| CTG ‘s experienced professional staff with extensive knowledge of the biopharmaceutical industry and the related regulatory standards are well seasoned to provide the highest level of Validation and Commissioning services to your company. Areas we provide these services include: |
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Equipment:
We provide the highest level of expertise for all your Equipment Validation needs.
CTG is extremely qualified and familiar with a large variety of equipment including:
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| Biotechnology Manufacturing Related Equipment |
| Scale Up |
Support Services |
Cell Culture: |
Down Stream Process |
| Incubators |
Autoclaves |
Bioreactors |
Size Filtration |
| Table Top Reactors |
Depyrogenation Ovens |
Micro Filtration Skids |
Viral Filtration |
| Wave- Bioreactors |
Ultrasonic Washers |
Centrifuges |
Column Packing Station |
| Flottle/ Flask Culture Set up |
Parts Washers |
Harvest Lines & Vessels |
UF/DF Skids |
| DDC Units |
Media & Buffer Tanks |
Conditioning Vessels |
Chromatography Skids |
| Rocker Panels |
Tanks |
Spin Filters |
Depth & Nano-filtration |
| Roller Units |
Transfer Lines |
Aspetic process |
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| Shakers |
SOP Stations |
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COP Stations |
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| Pharmaceuticals Process Related Equipment |
| Preparation |
Filling |
Finishing |
| Mixers/ Blenders |
Conveying Systems |
Packaging Equipment |
| Lyophilizers |
In-Line Washers |
Bar-Code Readers |
| Crystallization Process Equipment |
Depyrogenation Tunnels |
Inspection Stations |
| Centrifuges |
Filling Machines: Bottle / Syringe/ Vials / Ampoules |
Barrier Isolators |
| Siliconizer-Sterilizers |
Stoppering Machines |
Storage Areas/ Units |
| Scrubbers |
Capping Machines |
Tracking Systems |
| Granulators |
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Utilities Start-Up Validation:
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| Purified Water Systems (RODI, USP, WFI, Clean Steam) |
HVAC |
| Gas Delivery Systems (Process Air, Oxygen, Nitrogen, Carbon Dioxide, etc..) |
Clean-In-Place Skids |
| Supporting Water Systems (Chilled, Domestic) |
Waste Neutralization / Biohazardous Containment Systems |
| Cooling Systems (Glycol, Syltherm, Oil-based) |
Scrubbers |
| Dryer Vacuum Systems |
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Computer / Automation Validation:
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| 21 CFR Part 11 |
Detailed Design Specification (DDS) |
| Distributed Control System (DCS) |
Traceability Matrix |
| User Requirement Specification (URS) |
Computer System Validation Plan |
| Functional Requirement Specification (FRS) |
Gap Analysis |
| GAMP 4 Implementation |
ISA Standards (S88, S95) awareness |
| PLC and Microprocessor Controlled Validation |
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Laboratory Instrumentation:
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| TOC Analyzers |
Spectrophotometer |
| Moisture Analyzers |
UV/IR |
| Densitometers |
NIR |
| Differential Scanning Calorimeter |
NMR |
| Elemental Analyzer |
Titrators |
| Microbial Characterization System |
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| Prospective/Concurrent/Retrospective |
Clean Room Application |
| In-Process Monitoring |
Assay Qualification |
| Data Review and Study Certification |
Establishing Acceptance Criteria |
| Expert Evaluation |
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| Method selection and development |
Support existing methods or generate new protocols |
| Technical consultation for: |
Defining appropriate methods |
| Limits of detection and accuracy |
Quality requirements |
| Determining acceptability of observed method performance |
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| Strategic planning and implementation of cleaning programs |
Execution of cleaning validation protocols |
| Generation of protocols and reports |
Data interpretation |
| Process development and resource optimization |
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Facility Related Validation:
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| Surface Verification (Floor, Wall, Entrance, Filters, etc..) |
Environmental Testing/ Programs |
| Construction Verification (Materials, Design, Safety, etc..) |
Room Certification |
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If you have any questions regarding Validation Services
please contact us or call 484.356.0618
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