June 24, 2024

Regulating agencies such as the FDA, USDA, or NSF institutes compliance procedures during the production of any product that will have human contact or be ingested and that includes polyurethane tubing, which is used both in industrial applications, as well as in medical devices to name only a few.

The ability for the polyurethane tubing to perform in compliance with these agencies is critical.  And depending upon the application use of polyurethane tubes, it will determine under which regulating agency the manufacturer must comply.

Regulatory compliance encompasses the following agencies in relation to manufacturing polyurethane tubing:
FDA requires that the polyurethane tube be manufactured in compliance with GMPs that ensure it’s free of impurities and safe for human or animal use; which essentially means that they want to ensure that potentially volatile chemicals do not migrate from the polyurethane rod to the drug or medicine.

USDA regulations requires that polyurethane tubing be manufactured to assure food safety, protect natural resources, etc.  Similar to the FDA, it wants to ensure that the polyurethane tube does not contaminate the food or liquids that pass through it, but also that it be perform reliably to protect environmental surroundings and the public against exposure to potentially hazardous chemicals.

NSF regulates (similar to the UL) it requires that any application for which clear polyurethane tubing is used is safe for food, water, and consumer goods. In addition to customer protection, it also provides businesses with risk management solutions during the production of polyurethane tubing.

No one likes governmental intrusion, but when it ensures the safety of the public, in particular in the manufacturing of polyurethane tubing, then its regulations are quite justifiable.

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