Application Checklist for a Physical Containment Facility Level 2 Invertebrate Facility

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

Checklist against the requirements under Part A of the Gene Technology Regulator’s Guidelines for Certification of a Physical Containment Level 2 Invertebrate Facility Version 3.1 - 1 March 2013Please 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 Invertebrate 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 Invertebrate 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
Fully enclosed space bounded by walls, doors, windows, floors and ceilings
Yes
No
Notes/Details

Surface (incl. furnishing)
Impenetrable to GMOs or effective decontamination methods in place
Yes
No
Notes/Details

Joints
Sealed and impenetrable to GMOs housed in 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

Facility boundaries
Facility boundaries are designed to prevent escape of the animals being contained
Yes
No
Notes/Details

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

Self-Closing Door
Is a self-closing door installed
Yes
No
Notes/Details

Drainage exits
Fitted with barriers to prevent invertebrates and animals
Yes
No
Notes/Details

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

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

Eyewash
Equipment provided and maintained
Yes
No
Notes/Details

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 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

Hanging/Storage Provisions
Designated hanging or storage provisions for PPE
Yes
No
Notes/Details

Pests
Control strategy in place
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 Invertebrate Facility (these condition set out under Part B of Guidelines for Certification of Physical Containment Facilities PC2 Invertebrate Facility Version 3.1 – issued 1 March 2013)
Yes
No
Notes/Details