Products

OEM Manufacturing of Freeze-dried products
SPECTROS 150IU with bacteriostatic diluent
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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 technologyMain production steps Glass or plastic

 size
Batch sizeBatch size*
Freeze-dryVials washing
Vials dry heat sterilisation
Vials aspetic filling
Freeze-drying
1 ml1380
10 ml1280
20 ml1000
30 ml350
50 ml110
Aseptic fillingVials washing
Vials dry heat sterilisation
Vials aseptic filling
1 ml.380020 000
10 ml190010 000
20 ml13006 500
30 ml4002 000
50 ml2001 000
Terminal sterilisationVials washing
Vials dry heat sterilisation
Vials aseptic filling
Autoclaving
1 ml380016 800
10 ml19008 400
20 ml13006 800
30 ml4001 350
50 ml200840

* could be upscaled within 6 months on customer request

 

OEM Manufacturing of Freeze-dried products

Attention

Spectrum Pharma does not ship to countries, which classify these pharmaceuticals as special controlled or scheduled substances, including but not limited to the United States, Australia, Canada and Europe.

  • – We do not sell any products online.
  • – We do not sale to the public.
  • – We do not ship any products.
  • – We are not directly or indirectly associated with any websites that may engage in selling same or similar products.


Information contained within this website is not a prescription to use and is intended for information purposes only. Our products are made in Europe area and follow local laws accordingly, but FOR EXPORT ONLY. All manufacturing is in accordance with USP or BP Guidelines. Please Note: We are not an online store. We do not sell or ship to the USA, Europe, Australia or any other locations where prohibited. All information contained within this website or in any literature provided is not a prescription to use. Please seek the advise of a physician specializing in Andrology before use.