Spore forming bacteria that has been identified by the customer can be sent to Mesa Labs on a plate or slant. The bacteria will be grown targeting a 108 population, harvested, and inoculated into WFI (Water for Injection) or product ampoules. D-value analysis is conducted using the Survivor Curve Method.
Verification of D-value, Survival/Kill time, population, purity, and microbial identification listed on the Certificateof Analysis can be performed on other manufacturers’ biological indicators.
We can work with you to design a study around your product and sterilization method. Mesa can perform testing in steam, ethylene oxide, dry heat, and VHP processes.