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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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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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?
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This is from a formulator. Yes they do apply - and think you’ll likely find a relevant patent.