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Are Your Washers FDA Compliant?

When it comes to food, beverage, and pharmaceutical industries, companies are looking for FDA-approved materials for equipment manufacturing. While the nature of large components is undoubtedly specified, what about such small parts as nuts and gaskets?

Any domestic metric washer manufacturer should be able to tell you whether the materials it uses are FDA-compliant.

What Does It Mean To Be FDA Compliant?

A washer can be considered FDA compliant if it’s:

  • Made from GRAS (Generally Regarded As Safe) materials.
  • Follows existing FDA regulations. Some of the materials are already covered by the guidelines.
  • Submitted to FDA for food control notification.

Common FDA-Compliant Washer Materials

If you require washers for food or pharmaceutical needs, you may want to consider the following materials:

  1. Perfluorocarbon resins (PTFE)

PTFE is one of the most common materials used when FDA approved washers are required. The compliance of PTFE is described in the Code Of Federal Regulations, title 21 CFR 177.1550.

Filled PTFE washers can be used as FDA- approved when the filler, coloring agents, etc. are considered to be GRAS or covered by another regulation. In some cases, special tests may still be required to prove the compliance of the washer.

  1. Elastomers 

Besides PTFE, you could find many metric washers made from the elastomer. Elastomer (or rubber) washer material may be FDA- compliant. The elastomer components are described in the Code Of Federal Regulations, title 21CFR 177.2600.

Not all elastomer washers are suitable for the above-mentioned industries. The criteria must be studied thoroughly to find the acceptable rubber material types as well as acceptable fillers i.e. just any rubber washer won’t do. In some cases, extra testing may be required to ensure the elastomer compliance.

Other Things To Consider

Even if you are purchasing an FDA-compliant gasket, you need to ensure that adhesive used with the materials are also suitable. Some of the washers may also need an adhesive to aid in the assembly.

Though these adhesives are mostly required to ensure that the gasket is fully secured, they must also meet certain FDA requirements. The acceptable adhesive materials can be searched for in the Code Of Federal Regulations, title 21 CFR 175.105.

Another thing to consider is the ink, which is often used to mark washers. In order to make the assembly easier or to track the origins of the component, the component often adds identification information on one or both sides. The ingredients of the ink must be FDA-approved for contact with food or medicine in order for the washer to be considered suitable in such applications.

It’s worth noting that food and pharmaceutical industries may also need the washers to be compliant according to National Sanitary Foundation and U.S Pharmacopeia requirements.

Conclusion

When it comes to choosing the right washer materials, it’s very important to check all the industry requirements. FDA compliance is often necessary for all the equipment components. Even such seemingly minor things as marking ink must conform to the rules in order for the washer to be considered safe.