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Contract manufacturing

PharmIdea is growing its capacity and in a year we will be able to increase the output capacity to one million sterile vials per year.

Capacity and vial size

Production technology Main production steps Glass or plastic

Vial size Batch size Batch size*
Freeze-dry Vials washing
Vials dry heat sterilisation
Vials aspetic filling
Freeze-drying
5 ml 1380
10 ml 1280
15 ml 1000
50 ml 350
100 ml 110
Aseptic filling Vials washing
Vials dry heat sterilisation
Vials aseptic filling
5 ml 3800 20 000
10 ml 1900 10 000
15 ml 1300 6 500
50 ml 400 2 000
100 ml 200 1 000
Terminal sterilisation Vials washing
Vials dry heat sterilisation
Vials aseptic filling
Autoclaving
5 ml 3800 16 800
10 ml 1900 8 400
15 ml 1300 6 800
50 ml 400 1 350
100 ml 200 840

* could be upscaled within 6 months on customer request

Equipment

Manufacturing of sterile solution and sterile freeze-dried products in 1 – 100 ml vials

  • Bausch+Ströbel (Germany) semi-automatic vials washing machine
  • Isolator Isotech (Canada) class A (ISO 4/5) environment ensure vial’s filling under aseptic conditions for freeze-dried and heat sensitive products
  • Vials filling and closing equipment Flexicon (Denmark) placed in isolator
  • Vials freeze-dried process employ company Martin Christ (Germany) equipment with capacity 12 kg ice. Vials with up to 100 ml volume can be freeze-dried.
  • Sterilization of vials by autoclaving (Fedegari (Italy)) is possible as well.
  • Mean production batch size up to 1500 vials for freeze-dried and up to 5000 vials for solutions
  • Production capacity 150 – 300 thousand vials per year.

Investigational medicinal products manufacturing (IMP)

  • Product formulation development
  • Sterile products in vials (including cytotoxic) investigational medicinal products manufacturing for phase I – III studies
  • Clinical trial material labelling, release, dispatching and shipping