The application of a lethal sterilizing agent to finished product within a sealed container to achieve a predetermined sterility assurance level (SAL) of 10⁻⁶ or better (i.e. the theoretical probability of there being a single viable microorganism present on or in a sterilized unit is equal to or less than 1 x 10-6 (one in a million)).
Source: GMP Draft Annex 1
ISO 14644-1:2015 Compliant Cleanroom Monitoring
We discuss the changes to sampling procedures and monitoring plans for cleanrooms and clean zones in...Read more
The Importance of Cleanroom Validation
Cleanroom validation offers ISO compliance and peace of mind.Read more
10 Steps to a Cleaner Cleanroom
The risk of contamination affecting a product increases as operator activities increase within a cle...Read more