Safety Cabinet Validation / Certification

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.

Installation Qualification (IQ):

Verifies that the unit is properly installed and confirms that all necessary documents and parts as specified per the manufacturer are included

Operation Qualification (OQ):

Operational test designed to test product functionality as designed by the manufacturer. The OQ includes airflow analysis and HEPA filter integrity testing

Performance Qualification (PQ):

Challenge testing designed to provide assurance that the product will operate as designed during intended use. The PQ includes smoke testing to determine correct air flow pattern, noise level measurements, and particle counts.

There are 3 classes of BSC: Class I, II and III:

Class I Cabinets: unrecirculated airflow away from the operator that is discharged to the atmosphere after filtration through a HEPA filter.

They provide good operator protection but do not protect the material within the cabinet (the product) from contamination.

Class II Cabinets: designed for personnel, product and environmental protection. They are designed for work involving microorganisms in containment levels 2, 3 and 4 laboratories and are divided into two types (A and B) on the basis of construction type, airflow velocities and patterns, and

exhaust systems.

Within type (A), there are two subtypes, A1 and A2.

Within type (B), there are two subtypes, B1 and B2.

Class II cabinets are most commonly used in biomedical research laboratories because of their characteristics.

Class III Cabinets: are totally enclosed and gas-tight with HEPA filtered supply and exhaust air. Work is performed with attached long-sleeved gloves. The cabinet is kept under negative pressure of at least 120 Pa, and airflow is maintained by a dedicated exterior exhaust system. Class III cabinets protect the worker and the product. They are designed for work with level 4 pathogens and provide an alternative to the positive-pressure suit made for maximum containment laboratories.

Applied standard:



Tests proposed:

  1. Downflow velocity profiling:

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.

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