Cylinder Procedures

The FDA has regulations describing drug packaging (filling). In addition, there are specifications for the “container” and “closure.” In medical gases vocabulary, “container” means “cylinder” and “closure” means “valve.”

Materials examination and usage criteria – 21 CFR 211.122(a) states:

“There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials; such written procedures shall be followed.”

In other words, we must have written procedures about receiving cylinders, storing cylinders and pre-fill inspections, and those procedures must be followed.

Be sure your procedures are actually possible to perform in your environment. Failure to follow your own procedures can be as significant as the failure to follow an FDA regulation. For example, if your procedures require the use of an eight-ounce ball-peen hammer to conduct the dead ring test, you must use an eight-ounce ball-peen hammer. A wrench or cylinder cap would not be acceptable substitutes. In this case, you should either use the specified hammer or revise your procedures to allow equivalent tools. The FDA has been known to take a copy of the procedure to the fill area and observe an operator fill the cylinders. Our industry has received violations because of:

  1. Missing procedures
  2. Inappropriate procedures
  3. Failure to follow the procedures.

A prudent measure is to take your own fill procedure to the fill area and compare your employees’ actions against the written procedure. This review can be a valuable training tool, if you complete the training documentation.

The Pre-Fill Inspection
The “examination of packaging materials” mentioned in the regulation is primarily performed during the pre-fill inspection for new and returned high pressure cylinders. Your procedures should specify how to perform the following inspections:

  1. DOT markings such as retest date, pressure rating, ownership, etc.
  2. External damage (contamination, cuts, digs, gouges, corrosion, dents, bulges, etc.)
  3. Dead ring (hammer test)
  4. Valve inspection (CGA connection, correct safety device and rating, etc.)
  5. Residual test (odor test)
  6. Color inspection/paint (according to CGA C-9).

Beware of cylinders that are contaminated with bodily fluids. Though these contaminated cylinders are rarely found, they are potentially hazardous. OSHA Blood Borne Pathogen regulations require that these cylinders be decontaminated by people who are properly trained, have the proper equipment/procedures and have specific medical exams available to them. Most medical gas manufacturers are not able to properly clean a cylinder that has been contaminated with bodily fluids. You should have arrangements with a company that can properly perform this cleaning. The best protection is to train your drivers to never pick up or handle a cylinder that is contaminated with bodily fluids. The customer should have the cylinder cleaned before returning it to you for refilling.

New and repaired cryogenic oxygen containers may need additional examinations before they are fit for medical service. Many such containers will contain residual nitrogen when they are received at your plant. You should have purging, examination and testing procedures to assure that the nitrogen is removed from new or repaired cryogenic containers prior to being placed into medical service.

Gases and Welding Distributors Association

Thomas L. Badstubner Meet the Author
GAWDA’s FDA & Medical Gases Consultant Thomas L. Badstubner is president of AsteRisk LLC in Blackstone, Massachusetts. Members can reach him at 508-883-0927 and tom@asteriskllc.com.