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The Real Value Of Stability Testing In “Modern” Times
In considering the origins of product stability testing … an era in which refrigerated trucks, air conditioned warehouses & storefronts, and temperature-controlled conditions all along the distribution chain did not exist, I’m wondering just how valuable prolonged product stability testing is in an era where all of these things now exist and are the accelerated stability testing protocols and rules of thumb really indicative of anything of significant value. Granted, some modicum of product stability testing is necessary, but beyond a 30-day testing cycle … is there really any additional value?
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8 Replies
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I think there remains value in doing traditional stability tests.
While you are correct that the technology exists in the distribution chain that could keep product exposure to varied temperatures more controlled, this doesn’t happen in real life for the vast majority of personal care products.
And this doesn’t even take into consideration what each consumer is going to do with their product once they buy it.
The philosophy of stability testing is to ensure your product remains safe under the most extreme conditions it might potentially be exposed to.
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That’s part of my point, Perry. Preservative Challenge Testing ensures safety, but whether a cream breaks down or not is not really related to safety, but to usability. So, if the product is a pass on PCT and holds up for predictive of 1 year shelf life …
I seriously doubt that many consumer products are exposed to temperatures much above 80F throughout their life of use, except for perhaps sunscreens and things people may leave in their car. Otherwise, they are all used indoors, generally under temperature controlled conditions. Now, in less developed countries, it’s a different story.
The question is more along the lines of: Are the testing protocols that were developed for a different era still valuable/necessary testing protocols in a more advanced era where a lot of the conditions that were being controlled for no longer exist for the most part.
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Some value, perhaps. Although keeping samples of every batch for so long is counterproductive and excessive. The legisation should contemplate the different production levels and company structures and it doesn’t.
I have lost faith in updates or modifications. I think this will come with new methods of preservation. If something like gamma radiation becomes accessible and standard will force a change in protocols. Untill then, we are stuck. Or the day multinational companies consider the old ways doesn’t suit their interests and start lobbying for alternatives, perhaps.
Also, the “natural” trend and manufacturing process like what we saw in the lush video doesn’t help the case.
What protocols would you change if you had the chance?.
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Well, let me offer this perspective … if you need a product shelf life of longer than one year … you have a sales & marketing problem, more than you have a product stability problem.
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@MarkBroussard I think the current testing is extensive but also ensures that a product is as expected when a customer buys it and for the period they use it at home.
I generalize somewhat but here but Americans are fond of airconditioning, which is much less used in Europe. Therefore, 80F degrees is to be expected indoors if the outdoor temperature reaches the same level (which it does most summers). For instance I had a tinted lip-balm (ointment type) which seperated into pigments and oil-phase just because of the elevated temperature this year. (Honestly I expect it would have separated in accelerated testing but still).
I think the statement of one year shelflife or you have a sales issue is somewhat unreasonable. Color cosmetics may used less often than skincare and kept for longer by the consumer, but that does not necessarily invalidate sales as consumers also stock up on items if there is a sale.
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The world of cosmetics is too broad for a general answer. The necessary testing is going to depend on the product and the market in which it exists. I’ve seen products pass the standard tests, then fail in the real world because the standard tests didn’t adequately mimic the real world in that particular market.
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I have also lived in Europe, so I understand your commentary about air conditioning as I lived without it during the years I lived there … as I mentioned, this is not a position that is relevant for all geographies.
Color cosmetics … I generally consider skin care products and color cosmetics in completely different categories … my comments were intended to be relevant to skin care / hair care products.
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Yes, I have encountered that too. Had a product that performed well in stability testing and on-the-shelf testing at my lab. But, when I would send it to the client in California, the gel would shrink. We tried several different types of packaging … damned thing shrank every time it got to California.
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