Annex 1 and the PUPSIT requirement

Annex 1 of GMP is a set of regulations guiding the manufacturing of sterile medicinal products, setting stringent regulations for biopharmaceutical processes. Within this set of regulations, PUPSIT stands out as a fundamental procedure to ensure the integrity of components in the pharmaceutical production chain.

Pre-use post-sterilization integrity testing (PUPSIT) is a process used to verify the integrity of a sterilized filter before it is used in a critical process. This testing is conducted after sterilization to confirm that the filter has not been damaged or compromised during the sterilization process. PUPSIT is an important step in ensuring the sterility of the final product and is commonly used in the pharmaceutical, biotech, and medical device industries.

The general shift towards single-use technology in the pharmaceutical and biopharmaceutical industry can in part be attributed to the desire to eliminate certain elaborate steps like autoclaving. As systems made up of single-use components are sterilized in forehand by the supplier, autoclaving becomes obsolete and potential risks are reduced.

This article guides through the specific requirements of Annex 1 and sheds light on the diverse facets of PUPSIT, including its methods, advantages, associated challenges, and the possibilities of single-use technologies.

Full article: https://www.susupport.com/knowledge/manufacturing-processes/fill-filtration/annex-pupsit-requirement

Customized PUPSIT system: https://www.susupport.com/solutions/platform-systems/fill/pupsit-system