PhilGeis
Forum Replies Created
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There is a 3rd ed (2020) that includes more info - natural and multifunctional preservatives/preservation, detailed manufacturing etc. but it’s kinda pricey.
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Most major manufactuers use 100 cfu/g for all produicts.
FDA offers “Since there are no widely acceptable standards for numbers, temporary guidelines are used instead. For eye-area products, counts should not be greater than 500 colony forming units (CFU)/g; for non-eye-area products, counts should not be greater than 1000 CFU/g. “ -
I’m not familiar with efficacy of hydroxyacetophenone as preservative or booster or its chelating capability. One (I think Japanese) report concluded it might limit phenoxy migration into oil phase. I recall little else but supplier words on this stuff in context.
Note CIR (Cosmetic Ingredient Review) 2021 summary failed to render an opinion pending data needed to address its (dermal) safety.
Think this is a bad idea. You’ll just have phenoxy leaving at least a gap in fungal protection. You’re responsvbiel for the safety of your product - so on what basis do you think it’s safe?
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I’m with ketchito . Neither comnbination or supplier is exciting.
Hexane or Octane diol is ok vs, bacteria in testing - at substantial and expensive levels. Not sure why you need both. Tropolone is anther chelator for whiuch you’d have a tough time gettin risk assessment in this context. The related compound Hinokitol has some reported preservative function
The combination is not “hurdle”- it’s just another marketing-driven combination you generally can’t use outside US. -
some information chapter 7 - https://www.anme.com.mx/libros/Cosmetic%20Microbiology%20-%20A%20Practical%20Approach.pdf
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Rather than pursuing a simple add, why not use an effective system in the 1st place? Not aware Levulinate and Anisate are no more natural than the “natural” Benzoate and Sorbate. Aren’t these synthesized?
Graph A failed EP due to Candida albicans curve, not A. brasiliensis. Data from 1st and 2nd would justify “pass” by USP 15 topical critieria. -
Amen Matt - and something likely effective vs wild-type cepacia and aeruginosa - bugs that would happily eat these “preservatives”.
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The top graph appears to report efficacy of 1388 - Sodium Levulinate; Sodium Anisate - and the bottom adds GCMB glyceryl caprylate. Think performance of this very weak system shows the limited significance of preservative tests - whether USP 51, EP, ISO, ASTM. None of these is validated to anything - but regulatory compliance.
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Every preservative has this kind of claim and tese are nopt very compelling results.
They’re using the Euro Pharma test 5.1.3. http://uspbpep.com/ep60/5.1.%203.%20efficacy%20of%20antimicrobial%20preservation%2050103e.pdf
A bit more challenging than USP 51 but like it as n eother is validated. Offers 2 crtieria - A - normal pass and B acceptable if you can make up a good story to justify.
Top does not pass - A requires 2 log kill at day 14 for fungi and B one log - Candida fails both. Aspergillus brasiliensis meets B.
Bottom graph nominally meets criteria for all. -
At risk of pedantry - the dip slide such as Schuelke’s is not “validated” by external labs showing the same result. If it were - you wouldn’t need the external lab asnd it is clearly not.
The industry standard test (that would meet FDA expectations) includes growth promotion and neutralization controls for every product and internal lab controls maing is costly e.g. -https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/generalChapter61.pdfPretty sure a company reporting contamination of one product would find the FDA unsatisfied that dip slide was adequate for addressing micro quality of any product.
Dip slides might give you a heads up but shouldn’t replace accepted testing. If you can’t afford quality, perhaps don;t sell/distribute your product
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I’d not count on dip slides beyind water testing for anything beyond hygiene monitoring, hobby and presumptive testing.
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Analytically. This was needed to stay under EU cosmetic directive labeling re. contains formaledehyde.
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Do not have that information. Experience - at use levels of ~2500 ppm - 100-200 ppm “free” formaldehyde.
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Very poor preservation
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I’d not trust anything but your own data -includng that this chemical mixture is effective as preservative.
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Iwana said:Yes I agree with you. In use test is important factor. But does that effect the stability or only the PET or microbial ?
My co worker today said that the Accelerated Stability test is not good enough. As only when air enters into the product do we actually know if the product is stable.
Because again my co worker said that it is not a must to do that. He feels that only way to know product is stabile is to again check how the product will act when pumping it out over a period of time in exposer to air.Think your coworker is mislead by the PAO BS. Air is already present in the package.
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Gordof makes an excellent point reagrding functionality. In-use testing is also important to understanding if your preservative system as qualified actually works for consumers. Woukd be a good idea esp. for those using USP 51, a [pretty [oor asseassment device for cosmetcs.
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Please share the data.
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https://pubs.acs.org/doi/abs/10.1021/jf5063588
Reports quats ala GSE in Leucidal. -
To be countable, prob spores - and no. If you can’t see 1000/g, you’ll not see 100 or fewer.
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Extvolat said:Physicist_Formulator
Dear Physicist_Formulator, if you have any questions about our raw materials (Pine Extvolat), then you should also ask us to get more complete information. How do you think))? We will be happy to answer all your questions so that you have a more complete picture of Pine Extvolat.
There are no relevant data on your website. On wnat basis do you claim “self-preserving”? Please be aware, this is a safety claim - consumers have been blinded and even died from infections resulting from contaminated cosmetics.
What aree your data? -
Abdullah said:Pharma said:Maybe, maybe not. Some microbes aren’t visible at way higher amounts, don’t produce neither smell nor gas… just think about yoghurt. You wouldn’t know it’s spoiled milk if you didn’t know what yoghurt actually is.
What about mold? At what amount of contamination it can be visible by eyes?
Or the other way, if we can see the mold by eyes, what would be the minimum cfu/g of mold in that product?
You can seemold if it grows sufficiently on the surface. Not sure what you mean by minimum - it’s addressed by the same numerical quality limit.
The concept of cfu is not a good one for mold - mycelial fungi. The cells do not separate so one cfu could represent 19’s-100’s of cells.
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If ypur stbility samples (passing USP 51) were at significantly higher pH, you would repeat.
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To the point - for the great majoriy of product types, production with proper controls should deliver products with no detectable microorganisms.
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You’re correct. Stability (PET) indirectly addresses the chemical stability of the preservative system. Opening/closing/pumping is largely irrelevant to chemical stability - I’m familair with only one preservative that might be sensitive.
The stupidity of PAO takes this to the extreme. - stability doesn’t start until the package is opened.