Autoclaves/Steam Sterilizers EQ&C

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.