Sterility Bioburden Sterilization Validations Environmental Monitoring Package Integrity Consulting Services

Programs are available to monitor the viable particulate levels in clean rooms and critical controlled environments. Test programs follow the suggested guidelines in the U.S. Pharmacopeia and various ISO guidelines. Controlled environments should be regularly tested for viable microbial levels in circulating air and on work surfaces. Used as a Quality Control tool, environmental testing demonstrates control over the production of Medical Devices. APPLICABLE TEST PROFILES VIABLE AIR IMPACTOR SAMPLES RODAC TOUCH PLATE - SURFACE SAMPLES PASSIVE FALL-OUT SETTLING PLATES SURFACE SWAB METHODS WATER ANALYSIS / HETEROTROPHIC PLATE COUNT MICROBIAL IDENTIFICATON ON-SITE SAMPLE COLLECTION ROUTINE MONITORING PROGRAMS