BulletinISOcleanroomclassifications Australian Custom Pharmaceuticals uses advanced technology to produce a wide range of high-quality custom-compounded medications that are supplied Australia-wide. A new cleanroom facility was needed at the company’s Taren Point, NSW location to increase production capacity and to meet stringent TGA requirements. Compliance requirements were that ISO 14644-1 Class 7 (AS 1386 Class 350) air cleanliness be achieved in the cleanroom and an adjoining ante-room. A laminar flow unit in the cleanroom would provide ISO 14644-1 Class 5 (AS 1386 Class 3.5) conditions. Vilair-AAF was appointed to install and validate equipment to achieve the specified level of environmental control including:
- A dedicated reverse-cycle air conditioning unit to serve the facility
- AAF fan-assisted HEPA cleanroom modules for room air supply
- A stainless steel pass-through hatch for materials transfer
- Enhanced door seals and mechanisms to maintain room pressures
- Validation to Australian standards confirmed by independent NATA-accredited testing and certification
Minimal disruption to production was a critical factor in the development, with completion and handover required within eight weeks from inception. This objective was achieved within both time and budget constraints. The facility exceeds the design requirements in terms of air cleanliness by at least one classification level and is one of the ‘cleanest’ non-laminar flow cleanrooms recently built. The HVAC system was configured and sized to meet both existing requirements as well as future expansion.
Michael Tattersall, Operations Manager of the company, said that: “The new cleanroom will give us production capability for prescriptions, small-run eye drops, injectables and clinical trials. This also allows us to lease this top-grade facility with our internationally-trained staff to other companies.”