Language: English

The sterilization of medical devices is described in detail by various harmonized ISO standards. These harmonized standards provide guidance to establish, validate and maintain a successful sterilization process. The success of sterilization depends on the number of microorganisms (bioburden) on the product prior sterilization, the resistance of the bioburden against the sterilizing process and the environment the microorganisms are exposed to during sterilization. Besides the inactivation of viable microorganisms, the treated product (including packaging) shall retain is functionality and safety after sterilization throughout its specified shelf life. For establishing a sterilization process inactivation studies shall be conducted, from this data the extent of the routine sterilization process can be extrapolated. The validation of the sterilization process consists of an Installation-, Operational- and Performance-Qualification. It shall be demonstrated that the sterilization process reproducibly provides an adequate level of safety.

Maintaining a sterilization process includes e.g. adequate control procedures including bioburden monitoring, sterilization dose audits/re-qualifications and change control procedures.

All sterilization methods issued as harmonized standards have themselves proven to be safe over the course of time but various uncertainties during sterilization process establishment lead to a reduced efficiency.

Although the change control requirements for the sterilization process are sufficient the guidance for establishing a change control process remains unclear for sterilization as well as for medical devices in general.

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