Forms

RTF version Checklist for a Physical Containment Level 3 Animal Facility form (RTF file size 720 KB)
PDF printable version Checklist for a Physical Containment Level 3 Animal Facility form (PDF file size 143 KB)

Text Version

Below is the text from the Checklist for a Physical Containment Level 3 Animal Facility form.

Front Page - Checklist for a Physical Containment Level 3 Animal Facility

(Checklist against the requirements of the Gene Technology Regulator’s Guidelines for Certification of a Physical Containment Level 3 Animal Facility, Version 2.1 - 28 June 2010)


Organisation Name
Facility Name
IBC Name
Is this checklist provided as part of an application for:

Certification of a new facility?
Variation to an existing Certification?
For variations please provide the OGTR Certification Number

Name(s) and signature(s) of person(s) inspecting the facility (please print name clearly)

Date of Inspection

Time taken to complete this form:
Hours
Minutes

Please read this page first

Important Notes
  • If you require more space, please attach the information and indicate that you have added an attachment.
  • If in answer to any of the questions below you have indicated there is work pending completion or procedures yet to be implemented, please provide the expected completion date. Please be aware that the OGTR will require confirmation when work has been completed and it is unlikely the facility will be certified until this confirmation has been received.

Requirements for a Physical Containment Level 3 Animal Facility

Please tick the appropriate answer or provide the requested information for the following questions, which relate to the conditions applying to the specified Animal Facility.

Section 1 – Facility construction and access requirements

Please answer all questions in this section.

Requirement 1. 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.

Q. 1 Does the facility comply with requirement 1?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 2. The facility must be constructed to enable gaseous decontamination of the whole facility to be achieved.

Q. 2 Does the facility comply with requirement 2?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 3. All facility penetrations must be fitted with seals to limit air leakage.

Q. 3 Does the facility comply with requirement 3?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 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.

Q. 4 Does the facility comply with requirement 4?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 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.

Q. 5 Does the facility comply with requirement 5?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 6. Provision must be made for viewing of work areas from outside the facility.

Q. 6 Does the facility comply with requirement 6?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 7. All windows in the facility must be closed and sealed.

Q. 7 Does the facility comply with requirement 7?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 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:
  1. walls, floors, doors, windows and benches;
  2. furniture, including seating; and
  3. ceilings.
Q. 8 Does the facility comply with requirement 8?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 9. Benches, cupboards, and other fittings and services must be installed to enable decontamination, including gaseous decontamination, of all spaces in the facility. Open spaces between and under benches, cabinets and equipment must be accessible for cleaning.

Q. 9 Does the facility comply with requirement 9?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 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.

Q. 10 Does the facility comply with requirement 10?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 11. Where present, liquid drainage exits must be protected against entry or exit of invertebrates or other animals by the use of screens, liquid traps or an equivalent effective method. The apertures of the screen must be sufficiently small as to prevent entry or exit of invertebrates or other animals.

Q. 11.1 Is this requirement relevant to the facility?
Yes. Answer 11.2
No. Continue to requirement 12

Q. 11.2 Does the facility comply with requirement 11?
Yes
No - reason(s) for non-compliance and details of any actions being taken to rectify the situation.

Requirement 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.

Q. 12 Does the facility comply with requirement 12?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 13. Designated storage or hanging areas for personal protective clothing and equipment must be available within the work area. Storage for personal effects and non-laboratory clothing must be provided outside the facility.

Q. 13 Does the facility comply with requirement 13?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Section 2 – Containment equipment requirements

Please answer all questions in this section.

Requirement 14. Animals in the facility must be housed in primary containment devices within the work area.

Q. 14 Does the facility comply with requirement 14?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 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 0.2µmm 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.

Q. 15 Does the facility comply with requirement 15?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 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/NZS 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.

Q. 16 Does the facility comply with requirement 16?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Section 3 – Laboratory services and equipment requirements

Please answer all questions in this section.

Requirement 17. 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.

Q. 17 Does the facility comply with requirement 17?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 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:
  1. laboratory sink outlets;
  2. outlets within a class II BSC; and
  3. direct connection to an autoclave.
Backflow prevention must isolate the facility to the exclusion of all other areas.

Q. 18 Does the facility comply with requirement 18?
Yes – Please provide the location(s) of the backflow prevention device(s)
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 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.

Q. 19 Does the facility comply with requirement 19?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 20. The work area of the facility must contain eyewash equipment (either plumbed eyewash equipment or single-use packs of sterile eye irrigation fluids).

Q. 20 Does the facility comply with requirement 20?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 21. Any reticulated vacuum services must contain liquid disinfectant traps. Air drawn through the liquid disinfectant trap must be filtered with a filter with pore size of less than or equal to 0.2 Ám prior to connection to the vacuum pump.

Q. 21.1 Is this requirement relevant to the facility?
Yes. Answer 21.2
No. Continue to requirement 22

Q. 21.2 Does the facility comply with requirement 21?
Yes
No - reason(s) for non-compliance and details of any actions being taken to rectify the situation.

Requirement 22. Piped gas supplies to the facility must have reverse flow prevention on outlets located within the BSC.

Q. 22.1 Is this requirement relevant to the facility?
Yes. Answer 22.2
No. Continue to requirement 23

Q. 22.2 Does the facility comply with requirement 22?
Yes
No - reason(s) for non-compliance and details of any actions being taken to rectify the situation.

Section 4 – Ventilation requirements

Please answer all questions in this section.

Requirement 23. 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.

Q. 23 Does the facility comply with requirement 23?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 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.

Q. 24 Does the facility comply with requirement 24?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 25. The pressure differential must be achieved by means of an independent room exhaust fan located downstream of a HEPA filter and discharging to the outside atmosphere. All exhaust air and decontaminating gases used during gaseous decontamination of the facility must be able to be purged to the atmosphere in such a manner that it is dispersed away from occupied buildings and air intakes.

Q. 25 Does the facility comply with requirement 25?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 26. The work area must be equipped to measure and display the pressure difference between the facility and areas adjacent to the facility. The display must be located so that it can be read immediately before entering the facility.

Q. 26 Does the facility comply with requirement 26?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 27. The facility must be equipped with an alarm that will alert people both inside and outside the facility, and activated when the pressure in the facility is more than 25 Pa above the set point.

Q. 27 Does the facility comply with requirement 27?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 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.

Q. 28 Does the facility comply with requirement 28?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 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.

Q. 29 Does the facility comply with requirement 29?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 30. The exhaust filter must be a HEPA filter as specified in the definitions of the Guidelines for Certification of a PC3 Animal Facility, 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.

Q. 30 Does the facility comply with requirement 30?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 31. Each exhaust HEPA filter must be mounted in a gas-tight housing, with sealed access doors, and the ductwork between the facility and the HEPA filter housing must also be gas-tight. The design and location of the filter housing must allow for access to and integrity testing of the HEPA filter.

Q. 31 Does the facility comply with requirement 31?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Requirement 32. Filter housings must incorporate the following features:
  1. 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;
  2. secure filter element clamping and mounting tracks; and
  3. 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.
Q. 32 Does the facility comply with requirement 32?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Section 5 – Capacity to comply with certification conditions

Requirement 33. 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.

Q. 33 Does the facility comply with requirement 33?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.

Section 6 – Documentation to be supplied with the application

Requirement 34. The following documentation must be submitted with the application for certification of the PC3 Animal Facility:
  1. results of testing and commissioning of backflow prevention devices installed on water pipes supplied to the facility;
  2. results of testing and commissioning of HEPA filters installed in the facility;
  3. results of testing and commissioning of biological safety cabinets or other containment equipment (e.g. change stations, IVC) installed in the facility;
  4. results of testing and commissioning of the autoclave, or other heat-based decontamination equipment, installed in the facility; and
  5. a copy of the facility manual.
Q. 34 Does the facility comply with requirement 34?
Yes
No - please explain the reasons for non-compliance and details of EITHER any actions being taken to rectify the situation OR reasons why an exemption may be justified.