As the US FDA is ready to issue new medical gas protocols, GOW-MAC announces that it can assist medical gas manufacturers, suppliers, and distributors in maintaining compliance with the latest regulations.
US-based GOW-MAC instrument company can provide the analytical foundation to assist in meeting the new FDA medical gas protocols.
The company offers qualification, validation, system suitability processes and analytical training (optional) with every Series 400MGA or Series 580MGA gas chromatograph they manufacture.
The Series 400MGA or Series 580MGA automatically performs USP/NF nitrogen assay and identity test for medical nitrogen. The instrument company also offers assay and identity test GC systems for USP helium, USP oxygen, USP CO2, and USP nitrous oxide. Both instruments assure your product conforms to appropriate standards as required by 21 CFR 211.