Microformulation
Forum Replies Created
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As an amateur chemist without significant technical support, this would not be feasible. As JohnB so rightfully points out, just buy the stuff!
If you made it, lets say, how would you determine the yield and the final purity without Analytical testing.
This function is out of the reach of the assets available to most if not all Cosmetic Chemists. It is better to buy the product and move onto the Formulation. Don’t miss the forest for one very minor tree.
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Has it been determined if it is an allergy or inflammation? An true allergy is an IG modulated reaction and less common than many believe. Inflammation is a prostagladin modulated reaction and it occurs after chemical or enviromental insult. In many cases it is classified as a contact dermatitis. For the most dramatic presentation think poison ivy.
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They haven’t been caught yet. It is like explaining how people get away with breaking into houses.
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I will have to say that I tour a lot of plants and the Technical Staff I encounter are getting younger (or are we getting older?) and they are way more tech savvy. If you are a huge tech geek, there is a huge potential for integrating PLC’s, wireless technology and tablet based documentation.
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We used a hybrid system that the FDA loved. The Formulas and Master Records were created in the Lab using a computer and an internal Excel Spreadsheet template. When the product was approved, the record would contain the Formula, Process instructions (a usable batch record), the COA and Testing Results. It was approved by the Technical Director and then uploaded to the server as a write protected document. A Hard Copy was printed, marked “Master” and kept at the front of a hanging file system.
When manufacturing was done, a copy of the Master Record was printed by the Production Manager and endorsed by the hierarchy. It was stamped copy. This copy was used to complete the manufacturing. For example it had a hard copy that was used by the pre-weigh room as well as the batch master. When manufacturing was completed, the copies were scanned into the computer, a Batch Record was saved in a sub folder, generally with the same name as the Master, but appended with the Batch number. The original hard copies were then kept right behind the hard copy in the vertical hanging files. In the end, we had an archived hard copy and a digital record.
We used Excel for many reasons. First, I was tasked to set-up the system and all the computers had Office Suite. I had already networked them together and installed a central server. I used a third party software product to complete an offsite back-up each night as well as a secondary back-up onsite. We lost a terminal here and there in the course of time but never the server and never a hard copy.
It did require a defined signature trail, good hard copy archiving as well as some IT procedures to ensure document integrity. One other advantage was that the Chemists under me were able to use OneNote for their lab notebooks. I spent many hours writing templates. On the first few regulatory visits, edits were suggested and after 2 years or so we had a very refined system. We could have evolved and used tablets to record the signatures, pre-weighs and manufacturing as long as we installed a secure signature add-on. (For example, pre-weigh person one weighs the raw material, goes to the signature field, enters a password and the signature field was populated. etc.) We didn’t do this simply because it was the very earliest days of tablets and the Production environment was harsh. It could be feasible today.
This system also meshes with computerized weighing systems and other process equipment. I use it in my lab and all my IKA mixers are “plugged in through the RS ports and fed into the Mixmaster software. All this goes into my lab notebook (OneNote).
I can agree that hard copies get messy. I have received back pre-weigh sheets that were translucent with oils. I had to get creative since they couldn’t get fed into a scanner. I would have to photograph them and upload the image into the digital batch records and then dry them on a window sill before I could file them with the hard copy.
The technology exists and it can support manufacturing in such a way the FDA is happy. Our system had passed an FDA Audit and in fact the inspector was very impressed. She recommended some changes (which we incorporated) to make it more compliant. It can be done. It is likely not feasible for all but the best funded facility willing to train their staff.
I still have the template (it is open source and really my IP) available as I share it freely. It does require some strong IT skill and knowledge to ensure that digital records are not over written and in order to understand how the spreadsheet is utilized. If anyone wants a copy (Excel format), email me and I will gladly share. This may sound harsh, but I will only share it with credible commercial manufacturers. It is far too involved for any environment short of that setting.
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That really isn’t claiming it as an active, more so as a constituent ingredient.
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Wow!
I remember once we had a client that wanted to use a special “laser” aligned water from the Ukraine. Once the product was made, they wanted the pallets arranged in line with the magnetic North Pole to protect the “alignment” of the water.
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My new favorite comment came yesterday. I was speaking with a young lady and she wants to manufacture her product herself. I said that she should follow cGMP standards if she does so. She stated that she did her research and nowhere does the FDA mention cGMP. I offered to send her the links. She insisted that there is no use of cGMP in Cosmetics. I said I know there is and I have been doing this awhile. Her answer was “I am an English Major and I know how to research on Google.”
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Exactly what he just said ^^^^
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This clearly demonstrates why volumetric measurements (tsps, ounces) are flawed and not used by serious Formulators. Use wt/wt% and you won’t have this issue.
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The usage level really has nothing to do with the water content but rather more properly the application and if it is leave on or rinse off. Of course MCT should be rinse off. I would pull the manufacturer spec sheets.
Free water (Aw) which you may be referring to is measured with specialized equipment, not the water portion of the Formula. -
Why would you want to purchase it yourself? It is a processing aid ALREADY included in many of the pigment blends. It is generally used as a bulking agent.
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They are some of the most difficult emulsions to achieve. Keep at it.
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Here is a sample Formulation from the distributor. Usually they have better documentation. I would suggest reaching out to your rep. I think you are on the right track;
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What is your primary emulsifier? And are you SURE that you want 73% water suspended in 27% oil? Do you believe that this promotes stability? I know that current thought is that 60-80% water (or less than 74%) is stable but I have always found this to be a difficult and advanced problem to crack;
http://www.cosmeticsandtoiletries.com/research/methodsprocesses/4418977.html
Use that to do more research and you may get the problem solved. -
Even better. The powder is a pain to work with. I am sure some can tell stories. The liquid is easier but be sure to keep an eye on the total solids, especially from supplier to supplier.
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I wish I could debunk what Perry and Bob have said, but sadly I can’t.
I work with many starting lines and hence get challenged to meet these WF standards quite a bit. My take away has been that outside of their websites, WF’s doesn’t do a great job in the stores promoting their more selective tiers (Premium). In the end, my clients are finding that meeting the basic requirements and getting physically on to the WF shelves is endorsement enough and easier to achieve.
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If you are looking for more valid safety data, try the Cosmetic Ingredient Review (http://www.cir-safety.org/).
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@Belassi I couldn’t have said it better.
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Please don’t use the EWG as a source on here. The flaws of their database are numerous and have been covered at length. There are far better sources.
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Where are you located?
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You need an overhead mixer at minimum. A stick blender will give you this issue. I have also seen over aerated batches fail in stability.
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It is not something that I or even possibly a Cosmetic Formulator could do. I am familiar with these products and in most cases they are a rubber latex base. It is more of a Polymer Science Formulation.
However asking for a Formula outright is asking for free work. I would recommend looking at the Formulation resources (a pinned post) and hiring a Consultant outright. -
We don’t give out Formulas just like that. If you could post a similar product or even your starting Formula we would be glad to weigh-in. But remember most of us do this for a living. You are basically asking for free work.
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You are missing the point. A Tear Free product is generally made with Amphoteric surfactants. This is the primary factor. pH and avoiding sensitizing materials such as fragrances are secondary.