Containment Standards for Facilities Handling Aquatic Animal Pathogens - First Edition
Chapter 6 - Facility Certification
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Where appropriate, CFIA inspectors will conduct site visits and certify that facilities comply with these standards, thereby ensuring that they are constructed and operated in a manner that adequately contains aquatic animal pathogens.
Facilities handling aquatic animal pathogens should refer to Chapters 3 and 4 of these standards to ensure that their physical containment and operational practices are adequate to contain the pathogens that will be handled. In order to receive a Permit to Import, AQC2 and AQC3 facilities must be certified by the CFIA. Facilities importing pathogens and planning work that requires AQC2 in vitro containment may be required to complete a detailed certification checklist, whereas AQC2 in vivo facilities may be inspected by the CFIA. Facilities importing pathogens and planning work that requires AQC3 will undergo an inspection by CFIA inspectors. If a facility is not granted certification or its certification is revoked for any reason, the deficiencies must be corrected before the facility can be certified or recertified.
The critical containment components to be verified during certification of AQC2 in vivo and AQC3 facilities are outlined in section 6.3. All of these components are to be verified as part of the commissioning process for a new facility (some may not apply to AQC2 in vivo). Certification and recertification records must be retained for three years and they must be available for review by a CFIA inspector, who may elect to re-verify some or all of the components. All as-built drawings and specifications of AQC2 in vivo and AQC3 facilities must be submitted for review. The Biosafety Manual must also be submitted for review before work can be carried out with aquatic pathogens at the facility to be certified. Personnel training must be completed and documented. Users must understand containment principles and proposed procedures.
Recertification of AQC2 in vivo and AQC3 facilities must be done annually. Before program changes are implemented, operational procedures must be submitted to the CFIA for review and approval. Program changes include those related to the nature of the work or the procedures employed that could increase the risk of pathogen release from the facility.
6.3 Verification and Performance Testing of AQC2 in vivo and AQC3 Facilities
6.3.1 Room Integrity
Room integrity must be verified visually for cracks and also with a smoke pencil, or other visual aid, to confirm the integrity of all penetrations and seals on the containment perimeter (includes service penetrations and seals around doors, windows, autoclaves and dunk tanks). Floors, walls, and ceilings as well as wall/floor and wall/ceiling joints must be visually inspected for cracks, chips or wear.
6.3.2 Communication Devices
Communication and electronic data transfer systems (e.g., computer, telephone, facsimile) must be tested to ensure that they operate as specified. Communication should be maintained with minimum interruption during a power outage.
6.3.3 Door Interlocks
Interlocked doors and emergency overrides must be tested to ensure that doors cannot be opened simultaneously and that emergency egress overrides the interlocks.
6.3.4 Access Control and Security Devices
Access control and security devices (e.g., key, proximity card, keypad, biometric reader) on all entry points to the facility must be verified to ensure that they operate as intended.
6.3.5 Inward Directional Airflow
Inward directional airflow must be visually demonstrated at all critical doors (e.g., by holding a smoke pencil, or other visual aid, at each door leading to an adjacent area).
6.3.6 Autoclaves and Decontamination Systems
Autoclaves and other decontamination systems (dunk tanks, fumigation chambers, etc.) must be verified to ensure operation as specified and microbiologically tested using representative loads. A description of the different types of loads to be run and a short description of the load test procedure (laundry, solid waste, liquid waste, etc.) must be provided. Biological indicators or an internal load temperature probe must be used to confirm that treatment parameters have been achieved. References pertaining to the maintenance and efficacy of decontamination systems and disinfectants must be kept for three years.
6.3.7 Backflow Preventers
Water supply backflow preventers must be tested in accordance with CAN/CSA -B64.10-07/B64.10.1-07: Selection and Installation of Backflow Preventers/ Maintenance and Field Testing of Backflow Preventers (2007). Backflow prevention for other services (e.g., gases) must be verified to ensure that the system will operate as specified.
6.3.8 Emergency Generator
Emergency electrical generators must be tested under appropriate load conditions to ensure systems will operate as specified. Verification that all critical systems are on emergency power (including, but not limited to, controls, fans, security, critical equipment, phones, effluent treatment, etc.) must be provided.
6.3.9 Liquid Effluent Treatment
Effluent treatment systems must be verified for operation as specified and microbiologically tested using representative loads. A description of the different types of loads to be run and a short description of the load test procedure must be provided. The system and run criteria are to be validated by a microbiological challenge. Drains and associated piping leading to liquid effluent treatment systems (including associated vent lines) are to be tested in accordance with the National Plumbing Code of Canada, section 3.6 (1995).
6.3.10 Biological Safety Cabinets
Testing and certification of BSCs must be performed in accordance with NSF/ANSI 49-2008. Interlocks (i.e., Class II Type B2 BSC internal cabinet supply fan and exhaust fan) are to be tested in accordance with the applicable NSF standard.
6.3.11 Biosafety Manual
The Biosafety Manual, which may consist of a collection of SOPs, is a critical part of the certification documentation. SOPs must be updated on a regular basis and all changes must be submitted to the CFIA.
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