PhilGeis
Forum Replies Created
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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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Be esp. attentive to stability with sorbate
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CM as an FDA reg facility in GMP control and product within monograph??
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Will the R&D lab be making product for human use/application?
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Don;t know this one. On paper, it doesn’t look like much - a couple of diols f. Quats are pretty lame as cosmetic preservatives. Looks like the hooks are “free-from” labeling and cost with the broad spectrum/pH range assurances. Oddly, documents does not address efficacy - not even the usual boiler plate stuff.
My bias - diols fixed up for snake oil patent
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Micro contamination is a cryptic risk - esp. with addition of salt and sugar.
Note recent US recall - Castile Soap Towelette - Product is contaminated with Nesterenkonia lacusekhoensis..
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Bottled water may have been treated with ozone - residue that would oxidize your copper. Industrial ozonated systens use UV to eliminate the stuff. Activated carboon works - you might try bisulfite addition to test the concept.
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actually bisulfite would just address oxidation. You know that’s happening but a little might let you proceed
There are kits for ozone but I don;t know if they just look for general oxidation potential. https://www.hannainst.com/hi38054-ozone-test-kit.html?msclkid=7d6f1025ce521934fd02748b5ee1471a
hannainst.com
The HI38054 is a chemical test kit for the determination of ozone.
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Lots of labs offer the testing but not cheaply and are prob not eager to address single samples. If you were in mainland, I’d suggest ATL in Cincy Think there’s a Eurofins in Hawaii
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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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Suggest you know little of P&G or pine extracts.
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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.
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Your expectations are not consistent with reality or apparently experience.
It should be intuitive that a preservative is necessary and the products do not include anything known. The 3 year effective and surprising pine extract preservation based on <i style=”font-family: inherit; font-size: inherit; color: var(-bb-body-text-color);”> natural antimicrobial and antibacterial properties from something in their backyard they extracted themselves is pretty tough to buy - esp. from an obscure bunch with a past record of contamination. It should have anyone with relevant experience scratching their head. Suggest you review pine extract compositions in the literature - there’s nothing magic.
Please don’t blow off “once in a few years” FDA report for contamination. This is serious and brands and minor brands skate by on this frequently - 1) they have to discover the contamination and 2) turn themselves in. Contamination as made is also function of failed manufacturing hygiene and not directly relevant to in-use risk. That you failed to observe spoilage in one experience is not a valid assessment of preservation. Shampoos are generally resistant to fungal contamination and bacterial contamination is often cryptic - unapparent . In-use studies are designed with n>>1.
Please don’t be superficial regarding microbiological risks. Folks have been blinded and even died (including babies) from infections acquired from contaminated products. Safety is a positive assessment that must be confirmed, not presumed until shown otherwise. I’d not offer benefit of a doubt excuse for extraordinary claims with no data.
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70% is pretty tough, esp. at higher pH - if manage appropriately - sanitized production as RM and transport and delivery (one way totes and drum liners, sanitized tankers, unloading and storage, etc. ).
They aren;t bad but please don’t have too much faith in castile soap or pH 10 as preserved. These are good examples of potnetially susceptible stuff that happily passes USP/ISO preservative tests. I’d not go much below pH 12 in presuming no problem.
I’ve seen Serratia contaminaton of liquid (true) soap and note the following recent recall. Note recent recalls for micro contamination (aeruginosa) of Liquid laundry and - both pH >10.
Castile Soap Towelette
Product is contaminated with Nesterenkonia lacusekhoensis
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Don’t be surprised or an apologist for BS. Lots of extracts have antimicrobial potential in some zone of inhibition test. There’s s nothing special re. preservation about ’em - including pine extracts. Efficacy has been studied in many product contexts and re. specifc components/putative actives. Even if effective at cosmetic use levels (they are NOT) - batch to batch concentrations are so widely variable there is no reproducibility in efficacy.
This is just another crunchy granola marketing bunch, ignorant of the risk their green BS brings to consumers - here infants.