PHYSICAL CONTAINMENT LEVEL 2 (PC2) REQUIREMENTS
PC2 Certification is suitable for work with microorganisms which may cause animal, plant or human disease of moderate intensity i.e. Risk
Group 2 agents or biological material reasonably expected to contain these. Induction and ongoing training must be provided so that
laboratory personnel understand the work practices required to manage these risks. Work with microorganisms transmissible by the
respiratory route or that may produce infectious aerosols must be performed in a Biological Safety Cabinet.
PHYSICAL LAB REQUIREMENTS 1-19
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The laboratory must be an enclosed space (bounded by walls, floors, ceilings, windows and doors), devoid of gaps or openings to
exclude pests. Windows must be closed and sealed; doors must be closed while work is in progress.
Access doors must display signage showing the biohazard symbol, the level of containment and stating that entry is restricted to
authorised personnel only (as issued by the Office for Research Ethics and Integrity).
Equipment such as fridges used to store biological materials that are located outside the laboratory must display the biohazard
symbol.
Long term write-up areas (offices) must not be provided within the facility boundary.
There must be directional air flow into the laboratory and air shall not be recirculated to areas outside the PC2 area. Ventilated air
must not be directed towards doors or Biological Safety Cabinets.
Gas and water supplies must comply with backflow prevention requirements where practicable. For older laboratories this must be
managed through the absence of tubing and other equipment hanging into sinks due to contamination risk to water supply.
Floors must be smooth and slip resistant and coved to walls or exposed plinths. All surfaces and furniture must be easy to clean, have
impermeable surfaces and be resistant to the disinfectants used in the laboratory.
The floor under benches must be easily accessible for cleaning (absorbent material such as cardboard must not be stored directly on
the floor).
A dedicated hands free hand basin or alternative means of decontaminating hands (e.g. waterless disinfectant) must be provided near
the exit.
An eyewash station must be fitted or single-use, fresh eye irrigation fluids made available.
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Hooks for laboratory gowns must be provided within the laboratory near the exit and storage for outer garments and personal items
must be provided outside the laboratory.
Storage space (shelving) must be provided for reference documents, books and paperwork (other than worksheets) separate from the
workbench.
Spill kits and disinfectant appropriate for the agents in use in the facility must be available. Disinfectants must be clearly labelled with
contents, concentration, expiry or preparation date.
Suitable labelled containers including rigid sharps containers must be provided for collection of biological waste and must be safely
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stored until they are removed for disposal. Rubbish bins for non-hazardous waste to be handled by cleaners must be clearly
identifiable.
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Contaminated or potentially contaminated waste must be decontaminated by one or more of the following methods: chemical
disinfection, pressure steam sterilisation or incineration (EPA-approved incineration facility).
Where an autoclave is used onsite for the sterilisation of infectious waste: each load should be verified, monthly testing with
biological indicators (spore or enzyme testing) and recertification must be performed at least annually.
Personal protective clothing and equipment (PPE) such as laboratory gowns, safety glasses, gloves, face shields and other relevant
protective equipment must be available for laboratory personnel and visitors.
Pipetting devices must be provided.
A certified Biological Safety Cabinet must be available for aerosol-producing procedures with Risk Group 2 agents (or laminar flow
cytotoxic drug safety cabinet if working with prions) and biocontained centrifuges must have sealed rotor or bucket lids.
WORK PRACTICES/BEHAVIOURS 20-32
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Closed footwear and gowns (preferably long sleeved, back opening) that afford protection to the front part of the body must be worn
in the laboratory. Eye protection must be worn unless a documented risk assessment can justify a lesser requirement.
Gloves must be worn when working in a Biological Safety Cabinet and when handling potentially hazardous biological materials.
Additional PPE such as face shields and respiratory protection must be worn as determined by risk assessment.
Work with specimens containing microorganisms transmissible by the respiratory route or procedures that pose a significant risk from
aerosol production (e.g. shaking, mixing, sonicating) must be performed in a Biological Safety Cabinet.
Respiratory protective equipment must be worn when carrying out hazardous procedures outside a biological safety cabinet, such as
performing a spill clean-up involving a respiratory pathogen.
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Food, drink and personal items must not be bought into or stored in the laboratory. Eating, mouth pipetting, drinking, shaving,
smoking and applying cosmetics are prohibited in the laboratory. Long hair must be tied back.
Cultures of microorganisms must be clearly labelled (contents, owner, date etc) and stored off the bench in a dedicated area. The
production of aerosols should be minimised where possible (pipetting technique, wire loop flaming etc).
Transport of microorganisms outside the laboratory (including transport of waste for disposal) must occur within a second
unbreakable closed container, which can be readily decontaminated.
The use of sharps must be minimised (glassware should be replaced with plasticware whenever possible) and must be disposed of in
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suitable rigid walled containers. Needles must not be recapped or removed before disposal unless utilising special equipment to do
this.
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Benches must not be cluttered and must be decontaminated after work is completed and at least daily.
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Door handles, equipment, keyboards, telephones and writing material must be regularly decontaminated.
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Potentially contaminated reusable lab-ware must be decontaminated or disinfected prior to washing and re-use.
Laboratory personnel must advise maintenance and service personnel of biohazards in the laboratory. All equipment (also keyboards
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sitting on work benches) and adjacent surfaces must be decontaminated prior to maintenance or removal. Visitors must be supervised
at all times.
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PPE must be removed and hands decontaminated in a predetermined appropriate order before leaving the laboratory. (Removal of
gloves, hand decontamination, removal of eye-protection and gown, followed by second hand decontamination).
ADMINISTRATIVE REQUIREMENTS 33-37
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Documented identification of laboratory specific hazards, risk assessments and control measures used, must be in place and updated
when new methods are introduced or the function of the laboratory changes.
Documented procedures for transport, spill response and disposal of potentially contaminated biological material must be in place.
Training records against relevant Standard Operating Procedures (SOP) including control measures such as spill procedures must be
maintained for all personnel authorised to work in the laboratory.
Induction must include the training of laboratory personnel in the safe handling and disposal of potentially infectious material and
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specifically on the infectious microorganisms worked with in the area. Supervision by experienced staff must be provided until
demonstrated competence has been achieved. Training must be reviewed at least annually or when new information is obtained.
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A pest control program must be instituted.
Advisory note regarding PC3 certification:
Work with microorganisms which may result in serious infection of animals, plants or humans i.e. Risk Group 3 agents must be performed in a
certified laboratory. Specialist advice is needed for the additional building features, services and equipment required to minimise the risk of
infection to individuals, the community and the environment. Please contact the Office for Research Ethics and Integrity as soon as practicable
if considering high level physical containment to allow sufficient time for consultation and planning.