ENSURING YOUR SYSTEMS ARE OPTIMAL

Facilities, Utilities, Equipment (FUE) Qualification Support

FUE Qualification Support

At cGMP Consulting Inc., our customized Facilities, Utilities, and Equipment (FUE) Qualification Support services guarantee optimal performance of your facilities and systems, maintaining regulatory compliance and adhering to the highest standards of quality and safety. With a Risk-Based Approach (RBA) to qualification, our engineers meticulously evaluate and identify critical systems requiring qualification. This proactive method not only aligns with current FDA recommendations but also proactively mitigates risks and conserves valuable resources.

Furthermore, cGMP Consulting Inc. prioritizes Critical Aspects concerning product and process knowledge, ensuring paramount patient safety and product quality. Our dedicated team is committed to delivering tailored solutions that optimize your facilities and systems, streamline operations, and drive your organization toward enduring success in today’s ever-evolving regulatory landscape.

(FUE) Qualification Support

cGMP Consulting employs a team with experience in Qualification of equipment, facility, vendor, and process, including, but not limited to:

  • Automated Lyo Loading/Unloading (GEA, SKAN, IMA)
  • Automated Stopper Loading (Atec)
  • Capping Machine (Syntegon, B+S)
  • Clean Air (Atlas Copco)
  • Clean Nitrogen (AirGas)
  • Clean Rooms (Lindner)
  • Clean Steam (MECO)
  • Component Sterilizers (Syntegon / SBM)
  • Containment (Syntegon, SKAN)
  • Crimp Inspection (Seidenader)
  • Depyrogenation Tunnel (Syntegon, B+S)
  • Electronic Batch Records
  • Filling Machine (Syntegon, B+S)
  • Filter Integrity Testers (Pall)
  • Glove Testing Units (Syntegon, SKAN)
  • Lyophilizers/Freeze Dryers (GEA, IMA, Hull, Millrock, SP Scientific)
  • Mixing and Hold Tanks (TKMS)
  • Pharmaceutical Washing Machines (Amsonic Hamo)
  • SCADA Critical Utilities (Siemens)
  • SCADA EMS (Siemens)
  • Semi-Automated Inspection (Seidenader)
  • VHP Cycle Development
  • VHP Transfer Hatch (Franz Ziel)
  • Vial Washing Machine (Syntegon, B+S)
  • Water for Injection (Stainless Fabrication, Enerquip LLC, Alfa Laval)
  • Weight Booths (Franz Ziel)