PhilGeis
Forum Replies Created
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Please don’t delegate quality/safety responsibility. Validate at least in concept a suppliers’ CDA and do not take comfort in compliance re. regulations from folks that know little to nothing of relevant technology.
The objective of preservation is consumer safety in use - not shelf life. This is not a big company fetish.
If you’d like to discuss your contamination - please provide the spec and describe OOS and process.
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I understand your comment - and can only offer that many use clearly inadequate preservatives systems for which levulinate/anisate is poster child EU has given the ridiculous and meaningless PAO cover - an excuse to for marketing of risky products. PAO come from the idiot EU politicians - not from industry or technology. US is not special - our politicians just passed sweeping legislation for its own sake.
I am critical of what I believe are your practices - please, not of you personally. Your development and manufacturing are not in control with poor preservation accomodated by labeling rather than formulation and inadequate control of raw material quality.
PAO - opening the product is irrelevant to preservative stability/micro safety - I know of only one preservative whose stability is reasonably impacted at opening and that is based on uses rather than time. Chemical change began to moment the product was made - a moment that might be months or years from the first use/1st opening. Even if it were significant - we KNOW consmers do not respect exp. dates, and 6 months is unrealistic if there were interested.
Good luck
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Failed twice? Two batches or did you repat the intial test?
That is not a “Hurdle” - propane diol at 3% is not effective, pH 4..8 is well within the susceptible range. Evonik - phytate? is ok.
To have a hit in QC - it’s got to be pretty bad and not comes with poor preservation but also compromised manufacturing. To address the former - can you used benzoate, benzyl alcohol what else is in your corp. policy? But please address manuf issue - have ID”d a prob cause and CAPA completed?
btw - What is technical basis for ex and PAO dating? What is your dist and shelf timing and do you really expect consumers record and to toss it at 6 months?
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“Failed” - in challenge or manufactured QC?
That is silly system and not only likely contributor to this failure - certainly high risk for failure in consumer use whether it passed in challenge or not..
Describe your hurdle, please.
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If they dont know 61/62 - wonder what they mean by knowing USP. There aren’t many other micro methods in USP. Show the methods - they’re online , can they run them?.
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No! EWG Verified is BS! P&G’s products that used this in marketing are worth a look.
Benzoate is a good addition in shampoos - and benzyl alcohol/benzoate/chelator a good combination. But test it.
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P&G also invested heavily in Malassezia - dandruff etiology research after some folks from Pateur Institute figured out the taxonomy and biology of the relevant fungi. That was for advertising and professional “credentialing”
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Include Benzoate in any system - tho not enough on it’s own - its pKa is effectively lowered by typical shampoo surfacatnts. Not aware that tossing in other organic acids is that helpful but prob can’t hurt. Neither system is that great vs Gram negatives - so you might run challlenge testing diluted (50%, 70%) to get a feel for manufacturing/consumer risk.
Also take a look at preservative system in products P&G recently marketed with EWG (gack!).
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To ketchito’s point, P&G’s research and application re. Head & Shoulders/Wash & Co - considerable effort re. ZPT particle size, coacervate in formula and deposition technologies go into the product.
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Mike - your experience does not limit microbial contaminaton and some of the bugs that contaminate are not readily detected and products not accurate evaluated by routine methods. From liquid laundry (Halomonas and Pseudomonas aeuginosa) to liquid cleaners (Pseudomonas aeruginosa) to soap (Nesterenkonia) - recalls and publications document susceptibility of higb pH products..
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and all thse products were released based on in spec micro content testing
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Do you refer to stability? Finctionality?
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Ask who is 3rd party lab so you can talk directly. You want to confirm method, spec. and OOS protocol. Who will release? If not you - better be real confident if you delegate.
Please make sure to touch all the issues E.g. confirm micro spec - in QC micro, food guys are often more interested in the what and not the how many - for cosmetics its both and food whats are not the same as cosmetic whats.
How well in control is their water system?
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If you want to talk about the OOS - what were counts and ID?
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Process and package can mitigate risk of limited preservation. Can these help in your system?
Can you use benzyl alcohol and the diols? Does your formula include a chelator?
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As a general rule, that’s bull. The important metric is Aw of the water phase or product, as made and in use, not % in finished product. Powders are anhydrous and we know preservation is an issue for many.
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It is not cultural it is technical. Preservative testing is not validated to anything - neither manufacturing nor consumer ris. The asinsate/levulinate system - whatever result in challenge - clearly risks your consumers’ health, esp with the cynical 6 month PAO.
Have you ever run in-use testing?
As for manufacturing - a system that tests raw for micro contamination only after contamination is out of control in any conceot of GMP.
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There is no “AOAC/USP” - those are seperate compendia. Is this some in-house hybrid? Can you link the method they intend?
I understand they prob want to minimize complexity in their lab, but they sure aren’t being accomodating. Should I assume your business isn’t enough really to get their interest?
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This is from a formulator. Yes they do apply - and think you’ll likely find a relevant patent.
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It indeed is and as we’ve discussed, one of the bugs that characteristically contaminates soap is not readily detected by media used in conventional testing. Consumer contamination is another matter for which I understand few have the understanding and resources to address this aspect. of product risk
The larger issue is this - alkaline pH short of 11+ is not a barrier to contamination.
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Any fatty-acid based soap. P&G advertised its Zest against its own (but unnamed) Ivory soap. Lever advertised its Dove vs the same (also unnamed) Ivory for “mildness”.
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That’s a couple of weak organic acids with an ineffective organic acid and a weak unstable chelator. Even at a favorable pH </~ 5.5, that’s a poor system.
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Syndets last century were marketed on the basis of eliminate soap scum the hard water Ca salt of soap fatty acids - and were less irritating than C12 coconut fatty acid bar soaps.
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Surfactant solutions at pH 9-11 are susceptible to microbial contamination.