Glossary
Sterilisation / Sterilization
A validated process that removes or kills viable microorganisms by physical or chemical means.
Details
Sterilisation is the validated process that removes or kills viable microorganisms to create sterility, disinfection is treatment that reduces the microorganisms on a surface to a level appropriate for the intended purpose, and sterility is the resulting state — disinfection does not substitute for sterilisation. EU GMP Annex 1 §8.34 requires terminal sterilisation in the final container to be chosen wherever possible (it gives higher sterility assurance than aseptic processing), §8.36 requires every sterilisation process to be validated taking account of product composition, storage conditions, and the maximum time between the start of preparation and sterilisation, and to demonstrate for each loading pattern that all parts reach the required conditions, by physical measurement and, where applicable, biological indicators, and §§8.38–8.41 require loading patterns to be verified, worst case loads to be revalidated at least annually, and cycles falling outside validated parameters to be detected and investigated. Inspections cite the use of loading patterns that were never validated, autoclave cycle deviations left uninvestigated, sterilisation judged on a chemical indicator colour change alone (§8.44 states that this shows only that the process was undergone and does not indicate sterility), and the absence of the validation records for aseptic and sterilisation processes required by 21 CFR 211.113(b).
