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Version 3.1 – Effective 28 May 2012

These guidelines for certification of a Physical Containment Level 3 (PC3) Laboratory have been issued pursuant to section 90 of the Gene Technology Act 2000 (the Act) and, as applicable, corresponding State legislation.

Part A of these guidelines contains the requirements that must be met for certification of a PC3 Laboratory by the Gene Technology Regulator (the Regulator) under section 84 of the Act. The requirements apply to all applications for certification of PC3 Laboratories received on or after the day on which these guidelines take effect.

Part B outlines representative conditions of certification that the Regulator may impose on a PC3 Laboratory pursuant to section 86 of the Act.

Notes within the document are intended to provide information, and are not mandatory conditions or requirements.

Wherever possible, equipment should be independently tested by an entity other than the equipment supplier.

A list of the Australian/New Zealand Standards that are referred to throughout this document is 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 facility should be constructed so that upon commissioning it achieves an air leakage rate of no more than 120 L/min, at a differential pressure of 200 Pa. 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, or whenever any modifications take place that could affect the integrity of the seal. An air leakage rate of no more than 1200 L/min should be maintained.

Staff from the OGTR will inspect PC3 facilities prior to any decision being made on an application for certification. Prior to entering a facility, staff from the OGTR must be informed of any Workplace Health and Safety risks that they may be exposed to within the facility, including any chemical or microbiological risks, and of any vaccinations that may be required prior to entering the facility.