Bio-Process Systems Alliance Releases the 2023 Single-Use Manufacturing Component Quality Test Matrices
November 29, 2023
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.