1.Purpose for validation eto sterilization
1.1.the obtain of eto sterilization validation evidence that the equipment used for ETO sterilization has been provided and installed in accordance with its specification and can stably operate within predetermined limits and consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification.
1.2
This part specifies requirements for the development,validation and routine control of the ETO sterilization process and provide guidance for it to comply with relevant regulatory requirements like ISO 11135.
2. Scope
2.1.Relevant equipment used in ETO sterilization(Precondition room?Sterilizer?Aeration room?Incubator ,etc.).
3. Terms and Definitions
3.1.?IQ
Installation qualification:IQ
3.2.?OQ
Operation qualification:OQ
3.3.?PQ(MPQ/PPQ)
Performance qualification:PQ(Microbiological PQ/Physical PQ )
3.4.:Requalification
3.5.:Bioburden
3.6.:Biological indicator
3.7.:Fractional cycle
3.8.:Half cycle
3.9.:Full cycle
3.10.PCD: process challenge device
3.11.:Product and product family
3.12.?: Usable volume/Product load volume
3.13.:Sterility
3.14.SAL: Sterility assurance level
4. Responsibilities
4.1 The eto sterilization validation engineer is responsible for drafting the validation protocol, and the trained personnel and the uses are responsible for performing the validation and collecting relevant data to assist in the completion of the validation.
5. Procedure
5.1.IQ dilakukan untuk menunjukkan bahwa peralatan sterilisasi dan perlengkapan tambahan lainnya telah disediakan dan dipasang sesuai dengan spesifikasinya. Sebelum melakukan IQ, produsen peralatan akan melakukan FAT dan SAT untuk memastikan bahwa peralatan telah dikirimkan secara normal.