[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.83]

[Page 253]
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 113_THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN 
HERMETICALLY SEALED CONTAINERS--Table of Contents
 
                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.