U.S. Food and Drug Administration - Center for Devices and Radiological Health

Code of Federal Regulations
Title 21 - Food and Drugs
Revised as of April 1, 2001

21CFR113.3

[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.3]

[Page 225-227]
 
                        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 A--General Provisions
 
Sec. 113.3  Definitions.


    For the purposes of this part, the following definitions apply:
    (a) Aseptic processing and packaging means the filling of a 
commercially sterilized cooled product into presterilized containers, 
followed by aseptic hermetical sealing, with a presterilized closure, in 
an atmosphere free of microorganisms.
    (b) Bleeders means openings used to remove air that enters with 
steam from retorts and steam chambers and to promote circulation of 
steam in such retorts and steam chambers. Bleeders may serve as a means 
of removing condensate.
    (c) Come-up-time means the time which elapses between the 
introduction of steam into the closed retort and the time when the 
retort reaches the required processing temperature.
    (d) Commercial processor includes any person engaged in commercial, 
custom, or institutional (church, school, penal, or other organization) 
processing of food, including pet food. Persons engaged in the 
production of foods that are to be used in market or consumer tests are 
also included.
    (e) Commercial sterility: (1) ``Commercial sterility'' of thermally 
processed food means the condition achieved--
    (i) By the application of heat which renders the food free of--

[[Page 226]]

    (a) Microorganisms capable of reproducing in the food under normal 
nonrefrigerated conditions of storage and distribution; and
    (b) Viable microorganisms (including spores) of public health 
significance; or
    (ii) By the control of water activity and the application of heat, 
which renders the food free of microorganisms capable of reproducing in 
the food under normal nonrefrigerated conditions of storage and 
distribution.
    (2) ``Commercial sterility'' of equipment and containers used for 
aseptic processing and packaging of food means the condition achieved by 
application of heat, chemical sterilant(s), or other appropriate 
treatment that renders the equipment and containers free of viable 
microorganisms having public health significance, as well as 
microorganisms of nonhealth significance, capable of reproducing in the 
food under normal nonrefrigerated conditions of storage and 
distribution.
    (f) Critical factor means any property, characteristic, condition, 
aspect, or other parameter, variation of which may affect the scheduled 
process and the attainment of commercial sterility.
    (g) Flame sterilizer means an apparatus in which hermetically sealed 
containers are agitated at atmospheric pressure, by either continuous, 
discontinuous, or reciprocating movement, with impinging gas flames to 
achieve sterilization temperatures. A holding period in a heated section 
may follow the initial heating period.
    (h) Headspace, gross is the vertical distance between the level of 
the product (generally the liquid surface) in an upright rigid container 
and the top edge of the container (the top of the double seam of a can 
or the top edge of a glass jar).
    (i) Headspace, net of a container is the vertical distance between 
the level of the product (generally the liquid surface) in the upright 
rigid container and the inside surface of the lid.
    (j) Hermetically sealed container means a container that is designed 
and intended to be secure against the entry of microorganisms and 
thereby to maintain the commercial sterility of its contents after 
processing.
    (k) Incubation means the holding of a sample(s) at a specified 
temperature for a specified period of time for the purpose of permitting 
or stimulating the growth of microorganisms.
    (l) Initial temperature means the average temperature of the 
contents of the coldest container to be processed at the time the 
thermal processing cycle begins, as determined after thorough stirring 
or shaking of the filled and sealed container.
    (m) Lot means that amount of a product produced during a period of 
time indicated by a specific code.
    (n) Low-acid foods means any foods, other than alcoholic beverages, 
with a finished equilibrium pH greater than 4.6 and a water activity 
(a<INF>w</INF>) greater than 0.85. Tomatoes and tomato products having a 
finished equilibrium pH less than 4.7 are not classed as low-acid foods.
    (o) Minimum thermal process means the application of heat to food, 
either before or after sealing in a hermetically sealed container, for a 
period of time and at a temperature scientifically determined to be 
adequate to ensure destruction of microorganisms of public health 
significance.
    (p) Operating process means the process selected by the processor 
that equals or exceeds the minimum requirements set forth in the 
scheduled process.
    (q) Retort means any closed vessel or other equipment used for the 
thermal processing of foods.
    (r) Scheduled process means the process selected by the processor as 
adequate under the conditions of manufacture for a given product to 
achieve commercial sterility. This process may be in excess of that 
necessary to ensure destruction of microorganisms of public health 
significance, and shall be at least equivalent to the process 
established by a competent processing authority to achieve commercial 
sterility.
    (s) Shall is used to state mandatory requirements.
    (t) Should is used to state recommended or advisory procedures or to 
identify recommended equipment.
    (u) Vacuum-packed products means those products that are sealed in a 
container under the vacuum specified in

[[Page 227]]

the scheduled process, the maintenance of which vacuum is critical to 
the adequacy of the scheduled process.
    (v) Vents means openings through the retort shell, controlled by 
gate, plug cock, or other adequate valves used for the elimination of 
air during the venting period.
    (w) Water activity (a<INF>w</INF>) is a measure of the free moisture 
in a product and is the quotient of the water vapor pressure of the 
substance divided by the vapor pressure of pure water at the same 
temperature.



21CFR113.5

[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.5]

[Page 227]
 
                        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 A--General Provisions
 
Sec. 113.5  Current good manufacturing practice.

    The criteria in Secs. 113.10, 113.40, 113.60, 113.81, 113.83, 
113.87, 113.89, and 113.100 shall apply in determining whether the 
facilities, methods, practices, and controls used by the commercial 
processor in the manufacture, processing, or packing of low-acid foods 
in hermetically sealed containers are operated or administered in a 
manner adequate to protect the public health.



21CFR113.10

[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.10]

[Page 227]
 
                        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 A--General Provisions
 
Sec. 113.10  Personnel.

    The operators of processing systems, retorts, aseptic processing and 
packaging systems and product formulating systems (including systems 
wherein water activity is used in conjunction with thermal processing) 
and container closure inspectors shall be under the operating 
supervision of a person who has attended a school approved by the 
Commissioner for giving instruction appropriate to the preservation 
technology involved and who has been identified by that school as having 
satisfactorily completed the prescribed course of instruction. This 
person shall supervise only in those areas for which a school approved 
by the Commissioner identifies the person as having satisfactorily 
completed training.

Subpart B  [Reserved]



21CFR113.40

[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.40]

[Page 227-244]
 
                        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 C--Equipment
 
Sec. 113.40  Equipment and procedures.


    (a) Equipment and procedures for pressure processing in steam in 
still retorts--(1) Indicating mercury-in-glass thermometer. Each retort 
shall be equipped with at least one mercury-in-glass thermometer whose 
divisions are easily readable to 1  deg.F and whose temperature range 
does not exceed 17  deg.F per inch of graduated scale. Thermometers 
shall be tested for accuracy against a known accurate standard 
thermometer upon installation and at least once a year thereafter, or 
more frequently if necessary, to ensure their accuracy. Records of 
thermometer accuracy checks that specify date, standard used, method 
used, and person performing the test should be maintained. Each 
thermometer should have a tag, seal, or other means of identity that 
includes the date on which it was last tested for accuracy. A 
thermometer that has a divided mercury column or that cannot be adjusted 
to the standard shall be repaired or replaced before further use of the 
retort. Thermometers shall be installed where they can be accurately and 
easily read. Bulbs of indicating thermometers shall be installed either 
within the retort shell or in external wells attached to the retort. 
External wells or pipes shall be connected to the retort through at 
least a \3/4\-inch diameter opening and equipped with a \1/16\-inch or 
larger bleeder opening so located as to provide a full flow of steam 
past the length of the thermometer bulb. The bleeders for external wells 
shall emit steam continuously during the entire processing period. The 
mercury thermometer--not the recorder chart--shall be the reference 
instrument for indicating the processing temperature.
    (2) Temperature-recording device. Each still retort shall have an 
accurate temperature-recording device. Graduations on the temperature-
recording devices shall not exceed 2  deg.F within a range of 10  deg.F 
of the processing temperature. Each chart shall have a working scale of 
not more than 55  deg.F per inch within a range of 20  deg.F of the 
processing temperature. The temperature chart shall be adjusted to agree 
as nearly as possible with, but to be in no event higher than, the known 
accurate mercury-in-glass thermometer during the process time. A means 
of preventing unauthorized changes in adjustment shall be provided. A 
lock, or a notice from management posted at or near the recording device 
which provides a warning

[[Page 228]]

that only authorized persons are permitted to make adjustments, is a 
satisfactory means for preventing unauthorized changes. The recorder may 
be combined with the steam controller and may be a recording-controlling 
instrument. The temperature-recorder bulb shall be installed either 
within the retort shell or in a well attached to the shell. Each 
temperature-recorder bulb well shall have a \1/16\-inch or larger 
bleeder which emits steam continuously during the processing period. 
Air-operated temperature controllers should have adequate filter systems 
to ensure a supply of clean, dry air.
    (3) Pressure gages. Each retort should be equipped with a pressure 
gage that should be graduated in divisions of 2 pounds or less.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording-controlling instrument when combined with a recording 
thermometer. The steam controller may be air-operated and actuated by a 
temperature sensor positioned near the mercury-in-glass thermometer in 
the retort; a steam controller activated by the steam pressure of the 
retort is acceptable if it is carefully maintained mechanically so that 
it operates satisfactorily.
    (5) Steam inlet. The steam inlet to each still retort shall be large 
enough to provide sufficient steam for proper operation of the retort. 
Steam may enter either the top portion or the bottom portion of the 
retort but, in any case, shall enter the portion of the retort opposite 
the vent; for example, steam inlet in bottom portion and vent in top 
portion.
    (6) Crate supports. A bottom crate support shall be used in vertical 
still retorts. Baffle plates shall not be used in the bottom of still 
retorts.
    (7) Steam spreaders. Steam spreaders are continuations of the steam 
inlet line inside the retort. Horizontal still retorts shall be equipped 
with steam spreaders that extend the length of the retort. For steam 
spreaders along the bottom of the retort, the perforations should be 
along the top 90 deg. of this pipe, that is, within 45 deg. on either 
side of the top center. Horizontal still retorts over 30 feet long 
should have two steam inlets connected to the spreader. In vertical 
still retorts, the steam spreaders, if used, should be perforated along 
the center line of the pipe facing the interior of the retort or along 
the sides of the pipe. The number of perforations should be such that 
the total cross-sectional area of the perforations is equal to 1\1/2\ to 
2 times the cross-sectional area of the smallest restriction in the 
steam inlet line.
    (8) Bleeders. Bleeders, except those for thermometer wells, shall be 
one-eighth inch or larger and shall be wide open during the entire 
process, including the come-up-time. For horizontal still retorts, 
bleeders shall be located within approximately 1 foot of the outermost 
locations of containers at each end along the top of the retort; 
additional bleeders shall be located not more than 8 feet apart along 
the top. Bleeders may be installed at positions other than those 
specified above, as long as there is evidence in the form of heat 
distribution data that they accomplish adequate removal of air and 
circulation of steam within the retort. Vertical retorts shall have at 
least one bleeder opening located in that portion of the retort opposite 
the steam inlet. In retorts having top steam inlet and bottom venting, a 
bleeder shall be installed in the bottom of the retort to remove 
condensate. All bleeders shall be arranged so that the operator can 
observe that they are functioning properly.
    (9) Stacking equipment and position of containers. Crates, trays, 
gondolas, etc., for holding containers shall be made of strap iron, 
adequately perforated sheet metal, or other suitable material. When 
perforated sheet metal is used for the bottoms, the perforations should 
be approximately the equivalent of 1-inch holes on 2-inch centers. If 
dividers are used between the layers of containers, they should be 
perforated as above. The positioning of containers in the retort, when 
specified in the scheduled process, shall be in accordance with that 
process.
    (10) Air valves. Retorts using air for pressure cooling shall be 
equipped with a suitable valve to prevent air leakage into the retort 
during processing.
    (11) Water valves. Retorts using water for cooling shall be equipped 
with a

[[Page 229]]

suitable valve to prevent leakage of water into the retort during 
processing.
    (12) Vents. Vents shall be installed in such a way that air is 
removed from the retort before timing of the process is started. Vents 
shall be controlled by gate, plug cock, or other adequate type valves 
which shall be fully open to permit rapid discharge of air from the 
retort during the venting period. Vents shall not be connected directly 
to a closed drain system. If the overflow is used as a vent, there shall 
be an atmospheric break in the line before it connects to a closed 
drain. The vent shall be located in that portion of the retort opposite 
the steam inlet; for example, steam inlet in bottom portion and vent in 
top portion. Where a retort manifold connects several vent pipes from a 
single still retort, it shall be controlled by a gate, plug cock, or 
other adequate type valve. The retort manifold shall be of a size that 
the cross-sectional area of the pipe is larger than the total cross-
sectional area of all connecting vents. The discharge shall not be 
directly connected to a closed drain without an atmospheric break in the 
line. A manifold header connecting vents or manifolds from several still 
retorts shall lead to the atmosphere. The manifold header shall not be 
controlled by a valve and shall be of a size that the cross-sectional 
area is at least equal to the total cross-sectional area of all 
connecting retort manifold pipes from all retorts venting 
simultaneously. Timing of the process shall not begin until the retort 
has been properly vented and the processing temperature has been 
reached. Some typical installations and operating procedures reflecting 
the requirements of this section for venting still retorts are given in 
paragraph (a)(12)(i)(a) through (d) and (ii)(a) and (b) of this section.
    (i) Venting horizontal retorts. (a) Venting through multiple 1-inch 
vents discharging directly to atmosphere.
[GRAPHIC] [TIFF OMITTED] TR01JA93.369

    Specifications. One 1-inch vent for every 5 feet of retort length, 
equipped with a gate or plug cock valve and discharging to atmosphere; 
end vents not more than 2\1/2\ feet from ends of retort.
    Venting method. Vent valves should be wide open for at least 5 
minutes and to at least 225  deg.F, or at least 7 minutes and to at 
least 220  deg.F.

    (b) Venting through multiple 1-inch vents discharging through a 
manifold to atmosphere.
[GRAPHIC] [TIFF OMITTED] TR01JA93.370

    Specifications. One 1-inch vent for every 5 feet of retort length; 
and vents not over 2\1/2\ feet from ends of retort: Size of manifold--
for retorts less than 15 feet in length, 2\1/2\ inches; for retorts 15 
feet and over in length, 3 inches.
    Venting method. Manifold vent gate or plug cock valve should be wide 
open for at least 6 minutes and to at least 225  deg.F, or for at least 
8 minutes and to at least 220  deg.F.

    (c) Venting through water spreaders.
    [GRAPHIC] [TIFF OMITTED] TR01JA93.371
    

[[Page 230]]


    Size of vent and vent valve. For retorts less than 15 feet in 
length, 2 inches; for retorts 15 feet and over in length, 2\1/2\ inches.
    Size of water spreader. For retorts less than 15 feet in length, 
1\1/2\ inches; for retorts 15 feet and over in length, 2 inches. The 
number of holes should be such that their total cross-sectional area is 
approximately equal to the cross-sectional area of the vent pipe inlet.
    Venting method. Water spreader vent gate or plug cock valve should 
be wide open for at least 5 minutes and to at least 225  deg.F, or for 
at least 7 minutes and to at least 220  deg.F.

    (d) Venting through a single 2\1/2\-inch top vent (for retorts not 
exceeding 15 feet in length).
[GRAPHIC] [TIFF OMITTED] TR01JA93.372

    Specifications: A 2\1/2\-inch vent equipped with a 2\1/2\-inch gate 
or plug cock valve and located within 2 feet of the center of the 
retort.
    Venting method: Vent gate or plug cock valve should be wide open for 
at least 4 minutes and to at least 220  deg.F.

    (ii) Venting vertical retorts. (a) Venting through a 1\1/2\-inch 
overflow.
[GRAPHIC] [TIFF OMITTED] TR01JA93.373

    Specifications. A 1\1/2\-inch overflow pipe equipped with a 1\1/2\-
inch gate or plug cock valve and with not more than 6 feet of 1\1/2\-
inch pipe beyond the valve before break to the atmosphere or to a 
manifold header.
    Venting method. Vent gate or plug cock valve should be wide open for 
at least 4 minutes and to at least 218  deg.F, or for at least 5 minutes 
and to at least 215  deg.F.

    (b) Venting through a single 1-inch side or top vent.
    [GRAPHIC] [TIFF OMITTED] TR01JA93.374
    
    Specifications. A 1-inch vent in lid or top side, equipped with a 1-
inch gate or plug cock valve and discharging directly into the 
atmosphere or to a manifold header.
    Venting method. Vent gate or plug cock valve should be wide open for 
at least 5 minutes and to at least 230  deg.F, or for at least 7 minutes 
and to at least 220  deg.F.

    (iii) Other installations and operating procedures that deviate from 
the above specifications may be used if there is evidence in the form of 
heat distribution data, which shall be kept on file, that they 
accomplish adequate venting of air.
    (13) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process.
    (i) When maximum fill-in or drained weight is specified in the 
scheduled process, it shall be measured and recorded at intervals of 
sufficient frequency to ensure that the weight of the product does not 
exceed the maximum for the given container size specified in the 
scheduled process.
    (ii) Closing machine vacuum in vacuum-packed products shall be 
observed and recorded at intervals of sufficient

[[Page 231]]

frequency to ensure that the vacuum is as specified in the scheduled 
process.
    (iii) Such measurements and recordings should be made at intervals 
not to exceed 15 minutes.
    (iv) When the product style results in stratification or layering of 
the primary product in the containers, the positioning of containers in 
the retort shall be according to the scheduled process.
    (b) Equipment and procedures for pressure processing in water in 
still retorts--(1) Indicating mercury-in-glass thermometer. Each retort 
shall be equipped with at least one mercury-in-glass thermometer whose 
divisions are easily readable to 1  deg.F and whose temperature range 
does not exceed 17  deg.F per inch of graduated scale. Thermometers 
shall be tested for accuracy against a known accurate standard 
thermometer upon installation and at least once a year thereafter, or 
more frequently if necessary, to ensure their accuracy. Records of 
thermometer accuracy checks which specify date, standard used, method 
used, and person performing the test should be maintained. Each 
thermometer should have a tag, seal, or other means of identity that 
includes the date when it was last tested for accuracy. A thermometer 
that has a divided mercury column or that cannot be adjusted to the 
standard shall be repaired or replaced before further use of the retort. 
Thermometers shall be installed where they can be accurately and easily 
read. Bulbs of indicating thermometers shall be located in such a 
position that they are beneath the surface of the water throughout the 
process. On horizontal retorts, this entry should be made in the side at 
the center, and the thermometer bulbs shall be inserted directly into 
the retort shell. In both vertical and horizontal retorts, the 
thermometer bulbs shall extend directly into the water a minimum of at 
least 2 inches without a separable well or sleeve. The mercury 
thermometer--not the recorder chart--shall be the reference instrument 
for indicating the processing temperature.
    (2) Temperature-recording device. Each still retort shall have an 
accurate temperature-recording device. Graduations on the temperature-
recording devices shall not exceed 2  deg.F within a range of 10  deg.F 
of the processing temperature. Each chart shall have a working scale of 
not more than 55  deg.F per inch within a range of 20  deg.F of the 
processing temperature. The temperature chart shall be adjusted to agree 
as nearly as possible with, but to be in no event higher than, the known 
accurate mercury-in-glass thermometer during the process time. A means 
of preventing unauthorized changes in adjustment shall be provided. A 
lock, or a notice from management posted at or near the recording device 
which provides a warning that only authorized persons are permitted to 
make adjustments, is a satisfactory means for preventing unauthorized 
changes. The recorder may be combined with the steam controller and may 
be a recording-controlling instrument. The recording-thermometer bulb 
should be located adjacent to the bulb of the mercury-in-glass 
thermometer, except in the case of a vertical retort equipped with a 
combination recorder-controller. In such vertical retorts, the 
temperature recorder-control bulb shall be located at the bottom of the 
retort below the lowest crate rest in such a position that the steam 
does not strike it directly. In horizontal retorts, the temperature 
recorder-control bulb shall be located between the water surface and the 
horizontal plane passing through the center of the retort so that there 
is no opportunity for direct steam impingement on the control bulb. Air-
operated temperature controllers should have adequate filter systems to 
ensure a supply of clean, dry air.
    (3) Pressure gages. (i) Each retort should be equipped with a 
pressure gage, which should be graduated in divisions of 2 pounds or 
less.
    (ii) Each retort should have an adjustable pressure relief or 
control valve of a capacity sufficient to prevent an undesired increase 
in retort pressure when the water valve is wide open and should be 
installed in the overflow line.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording-controlling instrument when combined with a recording 
thermometer.
    (5) Steam introduction. Steam shall be distributed in the bottom of 
the retort

[[Page 232]]

in a manner adequate to provide uniform heat distribution throughout the 
retort. In vertical retorts, uniform steam distribution can be achieved 
by any of several methods. In horizontal retorts, the steam distributor 
shall run the length of the bottom of the retort with perforations 
distributed uniformly along the upper part of the pipe.
    (6) Crate supports. A bottom crate support shall be used in vertical 
still retorts. Baffle plates shall not be used in the bottom of the 
retort. Centering guides should be installed so as to ensure that there 
is about a 1\1/2\-inch clearance between the side wall of the crate and 
the retort wall.
    (7) Stacking equipment and position of containers. Crates, trays, 
gondolas, etc., for holding containers shall be made of strap iron, 
adequately perforated sheet metal, or other suitable material. When 
perforated sheet metal is used for the bottoms, the perforations should 
be approximately the equivalent of 1-inch holes on 2-inch centers. If 
divider plates are used between the layers of containers, they should be 
perforated as above. The positioning of containers in the retort, when 
specified in the scheduled process, shall be in accordance with that 
process. Dividers, racks, trays, or other means of positioning of 
flexible containers shall be designed and employed to ensure even 
circulation of heating medium around all containers in the retort.
    (8) Drain valve. A nonclogging, water-tight valve shall be used. 
Screens should be installed over all drain openings.
    (9) Water level indicator. There shall be a means of determining the 
water level in the retort during operation, e.g., by using a gage, water 
glass, or petcock(s). Water shall cover the top layer of containers 
during the entire come-up-time and processing periods and should cover 
the top layer of containers during the cooling periods. The operator 
shall check and record the water level at intervals sufficient to ensure 
its adequacy.
    (10)(i) Air supply and controls. In both horizontal and vertical 
still retorts for pressure processing in water, a means shall be 
provided for introducing compressed air at the proper pressure and rate. 
The proper pressure shall be controlled by an automatic pressure control 
unit. A check valve shall be provided in the air supply line to prevent 
water from entering the system. Air or water circulation shall be 
maintained continuously during the come-up-time and during processing 
and cooling periods; the adequacy of the air or water circulation for 
uniform heat distribution within the retort shall be established in 
accordance with procedures recognized by a competent processing 
authority and records shall be kept on file; if air is used to promote 
circulation, it shall be introduced into the steam line at a point 
between the retort and the steam control valve at the bottom of the 
retort.
    (ii) Water circulation. When a water circulating system is used for 
heat distribution, is shall be installed in such a manner that water 
will be drawn from the bottom of the retort through a suction manifold 
and discharged through a spreader which extends the length of the top of 
the retort. The holes in the water spreader shall be uniformly 
distributed and should have an aggregate area not greater than the 
cross-section area of the outlet line from the pump. The suction outlets 
should be protected with nonclogging screens to keep debris from 
entering the circulating system. The pump shall be equipped with a pilot 
light or other signaling device to warn the operator when it is not 
running, and with a bleeder to remove air when starting operations. 
Alternative methods for circulation of water in the retort may be used 
when established by a competent authority as adequate for even heat 
distribution.
    (11) Cooling water supply. In vertical retorts the cooling water 
should be introduced at the top of the retort between the water and 
container levels; in horizontal retorts the cooling water should be 
introduced into the suction side of the pump. A check valve should be 
included in the cooling water line.
    (12) Retort headspace. The headspace necessary to control the air 
pressure should be maintained between the water level and the top of the 
retort shell.
    (13) Vertical and horizontal still retorts. Vertical and horizontal 
still retorts should follow the arrangements in the diagrams below in 
this paragraph.

[[Page 233]]

Other installation and operating procedures that deviate from these 
arrangements may be used, as long as there is evidence in the form of 
heat distribution data or other suitable information, which shall be 
kept on file, that demonstrates that the heat distribution is adequate.
[GRAPHIC] [TIFF OMITTED] TR01JA93.375

            Legend for Vertical and Horizontal Still Retorts

    A--Water line.
    B--Steam line.
    C--Temperature control.
    D--Overflow line.
    E<INF>1</INF>--Drain line.
    E<INF>2</INF>--Screens.
    F--Check valves.
    G--Line from hot water storage.
    H--Suction line and manifold.
    I--Circulating pump.
    J--Petcocks.
    K--Recirculating line.
    L--Steam distributor.
    M--Temperature-controller bulb.
    N--Thermometer.
    O--Water spreader.
    P--Safety valve.
    Q--Vent valve for steam processing.
    R--Pressure gage.

[[Page 234]]

    S--Inlet air control.
    T--Pressure control.
    U--Air line.
    V--To pressure control instrument.
    W--To temperature control instrument.
    X--Wing nuts.
    Y<INF>1</INF>--Crate support.
    Y<INF>2</INF>--Crate guides.
    Z--Constant flow orifice valve.
    Z<INF>1</INF>--Constant flow orifice valve used during come-up.
    Z<INF>2</INF>--Constant flow orifice valve used during cook.

    (14) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process.
    (i) When maximum fill-in or drained weight is specified in the 
scheduled process, it shall be measured and recorded at intervals of 
sufficient frequency to ensure that the weight of the product does not 
exceed the maximum for the given container size specified in the 
scheduled process.
    (ii) Closing machine vacuum in vacuum-packed products shall be 
observed and recorded at intervals of sufficient frequency to ensure 
that the vacuum is as specified in the scheduled process.
    (iii) Such measurements and recordings should be made at intervals 
not to exceed 15 minutes.
    (iv) When the product style results in stratification or layering of 
the primary product in the containers, the positioning of containers in 
the retort shall be according to the scheduled process.
    (c) Equipment and procedures for pressure processing in steam in 
continuous agitating retorts--(1) Indicating mercury-in-glass 
thermometer. Each retort shall be equipped with at least one mercury-in-
glass thermometer whose divisions are easily readable to 1  deg.F and 
whose temperature range does not exceed 17  deg.F per inch of graduated 
scale. Thermometers shall be tested for accuracy against a known 
accurate standard thermometer upon installation and at least once a year 
thereafter, or more frequently if necessary, to ensure their accuracy. 
Records of thermometer accuracy checks which specify date, standard 
used, method used, and person performing the test should be maintained. 
Each thermometer should have a tag, seal, or other means of identity 
that includes the date on which it was last tested for accuracy. A 
thermometer that has a divided mercury column or that cannot be adjusted 
to the standard shall be repaired or replaced before further use of the 
retort. Thermometers shall be installed where they can be accurately and 
easily read. Bulbs in indicating thermometers shall be installed either 
within the retort shell or in external wells attached to the retort. 
External wells or pipes shall be connected to the retort through at 
least a \3/4\-inch diameter opening, and equipped with a \1/16\-inch or 
larger bleeder opening so located as to provide a full flow of steam 
past the length of the thermometer bulb. The bleeders for external wells 
shall emit steam continuously during the entire processing period. The 
mercury thermometer--not the recorder chart--shall be the reference 
instrument for indicating the processing temperature.
    (2) Temperature-recording device. Each retort shall have an accurate 
temperature-recording device. Graduations on the temperature-recording 
devices shall not exceed 2  deg.F within a range of 10  deg.F of the 
processing temperature. Each chart shall have a working scale of not 
more than 55  deg.F per inch within a range of 20  deg.F of the 
processing temperature. The temperature chart shall be adjusted to agree 
as nearly as possible with, but to be in no event higher than, the known 
accurate mercury-in-glass thermometer during the process time. A means 
of preventing unauthorized changes in adjustment shall be provided. A 
lock, or a notice from management posted at or near the recording device 
that provides a warning that only authorized persons are permitted to 
make adjustments, is a satisfactory means of preventing unauthorized 
changes. The recorder may be combined with the steam controller and may 
be a recording-controlling instrument. The temperature-recorder bulb 
shall be installed either within the retort shell or in a well attached 
to the shell. Each temperature-recorder bulb well shall have a \1/16\-
inch or larger bleeder opening emitting steam continuously during the 
processing period. Air-operated temperature controllers

[[Page 235]]

should have adequate filter systems to ensure a supply of clean, dry 
air.
    (3) Pressure gages. Each retort should be equipped with a pressure 
gage that should be graduated in divisions of 2 pounds or less.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording-controlling instrument when combined with a recording 
thermometer. A steam controller activated by the steam pressure of the 
retort is acceptable if it is carefully maintained mechanically so that 
it operates satisfactorily.
    (5) Bleeders. Bleeders, except those for thermometer wells, shall be 
one-eight inch or larger and shall be wide open during the entire 
process, including the come-up-time. Bleeders shall be located within 
approximately 1 foot of the outermost location of containers at each end 
along the top of the retort; additional bleeders shall be located not 
more than 8 feet apart along the top of the retort. All bleeders shall 
be arranged so that the operator can observe that they are functioning 
properly. The condensate bleeder shall be checked with sufficient 
frequency to ensure adequate removal of condensate or shall be equipped 
with an automatic alarm system(s) that would serve as a continuous 
monitor of condensate-bleeder functioning. Visual checks should be done 
at intervals of not more than 15 minutes. A record of such checks should 
be kept to show that the bleeder is functioning properly.
    (6) Venting and condensate removal. Vents shall be located in that 
portion of the retort opposite the steam inlet. Air shall be removed 
before processing is started. Heat distribution data or documentary 
proof from the manufacturer or from a competent processing authority, 
demonstrating that adequate venting is achieved, shall be kept on file. 
At the time steam is turned on, the drain should be opened for a time 
sufficient to remove steam condensate from the retort, and provision 
shall be made for continuing drainage of condensate during the retort 
operation. The condensate bleeder in the bottom of the shell serves as 
an indicator of continuous condensate removal.
    (7) Retort speed timing. The rotational speed of the retort shall be 
specified in the scheduled process. The speed shall be adjusted and 
recorded when the retort is started, at any time a speed change is made, 
and at intervals of sufficient frequency to ensure that the retort speed 
is maintained as specified in the scheduled process. These adjustments 
and recordings should be made every 4 hours or less. Alternatively, a 
recording tachometer may be used to provide a continuous record of the 
speed. A means of preventing unauthorized speed changes on retorts shall 
be provided. A lock, or a notice from management posted at or near the 
speed adjustment device that provides a warning that only authorized 
persons are permitted to make adjustments, is a satisfactory means of 
preventing unauthorized changes.
    (8) Emergency stops. If a retort jams or breaks down during 
processing operations, necessitating cooling the retort for repairs, the 
retort shall be operated in such a way that ensures that the product is 
commercially sterile, or the retort is to be cooled promptly and all 
containers either reprocessed, repacked and reprocessed, or discarded. 
When operated as a still retort, all containers shall be given a full 
still retort process before the retort is cooled. If, in such an 
emergency, a scheduled still process or another process established to 
ensure commercial sterility is to be used, it shall be made readily 
available to the retort operator.
    (i) Any containers in the retort intake valve or in transfer valves 
between cooker shells of a continuous retort at the time of breakdown 
shall either be reprocessed, repacked and reprocessed, or discarded.
    (ii) Both the time at which the reel stopped and the time the retort 
was used for a still retort process, if so used, shall be marked on the 
recording chart and entered on the other production records required in 
this chapter. If the alternative procedure of prompt cooling is 
followed, the subsequent handling methods used for the containers in the 
retort at the time of stopping and cooling shall be entered on the 
production records.
    (9) Temperature drop. If the temperature of the continuous retort 
drops

[[Page 236]]

below the temperature specified in the scheduled process while 
containers are in the retort, the retort reel shall be stopped promptly. 
An automatic device should be used to stop the reel when the temperature 
drops below the specified process temperature. Before the reel is 
restarted, all containers in the retort shall be given a complete 
scheduled still retort process if the temperature drop was 10  deg.F or 
more below the specified temperature, or alternatively, container entry 
to the retort shall be stopped and the reel restarted to empty the 
retort. The discharged containers shall be either reprocessed, repacked 
and reprocessed, or discarded. Both the time at which the reel stopped 
and the time the retort was used for a still retort process, if so used, 
shall be marked on the recording chart and entered on the other 
production records required in this chapter. If the alternative 
procedure of emptying the retort is followed, the subsequent handing 
methods used for the containers in the retort at the time of the 
temperature drop shall be entered on the production records. If the 
temperature drop was less than 10  deg.F, a scheduled authorized 
emergency still process approved by a qualified person(s) having expert 
knowledge of thermal processing requirements may be used before 
restarting the retort reel. Alternatively, container entry to the retort 
shall be stopped and an authorized emergency agitating process may be 
used before container entry to the retort is restarted. When emergency 
procedures are used, no containers may enter the retort and the process 
and procedures used shall be noted on the production records.
    (10) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process. The minimum headspace of 
containers, if specified in the scheduled process, shall be measured and 
recorded at intervals of sufficient frequency to ensure that the 
headspace is as specified in the scheduled process. The headspace of 
solder-tipped, lapseam (vent hole) cans may be measured by net weight 
determinations. The headspace of double seamed cans may also be measured 
by net weight determinations for homogenous liquids, taking into account 
the specific can end profile and other factors which affect the 
headspace, if proof of the accuracy of such measurements is maintained 
and the procedure and resultant headspace is in accordance with the 
scheduled process. When the product consistency is specified in the 
scheduled process, the consistency of the product shall be determined by 
objective measurements on the product taken from the filler before 
processing and recorded at intervals of sufficient frequency to ensure 
that the consistency is as specified in the scheduled process. Minimum 
closing machine vacuum in vacuum-packed products, maximum fill-in or 
drained weight, minimum net weight, and percent solids shall be as 
specified in the scheduled process for all products when deviations from 
such specifications may affect the scheduled process. All measurements 
and recordings of critical factors should be made at intervals not to 
exceed 15 minutes.
    (d) Equipment and procedures for pressure processing in steam in 
discontinuous agitating retorts--(1) Indicating mercury-in-glass 
thermometer. Each retort shall be equipped with at least one mercury-in-
glass thermometer whose divisions are easily readable to 1  deg.F and 
whose temperature range does not exceed 17  deg.F per inch of graduated 
scale. Thermometers shall be tested for accuracy against a known 
accurate standard thermometer upon installation and at least once a year 
thereafter, or more frequently if necessary, to ensure their accuracy. 
Records of thermometer accuracy checks which specify date, standard 
used, method used, and person performing the test should be maintained. 
Each thermometer should have a tag, seal, or other means of identity 
that includes the date on which it was last tested for accuracy. A 
thermometer that has a divided mercury column or that cannot be adjusted 
to the standard shall be repaired or replaced before further use of the 
retort. Thermometers shall be installed where they can be accurately and 
easily read. Bulbs of indicating thermometers shall be installed either 
within the retort shell or in external wells attached to

[[Page 237]]

the retort. External wells or pipes shall be connected to the retort 
through at least a \3/4\-inch-diameter opening, and equipped with a \1/
16\-inch or larger bleeder opening so located as to provide a full flow 
of steam past the length of the thermometer bulb. The bleeder for 
external wells shall emit steam continuously during the entire 
processing period. The mercury thermometer--not the recorder chart--
shall be the reference instrument for indicating the processing 
temperature.
    (2) Temperature-recording device. Each retort shall have an accurate 
temperature-recording device. Graduations on the temperature-recording 
devices shall not exceed 2  deg.F within a range of 10  deg.F of the 
processing temperature. Each chart shall have a working scale of not 
more than 55  deg.F per inch within a range of 20  deg.F of the 
processing temperature. The temperature chart shall be adjusted to agree 
as nearly as possible with, but to be in no event higher than, the known 
accurate mercury-in-glass thermometer during the process time. A means 
of preventing unauthorized changes in adjustment shall be provided. A 
lock, or a notice from management posted at or near the recording device 
that provides a warning that only authorized persons are permitted to 
make adjustments, is a satisfactory means for preventing unauthorized 
changes. The recorder may be combined with the steam controller and may 
be a recording-controlling instrument. The temperature-recorder bulb 
shall be installed either within the retort shell or in a well attached 
to the shell. Each temperature-recorder bulb well shall have a \1/16\-
inch or larger bleeder opening emitting steam continuously during the 
processing period. Air-operated temperature controllers should have 
adequate filter systems to ensure a supply of clean, dry air.
    (3) Pressure gages. Each retort should be equipped with a pressure 
gage, which should be graduated in divisions of 2 pounds or less.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording-controlling instrument when combined with a recording 
thermometer. A steam controller activated by the steam pressure of the 
retort is acceptable if it is mechanically maintained so that it 
operates satisfactorily.
    (5) Bleeders. Bleeders, except those for thermometer wells, shall be 
one-eighth inch or larger and shall be wide open during the entire 
process, including the come-up-time. Bleeders shall be located within 
approximately 1 foot of the outermost location of containers, at each 
end along the top of the retort; additional bleeders shall be located 
not more than 8 feet apart along the top. Bleeders may be installed at 
positions other than those specified above, as long as there is evidence 
in the form of heat distribution data that they accomplish adequate 
removal of air and circulation of heat within the retort. In retorts 
having top steam inlet and bottom venting, a bleeder shall be installed 
in the bottom of the retort to remove condensate. All bleeders shall be 
arranged in a way that enables the operator to observe that they are 
functioning properly.
    (6) Venting and condensate removal. The air in each retort shall be 
removed before processing is started. Heat distribution data or 
documentary proof from the manufacturer or from a competent processing 
authority, demonstrating that adequate venting is achieved, shall be 
kept on file. At the time steam is turned on, the drain should be opened 
for a time sufficient to remove steam condensate from the retort and 
provision should be made for containing drainage of condensate during 
the retort operation.
    (7) Retort speed timing. The rotational speed of the retort shall be 
specified in the schedules process. The speed shall be adjusted, as 
necessary, to ensure that the speed is as specified in the scheduled 
process. The rotational speed as well as the process time shall be 
recorded for each retort load processed. Alternatively, a recording 
tachometer may be used to provide a continuous record of the speed. A 
means of preventing unauthorized speed changes on retorts shall be 
provided. A lock, or a notice from management posted at or near the 
speed-adjustment device that provides a warning that only authorized 
persons are permitted to make adjustments, is a satisfactory means of 
preventing unauthorized changes.

[[Page 238]]

    (8) Critical factors. Critical factors specified in the schedules 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process. The minimum headspace of 
containers in each retort load to be processed, if specified in the 
scheduled process, shall be measured and recorded at intervals of 
sufficient frequency to ensure that the headspace is as specified in the 
scheduled process. The headspace of solder-tipped, lap seam (vent hole) 
cans may be measured by net weight determinations. When the product 
consistency is specified in the scheduled process, the consistency of 
the product shall be determined by objective measurements on the product 
taken from the filler before processing and recorded at intervals of 
sufficient frequency to ensure that the consistency is as specified in 
the scheduled process. Minimum closing machine vacuum in vacuum-packed 
products, maximum fill-in or drained weight, minimum net weight, and 
percent solids shall be as specified in the scheduled process for all 
products for which deviations from such specifications may affect the 
scheduled process. All measurements and recordings of critical factors 
should be made at intervals not to exceed 15 minutes.
    (e) Equipment and procedures for pressure processing in water in 
discontinuous agitating retorts--(1) Indicating mercury-in-glass 
thermometer. Each retort shall be equipped with at least one mercury-in-
glass thermometer whose divisions are easily readable to 1  deg.F and 
whose temperature range does not exceed 17  deg.F per inch of graduated 
scale. Thermometers shall be tested for accuracy against a known 
accurate standard thermometer upon installation and at least once a year 
thereafter, or more frequently if necessary, to ensure their accuracy. 
Records of thermometer accuracy checks which specify date, standard use, 
method used, and person performing the test should be maintained. Each 
thermometer should have a tag, seal, or other means of identity that 
includes the date on which it was last tested for accuracy. A 
thermometer that has a divided mercury column or that cannot be adjusted 
to the standard shall be repaired or replaced before further use of the 
retort. Thermometers shall be installed where they can be accurately and 
easily read. Bulbs of indicating thermometers shall be installed either 
within the retort shell or in external wells attached to the retort. The 
mercury thermometer--not the recorder chart--shall be the reference 
instrument for indicating the processing temperature.
    (2) Temperature-recording device. Each retort shall have an accurate 
temperature-recording device. Graduations on the temperature-recording 
devices shall not exceed 2  deg.F within a range of 10  deg.F of the 
processing temperature. Each chart shall have a working scale of not 
more than 55  deg.F per inch within a range of 20  deg.F of the 
processing temperature. The temperature chart shall be adjusted to agree 
as nearly as possible with, but to be in no event higher than, the known 
accurate mercury-in-glass thermometer during the process time. A means 
of preventing unauthorized changes in adjustment shall be provided. A 
lock, or a notice from management posted at or near the recording device 
that provides a warning that only authorized persons are permitted to 
make adjustment, is a satisfactory means for preventing unauthorized 
changes. This recorder may be combined with the steam controller and may 
be a recording-controlling instrument. The temperature-recorder bulb 
shall be installed either within the retort shell or in a well attached 
to the shell. Air-operated temperature controllers should have adequate 
filter systems to ensure a supply of clean dry air.
    (3) Pressure gages. Each retort should be equipped with a pressure 
gage which should be graduated in divisions of 2 pounds or less.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording-controlling instrument when combined with a recording 
thermometer.
    (5) Retort speed timing. The rotational speed of the retort shall be 
specified in the scheduled process. The speed shall be adjusted, as 
necessary, to ensure that the speed is as specified in the scheduled 
process. The rotational speed

[[Page 239]]

as well as the process time shall be recorded for each retort load 
processed. Alternatively, a recording tachometer may be used to provide 
a continuous record of the speed. A means of preventing unauthorized 
speed changes shall be provided. A lock, or a notice from management 
posted at or near the speed adjustment device that provides a warning 
that only authorized persons are permitted to make adjustment, is a 
satisfactory means of preventing unauthorized changes.
    (6) Air supply and controls. Means shall be provided for introducing 
compressed air at the proper pressure and rate, which shall be 
controlled by an automatic pressure control unit. A check valve shall be 
provided in the air supply line to prevent water from entering the 
system.
    (7) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process. The minimum headspace of 
containers, if specified in the scheduled process, shall be measured and 
recorded at intervals of sufficient frequency to ensure that the 
headspace is as specified in the scheduled process. The headspace of 
solder-tipped, lap seam (vent hole) cans may be measured by net weight 
determinations. When the product consistency is specified in the 
scheduled process, the consistency of the product shall be determined by 
objective measurements on the product taken from the filler before 
processing and recorded at intervals of sufficient frequency to ensure 
that the consistency is as specified in the scheduled process. Minimum 
closing machine vaccum in vacuum-packed products, maximum fill-in or 
drained weight, minimum net weight, and percent solids shall be as 
specified in the scheduled process for all products when deviations from 
such specifications may affect the scheduled process. All measurements 
and recordings of critical factors should be made at intervals not to 
exceed 15 minutes.
    (f) Equipment and procedures for pressure processing in steam in 
hydrostatic retorts--(1) Indicating mercury-in-glass thermometer. Each 
retort shall be equipped with at least one mercury-in-glass thermometer 
whose divisions are easily readable to 1  deg.F and whose temperature 
range does not exceed 17  deg.F per inch of graduated scale. Thermometer 
shall be tested for accuracy against a known accurate standard 
thermometer upon installation and at least once a year thereafter, or 
more frequently if necessary, to ensure their accuracy. Records of 
thermometer accuracy checks which specify date, standard used, method 
used, and person performing the test should be maintained. Each 
thermometer should have a tag, seal, or other means of identity that 
includes the date on which it was last tested for accuracy. A 
thermometer that has a divided mercury column or that cannot be adjusted 
to the standard shall be repaired or replaced before further use of the 
retort. Thermometers shall be installed where they can be accurately and 
easily read. The thermometer shall be located in the steam dome near the 
steam-water interface. When the scheduled process specifies maintenance 
of particular temperatures in the hydrostatic water legs, a mercury-in-
glass thermometer shall be located in each hydrostatic water leg in a 
position near the bottom automatic recorder. The mercury thermometer--
not the recorder chart--shall be the references instrument for 
indicating the processing temperature.
    (2) Temperature-recording device. Each retort shall have an accurate 
temperature-recording device. Graduations on the temperature-recording 
devices shall not exceed 2  deg.F within a range of 10  deg.F of the 
processing temperature. Each chart shall have a working scale of not 
more than 55  deg.F per inch within a range of 20  deg.F of the 
processing temperature. The temperature chart shall be adjusted to agree 
as nearly as possible with, but to be in no event higher than, the known 
accurate mercury-in-glass thermometer during the process time. A means 
of preventing unauthorized changes in adjustment shall be provided. A 
lock, or a notice from management posted at or near the recording device 
that provides a warning that only authorized persons are permitted to 
make adjustments, is a satisfactory means for preventing unauthorized

[[Page 240]]

changes. The recorder may be combined with the steam controller and may 
be a recording-controlling instrument. The temperature-recorder bulb 
shall be installed either within the steam dome or in a well attached to 
the dome. Each temperature-recorder bulb well shall have a \1/16\-inch 
or larger bleeder opening which emits steam continuously during the 
processing period. Additional temperature-recorder bulbs shall be 
installed in the hydrostatic water legs if the scheduled process 
specified maintenance of particular temperatures in the hydrostatic 
water legs. Air-operated temperature controllers should have adequate 
filter systems to ensure a supply of clean dry air.
    (3) Pressure gages. Each retort should be equipped with a pressure 
gage which should be graduated in divisions of 2 pounds or less.
    (4) Recording of temperatures. Temperatures indicated by the 
mercury-in-glass thermometer or thermometers shall be entered on a 
suitable form during processing operations. Temperatures shall be 
recorded by an accurate automatic recorder or recorders at the following 
points:
    (i) In the steam chamber between the steam-water interface and the 
lowest container position.
    (ii) Near the top and the bottom of each hydrostatic water leg if 
the scheduled process specifies maintenance of particular temperatures 
in the legs.
    (5) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording-controlling instrument when combined with a recording 
thermometer. A steam controller activated by the steam pressure of the 
retort is acceptable if it is carefully mechanically maintained so that 
it operates satisfactorily.
    (6) Venting. Before the start of processing operations, the retort 
steam chamber or chambers shall be vented to ensure removal of air.
    (7) Bleeders. Bleeder openings \1/4\-inch or larger shall be located 
at the top of the steam chamber or chambers opposite the point of steam 
entry. Bleeders shall be wide open and shall emit steam continuously 
during the entire process, including the come-up-time. All bleeders 
shall be arranged in such a way that the operator can observe that they 
are functioning properly.
    (8) Retort speed. The speed of the container-conveyor chain shall be 
specified in the scheduled process and shall be determined and recorded 
at the start of processing and at intervals of sufficient frequency to 
ensure that the retort speed is maintained as specified. The speed 
should be determined and recorded every 4 hours. An automatic device 
should be used to stop the chain when the temperature drops below that 
specified in the scheduled process. A means of preventing unauthorized 
speed changes shall be provided. A lock, or a notice from management 
posted at or near the speed-adjusting device that provides a warning 
that only authorized persons are permitted to make adjustments, is a 
satisfactory means of preventing unauthorized changes.
    (9) Critical factors. Critical factors specified in the scheduled 
process shall be measured and recorded on the processing record at 
intervals of sufficient frequency to ensure that the factors are within 
the limits specified in the scheduled process.
    (i) When maximum fill-in or drained weight is specified in the 
scheduled process, it shall be measured and recorded at intervals of 
sufficient frequency to ensure that the weight of the product does not 
exceed the maximum for the given container size specified in the 
scheduled process.
    (ii) Closing machine vacuum in vacuum-packed products shall be 
observed and recorded at intervals of sufficient frequency to ensure 
that the vacuum is as specified in the scheduled process.
    (iii) Such measurements and recordings should be made at intervals 
not to exceed 15 minutes.
    (g) Aseptic processing and packaging systems--(1) Product 
sterilizer--(i) Equipment--(a) Temperature-indicating device. Each 
product sterilizer shall be equipped with at least one mercury-in-glass 
thermometer or an equivalent temperature-indicating device, such as a 
thermocouple-recorder. Mercury-in-glass thermometers shall have 
divisions that are easily readable to 1  deg.F and whose temperature 
range does not

[[Page 241]]

exceed 17  deg.F per inch of graduated scale. Thermometers and 
temperature-indicating devices shall be tested for accuracy against a 
known accurate standard thermometer upon installation and at least once 
a year thereafter, or more frequently if necessary, to ensure their 
accuracy. Records of accuracy checks which specify date, standard used, 
method used, and person performing the test should be maintained. Each 
thermometer and temperature-indicating device should have a tag, seal, 
or other means of identity that includes the date on which it was last 
tested for accuracy. A thermometer that has a divided mercury column or 
that cannot be adjusted to essential agreement with the standard shall 
be repaired or replaced. Thermometers and temperature-indicating devices 
shall be installed where they can be accurately and easily read. The 
temperature-indicating device shall be the reference instrument for 
indicating the processing temperature.
    (b) Temperature-recording device. There shall be an accurate 
temperature recording device on each product sterilizer. The device 
shall be installed in the product at the holding-tube outlet between the 
holding tube and the inlet to the cooler. Temperature-recording devices 
shall have graduations that do not exceed 2  deg.F within a range of 10 
deg.F of the processing temperature. Each chart shall have a working 
scale of not more than 55  deg.F per inch within a range of 20  deg.F of 
the desired product-sterilization temperature. The temperature chart 
shall be adjusted to agree as nearly as possible with, but to be in no 
event higher than, a known accurate mercury-in-glass thermometer. A 
means of preventing unauthorized changes in adjustment shall be 
provided. A lock; or a notice from management posted at or near the 
recording device that provides a warning that only authorized persons 
are permitted to make adjustments, is a satisfactory means for 
preventing unauthorized changes.
    (c) Temperature recorder-controller. An accurate temperature 
recorder-controller shall be located in the product sterilizer at the 
final heater outlet. It shall be capable of ensuring that the desired 
product sterilization temperature is maintained. The chart graduations 
shall not exceed 2  deg.F within a range of 10  deg.F of the desired 
product sterilization temperature. Air-operated temperature controllers 
should have adequate filter systems to ensure a supply of clean, dry 
air.
    (d) Product-to-product regenerators. When a product-to-product 
regenerator is used to heat the cold unsterilized product entering the 
sterilizer by means of a heat exchange system, it shall be designed, 
operated, and controlled so that the pressure of the sterilized product 
in the regenerator is greater than the pressure of any unsterilized 
product in the regenerator to ensure that any leakage in the regenerator 
is from the sterilized product into the unsterilized product.
    (e) Differential pressure recorder-controller. When a product-to-
product regenerator is used, there shall be an accurate differential 
pressure recorder-controller installed on the regenerator. The scale 
divisions shall not exceed 2 pounds per square inch on the working scale 
of not more than 20 pounds per square inch per inch. The controller 
shall be tested for accuracy against a known accurate standard pressure 
indicator upon installation and at least once every 3 months of 
operation thereafter, or more frequently if necessary, to ensure its 
accuracy. One pressure sensor shall be installed at the sterilized 
product regenerator outlet and the other pressure sensor shall be 
installed at the unsterilized product regenerator inlet.
    (f) Metering pump. A metering pump shall be located upstream from 
the holding tube and shall be operated to maintain the required rate of 
product flow. A means of preventing unauthorized speed changes shall be 
provided. A lock, or a notice from management posted at or near the 
speed-adjusting device that provides a warning that only authorized 
persons are permitted to make adjustments, is a satisfactory means of 
preventing unauthorized changes.
    (g) Product holding tube. The product-sterilizing holding tube shall 
be designed to give continous holding of every particle of food for at 
least the minimum holding time specified in the scheduled process. The 
holding tube

[[Page 242]]

shall be designed so that no portion of the tube between the product 
inlet and the product outlet can be heated, and it must be sloped upward 
at least 0.25 inch per foot.
    (h) Flow-diversion systems. If a processor elects to install a flow-
diversion system, it should be installed in the product piping located 
between the product cooler and the product filler or aseptic surge tank 
and should be designed to divert flow away from the filler or aseptic 
surge tank automatically. Controls and/or warning systems should be 
designed and installed with necessary sensors and actuators to operate 
whenever the sterilizing temperature in the holding tube or pressure 
differential in the product regenerator drops below specified limits. 
Flow-diversion systems should be designed and operated in accordance 
with recommendations of an aseptic processing and packaging authority.
    (i) Equipment downstream from the holding tube. Product coolers, 
aseptic surge tanks, or any other equipment downstream from the holding 
tube, with rotating or reciprocating shafts, valve stems, instrument 
connections, or other such points, are subject to potential entry of 
microorganisms into the product. Such locations in the system should be 
equipped with steam seals or other effective barriers at the potential 
access points. Appropriate means should be provided to permit the 
operator to monitor the performance of the seals or barriers during 
operations.
    (ii) Operation--(a) Startup. Before the start of aseptic processing 
operations the product sterilizer and all product-contact surfaces 
downstream shall be brought to a condition of commercial sterility.
    (b) Temperature drop in product-sterilizing holding tube. When 
product temperature in the holding tube drops below the temperature 
specified in the scheduled process, product flow should be diverted away 
from the filler or aseptic surge tank by means of a flow-diversion 
system. If for any reason product subjected to a temperature drop below 
the scheduled process is filled into containers, the product shall be 
segregated from product that received the scheduled process. The 
processing deviation shall be handled in accordance with Sec. 113.89. 
The product holding tube and any further system portions affected shall 
be returned to a condition of commercial sterility before product flow 
is resumed to the filler or to the aseptic surge tank.
    (c) Loss of proper pressures in the regenerator. When a regenerator 
is used, the product may lose sterility whenever the pressure of 
sterilized product in the regenerator is less than 1 pound per square 
inch greater than the pressure of unsterilized product in the 
regenerator. In this case, product flow should be diverted away from the 
filler or aseptic surge tank by means of the flow-diversion system. If 
for any reason the product is filled into containers, the product shall 
be segregated from product that received the scheduled process and shall 
be reprocessed or destroyed. Product flow to the filler or to the 
aseptic surge tank shall not be resumed until the cause of the improper 
pressure relationships in the regenerator has been corrected and the 
affected system(s) has been returned to a condition of commercial 
sterility.
    (d) Loss of sterile air pressure or other protection level in the 
aseptic surge tank. When an aseptic surge tank is used, conditions of 
commercial sterility may be lost when the sterile air overpressure or 
other means of protection drops below the scheduled process value. 
Product flow to and/or from the aseptic surge tank shall not be resumed 
until the potentially contaminated product in the tank is removed, and 
the aseptic surge tank has been returned to a condition of commercial 
sterility.
    (e) Records. Readings at the following points shall be observed and 
recorded at the start of aseptic packaging operations and at intervals 
of sufficient frequency to ensure that these values are as specified in 
the scheduled process: Temperature-indicating device in holding tube 
outlet; temperature recorder in holding tube outlet; temperature 
recorder-controller at final heater outlet; differential pressure 
recorder-controller, if a product-to-product regenerator is used; 
product flow rate as established by the metering pump or as determined 
by filling and closing rates and, if an aseptic surge tank is used, 
sterile air pressure or other protection

[[Page 243]]

means; and proper performance of seam seals or other similar devices. 
The measurements and recordings should be made at intervals not to 
exceed 1 hour.
    (2) Container sterilizing, filling, and closing operation--(i) 
Equipment--(a) Recording device. The container and closure sterilization 
system and product filling and closing system shall be instrumented to 
demonstrate that the required sterilization is being accomplished 
continuously. Automatic recording devices shall be used to record, when 
applicable, the sterilization media flow rates, temperature, 
concentration, or other factors. When a batch system is used for 
container sterilization, the sterilization conditions shall be recorded.
    (b) Timing method(s). A method(s) shall be used either to give the 
retention time of containers, and closures if applicable, in the 
sterilizing environment specified in the scheduled process, or to 
control the sterilization cycle at the rate specified in the scheduled 
process. A means of preventing unauthorized speed changes must be 
provided. A lock, or a notice from management posted at or near the 
speed adjusting device that provides a warning that only authorized 
persons are permitted to make adjustments, is a satisfactory means of 
preventing unauthorized changes.
    (ii) Operation--(a) Startup. Before the start of packaging 
operations, both the container and closure sterilizing system and the 
product filling an

21CFR113.60

[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.60]

[Page 244-247]
 
                        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 D--Control of Components, Food Product Containers, Closures, and 
                          In-Process Materials
 
Sec. 113.60  Containers.


    (a) Closures. Regular observations shall be maintained during 
production runs for gross closure defects. Any such defects shall be 
recorded and corrective action taken and recorded. At intervals of 
sufficient frequency to ensure proper closure, the operator, closure 
supervisor, or other qualified container closure inspection person shall 
visually examine either the top seam of a can randomly selected from 
each seaming head or the closure of any other type of container being 
used and shall record the observations made. For double-seam cans, each 
can should be examined for cutover or sharpness, skidding or 
deadheading, false seam, droop at the crossover or lap, and condition of 
inside of countersink wall for evidence of broken chuck. Such 
measurements and recordings should be made at intervals not to exceed 30 
minutes. Additional visual closure inspections shall be made immediately 
following a jam in a closing machine, after closing machine adjustment, 
or after startup of a machine following a prolonged shutdown. All 
pertinent observations shall be recorded. When irregularities are found, 
the corrective action shall be recorded.
    (1) Teardown examinations for double-seam cans shall be performed by 
a qualified individual and the results therefrom shall be recorded at 
intervals of sufficient frequency on enough containers from each seaming 
station to ensure maintenance of seam integrity. Such examinations and 
recordings should be made at intervals not to exceed 4 hours. The 
results of the teardown examinations shall be recorded and the 
corrective action taken, if any, shall be noted.
    (i) Required and optional can seam measurements:
    (a) Micrometer measurement system:

[[Page 245]]



------------------------------------------------------------------------
            Required                             Optional
------------------------------------------------------------------------
Cover hook                        Overlap (by calculation).
Body hook                         Countersink.
Width (length, height)            ......................................
Tightness (observation for        ......................................
 wrinkle)
Thickness                         ......................................
------------------------------------------------------------------------

    (b) Seam scope or projector:

------------------------------------------------------------------------
             Required                             Optional
------------------------------------------------------------------------
Body hook                          Width (length, height).
Overlap                            Cover hook.
Tightness (observation for         Countersink.
 wrinkle)
Thickness by micrometer            .....................................
------------------------------------------------------------------------

    (c) Can double seam terminology:

[[Page 246]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.376

    (1) ``Crossover'': The portion of a double seam at the lap.
    (2) ``Cutover'': A fracture, sharp bend, or break in the metal at 
the top of the inside portion of the double seam.

[[Page 247]]

    (3) ``Deadhead'': A seam which is incomplete due to chuck spinning 
in the countersink.
    (4) ``Droop'': Smooth projection of double seam below bottom of 
normal seam.
    (5) ``False seam'': A small seam breakdown where the cover hook and 
the body hook are not overlapped.
    (6) ``Lap'': Two thicknesses of material bonded together.
    (ii) Two measurements at different locations, excluding the side 
seam, shall be made for each double seam characteristic if a seam scope 
or seam projector is used. When a micrometer is used, three measurements 
shall be made at points approximately 120 deg. apart, excluding the side 
seam.
    (iii) Overlap length can be calculated by the following formula:

The theoretical overlap length=
    CH+BH+T-W, where
    CH=cover hook
    BH=body hook
    T=cover thickness, and
    W=seam width (height, length)

    (2) For glass containers with vacuum closures, capper efficiency 
must be checked by a measurement of the cold water vacuum. This shall be 
done before actual filling operations, and the results shall be 
recorded.
    (3) For closures other than double seams and glass containers, 
appropriate detailed inspections and tests shall be conducted by 
qualified personnel at intervals of sufficient frequency to ensure 
proper closing machine performance and consistently reliable hermetic 
seal production. Records of such tests shall be maintained.
    (b) Cooling water. Container cooling water shall be chlorinated or 
otherwise sanitized as necessary for cooling canals and for recirculated 
water supplies. There should be a measurable residual of the sanitizer 
employed at the water discharge point of the container cooler.
    (c) Coding. Each hermetically sealed container of low-acid processed 
food shall be marked with an identifying code that shall be permanently 
visible to the naked eye. When the container does not permit the code to 
be embossed or inked, the label may be legibly perforated or otherwise 
marked, if the label is securely affixed to the product container. The 
required identification shall identify in code the establishment where 
packed, the product contained therein, the year packed, the day packed, 
and the period during which packed. The packing period code shall be 
changed with sufficient frequency to enable ready identification of lots 
during their sale and distribution. Codes may be changed on the basis of 
one of the following: intervals of 4 to 5 hours; personnel shift 
changes; or batches, as long as the containers that constitute the batch 
do not extend over a period of more than one personnel shift.
    (d) Postprocess handling. When cans are handled on belt conveyors, 
the conveyors should be so constructed as to minimize contact by the 
belt with the double seam, i.e., cans should not be rolled on the double 
seam. All worn and frayed belting, can retarders, cushions, etc. should 
be replaced with new nonporous material. All tracks and belts that come 
into contact with the can seams should be thoroughly scrubbed and 
sanitized at intervals of sufficient frequency to avoid product 
contamination. Automatic equipment used in handling filled containers 
should be so designed and operated as to preserve the can seam or other 
container closure integrity.



21CFR113.81

[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.81]

[Page 247-248]
 
                        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. 113.81  Product preparation.


    (a) Before using raw materials and ingredients susceptible to 
microbiological contamination, the processor shall ensure that those 
materials and ingredients are suitable for use in processing low-acid 
food. Compliance with this requirement may be accomplished by receiving 
the raw materials and ingredients under a supplier's guarantee that they 
are suitable for use, by examining them for their microbiological 
condition, or by other acceptable means.
    (b) Blanching by heat, when required in the preparation of food for 
canning, should be effected by heating the food to the required 
temperature, holding it at this temperature for the required time, and 
then either rapidly cooling

[[Page 248]]

the food or passing it to subsequent processing without delay. 
Thermophilic growth and contamination in blanchers should be minimized 
by the use of adequate operating temperatures and by cleaning. If the 
blanched food product is washed before filling, potable water should be 
used.
    (c) The filling of containers, either mechanically or by hand, shall 
be controlled so as to ensure that the filling requirements specified in 
the scheduled process are met.
    (d) The exhausting of containers for the removal of air shall be 
controlled so as to meet the conditions for which the process was 
designed. Compliance with the requirement may be accomplished by heat 
exhausting, mechanical exhausting, hot brining, or steam injection.
    (e) When the maintenance of pH (above 4.6) of a normally low-acid 
food is a basis for a scheduled process, there shall be careful 
supervision to ensure that the equilibrium pH of the finished product 
meets that of the scheduled process. The methodology described in 
Sec. 114.90 of this chapter should be used.
    (f) When the scheduled process sets forth critical factors to 
prevent the growth of microorganisms not destroyed by the thermal 
process, the factors shall be carefully controlled to ensure that the 
limits established in the scheduled process are not exceeded. When 
normally low-acid foods require sufficient solute to permit safe 
processing at low temperatures, such as in boiling water, there shall be 
careful supervision to ensure that the equilibrium water activity 
(a<INF>w</INF>) of the finished product meets that of the scheduled 
process. The scheduled thermal processes for foods having an a<INF>w</INF> 
greater than 0.85 and less than the a<INF>w</INF> that would allow the 
growth of spores of microorganisms of public health significance shall 
be sufficient to render the food free of microorganisms capable of 
reproducing in the food under normal nonrefrigerated conditions of 
storage and distribution.



21CFR113.83

[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.83]

[Page 248]
 
                        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. 113.83  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, a<INF>w,</INF> 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.



21CFR113.87

[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
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.



21CFR113.89

[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.89]

[Page 249-250]
 
                        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. 113.89  Deviations in processing, venting, or control of critical factors.

    Whenever any process is less than the scheduled process or when 
critical factors are out of control for any low-acid food or container 
system as disclosed from records by processor check or otherwise, the 
commerical processor of that low-acid food shall either fully reprocess 
that portion of the production involved, keeping full records of the 
reprocessing conditions or, alternatively, must set aside that portion 
of the product involved for further evaluation as to any potential 
public health significance. Such evaluation shall be made by a competent 
processing authority and shall be in accordance with procedures 
recognized by competent processing authorities as being adequate to 
detect any potential hazard to public health. Unless this evaluation 
demonstrates that the product had been given a thermal process that 
rendered it free of microorganisms of potential public health 
significance, the product set aside shall be either fully reprocessed to 
render it commercially sterile or destroyed. A record shall be made of 
the evaluation procedures used and the results. Either upon completion 
of full reprocessing and the attainment of commerical sterility or after 
the determination that no significant potential for public health hazard 
exists, that portion of the product involved may be shipped in normal 
distribution. Otherwise, the portion of the product involved shall be 
destroyed. All process deviations involving a failure to satisfy the 
minimum requirements of the

[[Page 250]]

scheduled process, including emergencies arising from a jam or breakdown 
of a continuous agitating retort necessitating cooling the retort for 
repairs, shall be recorded and made the subject of a separate file (or a 
log identifying the appropriate data) detailing those deviations and the 
actions taken.



21CFR113.100

[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.100]

[Page 250-251]
 
                        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 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 a<INF>w</INF> 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 251]]

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.



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