[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.40]

[Page 232-249]
 
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

[[Page 233]]

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 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

[[Page 234]]

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 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.

[[Page 235]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.371

    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

[[Page 236]]

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 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

[[Page 237]]

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 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

[[Page 238]]

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. 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


[[Page 239]]



            Legend for Vertical and Horizontal Still Retorts

    A--Water line.
    B--Steam line.
    C--Temperature control.
    D--Overflow line.
    E1--Drain line.
    E2--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.
    S--Inlet air control.
    T--Pressure control.
    U--Air line.
    V--To pressure control instrument.
    W--To temperature control instrument.
    X--Wing nuts.
    Y1--Crate support.
    Y2--Crate guides.
    Z--Constant flow orifice valve.
    Z1--Constant flow orifice valve used during come-up.
    Z2--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-

[[Page 240]]

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 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.

[[Page 241]]

    (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 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

[[Page 242]]

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 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

[[Page 243]]

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.
    (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

[[Page 244]]

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 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.

[[Page 245]]

    (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 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

[[Page 246]]

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 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

[[Page 247]]

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 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 reproc essed 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

[[Page 248]]

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 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 and closing system shall be brought to a condition of 
commercial sterility.
    (b) Loss of sterility. A system shall be provided to stop packaging 
operations, or alternatively to ensure segregation of any product 
packaged when the packaging conditions fall below scheduled processes. 
Compliance with this requirement may be accomplished by diverting 
product away from the filler, by preventing containers from entering the 
filler, or by other suitable means. In the event product is packaged 
under conditions below those specified in the scheduled process, all 
such product shall be segregated and handled in accordance with Sec. 
113.89. In the event of loss of sterility, the system(s) shall be 
returned to a condition of commercial sterility before resuming 
packaging operations.
    (c) Records. Observations and measurements of operating conditions 
shall be made and recorded at intervals of sufficient frequency to 
ensure that commercial sterility of the food product is being achieved; 
such measurements shall include the sterilization media flow rates, 
temperatures, the container and closure rates (if applicable) through 
the sterilizing system, and the sterilization conditions if a batch 
system is used for container sterilization. The measurements and 
recordings should be made at intervals not to exceed 1 hour.
    (3) Incubation. Incubation tests should be conducted on a 
representative sample of containers of product from each code; records 
of the test results should be maintained.
    (4) 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. Such measurements and 
recordings should be done at intervals not to exceed 15 minutes.

[[Page 249]]

    (h) Equipment and procedures for flame sterilizers. The container 
conveyor speed shall be specified in the scheduled process. The 
container conveyor speed shall be measured and recorded at the start of 
operations and at intervals of sufficient frequency to ensure that the 
conveyor speed is as specified in the scheduled process. Such 
measurements and recordings should be done at 1-hour intervals. 
Alternatively, recording tachometer may be used to provide a continuous 
record of the speed. A means of preventing changes in flame intensity 
and unauthorized speed changes on the conveyor 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. The surface temperature of at least one container 
from each conveyor channel shall be measured and recorded at the entry 
and at the end of the holding period at intervals of sufficient 
frequency to ensure that the temperatures specified in the scheduled 
process are maintained. Such measurements and recordings should be done 
at intervals not to exceed 15 minutes.
    (1) Process interruption. In the event of process interruption 
wherein the temperature of the product may have dropped, an authorized, 
scheduled emergency plan approved by a qualified person having expert 
knowledge of the process requirements may be used.
    (2) 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) Equipment and procedures for thermal processing of foods wherein 
critical factors such as water activity are used in conjunction with 
thermal processing. The methods and controls used for the manufacture, 
processing, and packing of such foods shall be as established in the 
scheduled process and shall be operated or administered in a manner 
adequate to ensure that the product is safe. The time and temperature of 
processing and other critical factors specified in the scheduled process 
shall be measured with instruments having the accuracy and dependability 
adequate to ensure that the requirements of the scheduled process are 
met. All measurements shall be made and recorded at intervals of 
sufficient frequency to ensure that the critical factors are within the 
limits specified in the scheduled process.
    (j) Other systems. All systems, whether or not specifically 
mentioned in this part, for the thermal processing of low-acid foods in 
hermetically sealed containers shall conform to the applicable 
requirements of this part and the methods and controls used for the 
manufacture, processing, and packing of these foods shall be as 
established in the scheduled process. These systems shall be operated or 
administered in a manner adequate to ensure that commercial sterility is 
achieved. Critical factors specified in the scheduled process shall be 
measured and recorded at intervals of sufficient frequency to ensure 
that the critical factors are within the limits specified in the 
scheduled process.

[44 FR 16215, Mar. 16, 1979, as amended at 62 FR 31722, June 11, 1997]