Diagnostics Contract Manufacturing Capability
capability for diagnostics manufacture includes:
- 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 for laboratories and immunodiagnostic companies that meet GLP and GMP requirements.
