WASHINGTON, Oct. 20, 2015 /PRNewswire-USNewswire/ -- The Bio-Process Systems Alliance (BPSA), the national trade association of the Single-Use bio-processing industry, is pleased to announce the release of its latest 2015 technical guide, Single-Use Manufacturing Component Quality Test Matrices.
Known as the "BPSA 2015 Matrices Guide," it is an update of the 2007 Matrices Guide, necessitated by the increased number of components, a growing number of test practices and new standards and the inclusion of two component types (sensors and chromatography). The Matrices Guide provides information on how SUT components are characterized and qualified. Main features of the Guide include:
- Coverage of six component categories (Chromatography, Connectors, Containers & Film, Sensors, Tubing, and Filters);
- Coverage of six test categories (Physical, Functional, Biological, Chemical, Regulatory, and Sterilization/Sanitization);
- Live links to public domain test methods or source locations; and
- A description of how each test is applied (e.g., in material qualification, product qualification and lot release).
This technical guide was a major 2015 BPSA initiative, with more than twenty participating technical contributors, and represents a milestone in BPSA's output on technical issues, to the benefit of users and suppliers alike. The document is intended for both SUT users and component and systems suppliers of single-use equipment. The guide also covers terms and definitions and is inclusive of a complete reference section.
The BPSA 2015 Quality Matrices Guide was executed by BPSA under the guidance of a volunteer member committee of subject-matter experts, and funded by BPSA's Elite Sponsors: Thermo Fisher Scientific, EMD Millipore, Pall Life Sciences, Parker domnick hunter, Renolit, Saint Gobain, AdvantaPure/NewAge Industries, Catalent, Charter Medical, Chemic, CPC,Entegris, Nordson Medical, and Sartorius-Stedim Biotech.
The Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led corporate member trade association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. BPSA facilitates education, sharing of best practices, development of consensus guides and business-to-business networking opportunities among its member company employees. For more information, please visit www.bpsalliance.org, or contact Executive Director Kevin Ott at [email protected].
Executive Director, BPSA
SOURCE Bio-Process Systems Alliance (BPSA)