Bio-Process Systems Alliance Releases 2020 Particulates Guide
ARLINGTON, Va., May 19, 2020 /PRNewswire/ — The Bio-Process Systems Alliance (BPSA), the international association of the single-use bio-processing industry, is pleased to announce the release of its new technical guide: 2020 Recommendations for Testing, Evaluation, and Control of Particulates from Single-Use Processing Equipment. This is a follow-on from the 2014 BPSA Guide and reflects industry’s ongoing progress in driving steady improvements to the cleanliness, safety and performance of polymer-based single-use bio-processing systems.
Known as the “2020 BPSA Particulates Guide,” the 37-page/12-chapter compendium was derived from a recognized need in the single-use technology (SUT) industry to address process issues inclusive of:
- Why particulates are a concern with SUT;
- What factors are key to assessing particulates in SUT;
- How to improve the detectability of particulates in SUT; and,
- How to drive continuous and rigorous improvements in particulates control.
The challenge of particulate control is becoming even more important as single-use systems find increasing uses in the last drug filtration step, final filling, and in vaccine, as well as cell and gene therapy development and manufacture.
The Guide is intended for SUT users, as well as component and systems suppliers, and includes a complete reference section, along with a User Requirements Template as an appendix.
The 2020 BPSA Particulates Guide was a dedicated 18-month project funded and executed with the input and guidance of a volunteer committee of subject-matter experts representing the following BPSA member companies: Avantor, The Bio-Process Institute, Colder Products Company, Eppendorf Bioprocess, Meissner Filtration Products, Merck & Co., Inc., MilliporeSigma, Nordson Medical, Pall Biotech, Saint-Gobain Life Sciences, Sanofi Pasteur, Sartorius-Stedim Biotech and Savillex.
Electronic download of the Guide is available now at www.bpsalliance.org.
For more information, e-mail BPSA Executive Director Kevin Ott at kott@socma.org.
About BPSA
The Bio-Process Systems Alliance (BPSA), an affiliate of SOCMA, was formed in 2005 as an industry-led international association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals, cell and gene therapies and vaccines. www.bpsalliance.org.
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SOURCE Bio-Process Systems Alliance (BPSA)
