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Order of testing - PET, Stability, HRIPT
Hi folks,
I am working on a skincare product and wanted to understand the sequencing of how I should do my testing (PET, Stability, HRIPT). Should they be done sequentially and in what order would you suggest? Is there anyway to accelerate this? (For example, starting PET at week X of the stability test)
In addition, I am buying the IP for the formula and want to use a different contract manufacturer for the production run. Do I need to do another set of tests when the new contract manufacturer makes a sample?
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4 Replies
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Sorry, realized this should be in the general forum.
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@cocoblue the correct logical order is stability > PET USP51 > HRIPT. If the formula is not thermodynamically stable then sterility testing and safety testing is no longer important. When you have (favorable) results documented for all three then you are free to choose any CDMO you want to; no need to run these again. After >35 years in that sector I can tell you the client who comes into play with formula ownership and integrity fully vetted like this gets instant “street cred” and the deference that goes with that. You will have a distinct advantage in the price quote too, the CDMO knowing you can move elsewhere at any time.
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Thank you very much, this is very helpful.
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Think you need a final formula, including preservative, before stability - unless you want to cycle mult. versions ands before expense of HRIPT. If it fails in PET fresh, it’ll be pointless to carry though stability - otherwise you may have a surprise with PET of 1st pull - a delay on product cycle. A new preservative system would prob have you repeat HRIPT.
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