When it comes to completing Depyrogenation Oven/Tunnel Installation, Operational, or Performance Qualifications, the protocols used need to verify that the Depyrogenation Oven/Tunnel has been installed correctly (IQ), demonstrate that the Depyrogenation Oven/Tunnel is operating properly (OQ), and show that the Depyrogenation Oven/Tunnel sterilization cycles are able to reproducibly meet your requirements (PQ).
Mesa’s Compliance and Validation Services Depyrogenation Oven / Tunnel Qualification protocols include:
- Document the Depyrogenation Oven/Tunnel Information (Make, Model, Serial Number, etc.). (IQ)
- Identification and Verification of all Critical Instruments used by the Depyrogenation Oven/Tunnel. (IQ)
- Verification that the Depyrogenation Oven/Tunnel 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 Depyrogenation Oven/Tunnel.
- Verification that the Depyrogenation Oven/Tunnel is able to meet and maintain the required temperature during the depyrogenation/sterilization cycle. (OQ)
- Verification that the Depyrogenation Oven/Tunnel depyrogenation/sterilization cycles can reproducibly meet the requirements for time, temperature, pressure, sterility assurance using endotoxin or biological indicator reduction. (PQ)
- Development of different Depyrogenation cycles to meet your needs & requirements for time, temperature, and endotoxin or biological indicator reduction.
By using Mesa’s Compliance and Validation Services to complete your Depyrogenation Oven / Tunnel qualifications, the completed IQ, OQ, or PQ protocols will provide a level of assurance that the Depyrogenation Oven/Tunnel has been installed properly, is operating correctly and is able to reproducibly meet your (the customer’s) depyrogenation/sterilization requirements.