Form C-CL3

• Provide name, title, email address, fax and phone numbers of a key contact for inquiries regarding the submission contents.
• Provide current contact information for the institute director, principal investigator (lab supervisor), facilities manager, and biosafety officer.

• A statement is required that there have been no changes to the program.
• Provide an updated list of animal pathogens manipulated and/or stored in the facility.
• Provide an updated list of animal species manipulated in the facility.
• A program change request must be submitted to this office before any new pathogen is introduced in the facility.
• If there are new procedures in use, please submit the appropriate safety and operational SOPs.

• For each required test or verification, describe the test procedure, acceptance criteria, observations, results, pass/fail decision, names, dates, signatures, witnesses and corrective measures required. Testing must be performed during the last 12 months.

• Visually and with a smoke pencil, or other visual aid, confirm the integrity of all penetrations and seals on the containment perimeter (include service penetrations, and seals around doors, windows, autoclaves and dunk tanks ).
• Visually inspect floors, walls, and ceiling for cracks, chips or wear, and verify integrity of wall/floor and wall/ceiling joints.
• List all defects, corrective measures and re-test results (if applicable)

• List by room, either in a table or schematic or by elevation (floors, walls, ceiling) of the facility.
• All joints should be periodically checked by smoke pencil or other visual aid.
• Certain small and large animal facilities may require pressure decay of the room. Please contact the Office of Biohazard Containment and Safety, Canadian Food Inspection Agency (CFIA) for details.

• Provide a list and a statement as to how they were verified as operational (phone, intercom, radio, video, etc).

• Communication should be maintained with minimum interruption during power outage.

• Indicate combination of doors which are interlocked (e.g. door A with door B, door B with door A and C).
• Verify the operation of interlocked doors to ensure that doors cannot be opened simultaneously.
• Verify that emergency egress overrides the interlocks.
• For facilities that do not have physically-interlocked doors, please confirm that procedures are in place to ensure that no critical combinations of doors can be opened simultaneously.

• Provide a plan of the facility and surroundings with clearly labelled doors (i.e. each individual door is uniquely identified).

• List access control and security devices (e.g. key, proximity card, keypad, biometric reader) on all entry points to the CL3 (change rooms, anterooms, pass through, etc).
• Provide verification that they operate as intended.
• If there is a door on the containment perimeter (e.g. equipment door, emergency exit), please indicate if that door is sealed and how access is controlled.

• Verify that a correct code/card works and also that an incorrect code/card will not work.

• Inward directional airflow to be visually demonstrated at all critical doors (e.g. by holding a smoke pencil, or other visual aid, at each door leading to adjacent area).
• Include a labeled floor plan (e.g. letter/legal sized format) with arrows indicating the directional airflow for each door tested.

• Air must flow towards areas of higher containment.

• Autoclaves to be verified for operation as specified and to be microbiologically tested using representative loads.
  • Include the time/temperature criteria required for your specific agent/waste.
  • Include a description of the different types of loads to be run and a short description of the load test procedure (e.g. laundry, solid waste, liquid waste, etc).
  • Include a time/temp chart and biological indicator test results for each load test performed. Positive control results must be included (from the same lot#).
• Provide verification that interlocking doors or visual/audible alarms are functioning as intended.
• All disinfection systems (e.g. dunk tanks, fumigation chambers, etc) to be verified to operate as intended and microbiologically tested using representative loads.

• Generally, for technologies based on heat, Geobacillus stearothermophilus spores are adequate and, for technologies based on chemicals, Bacillus subtilis spores are used.
• Resistance of test organism must be representative of organisms likely to be encountered.

• Provide a list of all backflow preventers associated with the lab (including type, general location, and purpose).
• Water supply backflow preventers must be tested in accordance with CAN/CSA -B64.10-07/B64.10.1-07: Manual for the Selection and Installation of Backflow Prevention Devices/Manual for the Maintenance and Field Testing of Backflow Prevention Devices (2007).
  • Provide backflow preventers test certificates.
  • Provide name and certification number of the tester
• Back flow prevention for other services (e.g. gases) to be verified to ensure that the system will operate as specified.

• This helps ensure all backflow preventers are accounted for.

• Provide a load test report.
• Verify that all critical systems are on emergency power (including but not limited to controls, fans, security, critical equipment, phones, effluent treatment, etc).
• Previous monthly test report is acceptable.

• Load testing results should verify that the generator can pick up and carry the load if required. When live load testing is not possible, simulated load testing is acceptable.

* for laboratories handling non-indigenous animal pathogens and/or certain parasites; and

* for animal housing rooms where the room is the primary containment barrier

• The system and run criteria are to be validated by microbiological challenge. Ideally, the methodology should be discussed with the Office of Biohazard Containment and Safety , CFIA.
  • Briefly describe the run criteria for the specific agent/waste in use.
  • Describe the microbiological challenge and verification procedures.
  • Provide trending charts, test reports, digital printouts and other data as pertinent.

• Complete this section if facility has a biowaste system, even if not working with non-indigenous animal pathogens.

• Provide a list of all BSCs associated with the lab plus the test certificate for each.
• Each BSC test certificate must contain the following information:
  • type of cabinet and type of exhaust connection (hard, thimble);
  • standard to which the cabinet was tested and the qualifications of the tester;
  • statement as to whether the HEPA filter was scanned or probed, and the pass/ fail criteria;
  • when a unit cannot be tested to NSF 49, it must be tested to manufacturer's specification; the particle penetration given as a percentage of the upstream challenge must be provided;
  • indication of any repairs to HEPA filter(s) and subsequent retest results;
  • downflow and inflow (exhaust) measurements and acceptable ranges specific for the model;
  • alarm test results - airflow tests, failure alarm test; and
  • test of airflow patterns within the cabinet.
• Class III BSC to be tested in accordance with BS EN 12469:2000: Biotechnology- Performance criteria for microbiological safety cabinets (2000); British Standards Institute, and Laboratory Safety Monograph: A Supplement to NIH Guidelines for Recombinant DNA Research (1979); National Cancer Institute Office of Research Safety and the Special Committee of Safety and Health Experts. Acceptance criteria: measured leakage from any point in the cabinet shall not exceed a leak rate of 10 X 107 cc/sec at 750 Pa (3 inches w.g.).
• Provide the calibration certificates for the equipment used for the verification (must be valid on date of test).

• This helps ensure all BSCs are accounted for.
• Class II B2 Puff back: the time from the moment of alarm detection of  failure to the moment of air reflux from the cabinet should be known. If not carried out when installed, testing and adjustment of the cabinet alarm should be done as to give the earliest warning possible to the user and maximize the amount of time before the puff back occurs.

 * Although this may not be a requirement for laboratories handling pathogens not transmitted via inhalation, if the system is in place, then testing should occur.

• Provide a list of all the HEPAs  associated with the lab plus the test certificate for each.
• Each HEPA filter is to be tested in situ  by particle challenge testing using the scanning method according to IEST-RP-CC-001.5, HEPA and ULPA Filters (2009); Institute of Environmental Sciences and Testing.
• Each HEPA filter test certificate must contain the following information:
  • statement confirming scan testing;
  • particle penetration for scan testing, given as a percentage of the upstream challenge concentration, not to exceed 0.01%; or particle penetration for probe testing, given as a percentage of the upstream challenge concentration, not to exceed 0.005%; and
  • indication of any repairs and retest results.
• Provide the calibration certificates for the equipment used for the verification (must be valid on date of test).
• Provide results of verification for small in-line filters (e.g. installed in mag gauge lines) or confirmation of scheduled maintenance/replacement.

• This helps ensure all HEPAs are accounted for.
• Small in-line filters do not need to be in-situ scan tested - a maintenance program to include visual inspection and regular replacement is adequate.
• When scan testing is not possible provide reason for probe testing.
• Particle penetration for probe testing, given as a percentage of the up stream challenge concentration not to exceed 0.005%.

 * Although this may not be a requirement for laboratories handling pathogens not transmitted via inhalation, if the system is in place, then testing should occur.

• The annual integrity testing  is not required if no physical modifications have been made to the HEPA filter housings. A statement confirming that no changes have been made is required.
• If modifications have been performed then consult this office to determine if testing is required.
• If testing is required, the test requirements are as follows: integrity of HEPA filter housings, with inlet and outlet bubble tight dampers installed into supply and exhaust ductwork, to be tested in-situ by pressure decay testing in accordance with ASME N510-1989: Testing of Nuclear AirTreatment Systems (1989-reaffirmed 1995). Acceptance criteria: rate of leakage not to exceed 0.1% of vol/min at 1000 Pa (4 inches w.g.) minimum test pressure.

• Changes include: holes/cuts in the housing, probes/pieces/equipment removed from the housing, additions, joints, repairs, etc
• The engineer shall provide the test pressure to be used (which is the system's maximum operating pressure) in accordance with ASME N509-2002: Nuclear Power Plant Air-Cleaning Units and Components (2002) - minimum test pressure 1000 Pa (4 inches w.g.).

* Although this may not be a requirement for laboratories handling pathogens not transmitted via inhalation, if the system is in place, then testing should occur.

• Annual pressure decay testing is not required if no physical modifications have been made to the ductwork. A statement confirming that no changes have been made is required.
• If any changes have been performed then consult this office to determine if testing is required.
• If testing is required, the test requirements are as follows: supply duct work, where backdraft protection is required on supply, and exhaust air ductwork located between containment perimeter and HEPA filter or bubble tight backdraft damper to be constructed in accordance with HVAC Air Duct Leakage Test Manual (1985); Sheet Metal and Air Conditioning Contractors National Association, Inc.
• To be tested in-situ by pressure decay method in accordance with ASME N510: Testing of Nuclear Air-Treatment Systems (1989- reaffirmed 1995). Acceptance criteria: rate of leakage not to exceed 0.1% of vol/min at 1000 Pa (4 inches w.g.) minimum test pressure.

• Changes include: holes/cuts in the ductwork, probes/pieces/equipment removed from the duct work, additions, repairs, etc
• The engineer shall provide the test pressure to be used (which is the system's maximum operating pressure) in accordance with ASME N509-2002: Nuclear Power Plant Air-Cleaning Units and Components (2002) - minimum test pressure 1000 Pa (4 inches w.g.).

• The annual testing of control systems is not required if no changes have been made to the system hardware or logic and if no HVAC failures or other problems have been encountered. A statement to this effect is required.
• If modifications have been performed, or if control system problems/failures have been encountered, then consult this office to determine if, and what, failure testing is required (note: this may necessitate the need for decontamination of the facility).
• If verification is required, test requirements are as follows: control systems to be tested for fail-safe operation by failure of system components (i.e. fan failure, electrical failure, BSC failure). This is to include audible alarms testing for detection of reversal of airflow across the containment barrier and air handling systems failure by simulation of alarm conditions.
• Submit control sequence of operation.

• Changes include: hardware or software changes, etc
• Failures to be reported include, but not limited to: frequent activation of the fail-safe mode, failure of the fail-safe mode to activate as expected, and positive pressurization of the containment area.