Based in Tullamarine, Melbourne, our state-of-the-art GMP registered facility has the expertise and capability to provide you with a cost effective solution for your manufacturing requirements.
- Aseptic liquid dispensing of biological products in a dedicated sterile dispensing suite
- Large capacity warm rooms (35ºC)
- Machine coating, washing, and blocking of microtitre plates with throughput of 750 plates per hour (Oyster Bay Pump Works Inc. USA)
- Steam sterilisation equipment with a capacity of 5.5 m3
- Dry sterilisation equipment with a capacity of 1000 10 mL vials
- Freeze drying (lyophilisation) with a capacity of 5,000 vials per batch
- Vacuum drying of microtitre plates with a capacity of 2,000 plates per batch
- On-tap vacuum & pressurised air system
- Large refrigerated rooms capable of storing intermediate & finished product
- Set up of QC protocols and SOP’s that meet GLP and GMP requirements.
- Sterile clean room that has HEPA filtered air that complies with Grade A and B air. The clean room has an associated air lock that meets Grade C air
- Laminar Flow Work Stations fitted with HEPA filters that meet Grade A air requirements
- Air Containment: Entry/Exit airlocks and 7 air handling systems to control cross contamination
- Room Pressure Control: Positive and Negative Pressure Control for dispensing suite, containment area and QC lab
- Temperature control & humidity monitoring: The temperature of the facility is fully computer controlled by a state of the art computer system. It is monitored 24/7 to comply with and exceed regulatory requirements for day-to-day operation and audit traceability
- Secure Building Entry System: access to the facility can only be obtained using a: swipe FOB entry card and is computer controlled
- Reverse osmosis purified water system that meets USP/EP/BP Purified Water requirements. The ROPW system also has a heater that can dispense the ROPW at 90ºC as required
- Pallet access: 2 meter wide corridors to allow pallet access to all rooms
- SAP Business 1 is used for inventory control, MRP, production orders and managing work in progress.