| Dewitt, NY – November 24, 2009: The Food | | | | either use the specified hammer or revise your |
| and Drug Administration (FDA) has regulations | | | | procedures to allow equivalent tools. The FDA has |
| describing drug packaging (filling). In addition, there | | | | been known to take a copy of the procedure to |
| are specifications for the “container” and | | | | the fill area and observe an operator fill the |
| “closure.” In medical gases vocabulary, | | | | cylinders.” Any divergence from the written |
| “container” means “cylinder” and | | | | procedure could constitute an FDA violation and |
| “closure” means “valve.” | | | | potential fine. |
| Materials examination and usage criteria 21 CFR | | | | Badstubner has more to share on this subject in |
| 211.122(a) states: “There shall be written | | | | “Cylinder Procedures” at Welding & Gases |
| procedures describing in sufficient detail the | | | | Today Online, the leading trade journal for the |
| receipt, identification, storage, handling, sampling, | | | | welding, welding equipment, industrial gases, |
| examination and/or testing of labeling and | | | | medical gases and specialty gases industry. |
| packaging materials; such written procedures shall | | | | For more information, contact Jeffrey |
| be followed.” | | | | Charboneau, editor of Welding & Gases Today, at |
| In other words, those in the business of gas | | | | or 315-445-2347. |
| cylinder filling, management and transport must | | | | About GAWDA |
| have written procedures about receiving cylinders, | | | | Founded in 1945, the Gases and Welding |
| storing cylinders and pre-fill inspections, and those | | | | Distributors Association (GAWDA) is the premier |
| procedures must be followed to the letter. | | | | source for manufacturing knowledge, education |
| In the current issue of Welding & Gases Today, | | | | and networking. Through its member journals ( |
| the journal of the Gases and Welding Distributors | | | | andgasestoday.org), e-magazines, newsletters and |
| Association (GAWDA), FDA and medical gases | | | | industry wiki ( GAWDA connects suppliers of |
| expert Thomas L. Badstubner discusses this | | | | gases and manufacturers of related equipment as |
| important issue in detail. “Be sure your | | | | well as manufacturers of welding equipment and |
| procedures are actually possible to perform in | | | | distribution leaders, for the purpose of safely |
| your environment,” Badstubner warns. | | | | delivering optimal solutions to the users of those |
| “Failure to follow your own procedures can be | | | | products. GAWDA publications are the |
| as significant as the failure to follow an FDA | | | | industry’s voice for all matters related to the |
| regulation. | | | | latest technology and the most up-to-date |
| “For example,” Badstubner continues, | | | | processes spanning welding equipment and |
| “if your procedures require the use of an 8 | | | | products and services related to industrial, medical, |
| oz. ball-peen hammer to conduct a cylinder dead | | | | specialty and cryogenic gases. A 501(c)3 |
| ring test, you must use an 8 oz. ball-peen | | | | organization, GAWDA members are located |
| hammer. A wrench or cylinder cap would not be | | | | throughout North America. |
| acceptable substitutes. In this case, you should | | | | |