Autoclave Validation / Qualification is manadatory for all
machines used for biological sterilization, in the biomedical and pharmaceutical industries within the FDA, WHO & EU controlled areas.
Sterilization can be accomplished by either physical or chemical means. The principal physical means is autoclaving; other physical methods include boiling and dry heat. Chemicals used for sterilization include the gases ethylene
oxide and formaldehyde, and liquids
such as glutaraldehyde
. Of all these sterilants,
autoclaving is the fastest, most reliable and hence; most commonly used within the FDA, WHO and EU zones of influence. It must always be remembered that it is also one of the easiest processes to get wrong. This is why regulators will nearly always scrutinize and ask about validation methods used in autoclave qualification / Qualification activities.
Autoclave validation / Qualification
must follow the routine validation / Qualification document string of;