[Code of Federal Regulations] [Title 9, Volume 2] [Revised as of January 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 9CFR318.305] [Page 278-290] TITLE 9--ANIMALS AND ANIMAL PRODUCTS CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents Subpart G--Canning and Canned Products Sec. 318.305 Equipment and procedures for heat processing systems. (a) Instruments and controls common to different thermal processing systems--(1) Indicating temperature devices. Each retort shall be equipped with at least one indicating temperature device that measures the actual temperature within the retort. The indicating temperature device, not the temperature/time recording device, shall be used as the reference instrument for indicating the process temperature. (i) Mercury-in-glass thermometers. A mercury-in-glass thermometer shall have divisions that are readable to 1F deg.(or 0.5C deg.) and whose scale contains not more than 17F deg./inch (or 4.0C deg./cm) of graduated scale. Each mercury-in-glass thermometer shall be tested for accuracy against a known accurate standard upon installation and at least once a year to ensure its accuracy. Records that specify the date, standard used, test method, and the person or testing authority performing the test shall be [[Page 279]] maintained on file by the establishment and made available to Program employees. A mercury-in-glass thermometer that has a divided mercury column or that cannot be adjusted to the standard shall be repaired and tested for accuracy before further use, or replaced. (ii) Other devices. Temperature-indicating devices, such as resistance temperature detectors, used in lieu of mercury-in-glass thermometers, shall meet known, accurate standards for such devices when tested for accuracy. The records of such testing shall be available to FSIS program employees. (2) Temperature/time recording devices. Each thermal processing system shall be equipped with at least one temperature/time recording device to provide a permanent record of temperatures within the thermal processing system. This recording device may be combined with the steam controller and may be a recording/controlling instrument. When compared to the known accurate indicating temperature device, the recording accuracy shall be equal to or better than 1F deg.(or 0.5C deg.) at the process temperature. The temperature recording chart should be adjusted to agree with, but shall never be higher than, the known accurate indicating temperature device. A means of preventing unauthorized changes in the adjustment shall be provided. For example, a lock or a notice from management posted at or near the recording device warning that only authorized persons are permitted to make adjustments, are satisfactory means for preventing unauthorized changes. Air-operated temperature controllers shall have adequate filter systems to ensure a supply of clean, dry air. The recorder timing mechanism shall be accurate. (i) Chart-type devices. Devices using charts shall be used only with the correct chart. Each chart shall have a working scale of not more than 55F deg./inch (or 12C deg./cm) within a range of 20F deg.(or 11C deg.) of the process temperature. Chart graduations shall not exceed 2F degrees (or 1C degree) within a range of 10F degrees (or 5C degrees) of the process temperature. Multipoint plotting chart-type devices shall print temperature readings at intervals that will assure that the parameters of the process time and process temperature have been met. The frequency of recording should not exceed 1-minute intervals. (ii) Other devices. Temperature/time recording devices or procedures used in lieu of chart-type devices must meet known accurate standards for such devices or procedures when tested for accuracy. Such a device must be accurate enough for ensuring that process time and temperature parameters have been met. (3) Steam controllers. 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 temperature/ time recording device. (4) Air valves. All air lines connected to retorts designed for pressure processing in steam shall be equipped with a globe valve or other equivalent-type valve or piping arrangement that will prevent leakage of air into the retort during the process cycle. (5) Water valves. All retort water lines that are intended to be closed during a process cycle shall be equipped with a globe valve or other equivalent-type valve or piping arrangement that will prevent leakage of water into the retort during the process cycle. (b) Pressure processing in steam--(1) Batch still retorts. (i) The basic requirements and recommendations for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, bulb sheaths or probes of indicating temperature devices and probes of temperature/ time recording devices shall be installed either within the retort shell or in external wells attached to the retort. External wells shall be connected to the retort through at least a \3/4\ inch (1.9 cm) diameter opening and equipped with a \1/16\ inch (1.6 mm) or larger bleeder opening so located as to provide a constant flow of steam past the length of the bulb or probe. The bleeder for external wells shall emit steam continuously during the entire thermal processing period. (ii) Steam controllers are required as described under paragraph (a)(3) of this section. [[Page 280]] (iii) Steam inlet. The steam inlet to each retort shall be large enough to provide steam for proper operation of the retort, and shall enter at a point to facilitate air removal during venting. (iv) Crate supports. Vertical still retorts with bottom steam entry shall employ bottom retort crate supports. Baffle plates shall not be used in the bottom of retorts. (v) Steam spreader. Perforated steam spreaders, if used, shall be maintained to ensure they are not blocked or otherwise inoperative. Horizontal still retorts shall be equipped with perforated steam spreaders that extend the full length of the retort unless the adequacy of another arrangement is documented by heat distribution data or other documentation from a processing authority. Such information shall be maintained on file by the establishment and made available to Program employees for review. (vi) Bleeders and condensate removal. Bleeders, except those for external wells of temperature devices, shall have \1/8\ inch (or 3 mm) or larger openings 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 (or 30 cm) 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 (2.4 m) apart along the top. Bleeders may be installed at positions other than those specified above, as long as the establishment has heat distribution data or other documentation from the manufacturer or from a processing authority demonstrating that the bleeders accomplish removal of air and circulate the steam within the retort. This information shall be maintained on file by the establishment and made available to Program employees for review. All bleeders shall be arranged in a way that enables the retort operator to observe that they are functioning properly. Vertical retorts shall have at least one bleeder opening located in the portion of the retort opposite the steam inlet. All bleeders shall be arranged so that the retort operator can observe that they are functioning properly. In retorts having a steam inlet above the level of the lowest container, a bleeder shall be installed in the bottom of the retort to remove condensate. The condensate bleeder shall be so arranged that the retort operator can observe that it is functioning properly. The condensate bleeder shall be checked with sufficient frequency to ensure adequate removal of condensate. Visual checks should be performed at intervals of not more than 15 minutes and the results recorded. Intermittent condensate removal systems shall be equipped with an automatic alarm system that will serve as a continuous monitor of condensate bleeder functioning. The automatic alarm system shall be tested at the beginning of each shift for proper functioning and the results recorded. If the alarm system is not functioning properly, it must be repaired before the retort is used. (vii) Stacking equipment--(a) Equipment for holding or stacking containers in retorts. Crates, trays, gondolas, carts, and other vehicles for holding or stacking product containers in the retort shall be so constructed to ensure steam circulation during the venting, come- up, and process times. The bottom of each vehicle shall have perforations at least 1 inch (2.5 cm) in diameter on 2 inch (or 5 cm) centers or the equivalent unless the adequacy of another arrangement is documented by heat distribution data or other documentation from a processing authority and such information is maintained on file by the establishment and made available to Program employees for review. (b) Divider plates. Whenever one or more divider plates are used between any two layers of containers or placed on the bottom of a retort vehicle, the establishment shall have on file documentation that the venting procedure allows the air to be removed from the retort before timing of the thermal process is started. Such documentation shall be in the form of heat distribution data or documentation from a processing authority. This information shall be made available to Program employees for review. (viii) Bleeder and vent mufflers. If mufflers are used on bleeders or vent systems, the establishment shall have on file documentation that the mufflers [[Page 281]] do not impede the removal of air from the retort. Such documentation shall consist of either heat distribution data or documentation from the muffler manufacturer or from a processing authority. This information shall be made available to Program employees for review. (ix) Vents--(a) Vents shall be located in that portion of the retort opposite the steam inlet and shall be designed, installed, and operated in such a way that air is removed from the retort before timing of the thermal process is started. Vents shall be controlled by a gate, plug cock, or other full-flow valve which shall be fully opened to permit rapid removal of air from retorts during the venting period. (b) Vents shall not be connected to a closed drain system without an atmospheric break in the line. Where a retort manifold connects several pipes from a single retort, the manifold shall be controlled by a gate, plug cock, or other full-flow valve and the manifold shall be of a size such that the cross-sectional area of the manifold is larger than the total cross-sectional area of all connecting vents. The discharge shall not be 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 such that the cross- sectional area is at least equal to the total cross-sectional area of all connecting retort manifold pipes from the maximum number of retorts to be vented simultaneously. (c) Some typical installations and operating procedures are described below. Other retort installations, vent piping arrangements, operating procedures or auxiliary equipment such as divider plates may be used provided there is documentation that the air is removed from the retort before the process is started. Such documentation shall be in the form of heat distribution data or other documentation from the equipment manufacturer or processing authority. This information shall be maintained on file by the establishment and made available to Program employees for review. (d) For crateless retort installations, the establishment shall have heat distribution data or other documentation from the equipment manufacturer or from a processing authority that demonstrates that the venting procedure used accomplishes the removal of air and condensate. This information shall be maintained on file by the establishment and made available to Program employees for review. (e) Examples of typical installations and operating procedures that comply with the requirements of this section are as follows: (1) Venting horizontal retorts. (i) Venting through multiple 1 inch (2.5 cm) vents discharging directly to the atmosphere. [GRAPHIC] [TIFF OMITTED] TC11SE91.017 Specifications (Figure 1): One, 1-inch (2.5 cm) vent for every 5 feet (1.5 m) of retort length, equipped with a gate, plug cock, or other full-flow valve and discharging to atmosphere. The end vents shall not be more than 2\1/2\ feet (or 75 cm) from ends of retort. Venting method (Figure 1): Vent valves shall be wide open for at least 5 minutes and to at least 225 deg.F (or 107 deg.C), or at least 7 minutes and to at least 220 deg.F (or 104.5 deg.C). (ii) Venting through multiple 1 inch (2.5 cm) vents discharging through a manifold to the atmosphere. [GRAPHIC] [TIFF OMITTED] TC11SE91.018 Specifications (Figure 2): One, 1-inch (2.5 cm) vent for every 5 feet (1.5 m) of retort length; vents not over 2\1/2\ feet (or 75 cm) from ends of retort; size of manifold for retorts less than 15 feet (4.6 m) in length, 2\1/2\ inches (6.4 [[Page 282]] cm), and for retorts 15 feet (4.6 m) and over in length, 3 inches (7.6 cm). Venting method (Figure 2): The manifold vent gate, plug cock, or other full-flow valve shall be wide open for at least 6 minutes and to at least 225 deg.F (or 107 deg.C) or for at least 8 minutes and to at least 220 deg.F (or 104.5 deg.C). (iii) Venting through water spreaders. [GRAPHIC] [TIFF OMITTED] TC11SE91.019 Specifications (Figure 3): Size of vent and vent valve. For retorts less than 15 feet (4.6 m) in length, 2 inches (or 5 cm); for retorts 15 feet (4.6 m) and over in length, 2\1/2\ inches (6.4 cm). Size of water spreader (Figure 3): For retorts less than 15 feet (4.6 m) in length, 1\1/2\ inches (3.8 cm); for retorts 15 feet (4.6 m) and over in length, 2 inches (or 5 cm). The number of holes shall be such that their total cross-sectional area is equal to the cross- sectional area of the vent pipe inlet. Venting method (Figure 3): The gate, plug cock, or other full-flow valve on the water spreader vent shall be wide open for at least 5 minutes and to at least 225 deg.F (or 107 deg.C), or for at least 7 minutes and to at least 220 deg.F (or 104.5 deg.C). (iv) Venting through a single 2\1/2\ inch (6.4 cm) top vent for retorts not exceeding 15 feet (4.6 m) in length. [GRAPHIC] [TIFF OMITTED] TC11SE91.020 Specifications (Figure 4): A 2\1/2\ inch (6.4 cm) vent equipped with a 2\1/2\ inch (6.4 cm) gate, plug cock, or other full-flow valve and located within 2 feet (61 cm) of the center of the retort. Venting method (Figure 4): The vent valve shall be wide open for at least 4 minutes and to at least 220 deg.F (or 104.5 deg.C). (2) Venting vertical retorts. (i) Venting through a 1\1/2\ inch (3.8 cm) overflow. [GRAPHIC] [TIFF OMITTED] TC11SE91.021 Figure 5 Specifications (Figure 5): A 1\1/2\ inch (3.8 cm) overflow pipe equipped with a 1\1/2\ inch (3.8 cm) gate, plug cock, or other full-flow valve and with not more than 6 feet (1.8 m) of 1\1/2\ inch (3.8 cm) pipe beyond the valve before a break to the atmosphere or to a manifold header. Venting method (Figure 5): The vent valve shall be wide open for at least 4 minutes and to at least 218 deg.F (or 103.5 deg.C), or for at least 5 minutes and to at least 215 deg.F (or 101.5 deg.C). (ii) Venting through a single 1 inch (2.5 cm) side or top vent. [[Page 283]] [GRAPHIC] [TIFF OMITTED] TC11SE91.022 Specifications (Figure 6 or 7): A 1 inch (2.5 cm) vent in lid or top side, equipped with a gate, plug cock, or other full-flow valve and discharging directly into the atmosphere or to a manifold header. Venting method (Figure 6 or 7): The vent valve shall be wide open for at least 5 minutes and to at least 230 deg.F (110 deg.C), or for at least 7 minutes and to at least 220 deg.F (or 104.5 deg.C). (2) Batch agitating retorts. (i) The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, bulb sheaths or probes of indicating temperature devices and probes of temperature/time recording devices shall be installed either within the retort shell or in external wells attached to the retort. External wells shall be connected to the retort through at least a \3/4\ inch (1.9 cm) diameter opening and equipped with a \1/16\ (1.6 mm) or larger bleeder opening so located as to provide a constant flow of steam past the length of the bulbs or probes. The bleeder for external wells shall emit steam continuously during the entire thermal processing period. (ii) Steam controllers are required as described in paragraph (a)(3) of this section. (iii) Steam inlet. The steam inlet to each retort shall be large enough to provide steam for proper operation of the retort and shall enter at a point(s) to facilitate air removal during venting. (iv) Bleeders. Bleeders, except those for external wells of temperature devices, shall be \1/8\ inch (or 3 mm) or larger and shall be wide open during the entire process including the come-up time. Bleeders shall be located within approximately 1 foot (or 30 cm) 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 (2.4 m) apart along the top. Bleeders may be installed at positions other than those specified above, as long as the establishment has heat distribution data or other documentation from the manufacturer or from a processing authority that the bleeders accomplish removal of air and circulate the steam within the retort. This information shall be maintained on file by the establishment and made [[Page 284]] available to Program employees for review. All bleeders shall be arranged in a way that enables the retort operator to observe that they are functioning properly. (v) Venting and condensate removal. The air in the retort shall be removed before processing is started. Heat distribution data or other documentation from the manufacturer or from the processing authority who developed the venting procedure shall be kept on file by the establishment and made available to Program employees for review. At the time the steam is turned on, the drain shall be opened to remove steam condensate from the retort. A bleeder shall be installed in the bottom of the retort to remove condensate during retort operation. The condensate bleeder shall be so arranged that the retort operator can observe that it is functioning properly. The condensate bleeder shall be checked with sufficient frequency to ensure adequate removal of condensate. Visual checks should be performed at intervals of not more than 15 minutes and the results recorded. Intermittent condensate removal systems shall be equipped with an automatic alarm system that will serve as a continuous monitor of condensate bleeder functioning. The automatic alarm system shall be tested at the beginning of each shift for proper functioning and the results recorded. If the alarm system is not functioning properly, it must be repaired before the retort is used. (vi) Retort or reel speed timing. The retort or reel speed shall be checked before process timing begins and, if needed, adjusted as specified in the process schedule. In addition, the rotational speed shall be determined and recorded at least once during process timing of each retort load processed. Alternatively, a recording tachometer can be used to provide a continuous record of the speed. The accuracy of the recording tachometer shall be determined and recorded at least once per shift by checking the retort or reel speed using an accurate stopwatch. A means of preventing unauthorized speed changes on retorts shall be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments are satisfactory means of preventing unauthorized changes. (vii) Bleeder and vent mufflers. If mufflers are used on bleeders or vent systems, the establishment shall have documentation that the mufflers do not impede the removal of air from the retort. Such documentation shall consist of either heat distribution data or documentation from the muffler manufacturer or from a processing authority. This information shall be maintained on file by the establishment and made available to Program employees for review. (3) Continuous rotary retorts. (i) The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, bulb sheaths or probes of indicating temperature devices and probes of temperature/time recording devices shall be installed either within the retort shell or in external wells attached to the retort. External wells shall be connected to the retort through at least a \3/4\ inch (1.9 cm) diameter opening and equipped with a \1/16\ inch (1.6 mm) or larger bleeder opening so located as to provide a constant flow of steam past the length of the bulbs or probes. The bleeder for external wells shall emit steam continuously during the entire thermal processing period. (ii) Steam controllers are required as described in paragraph (a)(3) of this section. (iii) Steam inlet. The steam inlet to each retort shall be large enough to provide steam for proper operation of the retort, and shall enter at a point(s) to facilitate air removal during venting. (iv) Bleeders. Bleeders, except those for external wells of temperature devices, shall be \1/8\ inch (3.2 mm) or larger and shall be wide open during the entire process, including the come-up time. B!eeders shall be located within approximately 1 foot (or 30 cm) 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 (2.4 m) apart along the top of the retort. Bleeders may be installed at positions other than those [[Page 285]] specified above, as long as the establishment has heat distribution data or other documentation from the manufacturer or a processing authority that the bleeders accomplish removal of air and circulate the steam within the retort. This information shall be maintained on file by the establishment and made available to Program employees for review. All bleeders shall be arranged so that the retort operator can observe that they are functioning properly. (v) Venting and condensate removal. The air in the retort shall be removed before processing is started. Heat distribution data or other documentation from the manufacturer or from the processing authority who deve!oped the venting procedure shall be kept on file by the establishment and made available to Program employees for review. At the time the steam is turned on, the drain shall be opened to remove steam condensate from the retort. A bleeder shall be installed in the bottom of the shell to remove condensate during the retort operation. The condensate bleeder shall be so arranged that the retort operator can observe that it is functioning properly. The condensate bleeder shall be checked with sufficient frequency to ensure adequate removal of condensate. Visual checks should be performed at intervals of not more than 15 minutes and the results recorded. Intermittent condensate removal systems shall be equipped with an automatic alarm system that will serve as a continuous monitor of condensate bleeder functioning. The automatic alarm system shall be tested at the beginning of each shift for proper functioning and the results recorded. If the alarm system is not functioning properly, it must be repaired before the retort is used. (vi) Retort speed timing. The rotational speed of the retort shall be specified in the process schedule. The speed shall be adjusted as specified, and recorded by the establishment when the retort is started, and checked and recorded at intervals not to exceed 4 hours to ensure that the correct retort speed is maintained. Alternatively, a recording tachometer may be used to provide a continuous record of the speed. If a recording tachometer is used, the speed shall be manually checked against an accurate stopwatch at least once per shift and the results recorded. A means of preventing unauthorized speed changes on retorts shall be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments are satisfactory means of preventing unauthorized changes. (vii) Bleeders and vent mufflers. If mufflers are used on bleeders or vent systems, the establishment shall have documentation that the mufflers do not impede the removal of air from the retort. Such documentation shall consist of either heat distribution data or other documentation from the muffler manufacturer or from a processing authority. This information shall be maintained on file by the establishment and made available to Program employees for review. (4) Hydrostatic retorts. (i) The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, indicating temperature devices shall be located in the steam dome near the steam/ water interface. Where the process schedule specifies maintenance of particular water temperatures in the hydrostatic water legs, at least one indicating temperature device shall be located in each hydrostatic water leg so that it can accurately measure water temperature and be easily read. The temperature/time recorder probe shall be installed either within the steam dome or in a well attached to the dome. Each probe shall have a \1/16\ inch (1.6 mm) or larger bleeder opening which emits steam continuously during the processing period. Additional temperature/time recorder probes shall be installed in the hydrostatic water legs if the process schedule specifies maintenance of particular temperatures in these water legs. (ii) Steam controllers are required as described in paragraph (a)(3) of this section. (iii) Steam inlet. The steam inlets shall be large enough to provide steam for proper operation of the retort. [[Page 286]] (iv) Bleeders. Bleeder openings \1/4\ inch (or 6 mm) or larger shall be located in the steam chamber(s) 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. (v) Venting. Before the start of processing operations, the retort steam chamber(s) shall be vented to ensure removal of air. Heat distribution data or other documentation from the manufacturer or from a processing authority demonstrating that the air is removed from the retort prior to processing shall be kept on file at the establishment and made available to Program employees for review. (vi) Conveyor speed. The conveyor speed shall be calculated to obtain the required process time and recorded by the establishment when the retort is started. The speed shall be checked and recorded at intervals not to exceed 4 hours to ensure that the correct conveyor speed is maintained. A recording device may be used to provide a continuous record of the conveyor speed. When a recording device is used, the speed shall be manually checked against an accurate stopwatch at least once per shift by the establishment. A means of preventing unauthorized speed changes of the conveyor shall be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments are satisfactory means of preventing unauthorized changes. (vii) Bleeders and vent mufflers. If mufflers are used on bleeders or vent systems, the establishment shall have documentation that the muffler do not impede the removal of air from the retort. Such documentation shall consist of either heat distribution data or other documentation from the muffler manufacturer or from a processing authority. This information shall be maintained on file by the establishment and made available to Program employees for review. (c) Pressure processing in water--(1) Batch still retorts. (i) The basic requirements for indicating temperature devices and temperature/ time recording devices are described in paragraphs (a)(1) and (2) of this section. Additionally, bulbs or probes of indicating temperature devices shall be located in such a position that they are beneath the surface of the water throughout the process. On horizontal retorts, the indicating temperature device bulb or probe shall be inserted directly into the retort shell. In both vertical and horizontal retorts, the indicating temperature device bulb or probe shall extend directly into the water a minimum of 2 inches (or 5 cm) without a separable well or sleeve. In vertical retorts equipped with a recorder/controller, the controller probe 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 so equipped, the controller probe 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 controller probe. Air-operated temperature controllers shall have filter systems to ensure a supply of clean, dry air. (ii) Pressure recording device. Each retort shall be equipped with a pressure recording device which may be combined with a pressure controller. (iii) Steam controllers are required as described in paragraph (a)(3) of this section. (iv) Heat distribution. Heat distribution data or other documentation from the equipment manufacturer or a processing authority demonstrating uniform heat distribution within the retort shall be kept on file at the establishment and made available to Program employees for review. (v) Crate supports. A bottom crate support shall be used in vertical retorts. Baffle plates shall not be used in the bottom of the retort. (vi) Stacking equipment. For filled flexible containers and, where applicable, semirigid containers, stacking equipment shall be designed to ensure that the thickness of the filled containers does not exceed that specified in the process schedule and that the containers do not become displaced and [[Page 287]] overlap or rest on one another during the thermal process. (vii) Drain valve. A nonclogging, water-tight drain valve shall be used. Screens shall be installed over all drain openings. (viii) Water level. There shall be a means of determining the water level in the retort during operation (i.e., by using a gauge, electronic sensor, or sight glass indicator). For retorts requiring complete immersion of containers, water shall cover the top layer of containers during the entire come-up time and thermal processing periods and should cover the top layer of containers during cooling. For retorts using cascading water or water sprays, the water level shall be maintained within the range specified by the retort manufacturer or processing authority during the entire come-up, thermal processing, and cooling periods. A means to ensure that water circulation continues as specified throughout the come-up, thermal processing, and cooling periods shall be provided. The retort operator shall check and record the water level at intervals to ensure it meets the specified processing parameters. (ix) Air supply and controls. In both horizontal and vertical still retorts, a means shall be provided for introducing compressed air or steam at the pressure required to maintain container integrity. Compressed air and steam entry shall be controlled by an automatic pressure control unit. A nonreturn valve shall be provided in the air supply line to prevent water from entering the system. Overriding air or steam pressure shall be maintained continuously during the come-up, thermal processing, and cooling periods. 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. The adequacy of the air circulation for maintaining uniform heat distribution within the retort shall be documented by heat distribution data or other documentation from a processing authority, and such data shall be maintained on file by the establishment and made available to Program employees for review. (x) Water recirculation. When a water recirculation system is used for heat distribution, the water shall be drawn from the bottom of the retort through a suction manifold and discharged through a spreader that extends the length or circumference of the top of the retort. The holes in the water spreader shall be uniformly distributed. The suction outlets shall be protected with screens to keep debris from entering the recirculation system. The pump shall be equipped with a pilot light or a similar device to warn the operator when it is not running, and with a bleeder to remove air when starting operations. Alternatively, a flow- meter alarm system can be used to ensure proper water circulation. The adequacy of water circulation for maintaining uniform heat distribution within the retort shall be documented by heat distribution or other documentation from a processing authority and such data shall be maintained on file by the establishment and made available to Program employees for review. Alternative methods for recirculation of water in the retort may be used, provided there is documentation in the form of heat distribution data or other documentation from a processing authority maintained on file by the establishment and made available to Program employees for review. (xi) Cooling water entry. In retorts for processing product packed in glass jars, the incoming cooling water should not directly strike the jars, in order to minimize glass breakage by thermal shock. (2) Batch agitating retorts. (i) The basic requirements and recommendations for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, the indicating temperature device bulb or probe shall extend directly into the water without a separable well or sleeve. The recorder/controller probe 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 steam to directly strike the controller bulb or probe. (ii) Pressure recording device. Each retort shall be equipped with a pressure [[Page 288]] recording device which may be combined with a pressure controller. (iii) Steam controllers are required as described in paragraph (a)(3) of this section. (iv) Heat distribution. Heat distribution data or other documentation from the equipment manufacturer or a processing authority shall be kept on file by the establishment and made available to Program employees for review. (v) Stacking equipment. All devices used for holding product containers (e.g., crates, trays, divider plates) shall be so constructed to allow the water to circulate around the containers during the come-up and thermal process periods. (vi) Drain valve. A nonclogging, water-tight drain valve shall be used. Screens shall be installed over all drain openings. (vii) Water level. There shall be a means of determining the water level in the retort during operation (i.e., by using a gauge, electronic sensor, or sight glass indicator). Water shall completely cover all containers during the entire come-up, thermal processing, and cooling periods. A means to ensure that water circulation continues as specified throughout the come-up, thermal processing, and cooling periods shall be provided. The retort operator shall check and record the adequacy of the water level with sufficient frequency to ensure it meets the specified processing parameters. (viii) Air supply and controls. Retorts shall be provided with a means for introducing compressed air or steam at the pressure required to maintain container integrity. Compressed air and steam entry shall be controlled by an automatic pressure control unit. A nonreturn valve shall be provided in the air supply line to prevent water from entering the system. Overriding air or steam pressure shall be maintained continuously during the come-up, thermal processing, and cooling periods. 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. The adequacy of the air circulation for maintaining uniform heat distribution within the retort shall be documented by heat distribution data or other documentation from a processing authority, and such data shall be maintained on file by the establishment and made available to Program employees for review. (ix) Retort or reel speed timing. The retort or reel speed timing shall be checked before process timing begins and, if needed, adjusted as specified in the process schedule. In addition, the rotational speed shall be determined and recorded at least once during process timing of each retort load processed. Alternatively, a recording tachometer can be used to provide a continuous record of the speed. The accuracy of the recording tachometer shall be determined and recorded at least once per shift by the establishment by checking the retort or reel speed using an accurate stopwatch. A means of preventing unauthorized speed changes on retorts shall be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments are satisfactory means of preventing unauthorized changes. (x) Water recirculation. If a water recirculation system is used for heat distribution, it 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. The suction outlets shall be protected with screens to keep debris from entering the recirculation system. The pump shall be equipped with a pilot light or a similar device to warn the operator when it is not running and with a bleeder to remove air when starting operations. Alternatively, a flow-meter alarm system can be used to ensure proper water circulation. The adequacy of water circulation for maintaining uniform heat distribution within the retort shall be documented by heat distribution data or other documentation from a processing authority, and such data shall be maintained on file by the establishment and made available to Program employees for review. Alternative methods for recirculation of water in the retort may be used provided there is documentation [[Page 289]] in the form of heat distribution data or other documentation from a processing authority maintained on file by the establishment and made available to Program employees for review. (xi) Cooling water entry. In retorts for processing product packed in glass jars, the incoming cooling water should not directly strike the jars, in order to minimize glass breakage by thermal shock. (d) Pressure processing with steam/air mixtures in batch retorts. (1) The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, bulb sheaths or probes for indicating temperature devices and temperature/time recording devices or controller probes shall be inserted directly into the retort shell in such a position that steam does not strike them directly. (2) Steam controllers are required as described in paragraph (a)(3) of this section. (3) Recording pressure controller. A recording pressure controller shall be used to control the air inlet and the steam/air mixture outlet. (4) Circulation of steam/air mixtures. A means shall be provided for the circulation of the steam/air mixture to prevent formation of low- temperature pockets. The efficiency of the circulation system shall be documented by heat distribution data or other documentation from a processing authority, and such data shall be maintained on file by the establishment and made available to Program employees for review. The circulation system shall be checked to ensure its proper functioning and shall be equipped with a pilot light or a similar device to warn the operator when it is not functioning. Because of the variety of existing designs, reference shall be made to the equipment manufacturer for details of installation, operation, and control. (e) Atmospheric cookers--(1) Temperature/time recording device. Each atmospheric cooker (e.g., hot water bath) shall be equipped with at least one temperature/time recording device in accordance with the basic requirements described in paragraph (a)(2) of this section. (2) Heat distribution. Each atmospheric cooker shall be equipped and operated to ensure uniform heat distribution throughout the processing system during the thermal process. Heat distribution data or other documentation from the manufacturer or a processing authority demonstrating uniform heat distribution within the cooker shall be kept on file by the establishment and made available to Program employees for review. (f) Other systems. All other systems not specifically delineated in this section and used for the thermal processing of canned product shall be adequate to produce shelf-stable products consistently and uniformly. (g) Equipment maintenance. (1) Upon installation, all instrumentation and controls shall be checked by the establishment for proper functioning and accuracy and, thereafter, at any time their functioning or accuracy is suspect. (2) At least once a year each thermal processing system shall be examined by an individual not directly involved in daily operations to ensure the proper functioning of the system as well as all auxiliary equipment and instrumentation. In addition, each thermal processing system should be examined before the resumption of operation following an extended shutdown. (3) Air and water valves that are intended to be closed during thermal processing shall be checked by the establishment for leaks. Defective valves shall be repaired or replaced as needed. (4) Vent and bleeder mufflers shall be checked and maintained or replaced by the establishment to prevent any reduction in vent or bleeder efficiency. (5) When water spreaders are used for venting, a maintenance schedule shall be developed and implemented to assure that the holes are maintained at their original size. (6) Records shall be kept on all maintenance items that could affect the adequacy of the thermal process. Records shall include the date and type of maintenance performed and the person conducting the maintenance. (h) Container cooling and cooling water. (1) Potable water shall be used [[Page 290]] for cooling except as provided for in paragraphs (h) (2) and (3) of this section. (2) Cooling canal water shall be chlorinated or treated with a chemical approved by the Administrator as having a bactericidal effect equivalent to chlorination. There shall be a measurable residual of the sanitizer in the water at the discharge point of the canal. Cooling canals shall be cleaned and replenished with potable water to prevent the buildup of organic matter and other materials. (3) Container cooling waters that are recycled or reused shall be handled in systems that are so designed, operated, and maintained so there is no buildup of microorganisms, organic matter, and other materials in the systems and in the waters. System equipment, such as pipelines, holding tanks and cooling towers, shall be constructed and installed so that they can be cleaned and inspected. In addition, the establishment shall maintain, and make available to Program employees for review, information on at least the following: (i) System design and construction; (ii) System operation including the rates of renewal with fresh, potable water and the means for treating the water so that there is a measurable residual of an acceptable sanitizer, per paragraph (h)(2) of this section, in the water at the point where the water exits the container cooling vessel; (iii) System maintenance including procedures for the periodic cleaning and sanitizing of the entire system; and (iv) Water quality standards, such as microbiological, chemical and physical, monitoring procedures including the frequency and site(s) of sampling, and the corrective actions taken when water quality standards are not met. (i) Post-process handling of containers Containers shall be handled in a manner that will prevent damage to the hermetic seal area. All worn and frayed belting, can retarders, cushions, and the like shall be replaced with nonporous materials. To minimize container abrasions, particularly in the seal area, containers should not remain stationary on moving conveyors. All post-process container handling equipment should be kept clean so there is no buildup of microorganisms on surfaces in contact with the containers. (Approved by the Office of Management and Budget under control number 0583-0015) [51 FR 45619, Dec. 19, 1986, as amended at 65 FR 34389, May 30, 2000]