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All About Nutraceutical Cleanrooms

March 27, 2023
vitamins, food supplements
Figure 1. Nutraceuticals

Nutraceuticals are also called dietary supplements. The FDA  requires that nutraceuticals be manufactured with Good Manufacturing Practices (GMP).  Cleanrooms are typically part of the GMP manufacturing requirement.


…… In addition, FDA’s regulations require those who manufacture, package, or hold dietary supplements to follow current good manufacturing practices that help ensure the identity, purity, quality, strength, and composition of dietary supplements…

Equipment used in nutraceutical cleanrooms typically conforms to NSF standards for food processing. Some examples nutraceuticals include vitamin pills, protein powders, protein bars, organic supplements, and protein drinks.

nutraceutical cleanroom, glass walls, stainless steel equipment, interior of ISO-7 cleanroom
Figure 2. Nutraceutical Cleanroom

As might be expected – cleanliness/easy to clean is considered the most important aspect of nutraceutical cleanrooms.

Common features of nutraceutical cleanrooms include:

  • Cleanable cleanroom modular walls. Common surfaces include melamine, vinyl, or FRP surfaces.
melamine cleanroom walls, cleanroom windows, exterior of ISO-7 cleanroom
Figure 3. Nutraceutical cleanroom with glass and melamine walls
  • Cleanroom measurable positive pressure / Magnehelic gauge
  • ISO7/class 10k or ISO8/class 100k particle count and air changes/hour requirements
recirculating modular cleanroom air flow diagram
Figure 4. Recirculating cleanroom air flow with ceiling mounted HEPA fan filter units
  • Cleanroom Ceiling mounted HEPA FFU and low wall air returns / exhaust grills
  • Cleanroom Temperature control
gown room exterior, cleanroom automatic sliding door
Figure 5. Nutraceutical cleanroom gown room
  • ISO-8 Gowning room / air lock
cleanroom heat welded vinyl floor
Figure 6. Heat welded cleanroom vinyl flooring
  • Easily cleanable floor with no cracks and crevices – typically epoxy or heat welded vinyl
  • Annual particle test and certification of cleanroom. Some companies also do viable testing with settling plates.

Summary: Nutraceutical cleanrooms are used to satisfy FDA GMP (good manufacturing practice). Typically these cleanrooms are ISO-7 or ISO-8. Important features include cleanable walls, easily cleanable floors with no cracks or crevices, and gown rooms.  

Property American Cleanroom Systems 2023

The author Anthony Chien has worked at American Cleanroom Systems for more than 10 years . He has more than 40 years of cleanroom experience. Anthony has a BS and MS in Electrical Engineering specializing in semiconductor manufacturing from the University of Illinois. American Cleanroom Systems is a design build modular cleanroom manufacturer based in Rancho Santa Margarita CA. It is expert in ISO-5 thru ISO-8 (class 100 to class 100k) modular cleanrooms for nutraceutical cleanrooms, pharmaceutical cleanrooms, medical device cleanrooms, and industrial cleanrooms.

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