[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: 21CFR113.100]

[Page 255-256]
 
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 F_Records and Reports
 
Sec. 113.100  Processing and production records.


    (a) Processing and production information shall be entered at the 
time it is observed by the retort or processing system operator, or 
other designated person, on forms that include the product, the code 
number, the date, the retort or processing system number, the size of 
container, the approximate number of containers per coding interval, the 
initial temperature, the actual processing time, the mercury-in-glass 
and recording thermometer readings, and other appropriate processing 
data. Closing machine vacuum in vacuum-packed products, maximum fill-in 
or drained weight, or other critical factors specified in the scheduled 
process shall also be recorded. In addition, the following records shall 
be maintained:
    (1) Still retorts. Time steam on; time temperature up to processing 
temperature; time steam off; venting time and temperature to which 
vented.
    (2) Agitating retorts. Functioning of condensate bleeder; retort 
speed; and, when specified in the scheduled process, headspace, 
consistency, maximum drained weight, minimum net weight, and percent 
solids.
    (3) Hydrostatic retorts. The temperature in the steam chamber 
between the steam-water interface and the lowest container position; 
speed of the container conveyor chain; and, when the scheduled process 
specifies maintenance of particular temperatures in the hydrostatic 
water legs, the temperatures near the top and the bottom of each 
hydrostatic water leg.
    (4) Aseptic processing and packaging systems. Product temperature in 
the holding tube outlet as indicated by the temperature-indicating 
device and the temperature recorder; product temperature in the final 
heater outlet as indicated by the temperature recorder-controller; 
differential pressure as indicated by the differential pressure 
recorder-controller, if a product-to-product regenerator is used; 
product flow rate, as determined by the metering pump or by filling and 
closing rates; sterilization media flow rate or temperature or both; 
retention time of containers, and closures when applicable, in the 
sterilizing environment; and, when a batch system is used for container 
and/or closure sterilization, sterilization cycle times and 
temperatures.
    (5) Flame sterilizers. Container conveyor speed; surface temperature 
at the beginning and at the end of the holding period; nature of 
container.
    (6) Food preservation methods wherein critical factors such as water 
activity are used in conjunction with thermal processing. Product 
formulation and scheduled processes used, including the thermal process, 
its associated critical factors, as well as other critical factors, and 
results of aw determinations.
    (7) Other systems. Critical factors specified in the formulation of 
the product or in the scheduled process.
    (b) Recording thermometer charts shall be identified by date, retort 
number, and other data as necessary, so they can be correlated with the 
written record of lots processed. Each entry on the processing and 
production records shall be made by the retort or processing system 
operator, or other designated person, at the time the specific retort or 
processing system condition or operation occurs, and this retort or 
processing system operator or other designated person shall sign or 
initial each record form. Not later that 1 working day after the actual 
process, and before shipment or release for distribution, a 
representative of plant management who is qualified by suitable training 
or experience shall review all processing and production records for 
completeness and to ensure that the product received the scheduled 
process. The records, including the recording thermometer chart(s), 
shall be signed or initialed and dated by the reviewer.
    (c) Written records of all container closure examinations shall 
specify the

[[Page 256]]

product code, the date and time of container closure inspections, the 
measurements obtained, and all corrective actions taken. Records shall 
be signed or initialed by the container closure inspector and reviewed 
by management with sufficient frequency to ensure that the containers 
are hermetically sealed.
    (d) Records shall be maintained to identify the initial distribution 
of the finished product to facilitate, when necessary, the segregation 
of specific food lots that may have become contaminated or otherwise 
rendered unfit for their intended use.
    (e) Copies of all records provided for in this part, except those 
required under Sec. 113.83 establishing scheduled processes, shall be 
retained at the processing plant for a period of not less than 1 year 
from the date of manufacture, and at the processing plant or other 
reasonably accessible location for an additional 2 years. If, during the 
first year of the 3-year record-retention period, the processing plant 
is closed for a prolonged period between seasonal packs, the records may 
be transferred to some other reasonably accessible location at the end 
of the seasonal pack.