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.
Per FDA
…… 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…
https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-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.
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:
- Muros modulares lavables para cuartos limpios. Common surfaces include melamine, vinyl, or FRP surfaces.
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
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
Figure 5. Nutraceutical cleanroom gown room
- ISO-8 Gowning room / air lock
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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