Biosafety cabinets are tested and certified to meet the existing recommendations. Test and certification of Biosafety Cabinets includes inflow velocity measurements,down flow velocity measurements, HEPA filter testing, and airflow pattern testing.
Our validation services ensure compliance with FDA, GMP/GLP, US Pharmacopoeia, and ISO standards.
There are 3 classes of BSC: Class I, II and III:
This test measures the velocity of air moving through the cabinet work space 10 cm above the bottom edge of the window.
2. HEPA filter integrity/leaks:
This test determines the integrity of downflow and exhaust HEPA filters, filter housings, and filter mounting frames.
3. Inflow or face velocity:
This test determines the measured and calculated inflow velocity through the work access opening and the calculated exhaust flow volume rates.
4. Airflow visualization testing – smoke test:
This test determines that the airflow along the entire perimeter of the work access opening is inward, that airflow within the work area is downward with no dead spots or refluxing, that ambient air does not pass on or over the work surface,and that there is no escape to the outside of the cabinet at the sides and topof the window
5. Cabinet integrity testing – soap bubble:
This test on exterior surfaces of all plenums determines whether welds, gaskets, plenum penetrations, and seals are free of leaks (for Class II A1 only).
6. Particulate monitoring:
controlling particulate matter are extremely important for product quality control. A particle counter is used to fi lter and count non-viable particle populations having size of 0.3 and 0.5μm.
7. Active air sampling – microbiological contamination:
active air sampling using an air sampler. Filtration and count of viable microorganisms (total bacterial flora and yeast and mould) per volume of air.
8. Surface bio-contamination:
sampling of internal working surface of the BSC using a non-selective culture media. Count of viable microorganisms (total bacterial flora and yeast and mould) per surface unit.