This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113]
[Page 225]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 113--THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS--Table of Contents
Subpart A--General Provisions
Sec.
113.3 Definitions.
113.5 Current good manufacturing practice.
113.10 Personnel.
Subpart B [Reserved]
Subpart C--Equipment
113.40 Equipment and procedures.
Subpart D--Control of Components, Food Product Containers, Closures, and
In-Process Material
113.60 Containers.
Subpart E--Production and Process Controls
113.81 Product preparation.
113.83 Establishing scheduled processes.
113.87 Operations in the thermal processing room.
113.89 Deviations in processing, venting, or control of critical
factors.
Subpart F--Records and Reports
113.100 Processing and production records.
Authority: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264.
Source: 44 FR 16215, Mar. 16, 1979, unless otherwise noted.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.3]
[Page 225-227]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 113--THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS--Table of Contents
Subpart A--General Provisions
Sec. 113.3 Definitions.
For the purposes of this part, the following definitions apply:
(a) Aseptic processing and packaging means the filling of a
commercially sterilized cooled product into presterilized containers,
followed by aseptic hermetical sealing, with a presterilized closure, in
an atmosphere free of microorganisms.
(b) Bleeders means openings used to remove air that enters with
steam from retorts and steam chambers and to promote circulation of
steam in such retorts and steam chambers. Bleeders may serve as a means
of removing condensate.
(c) Come-up-time means the time which elapses between the
introduction of steam into the closed retort and the time when the
retort reaches the required processing temperature.
(d) Commercial processor includes any person engaged in commercial,
custom, or institutional (church, school, penal, or other organization)
processing of food, including pet food. Persons engaged in the
production of foods that are to be used in market or consumer tests are
also included.
[[Page 226]]
(e) Commercial sterility: (1) "Commercial sterility" of thermally
processed food means the condition achieved--
(i) By the application of heat which renders the food free of--
(a) Microorganisms capable of reproducing in the food under normal
nonrefrigerated conditions of storage and distribution; and
(b) Viable microorganisms (including spores) of public health
significance; or
(ii) By the control of water activity and the application of heat,
which renders the food free of microorganisms capable of reproducing in
the food under normal nonrefrigerated conditions of storage and
distribution.
(2) "Commercial sterility" of equipment and containers used for
aseptic processing and packaging of food means the condition achieved by
application of heat, chemical sterilant(s), or other appropriate
treatment that renders the equipment and containers free of viable
microorganisms having public health significance, as well as
microorganisms of nonhealth significance, capable of reproducing in the
food under normal nonrefrigerated conditions of storage and
distribution.
(f) Critical factor means any property, characteristic, condition,
aspect, or other parameter, variation of which may affect the scheduled
process and the attainment of commercial sterility.
(g) Flame sterilizer means an apparatus in which hermetically sealed
containers are agitated at atmospheric pressure, by either continuous,
discontinuous, or reciprocating movement, with impinging gas flames to
achieve sterilization temperatures. A holding period in a heated section
may follow the initial heating period.
(h) Headspace, gross is the vertical distance between the level of
the product (generally the liquid surface) in an upright rigid container
and the top edge of the container (the top of the double seam of a can
or the top edge of a glass jar).
(i) Headspace, net of a container is the vertical distance between
the level of the product (generally the liquid surface) in the upright
rigid container and the inside surface of the lid.
(j) Hermetically sealed container means a container that is designed
and intended to be secure against the entry of microorganisms and
thereby to maintain the commercial sterility of its contents after
processing.
(k) Incubation means the holding of a sample(s) at a specified
temperature for a specified period of time for the purpose of permitting
or stimulating the growth of microorganisms.
(l) Initial temperature means the average temperature of the
contents of the coldest container to be processed at the time the
thermal processing cycle begins, as determined after thorough stirring
or shaking of the filled and sealed container.
(m) Lot means that amount of a product produced during a period of
time indicated by a specific code.
(n) Low-acid foods means any foods, other than alcoholic beverages,
with a finished equilibrium pH greater than 4.6 and a water activity
(aw) greater than 0.85. Tomatoes and tomato products having a
finished equilibrium pH less than 4.7 are not classed as low-acid foods.
(o) Minimum thermal process means the application of heat to food,
either before or after sealing in a hermetically sealed container, for a
period of time and at a temperature scientifically determined to be
adequate to ensure destruction of microorganisms of public health
significance.
(p) Operating process means the process selected by the processor
that equals or exceeds the minimum requirements set forth in the
scheduled process.
(q) Retort means any closed vessel or other equipment used for the
thermal processing of foods.
(r) Scheduled process means the process selected by the processor as
adequate under the conditions of manufacture for a given product to
achieve commercial sterility. This process may be in excess of that
necessary to ensure destruction of microorganisms of public health
significance, and shall be at least equivalent to the process
established by a competent processing authority to achieve commercial
sterility.
(s) Shall is used to state mandatory requirements.
[[Page 227]]
(t) Should is used to state recommended or advisory procedures or to
identify recommended equipment.
(u) Vacuum-packed products means those products that are sealed in a
container under the vacuum specified in the scheduled process, the
maintenance of which vacuum is critical to the adequacy of the scheduled
process.
(v) Vents means openings through the retort shell, controlled by
gate, plug cock, or other adequate valves used for the elimination of
air during the venting period.
(w) Water activity (aw) is a measure of the free moisture
in a product and is the quotient of the water vapor pressure of the
substance divided by the vapor pressure of pure water at the same
temperature.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.5]
[Page 227]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 113--THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS--Table of Contents
Subpart A--General Provisions
Sec. 113.5 Current good manufacturing practice.
The criteria in Secs. 113.10, 113.40, 113.60, 113.81, 113.83,
113.87, 113.89, and 113.100 shall apply in determining whether the
facilities, methods, practices, and controls used by the commercial
processor in the manufacture, processing, or packing of low-acid foods
in hermetically sealed containers are operated or administered in a
manner adequate to protect the public health.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.10]
[Page 227]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 113--THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS--Table of Contents
Subpart A--General Provisions
Sec. 113.10 Personnel.
The operators of processing systems, retorts, aseptic processing and
packaging systems and product formulating systems (including systems
wherein water activity is used in conjunction with thermal processing)
and container closure inspectors shall be under the operating
supervision of a person who has attended a school approved by the
Commissioner for giving instruction appropriate to the preservation
technology involved and who has been identified by that school as having
satisfactorily completed the prescribed course of instruction. This
person shall supervise only in those areas for which a school approved
by the Commissioner identifies the person as having satisfactorily
completed training.
Subpart B [Reserved]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.40]
[Page 227-244]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 113--THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS--Table of Contents
Subpart C--Equipment
Sec. 113.40 Equipment and procedures.
(a) Equipment and procedures for pressure processing in steam in
still retorts--(1) Indicating mercury-in-glass thermometer. Each retort
shall be equipped with at least one mercury-in-glass thermometer whose
divisions are easily readable to 1 deg.F and whose temperature range
does not exceed 17 deg.F per inch of graduated scale. Thermometers
shall be tested for accuracy against a known accurate standard
thermometer upon installation and at least once a year thereafter, or
more frequently if necessary, to ensure their accuracy. Records of
thermometer accuracy checks that specify date, standard used, method
used, and person performing the test should be maintained. Each
thermometer should have a tag, seal, or other means of identity that
includes the date on which it was last tested for accuracy. A
thermometer that has a divided mercury column or that cannot be adjusted
to the standard shall be repaired or replaced before further use of the
retort. Thermometers shall be installed where they can be accurately and
easily read. Bulbs of indicating thermometers shall be installed either
within the retort shell or in external wells attached to the retort.
External wells or pipes shall be connected to the retort through at
least a \3/4\-inch diameter opening and equipped with a \1/16\-inch or
larger bleeder opening so located as to provide a full flow of steam
past the length of the thermometer bulb. The bleeders for external wells
shall emit steam continuously during the entire processing period. The
mercury thermometer--not the recorder chart--shall be the reference
instrument for indicating the processing temperature.
(2) Temperature-recording device. Each still retort shall have an
accurate temperature-recording device. Graduations on the temperature-
recording devices shall not exceed 2 deg.F within a range of 10 deg.F
of the processing temperature. Each chart shall have a working scale of
not more than 55 deg.F per inch within a range of 20 deg.F of the
processing temperature. The temperature chart shall be adjusted to agree
as nearly as possible with, but to be in no event higher
[[Page 228]]
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
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,
[[Page 229]]
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.
[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.
[[Page 230]]
Size of water spreader. For retorts less than 15 feet in length,
1\1/2\ inches; for retorts 15 feet and over in length, 2 inches. The
number of holes should be such that their total cross-sectional area is
approximately equal to the cross-sectional area of the vent pipe inlet.
Venting method. Water spreader vent gate or plug cock valve should
be wide open for at least 5 minutes and to at least 225 deg.F, or for
at least 7 minutes and to at least 220 deg.F.
(d) Venting through a single 2\1/2\-inch top vent (for retorts not
exceeding 15 feet in length).
[GRAPHIC] [TIFF OMITTED] TR01JA93.372
Specifications: A 2\1/2\-inch vent equipped with a 2\1/2\-inch gate
or plug cock valve and located within 2 feet of the center of the
retort.
Venting method: Vent gate or plug cock valve should be wide open for
at least 4 minutes and to at least 220 deg.F.
(ii) Venting vertical retorts. (a) Venting through a 1\1/2\-inch
overflow.
[GRAPHIC] [TIFF OMITTED] TR01JA93.373
Specifications. A 1\1/2\-inch overflow pipe equipped with a 1\1/2\-
inch gate or plug cock valve and with not more than 6 feet of 1\1/2\-
inch pipe beyond the valve before break to the atmosphere or to a
manifold header.
Venting method. Vent gate or plug cock valve should be wide open for
at least 4 minutes and to at least 218 deg.F, or for at least 5 minutes
and to at least 215 deg.F.
(b) Venting through a single 1-inch side or top vent.
[GRAPHIC] [TIFF OMITTED] TR01JA93.374
Specifications. A 1-inch vent in lid or top side, equipped with a 1-
inch gate or plug cock valve and discharging directly into the
atmosphere or to a manifold header.
Venting method. Vent gate or plug cock valve should be wide open for
at least 5 minutes and to at least 230 deg.F, or for at least 7 minutes
and to at least 220 deg.F.
(iii) Other installations and operating procedures that deviate from
the above specifications may be used if there is evidence in the form of
heat distribution data, which shall be kept on file, that they
accomplish adequate venting of air.
(13) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process.
(i) When maximum fill-in or drained weight is specified in the
scheduled process, it shall be measured and recorded at intervals of
sufficient frequency to ensure that the weight of the product does not
exceed the maximum for the given container size specified in the
scheduled process.
(ii) Closing machine vacuum in vacuum-packed products shall be
observed and recorded at intervals of sufficient 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.
[[Page 231]]
(iv) When the product style results in stratification or layering of
the primary product in the containers, the positioning of containers in
the retort shall be according to the scheduled process.
(b) Equipment and procedures for pressure processing in water in
still retorts--(1) Indicating mercury-in-glass thermometer. Each retort
shall be equipped with at least one mercury-in-glass thermometer whose
divisions are easily readable to 1 deg.F and whose temperature range
does not exceed 17 deg.F per inch of graduated scale. Thermometers
shall be tested for accuracy against a known accurate standard
thermometer upon installation and at least once a year thereafter, or
more frequently if necessary, to ensure their accuracy. Records of
thermometer accuracy checks which specify date, standard used, method
used, and person performing the test should be maintained. Each
thermometer should have a tag, seal, or other means of identity that
includes the date when it was last tested for accuracy. A thermometer
that has a divided mercury column or that cannot be adjusted to the
standard shall be repaired or replaced before further use of the retort.
Thermometers shall be installed where they can be accurately and easily
read. Bulbs of indicating thermometers shall be located in such a
position that they are beneath the surface of the water throughout the
process. On horizontal retorts, this entry should be made in the side at
the center, and the thermometer bulbs shall be inserted directly into
the retort shell. In both vertical and horizontal retorts, the
thermometer bulbs shall extend directly into the water a minimum of at
least 2 inches without a separable well or sleeve. The mercury
thermometer--not the recorder chart--shall be the reference instrument
for indicating the processing temperature.
(2) Temperature-recording device. Each still retort shall have an
accurate temperature-recording device. Graduations on the temperature-
recording devices shall not exceed 2 deg.F within a range of 10 deg.F
of the processing temperature. Each chart shall have a working scale of
not more than 55 deg.F per inch within a range of 20 deg.F of the
processing temperature. The temperature chart shall be adjusted to agree
as nearly as possible with, but to be in no event higher than, the known
accurate mercury-in-glass thermometer during the process time. A means
of preventing unauthorized changes in adjustment shall be provided. A
lock, or a notice from management posted at or near the recording device
which provides a warning that only authorized persons are permitted to
make adjustments, is a satisfactory means for preventing unauthorized
changes. The recorder may be combined with the steam controller and may
be a recording-controlling instrument. The recording-thermometer bulb
should be located adjacent to the bulb of the mercury-in-glass
thermometer, except in the case of a vertical retort equipped with a
combination recorder-controller. In such vertical retorts, the
temperature recorder-control bulb shall be located at the bottom of the
retort below the lowest crate rest in such a position that the steam
does not strike it directly. In horizontal retorts, the temperature
recorder-control bulb shall be located between the water surface and the
horizontal plane passing through the center of the retort so that there
is no opportunity for direct steam impingement on the control bulb. Air-
operated temperature controllers should have adequate filter systems to
ensure a supply of clean, dry air.
(3) Pressure gages. (i) Each retort should be equipped with a
pressure gage, which should be graduated in divisions of 2 pounds or
less.
(ii) Each retort should have an adjustable pressure relief or
control valve of a capacity sufficient to prevent an undesired increase
in retort pressure when the water valve is wide open and should be
installed in the overflow line.
(4) Steam controller. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. This may
be a recording-controlling instrument when combined with a recording
thermometer.
(5) Steam introduction. Steam shall be distributed in the bottom of
the retort 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
[[Page 232]]
retorts, the steam distributor shall run the length of the bottom of the
retort with perforations distributed uniformly along the upper part of
the pipe.
(6) Crate supports. A bottom crate support shall be used in vertical
still retorts. Baffle plates shall not be used in the bottom of the
retort. Centering guides should be installed so as to ensure that there
is about a 1\1/2\-inch clearance between the side wall of the crate and
the retort wall.
(7) Stacking equipment and position of containers. Crates, trays,
gondolas, etc., for holding containers shall be made of strap iron,
adequately perforated sheet metal, or other suitable material. When
perforated sheet metal is used for the bottoms, the perforations should
be approximately the equivalent of 1-inch holes on 2-inch centers. If
divider plates are used between the layers of containers, they should be
perforated as above. The positioning of containers in the retort, when
specified in the scheduled process, shall be in accordance with that
process. Dividers, racks, trays, or other means of positioning of
flexible containers shall be designed and employed to ensure even
circulation of heating medium around all containers in the retort.
(8) Drain valve. A nonclogging, water-tight valve shall be used.
Screens should be installed over all drain openings.
(9) Water level indicator. There shall be a means of determining the
water level in the retort during operation, e.g., by using a gage, water
glass, or petcock(s). Water shall cover the top layer of containers
during the entire come-up-time and processing periods and should cover
the top layer of containers during the cooling periods. The operator
shall check and record the water level at intervals sufficient to ensure
its adequacy.
(10)(i) Air supply and controls. In both horizontal and vertical
still retorts for pressure processing in water, a means shall be
provided for introducing compressed air at the proper pressure and rate.
The proper pressure shall be controlled by an automatic pressure control
unit. A check valve shall be provided in the air supply line to prevent
water from entering the system. Air or water circulation shall be
maintained continuously during the come-up-time and during processing
and cooling periods; the adequacy of the air or water circulation for
uniform heat distribution within the retort shall be established in
accordance with procedures recognized by a competent processing
authority and records shall be kept on file; if air is used to promote
circulation, it shall be introduced into the steam line at a point
between the retort and the steam control valve at the bottom of the
retort.
(ii) Water circulation. When a water circulating system is used for
heat distribution, is shall be installed in such a manner that water
will be drawn from the bottom of the retort through a suction manifold
and discharged through a spreader which extends the length of the top of
the retort. The holes in the water spreader shall be uniformly
distributed and should have an aggregate area not greater than the
cross-section area of the outlet line from the pump. The suction outlets
should be protected with nonclogging screens to keep debris from
entering the circulating system. The pump shall be equipped with a pilot
light or other signaling device to warn the operator when it is not
running, and with a bleeder to remove air when starting operations.
Alternative methods for circulation of water in the retort may be used
when established by a competent authority as adequate for even heat
distribution.
(11) Cooling water supply. In vertical retorts the cooling water
should be introduced at the top of the retort between the water and
container levels; in horizontal retorts the cooling water should be
introduced into the suction side of the pump. A check valve should be
included in the cooling water line.
(12) Retort headspace. The headspace necessary to control the air
pressure should be maintained between the water level and the top of the
retort shell.
(13) Vertical and horizontal still retorts. Vertical and horizontal
still retorts should follow the arrangements in the diagrams below in
this paragraph. Other installation and operating procedures that deviate
from these arrangements may be used, as long as there is
[[Page 233]]
evidence in the form of heat distribution data or other suitable
information, which shall be kept on file, that demonstrates that the
heat distribution is adequate.
[GRAPHIC] [TIFF OMITTED] TR01JA93.375
Legend for Vertical and Horizontal Still Retorts
A--Water line.
B--Steam line.
C--Temperature control.
D--Overflow line.
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.
[[Page 234]]
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-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.
[[Page 235]]
(3) Pressure gages. Each retort should be equipped with a pressure
gage that should be graduated in divisions of 2 pounds or less.
(4) Steam controller. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. This may
be a recording-controlling instrument when combined with a recording
thermometer. A steam controller activated by the steam pressure of the
retort is acceptable if it is carefully maintained mechanically so that
it operates satisfactorily.
(5) Bleeders. Bleeders, except those for thermometer wells, shall be
one-eight inch or larger and shall be wide open during the entire
process, including the come-up-time. Bleeders shall be located within
approximately 1 foot of the outermost location of containers at each end
along the top of the retort; additional bleeders shall be located not
more than 8 feet apart along the top of the retort. All bleeders shall
be arranged so that the operator can observe that they are functioning
properly. The condensate bleeder shall be checked with sufficient
frequency to ensure adequate removal of condensate or shall be equipped
with an automatic alarm system(s) that would serve as a continuous
monitor of condensate-bleeder functioning. Visual checks should be done
at intervals of not more than 15 minutes. A record of such checks should
be kept to show that the bleeder is functioning properly.
(6) Venting and condensate removal. Vents shall be located in that
portion of the retort opposite the steam inlet. Air shall be removed
before processing is started. Heat distribution data or documentary
proof from the manufacturer or from a competent processing authority,
demonstrating that adequate venting is achieved, shall be kept on file.
At the time steam is turned on, the drain should be opened for a time
sufficient to remove steam condensate from the retort, and provision
shall be made for continuing drainage of condensate during the retort
operation. The condensate bleeder in the bottom of the shell serves as
an indicator of continuous condensate removal.
(7) Retort speed timing. The rotational speed of the retort shall be
specified in the scheduled process. The speed shall be adjusted and
recorded when the retort is started, at any time a speed change is made,
and at intervals of sufficient frequency to ensure that the retort speed
is maintained as specified in the scheduled process. These adjustments
and recordings should be made every 4 hours or less. Alternatively, a
recording tachometer may be used to provide a continuous record of the
speed. A means of preventing unauthorized speed changes on retorts shall
be provided. A lock, or a notice from management posted at or near the
speed adjustment device that provides a warning that only authorized
persons are permitted to make adjustments, is a satisfactory means of
preventing unauthorized changes.
(8) Emergency stops. If a retort jams or breaks down during
processing operations, necessitating cooling the retort for repairs, the
retort shall be operated in such a way that ensures that the product is
commercially sterile, or the retort is to be cooled promptly and all
containers either reprocessed, repacked and reprocessed, or discarded.
When operated as a still retort, all containers shall be given a full
still retort process before the retort is cooled. If, in such an
emergency, a scheduled still process or another process established to
ensure commercial sterility is to be used, it shall be made readily
available to the retort operator.
(i) Any containers in the retort intake valve or in transfer valves
between cooker shells of a continuous retort at the time of breakdown
shall either be reprocessed, repacked and reprocessed, or discarded.
(ii) Both the time at which the reel stopped and the time the retort
was used for a still retort process, if so used, shall be marked on the
recording chart and entered on the other production records required in
this chapter. If the alternative procedure of prompt cooling is
followed, the subsequent handling methods used for the containers in the
retort at the time of stopping and cooling shall be entered on the
production records.
(9) Temperature drop. If the temperature of the continuous retort
drops below the temperature specified in the scheduled process while
containers are
[[Page 236]]
in the retort, the retort reel shall be stopped promptly. An automatic
device should be used to stop the reel when the temperature drops below
the specified process temperature. Before the reel is restarted, all
containers in the retort shall be given a complete scheduled still
retort process if the temperature drop was 10 deg.F or more below the
specified temperature, or alternatively, container entry to the retort
shall be stopped and the reel restarted to empty the retort. The
discharged containers shall be either reprocessed, repacked and
reprocessed, or discarded. Both the time at which the reel stopped and
the time the retort was used for a still retort process, if so used,
shall be marked on the recording chart and entered on the other
production records required in this chapter. If the alternative
procedure of emptying the retort is followed, the subsequent handing
methods used for the containers in the retort at the time of the
temperature drop shall be entered on the production records. If the
temperature drop was less than 10 deg.F, a scheduled authorized
emergency still process approved by a qualified person(s) having expert
knowledge of thermal processing requirements may be used before
restarting the retort reel. Alternatively, container entry to the retort
shall be stopped and an authorized emergency agitating process may be
used before container entry to the retort is restarted. When emergency
procedures are used, no containers may enter the retort and the process
and procedures used shall be noted on the production records.
(10) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process. The minimum headspace of
containers, if specified in the scheduled process, shall be measured and
recorded at intervals of sufficient frequency to ensure that the
headspace is as specified in the scheduled process. The headspace of
solder-tipped, lapseam (vent hole) cans may be measured by net weight
determinations. The headspace of double seamed cans may also be measured
by net weight determinations for homogenous liquids, taking into account
the specific can end profile and other factors which affect the
headspace, if proof of the accuracy of such measurements is maintained
and the procedure and resultant headspace is in accordance with the
scheduled process. When the product consistency is specified in the
scheduled process, the consistency of the product shall be determined by
objective measurements on the product taken from the filler before
processing and recorded at intervals of sufficient frequency to ensure
that the consistency is as specified in the scheduled process. Minimum
closing machine vacuum in vacuum-packed products, maximum fill-in or
drained weight, minimum net weight, and percent solids shall be as
specified in the scheduled process for all products when deviations from
such specifications may affect the scheduled process. All measurements
and recordings of critical factors should be made at intervals not to
exceed 15 minutes.
(d) Equipment and procedures for pressure processing in steam in
discontinuous agitating retorts--(1) Indicating mercury-in-glass
thermometer. Each retort shall be equipped with at least one mercury-in-
glass thermometer whose divisions are easily readable to 1 deg.F and
whose temperature range does not exceed 17 deg.F per inch of graduated
scale. Thermometers shall be tested for accuracy against a known
accurate standard thermometer upon installation and at least once a year
thereafter, or more frequently if necessary, to ensure their accuracy.
Records of thermometer accuracy checks which specify date, standard
used, method used, and person performing the test should be maintained.
Each thermometer should have a tag, seal, or other means of identity
that includes the date on which it was last tested for accuracy. A
thermometer that has a divided mercury column or that cannot be adjusted
to the standard shall be repaired or replaced before further use of the
retort. Thermometers shall be installed where they can be accurately and
easily read. Bulbs of indicating thermometers shall be installed either
within the retort shell or in external wells attached to the retort.
External wells or pipes shall be connected to the retort through at
[[Page 237]]
least a \3/4\-inch-diameter opening, and equipped with a \1/16\-inch or
larger bleeder opening so located as to provide a full flow of steam
past the length of the thermometer bulb. The bleeder for external wells
shall emit steam continuously during the entire processing period. The
mercury thermometer--not the recorder chart--shall be the reference
instrument for indicating the processing temperature.
(2) Temperature-recording device. Each retort shall have an accurate
temperature-recording device. Graduations on the temperature-recording
devices shall not exceed 2 deg.F within a range of 10 deg.F of the
processing temperature. Each chart shall have a working scale of not
more than 55 deg.F per inch within a range of 20 deg.F of the
processing temperature. The temperature chart shall be adjusted to agree
as nearly as possible with, but to be in no event higher than, the known
accurate mercury-in-glass thermometer during the process time. A means
of preventing unauthorized changes in adjustment shall be provided. A
lock, or a notice from management posted at or near the recording device
that provides a warning that only authorized persons are permitted to
make adjustments, is a satisfactory means for preventing unauthorized
changes. The recorder may be combined with the steam controller and may
be a recording-controlling instrument. The temperature-recorder bulb
shall be installed either within the retort shell or in a well attached
to the shell. Each temperature-recorder bulb well shall have a \1/16\-
inch or larger bleeder opening emitting steam continuously during the
processing period. Air-operated temperature controllers should have
adequate filter systems to ensure a supply of clean, dry air.
(3) Pressure gages. Each retort should be equipped with a pressure
gage, which should be graduated in divisions of 2 pounds or less.
(4) Steam controller. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. This may
be a recording-controlling instrument when combined with a recording
thermometer. A steam controller activated by the steam pressure of the
retort is acceptable if it is mechanically maintained so that it
operates satisfactorily.
(5) Bleeders. Bleeders, except those for thermometer wells, shall be
one-eighth inch or larger and shall be wide open during the entire
process, including the come-up-time. Bleeders shall be located within
approximately 1 foot of the outermost location of containers, at each
end along the top of the retort; additional bleeders shall be located
not more than 8 feet apart along the top. Bleeders may be installed at
positions other than those specified above, as long as there is evidence
in the form of heat distribution data that they accomplish adequate
removal of air and circulation of heat within the retort. In retorts
having top steam inlet and bottom venting, a bleeder shall be installed
in the bottom of the retort to remove condensate. All bleeders shall be
arranged in a way that enables the operator to observe that they are
functioning properly.
(6) Venting and condensate removal. The air in each retort shall be
removed before processing is started. Heat distribution data or
documentary proof from the manufacturer or from a competent processing
authority, demonstrating that adequate venting is achieved, shall be
kept on file. At the time steam is turned on, the drain should be opened
for a time sufficient to remove steam condensate from the retort and
provision should be made for containing drainage of condensate during
the retort operation.
(7) Retort speed timing. The rotational speed of the retort shall be
specified in the schedules process. The speed shall be adjusted, as
necessary, to ensure that the speed is as specified in the scheduled
process. The rotational speed as well as the process time shall be
recorded for each retort load processed. Alternatively, a recording
tachometer may be used to provide a continuous record of the speed. A
means of preventing unauthorized speed changes on retorts shall be
provided. A lock, or a notice from management posted at or near the
speed-adjustment device that provides a warning that only authorized
persons are permitted to make adjustments, is a satisfactory means of
preventing unauthorized changes.
[[Page 238]]
(8) Critical factors. Critical factors specified in the schedules
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process. The minimum headspace of
containers in each retort load to be processed, if specified in the
scheduled process, shall be measured and recorded at intervals of
sufficient frequency to ensure that the headspace is as specified in the
scheduled process. The headspace of solder-tipped, lap seam (vent hole)
cans may be measured by net weight determinations. When the product
consistency is specified in the scheduled process, the consistency of
the product shall be determined by objective measurements on the product
taken from the filler before processing and recorded at intervals of
sufficient frequency to ensure that the consistency is as specified in
the scheduled process. Minimum closing machine vacuum in vacuum-packed
products, maximum fill-in or drained weight, minimum net weight, and
percent solids shall be as specified in the scheduled process for all
products for which deviations from such specifications may affect the
scheduled process. All measurements and recordings of critical factors
should be made at intervals not to exceed 15 minutes.
(e) Equipment and procedures for pressure processing in water in
discontinuous agitating retorts--(1) Indicating mercury-in-glass
thermometer. Each retort shall be equipped with at least one mercury-in-
glass thermometer whose divisions are easily readable to 1 deg.F and
whose temperature range does not exceed 17 deg.F per inch of graduated
scale. Thermometers shall be tested for accuracy against a known
accurate standard thermometer upon installation and at least once a year
thereafter, or more frequently if necessary, to ensure their accuracy.
Records of thermometer accuracy checks which specify date, standard use,
method used, and person performing the test should be maintained. Each
thermometer should have a tag, seal, or other means of identity that
includes the date on which it was last tested for accuracy. A
thermometer that has a divided mercury column or that cannot be adjusted
to the standard shall be repaired or replaced before further use of the
retort. Thermometers shall be installed where they can be accurately and
easily read. Bulbs of indicating thermometers shall be installed either
within the retort shell or in external wells attached to the retort. The
mercury thermometer--not the recorder chart--shall be the reference
instrument for indicating the processing temperature.
(2) Temperature-recording device. Each retort shall have an accurate
temperature-recording device. Graduations on the temperature-recording
devices shall not exceed 2 deg.F within a range of 10 deg.F of the
processing temperature. Each chart shall have a working scale of not
more than 55 deg.F per inch within a range of 20 deg.F of the
processing temperature. The temperature chart shall be adjusted to agree
as nearly as possible with, but to be in no event higher than, the known
accurate mercury-in-glass thermometer during the process time. A means
of preventing unauthorized changes in adjustment shall be provided. A
lock, or a notice from management posted at or near the recording device
that provides a warning that only authorized persons are permitted to
make adjustment, is a satisfactory means for preventing unauthorized
changes. This recorder may be combined with the steam controller and may
be a recording-controlling instrument. The temperature-recorder bulb
shall be installed either within the retort shell or in a well attached
to the shell. Air-operated temperature controllers should have adequate
filter systems to ensure a supply of clean dry air.
(3) Pressure gages. Each retort should be equipped with a pressure
gage which should be graduated in divisions of 2 pounds or less.
(4) Steam controller. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. This may
be a recording-controlling instrument when combined with a recording
thermometer.
(5) Retort speed timing. The rotational speed of the retort shall be
specified in the scheduled process. The speed shall be adjusted, as
necessary, to ensure that the speed is as specified in the scheduled
process. The rotational speed
[[Page 239]]
as well as the process time shall be recorded for each retort load
processed. Alternatively, a recording tachometer may be used to provide
a continuous record of the speed. A means of preventing unauthorized
speed changes shall be provided. A lock, or a notice from management
posted at or near the speed adjustment device that provides a warning
that only authorized persons are permitted to make adjustment, is a
satisfactory means of preventing unauthorized changes.
(6) Air supply and controls. Means shall be provided for introducing
compressed air at the proper pressure and rate, which shall be
controlled by an automatic pressure control unit. A check valve shall be
provided in the air supply line to prevent water from entering the
system.
(7) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process. The minimum headspace of
containers, if specified in the scheduled process, shall be measured and
recorded at intervals of sufficient frequency to ensure that the
headspace is as specified in the scheduled process. The headspace of
solder-tipped, lap seam (vent hole) cans may be measured by net weight
determinations. When the product consistency is specified in the
scheduled process, the consistency of the product shall be determined by
objective measurements on the product taken from the filler before
processing and recorded at intervals of sufficient frequency to ensure
that the consistency is as specified in the scheduled process. Minimum
closing machine vaccum in vacuum-packed products, maximum fill-in or
drained weight, minimum net weight, and percent solids shall be as
specified in the scheduled process for all products when deviations from
such specifications may affect the scheduled process. All measurements
and recordings of critical factors should be made at intervals not to
exceed 15 minutes.
(f) Equipment and procedures for pressure processing in steam in
hydrostatic retorts--(1) Indicating mercury-in-glass thermometer. Each
retort shall be equipped with at least one mercury-in-glass thermometer
whose divisions are easily readable to 1 deg.F and whose temperature
range does not exceed 17 deg.F per inch of graduated scale. Thermometer
shall be tested for accuracy against a known accurate standard
thermometer upon installation and at least once a year thereafter, or
more frequently if necessary, to ensure their accuracy. Records of
thermometer accuracy checks which specify date, standard used, method
used, and person performing the test should be maintained. Each
thermometer should have a tag, seal, or other means of identity that
includes the date on which it was last tested for accuracy. A
thermometer that has a divided mercury column or that cannot be adjusted
to the standard shall be repaired or replaced before further use of the
retort. Thermometers shall be installed where they can be accurately and
easily read. The thermometer shall be located in the steam dome near the
steam-water interface. When the scheduled process specifies maintenance
of particular temperatures in the hydrostatic water legs, a mercury-in-
glass thermometer shall be located in each hydrostatic water leg in a
position near the bottom automatic recorder. The mercury thermometer--
not the recorder chart--shall be the references instrument for
indicating the processing temperature.
(2) Temperature-recording device. Each retort shall have an accurate
temperature-recording device. Graduations on the temperature-recording
devices shall not exceed 2 deg.F within a range of 10 deg.F of the
processing temperature. Each chart shall have a working scale of not
more than 55 deg.F per inch within a range of 20 deg.F of the
processing temperature. The temperature chart shall be adjusted to agree
as nearly as possible with, but to be in no event higher than, the known
accurate mercury-in-glass thermometer during the process time. A means
of preventing unauthorized changes in adjustment shall be provided. A
lock, or a notice from management posted at or near the recording device
that provides a warning that only authorized persons are permitted to
make adjustments, is a satisfactory means for preventing unauthorized
[[Page 240]]
changes. The recorder may be combined with the steam controller and may
be a recording-controlling instrument. The temperature-recorder bulb
shall be installed either within the steam dome or in a well attached to
the dome. Each temperature-recorder bulb well shall have a \1/16\-inch
or larger bleeder opening which emits steam continuously during the
processing period. Additional temperature-recorder bulbs shall be
installed in the hydrostatic water legs if the scheduled process
specified maintenance of particular temperatures in the hydrostatic
water legs. Air-operated temperature controllers should have adequate
filter systems to ensure a supply of clean dry air.
(3) Pressure gages. Each retort should be equipped with a pressure
gage which should be graduated in divisions of 2 pounds or less.
(4) Recording of temperatures. Temperatures indicated by the
mercury-in-glass thermometer or thermometers shall be entered on a
suitable form during processing operations. Temperatures shall be
recorded by an accurate automatic recorder or recorders at the following
points:
(i) In the steam chamber between the steam-water interface and the
lowest container position.
(ii) Near the top and the bottom of each hydrostatic water leg if
the scheduled process specifies maintenance of particular temperatures
in the legs.
(5) Steam controller. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. This may
be a recording-controlling instrument when combined with a recording
thermometer. A steam controller activated by the steam pressure of the
retort is acceptable if it is carefully mechanically maintained so that
it operates satisfactorily.
(6) Venting. Before the start of processing operations, the retort
steam chamber or chambers shall be vented to ensure removal of air.
(7) Bleeders. Bleeder openings \1/4\-inch or larger shall be located
at the top of the steam chamber or chambers opposite the point of steam
entry. Bleeders shall be wide open and shall emit steam continuously
during the entire process, including the come-up-time. All bleeders
shall be arranged in such a way that the operator can observe that they
are functioning properly.
(8) Retort speed. The speed of the container-conveyor chain shall be
specified in the scheduled process and shall be determined and recorded
at the start of processing and at intervals of sufficient frequency to
ensure that the retort speed is maintained as specified. The speed
should be determined and recorded every 4 hours. An automatic device
should be used to stop the chain when the temperature drops below that
specified in the scheduled process. A means of preventing unauthorized
speed changes shall be provided. A lock, or a notice from management
posted at or near the speed-adjusting device that provides a warning
that only authorized persons are permitted to make adjustments, is a
satisfactory means of preventing unauthorized changes.
(9) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process.
(i) When maximum fill-in or drained weight is specified in the
scheduled process, it shall be measured and recorded at intervals of
sufficient frequency to ensure that the weight of the product does not
exceed the maximum for the given container size specified in the
scheduled process.
(ii) Closing machine vacuum in vacuum-packed products shall be
observed and recorded at intervals of sufficient frequency to ensure
that the vacuum is as specified in the scheduled process.
(iii) Such measurements and recordings should be made at intervals
not to exceed 15 minutes.
(g) Aseptic processing and packaging systems--(1) Product
sterilizer--(i) Equipment--(a) Temperature-indicating device. Each
product sterilizer shall be equipped with at least one mercury-in-glass
thermometer or an equivalent temperature-indicating device, such as a
thermocouple-recorder. Mercury-in-glass thermometers shall have
divisions that are easily readable to 1 deg.F and whose temperature
range does not
[[Page 241]]
exceed 17 deg.F per inch of graduated scale. Thermometers and
temperature-indicating devices shall be tested for accuracy against a
known accurate standard thermometer upon installation and at least once
a year thereafter, or more frequently if necessary, to ensure their
accuracy. Records of accuracy checks which specify date, standard used,
method used, and person performing the test should be maintained. Each
thermometer and temperature-indicating device should have a tag, seal,
or other means of identity that includes the date on which it was last
tested for accuracy. A thermometer that has a divided mercury column or
that cannot be adjusted to essential agreement with the standard shall
be repaired or replaced. Thermometers and temperature-indicating devices
shall be installed where they can be accurately and easily read. The
temperature-indicating device shall be the reference instrument for
indicating the processing temperature.
(b) Temperature-recording device. There shall be an accurate
temperature recording device on each product sterilizer. The device
shall be installed in the product at the holding-tube outlet between the
holding tube and the inlet to the cooler. Temperature-recording devices
shall have graduations that do not exceed 2 deg.F within a range of 10
deg.F of the processing temperature. Each chart shall have a working
scale of not more than 55 deg.F per inch within a range of 20 deg.F of
the desired product-sterilization temperature. The temperature chart
shall be adjusted to agree as nearly as possible with, but to be in no
event higher than, a known accurate mercury-in-glass thermometer. A
means of preventing unauthorized changes in adjustment shall be
provided. A lock; or a notice from management posted at or near the
recording device that provides a warning that only authorized persons
are permitted to make adjustments, is a satisfactory means for
preventing unauthorized changes.
(c) Temperature recorder-controller. An accurate temperature
recorder-controller shall be located in the product sterilizer at the
final heater outlet. It shall be capable of ensuring that the desired
product sterilization temperature is maintained. The chart graduations
shall not exceed 2 deg.F within a range of 10 deg.F of the desired
product sterilization temperature. Air-operated temperature controllers
should have adequate filter systems to ensure a supply of clean, dry
air.
(d) Product-to-product regenerators. When a product-to-product
regenerator is used to heat the cold unsterilized product entering the
sterilizer by means of a heat exchange system, it shall be designed,
operated, and controlled so that the pressure of the sterilized product
in the regenerator is greater than the pressure of any unsterilized
product in the regenerator to ensure that any leakage in the regenerator
is from the sterilized product into the unsterilized product.
(e) Differential pressure recorder-controller. When a product-to-
product regenerator is used, there shall be an accurate differential
pressure recorder-controller installed on the regenerator. The scale
divisions shall not exceed 2 pounds per square inch on the working scale
of not more than 20 pounds per square inch per inch. The controller
shall be tested for accuracy against a known accurate standard pressure
indicator upon installation and at least once every 3 months of
operation thereafter, or more frequently if necessary, to ensure its
accuracy. One pressure sensor shall be installed at the sterilized
product regenerator outlet and the other pressure sensor shall be
installed at the unsterilized product regenerator inlet.
(f) Metering pump. A metering pump shall be located upstream from
the holding tube and shall be operated to maintain the required rate of
product flow. A means of preventing unauthorized speed changes shall be
provided. A lock, or a notice from management posted at or near the
speed-adjusting device that provides a warning that only authorized
persons are permitted to make adjustments, is a satisfactory means of
preventing unauthorized changes.
(g) Product holding tube. The product-sterilizing holding tube shall
be designed to give continous holding of every particle of food for at
least the minimum holding time specified in the scheduled process. The
holding tube
[[Page 242]]
shall be designed so that no portion of the tube between the product
inlet and the product outlet can be heated, and it must be sloped upward
at least 0.25 inch per foot.
(h) Flow-diversion systems. If a processor elects to install a flow-
diversion system, it should be installed in the product piping located
between the product cooler and the product filler or aseptic surge tank
and should be designed to divert flow away from the filler or aseptic
surge tank automatically. Controls and/or warning systems should be
designed and installed with necessary sensors and actuators to operate
whenever the sterilizing temperature in the holding tube or pressure
differential in the product regenerator drops below specified limits.
Flow-diversion systems should be designed and operated in accordance
with recommendations of an aseptic processing and packaging authority.
(i) Equipment downstream from the holding tube. Product coolers,
aseptic surge tanks, or any other equipment downstream from the holding
tube, with rotating or reciprocating shafts, valve stems, instrument
connections, or other such points, are subject to potential entry of
microorganisms into the product. Such locations in the system should be
equipped with steam seals or other effective barriers at the potential
access points. Appropriate means should be provided to permit the
operator to monitor the performance of the seals or barriers during
operations.
(ii) Operation--(a) Startup. Before the start of aseptic processing
operations the product sterilizer and all product-contact surfaces
downstream shall be brought to a condition of commercial sterility.
(b) Temperature drop in product-sterilizing holding tube. When
product temperature in the holding tube drops below the temperature
specified in the scheduled process, product flow should be diverted away
from the filler or aseptic surge tank by means of a flow-diversion
system. If for any reason product subjected to a temperature drop below
the scheduled process is filled into containers, the product shall be
segregated from product that received the scheduled process. The
processing deviation shall be handled in accordance with Sec. 113.89.
The product holding tube and any further system portions affected shall
be returned to a condition of commercial sterility before product flow
is resumed to the filler or to the aseptic surge tank.
(c) Loss of proper pressures in the regenerator. When a regenerator
is used, the product may lose sterility whenever the pressure of
sterilized product in the regenerator is less than 1 pound per square
inch greater than the pressure of unsterilized product in the
regenerator. In this case, product flow should be diverted away from the
filler or aseptic surge tank by means of the flow-diversion system. If
for any reason the product is filled into containers, the product shall
be segregated from product that received the scheduled process and shall
be reprocessed or destroyed. Product flow to the filler or to the
aseptic surge tank shall not be resumed until the cause of the improper
pressure relationships in the regenerator has been corrected and the
affected system(s) has been returned to a condition of commercial
sterility.
(d) Loss of sterile air pressure or other protection level in the
aseptic surge tank. When an aseptic surge tank is used, conditions of
commercial sterility may be lost when the sterile air overpressure or
other means of protection drops below the scheduled process value.
Product flow to and/or from the aseptic surge tank shall not be resumed
until the potentially contaminated product in the tank is removed, and
the aseptic surge tank has been returned to a condition of commercial
sterility.
(e) Records. Readings at the following points shall be observed and
recorded at the start of aseptic packaging operations and at intervals
of sufficient frequency to ensure that these values are as specified in
the scheduled process: Temperature-indicating device in holding tube
outlet; temperature recorder in holding tube outlet; temperature
recorder-controller at final heater outlet; differential pressure
recorder-controller, if a product-to-product regenerator is used;
product flow rate as established by the metering pump or as determined
by filling and closing rates and, if an aseptic surge tank is used,
sterile air pressure or other protection
[[Page 243]]
means; and proper performance of seam seals or other similar devices.
The measurements and recordings should be made at intervals not to
exceed 1 hour.
(2) Container sterilizing, filling, and closing operation--(i)
Equipment--(a) Recording device. The container and closure sterilization
system and product filling and closing system shall be instrumented to
demonstrate that the required sterilization is being accomplished
continuously. Automatic recording devices shall be used to record, when
applicable, the sterilization media flow rates, temperature,
concentration, or other factors. When a batch system is used for
container sterilization, the sterilization conditions shall be recorded.
(b) Timing method(s). A method(s) shall be used either to give the
retention time of containers, and closures if applicable, in the
sterilizing environment specified in the scheduled process, or to
control the sterilization cycle at the rate specified in the scheduled
process. A means of preventing unauthorized speed changes must be
provided. A lock, or a notice from management posted at or near the
speed adjusting device that provides a warning that only authorized
persons are permitted to make adjustments, is a satisfactory means of
preventing unauthorized changes.
(ii) Operation--(a) Startup. Before the start of packaging
operations, both the container and closure sterilizing system and the
product filling 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
[[Page 244]]
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]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.60]
[Page 244-247]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 113--THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS--Table of Contents
Subpart D--Control of Components, Food Product Containers, Closures, and
In-Process Materials
Sec. 113.60 Containers.
(a) Closures. Regular observations shall be maintained during
production runs for gross closure defects. Any such defects shall be
recorded and corrective action taken and recorded. At intervals of
sufficient frequency to ensure proper closure, the operator, closure
supervisor, or other qualified container closure inspection person shall
visually examine either the top seam of a can randomly selected from
each seaming head or the closure of any other type of container being
used and shall record the observations made. For double-seam cans, each
can should be examined for cutover or sharpness, skidding or
deadheading, false seam, droop at the crossover or lap, and condition of
inside of countersink wall for evidence of broken chuck. Such
measurements and recordings should be made at intervals not to exceed 30
minutes. Additional visual closure inspections shall be made immediately
following a jam in a closing machine, after closing machine adjustment,
or after startup of a machine following a prolonged shutdown. All
pertinent observations shall be recorded. When irregularities are found,
the corrective action shall be recorded.
(1) Teardown examinations for double-seam cans shall be performed by
a qualified individual and the results therefrom shall be recorded at
intervals of sufficient frequency on enough containers from each seaming
station to ensure maintenance of seam integrity. Such examinations and
recordings should be made at intervals not to exceed 4 hours. The
results of the teardown examinations shall be recorded and the
corrective action taken, if any, shall be noted.
(i) Required and optional can seam measurements:
(a) Micrometer measurement system:
[[Page 245]]
------------------------------------------------------------------------
Required Optional
------------------------------------------------------------------------
Cover hook Overlap (by calculation).
Body hook Countersink.
Width (length, height) ......................................
Tightness (observation for ......................................
wrinkle)
Thickness ......................................
------------------------------------------------------------------------
(b) Seam scope or projector:
------------------------------------------------------------------------
Required Optional
------------------------------------------------------------------------
Body hook Width (length, height).
Overlap Cover hook.
Tightness (observation for Countersink.
wrinkle)
Thickness by micrometer .....................................
------------------------------------------------------------------------
(c) Can double seam terminology:
[[Page 246]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.376
(1) "Crossover": The portion of a double seam at the lap.
(2) "Cutover": A fracture, sharp bend, or break in the metal at
the top of the inside portion of the double seam.
[[Page 247]]
(3) "Deadhead": A seam which is incomplete due to chuck spinning
in the countersink.
(4) "Droop": Smooth projection of double seam below bottom of
normal seam.
(5) "False seam": A small seam breakdown where the cover hook and
the body hook are not overlapped.
(6) "Lap": Two thicknesses of material bonded together.
(ii) Two measurements at different locations, excluding the side
seam, shall be made for each double seam characteristic if a seam scope
or seam projector is used. When a micrometer is used, three measurements
shall be made at points approximately 120 deg. apart, excluding the side
seam.
(iii) Overlap length can be calculated by the following formula:
The theoretical overlap length=CH+BH+T-W, where
CH=cover hook
BH=body hook
T=cover thickness, and
W=seam width (height, length)
(2) For glass containers with vacuum closures, capper efficiency
must be checked by a measurement of the cold water vacuum. This shall be
done before actual filling operations, and the results shall be
recorded.
(3) For closures other than double seams and glass containers,
appropriate detailed inspections and tests shall be conducted by
qualified personnel at intervals of sufficient frequency to ensure
proper closing machine performance and consistently reliable hermetic
seal production. Records of such tests shall be maintained.
(b) Cooling water. Container cooling water shall be chlorinated or
otherwise sanitized as necessary for cooling canals and for recirculated
water supplies. There should be a measurable residual of the sanitizer
employed at the water discharge point of the container cooler.
(c) Coding. Each hermetically sealed container of low-acid processed
food shall be marked with an identifying code that shall be permanently
visible to the naked eye. When the container does not permit the code to
be embossed or inked, the label may be legibly perforated or otherwise
marked, if the label is securely affixed to the product container. The
required identification shall identify in code the establishment where
packed, the product contained therein, the year packed, the day packed,
and the period during which packed. The packing period code shall be
changed with sufficient frequency to enable ready identification of lots
during their sale and distribution. Codes may be changed on the basis of
one of the following: intervals of 4 to 5 hours; personnel shift
changes; or batches, as long as the containers that constitute the batch
do not extend over a period of more than one personnel shift.
(d) Postprocess handling. When cans are handled on belt conveyors,
the conveyors should be so constructed as to minimize contact by the
belt with the double seam, i.e., cans should not be rolled on the double
seam. All worn and frayed belting, can retarders, cushions, etc. should
be replaced with new nonporous material. All tracks and belts that come
into contact with the can seams should be thoroughly scrubbed and
sanitized at intervals of sufficient frequency to avoid product
contamination. Automatic equipment used in handling filled containers
should be so designed and operated as to preserve the can seam or other
container closure integrity.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.81]
[Page 247-248]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 113--THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS--Table of Contents
Subpart E--Production and Process Controls
Sec. 113.81 Product preparation.
(a) Before using raw materials and ingredients susceptible to
microbiological contamination, the processor shall ensure that those
materials and ingredients are suitable for use in processing low-acid
food. Compliance with this requirement may be accomplished by receiving
the raw materials and ingredients under a supplier's guarantee that they
are suitable for use, by examining them for their microbiological
condition, or by other acceptable means.
(b) Blanching by heat, when required in the preparation of food for
canning, should be effected by heating the food to the required
temperature, holding it at this temperature for the required
[[Page 248]]
time, and then either rapidly cooling the food or passing it to
subsequent processing without delay. Thermophilic growth and
contamination in blanchers should be minimized by the use of adequate
operating temperatures and by cleaning. If the blanched food product is
washed before filling, potable water should be used.
(c) The filling of containers, either mechanically or by hand, shall
be controlled so as to ensure that the filling requirements specified in
the scheduled process are met.
(d) The exhausting of containers for the removal of air shall be
controlled so as to meet the conditions for which the process was
designed. Compliance with the requirement may be accomplished by heat
exhausting, mechanical exhausting, hot brining, or steam injection.
(e) When the maintenance of pH (above 4.6) of a normally low-acid
food is a basis for a scheduled process, there shall be careful
supervision to ensure that the equilibrium pH of the finished product
meets that of the scheduled process. The methodology described in
Sec. 114.90 of this chapter should be used.
(f) When the scheduled process sets forth critical factors to
prevent the growth of microorganisms not destroyed by the thermal
process, the factors shall be carefully controlled to ensure that the
limits established in the scheduled process are not exceeded. When
normally low-acid foods require sufficient solute to permit safe
processing at low temperatures, such as in boiling water, there shall be
careful supervision to ensure that the equilibrium water activity
(aw) of the finished product meets that of the scheduled
process. The scheduled thermal processes for foods having an
aw greater than 0.85 and less than the aw that
would allow the growth of spores of microorganisms of public health
significance shall be sufficient to render the food free of
microorganisms capable of reproducing in the food under normal
nonrefrigerated conditions of storage and distribution.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.83]
[Page 248]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 113--THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS--Table of Contents
Subpart E--Production and Process Controls
Sec. 113.83 Establishing scheduled processes.
Scheduled processes for low-acid foods shall be established by
qualified persons having expert knowledge of thermal processing
requirements for low-acid foods in hermetically sealed containers and
having adequate facilities for making such determinations. The type,
range, and combination of variations encountered in commercial
production shall be adequately provided for in establishing the
scheduled process. Critical factors, e.g., minimum headspace,
consistency, maximum fill-in or drained weight, aw, etc.,
that may affect the scheduled process, shall be specified in the
scheduled process. Acceptable scientific methods of establishing heat
sterilization processes shall include, when necessary, but shall not be
limited to, microbial thermal death time data, process calculations
based on product heat penetration data, and inoculated packs.
Calculation shall be performed according to procedures recognized by
competent processing authorities. If incubation tests are necessary for
process confirmation, they shall include containers from test trials and
from actual commercial production runs during the period of instituting
the process. The incubation tests for confirmation of the scheduled
processes should include the containers from the test trials and a
number of containers from each of four or more actual commercial
production runs. The number of containers from actual commercial
production runs should be determined on the basis of recognized
scientific methods to be of a size sufficient to ensure the adequacy of
the process. Complete records covering all aspects of the establishment
of the process and associated incubation tests shall be prepared and
shall be permanently retained by the person or organization making the
determination.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.87]
[Page 248-249]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 113--THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS--Table of Contents
Subpart E--Production and Process Controls
Sec. 113.87 Operations in the thermal processing room.
(a) Operating processes and retort venting procedures to be used for
each product and container size being packed shall either be posted in a
conspicuous place near the processing equipment or be made readily
available to the retort or processing system operator and any duly
authorized employee of the Food and Drug Administration. Scheduled
processes must be
[[Page 249]]
made readily available to the supervisor and any duly authorized
employee of the Food and Drug Administration.
(b) A system for product traffic control in the retort room shall be
established to prevent unretorted product from bypassing the retort
process. Each retort basket, truck, car, or crate used to hold
containers in a retort, or one or more containers therein, shall, if it
contains any retorted food product, be plainly and conspicuously marked
with a heat-sensitive indicator, or by other effective means that will
indicate visually, to thermal processing personnel, those units that
have been retorted. A visual check shall be performed to determine
whether or not the appropriate change has occurred in the heat-sensitive
indicator as a result of retorting for all retort baskets, trucks, cars,
or crates, to ensure that each unit of product has been retorted. A
written record of these checks should be made.
(c) The initial temperature of the contents of the containers to be
processed shall be determined and recorded with sufficient frequency to
ensure that the temperature of the product is no lower than the minimum
initial temperature specified in the scheduled process. For those
operations that use water during the filling of the retort or during
processing, provision shall be made to ensure that the water will not,
before the start of each thermal process, lower the initial temperature
of the product below that specified in the scheduled process.
(d) Timing devices used in recording thermal process time
information shall be accurate to the extent needed to ensure that the
processing time and venting time specified in the scheduled process are
achieved. Pocket or wrist watches are not considered satisfactory for
timing purposes. Digital clocks may be used if the operating process and
the venting schedule have a 1-minute or greater safety factor over the
scheduled process.
(e) Clock times on recording-temperature charts should reasonably
correspond to the time of day on the written processing records to
provide correlation of these records.
(f) The steam supply to the thermal processing system shall be
adequate to the extent needed to ensure that sufficient steam pressure
is maintained during thermal processing, regardless of other demands of
steam by the plant.
(g) If mufflers are used on bleeders or vent systems, evidence that
the bleeders or vents are operated in a manner that does not
significantly impede the removal of air shall be kept on file. This
evidence may be in the form of heat distribution data or other
satisfactory evidence such as a letter from the manufacturer, the
designer, or a competent processing authority.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.89]
[Page 249-250]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 113--THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS--Table of Contents
Subpart E--Production and Process Controls
Sec. 113.89 Deviations in processing, venting, or control of critical factors.
Whenever any process is less than the scheduled process or when
critical factors are out of control for any low-acid food or container
system as disclosed from records by processor check or otherwise, the
commerical processor of that low-acid food shall either fully reprocess
that portion of the production involved, keeping full records of the
reprocessing conditions or, alternatively, must set aside that portion
of the product involved for further evaluation as to any potential
public health significance. Such evaluation shall be made by a competent
processing authority and shall be in accordance with procedures
recognized by competent processing authorities as being adequate to
detect any potential hazard to public health. Unless this evaluation
demonstrates that the product had been given a thermal process that
rendered it free of microorganisms of potential public health
significance, the product set aside shall be either fully reprocessed to
render it commercially sterile or destroyed. A record shall be made of
the evaluation procedures used and the results. Either upon completion
of full reprocessing and the attainment of commerical sterility or after
the determination that no significant potential for public health hazard
exists, that portion of the product involved may be shipped in normal
distribution. Otherwise, the portion of the product involved shall be
destroyed. All process deviations involving a failure to satisfy the
minimum requirements of the
[[Page 250]]
scheduled process, including emergencies arising from a jam or breakdown
of a continuous agitating retort necessitating cooling the retort for
repairs, shall be recorded and made the subject of a separate file (or a
log identifying the appropriate data) detailing those deviations and the
actions taken.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.100]
[Page 250-251]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 113--THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS--Table of Contents
Subpart F--Records and Reports
Sec. 113.100 Processing and production records.
(a) Processing and production information shall be entered at the
time it is observed by the retort or processing system operator, or
other designated person, on forms that include the product, the code
number, the date, the retort or processing system number, the size of
container, the approximate number of containers per coding interval, the
initial temperature, the actual processing time, the mercury-in-glass
and recording thermometer readings, and other appropriate processing
data. Closing machine vacuum in vacuum-packed products, maximum fill-in
or drained weight, or other critical factors specified in the scheduled
process shall also be recorded. In addition, the following records shall
be maintained:
(1) Still retorts. Time steam on; time temperature up to processing
temperature; time steam off; venting time and temperature to which
vented.
(2) Agitating retorts. Functioning of condensate bleeder; retort
speed; and, when specified in the scheduled process, headspace,
consistency, maximum drained weight, minimum net weight, and percent
solids.
(3) Hydrostatic retorts. The temperature in the steam chamber
between the steam-water interface and the lowest container position;
speed of the container conveyor chain; and, when the scheduled process
specifies maintenance of particular temperatures in the hydrostatic
water legs, the temperatures near the top and the bottom of each
hydrostatic water leg.
(4) Aseptic processing and packaging systems. Product temperature in
the holding tube outlet as indicated by the temperature-indicating
device and the temperature recorder; product temperature in the final
heater outlet as indicated by the temperature recorder-controller;
differential pressure as indicated by the differential pressure
recorder-controller, if a product-to-product regenerator is used;
product flow rate, as determined by the metering pump or by filling and
closing rates; sterilization media flow rate or temperature or both;
retention time of containers, and closures when applicable, in the
sterilizing environment; and, when a batch system is used for container
and/or closure sterilization, sterilization cycle times and
temperatures.
(5) Flame sterilizers. Container conveyor speed; surface temperature
at the beginning and at the end of the holding period; nature of
container.
(6) Food preservation methods wherein critical factors such as water
activity are used in conjunction with thermal processing. Product
formulation and scheduled processes used, including the thermal process,
its associated critical factors, as well as other critical factors, and
results of aw determinations.
(7) Other systems. Critical factors specified in the formulation of
the product or in the scheduled process.
(b) Recording thermometer charts shall be identified by date, retort
number, and other data as necessary, so they can be correlated with the
written record of lots processed. Each entry on the processing and
production records shall be made by the retort or processing system
operator, or other designated person, at the time the specific retort or
processing system condition or operation occurs, and this retort or
processing system operator or other designated person shall sign or
initial each record form. Not later that 1 working day after the actual
process, and before shipment or release for distribution, a
representative of plant management who is qualified by suitable training
or experience shall review all processing and production records for
completeness and to ensure that the product received the scheduled
process. The records, including the recording thermometer chart(s),
shall be signed or initialed and dated by the reviewer.
(c) Written records of all container closure examinations shall
specify the
[[Page 251]]
product code, the date and time of container closure inspections, the
measurements obtained, and all corrective actions taken. Records shall
be signed or initialed by the container closure inspector and reviewed
by management with sufficient frequency to ensure that the containers
are hermetically sealed.
(d) Records shall be maintained to identify the initial distribution
of the finished product to facilitate, when necessary, the segregation
of specific food lots that may have become contaminated or otherwise
rendered unfit for their intended use.
(e) Copies of all records provided for in this part, except those
required under Sec. 113.83 establishing scheduled processes, shall be
retained at the processing plant for a period of not less than 1 year
from the date of manufacture, and at the processing plant or other
reasonably accessible location for an additional 2 years. If, during the
first year of the 3-year record-retention period, the processing plant
is closed for a prolonged period between seasonal packs, the records may
be transferred to some other reasonably accessible location at the end
of the seasonal pack.
