Products

SPECTROS 150IU with bacteriostatic diluent
2019-08-18
OEM Manufacturing of injectable solutions
2019-08-21
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OEM Manufacturing of Freeze-dried products

Spectrum Pharma is growing its capacity and in a year we will be able to increase the output capacity to five million sterile freeze-dried products in vials per year.

Description

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 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 products
  • 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
Production technology Main production steps Glass or plastic

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

* could be upscaled within 6 months on customer request