October 25, 2017
FOR IMMEDIATE RELEASE
Contact:
Kevin Ott
Executive Director
Bio-Process Systems Alliance (BPSA)
ottk@socma.com
www.bpsalliance.org
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 end-user.
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.
About BPSA
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.
Categorized in: Affiliates