Validating an autoclave
The good news to manufacturers or other users of these guidelines is that many of the current validation practices are the same in the new document.
This article will outline the basic requirements for steam sterilizer validation via the halfcycle overkill method, and list some of the differences between the two documents.
REQUIREMENTS PRIOR TO VALIDATION The 17665 document makes it clear in numerous locations that the user’s quality system must adhere to ISO 13403 Medical devices — Quality management system — Requirements for regulatory purposes.
So if a user wishes to claim full compliance with the new 17665 steam standard, then their quality system must also be in compliance with ISO 13485, including items such as preventive/periodic maintenance and regular calibration for the sterilizer, documentation, change control, purchasing, etc.
Much of this type of information would be recorded in well-written validation protocols or validation final reports.
Biological indicators often use spores of the bacterial species Geobacillus stearothermophilus at a titer of greater than 106per BI, although other species or titers are sometimes used.
In our case, successful means all BIs are killed (no growth upon incubation) for the three consecutive halfcycles.
If, for example, there was no BI growth for the three test cycles at ten minutes exposure at 121 °C, then a 20-minute exposure at the same temperature would be adequate for routine daily processing, assuming all other aspects or requirements of the IQ/OQ/PQ are successful, documented, reviewed, and approved.
it is anticipated that the new 17665 standard will be recognized by the FDA and will be commonly employed to validate autoclave processes.They are commercially available or may also be created from the user’sproduct line by inserting spore strips, spore dots, inoculated threads, items or locations that are determined to be the most-difficult-to-sterilizeproduct or location in the load.There are many other activities or decisions to be made prior to or during the IQ/OQ, that are not necessarily detailed in either standard.It must be remembered that the load is part of the validation — that is, if the user makes significant changes to the load at any point in the future — then re-validation may be necessary.The previous ISO 11134 document gave relatively little guidance information and few specifications for conducting the test cycles necessary to qualify the user’s proposed fullcycle exposure time(s).
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For small chambers, as few as five or six BIs and temperature loggers may be needed. Large, multi-pallet-sized chambers may require many more samples per run.