PhilGeis
Forum Replies Created
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“Water is mixed with the dimethicone” - dimethicone oil in water is more readily preserved to pass a challenge test and may still be at risk in consumer use. Water in dimethicone oil emulsion will often fail challenge but is typically much more robust in consumer use.
Silicone oil emulsions are classic exceptions to conventional reasoning.
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Polysorbate complicates - at that level you may be neutralizing preservatives Don’t worry about carbon source - you’ve enough already and the relevant bugs can grow in disitilled water.
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To the aticle, only profoundly obscure journal publishing without useful review routine preservative testing data (probably old) from a contract lab reagrding one simplified formula. This is less than most sales borchures offer for Leucidal et al.
Please design a system that should be effective (Gram neg and pos bacteria and fungi) and confirm efficacy. Simply passing a USP 51 with whatever means little - virtually every recalled formlua passed the test. Look at competitve prodhuct
Gram neg - glycols are ok but you need more - phenoxy/EHG* is much better - esp.. with chelator EDTA. Gram +’s and fungi are not so bothered by glycols - phenox helps some for Gram +’s. Parabens could work vs. both but you try orgnaic acids if pH permits. IPBC (for fungi) ,Chlorphenesin might work.
What’s fornula and packaged.
*EHG is a booster esp. with phenoxy - useless alone
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That’s a poor presrvative system. Neither USP nor ISO simulates anything in use - they’re just tests that show some efficacy conventionallypresumed to justify marketing.. The latter has more demanding “pass” criteria (hopefully you satisfy A). Don’t know what pump certification means but “fail” means you fix the preservative system - not hide it in a pump paclage..
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Preventing fungal ex[ppsure is prob impossible as they’re (spores) ubiquitous but Fusarium and only Fusarium is odd and recalls Buasch & Lomb disaster. In local marketing Fusarium (and only Fusarium) in consumer use - not in QC. Expanded marketing without fix was disaster to company, employees and stock holders. e.g. https://levinlaw.com/practice-areas/renu-recall-bausch-lomb-eye-injuries
Leucidal was a bad decision as is “nontoxic, non allergic, hypoallergenic” - for which there is no preservative or ingredient.
Some questions - Do you see Fusarium in QC? Is this a water in silicone oil emulsion?
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Be aware FDA has two years to get their GMP draft reg’s out for comment and three to finalize. Agency is also charged to develop simplified GMP practices for smaller businesses to ensure that these regulation do not impose undue economic hardship for these businesses.
Further - small businesses are exempt from Section 606 mandatory GMP if their average gross annual sales for the previous 3-year period is less than $1,000,000 and do not make cosmetics that:
- cosmetics that come in contact with mucus membranes of the eye
- cosmetics that are injected
- cosmetics that are intended for internal use
- cosmetics that intend to alter the appearance for more than 24 hours
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For foods - QC counts are less important than what’s there - Salmonella, Listeria, coliforms etc. Hamburger has ~ million/gram and alot of E. coli. Grade A pastirized milk/ml not to exceed 20,000 tpc or 10 coliform. Think chips someplace have a 20,000/gram limit and no samonella.
Irradation - see https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=179&showFR=1. Be aware, appl can be limited to stuff like spices, NGO oppostion, labeling requirement in US that consumers may not like and i recall some countries constrain/ban irradiation of foods.
For cosmetics - FDA says 1000 in general and 100 for babies and eye.
Industry standard is <100 but in many applications there is no statistical difference between 100 and 200 in testing. Sounds odd - but you may be able justifiably to release with 200 with spec of 100. You can find thst justification on PMFlist. Most big guys control operating systems and raws to consistent no detect - something they need with high speed manufacturing and maximizing return.
Irradiation is problematic - it’s done routinely for earth derived raws like bentonite and talc but you can’t use it to fix an adulterated material - e.g. surfactant or shampoo contaminated/OOS with pseudomonas irradiated to sterility is still adulterated. If a RM supplier used irradiation- you should ask why. If there’s a problem with a raw in your product - it is your problem.
accessdata.fda.gov
CFR - Code of Federal Regulations Title 21
CFR - Code of Federal Regulations Title 21
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Potassium alum - ala Potasium Aluminum Sulfate - is not Aluminum free
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No. Cr in stainless (esp. 316) imparts resistance to the entire material whereas Zn plating is only a surface treatment. Tho Zn plated is cheaper, constant exposure to moisture - formulas, cleaning/sanitization , high and low pH, oxidizers like hypochlorite - and physical wear will exhaust/scratch the Zn layer generally and in detail reducing the impeller life.
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Wonder at the status then at the safety substantiation for the many alternative/natural ingredients and products. As this is noy CFSAN but a new FDA organization, folks migrating from CDER might want more than BS and an HRIPT.
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Suspension and deposition are as important as the ZPT active. You might look ar some of the P&G patents and article by Jim Schwartz re coacervate technology
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Do not use EDTA in a ZPT formula. It is not a matter of solution - it is no longer ZPT but the soluble sodium salt (PT) that will not deposi , not impact dandruff and will increase chemical risk due to PT solubility.
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what’s the pH and surfactant? maybe an orgnaic acid could fit in
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btw - might add the Fusarium to your challenge test
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“Mixed” - presume dimethicone is not water soluble is it 2 phase or emusified?
Storage or bottle printer - you might put out settle plates but isn’t the product in closed packaged by these operations?
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For what it’s worth, AET is largely routine now. Do you see a gap in the indies you know?
Wonder at EU style safety assessment. We’ll see.
Still think this regulation for regulation sake.
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I se your point, Mark but doubt it will make any diff in chemical safety tho it certainly lets the small guy off the quality hook.
We’ll see what passes for safety substatiation. Comprehensive approach of the bg companies will be much too costly for indies and iI wonder even at cost of HRIPT of finished product. Certainly EWG et al. will want to cash in credentialing. In the end - doubt it will make that much of an impact, esp as the body count isnlt there now.
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Sure does Mike - for the unscupulous and ignorant, softens and eliminates enforcement for those most likely to be compromised.. Ironic that big guys and their industry org were all in on it from the start and, in the final statute, lost the primary and very reasonable element they wanted - state preemption.
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Think so Mark and in all regards. Suppose GMP’ by Dec. would translate minimally to the current guidance document. Safety subsantiation of ingredients and products will range from heavy data-based tomes of big guys to cut and paste sales brochures and blessings from credentialing guys to “we’ve sold it for years and no one has ever complained”. Micro will be a cop out minimally to USP 51..
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Can you say more about Creative Peptides and mold cleaning/bleaching?
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No kidding, think you could help a lot of folks in this. And I would love to hear the stories as you bring some of the clowns to Jesus on compliance
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As I said - you know nothing of preservation or apparently the 1st amendment. You’re free to offer total BS as with your affection for MIC.
MIC’s are pretty meaningless - MBC might have some little relevance but efficacy in a agar/broth based test is not efficacy in a product. Please recall ISO/USP/EP whatever demands some degree of kill not inhibition. Every crappy preservative on the market shows great and useless MIC data.
Right - these folk discovered gold in their back yard. They’ll not let you see it or provide chemical data confirming - just a gee whiz cute comment.
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You could try a FA releaser (esp DMDM Hydantoin)- even CMIT - unstable but likely effective long enough without amines. Maybe phenoxy - I’ ve no epxerience wth it in context.
If in a pump package, it’s almost entirely a manufacturing issue. Once it’s in your system, it’s a devil to eliminate. How well in control are you?
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Please stop - you clearly know nothing of preservation or P&G.
P&G and others have extensively researched naturals, extracts (incl pine), eye of newt and toe of frog both individually and in combinatorial assays. We chased some into extensive safety and efficacy testing - none met the objectives of safely and effeciutvel preservating products. Naturals generally don’t protect consumers, for whatever efficacy and composition are inconsistent batch to batch, naturally include components of safety cocnern, must be tested for pesticides and can be sourced from ag sweatshops in Far East. And please stop with the MIC’s - those have little relevance to in-product efficacy.
Yes Carina’s source is backyard <i style=”font-family: inherit; font-size: inherit; color: var(-bb-body-text-color);”>This ingredient (made in-house with the sap from local pine trees)
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A few clarifications. IPBC is not a formaldehyde realaser and cosmetic preservatives are under FDA’s authority but are not regulated per se. FDA does not establish preservatives as “safe”.
Both Germall plus and Phenonip are effective against the range of bacteria and fungi that place cosmetics at risk. In my experience prefer Germall + in shampoos for solubility and Phenonip in creams/lotions.
the go to preservative system of the 70’s and 80’s was Germall/parabens.