Fermentors have been sitting clean for 6 months. Would like to do a CEHT. What criteria would you suggest? Is it a waste of time to do micro testing since when used next fermentors are sterilized with sufficient lethality to kill anything of concern.
Equipment is under a cleaning validation protocol. Swab and rinse samples for residual product were performed after last use as well as visual inspection. The equipment was started up and tested mechanically every month. Aside from the mechanical what would be acceptable requirements for Chemical and Microbial limits in a CEHT study.
Its good. If it is commercial size fermentor --more than 100L you can do one test by filling the media and keeping it for 24 hours and conduct a microbial test by drawing samples.
This proves many points.
for established the clean equipment hold time the equipment kept in controlled enviorment conditions. Microbiological swab sample are collected from different locations of equipments which are previously defined in protocol (Hard to clean locations) at a reqular interval of time defining in the protocol. there is no need to perform any chemical analysis for previous residue if cleaning procedure is already validated.