PhilGeis
Forum Replies Created
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As matt said - 40-45C for 1 and 3 months. For accelerated, I’d not go greater in temp or longer in time. Rule of thumb is 3 months accelerated/rapid aged product data justifies 1 yrs stability but that is not validated. I use 1 month stability (preservation) data to justify marketing for cosmetics and 3 for OTC drugs with 1 yr ex data. .
You must confirm with real time data out to three years.
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Doing a test here.
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As matt said, conventional is - 40-45C one and three months, with latter approx 1 year stability. I’ve gone to market on 1 month data for cosmetics and 3 for OTC’s. .
This is rule of thumb - not validated - and may be be appr. for all products. You must execute real time stability to confirm.
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Assume raw material are within their ex date. That date is not generally considered in finished product ex dating.
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No.
From the micro side, the necessity of removing bugs indicates a contaminated/adulterated raw material that would establish your finished product as adulterated. Cosmetic manufacturing is nonsterile and it’s hard to imagine how this could even be accomplished without immediate recontamination.
From the particulate side, the adulteration is also in question and such filtration is very inefficient and it’s unwise to become your own raw material reconditioner. Pay the supplier to deliver the material you need to make product. You’re in the cosmetic not raw material business.
For susceptible stuff you might make in house such as a proprietary ferment, preserve it. whether filtered or not.
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This seems absurd - but no more so than the same claim on any cosmetic.
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SDS addresses the raw material, not in application. Beyond the product, the combination is irrelevant. Down the drain fate is a function of the individual chemical and sanitary sewers/sewage treatment. Sorry, I no longer have relevant environmental safety data. Can only say it met the envir. safety standards.
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You’ve no preservative for Gram positive bacteria or fungi
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About what I’d expect from the government- a study that only asks for more studies.
It certainly lived up to its title - “Studies on…”. They report studies that answer nothing. Noting similarities and differences between mouse and human hair growth, they offer no final comment as to validity. “Overall Conclusion” is pretty useless - focused on cytology, the central question of in vivo cosmetic hair loss is kicked down the road to future studies.
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perhaps to adjust pH
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as matt said
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40-45C for 1 and 3 months. I’d NOT go beyond 3 months or 45C. I’ve gone to market with passing preservative data from 1 month.
The ex date projected from this kind of testing is kinda flakey. There is an ISO method 18811 that prob could be seen as precedent but its no more validated than any. The comment you use is about as good as any.
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Can’t add much more to what Matt said. 86 the EDTA - need something for the fungi - what’s pH and what is your po9licy as in parabens formaldehyde releasers etc.)??
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I’m with you
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Depends on what’s “best.” Brand success in sales doesn’t look to a balance but to a push on the “fluff” as far as regulators will allow and consumer swallow - and hopeful consumers will swallow a lot. Witness clean beauty, antiaging, paraben-free, recyclable or compostable packaging.
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“…less harmful ingredients” admits they are harmful but less so than other ingredients that might be used. Don’t think that is a helpful claim in comparison to the propaganda of clean beauty and natural perceptions.
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It’s not just the coacervate technology. Efficacy via active deposition based on physical aspects is also studied/controlled.
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Thanks Anca. I wish I could offer something that informed consumers regarding the risks they assume with the BS clean and natural preservation - or the total BS of the cynical preservative free. But I do not.
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What’s pH?
For safety I’d look at CIR
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Agree - and with any consumer.
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Why 12 months.
Recall please cosmetic preservatives are primarily intended to control contamination in use. “We never had a problem”. Testing quality into a product is questionable GMP’s.
But yo the justification - why no preservative? As there is a risk, why do you think it appropriate to offer that risk to consumers - here children?
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Right - a specific number of bottles. As trivial as it sounds, this should be a SOP with trained assessors - trained in what is acceptable.
Gram negative bacteria are BY FAR your greatest risk - the primary cause of recalls for micro. Yeast and mold are not commonly found in tap water at any significant level. Gram negative bacteria are common and usually as biofilm chunks.
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If you’re speaking of virgin bottles - you should put on the specification visual observation of dust and filth. Most do not treat them further. I know some may check 1st 3 receipts from a new supplier by checking microbial content of rinse water of a few bottles. If excessive counts OR Gram neg., bacteria, find another supplier.
Washing with anything is a bad idea as (tap) water typically includes Gram neg bacteria. Don’t try to make up for a sloppy supplier.
If you refer to bottles recovered from the market and reused for fresh production - STOP IT!!
If you plan to produce “lightly or self-preserved natural products” - STOP IT!
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Agree - 8-10 is typical range
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I’d not delegate safety, esp. micro safety, responsibility to government bureaucrats.
NOEL no observed effect level - based on testing or modeling the level showing no toxic effect - in practice one works with ingredient levels establishing a safety factor (1/100-1000x) .