Commissioning / Validation
The responsibilities and jobs associated with the Commissioning and Validation efforts will be performed by staff members with the specialized knowledge of the assignment. CTG is extremely knowledgeable regarding integration of Commissioning and Validation to streamline qualification requirements. The related services we offer include:
Compliance Support
• Project Management
• Validation Strategy Development
• Quality Program Implementation
• Life-Cycle Planning
• Regulatory Compliance Consultation
• Document Control Advancement
System/Process Auditing
• Hands On Support
• Protocol Preparation
• Protocol Execution
• Thermal Mapping
• Biological Indicator Studies
• P&ID and Drawing Verification
• Testing of Sterilization Processes
• Specification Development
• Report Writing
• Start Up Implementation
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:
- Equipment
- Methods Validation
- Utilities
- Cleaning Procedures and Process
- Computer System
- Automated Systems
- Laboratory Instrumentation
- Facilities Related Validation
- Process Validation
| 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 |
| Bottle/ 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 | Aseptic Process | |
| Shakers | SOP Stations | ||
| COP Stations | |||
| 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 | ||
| Utilities Start-Up Validation | |
| Purified Water Systems (RODI, USP, WFI, Clean Steam) | HVAC |
| Gas Delivery Systems (Process Air, Oxygen, Nitrogen, Carbon Dioxide) | Clean-In-Place Skids |
| Supporting Water Systems (Chilled, Domestic) | Waste Neutralization / Biohazardous Containment Systems |
| Cooling Systems (Glycol, Syltherm, Oil-based) | Scrubbers |
| Dryer Vacuum Systems | |
| Computer / Automation Validation | |
| 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 | |
| Delta V | |
| Laboratory Instrumentation | |
| TOC Analyzers | |
| Moisture Analyzers | UV/IR |
| Densitometers | NIR |
| Differential Scanning Calorimeter | NMR |
| Elemental Analyzer | Titrators |
| Microbial Characterization System | |
| Process Validation | |
| Prospective/Concurrent/Retrospective | Clean Room Application |
| In-Process Monitoring | Assay Qualification |
| Expert Evaluation | |
| Method Validation | |
| Method Selection and Development | Support Existing Methods or Generate New Protocols |
|
Technical Consultation for: • Limits of Detection and Accuracy • Determining Acceptability of Observed Method Performance |
|
| Cleaning Validation | |
| Strategic Planning and Implementation of Cleaning Programs | TOC and Swab Sampling |
| Generation of Protocols and Reports | Data Interpretation |
| Process Development and Resource Optimization | |
| Facility Related Validation | |
| Surface Verification (Floor, Wall, Entrance, Filters, etc..) | Environmental Testing/ Programs |
| Construction Verification (Materials, Design, Safety, etc..) | Room Certification |
