Are you cleaning your cylinders according to the FDA CFR Section 211.80 to Section 211.94?

Drug product containers and closures play a critical role in assuring that the drug product provided to the patient has the appropriate same strength, quality, and purity.  This presents unique risks to be considered that are not present in other industries where the containers and closures are used only once.  Therefore, all high pressure cylinders and all cryogenic vessels and their associated valves are required to undergo strict pre-fill inspections, prior to filling with a medical gas.  The agency is currently investigating the possibility of requiring dedicated medical drug containers.

Adequate cleaning procedures should be established and followed in order to prevent any contamination or impurities from being introduced into a medical drug container.

The FDA has received several reports of patients suffering injuries due to high pressure cylinders that were contaminated with unusual chemicals, such as Freon 14, benzene, chlorine, etc.  All high pressure cylinders are required to be cleaned prior to the introduction of a medical gas.

To properly clean/disinfect cylinders, providers should:

1. Use the right cleaner/disinfectant on the cylinder body only (NOT on the valve opening). For label adhesive and grime, try Applied's Label Remover 3G. 
2. Ensure NO contaminants are left behind by inspecting according to CGA G-4.1 and use a black light (Applied PN: 1100-9994).
3. If contaminants are found, use a CGA listed and approved oxygen cleaner (like Applied’s Oxygen Equipment Cleaner).