Contract manufacturing

PharmIdea's production capacity is up to one million sterile vials per year

Capacity and vial size

Production technology Main production steps Vial size (1) Production batch size
Cytotoxic products Non-cytotoxic products
Freeze-drying Preparation of intermediate product 8 ml up to 1550 up to 6550
Sterilizing filtration of solution 10 ml up to 1150 up to 5470
Vials aseptic filling 30 ml up to 490 up to 3430
Freeze-drying (depends on freeze-dryer capacity)(2) (depends on freeze-dryer capacity)(2)
Vials aseptic stoppering and sealing
Aseptic filling Preparation of intermediate product 2 ml Up to 20 L
solution volume (3)
Up to 350 L
solution volume (3)
Sterilizing filtration of solution 6 ml
Vials aseptic filling 8 ml
Vials aseptic stoppering and sealing 10 ml
30 ml
Terminal sterilisation Preparation of intermediate product 2 ml Up to 20 L
solution volume (3)
Up to 350 L
solution volume (3)
Sterilizing filtration of solution 6 ml
Vials aseptic filling 8 ml
Vials aseptic stoppering and sealing 10 ml
Terminal sterilisation by steam 30 ml
  • (1) Any other size of vials in range 1 – 100 ml may be considered
  • (2) Batch size for other vials size may be requested separately
  • (3) More detailed calculation can be done, knowing the specific size of vials and fill volume

 

Investigational medicinal products (IMP) manufacturing

  • Sterile IMP (including cytotoxic) manufacturing in vials for phase I – III studies
  • Clinical trial material labelling, release, dispatching and shipping