While establishing the product stability of a metered dose inhaler, would you consider leak-test to be part of stability program?
My suggestion, is that it is to be considered as part of stability program...(because, the formula assumes that the rate-of-leak (as measured at T0 time point) is constant; )
If it is not part of normal stability program; the leak test need to be established a part of design-verification of device. (simulate all the stress-conditions of product shelf life)
My suggestion, is that it is to be considered as part of stability program...(because, the formula assumes that the rate-of-leak (as measured at T0 time point) is constant; )
If it is not part of normal stability program; the leak test need to be established a part of design-verification of device. (simulate all the stress-conditions of product shelf life)
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