Stability testing

Do most of you use an outside site for stability testing? I’m basically making mist (that I’ve done a thousand times before) and the client is asking me about stability testing. Honestly I freeze it, leave it under a humidifier, by the window or let it roll around in my car for 4 seasons. Not very advanced but I’ve been trusting it. Advice please. 
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Comments

  • PhilGeisPhilGeis Member, Professional formulator
    If you sell, you should approach stability in a professional manner.    You'll find testing lab offering stability testing on the net.
  • MicroformulationMicroformulation Member, Professional Chemist
    The buyers I work with would demand a more structured stability test. Unless you have the needed equipment on board, you are best to send it out. It also grants you third-party validation.

    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
  • The buyers I work with would demand a more structured stability test. Unless you have the needed equipment on board, you are best to send it out. It also grants you third-party validation.

    I understand. What is the document they present? Is stability a specialized field or could I produce one using proper conditions?
  • PhilGeisPhilGeis Member, Professional formulator
    They have the facilities and controls and will issue a report you can show your client.
    Trying to establish it yourself will be tough and not cost effective.
    See: https://ifscc.org/wp-content/uploads/2018/05/2-Fundamentals-of-Stability-Testing.pdf
  • MicroformulationMicroformulation Member, Professional Chemist
    You would need lots of lab equipment that you likely don't have. Our stability oven was over 10K when new and we have to get it certified yearly. We test objectively for SG, pH (calibrated and logged), Viscosity (Brookfield calibrated yearly), visual appearance, and other metrics. We observe it across 3 accelerated cycles for changes. The final certificate is signed by a Chemist.

    Don't try to half-ass it or buy all that equipment for a rarely executed protocol. Call Microconsult for example out of Texas (https://microconsultinc.com/) and you would be surprised how affordable it is, especially when contrasted to buying the bench equipment. Also, you get a credible and credentialed certificate from a Professional. I consult with a company to evaluate these submissions to buyers, and we look closely at these forms.

    Don't do it. Make a sample, FedEx it to a lab, and wait for the test results.

    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
  • If you're worried about cost have you thought of billing the client for third party stability testing? Obviously be up front with them about the cost beforehand but many clients are willing to pay for professional stability testing if you aren't able to provide it. 

    We have our own equipment in the lab but a few times clients have asked for a third party to also test the stability and we'd tell them the cost ahead of time and bill them for it.
    Lab Assistant to a Cosmetic Formulator at a contract manufacturing company. New to the field and willing to learn.
  • We have used Allied Analytical for stability testing in the past and they were great.  

  • You would need lots of lab equipment that you likely don't have. Our stability oven was over 10K when new and we have to get it certified yearly. We test objectively for SG, pH (calibrated and logged), Viscosity (Brookfield calibrated yearly), visual appearance, and other metrics. We observe it across 3 accelerated cycles for changes. The final certificate is signed by a Chemist.

    Don't try to half-ass it or buy all that equipment for a rarely executed protocol. Call Microconsult for example out of Texas (https://microconsultinc.com/) and you would be surprised how affordable it is, especially when contrasted to buying the bench equipment. Also, you get a credible and credentialed certificate from a Professional. I consult with a company to evaluate these submissions to buyers, and we look closely at these forms.

    Don't do it. Make a sample, FedEx it to a lab, and wait for the test results.

    Gotcha. It doesn’t seem necessary though recommended. (For this simple formulation anyway)
  • PhilGeis said:
    They have the facilities and controls and will issue a report you can show your client.
    Trying to establish it yourself will be tough and not cost effective.
    See: https://ifscc.org/wp-content/uploads/2018/05/2-Fundamentals-of-Stability-Testing.pdf
    Thanks. I can for sure see my way is certainly not very credible in “report” format. I’ll double check that they really need this for a simple formula like this. I don’t see anyone asking for it though (retailers/health Canada/FDA) 
  • PhilGeisPhilGeis Member, Professional formulator
    It is necessary - someone can claim a micro or chemical injury and you'll have no data to refute and will hear their lawyer state you had not followed industry standards.  FDA says - 
    "There are no U.S. laws or regulations that require cosmetics to have specific shelf lives or have expiration dates on their labels. However, manufacturers are responsible for making sure their products are safe.  FDA considers determining a product’s shelf life to be part of the manufacturer’s responsibility."
    https://www.fda.gov/cosmetics/cosmetics-labeling/shelf-life-and-expiration-dating-cosmetics
  • How much do stability tests cost in US?
  • MicroformulationMicroformulation Member, Professional Chemist
    How much do stability tests cost in US?
    They vary, but I know Microconsult will email you an estimate if you submit the online form. They are affordable and used by many lines.

    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
  • Actually, I already have a lab I cooperated with, I'm just curious how my local prices compare with US prices in general. If I pay 140 USD for a stability test (16 weeks, 4 & 40 °C, product packaging vs glass benchmark), would you say it's a good price?
  • MicroformulationMicroformulation Member, Professional Chemist
    @grapefruit22 Yes, that is a great price, especially with a credible lab and the stability report. You may find that your clients will like the fact that the test was sent off for "third-party stability validation."

    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
  • @Microformulation, thanks, good to hear that.
  • @grapefruit22 Hi, do you mind if I ask who are you using for your Stability Testing as that is an awesome price 
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