BPSA Releases Additional FAQs on Single-Use Systems for Integrity Assurance

Arlington, VA – The Bio-Process Systems Alliance (BPSA) has released the next five Frequently Asked Questions (#6–10) on Single-Use Systems (SUS) for Integrity Assurance. Developed by BPSA’s Integrity Assurance Committee, these FAQs address key industry concerns related to the integrity and testing of single-use systems and components. They are designed to assist both manufacturers and end-users in maintaining the integrity of SUS throughout the bioprocessing lifecycle.

The newly released FAQs include:

• Do I have to perform an integrity test at the point of use (POU)?
• Is there a difference between testing at the end-user site and testing at the SUS supplier’s manufacturing site?
• When is it appropriate to perform a POU leak test vs. a POU integrity test?
• Should integrity testing be performed at every stage of biologics manufacturing?
• What information should suppliers provide to support the use of assemblies in sterile product manufacturing?

BPSA published the Design, Control, and Monitoring of Single-Use Systems for Integrity Assurance in 2017, that offered recommendations for both suppliers and end-users on strategies, tools, and procedures to enhance integrity assurance. In 2023, BPSA released Design, Control & Monitoring of SUS for Integrity Assurance: Volume 2 as a follow-up to the 2017 guide. View BPSA’s library of technical industry resources here.

“We would like to express our appreciation to the BPSA Integrity Assurance Committee and its Chair, Patrick Evrard of Cytiva, for their guidance and insight in preparing these FAQs,” said BPSA Executive Director Chris Clark. “These resources play an important role in helping companies strengthen the reliability of their 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.