All About Nutraceutical Cleanrooms

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.

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.

• Cleanroom measurable positive pressure / Magnehelic gauge
• ISO7/class 10k or ISO8/class 100k particle count and air changes/hour requirements

• Cleanroom Ceiling mounted HEPA FFU and low wall air returns / exhaust grills
• Cleanroom Temperature control

• ISO-8 Gowning room / air lock

• 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.