GMP Annex 1 has introduced a requirement for pre use, post sterilisation integrity testing (PUPSIT) on sterilising filters. The requirement safeguards against damage incurred to a filter during sterilisation compromising the sterility of the product, but introduces complexity to manufacture. This presentation will discuss the risks PUPSIT introduces to a system and how good assembly design can help to alleviate some of them.

About the speaker

Alex Weera is the Lead Applications Engineer for WMArchitect at Watson-Marlow Fluid Technology Solutions. Joining WMFTS’s single use technology business from their internal graduate scheme in 2021, she is currently responsible for the design of their range of single use assemblies. She started her career at WMFTS after obtaining a masters degree in chemical engineering from the University of Manchester.