![]() If you are inspecting a contract sterilizer, Inspectional Objectives 2 through 5, described below, are applicable and must be performed. Other specifications may include sterilant residues and endotoxin levels. For sterilization processes, the primary device specification is the desired Sterility Assurance Level (SAL). Developing processes that are adequate to produce devices that meet specifications, validating (or fully verifying the results of) those processes, and monitoring and controlling the processes are all steps that help assure the result will be devices that meet specifications. The purpose of the production and process control subsystem (including sterilization process controls) is to manufacture products that meet specifications. Verify that personnel have been appropriately qualified and trained to implement the sterilization process.If the sterilization process is software controlled, confirm that the software was validated.Review the equipment adjustment, calibration and maintenance.Determine whether the nonconformances were handled appropriately and.If review of the Device History Records (including process control and monitoring records, acceptance activity records, etc.) reveals that the sterilization process is outside the firm's tolerance for operating or performance parameters:.Verify that the process is controlled and monitored. ![]() Review the specific procedure(s) for the sterilization process selected and the methods for controlling and monitoring the process.Confirm that the sterilization process was validated by reviewing the validation study.
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