BSL-3 Laboratory Commissioning: An Acceptance Checklist

Commissioning stages

Stage	What happens
Design review	Check that the design meets the applicable standard and the risk assessment: containment level, pressure cascade, HEPA locations, decontamination method.
Construction inspection	Inspect seals, penetrations, finishes, duct routing and equipment installation before ceilings and walls are closed.
Component tests	Test each system on its own: airtightness, HEPA filters, dampers, fans, alarms, autoclave, biosafety cabinets.
Integrated tests	Run the facility as a whole, including start-up, shutdown and failure scenarios.
Decontamination validation	Prove the room and equipment can be decontaminated.
Handover	Documents, training and a baseline for periodic recertification.

National standards set the specific tests and limits — for example China’s GB 50346 lists the integrated performance tests required before a biosafety laboratory is accepted, and the Canadian Biosafety Standard sets performance and verification tests for each containment level. Build the commissioning plan from the standard that applies.

Checklist

1. Room envelope

• Walls, floor and ceiling continuous, sealed and cleanable; all penetrations sealed.
• Airtightness proven by the method the standard requires — see BSL-3 room airtightness testing.
• Room can be sealed for gaseous decontamination: dampers, doors, drains and pass-throughs.

2. Ventilation and pressure cascade

• Supply and exhaust airflows at design values.
• Directional airflow from the least to the most contaminated area confirmed with a visual method at each door.
• Pressure differences between rooms at design values and displayed at the entry.
• No recirculation of laboratory exhaust air to other areas.

3. Alarms, interlocks and failure modes

• Pressure and airflow alarms at the correct setpoints, with audible and visual signals inside and outside.
• Door interlocks prevent opening both doors of an airlock at the same time; emergency override works and is alarmed.
• Supply fan failure, exhaust fan failure, power failure and control system failure each tested: the laboratory must not become positive to surrounding areas and air must not reverse through doors.
• Switch-over to standby fans and emergency power tested, and the recovery to normal pressures recorded.
• Start-up and shutdown sequences tested so that pressure reversal does not happen when the system starts or stops.

4. Exhaust filtration

• Exhaust HEPA filters leak tested in place by scanning or the method the housing allows — see HEPA filter in-situ leak testing.
• Housings can be isolated and decontaminated before filter change; bag-in/bag-out or in-situ decontamination provisions work.
• Isolation dampers close tightly and are accessible for maintenance.

5. Primary containment equipment

• Biosafety cabinets certified after installation, in their final position, with the room HVAC running — inflow, downflow, filter integrity and airflow pattern.
• Cabinet exhaust connections (if ducted) balanced and alarmed.
• Centrifuges with sealed rotors or safety cups, and other containment devices, checked.

6. Waste and transfer

• Autoclave or other waste decontamination validated with the loads it will process, including biological indicators.
• Double-door autoclave and pass box interlocks work; seals at the barrier wall tested.
• Liquid effluent treatment, where the risk assessment requires it, validated.

7. Personnel areas and services

• Changing sequence, hand-wash and, where required, exit showers working as designed.
• Communication between the laboratory and outside, and emergency lighting.
• Utilities protected against backflow: vacuum lines with filters, water with backflow prevention.

8. Decontamination

• Room gaseous decontamination validated with biological indicators at worst-case locations, including inside equipment left in the room.
• Residual decontaminant measured before re-entry.
• Procedure, sealing points and safety controls documented — see preparing a room for VHP decontamination.

Evidence to keep

• Test protocols with acceptance criteria approved before testing.
• Raw data, instrument calibration certificates and tester qualifications.
• Deviations, corrective actions and retests.
• As-built drawings, control setpoints and alarm lists.
• A summary report that becomes the baseline for annual or periodic recertification.

Recertification

Most standards require the critical tests — airflow, pressures, alarms, failure modes, HEPA integrity and biosafety cabinet certification — to be repeated at least annually and after modifications. Keep the commissioning results as the reference so that drift can be seen.