BPSA Releases Frequently Asked Questions about Single-Use Systems (SUS) for Integrity Assurance
October 23, 2024
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.