I believe the proposed USP specs are ˜10 CFU for the total plate count, ˜10 CFU for total yeast and molds count, ˜10 coliforms, ˜10 enterobacterial. In EP it is ˜100 CFU bacteria+fungi and absence of P. aeruginosa and S. aureus.
I would think you would definitely want absence of Pseudomonas and Staph and probably some other objectionable organisms like Strep and other known respiratory tract pathogens.
Date: Tue, 2 May 2006 11:33:56 -0700
From: Sandy Mohan <[log in to unmask]>
Subject: Re: Microbial limits
Does anyone know what microbial limits are used for inhalers -
metered-dose or dry powder inhalers?=20
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