Bio-Process Systems Alliance Releases the 2023 Single-Use Manufacturing Component Quality Test Matrices
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 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 2023 QTM technical guide was developed by a volunteer committee of BPSA members, with leadership from the BioProcess Institute (North Kingstown, RI).