Forms

RTF version of Application checklist for a Physical Containment Facility Level 2 Laboratory (RTF 247 KB)
PDF version of Application checklist for a Physical Containment Facility Level 2 Laboratory (PDF 134 KB)

Text Version

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

Checklist against the requirements under Part A of the Gene Technology Regulator’s Guidelines for Certification of a Physical Containment Level 2 Laboratory 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 Laboratory Version 3.2 – 1 March 2013. Rather, it is provided to assist those who find it convenient to use for the above mentioned inspection.
  • 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 Laboratory 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 - Fully enclosed space bounded by walls, doors, windows, floors and ceilings
Yes
No
Notes/Details

Surface (incl. furnishing) - Smooth, impermeable to water, cleanable and resistant to damage by cleaning agents used in the facility
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 (either a plumbed eyewash or single use packs of sterile eye irrigation fluids)
Yes
No
Notes/Details

Aerosol containment - PC2 Risk Group 2 GM micro-organisms dealings proposed will produce aerosols
If Yes - BSC installed (Class I or Class II BSC must be installed in accordance with the requirements of AS 2252.4)
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 - Provisions for the storage or hanging of 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 conditions are set out under Part B of Guidelines for Certification of Physical Containment Facilities PC2 Laboratory Version 3.2 – issued 1 March 2013)
Yes
No
Notes/Details