Biofilm detection in aseptic processing equipment, filling lines, and isolators to ensure sterile conditions.
Clean-in-Place and Sterilize-in-Place system verification to meet FDA validation requirements.
Purified water and WFI system biofilm monitoring to prevent microbial contamination.
Environmental monitoring and surface contamination detection in controlled manufacturing areas.
Visual inspection documentation for IQ/OQ/PQ protocols and regulatory submissions.
FDA 21 CFR Part 211 and EU GMP compliance through comprehensive visual inspection documentation.