Fully automated vial wash, depyrogenation, filling and capping line with operational Restricted Access Barrier system (oRABs) fully qualified as Grade A in B background.
All product contact surfaces utilize single-use / disposable elements to prevent cross contamination.
Faster changeover compared to traditional filling lines.
Capabilities
Filling Process: peristatic pump with single head
Filling volume range: 0.2 mL – 50 mL
Weight check: 100% or statistical IPC
System hold-up liquid ≤70mL
Multiple validated container and closure configurations (2R, 6R, 8R, 10R, 14R, 20R and 50R)
Typical batch size of 1,000 – 10,000 vials
Future
Facility has layout and structure to install high speed filling line (300 vial/min), batch size reach to 50,000-100,000 units and lyophilizer.
Prefilled syringe and cartridges may also be provided.