PhilGeis
Forum Replies Created
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Change preservative system.
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prob need a preservative
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Do prob need better preservation. Check similar products on the shelf.
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Checked for micro contamination?
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You are over preserved. EDTA at 0.1% of acid with either phenoxy 5000 ppm/EHG or isothiazolinone/benzoate 2500 ppm.
No Benzalkonium chloride.
I don’t know which isothiazolinone commerical product you’re using BUT do not exceed 7.5 ppm active of total MIT/CMIT
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You might offer that you want products tested to industry standards. Do not doubt for a moment that any legal action regarding product quality will observe “inappropriate” methods whether of technical signficance or not.
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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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The proof is in the consumers hands. Show me your in-use data - it is your claim and responsibility. And please not just USP 51 of the juice.
Please understand, USP 51 is borrowed from pharma and has no validition for cosmetics - passing does not mean it’s effective in plants and more importantly in the hands of consumers - the actual purpose of preservation. Inexperienced folks take it as gospel - and such folks typically consider testing the juice qualifies the wipe product. The big variable is the substrate that operates as a chromatographic medium. Esp. for tub fill, the preservative will be in the top wipes and not the others.
Proper testing uses the finshed wipes - top and bottom of tub fill.
Benzoic acid is not effective against pseudomonads at any pH. Are you aware of the pH dynmaic for orgnaic acids? That it passes as juice - even with complete kill means little to the world of pseudomonads. The ATCC isolate used in USP 51 is a lab creature - isolated ~60 years ago from a lesion and it carries no resistant plasmids.
Using that crap preservaitve systemn for a baby wipe is a terrible idea.
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Bull - must be aware of the pH dynamics of benzoate and the development of wipe preservative systems. A known weak system on its face - just benzoate - passing equally weak USP 51, prob with juice, as an excuse to market - is a profoundly flawed approach to wipes preservation.
Pity your consumers.
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Quite famliar with the components - an organic acid and a weak chelator stabilized with gluconic acid. You don’t even know the pH and your offering that silly combination that, under the best conditions, has nothing for Gram negative bacteria.
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No!
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I understand. What is pH? “Clean” in context of baby is a risky proposition. what is your challenge test?
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Need to control pH both as made and instability for benzoic - your only protection vs. fungi and staph.
Can you use benzyl alcohol?
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The concentrate is a manufacturing intermediate/premix to be diluted before packaging for retail?
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This is for personal use?
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Dilution to 80%??? This is a major problem - most tap water includes Pseudomonas aeruginosa AND in context of biofilm. Are you challenge testing with diluted product? At minimum you need to get in-use micro data as you’ve effectively engaged consumers and their water in your manufacturing.
Be aware - a similar approach (point of use dilution - shampoo) was associated with serious outbreak of infection that led to one death at a cancer hospital. https://academic.oup.com/jid/article-abstract/158/3/655/2190564
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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?