From:
Date: 27 Jan 2000
Time: 07:34:38
The "Zero pathogens" requirement is expressed on a "per gram" basis. Therefore I think it is appropriate to think of my bulk powder (metric tons) in terms of "gram" units and choose a sampling plan based upon the number of grams in the lot. The test is done on a 10 gram sample however, and therefore it can be argued that this is the basic unit.
"Zero tolerance" is indicative of the fact that there is no reason to expect a USP pathogen in the product. If it is there it is because of a breach in the processing/packaging and introduction from an outside source. Historically the USP's concept of zero defect arose from the fact that FDA wanted manufacturers to identify the background bioburden in their non-sterile product and set up criteria for four (randomly selected) pathogens. If these are not present, than it is unlikely that other pathogens are present. For bulk powder it is probabl