Equipment Validation

ADVENT provides Process System Equipment and Analytical Equipment Validation services for all phases of Biopharmaceutical manufacturing.

  Process System Equipment Validation Services:

• Ultra-Filtration
  
• Chromatography
  
• Centrifugation
  
• Batch Fermentation/Cell Culture
  
• Continuous Perfusion Fermentation
  
• Clean In Place
  
• Steam In Place
  
• Autoclave
  
• Viral Inactivation
  
• Pasteurization
  
• Lyophilization
  
• Freeze/Thaw System

Analytical Equipment Validation Services:

• Total Organic Carbon Analyzers
  
• Spectrophotometers
  
• Bimolecular Interaction Analyzers
  
• Capillary Electrophoresis

Autoclave Experience:

• Fedegari, Finn Aqua IOQ, PQ, RQ
• Fedegari, Finn Aqua, Castle RQ
• Finn Aqua IOQ, PQ
• Dry Heat Oven

Building Automation System Experience:

• Johnson Controls
• Andover Controls, Siemens and Voltec

Centrifuge, Chromatography, Filter Press & UF/DF Skid Experience:

• Control System Software OQ
• Validation IQ, OQ
• Cleaning Validation
• IQ/OQ/PQ for equipment and controls

Chromatography Column Packing Experience:

• Process Development Studies

CIP Systems Experience:

• Process Development
• User Training
• Allen Bradley PLC Software OQ
• CIP Abort Mitigation
• CIP IQ/OQ/PQ

Clinical Manufacturing Facility Experience:

• Fermentor, transfer lines, media exchange IQ,OQ,PQ

Commissioning Experience:

• Fermentation Suite
• Purification Suite
• CIP Systems
  

Depyrogenation Tunnel Experience:

• Tunnel Sterilizer RQ
• Dry Heat Oven
  

Fermentor Experience:

• Cleaning, SIP
• IQ, OQ
• OQ, PQ
  

HVAC Systems Experience:

• IQ, OQ, PQ
• IOQ, OQ, PQ

Lyophilizer Experience:

• Stokes Lyophilizer Full Upgrade
• Edwards Lyophilizer RQ
• Stokes Lyophilizer RQ
• Edwards Lyophilizer RQ
• Edwards Lyophilizer Cleaning Validation
  

Parts Washer Experience:

• Huebsh Stopper Washer
• Stopper Processors ICOS, SMEJA, Huber
• Hamo T- 410/T-420

Pasteurizers, Viral Inactivation Experience:

• Thermal Mapping and Insulation Verification, IQ, OQ, PQ

Purification Suite Experience:

• IQ, OQ, PQ of Chromatography & UF/DF Skid, Thaw Tank, Viral Inactivation Tank, and Carts & Transfer Lines

Reverse Osmosis Experience:

• IQ, OQ
• IQ, OQ
• IQ, OQ
• OQ, PQ
  

Sterility Isolators Experience:

• Laboratory Modification Including Equipment Installation, SAT, IQ, OQ

Vial Washer Experience:

• Vial Washer RQ
• Glass Washer IOQ
  

Water Systems Experience:

• HWFI CWFI Capacity Studies
• Purified Water System Validation
• Purified Water System Design
• Reverse Osmosis IQ, OQ PQ
  

For more information about our services and products: Contact Us