Containment requirements that must be met in order for a Physical Containment Level 3 (PC3) Animal Facility to be certified by the Gene Technology Regulator (the Regulator).
Section 90 of the Gene Technology Act 2000
These are the requirements for the certification of a PC3 Animal Facility issued under section 90 of the Gene Technology Act 2000 (the Act) and, as applicable, corresponding State legislation. These requirements apply to applications for certification of PC3 Animal Facilities received on or after the day on which these guidelines take effect.
To be granted certification, a facility must meet each of the requirements for certification of a PC3 Animal Facility, unless the facility receives a written exemption from meeting a particular requirement from the Regulator or a delegate of the Regulator. Additional conditions may also be imposed on the facility by the Regulator or a delegate of the Regulator.
Definitions and acronymsUnless defined otherwise in these requirements, words and phrases used in the requirements have the same meaning as in the Act and the Gene Technology Regulations 2001.
Words in the singular include the plural and words in the plural include the singular.
Where any word or phrase is given a defined meaning, any other part of speech or other grammatical form in respect of that word has a corresponding meaning.
Where a word in the text is bolded, it indicates that the word has been defined (see below).
|aerosol||Suspension in air of finely dispersed solids and liquids.|
|airlock||A separate, fully-enclosable space with two doors designed to limit pressure fluctuations during entry and exit. |
The airlock must remain a clean area. No dealings with GMOs are permitted in the airlock.
|autoclave||Pressure steam steriliser.|
|dealings or deal with||In relation to a GMO, means the following:
|decontamination||A physical or chemical process which removes, kills or renders non-viable the GMOs being dealt with in the facility, but does not necessarily result in sterility.|
|facility||The whole of the space that is to be certified by the Regulator to a specific level of containment. A certified facility comprises the work area (including the inner change room, where present) and the airlock.|
|GMO||Genetically Modified Organism.|
|HEPA filter||A High-Efficiency Particulate Air filter corresponding to one of the following two types:
|inner change room||A separate, fully-enclosable space within the facility used by authorised persons for donning facility clothing and PPE on entry and for removing it on exit.|
|micro-organism||An organism too small to be viewed by the unaided eye, including bacteria, fungi, viruses and some multicellular organisms. For the purposes of these guidelines, this definition includes viral vectors.|
|outer change room||Space used by authorised persons to remove personal clothing prior to entry and to don personal clothing on exit from airlock. The outer change room is not part of the certified space of the facility.|
|PC3||Physical Containment Level 3.|
|the Regulator||The Gene Technology Regulator.|
|work area||Any area inside a facility that is not performing the function of an airlock.|
Procedures on GMOs must only take place in the work area.
Facility construction and access requirements1. The facility must be a fully enclosable space, bounded by walls, doors, windows, floors and ceilings, which permits operation of the facility under negative pressure.
2. The facility must be constructed to enable gaseous decontamination of the whole facility to be achieved.
3. All facility penetrations must be fitted with seals to limit air leakage.
4. The facility boundaries (walls, windows, doors, floors, ceilings etc.) must be constructed to prevent the escape of the animals being contained and to prevent the incursion of pests.
5. Entry of authorised persons into the work area must be through an airlock. Airlock doors must be self-closing, fitted with seals at the top, bottom and both sides of the door, and contain a viewing panel. The outer airlock door must be lockable. Physical mechanisms (e.g. interlocking or alarm system) must be in place to ensure that only one door can be opened at any time.
NOTE: The use of interlocks requires the provision of manual overrides in case of emergencies.
NOTE: This may include the use of windows, viewing panels in doors, or video cameras.
8. The following surfaces in the facility must be smooth, impermeable to water, easily cleanable, and resistant to damage by the cleaning agents, chemical and gaseous decontaminants that will be used in the facility:
- walls, floors, doors, windows and benches;
- furniture, including seating; and
10. Any openings in the walls or ceiling, such as ventilation inlets and outlets, must be screened. The screens must be fixed and sealed against their mounting. The apertures of the screen must be sufficiently small as to prevent entry or exit of invertebrates or other animals.
NOTE: Where HEPA filters are external to the facility and connected to it by ducting then the screens should be mounted as close as practicable to the junction of the ducting with the facility boundary.
12. The facility must have two alternative, independent communication systems for contact between persons inside and outside the facility. Two-way communication must be able to be conducted on at least one system.
NOTE: Suitable alternative independent communication systems may include a normal telephone service and a dedicated mobile telephone that is kept charged and does not leave the facility. A networked computer can also be used provided it is connected to an attended location outside the PC3 facility.
Containment equipment requirements14. Animals in the facility must be housed in primary containment devices within the work area.
15. Primary containment devices for animals must be fitted with exhaust HEPA filters, either as individually ventilated cages (IVC) or within HEPA-filtered ventilated enclosures.
Exhaust systems on the primary containment devices must be sealed to prevent escape of GMOs. In normal operation, all exhaust air from the cages must be contained and filtered to a standard that is equivalent to HEPA filtration. Air must be drawn through the primary containment devices to remove aerosols.
On removal and in transit to a BSC or change station, the primary containment devices must maintain a seal integrity equal to HEPA filtration or 0.2µm membrane filtration. The arrangement of cage or enclosure HEPA-filtration must ensure that the work area is not exposed to GMOs during normal operation and routine maintenance of cages, racks or other equipment.
Safety mechanisms must be in place that prevent the primary containment devices and exhaust air paths from becoming positively pressured relative to the surrounding area in the event of failure of the exhaust fan. The system must also be alarmed to indicate when operational malfunctions occur.
16. The work area of the facility must contain a biological safety cabinet (BSC), or other aerosol containment equipment approved in writing by the Regulator (e.g. cage change stations), appropriate for the dealings which are to be undertaken in the facility. Installation, use, decontamination and testing of Class I and Class II BSC must be in accordance with the requirements of AS 2252.4.
Aerosol containment equipment must also be installed in accordance with the manufacturer’s instructions and the requirements of the relevant AS/NZS, where available. Such containment equipment must be tested, commissioned and results documented before use.
NOTES: The type of BSC or other aerosol containment equipment will need to accommodate the changing of animal cages, bedding, feed and water without compromising containment of GMOs.
Laboratory services and equipment requirements17. The facility must contain an autoclave that is suitable for the load size and type of material to be decontaminated. The autoclave must not be located in the airlock.
NOTES: The autoclave should preferably be of double-ended type with interlocked doors, with the inner door opening into the facility and the outer door opening externally to the facility.
18. The following water supplied to the facility must be protected against backflow by registered testable devices that have a high hazard rating for protection against both back-pressure and back-siphonage in accordance with the requirements of AS/NZS 3500.1:
- laboratory sink outlets;
- outlets within a class II BSC; and
- direct connection to an autoclave.
19. The work area of the facility must contain either a dedicated hand wash basin fitted with tap(s) of the hands-free operation type and supplied with potable water, or some other means of decontaminating hands at or near the exit of the work area. If the facility contains multiple work areas, each work area must contain a dedicated hand wash basin or some other means of decontaminating hands, at or near the exit of that work area.
NOTE: Alternatives to wash basins, such as dispensers filled with decontaminant solutions are considered suitable, provided the decontaminant solution is appropriate for the organisms being used in the facility.
NOTE: AS/NZS 2982 provides information on eyewash equipment. If the facility contains multiple work areas, consideration should be given to providing eyewash equipment in each work area.
NOTE: Unused vacuum points do not require liquid traps provided they are closed with tamper-proof fittings that prevent accidental use.
NOTE: A filter with pore size of less than or equal to 0.2 Ám is appropriate.
Ventilation requirements23. The facility must have a ventilation system that establishes a negative air pressure gradient in the facility and directional airflow into a work area. All exhaust air from the facility must be filtered. Where facilities have a supply air system, the supply and exhaust air systems must be interlocked to prevent positive pressurisation of the facility in the event of failure of the exhaust system.
NOTES: Failure of a single component, such as an exhaust fan or a supply fan, can result in extremely high positive or negative pressures in the facility. Alarms and failure mode operations of ventilation systems must address this risk to ensure that interlocks operate rapidly to stop systems.
An automatic changeover emergency power source, emergency lighting and communication systems should be considered. The emergency power source should be adequate to operate the ventilation systems, primary containment equipment, and facility access.
Ventilation equipment should be located to ensure a flow of incoming air from the vicinity of the entry door towards the highest risk microbiological work areas.
Ventilation inlets and outlets should be located to minimise the disturbance to the operation of any Class I and Class II BSC installed.
24. The work area must be maintained at an air pressure of at least 50 Pa below the pressure of adjacent areas outside the facility when both doors of the airlock are closed. When either door is open, the work area pressure must remain at least 25 Pa below that of the adjacent areas outside of the PC3 containment barrier.
NOTE: The facility ventilation system should be able to accommodate fluctuations due to wind and other building ventilation systems in maintaining the facility pressure gradient.
NOTE: A variable speed drive on the exhaust fan is preferred to facilitate room pressure control adjustments.
27. The facility must be equipped with an alarm that will alert people both inside and outside the facility, and be activated when the pressure in the facility is more than 25 Pa above the set point.
NOTES: The purpose of the alarm is to indicate a malfunction of the air system and therefore the alarm should not be triggered during the course of normal opening and closing of the doors.
28. The facility must have an emergency stop button for the ventilation system, which is easily accessible in case of an emergency. The emergency stop button must operate independently of the main ventilation control and main facility pressure control system such that emergency isolation of the ventilation can be implemented in event of central control system malfunction.
29. Supply or replacement air to the facility must have Type 1 Class A or Class B filters complying with AS 1324.1 and having a minimum arrestance efficiency of 90% when tested in accordance with AS 1324.2 with Test Dust No. 4. Where replacement air is drawn from adjacent areas, adjustable dampers must be provided in the transfer aperture to assist in setting up the reduced room pressure. This aperture and filter must not be mounted in the door.
30. The exhaust filter must be a HEPA filter as specified in the definitions to this document, or another filter that meets all requirements of AS 4260 with a minimum performance of Grade 2. An exhaust pre-filter of the same or higher standard as the supply filter must be installed and mounted upstream of the HEPA filter. Filters must be selected to meet the expected quantity and type of animal debris, e.g. animal dander, hair, dusts and down.
NOTE: Pre-filters should be located within the work area for ease of replacement.
32. Filter housings must incorporate the following features:
- a gas-tight isolating valve on the air outlet duct (and supply duct if present). If gaseous decontamination of the filter is to be performed separately from decontamination of the facility, isolating valves on the air inlet duct and upstream and downstream valved ports are also required;
- secure filter element clamping and mounting tracks; and
- if the housing contains upstream and downstream valved pressure tappings to permit monitoring and display of the filter air flow pressure drop, the tapping on the facility side of the HEPA filter must be fitted with 0.2µm hydrophobic membrane type filters that are protected from physical impact.
Capacity to comply with certification conditions33. The applicant must be able to demonstrate a capacity to comply with the conditions of certification that will generally be applied to a certified PC3 Animal Facility. These conditions are found in Part B of this document.
Documentation to be supplied with the application34. The following documentation must be submitted with the application for certification of the PC3 Animal Facility:
- results of testing and commissioning of backflow prevention devices installed on water pipes supplied to the facility;
- results of testing and commissioning of HEPA filters installed in the facility;
- results of testing and commissioning of biological safety cabinets or other containment equipment (e.g. change stations, IVC) installed in the facility;
- results of testing and commissioning of the autoclave, or other heat-based decontamination equipment, installed in the facility; and
- a copy of the facility manual.