Cleanroom contractor in Australia: rules for buyers

By ZY Cleanroom · Updated 2026-11-01 · Sources at the end of the page

Which rules apply to your plant

TGA says an Australian site that makes medicines needs a TGA manufacturing licence, while overseas sites need GMP clearance (TGA, manufacturing licence guide).

The Therapeutic Goods (Manufacturing Principles) Determination 2020 incorporates the PIC/S Guide to GMP. An amending determination, commenced on 1 September 2025, updated it to PE 009-17 of 25 August 2023, excluding Annexes 4, 5 and 14. For sterile goods, it applies to manufacture on or after 1 March 2026, to the extent it incorporates clauses 2.1, 2.3, 7.14 and 9.31 of Annex 1 (Federal Register of Legislation).

For hospitals, AS 1668.2:2024 on mechanical ventilation replaces the 2012 edition, adds HEPA leak-testing provisions under AS ISO 14644.3 or AS 1807, and modifies the provisions for operating theatres (IHEA). Confirm with the certifier which edition the project follows.

Who builds cleanrooms here

Licensed medicine manufacturers are the regulated buyers. Hospitals are the second group, because AS 1668.2 covers ventilation for health-care functions. This reading comes from the rules above, not from market statistics.

What a foreign supplier must arrange

An Australia-wide asbestos ban has applied since 31 December 2003, and importing asbestos or goods containing it is prohibited under regulation 4C of the Customs (Prohibited Imports) Regulations 1956. Importers need to know their goods back to the point of manufacture. The Australian Border Force can hold goods and, where assurance is lacking, require testing in Australia by a NATA-accredited laboratory at the importer's cost (ABF Customs Notice 2024/32).

The National Construction Code 2025 was scheduled for release on 1 May 2026, and each state and territory sets its own adoption date. A trade report of 30 April 2026 listed Victoria on 1 May 2026, New South Wales, Queensland and South Australia on 1 May 2027, the ACT with a 12-month transition, and no date yet for Western Australia and the Northern Territory (HVAC&R News). Check current dates with the owner's certifier.

What to send for a first scope

Send the room list with the ISO 14644-1 class and occupancy state for each room. Add floor plans and ceiling heights. State the state or territory, whether the rooms serve a medicine plant or a hospital, whether they are sterile, and which edition of the NCC and AS 1668.2 the certifier applies. Say which items will be imported, so asbestos assurance can be planned.

Send your room list to ZY Cleanroom, a cleanroom design-and-build contractor with its own panel factory in Tianjin, China, to have a first scope prepared. CE-marked and FM-approved panels can be supplied for projects that require them, and other certification can be arranged per project.

Who does the site work

Site work is delivered with a licensed local contractor: yours, or one named in the contract. ZY supplies the design, panels, doors and numbered drawings.

Related guides

• How to audit a cleanroom panel factory, on site or by video
• Cleanroom cost per m²: published ranges by ISO class
• How to Import a Cleanroom from China
• The Cleanroom Project Lifecycle
• Turnkey cleanroom contractor
• Room list builder

Sources

• TGA, Australian manufacturing licences and overseas GMP certification, user guide section 1 (checked 1 November 2026)
• Federal Register of Legislation, Therapeutic Goods (Manufacturing Principles) Amendment (PIC/S Guide) Determination 2025, explanatory statement (commenced 1 September 2025)
• IHEA, AS 1668.2-2024 Lunch + Learn summary (session of 2 July 2025; checked 1 November 2026)
• Australian Border Force, Customs Notice 2024/32, Assurances that imported goods do not contain asbestos
• HVAC&R News, NCC 2025 released: who is adopting it? (30 April 2026)
• PIC/S, list of participating authorities (checked 1 November 2026)