Based in Tullamarine, Melbourne, our state-of-the-art GMP registered facility has the expertise and capability to contract manufacture immunoassays (ELISA and associated reagents and components).
- 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 SOPs that meet 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. It is monitored 24/7 to comply with regulatory requirements.
- Secure Building Entry System
- Pallet access: 2 meter wide corridors to allow pallet access to all rooms