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A heart rate monitor in a medical setting.

Medical Device Cleanrooms 101

Have you ever considered all the invisible battles that need to be fought in order to keep medical devices safe? Given that these devices are often implanted inside people, you can see why small particles may cause malfunctions or even disease within patients. When every particle poses such a threat, sterile environments (and thereby cleanrooms) become a necessary part of the manufacturing and assembly of medical devices. In this article, we’ll cover medical device cleanroom design, regulations, and more.

Medical Device Cleanroom Design

Designing a medical device cleanroom is often similar to other types of cleanrooms, and it involves various elements, including the following:

  • Airflow: Medical device cleanrooms may use laminar or unidirectional airflow systems to keep a constant flow of filtered air, which helps remove particles quicker and more efficiently.
  • Filtration: High-efficiency particulate air (HEPA) filters remove at least 99.97% of particles that are 0.3 micrometers, which prevents most if not all of the viable particles from recirculating through the air.
  • Measures for Controlling Contamination: Additional measures, such as air showers, sticky mats, carefully planned access points, and pass-through chambers, help reduce the chances of introducing more contaminants into the space.

Similarly, the choice of materials is also important in keeping particle levels low. In general, non-porous and easy-to-clean materials are chosen for the surfaces in the cleanroom. For example, vinyl or epoxy may be used for flooring, and stainless steel may be used for the walls/ceilings. The furniture and equipment in the space is also carefully chosen, and they must also not contribute too much to particle counts.

Cleanroom flooring with seamless, non-porous surfaces for maintaining sterility.

Regulatory Standards for Medical Device Cleanrooms

It’s no secret that the healthcare industry is heavily regulated, and the medical device sector is no exception. Sticking to regulations is absolutely necessary to ensure that products are safe and effective. Each stage of the medical device manufacturing process, including production, assembly, and packaging, have different cleanliness requirements, and as a result, they often fall under separate classifications. That being said, most medical device cleanrooms must comply with ISO Class 5-8 standards.

In the United States, key regulations include:

  • ISO Standards: ISO 14644-1 specifies the classification of air cleanliness in cleanrooms, and ISO 13485 sets requirements for quality management systems.
  • Current Good Manufacturing Practices (cGMP): cGMP guidelines, enforced by the FDA, cover all aspects of production to ensure consistent product quality.

Cleanroom Classifications and Uses

We mentioned previously that medical device cleanrooms typically fall between ISO Class 5 and ISO Class 8. However, the use of each class depends on the specific stage of medical device production or else the type of medical device being produced:

  • ISO Class 5: This class is important for manufacturing critical devices such as surgical tools and implantable devices (e.g., artificial joints, catheters). Since these devices make direct contact with the inside of the body, they need to be produced with the highest levels of cleanliness.
  • ISO Class 6: These spaces are also used for producing critical devices that require strict particle control but are not as sensitive as those produced in ISO Class 5 cleanrooms.
  • ISO Class 7: Typically used for the production of non-critical and semi-critical devices. Examples include certain diagnostic equipment, such as stethoscopes, as well as devices that come into contact with mucous membranes, such as endoscopes or laryngoscopes.
  • ISO Class 8: This class is often used for the packaging of medical devices. These environments, while much less strict, still provide a relatively clean space.

The class of cleanroom required increases with the sensitivity of the devices and the further they go within the human body. Smaller and more intricate parts that need to be placed within the human body will always demand cleaner spaces.

The Bottom Line

Cleanrooms have become an indispensable part of medical device manufacturing. By following strict regulations, such as ISO 14644-1, ISO 13485, and cGMP, manufacturers can achieve high levels of cleanliness and compliance. This ensures that medical devices are safe, effective, and reliable, which ultimately safeguards patient health.

Ready to make sure that your medical devices are produced in the cleanest possible environment? Contact Allied Cleanrooms today for a free quote!

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