October 25, 2017
FOR IMMEDIATE RELEASE
Bio-Process Systems Alliance (BPSA)
Now available for download at http://bpsalliance.org/technical-guides
Arlington, VA – The Bio-Process Systems Alliance (BPSA) announced today that its new technical guide to Design, Control and Monitoring of Single-Use Systems for Integrity Assurance is now available for download at http://bpsalliance.org/technical-guides.
The uptake of single-use technologies (SUT) in more critical good manufacturing practices (cGMP) processes and applications has made assurance of integrity a critical quality attribute for both suppliers and end-users.
“I expect this to be one of the most significant documents written in the last five years to support our mission of driving the adoption of single-use technologies worldwide,” said Kevin Ott, BPSA Executive Director.
The document provides recommendations to both suppliers and end-users in the single-use technology industry regarding strategies, tools and procedures that can assist in providing enhanced assurance of integrity of single-use systems. It can help end-users convey their specific requirements to the supplier. In turn, suppliers can use the document to demonstrate what they can provide to
The technical guide divides best practices into two separate but complementary sections – a risk-based approach and practical tests for SUTs.
The document was written by a working group of end-users and suppliers who recognized the need to provide guidance in the absence of industry standards.
The Bio-Process Systems Alliance (BPSA) is an industry association whose mission is dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of pharmaceuticals 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 on BPSA, visitwww.bpsalliance.org.
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