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Text version

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

Checklist against the requirements under Part A of the Gene Technology Regulator’s Guidelines for Certification of a Physical Containment Level 2 Aquatic Facility Version 3.1 - 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 Aquatic Facility Version 3.1 - 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 Aquatic Facility Version 3. 1 - 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
Entry of surface run off water prevented
Yes
No
Notes/Details

Floor Bunding
Imperious to water and with joints sealed
Yes
No
Notes/Details

Secondary Containers
Meets the volume requirements as stated in Requirement 5 of Part A
Yes
No
Notes/Details

Effluent
Is a process in place to decontaminate the effluent
Yes
No
Notes/Details

Drainage exits
Drainage exits are fitted with barriers to prevent animals including invertebrates from entering or escaping the facility
Yes
No
Notes/Details

Openings
Any openings in the walls, ceiling or roof are filtered or screened at the boundary to prevent entry or exit of animals including invertebrates
Yes
No
Notes/Details

Decontamination of hands
Hands free washbasin fitted
Yes
No
Notes/Details
OR Yes
No
Notes/Details

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

Aerosol containment
PC2 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 prevention
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

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)

Eyewash
Equipment provided (either a plumbed eyewash or single use packs of sterile eye irrigation fluids)
Yes
No
Notes/Details

Surfaces including furnishings
Smooth, impermeable to water, cleanable and resistant to damage by cleaning agents used in the facility
Yes
No
Notes/Details

Hanging/Storage Provisions
Designated hanging or storage provisions for PPE.
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 Laboratory (these condition set out under Part B of Guidelines for Certification of Physical Containment Facilities PC2 Aquatic Facility Version 3.1 – issued 1 March 2013)
Yes
No
Notes/Details