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Microbiological testing requirements for dry powders
Dear all,
my company is producing dry powder scrub which contains several natural ingredients, such as clay, flower petals, rice powder and ground apricot kernels. Since it is being sold as a dry powder in a plastic, narrow neck bottles (no direct finger access) we did not think it would require any microbiological testing - is this the right approach? Should we still perform such testing or it would be sufficient to write a warning about keeping the product away from water to avoid possible contamination? Also, if we need to use a preservative for such products after all, which one would you recommend? -
3 Replies
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We use dry extract derived from plants.Supplier gives us COA with Microbial testing done like Total Plate count. Yeast/mold, E-coli, Salmonella. -
anait said:Dear all,
my company is producing dry powder scrub which contains several natural ingredients, such as clay, flower petals, rice powder and ground apricot kernels. Since it is being sold as a dry powder in a plastic, narrow neck bottles (no direct finger access) we did not think it would require any microbiological testing - is this the right approach? Should we still perform such testing or it would be sufficient to write a warning about keeping the product away from water to avoid possible contamination? Also, if we need to use a preservative for such products after all, which one would you recommend?Your products should get microbiological testing as they could have dormant bacterial spores that will grow when exposed to water and nutrients.
If someone gets sick from it and sues you, you’re likely to lose the lawsuit and lose most of your assets and get your business closed until you get rid of the spores.As an extreme example, imagine someone unknowingly sells powdered products with Anthrax spores.
While bacteria won’t grow in powders, they will surely grow in households or inside human or animal hosts.
Once they trace back to him, it’s game over.https://www.fda.gov/Cosmetics/ProductsIngredients/PotentialContaminants/ucm433748.htm
https://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm565586.htm
It’s usually easier and cheaper to outsource microbial testing, unless you’re a really large company.
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Dry powders rarely have bacterial problems (unless the material itself already had bacterial problems in its raw form and subsequent processing did not get rid of it). In point of fact, keeping something dry is a somewhat decent way to make sure you don’t have a microbiological problem. Also helps with yeast/mildew.
If your product is intended to be wet, than you probably want a low bacterial count + preservative. Some natural products, are very dirty. You just cant get past the source. Others more refined versions, typically have less bacteria as the processing gets rid of it.
Rarely is there a cut-and-dried answer. And much depends on the source, and the processing.
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you are asking a fair amount of legal questions. this would require consulting a lawyer.
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