Pedigree requirements implemented by the FDA for medical gases will be the template for food and beverage grade gases in the near future, suggests Ron Ball.
The quality specifications for food and beverage grade and medical grade gases are very different. However, each of these different grades of gas depends on one thing – the paperwork pedigree – to distinguish them from common industrial grades of the same gas. At the same time, new Federal and state regulatory agencies are turning their focus to the prevention of prescription drug counterfeiting through the implementation of new rules and regulations requiring something called a ‘prescription drug product fingerprint’.
This article will look at recent changes in some parts of the US, what are these new requirements, and what can gas producers look forward to in the coming months.
Differing product specifications
The specification for product assay of medical grade gases in the US is typically only 99 percent, while in other parts of the globe, such as Europe and Asia, for common medical gases such as oxygen and nitrogen, the assay specification is typically 99.5 percent. In the US, the United States Pharmacopeia (USP) established these assay specifications early in the last century. They were based on the manufacturing processes used by industry then and the limited analytical capabilities of that era. In those days, a 99 percent pure product was a high standard to achieve. Nowadays, with our ultra modern air separation facilities and digital analyzer systems capable of measuring impurities to a single part per million (ppm) and better, 99 percent pure medical gas is a much easier threshold to achieve.
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