Glossary

Overkill Sterilisation

Also writtenoverkill sterilization

A sterilisation process set to deliver at least a 12 log10 reduction of a biological indicator of appropriate resistance.

Source · EudraLex Volume 4, Annex 1 (2022), §11 Glossary: Overkill sterilisation

Details

The overkill approach gives high sterility assurance while depending less on precise heat resistance data for the initial bioburden, but the thermal stability of the product and container has to be demonstrated alongside it. Inspections cite inadequate justification for the 12 log reduction, worst case loading and cold spots, BI characterisation, and pre-sterilisation bioburden monitoring. Check cycle development and PQ, BI data, heat distribution and penetration, bioburden trends, and product stability data.

Related sections

EU GMP Annex 1 §§8.37–8.43, 10.3, 11 Glossary

Related terms

Sterilisation / Sterilization2 casesBiological Indicator9 casesSterility Assurance Level (SAL)2 cases

Source

EudraLex Volume 4, Annex 1 (2022), §11 Glossary: Overkill sterilisation

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