PhilGeis
Forum Replies Created
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Please recall - FDA enforcement only addresses manufacturing contamination and recalls are voluntary. Many - perhaps most - contaminations are not reported.
Consumer contamination is much more common and obscure. -
@Herbnerd - reasonable thought butnone of the compendial methods meet what most major manuf’s expect either in protocol, efficacy or both.
@grapefruit22
Take a look at these for closure perspective
https://journals.asm.org/doi/abs/10.1128/aem.56.5.1476-1479.1990
https://www.sciencedirect.com/science/article/abs/pii/S0002939414708323
https://www.aptar.com/wp-content/uploads/2022/04/Overview-of-microbial-integrity-tests-for-preservative-free-nasal-spray-pumps-and-multidose-eyedroppers.pdfSome folks have offered protocols, but with the objective of protecting consumers through millions of units over years, prob the best for major guys is large(geographic)-based in-use evaluation.
Wish I could access the Schnittger (Este Lauder ) paper for you. The product failed challenge but in-use found no contamination. The dynamic was its water-in-oil formula. Inoculum in challenge droplets never found the formula water droplets with preservative so very little efficacy. Similarly, in-use bugs never found any water where they might grow.
Water in oil emulsions are generally more hostile for that.You prob shouldn’t have asked, I get carried away.
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@Pharma
My (just a ) guess was that pseudomonad siderophores have a greater affinity for Fe, Mg than hydoxamates - cap, ZPT, NaPT.
ZPT is used in Head & Shoulders - as a raw material, it’s supplied as a ~26% saturated slurry that comes contaminated with pseudomonads unless preserved. -
There is no gold technical standard - in a regulatory sense these tests are validated in their respective authority.
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@grapefruit22
Each company has it’s own protocol and returns from consumer (rather than clinical testing are a typical part. Global countries have to consider different cultural practices - e.g. a single use (in US) sachet of shampoo may be used for months in other countries.
The test itself may also calibrated - e.g. https://journals.asm.org/doi/abs/10.1128/aem.53.8.1827-1832.1987Others rely as heavily on in use testing as challenge. Don’t have a link to the paper cited but these guys showed failing challenge results were irrelevant to the micro quality through consumer use
Schnittger, S., J. Sabourin, and D. King. “Preservation of water-in-silicone emulsions.” JOURNAL OF COSMETIC SCIENCE 53.1 (2002): 78-80. -
It is possible - the issue in addition to efficacy is the effort needed to qualify each product preservative application separately as opposed to a system that carries over from product to product.
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the largest companies are not “adapting to the new standards”. To the extent they’re using other preservatives - they are still using the standard of consumer use and not USP 51. I’m familiar with some of the seemingly “lesser” systems and those are the product of a lot of effort and carefully controlled to meet the corp standards. That doesn’t mean some corp (advertsing or marketing) VP didn’t decide to take a risk for specific sku’s.
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Every formula in FDA enforcement reports passed PET - USP 51. Passing the test means little and garbage systems - esp. “natural” and the contrivance of “hurdle” - readily pass.
As ketchito said, those working to the purpose of preservation - protecting the consumer in use, - maintain the traditional systems despite the market pressures driven by EWG BS, “clean beauty”, priority lists, Ecocert head fakes, etc.
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@Pharma
I’ve had some luck with phytate.
Hydroxamates are good for fungi - not for pseudomonads. The best known are pyrithiones - Zn (ZPT) and Na. -
Phytic acid
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@ketchito
I too have the greatest respect for pole dancers as well as all similarly situated artists. -
antimicrobial toilet paper
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This is a paddle culture?
Tho’ one usually sees bacteria (esp. pseudomonads), distilled water does grow bugs. I’d complain to the supplier. -
@Formi
Yes -
@ketchito
Right. There are a few article on this and I certainly saw efficacy of the concept in challenge.
https://www.sciencedirect.com/science/article/abs/pii/0003267080870474 -
I did not see mention micro test on an expanded product.
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Clostridium botulinum is not a cosmetic problem - pseudomonads are the primary risk contaminate well below 4.7.
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@Pharma
I’d not buy any of it. -
Phenylethyl is not the equal of Phenoxyethyl.
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Curious - why is this called an “oil”?
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Yes - pentylene glycol is prob not necessary but do add EDTA. 1% 9010 is a bit high. 5000 ppm phenoxy is a good target.
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EDTA is useless with that much Mg salt. You’re ;prob ok as described.
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Bunch of secondary preservatives. Suggest you go for efficacy and consumer protection rather than politically correct standards.
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@Perry
Bet we can find some org. to call anything natural - the license to deceive is cheaply bought. -
If in aqueous solution - you’ll need microbiological preservatives. I’m not aware preservatives are added to powder colorants - assume they’d be identified in relevant CFR section.