- What are the categories of biological containment in use?
- What documentation does Federal Select Agent Program require, to verify the ability of a BSL-3/ABSL-3 HVAC system to maintain secondary containment under failure conditions?
- Is there a requirement to perform failure tests of multiple exhaust fans at the same time?
- If the facility design includes backup emergency power, does Federal Select Agent Program require that an electrical system load switch, from utility power to generator, be performed for the normal power failure/restart test?
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The term "containment" is used in describing safe methods for managing infectious materials in the laboratory environment where they are being handled or maintained. The purpose of containment is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous agents.
Primary containment, the protection of personnel and the immediate laboratory environment from exposure to infectious agents, is provided by both good microbiological technique and the use of appropriate safety equipment. The use of vaccines may provide an increased level of personal protection.
Secondary containment, the protection of the environment external to the laboratory from exposure to infectious materials, is provided by a combination of facility design and operational practices. Therefore, the three elements of containment include laboratory practice and technique, safety equipment, and facility design. The risk assessment of the work to be done with a specific agent will determine the appropriate combination of these elements.
Information about containment and classification of Biosafety Levels 1-4 is available in the BMBL.
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When tests are performed of exhaust fan failure or of normal power failure/restart, monitoring of the containment laboratory’s differential pressure or airflow must be performed and recorded by some means throughout the testing period. Two examples of how this monitoring may be done are: witness observations of airflow using a smoke stick, or dry ice in a container of water, at the base of closed laboratory doors; or pressure differential trending data collected by a building automation system or by witness observations of gauges. The results recorded during the tests must be provided as part of the test documentation.
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If redundant exhaust fans are present, a test should be performed to demonstrate the ability to transition to an alternate fan without reversal of airflow from potentially contaminated laboratory space into “clean” areas outside the containment boundary. There is no requirement to perform a catastrophic failure or institute a total systems shutdown for multiple exhaust fans. However, it may be beneficial to perform such a test when re-commissioning is required.
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No, an electrical load switch is not specifically required, because of the disruptive effect which electrical load switching may have on building occupants and the potential hazards to electrical components. The load switch is one option for the performance of normal power failure/restart testing. Another option is to simulate the loss and restart of normal power by simultaneously shutting off both the supply and the exhaust fans which serve the laboratory space, while monitoring and recording the differential pressure or airflow, and then simultaneously turning on both the supply and the exhaust fans, while monitoring and recording airflow or differential pressure.
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