[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.83]
[Page 253]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 113 THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED
Subpart E Production and Process Controls
Sec. 113.83 Establishing scheduled processes.
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 headspace,
consistency, maximum fill-in or drained weight, aw, 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, process calculations
based on product heat penetration 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 period 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 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.
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