It may take years of testing, including both clinical studies as well as with test subjects, to finally get the formula you want but that is only the beginning. The process of a formula becoming an actual product is arduous and depends on the product category, however, it is none the less relatively straight forward. Understanding these steps are critical in allowing you to put together a time line; refine your budget and to do cash flow projections.
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Using our signature product as an example, the wrinkle cream with SPF 30, here are the steps needed, and in this order. If the product fails any step along the way, reformulation is required and then you go back to step 1.
- 1. Repeat Insult Patch Test (RIPT) - 2 months - this test is conducted on individuals where the product is applied to the skin and covered with a patch. The subject is later checked for any sensitivity to the skin. This process is repeated throughout 8-9 weeks.
- 2. Micro Challenge - 2 months - this test verifies that the preservatives used in the product are capable of fighting off bacteria when introduced to the formula.
- 3. Stability - 3 months - conducted in a glass jar - this test makes sure the product doesn't break down over time.
- 4. Compatibility - 1 month - conducted in the packaging to be used - this test makes sure the formula doesn't react (i.e. chemical reaction) to the ingredients in the packaging.
- 5. SPF and Critical Wavelength - 2 weeks - testing is done on actual subjects - this tests to make sure the product meets the guidelines for Broad Spectrum (UVA and UVB) recently released by the FDA (see Blog dated June 15th FDA Regulation Means an Even Playing Field).
- 6. Engineering - 1 week - the engineers make sure the component is compatible with the production line as well as testing the evacuation process.
I have though we were 6 months away from launching for over a year. And with every step I felt like there were two new ones added. However, we now have a time frame.
We are in the middle of Stability Testing and we will conduct the SPF/Wavelength test in conjunction with the Compatibility study. This should be completed around the end of October and at this time we would submit a purchase order to the manufacturer.
Production time can vary anywhere from 12 -14 weeks.
This puts us on track for a February 2012 Launch. Super excited!!
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