[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: 21CFR113.87]
[Page 253-254]
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. 113.87 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 254]]
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
estab lished 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.
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