Qualifying our Portable Incubator for on site work including Biological Indicator testing

Our Validation Engineers perform Thermal mapping of Incubators, fridges, freezers using Vaisala data loggers and this is currently showing good control in our 55C to 60C range.

We need to qualify our portable incubator for the site as we have a job starting next week where Sterilisation Processes require Biological and Thermal testing but the site QC Micro is not up and running yet so our lab incubator for BI incubation is being qualified (55 to 60 C).

We are using self contained BI’s for the cycle development work so that there are no requirements for aseptic handling of the BI’s, we can handle these without any lamina flow booth or sterile media provided we have a qualified incubator on site.