Yes, it is an important test that is required as a pharmacopieal test. It is a serious contaminant of infant rehydrating formula or powdered infant formula. Also, the first causes of neonatal meningitis are believed to be caused by E. Sakazakii. It is a general contaminant of starch and lactose. It is produced either by wet or dry processes. Wet granulation is achieved by dissolving the soluble excipients in solvent like water then granulate the less soluble one. These granules is dried after that either by fluidized bed dryer or spray drying. Another method instead of , wet granulation, is spray drying of dissolved solutes on less soluble components either by modified fluidized bed dryer or in coating pan. In the dry process, mixing of main active ingredients like skimmed milk with the remaining excipients in a mixer for a certain validated time and validated rpm mixer. The drawbacks associated with dry method is the the higher possibility of segregation of active particularly lactose. The contamination may occur during processing or post-processing in pre-packaging and final packaging stage. In addition to the different manufacturers have different age of operators (diseased personnel) or building materials (epoxy) or cleanability. All these factors may be the predisposing factors for contamination of infant formula after drying stage.

FDA developed an act named infant formula act concerning with the production and distribution of infant formula in a way that prevent its contamination. This act complies with current good manufacturing practice (cGMP). For example, FDA 2002,d which depends on previous methods with exceptions like rehydrating the infant formula with distilled water instead of buffered peptone water and enriched samples (0.1ml) are streaked on violet red bile glucose agar rather than pour-plating 1 ml in the same agar.

Finally, starch and lactose are common excipients in tablet production so I think that this test may be applied for tablet dosage forms containing these excipients. Also, a good control must be established for quality control of raw materials in all pharmaceutical manufacturers.

Thanks for your comment Ramy. I was Aware of current restriction for infant formula, but for adult tablets cronobacter (

For adults it does not fall under the catagory of specified organism. However it is in the list of objectionable organism which can become an opportunistic pathogen.