biological indicator spore testing procedure

Biological indicator spore testing procedure verification#

As such, BIs contain endospores that are much more resistant and present in a far larger number than the microorganisms encountered in the presterilization bioburden of any product to be sterilized. They are used to demonstrate the sterilizing effect of the process. BIs intended for monitoring and controlling sterilization processes are preparations of bacterial endospores that are highly resistant to a particular sterilization process. It is not entirely clear to everybody why BIs are used at all.

Biological indicator spore testing procedure verification#

This article elucidates some reasons for the surprising variations in understanding the verification of sterilization effectivity by BIs. It is even more confusing that within the pharmaceutical industry, the view on validation of sterilization processes and the use of BIs is not the same on both sides of the Atlantic. Validation of sterilization processes is regarded quite differently in hospitals and in the manufacture of medical devices than in the manufacture of pharmaceutical products. Although it may not be surprising that sterilization is regarded differently in hospitals than in the canning industry, the differences in the healthcare sectors are more difficult to understand. In discussions between colleagues dealing with steam-sterilization processes in the pharmaceutical industry, the medical device industry, or in hospitals, it frequently becomes obvious that sterility assurance and the use of biological indicators (BIs) as tools for the validation of sterilization cycles is not a commonly well understood and clear concept.