Preparing Medical Containers

FDA evaluates practice of container reuse.

One of the unique aspects of medical gases compared to traditional pharmaceuticals is that our industry reuses our drug containers. During our site audits, it is quite common to see medical cylinders that have been in service for over a half century. Outside of a museum, I doubt there is anywhere you could find a pill bottle that old. Reuse of containers is a significant factor in FDA’s thinking as they revise their guidance documents for our industry. Once the medical gas guidance document is finalized, we expect it will have a significant impact on requirements for preparing containers to enter medical gas service. The past practice used by many firms to put an industrial container into medical service simply by changing the label, and maybe the paint, will no longer be acceptable. This article will examine some of the anticipated changes FDA will require.

The changing requirements for preparing medical containers stems from FDA’s concerns over potential industrial contaminants entering the medical gas supply stream. While rare, there are a small handful of documented instances where this has occurred in our industry, which appears to be driving FDA’s change in thinking on container prep.

We anticipate future requirements will create two new areas of concern for manufacturers: new units, and units moving into medical service. Future considerations for new units will likely require medical gas manufacturers to work closely with their container and valve suppliers. We expect that medical gas firms will have to start collecting and maintaining appropriate documentation attesting to the container’s suitability for medical service. Documents provided by the supplier, such as a certificate of suitability for medical service, or cleaning and testing documentation, will likely suffice. When you receive new containers in the future, we anticipate quarantine, inspection and release for use by the QC Unit are likely to become considerations. Firms that assemble their own cylinders and valves, or have it done by a third party, will likely need to document some of the activities in this process, such as performing internal inspections.

Hydrotesting medical cylinders also has potential future considerations. These include knowing the answer to questions such as: Does your vendor use only potable grade water to perform testing? What controls and safeguards do they employ to ensure cylinder internals are not contaminated while the valve is out of the cylinder? Since UT testing does not expose cylinders to these risks, it is likely to become the preferred retest method for medical gas cylinders in the future.

Units previously in industrial gas service that enter medical gas service, even in the same gas service, will likely have revised prep and documentation requirements. The burden will be on medical gas firms to ensure the container is suitably prepared for medical service, and documentation of that process is kept. One potential FDA expectation we are likely to see is that all containers entering medical service must go through an approved cleaning/prep process. Since there are so many different styles and types of containers in our industry, there will probably not be a single, one-size-fits-all approach to container qualification.

Container qualification and prep requirements is an area we are watching closely on behalf of the GAWDA membership. As FDA begins to communicate to our industry definitive expectations, we will be providing members with specific details they need to attend to in order to maintain compliance in their business.

Gases and Welding Distributors Association
Meet the Author
GAWDA Medical Gases Consultant J. Robert Yeoman is president & CEO of B&R Compliance Associates LLC in Lehigh Valley, Pennsylvania. Members can reach him at (610) 868-7183 and at bob.yeoman@brcompliance.com.