Glossary

Terminal Sterilisation

Also writtenterminal sterilization

Filled Sealed Sterilisation
Illustration

Applying a sterilisation process to the product after it has been filled and sealed in its final container.

Source · EU GMP Annex 1 (2022), Glossary, Terminal Sterilisation

Related sections

EU GMP Annex 1 §§2–10 21 CFR 211.42 21 CFR 211.113

Related terms

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

Source

EU GMP Annex 1 (2022), Glossary, Terminal Sterilisation

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