I have to validate an small autoclave for an analytical lab and I would like to know what kind of test should I perform for OQ. They spect the unit be tested for empty and loaded chamber.
For a small lab autoclave, IF you need to demonstrate lethality for loads, easiest way may be to use Log 6 stearothermophilus BI’s and set cycle exposure times to what is needed to get all kill for high confidence of sterility. On many small ones, entrance for TC’s is not an option. Wireless thermisters such as those made by Data Trace can be used for temperature mapping if needed or ‘in-load’ penetration studies. Russ
For OQ, I would do empty chamber thermal profiles. Typically, you would do cycle development in another protocol and then validate loads.