Large scale filling capacities at BioConnection

Large scale filling line

Automated filling line in “tunnel” design

Filling line (Groninger)
  • Vial washing machine
 in grade D cleanroom
  • Depyrogenisation oven
 in grade D cleanroom
  • 4 needle Filling machine
    (incl 100% IPC + stoppering)
 grade A open RABS in grade B cleanroom
  • Capping machine
 grade A open RABS in grade D cleanroom
Lyophilizer (HOF) grade A open RABS in grade B cleanroom
  • 10.2 m²
  • Automated loading/ unloading
  • 7 shelves
Capacity
  • Liquids: up to 500L + / batch
  • Freeze dried: up to 200L/ batch
  • Up to 40 million vials/ year (2 RDIN, liquid)
  • Up to 4 million vials/ year (2 RDIN, freeze dried)
  • Speed (default): 11.520 vials/ hr (2 RDIN)
  • Vial sizes: 2 RDIN up to 50 RDIN vials

EMA and US-FDA certified facility

Large-scale filling line + 10 m² freeze dryer

Compounding volumes: up to 500L+

Indicative maximum batch sizes (*)

Vial size Liquid product Freeze dried product
2 RDIN 57,000 – 150,000 44,900
6 RDIN 57,000 – 150,000 23,200
10 RDIN 50,000 – 150,000 19,600
20 RDIN 25,000 – 100,000 12,600
25 RDIN 20,000 – 80,000 12,600
50 RDIN 10,000 – 40,000 6,800

(*) Actual batch size depends on requested scale of production and filling volume/vial. Examples are based on a 50% filling volume/vial (e.g. 25 ml fill in a 50 RDIN vial, etc.)