A: SECTION 113 OF THE NOVEMBER 25, 2008 REVISION OF ANNEX 1, states, “The integrity of the sterilized filter should be verified before use.” The statement implies that integrity of this filter should be determined after sterilization of the filter but before use. The acronym used for Pre-use Poststerilization Integrity Test is PUPSIT.
PUPIST of a sterilized filter usually means manipulating the downstream sterile side of the filter and increasing the complexity of maintaining sterility of the sterilized filtrate side. The impact of a sterile filtrate-side manipulation can be viewed as a critical human intervention; therefore, it may add risk to product quality and patient safety if sterility is compromised. The generic enforcement of PUPSIT has been seen as problematic, and the effort to implement such a test after thorough risk assessment is much more desirable.
Maik is CEO of G-CON Manufacturing and founder of BioProcess Resources. He has more than 30 years of experience.