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Project

Freeze Dryer & Filling Line Aseptic Isolator for handling cytotoxic products

Year

2020

Location

South Korea

Description

Comprising of an aseptic Isolator system covering the filling line and lyo loading and unloading. The Isolator System is designed for the filling of vials with aseptic liquid then Lyophilisation followed by capping / crimping and washing prior to removal from the line.  The line also offers operator protection to a working OEL (Occupational Exposure Limit) of less than 1µg/m³ TWA over an 8hr operational period.

Scope

Sterile Multi-Chamber Filling/Lyophilisation Line comprising: –

  • 7 module system
  • Filling & Closing machine Isolator
  • Buffer Conveyors
  • Lyo Isolator integration
  • VHP biodecontamination system
  • Viable Monitoring system
  • Non-viable Monitoring system
  • RFID Glove Tester
  • Cold shelf loading system
  • Low temperature air handling unit