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BPSA Releases Frequently Asked Questions about Single-Use Systems (SUS) for Integrity Assurance

Arlington, VA – The Bio-Process Systems Alliance (BPSA) is pleased to announce the release of a new FAQ resource on the integrity assurance of single-use systems (SUS). These FAQs, developed by BPSA’s Integrity Assurance Committee, address common industry questions about the integrity and testing of single-use systems and components. They are designed to assist both manufacturers and end-users in ensuring the integrity of their single-use systems throughout the bioprocessing lifecycle.

Key FAQs Include:

  • Is it possible to perform a leak/integrity test on SUS post-use?
  • Why is it often recommended to use a porous spacer when testing SUS in its container?
  • Does the compressed air used to perform a leak/integrity test at the supplier(s)’ site need to be filtered?
  • Will the leak/integrity test damage my SUS product?
  • What is the difference between a leak test and an integrity test?

These integrity assurance FAQs are the first in a series of FAQs and will be updated as needed by BPSA. In addition to these FAQs, BPSA offers comprehensive technical guides on SUS integrity assurance in its industry resources library. In 2017, BPSA published the Design, Control, and Monitoring of Single-Use Systems for Integrity Assurance, which provided recommendations for both suppliers and end-users regarding strategies, tools, and procedures to enhance the integrity assurance of single-use systems. In 2023, BPSA published Design, Control & Monitoring of SUS for Integrity Assurance: Volume 2, as a follow-up to the 2017 guide.

These resources are essential tools for companies looking to enhance the reliability and safety of their single-use technologies. “I want to thank the BPSA Integrity Assurance Committee, and its Chair, Patrick Evrard of Cytiva, for their leadership and hard work in developing these FAQs,” said BPSA Executive Director, Chris Clark. “SUS Integrity has always been a crucial quality attribute for suppliers, end-users, and regulatory authorities, and the new Annex 1 makes it even more critical.  These FAQs will play a key role in advancing both the use and integrity of single-use systems.”

Submit Your Questions:

If you have additional questions about SUS integrity assurance, you can submit them to bpsa@socma.org. All inquiries will be reviewed by BPSA’s Integrity Assurance Committee, and the most relevant questions will be added to the list of FAQs as the resource is updated.

For more information about BPSA industry resources or joining the BPSA member network and technical committees, visit the BPSA website or contact us at bpsa@socma.org.

About BPSA

The Bio-Process Systems Alliance (BPSA), an affiliate of SOCMA, was formed in 2005 as an industry-led international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. www.bpsalliance.org.

Home > Resources > News > Integrity Assurance
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BPSA Releases Volume 2 of Its Technical Guide for the Design, Control, and Monitoring of Single-Use Systems (SUS) for Integrity Assurance

ARLINGTON, VA – The Bio-Process Systems Alliance (BPSA) announced the release of its latest guide, Design, Control & Monitoring of SUS for Integrity Assurance: Volume 2, which serves to follow up to BPSA’s 2017 guide, Design, Control & Monitoring of SUS for Integrity Assurance.

The increasing use of single-use technologies (SUTs) in bioprocessing has made integrity assurance a critical quality attribute for both suppliers and end-users of SUTs. In 2017, the BPSA published the Design, Control, and Monitoring of Single-Use Systems for Integrity Assurance that provided 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.

This 49-page guide (Volume 2) provides case studies illustrating the principles developed in Volume 1; updates to key technologies used by the industry; updates to the regulatory landscape and industry guidance, and case studies covering specific applications such as elevated pressure situations and containment of powders. The guide also addresses essential concepts such as Quality by Design (QbD) and fostering collaboration between suppliers and end-users.

“The bioprocessing industry has made tremendous progress on leak and integrity testing of SUS over the past few years, and the examples and case studies included in this guide illustrate the progress the single-use industry has made,” said Patrick Evrard of Cytiva, and Chair of the BPSA Integrity Assurance Committee.

“I want to thank the BPSA Integrity Assurance Committee, and its Chair, Patrick Evrard of Cytiva, for their leadership and hard work on this guide,” said BPSA Executive Director, Chris Clark. “This guide is an important tool for suppliers and end-users alike and supports our mission of driving the adoption of SUS worldwide.”

Please visit  https://bpsalliance.org/technical-guides to download the guide.

About BPSA The Bio-Process Systems Alliance (BPSA), an affiliate of SOCMA, was formed in 2005 as an industry-led international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. www.bpsalliance.org.