Microformulation
Forum Replies Created
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I have several sources I refer people to in the UK. This client was in Nigeria.
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Do other Consultants in this group limit the area in which they practice? Yesterday I told a Sales Lead that I restrict my work to North Americana they got a bit upset. I have found that with the differing material suppliers, regulations, and shipping that these out of Country jobs are unlikely to be successful. Am I out of line here? I have plenty of work, but they seemed quite put-out.
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Good Analogy.
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@perry I was being facetious. I had a discussion with several Contract Manufacturers a few weeks ago at dinner and they were regaling me with tales of some DIY products that made it to them. One, for example, had 5% Vitamin E as a “preservative.” Another was a lotion with a pH of 9.5.
It is really a cautionary tale not to under-estimate the complexity of making a safe, effective and consistent product.
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Plus, why do we even need Consultants anymore? I see so many posts “I am an XXXX who has never taken any Chemistry classes and I am trying to make an XXXX” that we must be obsolete.
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Have clear contracts.
Vet your clients carefully. If you produce a product that they do not have the budget to produce, they will assign some of the blame to the Formulator.
I have had Labs make some changes to the Formulation as part of the Process scale-up which is inevitable. However, this is the limit of any lab work I will pass on to a manufacturer. I do my own stability. If there is micro-testing required I will outsource this and have the client pay the provider directly.
If you have a clear plan and timelines, clear contracts and work with clients who are positioned to be successful, you will do well. For me, this was part of the learning curve in my first few years.
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Good lord.
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It is not me being difficult. And I am not saying that you implied that.
Most of us are trained in the proper range of ingredients by percentage and this is how the references and distributors promote them. If they say a raw material is used at 2%, I am done with my calculation. Every 100 grams of final product will have 2 grams of that raw material. With your notation, if I said you need to add 2% Beeswax perhaps, you will be many calculations away.
Next, wt/wt% is scaleable. With tsp’s when you need to increase the batch size by a factor of 100, you are still far off. Wt/Wt& simplified this. Also, volumetric measurement is inaccurate. This inaccuracy is compounded when you scale up. A tsp could be off (depending on the measurer) by a large amount, say 5%. Your weight measurements are as accurate as your scale and many go to 0.01 grams.
Lastly, this is the notation Contract manufacturers use. Would you try to take this product for manufacturing the math would have to be reworked.
As it is, you rightfully have a recipe, not a Formula.
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First you need to weigh your Essential oils, not use Drops.
http://swiftcraftymonkey.blogspot.com/2010/11/question-how-to-convert-recipes-from.html
Wt/Wt% is based upon percentages. For example if a product is used at 1%, for every 100 grams of product, there is one gram of the ingredient.
These are the basics you must learn first.
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Step 1. Convert this to wt/wt%. Fluid ounces and tsp’s are not proper Cosmetic notation.
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No stability testing challenges the formula to see if it is stable for the emulsion, changes in odor, color and any number of factors under a certain protocol. There is no mandated protocol but most follow the guidance of the PCPC.
Challenge testing only assesses the preservative, not the physical factors.
Go to the site for Microchem, a testing Lab in Texas. They answer some of these questions.
You can NOT do these tests yourself unless you have expensive equipment and the knowledge. Send it out to someone like Microchem.
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Expiration dates are generally not used in Cosmetics. There are liability issues attached.
To determine shelf lift, you must run stability testing. This is generally out of the scope of smaller manufacturers. Send it out!
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Talk to a Regulatory person. Period. Don’t interpret the law yourself as a layperson.
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Wow, I see that XYZ is a Cosmetic company. Now I need a new generic name for a non-existent Cosmetic company!
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Remember this. Cosmetic Raw material distributors are not selling finished goods and as such don’t have to comply with the FDA Cosmetic Claims. It is WRONG to assume that since Induchem made a statement in their pdf you can make it. I would highly, highly, highly recommend that you consult with a Regulatory expert. You are making a naive error that many have.
I am sure others will weigh-in as well. Good luck. That is all I need to say. Won’t be me facing the FDA.
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Not sure who you hired, but you should work closely with him.
You can have him cite references, but in my opinion Claims substantiation really falls upon the Marketer of this project, in this case you.
Hair “growth” is a controversial area because a. if it really works it is an OTC and b. OTC’s have a list of what you MAY use and it must be pre-approved.
It is a lengthy process to get a new OTC approved. So in the end you have to make a Cosmetic product and avoid proof that it works.
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@mandyslaymanxo XYZ is a made-up name that I use when trying to make a point. I didn’t even know one existed! Cool.
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A predicted required HLB would simply help you to determine the needed emulsifiers to create an emulsion with the oil. It does not address the environmental benefit that was proposed and in fact the emulsified oil would still contain the contaminants.
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I have tried to obtain this material numerous times from my Rep, John Grey. It is still out of stock. We wanted to try it in a beer shampoo to make it “suds up” when opened. This was still the case as of June 1st. You could contact Phoenix directly to see if the issue is resolved.
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As @Bobzchemist properly states talk to several Consultants. Not every consultant is a best fit.
Also, as a Consultant, I have NEVER had a client spend too much time on their pre-Formulating Marketing. Ask yourself; who is my ideal client, who is my competition, don’t obsess about the Chemistry but when looking at the competition ask yourself “why does this particular ingredient keep popping up?”
If you even begin to mumble the catch-all phrase “natural”, stop yourself and refine this term. Explore the natural standards and ask if you can get a product credibly certified as this is looking to be becoming more important. If not craft a “Raw Material Philosophy.” “XYZ Cosmetics avoids the use of parabens, formaldehyde donors……..and uses plant based materials to produce safe and effective products.” The list of avoided materials in many cases do not have a strong Scientific reason to avoid, but in the market where we have to deal with perception, you must consider these.
Get a realistic budget. In my experience, two factors will affect you. One is being underfunded. Two is not having an effective Sales and Marketing strategy.
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@johnb Great points. I have worked with several Hair stylists who have attempted to develop their own lines. Even with a “perfect” Formulation which met all the performance and marketing benchmarks, other Market forces usually torpedoed the product. I suppose if you are going to be successful and crack this nut, you would find that your success is only secondary to the effectiveness of the Formulation and it’s success would rest primarilly on some sort of savvy Marketing that would give it visibility in the Market.
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@Bobzchemist Is absolutely correct. Even with a moderate budget it would be expensive to develop more than 2 or 3 Formulations at a time.
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There is a pinned post that lists Formulators on the main Page “Formulation Services.”
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@Bobzchemist I also think that when you are “compliant” (which I endorse only as a compromise, mainly so I can get past the “is this allowed” conundrum) you are likely to cut some corners with documentation. Much of the protection in certification is the higher documentation and QA standards but ultimately the third party protections and validation one gains under the certifying body. In a lawsuit, much rests on impressions and the level to which you reasonably apply your due diligence.
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Interesting and pertinent article here.