Terminal Sterilisation
Sterilising the product in its final sealed container, usually by moist heat, giving a calculable and verifiable sterility assurance level.
Why regulators prefer it
Sterility assurance becomes arithmetic — an F0 value and a demonstrated SAL of 10⁻⁶ — rather than a behavioural argument. Annex 1 expects a documented justification whenever terminal sterilisation is not used.
The constraint
Not every molecule survives it. Where degradation under autoclave conditions is demonstrated, aseptic processing is justified with that data attached.
Related terms
Where this applies
General Injectables
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