[PhilGeis]

<div>ATF indicates specific denatured alcohols for cosmetics.</div>

https://www.ecfr.gov/current/title-27/chapter-I/subchapter-A/part-21

See subpart D.

ecfr.gov

27 CFR Part 21 -- Formulas for Denatured Alcohol and Rum

27 CFR Part 21 -- Formulas for Denatured Alcohol and Rum

[PhilGeis]

Happi is a source of model formulas

[PhilGeis]

Gluconolactone hydrolyzes/breaks down spontaneously in solution to gluconic acid. Consider https://pubmed.ncbi.nlm.nih.gov/25043489/

Are you determining urea levels in stability testing?

[PhilGeis]

They also claim 5% “glycine” when they apparently mean glycerine.

[PhilGeis]

Benzoate is more effective in combination with surfactants and can be enough to pass USP 51. It is not enough to protect in use.

[PhilGeis]

attachment did not open so here are syllabi

First Semester

Module 1: Introduction to Microbiology (1/8-1/14)

Module 2: Sources of Microorganisms (1/15-1/21)

Module 3: Preservatives in Personal Care (1/22-1/28)

Module 4: Product Development Risk Assessments (1/29-2/4)

Module 5: Microbiology Laboratory Functions (2/5-2/11)

Module 6: Rapid Methods and Quality Control (2/12-2/18)

Module 7: Case Study and Midterm Exam (2/19-2/25)

Module 8: The Regulatory Environment (2/25-3/1)

Module 9: The Business Environment and Brand Equity (3/3-3/8)

Module 10: Leading Individuals and Teams (3/10-3/15)

Module 11: Case Study (3/17-3/22)

Module 12: Quality Assurance (3/24-3/29)

Module 13: Design and Risk Assessment (3/31-4/5)

Module 1: Introduction to the Course and Manufacturing Facilities Part 1 (5/6-5/12)

Second Semester

Module 1: Introduction to the Course and Manufacturing Facilities Part 1 (5/6-5/12)

Module 2: Manufacturing Facilities Part 2 and Clean Design Principles (5/13-5/19)

Module 3: Equipment Cleaning - the Chemistry and Effective Methods (5/20- 5/26)

Module 4: Equipment Cleaning - Validation and Case Study (5/27-6/2)

Module 5: CIP COP System application & Design, Hygienic Equipment Fabrication & Design (6/3-6/9)

Module 6: Surface Finishes and Concepts from Physics and their Application (6/10-6/16)

Module 7: Piping Schematics and Water System Part 1 (6/17-6/23)

Module 8: Material Review and Mid-term Exam (6/24-6/30)

Module 9: Water System Design, Testing and Validation (7/1-7/7)

Module 10: Good Manufacturing Practices & HVAC (7/8-7/14)

Module 11: Compressed Air and Environmental Monitoring Program (7/15-7/21)

Module 12: Micro Investigations, Case Studies and Hygienic Risk Assessment (7/22-7/28)

[PhilGeis]

There hasn’t been a really effective new molecule since isothiazolinones. So we have the classic line up, all off patent. Anyone can make them - so preservatives are commodities. The cosmetic market is a small one, and suppliers can’t make it competing simply on price for commodity chemicals. Inventing/ patenting novel combinations with the boiler plate natural (by some definition) broad spectrum across wide pH, here with the skin friendly BS for niacinamide, lets them occupy a premium priced marketing space.

I’d like it better if they’d pursue new molecules at the same time (Arxada may be) but the payback after all the chemistry, micro testing, safety testing, regulatory approval, marketing etc. is marginal for cosmetics and the chances of success are about the same as new drug development.

It’s certainly cheaper to formulate with individual chemicals - the big guys do this. Ironic that high, priced combos are usually less effective but they do work the balance sheets.-

[PhilGeis]

I saw the article - 100% marketing. I know some of the folks offering information - good technical folks doing the best they can with what their companies produces and demands of them.

These are no doubt patented combinations. Niacinamide is not a preservative - think they add it in interest of “protecting the skin”. Polylysine is a cationic and BS as a preservative. Glyceryl caprylate is an ester - multifunctional booster but too susceptible to Gram neg esterases to function as primary. Decyl glycol is just that - a glycol - but less commonly used so may serve patent novelty.

[PhilGeis]

Growth? How will you support the claim?

[PhilGeis]

No experience with the stuff - don’t see it on CIR so wonder at safety assessment needed under MoCRa. Evonik comment ~ PEA and Phenooxyethyl

Phenoxy propanol in on Annex 5 for rinse off only.

• This reply was modified 4 months ago by  PhilGeis.

[PhilGeis]

Phenoxyethanol should not be greater than 1%, 0.5-0.8% is good.

What’s product pH?

[PhilGeis]

Please idenity the preservative actives and their specific %’s. Folks are not going to chase down the cats and dogs of commercial mixtures.

EDTA at ~0.1% accid

[PhilGeis]

As a water in oil emulsion, product is not at risk for consumer contamination but you need too ensure the just need to ensure the “water soluble extract” as is won’t grow bugs.

Also, it’s likely to fail challenge testing so don’t bother, the test is meaningless here.

[PhilGeis]

The specific marketed product - are you referring to Latisse and similar Bimatoprost products? These are drugs specifically approved by FDA.

[PhilGeis]

what product would this be?

[PhilGeis]

FDA does not approve cosmetic ingredients.

[PhilGeis]

Please don’t believe all the marketing BS, esp. from a repacker. Phenoxy/EHG is not that good vs fungi and not great vs Gram + bacteria.

[PhilGeis]

The list hasn’t been touched for decades but for alerts from activists - Parabens - and the contact derm folks - MIT. There is and has been virtually no use of OPP to for anyone to notice. Even the activists are not so stupid as to sensationalize something no one uses and the derm folks deal with reality.

The stuff is not only classified as a carcinogen, it is an irritant.

[PhilGeis]

Mike is spot on. You shouldn’t expect to understand a disease process based on folks offering a few sentences in the forum.

[PhilGeis]

Execute

https://cosmeticseurope.eu/files/5914/6407/8121/Guidelines_on_Stability_Testing_of_Cosmetics_CE-CTFA_-_2004.pdf

[PhilGeis]

You should post as a primary question.

[PhilGeis]

Hot filled tubes are certainly at very limited risk.

Why not make/package product and let your freinds screw around with it, encourage them to use and often in any way they wish - get it back and check for bugs.

[PhilGeis]

Good grief - forget Natacide and other mystery preservatives. Phenoxy is prob not great - flashing off at 100C, partitoning is not favorable with w-in-o and Gram negs are prob not your biggest risk. Please talk about the chemical not the commericial name.

Challenge - fail not because it’s unpreserved but because the challenge droplets with bacteria/fungi never effectively merge with water in your water-in-oil emulsions. The same phenomenon governs contamination in use. Unlesss exposed to water in use - your risk is fungal contamination under high humidity so phenoxy is not that useful. If direct exposure to water - preservative in water droplets in w-in-o prob won’t see the bugs and any preservatibe will not be effectively available. Bugs from skin don’t come woth enough water to grow.

• This reply was modified 4 months, 2 weeks ago by  PhilGeis.

[PhilGeis]

Not sure you need a preservative. If really 100C, you’ll certainly eliminate process contamination. Is it hot fill? and what is package? Water in oil - are intrinsically less susceptible. Challenge testing is not suitable - it’ll prob fail preservative or no. You wonder where the glycerol is - if in water phase, it’ll have an effect. Where does it come in process?

Right - you’ll never get preservative in post process.

The real test would be in use.

[PhilGeis]

I’ve used it in disinfectants - consumers complained about skin irriation. Never used it as a cosmetic preservative.