The Bio-Process Systems Alliance (BPSA) has released additional Frequently Asked Questions 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 [https://bpsalliance.org/bpsa-integrity-assurance-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.
Source: https://bpsalliance.org/bpsa-integrity-assurance-faqs/
Bron: BPS Alliance