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
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