Validation of Autoclave Using Biological Agent

Autoclave is a common equipment found in most microbiology laboratories in hospitals, universities, research institutes as well as food, dairy and pharmaceutical product manufacturing facilities. The main function of this equipment is to sterilize glass apparatus, biological media and medical devices. In addition, it is also used for decontamination of biological wastes. Autoclave validation is a quality assurance procedure used to ensure that the autoclave has reached a sufficient temperature for an adequate amount of holding time to sterilize biological agents and wastes. To ensure that this sterilization process is successful, several steps can be taken either by using a datalogger, biological indicator or chemical indicator. In this experiment, the sterilization process was carried out on several types of samples using biological indicators containing Geobacillus stearothermophilus bacteria ATCC 7953. The results of this experiment are very important because they provide information on whether the selected parameters are suitable for the capacity of the product which indirectly affects the overall sterilization process. The autoclave validation process is also one of the procedures that must be done to comply with Good Manufacturing Practices (GMP) guidelines. (author)