Microbiology decision tree

Fig. 5-9 Decision tree used to accept or reject results from collaborative trials to establish the potencies of antibiotics to be used as chemical reference substances for microbiological assay standards.

FIGURE 8.6 Critical Control Point Decision Tree. (Based on FDA (1997), Hazard Analysis and Critical Point Principles and Application Guidelines, National Advisory Committee on Microbiological Criteria for Foods, August.)... 

For other materials (for instance, equipment and supplies for aseptic manufacture) where the mechanisms of inactivation rely on direct contact between the steam and the item being sterilized and therefore where air removal is matter of importance, the choice of substrate for Bis generally lies between using commercially available paper spore strips and the material itself The decision tree in 4 may be helpful. Regulatory pressure is currently toward use of inoculated product, but commercially available spore strips are more convenient. Tailor-made inoculated product requires substantial amounts of microbiological expertise. The decision tree in Fig. 4 may be helpful in selecting which approach is best in particular circumstances. 

Microbiological attributes are required where preparation and storage can significantly compromise microbiological quality. Scheme 7 shows a decision tree for the disposition of microbiologically related attributes. 

Scheme 7 Decision tree for the disposition of microbiological attributes. Source. Courtesy of Pharmquest Corporation, Mountain View, California, U.S.A.

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