Fill & Finish
Facility
-
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.
-
Automated inspection of liquid products.
-
Automated packaging line (labelling and carton).