How “clean” is a Class 10,000 Clean Room?

People may not realize how important it is for a custom manufacturer of medical tubing to manufacture the medical grade tubes in a class 10,000 Clean Room, unless you work in the medical industry.

But the fact that medical grade tubing undergoes its production process in a clean room ensures that the patient will only be treated with high quality, sterile equipment.

So what exactly is a “Class 10,000 Clean Room and why is it important in the manufacturing of medical grade tubing?

For starters, by definition, its rating is derived from an evaluation of there being “no more than 10,000 particles larger than 0.5 microns in any given cubic foot of air.”

If that sounds confusing, think of it like this—the manufacturing environment to produce medical grade tubes is an area where the air quality, temperature, and humidity are highly regulated in order to protect sensitive equipment from contamination.  This is accomplished by sophisticated air filtering systems that removes dust particles and other impurities that may negatively impact the quality of the medical grade tubing.

And not only is the room’s environment conditions perfectly balanced to ensure the successful production of the medical grade tube, those who work in the clean room are also held to clean room standards.

During the manufacturing process, the environment and the medical grade tubing is protected against human contamination such as lint particles from clothing, and skin and hair particles that could jeopardize the quality of the medical grade tubes. As such, all personnel must wear special protective clothing.

While the process to manufacture medical grade tubes may sound overly-cautious, it’s because of this level of strict adherence to GMPs (good manufacturing practices) that manufacturing medical grade tubing can deliver such safe reliability to the medical industry.


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