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

Summary of our services

Drug product development

  • Formulation development
  • Process and analytical development & validation
  • Lyo-cycle development and/or optimization
  • Transfer and scale-up to clinic
  • Transfer and scale-up to market

Freeze drying

  • Shelf areas ranging from 3 m² up to 10 m²

Clinical trial material services

  • Labeling
  • Clinical trial packaging
  • QP release
  • Storage

Fill and Finish

  • Batch sizes: from 1 unit up to 150,000 units per batch
  • Clinical and commercial scale
  • Automated fill and hand fill
  • Aseptic filling
  • Vials: from 2 RDIN up to 50 RDIN
  • Syringes: from 0.5 ml up to 10 ml
  • Other primary packs: via handfill
  • Terminal sterilization