Compliance Technology Group
Compliance Technology Group, Inc. is a full-service consulting firm specializing in Commissioning/Validation, Steam Quality Testing, and HEPA Filter Certification services for pharmaceutical, biotech, medical device, and medical diagnostic industries. They focus on preparing and executing commissioning/validation documents for equipment, utilities, processes, laboratory instruments, and computerized systems, ensuring client compliance with applicable government regulations. Their experienced team manages projects of any size, offering services such as system/process auditing, protocol support, thermal mapping, biological indicator studies, and more. They also provide extensive validation test equipment, maintained and calibrated with NIST traceable schedules, and have a broad portfolio of services to meet regulatory compliance needs.
Industries
Nr. of Employees
medium (51-250)
Compliance Technology Group
Services
End-to-end commissioning and validation support for equipment, utilities, processes, and facilities including protocol development, execution, and reporting.
On-site steam testing for non-condensable gases, dryness value and superheat to support sterilization qualification and troubleshooting.
Certification and testing of cleanrooms, fume hoods and biosafety cabinets to ISO/IEST/Federal standards including HEPA leak testing and airflow profiling.
Qualification and method validation for laboratory instruments and analytical methods, including TOC, NIR, moisture analyzers and titrators.
Validation support for purified water, clean steam, HVAC, CIP/SIP skids, gas delivery and other facility utilities.
Project management, protocol execution, P&ID verification, report writing and start-up implementation to integrate validation activities with client teams.
End-to-end commissioning and validation support for equipment, utilities, processes, and facilities including protocol development, execution, and reporting.
On-site steam testing for non-condensable gases, dryness value and superheat to support sterilization qualification and troubleshooting.
Certification and testing of cleanrooms, fume hoods and biosafety cabinets to ISO/IEST/Federal standards including HEPA leak testing and airflow profiling.
Qualification and method validation for laboratory instruments and analytical methods, including TOC, NIR, moisture analyzers and titrators.
Validation support for purified water, clean steam, HVAC, CIP/SIP skids, gas delivery and other facility utilities.
Project management, protocol execution, P&ID verification, report writing and start-up implementation to integrate validation activities with client teams.
Expertise Areas
- Commissioning and qualification (C&Q)
- Process and cleaning validation
- Steam quality testing and diagnostics
- Cleanroom and HEPA certification
Key Technologies
- Thermal mapping
- Biological indicator testing
- Airflow visualization / smoke studies
- Steam quality testing (NCG, dryness, superheat)