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

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

Fermentor Experience

• Cleaning, SIP
• IQ, OQ
• 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

Sterility Isolators Experience

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

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