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Medical Gases
The Food and Drug Administration (FDA) classifies compressed and cryogenic medical gases asdrug products. To ensure the identity, strength, quality and purity of finished drug products they must be produced and distributed in accordance with current Good Manufacturing Practices (GMP’s). These GMP’s must be followed during all phases of the production and distribution from the basic air separation facility to the final cylinder filling facility. GMP’s also require that finished medical gas drug products must pass required testing prior to release. Documentation of the finished product testing results must be maintained by the producing entity to provide traceability of all medical gas products.
The Industrial Gas Suppliers Alliance (IGSA) members are registered with the Food and Drug Administration (FDA). To ensure that IGSA members provide quality medical products to hospitals, nursing homes, and homecare providers in our local communities IGSA members use GMP’s that are developed by review of the best practices published by the Compressed Gas Association (CGA) and Gas and Welding Distributors Association (GAWDA). Our customers look to our members to help reduce their costs with alternative products as well as safety recommendations to reduce the risk from the hazards of high pressure cylinders around employees and patients. The Industrial Gas Suppliers Alliance understands the importance of our local service and technical support to our communities during times of local or national emergencies and has the personnel, facilties, and equipment to make a difference.