When completing Installation, Operational, or Performance Qualifications on an Autoclave, the protocols used need to verify that the Autoclave has been installed correctly (IQ), demonstrate that the Autoclave is operating properly (OQ), and show that the Autoclave sterilization cycles are able to reproducibly meet your requirements (PQ).
Mesa’s Compliance and Validation Services Autoclave Qualification protocols include:
- Documentation of the Autoclave information (Make, Model, Serial Number, etc.). (IQ)
- Identification and Verification of the Critical Instruments used by the Autoclave. (IQ)
- Verification that the Autoclave Controls and Alarms operate as required by the customer and per the manufacturer’s specifications. (OQ)
- Verification that Standard Operating Procedures are available for the operation, maintenance and/or cleaning of the Autoclave. (OQ)
- Verification that the Autoclave is able to meet and maintain the required temperature during the sterilization cycle. (OQ)
- Verification that the Autoclave sterilization cycles can reproducibly meet the requirements for time, temperature, pressure, and sterility assurance using biological indicators and lethality. (PQ)
- Development and Verification of Autoclave sterilization cycles to meet your needs & requirements for time, temperature, pressure, and sterility assurance using biological indicators. (OQ/PQ)
By using Mesa’s Compliance and Validation Services to complete your Autoclave qualifications , the completed IQ, OQ, or PQ protocols will provide a level of assurance that the Autoclave has been installed properly, is operating correctly and is able to reproducibly meet your (the customer’s) sterilization requirements.