Autoclave Validations

As per USP <1211>, Sterilization and Sterility Assurance of Compendial Articles, pharmaceutical manufactures and in-house laboratories must perform an initial validation of the autoclave. Generally this is performed as part of the initial IQ/OQ done for the new equipment, but it must also be performed if any major changes are made to the instrument. Validation will establish that the equipment controls and associated instrumentation are functioning properly according to the specific needs of our clients and will achieve desired sterility of the test articles. Generally, the validation will only need to be performed once unless there is a modification to the procedure (i.e. temperature or time). Furthermore, a re-validation of the autoclave has to be performed after there are any major changes to the equipment. Each individual autoclave must be validated, with some prior thought put into the development of the validation protocol for: the types of articles that will be sterilized the load configuration the worse case scenario of both article type and load configuration

Example of Autoclave Validation, worse case scenario temperature mapping (used for informational purposes only). After the clients needs and expectations have been fully explored, the autoclave validation protocol can be written. The typical protocol is broken down into three activities:

Empty Chamber mapping using a NIST calibrated multi-channel thermocouple. The goal of this initial phase is to identify any and all cold spots in the autoclave chamber. Worse case scenario load challenge. This is based on the test articles the client will need to sterilize, and the largest load that will be sterilized in a single cycle. Data review and Reporting. It is critical that the Validation show conformance to USP <1211>, Sterilization and Sterility Assurance of Compendial Articles as well as to the Acceptance Criteria of the Autoclave Validation Protocol.