FOR IMMEDIATE RELEASE

Contact: Barry Eisenberg
(202) 974-5210
Email: beisenberg@plasticsindustry.org

SPI'S BIO-PROCESS SYSTEMS ALLIANCE RELEASES NEW COMPONENT QUALITY TEST MATRICES

First-of-its-kind guide will help maintain component quality of single-use bioprocess systems

WASHINGTON, D.C. (April 11, 2007)—The Bio-Process Systems Alliance (BPSA), a business unit of the Society of the Plastics Industry, Inc. (SPI), today announced the release of the BPSA Component Quality Test Matrices—an industry guide that identifies test methods used for key components (e.g., filter capsules, films and containers, tubing and connectors and fittings) of a single-use bioprocess system. In addition, the test matrices describe the methods in common language, provide information on test frequencies and list reference standards and regulatory guidelines. The publication of the matrices marks the first time a supplier organization has compiled this information in an easy-to-use format.

" Users and regulators of single-use bioprocess systems need to understand the typical tests done on individual components, what the test results mean, what test references are used and how often tests are conducted by suppliers," said Jerry Martin, chair of the BPSA Guidelines and Standards Committee and senior vice president for scientific affairs, Pall Life Sciences (East Hills, N.Y.). " One of BPSA's core activities is to educate and to develop guides that help safeguard the quality of drugs produced using these technologies. These test matrices do just that."

The BPSA Component Quality Test Matrices is available to download at http://www.bpsalliance.org/bpsamatrices.pdf.

The BPSA Component Quality Test Matrices is the first in a series of guides that BPSA is developing for its constituents, users and regulators. Future guides will address additional topics including sterility claims, extractables and leachables and other relevant systems-based issues.

The BPSA was launched by SPI in early 2006 to promote the interests of makers of single-use process components and systems within the bio-pharmaceutical industry. In addition to growing the market, establishing industry guides, promoting development of standards and educating customers, the BPSA serves as a forum for commercial members to recognize common best practices for quality testing of materials and functionality.

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Founded in 1937, The Society of the Plastics Industry, Inc., is the trade association representing one of the largest manufacturing industries in the United States. SPI's members represent the entire plastics industry supply chain, including processors, machinery and equipment manufacturers and raw materials suppliers. The U.S. plastics industry employs 1.1 million workers and provides nearly $341 billion in annual shipments.

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