Validation of a microwave sterilizer for injection ampules.

A program for validating the microwave sterilizer, which is a new type of sterilizer, was established and implemented. This program includes the following tests specific to microwave sterilizers: the internal pressure strength of ampules, the acceptable range of sterilizing temperature, performance and calibration of the infrared thermometer and the plane blackbody, maintaining of sterilizing temperature, the processing speed (sterilizing time), the unacceptable ampules selection mechanism, microwave leaks, and a microbiological challenge test of the ampule head space using a biological indicator. Injectable preparations of mecobalamin and diprophylline were used as models for validation of the microwave sterilizer. The bioburden approach was used for injectable mecobalamin preparation, and the over-kill approach was used for injectable diprophylline preparation. The basis for practical use of this microwave sterilizer has been confirmed by the establishment and implementation of this validation program.