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.