[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.40]
[Page 232-249]
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
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 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.
[[Page 233]]
(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 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.
[[Page 234]]
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
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.
[[Page 235]]
[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 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
[[Page 236]]
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 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.
[[Page 237]]
(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. 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.
[[Page 238]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.375
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.
[[Page 239]]
(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 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
[[Page 240]]
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 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,
[[Page 241]]
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 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--
[[Page 242]]
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.
(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
[[Page 243]]
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 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
[[Page 244]]
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
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
[[Page 245]]
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 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
[[Page 246]]
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 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
[[Page 247]]
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 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
[[Page 248]]
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.
(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
[[Page 249]]
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]
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