Modular cleanroom project for aseptic preparation in Australian pharmacies.

1. GMP requirement
The cleanroom does not need to fully meet the requirements of a TGA-licensed GMP manufacturing facility (PIC/S PE 009).

It is intended for sterile compounding within a pharmacy setting. The design and performance should therefore align with ISO 14644 classifications and the principles used for sterile compounding in Australia (consistent with Pharmacy Board of Australia guidelines, which reference PIC/S PE 010 or equivalent standards such as USP <797>).

In practical terms, we need:

• Correct ISO classifications (ISO 5 in the primary engineering controls, ISO 7 buffer room, ISO 8 ante-room)
• Suitable pressure cascade, air changes, HEPA filtration, and cleanable construction
• Documentation that supports later local validation/qualification in Australia

Full manufacturing GMP licensing and the associated documentation package are not required for this project.

2. AHU vs FFU solution
Given the relatively small footprint (~5 m × 5 m classified suite), a well-designed FFU-based system is acceptable and often preferred for this type of modular compounding cleanroom.

Please quote a FFU solution as the base option. If you also wish to offer a dedicated AHU alternative, we are happy to review both, but FFU is our preferred starting point for this size of suite.

Please ensure the FFU design can still achieve the required air changes, pressure differentials, and temperature control for the ISO 7 and ISO 8 zones under operational conditions.

Please proceed with the quotation on this basis. Let us know if you need any further details.