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Defining Qualified Persons as Process Authorities

Part 113.83 of 21 CFR Thermally Processed Low-acid Foods Packaged in Hermetically Sealed Containers refers to "establishing scheduled processes" and states:

"Scheduled processes for low-acid foods shall be established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers and having adequate facilities for making such determinations. The type, range, and combination of variations encountered in commercial production shall be adequately provided for in establishing the scheduled process. Critical factors, e.g. minimum head space,consistency, maximum fill-in or drained weight, water activity (a w) , etc.that may affect the scheduled process, shall be specified in the scheduled process. Acceptable scientific methods of establishing heat sterilization processes shall include, when necessary, but shall not be limited to,microbial thermal death time data, and inoculated packs.

Calculation shall be performed according to procedures recognized by competent processing authorities. If incubation tests are necessary for process confirmation,they shall include containers from test trials and from actual commercial production runs during the periods of instituting the process. The incubation tests for confirmation of the scheduled processes should include the containers from the test trials and a number of containers from each of the four or more actual commercial production runs. The number of containers from actual commercial production runs should be determined on the basis of recognized scientific methods to be of a size sufficient to ensure the adequacy of the process. Complete records covering all aspects of the establishment of the process and associated incubation tests shall be prepared and shall be permanently retained by the person or organization making the determination." (Our emphasis.)

How We Can Help

Food Safety and Process Technology has more than 50 years of experience in food safety technology as food scientists and processing experts. We are qualified process authorities for food processing companies nationwide. For more information about our Qualified Process Authorities, contact us.