Covid update

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: ~ 30L up to 1.000L/ batch
  • Freeze dried: ~ 30L 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

Flexible and small scale

Compounding volumes: 2L – 50L
Freeze dryer: 3m²

Batch sizes (*)

Vial size Liquid product Freeze dried product
2 RDIN 18.700 11.000
6 RDIN 8.300 – 13.000 5.700
10 RDIN 5.000 – 11.000 4.800
20 RDIN 2.500 – 6.700 3.000
25 RDIN 2.000 – 6.700 3.000
50 RDIN 1.000 – 3.250 1.400

(*) Actual batch size depends on requested filling volume/vial.

Large scale filling line + 10 m² freeze drier

Compounding volumes: >50L
Freeze dryer: 10m²

Batch sizes (*)

Vial size Liquid product Freeze dried product
2 RDIN 74.800 – 161.200 44.300
6 RDIN 74.800 – 161.200 23.200
10 RDIN 50.000 – 161.200 19.600
20 RDIN 25.000 – 100.000 12.300
25 RDIN 20.000 – 80.000 12.300
50 RDIN 10.000 – 40.000 6.800

(*) Actual batch size depends on requested filling volume/vial.
Examples are based on a fill volume of 50%/vial.

bioconnection

Covid-19 update BioConnection

BioConnection has taken precautions related to the global outbreak of the Covid-19 virus. To start with; we are currently in full operation and running on-schedule with regard to our planned productions. Our production department is on full strength and we have no shortages of material(s) nor do we foresee them.

For our personnel we are following the guidelines as issued by the Dutch National Institute for Public Health and the Environment, RIVM (www.rivm.nl). This means that people stay at home when they show (early) symptoms connected to Covid-19. Furthermore BioConnection employees work from home as much as possible. We avoid shaking hands and keep distance from each other. We take every precaution as advised to prevent the spread of the Covid-19 virus and will fully comply to the requests as stated and/or enforced by the authorities.

Our expansion project (expansion.bioconnection.eu) is running as planned to start GMP production in Q2 2021. We stay in close contact with our suppliers for the production equipment.

We review for Covid policy changes by the authorities on a daily base and adapt to them. If changes occur, this statement will be updated accordingly so you always have the latest information. In case you have any questions, please do not hesitate to contact us via our general number or website. Current customers of BioConnection, can contact their dedicated program manager. In case you want BioConnection to become a partner in your development or manufacturing, please contact our Business Development department via contact@bioconnection.eu.

The BioConnection Management Team.

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