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To provide a robust and controlled operational environment the facility is provided with the following key features:
  • Validated Environmental Monitoring System for all GMP areas (recording and generating alarms for temperature, pressure & humidity ) with facility wide information displays.
  • Commissioned Building Automation System (HVAC & support utility systems) with facility wide information displays
  • Seamless modular clean room system to all GMP areas
  • Walk on ceilings for external service/maintenance
  • Door interlock system and card access control system
  • Video monitoring of all areas
  • Synchronized clock system
The facility is provided with the following utility systems:
  • Purified water generation & distribution system:
    • 4,100Ltrs/Hr
    • 20,000Ltrs storage system
  • Water for Injection generation & distribution:
    • 3,300Ltrs/Hr
    • 10,000Ltrs storage system
  • Pure steam generation & distribution:
    • 1,600 Kg/Hr
  • Compress air generation & distribution
  • Nitrogen distribution
  • Plant steam generation & distribution
  • Heating hot water generation & distribution
  • Chilled water generation & distribution
  • Waste treatment/neutralization system

 

The facility and process incorporates the following redundant and back up systems:
  • WFI storage (sufficient to complete any production batch started)
  • Redundant WFI distribution system
  • Purified water storage (sufficient to complete any production batch started)
  • Redundant purified water distribution system
  • Redundant air compressors
  • Redundant steam boilers with dual fuel services (oil & gas)
  • Redundant heating hot water distribution system
  • Redundant chilled water & distribution system
  • Redundant power transformers
  • UPS to all critical control systems
  • Back up generator
OncoGenerix