1.Purpose for validation 环氧乙烷灭菌
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 is undertaken to demonstrate that the sterilization equipment and any ancillary items have been supplied and installed in accordance with their specification. Before performing IQ, the equipment manufacturer will conduct FAT and SAT to ensure that the equipment has been delivered normally.