U.S. Food and Drug Administration: "Guide to Inspections of Aseptic Processing and Packaging for the Food Industry"

Read this introduction to learn about how we ensure that the food that we eat is packaged in a manner that will prevent microbial contamination. This document was prepared by the FDA to act as a guide for industries involved in packaging food.


Inspections of aseptic processing and packaging systems for Low Acid Canned Food (LACF) are some of the most complex inspections of food manufacturing operations. The major difference between aseptic processing and the more "conventional" types of LACF processing is that a process authority(s) must establish a process that ensures commercial sterility not only of the product but also for:

  1. the product sterilization system (hold tube) and all equipment downstream from the holding tube including the filler;
  2. the packaging equipment; and
  3. the packaging material.

Documentation of production operations must be maintained by the firm showing that commercially sterile conditions are achieved and maintained in all these areas. Any breach of a scheduled process for the processing or packaging system means that the affected product must be destroyed, reprocessed or segregated and held for further evaluation. In addition, the processing and packaging system must be cleaned and re-sterilized before processing and/or packaging operations can resume.

Aseptic processing equipment sterilization procedures often use steam or hot water under pressure. Packaging equipment and packaging materials are sterilized with various medium or combination of mediums (i.e., saturated steam, superheated steam, hydrogen peroxide and heat and other treatments). Sterilization procedures are often validated by placing resistant microbial spores on adhesive strips at strategic locations in equipment or on container materials. Results of microbial validation studies are filed with CFSAN in support of scheduled process filings.

In addition to instructions and information provided in the Guide To Inspections Of Low Acid Canned Food Manufacturers (Parts 1, 2 and 3, hereafter referred to as the LACF Inspection Guide), direct attention to the following points when inspecting firms using aseptic processing and packaging. Before conducting the inspection, review the file jacket for the firm for previous establishment inspection reports (EIR's) and other pertinent information. Previous EIR's may provide a history of the installation of new, or modifications to, equipment and instrumentation. Review prior documentation dealing with incidents such as recalls, container integrity problems (involving leakers, swollen containers and visual external defects).

Last modified: Tuesday, July 26, 2016, 11:52 AM