Processess - Test and Demonstration Area

The Containment systems test and demonstration area is located in Building 5 of the ILC Dover Campus.

  • Test Stand (shown prior to test upgrade)
    • 2 Vessels
    • 2 Discharge Ports
    • 9 Charge Ports
  • "SMEPAC" Test Area
    • Encapsulates 1/2 of total test stand
    • Class 100,000 installation
    • 1st Floor — 16'x16'x8'
    • 2nd Floor — 12'x16'x8'
    • Fixed ladder access and hoist pass thru between floors eliminates eliminates outlier contamination transfer
    • Airlock for personnel entry
  • Independent third party support
    • Clean room validation and certification
      • Third party Test procedure
      • Federal standard 209
      • ISO 14644
      • FDA guidelines for industry's sterile drug products produced by aseptic processing. Current good manufacturing practices — September 2004
    • Containment Verification Testing
      • OSHA Technical manual
      • Best industrial hygiene practices
      • ISPE good practice guide, assessing the particulate containment performance of pharmaceutical equipment — 2005 Edition

Used for new product development design verification, training and factory acceptance testing.

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