In the food and pharmaceutical industry, ensuring the safety and quality of products reaching the end consumer is a top priority. Materials that come into contact with food or pharmaceutical products must meet stringent international standards to ensure their safety.
In this article, we will analyze what are known as FDA materials and the different approvals of elastomers for the food and pharmaceutical industry that exist, understanding their specific function and their practical application in the maintenance and manufacture of machinery for this demanding sector.
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FDA materials and the different regulations for approved elastomers
To start talking about the approved elastomers available, we must begin by explaining exactly what elastomers are: elastomers are a type of polymer whose main characteristic is their elasticity. They are key components in sealing and gasketing systems in the food and pharmaceutical industry, and are used in food processing, storage and transport equipment, pharmaceuticals and medical devices.
Although the expression “FDA material” is the most common one, there are different materials and types of approved elastomers by accepted international standards, which comply with specifications for contact with food or other products for human consumption.
FDA (Food and Drug Administration)
The Food and Drug Administration (FDA) is one of the oldest and most recognized regulations worldwide, and establishes a list of approved materials for these applications, which are safe for contact with food and drugs. Although it is U.S.-based, the FDA has global acceptance, which has made it a benchmark in the approval of elastomers for these industries.
Thus, FDA materials would be approved elastomers that comply with the different controls established by this agency, ensuring their safety in contact with food or drugs in the face of industrial use, mechanical wear, chemical exposure, temperature or aggressive chemical cleaning systems.
It should also be noted that the FDA promulgates a list of substances and chemicals as “acceptable for food contact”. These elastomer compounds manufactured with approved substances are considered “FDA compliant”, without necessarily being laboratory tested. However, a strict approval of a compound would involve specific migration tests, distinguishing water-based products from fatty products. Dry products do not require migration testing.
Standard EN 1935/2004 (European Standard)
The EN 1935/2004 standard regulates the food contact materials in Europe. Although it is not as specific as the FDA in terms of permitted substances or migration testing, it establishes a general framework that must be respected throughout the European Union.
Compliance with EN 1935/2004 facilitates the commercialization of equipment and materials throughout the European market, reducing regulatory barriers (and consequently benefiting manufacturers).
3A Sanitary Standards
Initially developed for the dairy industry in the United States, the 3A Sanitary Standards have become a standard for the dairy industry. recognized standards in the manufacture of aseptic equipment.
This regulation defines specifications for the design, manufacture and installation of equipment and ensures that materials and components are easy to clean and maintain safety in food processes.
The 3A Sanitary Standards are especially relevant in the dairy industry and in liquid product processing systems, where cleanliness and hygiene are critical.
USP Class VI (United States Pharmacopeia)
The USP Class VI standards are essential in the pharmaceutical industry.. It sets standards to ensure that materials are safe and do not interact adversely with pharmaceutical products.
Compliance with this standard for approved elastomers is frequently required by manufacturers and end users of these types of installations. It is a commonly requested approval in the manufacture of medical equipment, injection systems and pharmaceutical processing equipment.
NSF (National Science Foundation)
Within elastomers and their homologation, NSF certifies products in contact with food and drinking water. It is an independent U.S. organization that evaluates materials based on public health and safety standards. These NSF-approved materials are used in water distribution systems and in the manufacture of liquid food processing machinery components.
FDA materials and existing elastomer types
At Epidor we offer a wide variety of certified materials: EPDM, Nitriles, Silicones, Fluorocarbons (FPM), PTFE, POM... including certified detectable materials for Tri-Clamp type hygienic seals, but also for O-rings or even for any custom-made part manufactured by molding or machining, all of them elastomers approved for the food and pharmaceutical industry that comply with regulations such as FDA, ADI free, CE1935/2004, Phthalate free, and some USP Cl VI.
In the case of detectable materials, these are materials that comply with the regulation, a FDA elastomer base and plastics detectable in metal and visible by X-rays which provide added security for sensitive applications.
Our technical team of experts in approved elastomers and FDA material is at your disposal to help you select the material that best suits your specific needs. We guarantee quality, safety and performance in every solution!
Do you have doubts and want to know which FDA approved elastomers and FDA material does your food or pharmaceutical industry need?? Contact Epidor and we will help you ensure greater safety and increased productivity.