Glossary

Sterilising-grade Filter

Also writtensterile filtersterilizing filter

A filter, normally of a maximum nominal pore size of 0.22 µm, suitably validated to remove microorganisms from a liquid or gas and so give a sterile filtrate.

Source · EudraLex Volume 4, Annex 1 (2022), §§6.19, 8.79–8.95

Details

A sterilising-grade filter is the key microbial barrier for products that cannot be terminally sterilised, so product compatibility, adsorption, extractables, and microbial retention all have to be verified. Inspections cite inadequate control of the compatibility of filter and product, the maximum time, pressure, and volume, the pre-filtration bioburden, and integrity testing. Look at filter validation, the supplier's certificate, the process parameters, PUPSIT and post-use testing, and the batch record.

Related sections

EU GMP Annex 1 §§6.19, 8.79–8.95

Related terms

Filter Integrity Test5 casesPre-use Post Sterilisation Integrity Test (PUPSIT)Aseptic Processing1,540 cases

Source

EudraLex Volume 4, Annex 1 (2022), §§6.19, 8.79–8.95

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