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What is the FDA and What is an FDA Elastomer?

October 7, 2013
FDA Approved Sanitary Tri-clamp Gasket

FDA Approved Sanitary Tri-clamp Gaskets

When you think of sanitary process equipment you normally think of stainless steel items. Along with stainless steel, most pieces of sanitary process equipment contain elastomeric (rubber) products as well.  Sanitary pumps have cover o rings and in many cases lip seals.  Valves have elastomeric o-rings, gaskets and valve seats.  And every tri-clamp union has a sanitary gasket.

For the food and beverage industry, sanitary gaskets and o-rings are required to be constructed of FDA materials.  In the bio-pharmaceutical industry, besides being made from FDA approved materials, sanitary o-rings and gaskets normally have to be tested to USP Class VI as well.  This post will give clarity to what FDA approval of sanitary elastomers means.  We will address USP Class VI in a future post.

FDA, let’s begin by explaining what those letters stand for and what this organization’s function is in our world.

The letters FDA stand for The Food and Drug Administration

The Food and Drug Administration is a US Federal Agency that is in charge of guaranteeing that foods are safe, healthful and sanitary and that human and veterinary drugs, biological products and medical devices are safe and effective; cosmetics are safe; and electronic products that release radiation are safe.

The FDA regulates the safety and goodness of food in the United States and also sets conditions for its labeling.  It conducts regular examinations of food producers and processors to conclude if they are following these regulations. Those that are not can tackle a gamut of penalties including being forced to shut down.

In the Drug industry before a new drug can be developed and distributed to the market, its manufacturer must prove to the FDA that it is safe and successful. To do so it must be created and tested in agreement with FDA regulations. Drugs that meet this criteria are deemed FDA approved. There are also many FDA regulations regarding the labeling and marketing of these drugs. Biologics such as vaccines are subject to similar rules.

Although the control of the FDA is restricted to the United States, FDA parameters are frequently accepted as international control standards. Through its Codes of Federal Regulations the FDA declares a list of materials and chemicals that are approved for contact with food. FDA CFR 21.177.2600 paragraphs A to D describe the significant regulations for ‘Rubber articles intended for repeated use’. This lists the ingredients, and any measurable limits, that may be used in a rubber compounds for molded products intended for recurrent use in all stages of food manufacture, preparation and transportation.

FDA CFR 21.177.2600 paragraphs E and F also specify limits on extractable products if the FDA rubber seal is to be used in contact with aqueous or fatty foods. The regulation specifies extraction test limits in water and n-hexane. It is important to note that for an FDA rubber material to be compliant to these conditions, then this claim must be supported with appropriate documentation such as a manufacturer’s FDA certificate.

FDA does not ‘approve’ products to CFR 21.177.2600. It is for the manufacturer of the finished FDA rubber product to show compliance by issuing a FDA certificate. It is also important to note that while a component may be made from a FDA rubber material that is appropriate for food contact; this does not mean that the part is technically suitable for its intended application.

Holland Applied Technologies stocks a wide assortment of FDA approved Elastomers O-rings, hygienic gaskets and custom-designed components from a range of FDA-compliant rubber materials, including NBR, EPDM, Silicone, HNBR, FKM, and FFKM.

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