Containment Standards for Facilities Handling Aquatic Animal Pathogens - First Edition
Chapter 3 - Physical Requirements for Aquatic Containment Facilities
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This section describes the physical requirements for the containment of aquatic animal pathogens. When working with various aquatic animal pathogens, the facility must be capable of containing the pathogen(s) requiring the highest level of containment. New facilities must be constructed to meet applicable building codes and other relevant legislated or regulatory requirements.
In addition to the requirements and recommendations set out in this chapter, the design of the live animal holding facility must also comply with and meet the physiological, husbandry and welfare requirements for the animal species under investigation as specified by the Canadian Council on Animal Care (CCAC)Footnote 6
3.1 Primary Containment
Primary containment devices, such as BSCs and centrifuges with sealed rotors, are used in conjunction with good microbiological techniques to reduce or eliminate potential exposure to infectious agents within a containment zone. In a live aquatic animal holding facility, the primary containment devices are the live animal holding tanks or possibly the tank room.
3.2 Secondary Containment
The design of the entire facility, along with operational practices,provides secondary containment to prevent or reduce potentialexposure outside the containment zone. The selection, design and installationof casework, surface finishes, and air handling systems, along with the use ofappropriate sealants, are factors that determine how well a facility cancontain aquatic animal pathogens. Dedicated and trained staff who followdocumented procedures and effectively utilize primary containment devices arean essential complement to proper facility design and construction.
3.3 Risk Mitigation
Where feasible, risk mitigation measures should be applied within containment facilities, to further reduce the risk of aquatic animal pathogen release and thereby effectively reduce the physical containment requirements needed for a particular pathogen. These measures may include providing adequate separation between infected and non-infected aquatic animals, and rendering all infectious material non-viable at the end of experiments. Risks from aquatic animal pathogens can also be mitigated by locating new containment facilities in areas where susceptible aquatic species are not present.
3.4 Design Considerations for New Facilities
Facility design needs to address issues specific to aquatic animal pathogens in order to enhance the overall performance and operation of a containment laboratory or live aquatic animal holding facility. Designers, owners and operators should consider:
- Facility location - The site selection process for a containment facility should include an assessment of local aquatic programs as well as the local environment. The risks to aquaculture and the environment, including the impact of possible pathogen releases, should be considered before any work is begun with a particular aquatic animal pathogen. In areas prone to natural disasters, buildings and support systems for containment facilities should meet more stringent building code requirements.
- Energy conservation - If energy conservation measures are envisaged (e.g., through the use of building automation controls, night air-change set-back (reductions), heat recovery and air recirculation), these measures must not compromise the level of containment provided by the facility.
- Containment facilities require frequent wash downs of surfaces and these surfaces need to be resistant to chemical attack, absorption, and the effects of salt water in some cases. The use of epoxy bench-top surfaces or other non-absorbent solid surfaces is required.
- To facilitate decontamination and maintenance, systems such as liquid effluent treatment systems and HEPA filter housings must be located as close to the containment perimeter as possible, and consideration must be given to installing valves to isolate sections of plumbing and ductwork. Appropriately sized screens or filters may be used to collect some of the sediment and organic material before it enters the liquid effluent treatment system.
- New facilities require storage space for supporting operations, cleaning equipment, spill management, emergency safety response tools and equipment. The provision of dedicated equipment, storage areas and paperwork workstations inside the containment zone should be considered to minimize traffic into and out of the containment facility.
- Air handling systems should be designed to accommodate the additional moisture that is generated in live aquatic animal holding facilities and that auxiliary localized dehumidifiers may be required.
- Inward directional airflow – Some standards (i.e., ANSI/AIHA Z-9.5-2003) recommend or require the use of inward directional airflow for new laboratory construction. Although it is advisable for all new and existing facilities to have inward directional airflow, this is a requirement for AQC2 in vivo and AQC3 facilities but only a recommendation for AQC2 in vitro facilities.
- Circuit breakers and shut-off valves should be located outside the containment perimeter to facilitate maintenance.
- Liquid effluent treatment systems must be designed with convenient sampling ports allowing for the collection of samples of treated effluent to monitor decontamination efficacy.
- Animal delivery systems must be taken into consideration to ensure proper containment in the live animal holding facilities and disinfection of the transport mechanism (i.e., container or vehicle) used.
3.5 Physical Containment Requirements
The following tables describe the physical containment requirements for AQC2 and AQC3 in vitro and in vivo (also called live animal holding) facilities and large scale facilities.
The following symbols are used:
Required
Recommended
The absence of a symbol in the tables indicates that an item is either not required or not applicable. Where or are followed by the suffix "LS", the item applies only to large scale facilities. Where the suffix "LS" is not present, the item applies to all facilities (live animal holding, in vitro, and large scale facilities). In the instances where the item does not apply to an in vitro facility, this will be specified in the text.
3.5.1 Structure, Location and Access
3.5.1 | Structure, Location and Access | AQC2 | AQC3 |
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1 | Containment zone to be separated from public areas and offices by lockable doors. | ||
2 | Dedicated paperwork stations within the containment zone to be located away from aquatic animal holding areas. | ||
3 | Support facilities for waste disposal, feed, storage, aquatic animal handling, equipment cleaning, and outer garment storage (boots, accessories, etc.) to be located within the containment zone. | ||
4 | A dedicated area or necropsy room for experimental activities such as animal necropsy, tissue manipulations and surgical preparation to be provided within the containment zone. [Not required for in vitro work.] |
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5 | Access limited to authorized personnel. | ||
6 | Restricted access to the containment zone is to be ensured through a controlled access system (e.g., electronic access card, code or equivalent). | ||
7 | Signage to be installed on entry doors to the containment zone indicating containment level, contact information, and entry requirements. | ||
8 | Entry to containment zone to be provided via an anteroom. [Not required for AQC2 in vitro work.] |
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9 | Anteroom doors not to be opened simultaneously (interlocking doors, audible or visual alarms, or protocols are acceptable). | ||
10 | Interlocked doors, if present, to have manual overrides for emergency exit. | ||
11 | Entry to containment zone must have clothing change area designed to separate personal clothing from dedicated facility clothing for the zone (i.e., "clean" change area separated from "dirty" change area) in keeping with specific Personal Protective Equipment (PPE) requirements. | ||
12 | Exit from facility should be provided with a walk-through shower on the containment barrier (i.e., between "clean" and "dirty" change rooms). | ||
13 | Size of door openings designed to allow passage of all anticipated equipment. | ||
14 | Live aquatic animal entry to the holding facility to be provided in a manner that prevents breach of containment. [Not required for in vitro work.] |
3.5.2 Surface Finishes and Casework
3.5.2 | Surface (i.e., floors, walls, ceilings, sealants) Finishes and Casework | AQC2 | AQC3 |
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1 | Doors, frames, casework and bench-tops and all material supporting animal holding units (i.e., tanks and equivalent structures) to be non-absorbent (wood surfaces are not permitted). | ||
2 | Surfaces to be scratch, stain, moisture, chemical and heat resistant in accordance with facility function. | ||
3 | Surfaces to provide impact resistance in accordance with facility function. [Only a recommendation for AQC2 in vitro work.] |
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4 | Surfaces to be continuous and compatible with adjacent and overlapping materials (i.e., to maintain adhesion and a continuous perimeter). [Only a recommendation for AQC2 in vitro work.] |
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5 | Interior coatings to be cleanable and resistant to chemicals, as well as to repeated disinfection in accordance with function (e.g., will withstand disinfection or fumigation). | ||
6 | Continuity of seal to be maintained between the floor and wall (a continuous cove floor finish up the wall is recommended). [Only a recommendation for AQC2 in vitro work.] |
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7 | Floors to be slip-resistant. | ||
8 | Bench-tops designed to contain spills of materials (e.g., with marine edges and drip stops, trays or other equivalent strategy). [Only a recommendation for AQC3 in vitro work.] |
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9 | Backsplashes, if installed tight to wall, to be sealed at wall-bench junction. [Only a recommendation for AQC2 in vitro work.] |
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10 | All animal holding units to be provided with covers or equivalent strategies to prevent splashing transfer between tanks and reduce room humidity. |
3.5.3 Containment Perimeter
3.5.3 | Containment Perimeter | AQC2 | AQC3 |
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1 | Autoclave or other validated and acceptable means of waste decontamination to be located within the containment zone. If not available in the containment zone, then strict waste control procedures must be implemented for the transport of waste in leak-proof and impact-resistant containers to a suitable autoclave within the facility or off site to a certified waste disposal facility. | ||
2 | Dedicated double-door barrier autoclave is to be located on the containment perimeter; equipped with interlocking doors (recommended) or audible or visual alarms, to prevent the simultaneous opening of both doors. Body of autoclave should be located outside the containment zone for ease of maintenance. | ||
3 | Autoclave condensate drain to have a closed connection; an open connection is allowable if located within the containment barrier. | ||
4 | Autoclave to be equipped with a cycle log recorder to record time, temperature, and pressure. | ||
5 | Waste decontamination processes (heat, chemical, etc.) must be equipped with an appropriate monitoring and recording system in order to capture critical operational parameters such as date, cycle number, time, temperature, chemical concentration and pressure. | ||
6 | Water decontamination processes (chlorine, ultra violet, heat, ozone injection, etc.) must be equipped with a monitoring and log recording system to record critical operational parameters. [Not applicable to in vitro work.] |
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7 | Dedicated equipment for euthanasia to be provided within the containment zone. [Not applicable to in vitro work.] |
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8 | Containment zone to be proofed against entry or exit of vermin and insects. | ||
9 | Within each separate live animal holding room, a combination of sealed surfaces and appropriate drainage must be provided to retain the largest single volume of contaminated liquids present within the containment zone. [Not applicable to in vitro work.] |
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10 | All penetrations of the containment perimeter, including all conduits and wiring, to be sealed with non-shrinking sealant. [Not required for AQC2 in vitro work.] |
3.5.4 Heating, Ventilation and Air Conditioning (HVAC)
Processes carried out in laboratories and live aquatic animal holding facilities may increase the risk of aerosol transmission of aquatic animal pathogens. This risk can be mitigated through the use of BSCs and through the provision of inward directional airflow. There are standards that recommend or require the use of inward directional airflow for new laboratory constructions. Other reasons for maintaining inward directional airflow include control of odours from animals, proper ventilation for chemical use (e.g., during decontamination), humidity control, compliance with CCAC requirements, and prevention of cross-contamination.
3.5.4 | Heating, Ventilation and Air Conditioning (HVAC) | AQC2 | AQC3 |
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1 | Provide appropriate ventilation for use of chemicals (e.g., during large vessel decontamination). | ||
2 | Inward directional airflow to be provided at the containment perimeter such that air will flow towards area of higher containment. [Only a recommendation for AQC2 in vitro work.] |
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3 | Visual pressure differential monitoring devices to be provided at entry to containment area. | LS | |
4 | Alarm (visual or audible) to be provided within the containment area and outside the containment area (i.e., to warn others and maintenance personnel) to signal air handling systems failure. | LS | |
5 | Supply air system to be interlocked (i.e., fans, dampers, electrical) with exhaust air system, to prevent sustained laboratory positive pressurization. | LS |
The requirements for air quality, supply and exhaust air, and air recirculation within a containment zone for a veterinary biologics manufacturing and testing facility depend on the specific pathogen(s), procedures performed, and design and construction of the facility. Therefore, HVAC requirements for veterinary biologics manufacturing and testing facilities will be determined on a case-by-case basis. Some of these requirements include HEPA filtration of supply and exhaust air as well as sealed and dedicated supply and exhaust ductwork. For more details on these requirements, VBS must be contacted.
3.5.5 Facility Services
Facility services include all plumbing, electrical, gas, oil and safety equipment, etc., related to the operation of the facility. All such systems must be installed in a manner that does not compromise the containment required for the aquatic animal pathogens to be handled in the facility.
3.5.5 | Facility Services | AQC2 | AQC3 |
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1 | Hooks or lockers to be provided for clothing and personal protective equipment at facility entry/exit; street and facility clothing areas must remain separated. | ||
2 | Hand washing sinks to be located near the point of exit (either near the exit from the facility and/or on the dirty side of the anteroom). | ||
3 | Hand washing sinks to be provided with "hands free" capability. | ||
4 | Foot bath to be provided on the dirty side of the anteroom. [Not required for in vitro work.] |
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5 | Appropriate primary containment devices to be available (e.g., BSCs), as required, to minimize potential contamination of the containment zone. | ||
6 | Class I and II BSCs to be tested in situ in accordance with NSF/ANSI 49-2008. | ||
7 | Emergency eyewash facilities to be provided in the containment zone in accordance with facility activities and applicable regulations (i.e. ANSI Z358.1-2004). | ||
8 | Emergency shower equipment to be provided in the containment zone in accordance with facility activities and applicable regulations (i.e., ANSI Z358.1-2004). | ||
9 | Communication system to be provided between laboratories and/or live animal holding facility zones and outside containment zone. [Not required for AQC2 in vitro work.] |
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10 | Systems (e.g., fax, computer) to electronically transfer information and data to be provided (note: paperwork may be removed from the live animal holding zone after decontamination). | ||
11 | Water quality monitoring equipment (such as pH meters and temperature controls) to be located outside the containment zone or be subject to decontamination prior to removal from containment zone. | ||
12 | Water supply services to be provided with backflow prevention in accordance with CAN/CSA-B64.10-07/B64.10-07, and isolation valve to be located in close proximity to the containment perimeter. [Not required for AQC2 in vitro work.] |
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13 | Drains and associated piping to be separated from zones of lower levels of containment. [Not required for AQC2 in vitro work.] |
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14 | Drainage traps to be provided to required deep seal depth in accordance with air pressure differentials. | ||
15 | A backup system to be provided to supply air or oxygen to animals inside the facility in case of power supply failure. [Not applicable to in vitro facilities.] |
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16 | Electrical outlets to be installed well above floor level, sealed to be water tight, and covered. [Not required for in vitro work.] |
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17 | Power system circuit breakers to be located outside containment perimeter. [Not required for AQC2 in vitro work.] |
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18 | Alarm system to be provided to indicate failures (excessive water levels, failure of backflows, etc.). [Not applicable to in vitro work.] |
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19 | Life-safety systems, lighting, BSCs and other critical equipment to be supported by emergency power. |
3.5.6 Liquid Effluent Treatment for Live Animal Holding Facilities
3.5.6 | Liquid Effluent Treatment | AQC2/AQC3 in vivo |
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1 | Drains from live animal holding tanks, sinks, sumps, showers, or drainage in contact with contaminated materials to be connected to an effluent treatment system. | |
2 | Drains and associated piping leading to liquid effluent treatment system (including associated vent lines) to be tested in accordance with the National Plumbing Code of Canada, section 3.6 (1995). | |
3 | Drains connected to effluent treatment systems to be sloped towards the decontamination system to ensure gravity flow; consideration should be given to installing valves to isolate sections for decontamination. | |
4 | The effluent treatment system (e.g., piping, valves, tank) to be heat and chemical resistant consistent with use. | |
5 | A backup effluent decontamination system or holding system must be in place to prevent discharge of untreated or partially treated effluent. | |
6 | Effluent treatment systems that are not completely closed and contained must be housed in a room designed to the same containment level as the highest level of containment of the laboratory being serviced. | |
7 | The following provisions apply to the room housing a completely closed and contained liquid effluent treatment system:
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8 | Alarm system to be provided to indicate failure of effluent treatment system. | |
9 | Exposed facility service piping with stand-offs to allow access for maintenance and cleaning. | |
10 | Water supply shut-off valves and other controls to be located outside the containment zone. | |
11 | Systems must be in place to ensure that in the event of effluent system failure, water supply lockout to tanks is activated before spill retention capacity is reached. | |
12 | All effluent drainage pipes must be labelled for ease of accurate identification. | |
13 | All effluent drainage pipes should be accessible for regular inspection for any leaks, repair and maintenance. | |
14 | The effluent system must be equipped with a sludge/sediment removal/collection system. |
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