PhilGeis
Forum Replies Created
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Please be aware that anhydrous products can be contaminated. Note recall of an anhydrous eye ointment due to Bacillus cereus contamination.
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#1 is a good better system with pH control.
The organic acids alone or in combination are poor - at any pH. At acidic pH, they mainly target fungi and Gram positive bacteria and are very weak vs. Gram negatives - the most common contaminants. they can also form poorly soluble salts with divalent cations like Mg and Ca - that you might find with kaolin. Phenoxy is best for Gram negatives . Here too. kaolin may screw you up - might absorb the phenoxy. A chelator would help but that too could be screwed up with divalent cations from kaolin
#1 combination should give you a good start.
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The no-no lists are marketers’ and retailers’ - telling consumers what they should want - not a compelling % of `consumers.
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Content testing is important but preservative testing by typivcl protocol is pretty meaningless for such products. You should get a risk assessment for product and production.
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3 and. as Abdullah suggested, with a chelator.
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Think recent fed legislation (MoCRA) should preempt moronic state BS like this.
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If you‘re +/- duo - prob makes no diff but should sanitize with hypochlorite.
If manufacturer to any significant volume, get rid of the plastic, add separate sanitizing step, if liquid detergent make sure it’s not contaminated.
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1 and 3 are little more thanphenoxy and marketing.
Divalent cations (this context)Salts of organic acids can mitigate their limited solubility/efficacy
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That is a pretty poor preservative system at any pH.
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Similar reports for Avons Skin
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Old system allowed a great number of discussion posts on screen at one time - this one allows fewer
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FDA improved (finally!) their previous (really crappy) Chapter 23 BAM for cosmetics QC ~decade ago but it’s still kinda flakey. Suggest relevant ISO’s, CTFA’s. or even USP 61/62.
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Looks like some lily-livered scoundrel bushwhacked him!
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@Microformulation
They received > 200 questions. hope they’ll answer those they can -
@MarkBroussard
Sorry Mark - you would have found it interesting.
Nope. That’s on FDA’s list of development items. They emphasized product in place of ingredient but suggested ingredient news could screw up a product assessment. -
Don’t know if you guys sat in - some points cam across to me that folks here should understand
- safety that all must substantiate is for product, not ingredients per se
- adverse event reporting can be by website - assume company’s website as in
“none reported”
- FDA recall authority is for Class I recalls, the most serious - almost all
cosmetic recalls are the less serious classes II or III.
- A lot of stuff is hanging fired until FDA sets up the regs - GMP’s big sand small business, fragrance allergen labeling (but might go to school on EU) -
Today!
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It’s used in cosmetics soaps typically as tallowate - FDA does not have authority over pure soap.
if your concern is for BSE - see: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=700.27 -
your water phase pH?
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What presrvative do you propose?
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Adding to ngarayeva001’s good comment, be aware you may have trouble passing a preservative test whatever preservative you use as inoculum droplets may not encounter water droplets with preservative. That should not be considered a show stopper.
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@BUNSEN87
Sure - “trend” means exploitation of consumer ignorance that sells ingredients with little safety information and rejects those whose safety is well established. -
Aw tells you the risk in use. Your primary risk is humidity and fungi. Packaging must protect vs. direct water addition.
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There is no challenge test that’s appropriate and applying aq. product standards is not appropriate.
Your worry is growth of fungi - if its wet enough for bacteria, you haven’t a chance. Get the lab to run AW (water activity) on product held at humidified conditions.
What is the pres system you’ve tried? -
The final product is an anhydrous powder? How are you testing it for preservation, and what is bioburden of the rice starch?
Think you need to generate some in-use data - not only direct water contamination but taking up water from humid shower environment.Please drop the “too much food’ context - bacteria can grow in distilled water and fungi on basement walls.