Validation

Full compliance with regulatory requirements is the cornerstone of successful product development. From high-level validation approaches to detailed on-site services, our professionals can help with these and other systems.

Performance of:

  • Factory Acceptance Testing (FAT)
  • Commissioning and Start-up

Validation of:

  • Facilities and Utility Systems
    USP Water-for-Injection, USP Purified Water, Pure Steam, RODI Water, HVAC, Clean Compressed Air, Gas Systems, Chilled Water, Plant Steam
  • Process Equipment
    Fermentors/Bioreactors/Single-use Systems, Chromatography Skids, Autoclaves, Glasswashers, Centrifuges, Depyrogenation Ovens, Controlled Temperature Units and Cold Rooms, Microfluidizers, Shaker-Incubators, Microfiltration/Ultrafiltration Skids
  • Lab/Analytical Instruments and Assays
    Incubators/Refrigerators/Freezers, Plate Readers, Thermocyclers, HPLC, Sterility, TOC, Gel and Blot Methods, IR/FTIR/NMR
  • Computer Systems
    BMS/BAS, Part 11, Software Testing and Validation

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