the microbial limits tests do not address themselves to “objectionable” microorganisms, how is the manufacturer to determine if there are “objectionables” in a lot of product awaiting release? One approach is suggested by FDA - once all organisms grown in the total count studies (total aerobic as well as total yeast and mold) are identified, a qualified microbiologist would conduct a risk analysis on the presence of that organism in that medication (4). This risk analysis should incorporate a minimum of four separate analyses: Absolute numbers of organisms seen Microorganism’s Characteristics Product Characteristics Potential Impact on Patients


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