Question: What Class clean room is required to manufacture FDA approved N95 masks, isolation gowns, surgical masks, etc?

There are various benchmarks for FDA approved products such as surgical N95 masks and surgical isolation gowns. Before we get to the answer, lets look more closely at what types of products and devices are FDA regulated.

Does the FDA Regulate PPE?

Some PPE items are regulated by the FDA, others are not. Naturally, any item label, approved, and specified as a medical device is approved and regulated by the FDA. Some N95 mask are certified for healthcare and surgical use and thus require more elaborate production controls. Further, some face masks require “cleanroom rated” materials which will not shed lint or fibers.

Does the FDA Regulate N95 Masks?

The FDA regulates products such as surgical N95 respirators and surgical-grade gowns. (Considered medical devices). Masks and PPE for non-medical purposes are not medical devices and are not regulated by the FDA.

FDA Cleanroom Standards for PPE Production

In general, the FDA does not provide specific guidance on cleanroom build specifications or requirements. They will defer to USP or CGMP standards. Most USP and CGMP cleanroom build requirements are based on ISO 14644-1, a baseline where we start all of our cleanroom builds.

Cleanroom Requirements for Sterile vs Non Sterile Devices

Something like an intracavity device or other sterile medical device may require an ISO 5 cleanroom, whereas medical device packaging and other less sensitive processes are usually specified at ISO 7 or ISO 8.

Cleanroom ISO Class for Sterility Assurance

It really depends on how the final device will be classified, labeled, what it will be used for, and what degree of sterility assurance it requires (if any). For example, the desired Sterility Assurance Level (SAL) for garments to be used in sterile pharmaceutical manufacturing is 10^6, which translates into an assurance that a sterile garment has only one-in-one million probability of being non-sterile.

ISO class is just one aspect of delivering a production ready cleanroom. Sterile procedures normally demand cascading cleanroom suites of positive pressure, air quality monitoring, precise pressure differentials, aggressive cleaning regimens, and air tight seals.

Terminally Sterile Device Manufacturing

If you’re looking to manufacture anything terminally “sterile”, like sterile surgical gowns or masks, you’d spec an ISO 5 cleanroom at the least. (ISO 5 is the general standard of a “sterile” or aseptic workflow environment. For items that will be sterilized after production, an ISO 7 medical device cleanroom is a common benchmark.

Clean Rooms for Sterile Products

An ISO 5 room would be similar in nature to cleanrooms built under USP 797 (sterile) or USP 795 (non-sterile) standards. The room has a cascading suite of positive pressure rooms which start at an ISO 7 or 8 buffer / ante for gowning and product preparation, while the critical production processes are carried out in the interior ISO 5 room.

Assessing Cleanroom Requirements for Garment and Apparel Manufacturing

It’s crucial to assess the specific sensitivities of the product, size of the operation, and how clean/dirty the process is under working conditions. This is generally where project leads will reach out to a PAC cleanroom construction specialist, as we can deliver full turn-key cleanroom systems that are guaranteed to validate for all major industry benchmarks and compliance needs.