USP 43 1229.2 Moist Heat Sterilization of Aqueous Liquids
“The biological challenge is either directly inoculated into a liquid-filled container or is introduced via self-contained units provided there is adequate correlation between their resistance and the resistance that would occur in the process fluid...The resistance of the indicator in the product (and surrogate fluid, where used) must be known.”
EP 9.2 Par. 5.1.2 - Biological Indicators and related microbial preparations
“Spores inoculated into a product or onto surfaces are known to react differently to sterilising conditions as compared to biological indicator units”.
D-value studies are needed to know the impact that the properties of the material to be sterilized have on the resistance of microorganisms and to prove that the biological indicator used to validate the cycle represents an adequate challenge to ensure the required sterility assurance level (SAL) on the product being sterilized.
Topics covered include standards and references on D-values, parameters affecting microorganism resistance, liquid pharmaceutical D-value studies, custom made biological indicators.
Product and Applications Engineer - Sterilization and Disinfection Control
Kurt McCauley has a B.S. in Microbiology and is a Product & Application Engineer in the Sterilization and Disinfection Control Division of Mesa Laboratories. He began work at Mesa in 1995 and has been involved with all aspects of biological indictor production and development. Mr. McCauley currently serves as Co-chair for AAMI Working Group 91 (Resistometers) and is an active member of both AAMI/ ISO Working Groups 4 (biological indicators) and 6 (chemical indicators).