GlaxoSmithKline Process Using Pall Rapid Microbiological Test Is First Approved By FDA.Business Editors/Health/Medical Writers BIOWIRE2K EAST HILLS, N.Y.--(BUSINESS WIRE)--May 27, 2004 Pall Corporation Pall Corporation NYSE: PLL, formerly Micro Metallic Company, is an East Hills, New York based global business in the diverse field of filtration, separations and purification. Total revenues for fiscal 2006 were $2 billion, with over 11,000 employees and $56. (NYSE NYSE See: New York Stock Exchange :PLL PLL - phase-locked loop ) announced today that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) granted GlaxoSmithKline (GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) ) approval to use the Pallchek(TM) Luminometer as part of the quality control process for its prescription nasal spray Nasal sprays are used for the nasal delivery of a drug or drugs, generally to alleviate cold or allergy symptoms such as nasal congestion. Although delivery methods vary, most nasal sprays function by instilling a fine mist into the nostril by action of a hand-operated pump product in its Parma, Italy facility. The Pall rapid test enables GSK to release product to market up to four days earlier than before. GSK is the first pharmaceutical company to obtain approval to release a prescription product to market using a rapid detection technology under the FDA Process Analytical Technologies (PAT) program. The FDA PAT initiative is designed to encourage manufacturers to adopt new analytical technologies to better control manufacturing processes and provide greater assurance of product safety. The Pallchek Luminometer uses a proprietary rapid method to detect microbiological contamination. Results are known within 24 hours of testing versus the three to five days traditional technologies require. "The FDA approval of Pallchek Luminometer technology as part of the GSK process sends a strong message of confidence in the test's accuracy and sensitivity, and supports more routine and widespread use of rapid microbiology analysis methods," says Kenneth L. Harris, President of Pall BioSciences. "Twenty-four hour rapid detection facilitates faster movement of products through the system while assuring safety." Although acceleration of chemistry-based measurement has been in progress for some time under the PAT initiative, microbiological methods have historically taken days or weeks to provide results. This delays the ability to release a product to the market in a timely manner and increases warehousing and associated costs. Until now, use of rapid microbiology detection methods in the pharmaceutical and personal care products industries has been restricted to less critical applications such as raw material and in-process monitoring. The Pallchek Luminometer identifies the presence or absence of microbiological contamination in less than 24 hours by assessing the presence of a specific molecular marker of the test organisms. This means pharmaceutical companies can take faster corrective action should contamination be identified. The Pallchek Luminometer provides a simple, easy-to-use and cost-effective tool to monitor microbiological contamination in final products, Water For Injection, raw materials and the manufacturing environment. The process approval received by GSK Parma covers the use of the Pallchek Luminometer for specific non-sterile products as well as Pharmaceutical Grade Water. Rapid testing is the fastest growing segment of the microbial microbial pertaining to or emanating from a microbe. microbial digestion the breakdown of organic material, especially feedstuffs, by microbial organisms. testing market in the pharmaceutical and personal care product industries, and is expected to exceed $90 million by 2007, according to Strategic Consulting Inc. About Pall Corporation Pall Corporation is the leader in the rapidly growing field of filtration, separations and purification. Pall's business is organized around two broad markets: Life Sciences and Industrial. The Company provides leading-edge products to meet the demanding needs of customers in biotechnology, pharmaceuticals, transfusion medicine transfusion medicine Blood banking A subspecialty of clinical pathology or internal medicine which is involved in Pt management through administration of blood cells and blood products including fresh-frozen plasma and cryoprecipitate; TM specialists are versant in , semiconductors, municipal drinking water drinking water supply of water available to animals for drinking supplied via nipples, in troughs, dams, ponds and larger natural water sources; an insufficient supply leads to dehydration; it can be the source of infection, e.g. leptospirosis, salmonellosis, or of poisoning, e.g. , aerospace and broad industrial markets. Total revenues are $1.6 billion. The Company headquarters are in East Hills, New York East Hills is a village in Nassau County, New York on the North Shore of Long Island. It is considered part of the Greater Roslyn area, which is anchored by the Village of Roslyn. As of the United States 2000 Census, the village population was 6,842. with operations in more than 30 countries. Further information is available at www.pall.com. This release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements are based on current Company expectations and are subject to risks and uncertainties which could cause actual results to differ materially. Such risks and uncertainties include, but are not limited to: fluctuations in foreign currency exchange rates; regulatory approval and market acceptance of new technologies; changes in product mix and product pricing and in interest rates and cost of raw materials; the Company's success in enforcing its patents and protecting its proprietary products and manufacturing techniques and its ability to achieve the savings anticipated from its cost reduction initiatives; global and regional economic conditions and legislative, regulatory and political developments; and domestic and international competition in the Company's global markets. Additional information regarding these and other factors is available on the Web at www.pall.com and is included in the Company's reports filed with U.S. Securities and Exchange Commission. Copies of such reports can be obtained, without charge, at: www.sec.gov. Editors Note: To learn more about the Pallchek Luminometer and Pall products for Microbiological QA/QC QA/QC Quality Assurance/Quality Control , please visit http://www.pall.com/laboratory_7489.asp?level0=0. |
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