CGA M-25

The scope of this publication covers all packaged medicinal gases as listed below produced by EIGA members and approved as designated medical gases by the U.S. Food and Drug Administration (FDA) or authorised as medicinal products in other jurisdictions. It covers both compressed and liquefied gases, supplied in high pressure cylinders as well as cryogenic liquids, supplied either by tankers into bulk storage tanks or in portable cryogenic containers. It considers all manufacturing processes, including the starting materials used, as well as the CCS used to supply these medicinal gases for patient use.

It covers the quality of the gas up to the point of delivery into the customer’s storage tank or at the outlet valve in either high pressure cylinders or portable cryogenic containers. It does not address the quality of the gas once it has been distributed to the usage point via the customer’s pipeline system.

This publication covers all licensed medicinal gases currently supplied by EIGA, CGA, AIGA, and JIMGA members as follows:

• oxygen;
• synthetic medical air;
• medical air;
• carbon dioxide;
• nitrous oxide;
• nitrogen;
• xenon;
• helium;
• nitrous oxide/oxygen mixtures (normally 50/50 mixture);
• nitric oxide in nitrogen (normally up to 1000 ppm nitric oxide in nitrogen);
• helium/oxygen mixtures (normally 80/20 mixture);
• carbon dioxide/oxygen mixtures (normally 5% but in some cases up to 20% carbon dioxide in oxygen); and
• methane/acetylene/carbon monoxide and oxygen in nitrogen (normally up to 0,3% of each component with 21% oxygen in nitrogen) referred to as lung function mixture.

It considers all manufacturing processes including any starting materials used, up to the filling of the medicinal gas into the CCS or into the customer’s bulk storage tank.

It does not cover medicinal gases that are produced using on-site manufacturing equipment such as pressure swing adsorption (PSA) or air compressing plants on the customer’s premises.

It does not include particles that could be added by the equipment connected by the customer, and only covers the manufacturing process.