PhilGeis
Forum Replies Created
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It looks like the CM needs help to meet your specs. Either you/your partner invest expertise or find a capable CM. I’d not waste much time in addressing the “or”.
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Another miracle “natural” preservative - broad spectrum, wide pH range, heat stable, even “multifunctional” and vegan and some wonderful data. That never happens. In real life, there are no such miracles - efficacy as it may be is due to chemical consitituent(s) alone or in combination at effecitive level(s).
As with any complex mixture, composition can vary from batch to batch. Presuming the miracle and as preservation is a critical function, supplier (Ashland) needs to provide CoA that confirms analytically the active principles are at specified levels. Failing that you should do efficacy testing for each product with each batch.
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p-Hydroxybenzyl acetone 4-p-Hydroxyphenyl)-2-butanone - the active. It is produced synthetically and naturally of course from raspberries. Also synthesized by bacteria and fungi from 5 ppm with one report of max level~100 ppm. So if natural extract - how much raspberry ketone is in raspberry ketone.
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Seems they ought to have more than just this page - some reason to believe it works.
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Raw material spec is discretionary but to your concern, you don’t want the raw to put your finsihed product out of spec. If the spec on the material is 10/g - 200 puts it out of spec making it and any relevant product adulterated. 10/g for is pretty low for this kind of stuff.
Can you describe the raw material - a fluid extract? powder? and the finshed product shampoo? cream? pH? The “at least 200” here might mean the stuff is indeed moldy/adulterated - recall mold growing as colonies will not disperse well. As Mark said, citric acid is not going to help.
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Prob not much of a preservative sysrem. what’s pH?
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Why are you buying Pantene if you are unhappy with its price?
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Mark’s post was spot on for dates of compliance. Agree, timing looks tough but the Agency will likely take the position that safety has always been a requirement and this merely asks that it be documented. To your concern for anhydrous, generate a justifying risk assessment
Establish your “responsible person”.
Begin your own adverse reporting system.
Work in good faith. Comply to the letter of the law - no more no less. Ask questions here.
Be aware - this is a new group at FDA. We don’t know if it will include the CFSAN folks who had cosmetics before but the CFSAN guys I know do not expect to move . In any case, the new bunch is scrambling to build an org. and meet their own target dates.
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Can you recall the programs MS graduates’ schools/programs?
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M5 - excellent!!!
86 the sorbate; hold pH and benzoate; consider phenylethyl (note rose odor), diols (pentylene , octane); a little ethanol 4% can help, need a chelator (EDTA, GLDA , worry at stability for gluconolactone), no unknown mixtures (Leucidal, EO’s and extracts).
Product - what surfactants (some effectively increase benzoate pKa); tub/sachet fill or online conversion? any heat in process? package open to consumer in use or single sheet pull out?
Good luck - appreciate your prefessionalism.
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I think so<div>
see: https://www.ecfr.gov/current/title-27/chapter-I/subchapter-A/part-21#subpart-D
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Think that is Specially Denatured (SD) alcohol SD-40B. Hopw is it labeled?
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Yes -mechanical penetration for physical status of solid deodorant
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True - consumers do not accept a product as premium (in performance) unless priced as premium.
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You can’t clean up an OOS raw material.
Alot of naturals are effectively preserved by Aw with glycols - fungi being the remaining, moderate risk. Adding more preservative to an OOS material does not change its adulterated status and in this case prob won’t work.
Shampoos and conditioners very rarely have problems with fungi, but this is the supplier’s problem to fix, not yours to accept/attempt to control the risk as proxy for your customer - who owns the risk you take. Suppliers CDA specs - total aerobic count @ 100/g and fungi and “levaduros” (yeast) @ 10. Your 200 and greater shows these guys are not in control. Start up with this and you’ll be stuck with whatever they send - accept it or shut down production. They’ll say no one else complains - so get 3rd party lab data to support your complaint.
Decide what you’ll share with your customer.
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To graillotion’s exce;lent post, I’ll add that metely adding prreservatives means little AND the comment that the problem was the consumers’ is absurd - the purpose of preservation is to protect the consumer during use.
The product should be recalled. What brand is this?
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Nope there is a range - suave is positoned more economically and there are store brands. So why do folks buy Pantene?
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Thanks Mark.
The anhydrous tests I’ve seen are tests for the sake of a test. They strain to offer any sense of reality. Failure may mean little to nothing re. actual risk but more apt to fail than not - sure would screw up ones safety assessment. Jumping in with a product already on the market could be a disaster - failure a time bomb waiting for some regulator or law suit to discover.
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Mark can you share the FDA source comments mentioned?
Disagree with running some test on whatever “anhydrous” product - unless you know what the results should be, have reason to beleive you’ll pass and plan to do it ongoing. USP 51 is weak enough in validation - many anhydrous tests are pretty flakey.
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There are no specifics at this time tho’ HRIPT is reasonable - but may be be minimal. If micro is required, it’ll probably be satisfied with a risk assessment that includes challenge as appropriate.
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No - this is a drug question. MoCRA only addresses cosmetics and does not impact development labs
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I’m good at confusing!
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No - it is a QC method that assures the stick is sufficiently “hard” as judged by depth of penetration using a probe.
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https://access.personalcarecouncil.org/Shop/Publications/Product-Details?productid={77D37D7B-711E-ED11-B83E-0022482235A6}
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Great Picture!
Yup - the CTFA (PCPC) cosmetic industry methods. https://blog.microbiologics.com/preservative-testing-choice-of-challenge-isolates/
blog.microbiologics.com
Preservative Testing - Choice of Challenge Isolates - Microbiologics Blog
“What you see is that the most outstanding feature of life’s history is a constant domination by bacteria.” – Stephen J. Gould. Preservation capacity is a central element of consumer product quality. Though necessary to any microbiological risk assessment, adequate … Continue reading