European standard approved by CEN on May 19, 2024. Supersedes EN 556-1:2001 and EN 556-1:2001/AC:2006. Available in English, French, and German versions
EU Annex 1 requires sterilizing filter integrity testing since 1998. PUPSIT tests filter integrity after sterilization before use. Concerns exist about filter flaw masking during filtration
Sterilizing-grade PES membrane with 0.2 μm hydrophilic film. Flow rates up to 2.5 times faster than other sterilizing membranes. Compatible with wide pH range from 1 to 14. Reduces filtration time by half while maintaining batch volume
PUPSIT ensures sterilisation filter integrity before product filtration. First introduced in EMA Guide in 1997, mandatory in Australian GMP since 2002. Required in EU guidelines, WHO guidelines, and other pharmaceutical regulations
PUPSIT is mandatory for final fill filtration in biopharmaceuticals. First introduced in 1996 Annex 1, updated in 2008. Aims to detect microscopic flaws during filtration process
Electrons penetrate medical devices and pharmaceutical products in final packaging. Advanced electronics precisely control electron beam and material penetration. Process involves accelerating electrons to near light speed through scan chamber