Solutions for Biological Indicator Problems from a Quality Assurance Viewpoint

Abstract

A biological indicator (BI) is a useful product to confirm sterility assurance after a sterilization procedure. In ISO 11138 and 14161, the concrete procedures regarding the use of BI are described for BI manufacturers and users, respectively. There are several problems involving BI use which must be addressed. These include population verification, D value verification and the general misuse of BI and so on. In this paper, the author will present concrete examples of the above situations and describe how to deal with these problems.