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. 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.
Installation Qualification (IQ)
Validation of an autoclave begins with the execution of the Installation Qualification (IQ) protocol. The IQ protocol verifies and documents that the Autoclave is installed correctly and meets all of the manufacturer and user requirements. 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.
Operational Qualification (OQ)
The next step in the validation of the autoclave is the execution of the Operational Qualification (OQ) protocol. 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. Execution of the OQ protocol involves verifying the parameters/settings (e.g. general system options, cycle length, sterilization temperature, leak testing, or air removal) of the sterilization cycles. It also ensures that the system alarms are operating correctly, that the equipment is functioning properly (e.g. 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).
Performance Qualification (PQ)
The execution of the IQ and OQ protocols covers the validation of the autoclave. In order to validate a sterilization cycle, a Performance Qualification (PQ) protocol must be executed. The PQ demonstrates that the sterilization cycle(s) can repeatedly achieve the required Sterility Assurance Level (SAL) 1. In order to confirm that the necessary SAL can be reached, the sterilization cycle must be temperature mapped.
To perform a temperature mapping, data loggers are placed throughout the autoclave chamber (distribution data loggers) and the load being sterilized (penetration data loggers). Each penetration data logger should have a Geobacillus stearothermophilus biological indicator attached to or placed near it. All data loggers used should have at least a 3 point NIST traceable calibration performed prior to use. The biological indicators used must have a population of ≥ 1 x 106 organisms, and a D‑value of 1.5 to 3.0.
To confirm that the required SAL has been attained, the temperature data recorded by the penetration data loggers during the cycle is evaluated to determine the lethality value (FO). Typically, the required FO is determined by the multiplying the D-value of the biological indicator used by 12.
Incubation and enumeration of the biological indicators also demonstrates whether or not the required SAL was reached. If the biological indicator population has been completely reduced (no growth of the biological indicators is observed after incubation), this indicates that the necessary SAL has been reached during the sterilization cycle.
For an autoclave sterilization cycle to be considered validated, three successful temperature mapping tests must be completed with passing results for all of the predetermined acceptance criteria.
Mesa Validation Experts have the knowledge and experience needed to help you complete the IQ/OQ/PQ for your steam sterilization equipment and processes, so you can rest assured that your medical devices, production or packaging components, final pharmaceutical product, or bulk active pharmaceutical ingredients are being terminally sterilized – optimally, reproducibly, and consistently. Contact us today to learn more about the validation of a steam sterilization process.
1 – The SAL is the probability of a single unit being non-sterile after it has been subjected to sterilization or the killing efficacy of a sterilization process. A typical SAL is 10-6, which is a 1 in 1,000,000 chance of a non-sterile unit.
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