Full menu

Support Processes

Samsung BioLogics is equipped with a novel, state-of-the-art Fill and Finish facility with aseptic filling, lyophilizers with automated loading and unloading, and capping integrated within a Restricted Access Barrier System (RABS). All processes are cGMP compliant and are validated to meet customer and regulatory requirements. Samsung BioLogics’ dedication to quality and optimal services is visible in everything we do, from small-scale clinical trials to large-scale commercial production.

Samsung's drug product facility is designed to meet
all FDA and EU Annex 1 requirements for Sterile Drug Product Manufacturing

Terminal Sterilization

Terminal Sterilization Specifications items include Sterilization, and so on.
Sterilization
Equipment
  • One (1) Terminal Sterilizer
Capacity/Capability
  • 8000L chamber capacity
  • Max. capacity: 2R vials 180,000, 6R vial 90,000, 10R vial 68,000, 20R vial 43,000
  • Vacuum pulse and air/steam mix
Terminal Sterilization Specifications items include Sterilization, and so on.
Sterilization
Equipment
  • One (1) Terminal Sterilizer
Capacity/Capability
  • 8000L chamber capacity
  • Max. capacity: 2R vials 180,000, 6R vial 90,000, 10R vial 68,000, 20R vial 43,000
  • Vacuum pulse and air/steam mix

Leak Detection

Leak Detection Specifications items include Leak Detection, and so on.
Leak Detection
Equipment
  • Leak Detector
Capacity/Capability
  • 12,000 vials/hr (20R vial)
  • Includes Headspace Analysis (HSA), Pressure Decay and Vacuum Decay
  • Liquid and lyophilized vials
Leak Detection Specifications items include Leak Detection, and so on.
Leak Detection
Equipment
  • Leak Detector
Capacity/Capability
  • 12,000 vials/hr (20R vial)
  • Includes Headspace Analysis (HSA), Pressure Decay and Vacuum Decay
  • Liquid and lyophilized vials