Microformulation
Forum Replies Created
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It really depends on your Formulation, but it’s not a hard fast rule that you have to wait. There is a recent discussion you can refer to about post-manufacturing and viscosity. It is very much Formula dependent.
In production, I have generally seen the product placed in “QC Hold” post-manufacturing. It is in a sanitized container. This hold allows Micro to get back and for the batch to meet the specs as defined.
I would not leave it out overnight with the lid off. We don’t use laminar flow hoods in Cosmetics.
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It’s actually quite common, especially with certain fatty alcohols. At a company I worked with we would recheck these batches at 24 and 48 hours post-manufacturing while they were still in QC hold.
As mentioned previously, the viscosity will not be seen at 45C. You would use RT samples.
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<div>Consider using caramel. If you look you will see it in many sunless tanners.
</div><div>On a similar note augmenting the DHA with Erythrulose could give a more natural looking tan. However it is often avoided to to additional costs.
Sunless tanners are a product that you MUST track costs rigorously. In the end it usually comes down to cost per gallon.
Anecdotally I can relay an experience we had. A client wanted a “natural/organic” sunless tanners. He believed that being organic would set him apart. He lost his shirt. The market was more concerned with price and efficacy. Organic/natural was at best a tertiary concern. They had to dispose of over 1000 gallons of outdated product. Two other lines have gone that way by their STRONG insistence with similar results.
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More than likely you will see this Formula become an OTC product with all the requisite Regulatory obligations. https://www.fda.gov/drugs/otc-drug-review-process-otc-drug-monographs</div><div>
https://chemistscorner.com/a-list-of-cosmetics-that-have-fda-monographs/
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Use a different hold agent than sugar. It will leave a white residue as it dries and it is extremely difficult to preserve.
Also, it is infinitely easier to critique a Formula when it is written in wt/wt%. Metric is the language of science.
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You would need to post the Formulation with percentages to get any real help. My first impression is Leucidal is a horrible preservative and would be unlikely to be effective in this product.
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You will need to be careful with your claims. Any claims that it causes hair to grow or it proposes a physiological response would be disallowed. I have seen several lines get enforcement actions over this issue.
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Here are some companies that promote oils with high levels of ceramide. You can access their product sheets with some research.
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We did try the product early on. (It has been available longer than many believe). It isn’t a multifunctional preservative but a booster. Our client was presented the product by a rep and included it in the initial Product Design. We used it as part of a preservative system that passed testing, but most likely from the other aspects of the preservative system. The client dropped the product during the “Oh Crap, why is my product so expensive to manufacture” phase. The revised product also passed testing without the booster.
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My UL Prospector account already provides all this information in the material search.
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Receiving a suitable response within this forum is unlikely. The focus
here primarily revolves around the design and production of cosmetic and
over-the-counter products. Your inquiry would be better suited for a
forum dedicated to cosmetology practices. -
We have encountered multiple occurrences involving the utilization of Sodium Levulinate/Sodium Anisate as a preservative system. Additionally, we have been consulted by companies whose formulations incorporating Sodium Levulinate/Sodium Anisate have faced challenges in passing Production Micro testing and Quality Control.
As has been underscored, this preservative system demonstrates efficacy within controlled laboratory or ideal conditions; however, its performance is substantially contingent on the specific production processes. Some manufacturers have encountered elevated levels of Quality Control failures beyond the ordinary range.
In light of these observations, I would strongly advocate for the adoption of a more resilient preservation system.
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This would be an OTC Drug in the US. You will find more information in the US Pharmacopeia or other Pharmacy sources. I would be hesitant to make this product as a Cosmetic product as it needs to comply with the monograph and it would need to be registered as an OTC. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=dcc5a175-97a0-4e5f-a74d-1a7059d0bfff
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Can’t say how I know, but the initial packaging was purchased surplus from McKernen. When the initial allotment was used they purchased directly from a supplier. It’s common with emerging lines such as Suki. We work with emerging lines. https://www.mckernan.com/
mckernan.com
McKernan Packaging offers wholesale bottles, surplus bottles and wholesale jars to customers worldwide. Offering continuous stock bottles, jars and packaging such as sprayers, pumps and closures at discount wholesale prices in bulk.
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December 29, 2023
- MoCRA comes into effect.
- Products and facilities must be registered
- Safety substantiation must be available (toxicological risk assessment, cosmetic safety report)
- Responsible person has to establish a listing for existing cosmetic productsJune 29, 2024
- List of fragrance allergens must be on the ingredients list
- Cosmetics labels must include a domestic address, phone number, or electronic contact information of the responsible person
- If international, electronic information (website, email is required)
- The brand can be its own RP (Responsible Person)
- Foreign manufacturing companies must appoint a US agent
- Must be compliant with ISO / GMP guidelines
- Companies must have an adverse event reporting source on their website
- Responsible person must maintain records of all adverse events for 6 years and must report serious adverse events within 15 days
- Facility registration: update new information within 60 days
- Product listing: annual update is sufficient -
Remove the Cocoa Butter and Shea Butter or reduce them to label copy levels if they are critical to the marketing story.
I think I would go back to the design phase and perhaps look at some starting Formulations from reputable suppliers (Koster Keuenen, Strahl&Pitsch, Prospector Formulations, and other numerous online sources).
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Euxyl K700 and Dermofeel PA as a chelant. We were limited in our use of glycols due to the type of product and the client’s request. Packaging was critical, it was pH dependent, and “theoretical Aw” was also utilized as a part of a hurdle technique. As often happens, the client attended a Trade Show and was “sold” on the product by the rep as a multifunctional preservative rather than a booster.
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Most of these commodity shampoos are produced by larger companies and I assure you most have better Quality Programs in place than 90% of the other facilities I have toured. It’s not a decrease in quality, it’s the fact that they are able to get volume discounts on materials. The more you buy, the better the price. Also, they have pretty well-run lines and it eliminates as much manual labor as possible.
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As you build the Formulation and vet materials you ensure the overall Formulation is compliant. This is pretty straightforward. Simply, it’s not a product that we would gain any real benefit from.
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I would have to agree. We have emailed some questions to the FDA regarding issues and the responses essentially were “we don’t know yet.”
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Most definitely speculating. The Guidance has been lacking for the most part.
That language was used in a slide during an FDA Seminar I attended (online). The FDA was very unclear regarding what will be required. When discussing the Fragrance Declaration the presenter submitted the EU Fragrance Declaration standards as their guidance for labeling Fragrance allergens.
Honestly, most of my clients are lines that do not manufacture themselves so we have been concentrating on registering their products and ensuring they have a RP assigned. We are also working on setting up adverse incident reporting procedures and updating the websites. Our clients generally do PET and patch testing already.
Many of the plants we work with are scrambling to meet the ISO/GMP standards. This is a huge undertaking and we have been referring them to other service providers.
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I’m only a few years away from retirement. I have already been approached to be a RP for some of our clients so it sounds lucrative.
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The Essential Oils also have fragrance allergens which must be declared. In fact, some of my clients have seen far more reactions to EO’s than many fragrances.
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It will recrystallize fairly quickly. It would predictably fail stability each time.