Autoclave Validation / Qualification is manadatory for all
machines used for biological sterilization, in the biomedical and pharmaceutical industries.
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 and most reliable, which is why the regulators always scrutinize autoclave validation / Qualification activities.
Autoclave validation / Qualification
must follow the routine validation / Qualification document string of;