| December 17, 2025, (ARLINGTON, VA) – The Bio-Process Systems Alliance (BPSA) is pleased to announce the publication of its latest technical resource, Automation of Single-Use Unit Operations in Bioprocessing: Traps, Tips & Trends. Automation in bioprocessing—especially for single-use systems—can boost efficiency and consistency, enable real-time control, and support flexible and scalable manufacturing. This comprehensive white paper provides practical guidance for suppliers and end-users of single-use systems integrating automation into single-use bioprocesses. The document presents the perspective of two personas with different backgrounds in automation and single-use technologies, and addresses key topics including: -Fundamentals of automation and control strategies for single-use systems -Common pitfalls and best practices for implementation -Real-world examples of highly automated bioprocessing facilities -Insights on digital communication and data integrity Developed by the BPSA Automation Committee, this white paper aims to bridge the knowledge gap between automation engineers and single-use technology specialists. It is designed to help companies improve efficiency, reduce risk, and accelerate innovation in bioprocessing. “This white paper represents a significant step forward in helping our industry automate systems and processes, enabling us to get important, life-saving products to our customers, patients and consumers faster. I especially want to thank the two co-chairs of the BPSA Automation Committee, Stuart Tindal, EngD, PhD of Sartorius, and Hernan Parma of Renolit Healthcare, for their leadership,” said Chris Clark, BPSA Executive Director. “I also want to thank and congratulate the broader BPSA Automation Committee for their dedication and collaboration in producing this important BPSA resource.” The white paper is now available for download at: https://www2.bpsalliance.org/forms/store/ProductFormPublic/automation-of-single-use-unit-operations-in-bioprocessing-traps-tips-and-trends About BPSA The Bio-Process Systems Alliance (BPSA) is an industry-led trade association dedicated to advancing the adoption and implementation of single-use technologies in biopharmaceutical manufacturing. For more information, visit www.bpsalliance.org. Contact: Christopher Clark Executive Director 571-348-5109 cclark@socma.org |
Tag: BPSA Technical Guide
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.
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.