BPSA Releases Technical Guide for Design, Control and Monitoring of Single-Use Systems for Integrity Assurance

Thursday, October 26, 2017 General News
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Now available for download at bpsalliance.org/technical-guides

ARLINGTON, Va., Oct. 25, 2017 /PRNewswire-USNewswire/ -- 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, visit www.bpsalliance.org.

Contact: Kevin Ott Executive Director Bio-Process Systems Alliance (BPSA) [email protected] www.bpsalliance.org

 

View original content:http://www.prnewswire.com/news-releases/bpsa-releases-technical-guide-for-design-control-and-monitoring-of-single-use-systems-for-integrity-assurance-300543414.html

SOURCE Bio-Process Systems Alliance (BPSA)



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