Digitizing your Cleaning Validation Program and Strategy
European Annex 1 encourages companies to develop a “Total Contamination Control Strategy” (TCCS). TCCS starts with proper determination of Maximum Safe Carryover (MSC), calculated based on health-based exposure limits (HBELs), a routine cleaning program to evaluate effectiveness of the steps used, followed by microbial Environmental Monitoring, Water and Utilities Monitoring, HVAC filter qualifications, Media Fills,…