Why Cleanliness Testing is Essential for Medical Devices

young woman wearing protective clothes conducting cleanliness testingWhen medical devices are created for implantation into someone’s body, quality is of the utmost importance. While the actual construction and materials used in the medical device are essential to product quality, cleanliness is equally—if not more—important.

Cleanliness testing can ensure that your medical devices are free from contaminants that could lead to product failure, or pose safety risks to patients. In addition, the FDA requires that medical device manufacturers follow specific cleanliness validation procedures. Cleanliness testing can ensure that your products are meeting those FDA guidelines.

What is Cleanliness Testing?

Cleanliness testing aims to reveal any contaminants in, on, or outgassing from a product. Analytical tests such as liquid particle counting, outgassing testing, and ion chromatography are some of the most common types of cleanliness testing.

Why Cleanliness Testing is Essential

Cleanliness testing is essential to the medical device manufacturing industry because it can identify contaminants left behind during the production, packaging, and cleaning stages.

For example, rigorous cleaning is part of the medical device manufacturing process. However, undesirable particles can still be left behind even after cleaning. Cleanliness testing will reveal if particles are present and identify what those particles are.

Cleanliness testing can also help manufacturers:

  • Identify potential product failures
  • Ensure that the medical device works as intended
  • Prevent slow healing times, rejection and infections
  • Avoid litigation
  • Ensure warrantees are holding up

In addition, as part of its cleanliness guidelines for medical devices, the FDA often requests documentation of how residual materials were removed from newly manufactured devices. Cleanliness testing through an experienced lab can help determine whether your processes are effective. Cleanliness testing can also help pinpoint where and why contamination is happening.

Cleanliness is a core value as well as a requirement for medical device manufacturers. Cleanliness testing can ensure that you’re selling a high quality, and safe product.

For more information on cleanliness testing services by Innovatech Labs, contact us today.

Tags: , ,

Leave a Reply