In June 2003, the FDA issued a new Guidance Document on medical gas usage. Since then the pharmaceutical and bio-pharmaceutical industry has begun the process of qualifying gases they routinely use in production operations.
Gas Analysis Services provide a complete solution for the analysis of medical and pharmaceutical process gases. Using a combination of on site and laboratory analysis all current regulatory requirements can be met.
GAS Analysis Services has invested in the technology and personnel required to offer comprehensive gas testing services for pharmaceutical and biotechnology clients. Commonly tested gases include:
• Nitrogen to USP / EP standards
• Carbon Dioxide to USP / EP / EIGA standards
• Oxygen to USP / EP standards
• Compressed Air to USP / EP / ISO standards
The GAS team work with clients to develop gas testing validation protocols and reports to insure company’s meets HPRA / EMA / FDA requirements for gas usage.
GAS also carries out both viable and non-viable particulate count testing on all compressed gases or such as Nitrogen, Oxygen, Argon, Carbon Dioxide, Hydrogen, Helium, Compressed Air