Sterile Contract Manufacturing

Our sterile contract-manufacturing site offers the following sterile injectable capabilities.

  • Terminal Sterilization capabilities
  • Ampoule formats: 1 mL, 2 mL, 3 mL, 4 mL, 5 mL, 6 mL, 10 mL and 15 mL
  • Batch sizes range from 30 L to 1000 L
  • Our facility is equipped with:
  • Two ampoule washing, depyrogenation and filling machines from Bosch, Germany with filling capacity of
    24,000 unit/hour for 2 mL ampoule
  • Two autoclaves for terminal sterilization from Fedegari, Italy and De Lama, Italy with chamber volume of 2 m³ and
    4 m³ respectively
  • Three Automatic Optical inspection machines:
    Two from Brevetti, Italy with capacity of 12,000 unit/hour and 18,000 unit/hour for 2 mL ampoule
    One from GF, Italy with capacity of 18,000 unit/hour for 2 mL ampoule

  • Fully automated Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems
  • Production of Water For Injection (WFI) and Highly Purified Water (HPF) according to EP specifications.
  • Ventilation system consist of class A, B, C and D. All filling procedures are carried out in A and B classes. All other operations are take place in class C and D..
  • All laboratories are operated under Good Laboratory Practices (GLP) by highly qualified personnel.
  • Empty glass ampoules are produced within our facility through seven machines from Moderne Mechanique, France.
  • Production capacity per machine: 25 million/unit annually for 2 mL ampoule.
  • Production range: 1-25 mL