Forms

RTF version of the Checklist for a Physical Containment Level 2 Large Scale Facility form (RTF File Size - 46 KB)
PDF version of the Checklist for a Physical Containment Level 2 Large Scale Facility form (PDF File Size - 11 KB)


Text Version

Below is the text from the Checklist for a Physical Containment Level 2 Large Scale Facility form.

(Checklist against the requirements of the Gene Technology Regulator’s Guidelines for Certification of a Physical Containment Level 2 Large Scale Facility)

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 2 Large Scale Facility

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

Section 1 – Facility requirements

Please answer all questions in this section.

Requirement 2. The facility to be certified must be a fully enclosable space bounded by walls, doors, windows, floors and ceilings, to prevent the release of any genetically modified organisms (‘GMOs’).

Q. 2.1 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. Any openings in the walls, ceiling or roof, such as air vents, must be screened with insect proof mesh.

Q. 3.1 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 following surfaces in the facility must be smooth, impermeable to water, cleanable, and resistant to damage by the cleaning agents and/or disinfectants that will be used in the facility:

  1. walls, floors, and benches; and
  2. ceilings, and any other surfaces, where contamination can occur or where decontamination is required.
Facility furniture, including seating, must be able to be decontaminated.

Q. 4.1 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. If the facility has floor drainage exits, all effluent from these drains must be decontaminated by heat treatment or chemical treatment before being discharged. If the facility has a sink, then all liquid effluent must be decontaminated prior to discharge down the sink.

Q. 5.1 Is this requirement relevant to your Large Scale Facility?
Yes. Answer 5.2
No. Continue to Requirement 6

Q. 5.2 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. Open spaces between and under benches, cabinets and equipment must be accessible for cleaning.

Q. 6.1 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. The facility must contain either a wash basin fitted with hands-free tap(s) and supplied with potable water, or some other means of decontaminating hands.

Q. 7.1 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. Emergency drench showers and eyewash equipment (either plumbed eyewash equipment or single-use packs of sterile eye irrigation fluids) must be provided within the facility.

Q. 8.1 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. Potable water supplied to the facility must be provided with backflow prevention by a registered testable device that has a high hazard rating for protection against both back-pressure and back-siphonage in accordance with the requirements of Australian Standard/New Zealand Standard (‘AS/NZS’) 3500.1.

Q. 9.1 Does the facility comply with requirement 9?
Yes - Please provide details of where the backflow prevention device is located.
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. Designated storage or hanging provisions for protective clothing must be available within the facility.

Q. 10.1 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.

Section 2 – Containment equipment requirements

Please answer all questions in this section.

Requirement 11. All cultures of GMOs, with the exception of inocula and samples taken during production, must be contained within a closed system (ie, closed vessel used for propagation, growth and storage, and closed lines used for transfer).

Any closed system must be capable of being decontaminated in situ.

Gaseous exhaust products removed from any closed system must be filtered to prevent release of aerosols containing GMOs.

Q. 11.1 Does the facility comply with requirement 11?
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 12. Where procedures in the facility (other than the process of inoculating, culturing GMOs within, and taking samples from, closed systems) will produce aerosols containing GMOs then the facility must contain a biological safety cabinet, or other equipment specifically approved in writing by the Gene Technology Regulator (‘the Regulator’) that is designed to contain aerosols.

Where any Class I or Class II biological safety cabinets is installed it must be installed in accordance with the requirements of AS/NZS 2647.

Q. 12.1 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. Other equipment used to process GMOs, (eg centrifuges, filtration systems), must be designed to contain the organisms.

Q. 13.1 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.

Requirement 14. Secondary containment, such as bunding, must be provided to retain any leakage from the closed system. It must be of sufficient capacity to retain:
  1. the maximum volume of fluid in the closed system; and
  2. the volume of any disinfectant that might be used,
with additional capacity to prevent any expected general fluid movement from breaching the secondary containment.

Q. 14.1 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.

Section 3 – Capacity to comply with certification conditions

Please answer the question in this section.

Requirement 15. The facility must be able to demonstrate that it is capable of complying with the conditions of certification that will be applied to a certified PC2 Large Scale Facility, as attached to the ‘Requirements for Certification’ in the Guidelines for Certification of Physical Containment Facilities, PC2 Large Scale Version 2.1.

Q. 15.1 Will the facility be capable of complying with the conditions of certification that will be applied to a certified PC2 Large Scale Facility?
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.