[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.87]

[Page 248-249]
 
                        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 CONTAINERS--Table of Contents
 
               Subpart E--Production and Process Controls
 
Sec. 113.87  Operations in the thermal processing room.

    (a) Operating processes and retort venting procedures to be used for 
each product and container size being packed shall either be posted in a 
conspicuous place near the processing equipment or be made readily 
available to the retort or processing system operator and any duly 
authorized employee of the Food and Drug Administration. Scheduled 
processes must be

[[Page 249]]

made readily available to the supervisor and any duly authorized 
employee of the Food and Drug Administration.
    (b) A system for product traffic control in the retort room shall be 
established to prevent unretorted product from bypassing the retort 
process. Each retort basket, truck, car, or crate used to hold 
containers in a retort, or one or more containers therein, shall, if it 
contains any retorted food product, be plainly and conspicuously marked 
with a heat-sensitive indicator, or by other effective means that will 
indicate visually, to thermal processing personnel, those units that 
have been retorted. A visual check shall be performed to determine 
whether or not the appropriate change has occurred in the heat-sensitive 
indicator as a result of retorting for all retort baskets, trucks, cars, 
or crates, to ensure that each unit of product has been retorted. A 
written record of these checks should be made.
    (c) The initial temperature of the contents of the containers to be 
processed shall be determined and recorded with sufficient frequency to 
ensure that the temperature of the product is no lower than the minimum 
initial temperature specified in the scheduled process. For those 
operations that use water during the filling of the retort or during 
processing, provision shall be made to ensure that the water will not, 
before the start of each thermal process, lower the initial temperature 
of the product below that specified in the scheduled process.
    (d) Timing devices used in recording thermal process time 
information shall be accurate to the extent needed to ensure that the 
processing time and venting time specified in the scheduled process are 
achieved. Pocket or wrist watches are not considered satisfactory for 
timing purposes. Digital clocks may be used if the operating process and 
the venting schedule have a 1-minute or greater safety factor over the 
scheduled process.
    (e) Clock times on recording-temperature charts should reasonably 
correspond to the time of day on the written processing records to 
provide correlation of these records.
    (f) The steam supply to the thermal processing system shall be 
adequate to the extent needed to ensure that sufficient steam pressure 
is maintained during thermal processing, regardless of other demands of 
steam by the plant.
    (g) If mufflers are used on bleeders or vent systems, evidence that 
the bleeders or vents are operated in a manner that does not 
significantly impede the removal of air shall be kept on file. This 
evidence may be in the form of heat distribution data or other 
satisfactory evidence such as a letter from the manufacturer, the 
designer, or a competent processing authority.