PhilGeis
Forum Replies Created
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Like ZPT, that’s the basis for its efficacy. Yes, Fe saturated will screw it up. Why would you consider this?
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Storing bulk for an extended period is a stability complication as it’s different -volume/humidity/ temperature/container composition - vs finished packaged product. Ideally you would perform finished product stability using the old, aged-in-bulk product subsequently packed out for sale - not fresh as chemical changes started the moment product was made, not just when it went into final consumer package.
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3 weeks isn’t a useful period. The concept is borrowed from OTC drug reg and there the rule of thumb projects 1 year stability projected from appropriate testing (including challenge) of product after 3 months at 40-42C. https://www.chpa.org/public-policy-regulatory/voluntary-codes-guidelines/guideline-stability-testing-nonprescription-otc
I know some in the cosmetics industry have used 1 month 40-42 for 1 year and 3 months for 2 based on validation with their own data.
In any case, you mist still run stability qualification of real time aged products to confirm and have a plan to address (recall?) if failure observed in real time testing.
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Might be related to micro contamination. If as it appears, benzoate is your only preservative, you’re clearly underpreserved.
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To your general concern, ask the supplier to share their stability data. To EDTA -an ex date is not very useful. The stuff is pretty damn stable.
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Can’t help re your inquiry - but why cottonwood sap? How did you decide it was safe in cosmetics?
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Assume the formula provided was not from ingredient label.
To the 1st question and with restraint - because the person making the change knows nothing of preservation.
SAP discontinued? If you meant manufacturing of the cartoon preservative Iscaguard SAP - it may be that the number of suckers in the industry was insufficient to make a profit.
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Be aware of the risk. The bacterium in question is endemic to the SE Asia, Japan, Australia - less common in Western hemisphere and was (maybe still is) designated a bacterial warfare agent.
cpsc.gov
Return product to Walmart for destruction and receive a full refund and $20 Walmart Gift Card. Consistent with CDC recommendations, consumers should immediately stop using the recalled aromatherapy room spray, double bag the bottle in clean, clear zip-top resealable bags, … Continue reading
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manufactured in India
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I‘ll add, presuming a short shelf life for any category of product is irresponsible. Hydrosols are not preservatives.
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If below was an accurate IPCS quote - think OP has a point. The question is not the component ingredient - but the combination. Happy to understand your evidence of “vigorous” (rigorous) efficacy or significant clinical testing of combinations. Think the cats and dogs combinations are marketing driven (esp. COSMOS, retailer priority list, clean beauty compliant). I doubt safety relies much more than established use/positive listing(even GRAS) and CIR/SCCP opinions re. components.
To the specific ECT question here - please note that supplier Lonza now Arxada claims “broad spectrum” through pH range of “3-8”. IPSC apparently questions the 2nd, and I’d not be confident of either. Many repackers add “natural”. In any case, I’d not use that combination alone as I doubt efficacy vs Gram negative bacteria, the primary group contaminating cosmetic. This was apparently OP’s observation.
My bias - teach preservation by addressing known efficacy of components rather accepting if not defending marketing stories of suppliers.
“You do understand that suppliers get their inputs and pH ranges by scientists who do vigorous testing on the ingredient. It isn’t just blindly advertised. Every ingredient undergoes significant clinical trials to ensure they are safe at a specific range as well as pH range. And any preservative can fail for a number of reasons, it doesn’t mean that the preservative is not broad spectrum. It means that the formulation has incompatibilities which is why the preservative is failing.”
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Heating to eliminate contamination? Micro stability derives from preservation - that is intended to protect consumer in use. Heating serves no purpose and could compromise the preservative.
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If you’re not worried about preservative/preservation, you’ve got more flexibility. You maybe looking at a consumer perception matter, the risk to your brand not consumer safety.
What stability parameters are you running?
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Can’t fix a micro problem, if that’s what it is. sorry, don’t have knowledge to address what it might be or a fix if just chemical.
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Gluconate is a poor chelator, and you have gluconolactone that hydrolyzes to gluconic acid/gluconate. For a chealtor use EDTA, GLDA, phytic acid, etc..
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Prob not enough. At right pH, sorbate may not be needed but drop the gluconate.
As graillotion said - you need something for Gram negative bacteria - your greatest risk. Perhaps try phenoxyethanol.
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Let me explain my concerns. You marketed an unpreserved product in a very micro sensitive context and volunteered a novel concept - “shelf life” control/labeling/something as the critical quality parameter. I’ve not seen this in relevant experience in the global consumer product industry - and it appears to establish a finite period of quality that would not appear to consider/extend into consumer exposure. That regulators in your region haven’t exception is irrelevant - most anywhere have little to no real life experience/insight and those in your region, with exception of TGA, are not known for their expertise.
You volunteered it - so why would you not explain? Is this like your all-natural product that is less unnatural than other formulations or has the concept more substance?
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Sure Mike - no need to justify what appears to be more self-serving BS.
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but to what cosmetic benefit?
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As a scientist, could you be specific? What test(s), what period of “shelf life specified, what time distribution and retail management?
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This is a water bug along the lines of cepacia, Mike. Most likely from an out of control water system. A condition not isolated to India. There are irresponsible folks making products globally.
Again Mike - on what technical basis did you establish the brief “shelf life” date in your unpreserved product?
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Perhaps it’s not irresponsible. Assuming one knows the risk, I’d call it cynical marking to support a meaningless claim. I haven’t encountered many of this consequence that actually went to market in my career.
Cynical contrivance to excuse an unpreserved product with an irrelevant metric borrowed from cosmetics. The consumer does not control timing of warehousing, distribution and retail shelf life. I don’t know if labeling cites a date certain or a period, but the scenario offered relies on consumers compliance to toss a product when they 1) don’t expect such caution on products of this category and 2) do not comply even to cosmetics EX dates.
Waving “GMP’s” flag is pretty silly for an unpreserved susceptible household product- it has have limited to no relevance re. its micro contamination.
This is not a seat belt dynamic - where consumers make the affirmative decision of compliance.
Mike - to the technical point - what database established even this brief ex/self life date? Unpreserved products would seem to have no confident expectation of any uncontaminated period. Also, how much of the designated self life period is consumed by consumer gets the product?
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And not aware of a legal version or sorbate for US household products. Legal (EPA registered) benzoate can be obtained from Emerald Kamala (Lanxess).
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They should be with right pH. Added as salts. I prefer just benzoate - sorbic acid stability can be troublesome.
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Neither would be legal in US. Add alcohol think the limit is 5%- not enough on its own but it helps. Preserve with Dantogard +- DMDM hydantoin + IPBC - legal in this application. Some add phenoxy with the “solvent” excuse but it’s not thre best if you have freedom to use others.
https://www.azelisamericascase.com/wp-content/uploads/2020/03/Dantogard-Plus-Liquid.-PDS.pdf