The Importance of FDA Approved O-rings

O-rings are elastomer mechanical gaskets that are designed to be placed in the groove of a machine component. They are usually manufactured in the shape of a torus, which is why they are also known as toric or packing joints. During assembly, the o-ring is compressed between two parts, thus creating a seal between them.

Like any other machine component, immense importance is given to the examination and certification of the o-rings. One of the most common yet important certifications is FDA approval.

Why FDA Approval is Important?

The Food and Drug Administration has laid down more than 200 laws ensuring a consistent safe and sterile manufacturing of components and products. This helps to ensure public health and safety at all times.

When a product like an o-ring is given FDA certification, it means that:

  • The product has been manufactured using materials that are approved by the FDA such as silicone, PTFE, FKM, and Buna.
  • It has undergone thorough examination and has been deemed fit for use.
  • The manufacturer has produced the component while adhering to all known manufacturing standards.

If an o-ring is not given approval, and is still used in an industrial application, it can lead to disastrous consequences, such as:

  • It can lead to early contamination of the product, thus requiring frequent changes. This will lead to regular shutdowns and downtime.
  • It can result in the product losing its capabilities much faster, causing a leak in the system, which will result in a complete breakdown of the machine.

fda approval o-rings

FDA Standards for High Quality and Performance O-rings

To ensure designed and manufactured o-rings with highest quality, the FDA has laid down a standard titled CFR 21.177.2600. This standard describes in detail the regulations that are required for rubber articles, which are manufactured for repetitive use. As mentioned above, it also lists the materials and rubber polymers that can be used to create the product.

So if you are on the lookout for a seal manufacturer and supplier, make sure you check that his products are FDA approved.

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