devices are available in 1-shot or 5-shot configurations, and are sized to fit most standard vessel ports. Gore also offers a full range of modular peripherals for the devices, including pre-attached gaskets, various collection container options and choice of platinum-cured silicone or thermoplastic elastomer tubing.

About W. L. Gore & Associates, Inc.
W. L. Gore & Associates, Inc. is a worldwide presence, providing diverse, highperformance solutions in pharmaceutical, consumer, industrial, electronic, medical and surgical markets.

For 50 years, 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, perhaps best known as the inventors of ePTFE and the makers of GORETEX fabric, is a leading manufacturer of thousands of advanced technology products. With annual sales of over $2B,

Gore recently claims a manufacturing or sales presence in more than 80 countries and employs more than 8,000 associates in 45 facilities throughout the world. Gore is one of only three companies included inevery selection of Fortune Magazine's "100 Best Companies to Work For" since the list began in 1984. The company is celebrating its 50th anniversary in 2008. Within the Enterprise, Gore PharmBIO Products is focused on fueling the ongoing development of high-performance, technology-driven products and applications to better serve customers in the global pharmaceutical and bioprocess markets. For more information about W. L. Gore & Associates, Inc. and Gore PharmBIO Products, visit www.gore.com/pharmbio.

SOURCE: Gore PharmBIO Products