Gas Testing Analytical
Independent laboratory and service provider focused on testing, sampling, validation, and monitoring of process gases and related utilities for pharmaceutical, biotechnology, and medical device manufacturers. Services include pharmacopeial monograph testing, on-site and self-service sampling, system qualification and validation, method development, contamination investigation, and audit-ready reporting aligned to USP/EP/ISO and cGMP expectations.
Industries
Nr. of Employees
small (1-50)
Gas Testing Analytical
Clifton, New Jersey, United States, North America
Products
Sampling kit rental
Kits and instructions for client-collected gas sampling with laboratory analysis of returned samples.
Audit-ready deliverables (reports, COAs, validation reports)
Audit-ready validation reports, certificates of analysis, sampling documentation, and integrated interpretation across parameters to support regulatory submissions and inspections.
Sampling kit rental
Kits and instructions for client-collected gas sampling with laboratory analysis of returned samples.
Audit-ready deliverables (reports, COAs, validation reports)
Audit-ready validation reports, certificates of analysis, sampling documentation, and integrated interpretation across parameters to support regulatory submissions and inspections.
Services
Laboratory testing of process gases to pharmacopeial and international standards with traceable methods and certificates of analysis.
Technician-led on-site sampling at source, distribution headers, and points of use using calibrated manifolds and field instruments to collect representative samples.
Rental sampling kits, SOPs, and training enabling customers to collect their own samples for laboratory analysis and reporting.
Comprehensive validation services including protocol design, risk assessment, seasonal and operational-state sampling, statistical analysis, and final validation reports for gas and related utility systems.
Custom method development and validation for gas-phase analytes, including LOD/LOQ characterization and recovery studies to support vendor lot release and unique matrices.
Assistance with acceptance criteria development, inspection readiness, and audit-response documentation aligned to USP/EP/ISO and FDA cGMP expectations.
Laboratory testing of process gases to pharmacopeial and international standards with traceable methods and certificates of analysis.
Technician-led on-site sampling at source, distribution headers, and points of use using calibrated manifolds and field instruments to collect representative samples.
Rental sampling kits, SOPs, and training enabling customers to collect their own samples for laboratory analysis and reporting.
Comprehensive validation services including protocol design, risk assessment, seasonal and operational-state sampling, statistical analysis, and final validation reports for gas and related utility systems.
Custom method development and validation for gas-phase analytes, including LOD/LOQ characterization and recovery studies to support vendor lot release and unique matrices.
Assistance with acceptance criteria development, inspection readiness, and audit-response documentation aligned to USP/EP/ISO and FDA cGMP expectations.
Expertise Areas
- Utility gas testing and qualification (USP/EP/ISO)
- Compressed air and nitrogen system validation
- Purified water system qualification and monitoring
- Cleaning verification and TOC-based cleaning assessment
Key Technologies
- Gas chromatography with thermal conductivity detection (GC-TCD)
- Cavity ring-down spectroscopy (CRDS) for moisture
- Electrolytic hygrometry
- Total Organic Carbon (TOC) analysis
News & Updates
Announcement of a joint venture to establish a specialized laboratory for pharmacopeial gas and utility testing operating within cGMP, FDA-registered laboratory space and using a Part 11-capable quality platform.
Guide to building defensible test plans for vapor-phase and liquid nitrogen, including sampling locations, methods, safety, and applicable monographs and standards.
Discussion of the multidisciplinary skills (microbiology, particulate science, analytical chemistry, physics/engineering) required for robust gas testing programs.
Case study summarizing compressed air qualification, hydrocarbon remediation, cleaning validation, and purified water qualification for a new oral solid dosage facility.
Announcement of a joint venture to establish a specialized laboratory for pharmacopeial gas and utility testing operating within cGMP, FDA-registered laboratory space and using a Part 11-capable quality platform.
Guide to building defensible test plans for vapor-phase and liquid nitrogen, including sampling locations, methods, safety, and applicable monographs and standards.
Discussion of the multidisciplinary skills (microbiology, particulate science, analytical chemistry, physics/engineering) required for robust gas testing programs.
Case study summarizing compressed air qualification, hydrocarbon remediation, cleaning validation, and purified water qualification for a new oral solid dosage facility.