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Stability Protocol
  • I have a question here:


    We are a Private Label cosmetic Manufacturers.


    We are following an in-house Accelerated Stability guideline for our cosmetic Productsfor 3 months @ 40C, 1 month @ 50 and 3 Freeze Thaw cycles and check pH, Viscosity, specific gravity, Color and Odor at regular intervals.


    Do we need an outside approval for our Stability process? Do this Stabiltiy Protocol translate to the one which is approved by USP 34 ?


     


    Kindly advise,


    Thanks

  • For cosmetics, the only stability regulation is that you have a written stability protocol.  So, as along as yours is written down, that is enough.
  • Hello - can you please tell me where I can find more information regarding product testing as Nirmal describes above? I'm close to completing my water-based formulas and need to know the next steps in as much detail as you can provide, including any resources and equipment that may need to be purchased. If I've overlooked this on the forum please forgive me. I also see where you posted "standard stability testing for cosmetics is 1 year". Is it unadvisable to test for a shorter period of time?


    Anxiously awaiting your reply.

  • Please forgive me. I did locate the article "How to Stability Test a Cosmetic Formula". Very, very helpful. Can you reccommend a company where I can purchase florescent and natural light boxes? Also if you can reccommend a lab (I live in Georgia but it doesn't have to be Georgia) that does microbial testing or one that I can purchase agars to conduct my own testing? I'm assuming I'll need to purchase a laboratory incubator as well? 


    Thank you very much

  • Don't do your own microbial testing, you can't possibly justify the expense for the equipment, supplies and time. As far as I know, there isn't a lab in Georgia that does this kind of testing (we're in Kennesaw, and we've checked). We use AFL in Texas
     (865 Greenview Dr, Grand Prairie TX 75050):
    Our contact is Anita Klu Phone 972.336.0336
  • Sending out makes sense until you get to a certain size, then it does become cheaper to get an in house microbiologist. Most places I've either worked for, or visited have Micro labs, but these were high volume producers supplying the big retailers in the UK/Europe, who all required TVC passes (<100cfu/ml) before shipping.


    If you're just looking for challenge on a handful of products, as Robert says, punt it out.

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