Friday 24 November 2017

Technical Guide for Design, Control and Monitoring of Single-Use Systems

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

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.

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