This project involved a new multipurpose facility to produce a variety of biologicals for clinical trials (Phase-I and Phase-II) under good manufacturing practice (GMP) regulations at the CSIRO Clayton site. The GMP Facility will enable process development and production of clinical-grade biologicals.
Critical Piping Package:
The Critical Piping scope included procurement, fabrication, delivery, installation, testing, documentation and handover associated with:
- Water For Injection Distribution
- Pure Steam Distribution
- Nitrogen Gas Supply and Distribution (including gas manifold)
- Carbon Dioxide Gas Supply and Distribution (including gas manifold)
- Oxygen Gas Supply and Distribution (including gas manifold)
- Process Air Distribution
- Instrument Air Distribution
- Temperature Control Units
- Waste Collection (including treatment tank package)
- Waste Transfer
- Plant Steam
- Installation of 18 clean room General Service Outlet panels
Water For Injection Tank Package:
The Water For Injection Tank scope included design, procurement, fabrication, delivery, installation, testing, documentation and handover of a WFI tank.
Mechanical for Process Package:
The Mechanical For Process scope included procurement, fabrication, delivery, installation, testing, documentation and handover associated with:
• Process Cooling Water (including purchasing and installing the chiller)
• Plant Steam (including purchasing and installing the plant steam boiler)
• Compressed Air (including purchasing two compressors and an air receiver)
This scope also included the supply & installation of a Drying Cabinet and the installation of Principal Supplied Specialist Equipment.
