Is it required in Europe to use microbiological bioindicators in Steam in Place Sterilisation Validation Process?
Antonio Doménech
Laboratorios Thea

Validation of steam sterilisation in case of medical devices is described in the european harmonized norm EN554. This norm specifies the requirements for the process validation of the sterilization of medical devices by moist heat. The EN 554 does not require the use of biological indicators for the validation.

Also see the final version of Annex 15 to the EU quide to GMP with the title Qualification and Validation. It is to be found on the following adress: http://pharmacos.eudra.org/F2/eudralex/index.htm

Kind regards

Ing. J.J.J. Patijn
Projectleader Validations & Monitoring KW2 B.V.