Previous attempts by the food industry to file an aseptic process for a particulate product with the Food and Drug Administration were not successful because of the enormity of the task and the absence of any established protocol. Recent workshops conducted jointly by the National Center for Food Safety and Technology (NCFST) and the Center for Aseptic Processing and Packaging Studies (CAPPS) developed a case study which served as a framework for a validation study for filing with FDA.
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