Question
Due to liability issues it is imperative that drug makers have rigorous quality-control standards. Production control at Betapharm requires that its Malic acid input have
Due to liability issues it is imperative that drug makers have rigorous quality-control standards.
Production control at Betapharm requires that its Malic acid input have a pH level between 2.9
and 3.1, and the size of each particle of Malic acid be between 7 and 10 microns. Any substance
with attributes falling beyond either the pH or size tolerances would be considered defective.
Betapharm required that its suppliers have a defect rate of no more than 210
-9
. Marina's report
indicates that Chun Wu planned to use a two-step serial process: (A) Malic acid pH titration; and
(B) Malic acid grinding.
Chun Wu's step (A) is carried out in a reactor which sets the acid pH to a mean of 3.0 with a
standard deviation of 0.016 pH. Step (B) grinds material to a mean of 8.5 microns with a standard
deviation of 0.27 microns.
She estimated that reducing step (B)'s standard deviation by a factor
of x% would cost (200,000)(x%) annually in calibration and sampling expenses
Estimate how much it will cost annually to bring Chun Wu up to Betapharm's required quality level.
I have no idea how to do the last part? I have the sigma capability but dont know how to move from here.
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