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Version 2.1 – Effective 28 June 2010
The guidelines (Part A) contain the requirements for certification of a Physical Containment Level 3 (PC3) Animal Facility issued pursuant to section 90 of the Gene Technology Act 2000 (the Act) and, as applicable, corresponding State legislation.
These guidelines are intended for PC3 Animal Facilities in which animals are housed within primary containment devices that contain both the animal and any micro-organisms they may be infected with.
Once a facility is certified, the Regulator imposes conditions on the facility pursuant to section 86 of the Act. The conditions of certification outlined in this document (Part B) detail representative conditions that may apply to a PC3 Animal Facility. Individual certification conditions may differ from these depending upon the design, construction and proposed dealings to be conducted in the facility. Once issued, the conditions may be varied by the Gene Technology Regulator (the Regulator) as necessary and appropriate.
A list of the Australian/New Zealand Standards that are referred to throughout this document is also attached.
A separate document - Explanatory Information on Guidelines for Certification of Physical Containment Facilities - contains details about obtaining and maintaining certification. This document can be downloaded from the Office of the Gene Technology Regulator (OGTR) website.
A PC3 Animal Facility should be constructed so that it achieves upon commissioning an air leakage rate, at a differential pressure of 200 Pa, of no more than 120L/min. After commissioning, and in accordance with the Australian/New Zealand Standard AS/NZS 2243.3, it is recommended that the air leakage rate of the facility is retested at least once every 5 years and that an air leakage rate of no more than 1200L/min should be maintained.
The OGTR will inspect PC3 Facilities prior to any decision on an application for certification.