All data loggers used should have at least a 3 point NIST traceable calibration performed prior to use. Each penetration data logger should have a Geobacillus stearothermophilus biological indicator attached to or placed near it. To perform a temperature mapping, data loggers are placed throughout the autoclave chamber (distribution data loggers) and the load being sterilized (penetration data loggers). In order to confirm that the necessary SAL can be reached, the sterilization cycle must be temperature mapped. The PQ demonstrates that the sterilization cycle(s) can repeatedly achieve the required Sterility Assurance Level (SAL) 1. In order to validate a sterilization cycle, a Performance Qualification (PQ) protocol must be executed. The execution of the IQ and OQ protocols covers the validation of the autoclave.
verification that the control system functions as specified by the equipment manufacturer, and air removal verification), and that the autoclave is able to achieve and maintain the required sterilization conditions during the sterilization cycle(s). It also ensures that the system alarms are operating correctly, that the equipment is functioning properly (e.g.
general system options, cycle length, sterilization temperature, leak testing, or air removal) of the sterilization cycles. Execution of the OQ protocol involves verifying the parameters/settings (e.g. The OQ protocol verifies and documents that the autoclave is programmed and operating correctly, and is able to meet all of the manufacturer and user requirements. The next step in the validation of the autoclave is the execution of the Operational Qualification (OQ) protocol. During the execution of the IQ protocol, the equipment drawings, calibration status of critical instruments, critical instruments and valves information, utility information, and standard operating procedures for the autoclave are all confirmed. The IQ protocol verifies and documents that the Autoclave is installed correctly and meets all of the manufacturer and user requirements.
Validation of an autoclave begins with the execution of the Installation Qualification (IQ) protocol. Validation of the autoclave and the sterilization cycle(s) is required by ANSI, AAMI, ISO, and the FDA to ensure that all items that are required to be sterile are able to consistently and reliably be sterilized to reduce the chance of introducing or spreading an infectious microorganism. If terminal steam sterilization of medical devices, production or packaging components, final pharmaceutical product, or bulk active pharmaceutical ingredients is required, it is necessary that both the sterilization cycle(s) and the autoclave be validated.