Advanced797, LLC

Pharmacy Clean Room Testing and certification of ISO Class 5 Primary Engineering Controls (PECs), including: biological safety cabinets (BSC) , laminar flow clean benches (LAFW), workstations and clean air devices and isolators. Testing and certification of ISO Class cleanrooms (buffer areas) and anterooms including: particle counting, airflow volume profiling, air exchange rates, HEPA filter integrity testing, room pressurization monitoring and temperature and humidity monitoring. Microbiology sampling plan development, Air impaction and surface collection, DNA genotyping, reporting and analysis, Pharmacy staff initial and ongoing competency training and testing services for Aseptic Technique/Media Fill (CATT Kit) and gloved fingertip sampling. Contamination investigation and consultation. Clean room design USP 795, 797 and 800 education, microbiology remediation, 483 Consultations, SOP Development, GAP Analysis, Hazardous Drug, USP 800, USP 797, sterile products