Terminal Sterilisation

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

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