Solutions for biological indicator problems from a quality assurance viewpoint.
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.
Royalty-Hann
Wendy
W
Raven Labs, a Division of Mesa Laboratories, Inc. 8607 Park Drive, Omaha, Nebraska 68127, USA.
D007202:Indicators and Reagents; D008828:Microbiological Techniques / Q000379:methods*; D011786:Quality Control; D013171:Spores, Bacterial / Q000302:isolation & purification*; D013242:Sterilization / Q000379:methods* / Q000592:standards
D007202:Indicators and Reagents