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Text version

Below is the text from the Application Checklist for a Physical Containment Facility Level 2 Plant Facility form.

Checklist against the requirements under Part A of the Gene Technology Regulator’s Guidelines for Certification of a Physical Containment Level 2 Plant Facility Version 3.2 - 1 March 2013
Please Note
  • The use of this checklist proforma is not mandatory in order to conduct an inspection of certified facilities for compliance with the requirements of certification under Part A of Guidelines for Certification of a Physical Containment Level 2 Plant Facility Version 3.2 - 1 March 2013. Rather, it is provided to assist those who find it convenient to use for the above mentioned.
  • This proforma is based on the requirements of certification as detailed in the Gene Technology Regulator’s Guidelines for Certification of a Physical Containment Level 2 Plant Facility Version 3. 2 - 1 March 2013. (the Guidelines). Applicants must refer to these guidelines for full details of the requirements before confirming compliance on the application form.
  • If in answer to any of the questions below it is indicated that the facility does not meet the requirements of certification under Part A of the Guidelines or may not be able to meet the expected conditions of certification, as listed in Part B of the Guidelines, then this information should be reported under section 3 of the Application for the Certification of a Physical Containment Facility along with any suggested strategies to support the application for certification of the facility.
  • Please do not send this report to the OGTR unless specifically requested.

Organisation name:
Facility name:
Inspected by:
Date

Facility and fitting requirements


Facility (Flooding)
Is the facility located in a flood and/or storm surge prone area as described in Requirement 1 of Part A
Yes
No
Notes/Details
If yes; Is a Risk Management Plan in place to minimise the risk of loss of containment during flood and storm surge events
Yes
No
Notes/Details

Facility boundaries
Fully enclosed space bounded by walls, doors, windows, floors and ceilings
Yes
No
Notes/Details
Maintained to be rigid, durable and suitable for the environmental conditions they are exposed to, and able to withstand expected wear and tear
Yes
No
Notes/Details
Transparent sections are made of glass, polycarbonate sheeting or similar durable material
Yes
No
Notes/Details
Boundaries are impact resistant or protected from impact
Yes
No
Notes/Details
Entry of surface run off water prevented
Yes
No
Notes/Details

Surface
Impermeable to GMOs or effective mechanisms in place to decontaminate them
Yes
No
Notes/Details

Anteroom
Facility has an anteroom and entry to the facility is via the anteroom
Yes
No
Notes/Details

Decontamination of hands
Yes
No
Notes/Details
OR
Other means of decontamination of hands
Yes
No
Notes/Details

Drainage exits (Barriers)
Fitted with barriers to prevent invertebrates, animals or GM plants or GM propagative plant material entering or escaping via the drains
Yes
No
Notes/Details

Drainage exits (Effluent Control)
Fitted with liquid traps that are permanently filled with appropriate decontaminant
OR
Liquid entering drains contained and treated as waste
Yes
No
Notes/Details

Openings in walls, ceilings or roof
Any openings are screened or filtered at the boundary
Yes
No
Notes/Details

Control of release of pollen or seeds
Mechanisms in place to prevent the release of pollen or seeds.
Yes
No
Notes/Details

Hanging/Storage Provisions
Provisions for the storage or hanging of PPE.
Yes
No
Notes/Details

Open spaces under benches etc.
Accessible for decontamination
Yes
No
Notes/Details

Pests
Control strategy in place
Yes
No
Notes/Details

Dealings involving GM micro organisms

These requirements must also be met if any of the dealings in the facility are to involve GM micro organisms

Aerosol containment
PC2 Risk Group 2 GM micro-organisms dealings proposed will produce aerosols
Yes
No
Notes/Details
If yes - BSC installed (Class I or Class II BSC must be installed in accordance with the requirements of AS2252.4)
Yes
No
Notes/Details
OR
Other equipment to contain aerosols to be used (will require written permission from the Regulator)
Yes
No
Notes/Details

Backflow
Device or system that may cause contamination of a potable water supply with GMOs requiring PC2 containment connected directly or indirectly to any part of a water service
Yes
No
Notes/Details
If yes - Backflow risk assessment has been carried out
Yes
No
Notes/Details
Backflow prevention necessary and prevention measures implemented in accordance with the requirements of AS/NZS 3500.1
Yes
No
Notes/Details

Capacity to comply with certification conditions


Capacity to comply
Demonstrated capacity to comply with the conditions of certification that will generally be applied to a certified PC2 Plant Facility (these condition set out under Part B of Guidelines for Certification of Physical Containment Facilities PC2 Plant Facility Version 3.2 – issued 1 March 2013)
Yes
No
Notes/Details