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Bio-Process Systems Alliance Releases the 2023 Single-Use Manufacturing Component Quality Test Matrices

Arlington, VA – The Bio-Process Systems Alliance (BPSA), the international trade association of the single-use bio-processing industry, announced the release of the 2023 Single-Use Manufacturing Component Quality Test Matrices (QTM).

Originally developed in 2007, the BPSA QTM is designed as a technical guide to help facilitate the validation and qualification of single-use products. The latest third edition was necessitated by the rise in the number of components, the expansion of test practices, and the introduction of new standards.

The guide includes six comprehensive test categories—physical, functional, biological, chemical, regulatory, and sterilization/sanitization—commonly associated with single-use components. Additionally, it covers seven individual single-use component categories, including chromatography, connectors, valves and retainers, containers and film, sensors, tubing, filters, and single-use assemblies. The guide provides links to public domain test methods or source locations, detailed descriptions of how each test is applied (e.g., in material qualification, product qualification, and lot release), and a comprehensive list of terms and definitions in a dedicated reference section.

The 2023 QTM technical guide was developed by a volunteer committee of BPSA members, with leadership from the BioProcess Institute (North Kingstown, RI). “The BPSA QTM is a very important tool for single-use suppliers and end-users alike, and this update will help advance the single-use bioprocessing industry,” said Kirsten Strahlendorf of Sanofi, and Chair of the BPSA Scientific Advisory Board.

The updated QTM technical guide also accounts for changes to common practices by single-use component and assembly providers as well as sterilization process compatibility, pre-use treatment, as well as sterilization (irradiation and thermal) exposure to test samples.

The 2023 BPSA QTM technical guide is now available for download at https://bpsalliance.org/resources/technical-guides/ . For additional information, please contact BPSA Executive Director Chris Clark at cclarck@socma.org.

The Bio-Process Systems Alliance (BPSA), 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. BPSA facilitates education, sharing of best practices, development of consensus guides and business-to-business networking opportunities among its member company employees.  www.bpsalliance.org.

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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.