AIE Laboratory Services provides biosafety cabinet certification and service for biotechnology startups, pharma companies, academic labs, hospitals, and other institutions in Greater Boston and throughout New England. But how do you know when and if your biosafety cabinet needs to be certified?

Biosafety cabinet certification schedule

A biological safety cabinet (BSC) is a primary engineering control used to protect personnel against biohazardous or infectious agents and to help maintain quality control of the material being worked with as it filters both the inflow and exhaust air.  They are also referred to as a laminar flow or tissue culture hood. BSCs primarily protect against exposure to particulates or aerosols, with a portion of the air in most BSCs recirculated back into the lab through its exhaust HEPA filter.

But how can you make sure that your biosafety cabinet is maintaining the necessary level of protection for the lab and lab personnel? And how often should you certify a biosafety cabinet? REGULAR TESTING AND CERTIFICATION. Field certification is an essential practice ensuring that the cabinets maintain their specifications. HEPA filters will collect particles over time and need adjustments to maintain their proper airflow. NSF recommends that BSC’s go no more than 12 months between certifications, with some applications requiring semi-annual certifications. This ensures that research material is properly contained and protected to produce accurate results.

While an annual certification is the standard for most labs other events might warrant more frequent testing, including accidents, moves and relocations, major maintenance or repair projects, replacement of one or both HEPA filters, and after periods of extended inactivity.

How do you test or certify a biological safety cabinet?

The following are the potential tests performed as described by NSF:

• Pressure decay / Soap Bubble– Determines the overall seal integrity of the cabinet outer hull. Including exterior surfaces of all plenums, welds, gaskets, plenum penetrations, and seals.
  • Pressure decay –The cabinet shall hold 2 inches w.g. (500 ± PA) ± 10% for 10 minutes.
  • Soap bubble –All weds, gaskets, penetrations, and seals on exterior surfaces of air plenums shall be free of soap bubbles when at 2 inches w.g. (500 ± PA) ± 10% pressure above atmospheric.
• HEPA/ULPA filter leak test– Determines the integrity of downflow and exhaust HEPA/ULPA filters, filter housings, and filter mounting frames.
• Site installation assessment tests– These tests are performed to verify that the biosafety cabinet is integrated properly into the facility. This includes:
  • Sash alarms.
  • Exhaust airflow alarms and interlock.
    • Exhaust alarm systems – Type B1 or B2 hoods.
    • Exhaust alarm system – Type A1 or A2 canopy connection.
    • Exhaust alarm system – Type C1.
  • Cabinet alarm systems – Type A1, A2, or C1.
  • Airflow alarm system – Type A1, A2, or C1.
  • Internal supply /exhaust fan interlock alarm – Type A1, A2, or C1.
• Electrical leakage and ground circuit resistance and polarity tests – All new cabinets shall conform the requirements of the current edition of any national standard that is based on IEC610-1. Cabinets initially qualified under versions of NSF/ANSI 49 prior to the 2009 edition shall conform to UL61010A-1¹⁷ or may refer to NSF 49-1992 for Electrical Leakage, Ground Circuit Resistance, and Polarity tests if necessary.
• Light intensity test– Determines the light intensity on the work surface of the cabinet in fc (lux).
• Vibration test – This test determines the amount of vibration in the operating cabinet.
• Noise level test– This test provides a uniform method for measuring the noise level produced by the cabinet. The methods can be performed in most acoustically ordinary rooms.
• Stability tests – These tests demonstrate the structural integrity and stability of a biosafety cabinet for the following:
  • Resistance to overturning under applied forces.
  • Resistance to distortion under applied forces.
  • Resistance to deflection of work surfaces under load.
  • Stability with respect to tipping under load.
• Motor / blower performance – This test demonstrates that when the cabinet is operated at the nominal set point velocities and without readjusting the fan speed control, a 50% increase in pressure drop across the new filter shall not decrease total air delivery more than 10%.
• Downflow velocity test – This test measures the velocity of air moving through the cabinet workspace 4 inches (100 mm) above the bottom edge of the sash.
• Inflow velocity (face velocity) test – This test determines the measured and calculated inflow velocity through the work access opening and the calculated exhaust flow volume rates.
• Personal, product, and cross-contamination protection (biological) tests – These tests determine whether aerosols will be contained within the cabinet, outside contaminants will not enter the cabinet work area, and aerosol contamination of other equipment in the cabinet will be minimized.
• Airflow smoke patterns test – This test determines 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 top of the sash.
• Drain spillage trough leakage test – Demonstrates the containment capability of the spillage trough under the work surface.

Why do I need to have my BSC certified and tested? What’s the point?

Biological safety cabinets prevent exposure to microbiological contamination. If this equipment is not working properly, the risk of exposure to harmful contaminants increases, especially if the user is unaware of the failure.

Poor placement, poor inflow velocity or downflow velocity, failed HEPA filters, elevated sashes, crowded work area and poor user techniques compromise the biosafety cabinet’s containment capacity. These problems will not be noticed unless a BSC test is conducted or if users become seriously contaminated and consequently ill. Because of this, biological safety cabinet validation is extremely important.

Malfunctioning biosafety cabinets compromise worker safety, putting lab personnel at risk for infection by biological hazards and other infectious agents which can be life threatening. Improper sealing or ventilation of cabinets poses a danger to workers not only in the lab in which the cabinet is used but also throughout the facility, as well as in the external environment.

Moreover, if samples are contaminated or compromised beyond acceptable standards they are rendered unusable. And because patent submissions and maintenance are dependent on verified, certified conditions falling outside of certification compliance puts patent submissions and renewals at risk.

Can I test my BSC by myself rather than hiring a certifier?

Due to the specialized knowledge required for a proper and safe certification of biosafety cabinets, NSF International administers an accreditation program to accredit field certifiers. Field certifiers must pass a written and practical test administered by NSF before becoming accredited. In addition, continuing education and periodic reexaminations are required for accreditation.

Please contact AIE Laboratory Services today for information on biosafety cabinet certifications, including  pricing and availability. Thanks!