Subpart A-General Provisions § 113.3 Definitions. PART 113 ... · 21 cfr part 113 PART...

21 cfr part 113

PART 113-THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLYSEALED CONTAINERS

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 ProductContainers, 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 ofcritical 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 otherwisenoted.

21 cfr ubpartA_P 113

Subpart A-General Provisions

21 cfr 113.3

§ 113.3 Definitions.

For the purposes of this part, the following definitionsapply:

(a) Aseptic processing and packaging means the fillingof a commercially sterilized cooled product intopresterilized containers, followed by aseptic hermeticalsealing, with a presterilized closure, in an atmospherefree of microorganisms.

(b) Bleeders means openings used to remove air thatenters with steam from retorts and steam chambers andto promote circulation of steam in such retorts andsteam chambers. Bleeders may serve as a means ofremoving condensate.

(c) Come-up-time means the time which elapsesbetween the introduction of steam into the closed retortand the time when the retort reaches the requiredprocessing temperature.

(d) Commercial processor includes any personengaged in commercial, custom, or institutional(church, school, penal, or other organization)processing of food, including pet food. Personsengaged in the production of foods that are to be usedin market or consumer tests are also included.

(e) Commercial sterility: (1) "Commercial sterility" ofthermally processed food means the conditionachieved-

(i) By the application of heat which renders the foodfree of-(a) Microorganisms capable of reproducing in the foodunder normal nonrefrigerated conditions of storage anddistribution; and

(b) Viable microorganisms (including spores) of publichealth significance; or

(ii) By the control of water activity and the applicationof heat, which renders the food free of microorganismscapable of reproducing in the food under normalnonrefrigerated conditions of storage and distribution.

(2) "Commercial sterility" of equipment and containersused for aseptic processing and packaging of foodmeans the condition achieved by application of heat,chemical sterilant(s), or other appropriate treatmentthat renders the equipment and containers free ofviable microorganisms having public healthsignificance, as well as microorganisms of nonhealthsignificance, capable of reproducing in the food undernormal nonrefrigerated conditions of storage anddistribution.

(f) Critical factor means any property, characteristic,condition, aspect, or other parameter, variation ofwhich may affect the scheduled process and theattainment of commercial sterility.

(g) Flame sterilizer means an apparatus in whichhermetically sealed containers are agitated atatmospheric pressure, by either continuous,discontinuous, or reciprocating movement, withimpinging gas flames to achieve sterilizationtemperatures. A holding period in a heated section mayfollow the initial heating period.

(h) Headspace, gross is the vertical distance betweenthe level of the product (generally the liquid surface) inan upright rigid container and the top edge of thecontainer (the top of the double seam of a can or thetop edge of a glass jar).

(i) Headspace, net of a container is the verticaldistance between the level of the product (generally theliquid surface) in the upright rigid container and theinside surface of the lid.

(j) Hermetically sealed container means a containerthat is designed and intended to be secure against theentry of microorganisms and thereby to maintain thecommercial sterility of its contents after processing.

(k) Incubation means the holding of a sample(s) at aspecified temperature for a specified period of time forthe purpose of permitting or stimulating the growth ofmicroorganisms.

(l) Initial temperature means the average temperatureof the contents of the coldest container to be processedat the time the thermal processing cycle begins, asdetermined after thorough stirring or shaking of thefilled and sealed container.

(m) Lot means that amount of a product producedduring a period of time indicated by a specific code.

(n) Low-acid foods means any foods, other than

alcoholic beverages, with a finished equilibrium pHgreater than 4.6 and a water activity (a w) greater than0.85. Tomatoes and tomato products having a finishedequilibrium pH less than 4.7 are not classed as low-acid foods.

(o) Minimum thermal process means the application ofheat to food, either before or after sealing in ahermetically sealed container, for a period of time andat a temperature scientifically determined to beadequate to ensure destruction of microorganisms ofpublic health significance.

(p) Operating process means the process selected bythe processor that equals or exceeds the minimumrequirements set forth in the scheduled process.

(q) Retort means any closed vessel or other equipmentused for the thermal processing of foods.

(r) Scheduled process means the process selected bythe processor as adequate under the conditions ofmanufacture for a given product to achieve commercialsterility. This process may be in excess of thatnecessary to ensure destruction of microorganisms ofpublic health significance, and shall be at leastequivalent to the process established by a competentprocessing authority to achieve commercial sterility.

(s) Shall is used to state mandatory requirements.

(t) Should is used to state recommended or advisoryprocedures or to identify recommended equipment.

(u) Vacuum-packed products means those products thatare sealed in a container under the vacuum specified inthe scheduled process, the maintenance of whichvacuum is critical to the adequacy of the scheduledprocess.

(v) Vents means openings through the retort shell,controlled by gate, plug cock, or other adequate valvesused for the elimination of air during the ventingperiod.

(w) Water activity (aw) is a measure of the freemoisture in a product and is the quotient of the watervapor pressure of the substance divided by the vaporpressure of pure water at the same temperature.

21 cfr 113.5

§ 113.5 Current good manufacturing practice.

The criteria in §§113.10,113.40, 113.60,113.81,113.83,113.87, 113.89, and113.100 shall apply indetermining whether the facilities, methods, practices,and controls used by the commercial processor in themanufacture, processing, or packing of low-acid foodsin hermetically sealed containers are operated oradministered in a manner adequate to protect the publichealth.

21 cfr 113.10

§ 113.10 Personnel.

The operators of processing systems, retorts, asepticprocessing and packaging systems and productformulating systems (including systems wherein wateractivity is used in conjunction with thermal processing)and container closure inspectors shall be under theoperating supervision of a person who has attended aschool approved by the Commissioner for givinginstruction appropriate to the preservation technologyinvolved and who has been identified by that school ashaving satisfactorily completed the prescribed courseof instruction. This person shall supervise only in thoseareas for which a school approved by theCommissioner identifies the person as havingsatisfactorily completed training.

21 cfr ubpartBP 113

Subpart B[Reserved]

21 cfr ubpartC_P 113

Subpart C-Equipment

21 cfr 113.40

§ 113.40 Equipment and procedures.

(a) Equipment and procedures for pressure processingin steam in still retorts-(1) Indicating mercury-in-glassthermometer. Each retort shall be equipped with atleast one mercury-in-glass thermometer whosedivisions are easily readable to 1 °F and whosetemperature range does not exceed 17 °F per inch ofgraduated scale. Thermometers shall be tested for

accuracy against a known accurate standardthermometer upon installation and at least once a yearthereafter, or more frequently if necessary, to ensuretheir accuracy. Records of thermometer accuracychecks that specify date, standard used, method used,and person performing the test should be maintained.Each thermometer should have a tag, seal, or othermeans of identity that includes the date on which it waslast tested for accuracy. A thermometer that has adivided mercury column or that cannot be adjusted tothe standard shall be repaired or replaced before furtheruse of the retort. Thermometers shall be installedwhere they can be accurately and easily read. Bulbs ofindicating thermometers shall be installed either withinthe retort shell or in external wells attached to theretort. External wells or pipes shall be connected to theretort through at least a 3/4-inch diameter opening andequipped with a \1/16\-inch or larger bleeder openingso located as to provide a full flow of steam past thelength of the thermometer bulb. The bleeders forexternal wells shall emit steam continuously during theentire processing period. The mercury thermometer-notthe recorder chart-shall be the reference instrument forindicating the processing temperature.

(2) Temperature-recording device. Each still retortshall have an accurate temperature-recording device.Graduations on the temperature-recording devices shallnot exceed 2 °F within a range of 10 °F of theprocessing temperature. Each chart shall have aworking scale of not more than 55 °F per inch within arange of 20 °F of the processing temperature. Thetemperature chart shall be adjusted to agree as nearlyas possible with, but to be in no event higher than, theknown accurate mercury-in-glass thermometer duringthe process time. A means of preventing unauthorizedchanges in adjustment shall be provided. A lock, or anotice from management posted at or near therecording device which provides a warning that onlyauthorized persons are permitted to make adjustments,is a satisfactory means for preventing unauthorizedchanges. The recorder may be combined with thesteam controller and may be a recording-controllinginstrument. The temperature-recorder bulb shall beinstalled either within the retort shell or in a wellattached to the shell. Each temperature-recorder bulbwell shall have a \1/16\-inch or larger bleeder whichemits steam continuously during the processing period.Air-operated temperature controllers should haveadequate filter systems to ensure a supply of clean, dryair.

(3) Pressure gages. Each retort should be equippedwith a pressure gage that should be graduated indivisions of 2 pounds or less.

(4) Steam controller. Each retort shall be equippedwith an automatic steam controller to maintain theretort temperature. This may be a recording-controllinginstrument when combined with a recordingthermometer. The steam controller may be air-operatedand actuated by a temperature sensor positioned nearthe mercury-in-glass thermometer in the retort; a steamcontroller activated by the steam pressure of the retortis acceptable if it is carefully maintained mechanicallyso that it operates satisfactorily.

(5) Steam inlet. The steam inlet to each still retort shallbe large enough to provide sufficient steam for properoperation of the retort. Steam may enter either the topportion or the bottom portion of the retort but, in anycase, shall enter the portion of the retort opposite thevent; for example, steam inlet in bottom portion andvent in top portion.

(6) Crate supports. A bottom crate support shall beused in vertical still retorts. Baffle plates shall not beused in the bottom of still retorts.

(7) Steam spreaders. Steam spreaders are continuationsof the steam inlet line inside the retort. Horizontal stillretorts shall be equipped with steam spreaders thatextend the length of the retort. For steam spreadersalong the bottom of the retort, the perforations shouldbe along the top 90° of this pipe, that is, within 45° oneither side of the top center. Horizontal still retortsover 30 feet long should have two steam inletsconnected to the spreader. In vertical still retorts, thesteam spreaders, if used, should be perforated along thecenter line of the pipe facing the interior of the retort oralong the sides of the pipe. The number of perforationsshould be such that the total cross-sectional area of theperforations is equal to 11/2 to 2 times the cross-sectional area of the smallest restriction in the steaminlet line.(8) Bleeders. Bleeders, except those for thermometerwells, shall be one-eighth inch or larger and shall bewide open during the entire process, including thecome-up-time. For horizontal still retorts, bleedersshall be located within approximately 1 foot of theoutermost locations of containers at each end along thetop of the retort; additional bleeders shall be locatednot more than 8 feet apart along the top. Bleeders maybe installed at positions other than those specifiedabove, as long as there is evidence in the form of heatdistribution data that they accomplish adequateremoval of air and circulation of steam within theretort. Vertical retorts shall have at least one bleederopening located in that portion of the retort oppositethe steam inlet. In retorts having top steam inlet andbottom venting, a bleeder shall be installed in the

bottom of the retort to remove condensate. All bleedersshall be arranged so that the operator can observe thatthey are functioning properly.

(9) Stacking equipment and position of containers.Crates, trays, gondolas, etc., for holding containersshall be made of strap iron, adequately perforated sheetmetal, or other suitable material. When perforatedsheet metal is used for the bottoms, the perforationsshould be approximately the equivalent of 1-inch holeson 2-inch centers. If dividers are used between thelayers of containers, they should be perforated asabove. The positioning of containers in the retort, whenspecified in the scheduled process, shall be inaccordance with that process.

(10) Air valves. Retorts using air for pressure coolingshall be equipped with a suitable valve to prevent airleakage into the retort during processing.

(11) Water valves. Retorts using water for cooling shallbe equipped with a suitable valve to prevent leakage ofwater into the retort during processing.

(12) Vents. Vents shall be installed in such a way thatair is removed from the retort before timing of theprocess is started. Vents shall be controlled by gate,plug cock, or other adequate type valves which shall befully open to permit rapid discharge of air from theretort during the venting period. Vents shall not beconnected directly to a closed drain system. If theoverflow is used as a vent, there shall be anatmospheric break in the line before it connects to aclosed drain. The vent shall be located in that portionof 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 pipesfrom a single still retort, it shall be controlled by a gate,plug cock, or other adequate type valve. The retortmanifold shall be of a size that the cross-sectional areaof the pipe is larger than the total cross-sectional areaof all connecting vents. The discharge shall not bedirectly connected to a closed drain without anatmospheric break in the line. A manifold headerconnecting vents or manifolds from several still retortsshall lead to the atmosphere. The manifold header shallnot be controlled by a valve and shall be of a size thatthe cross-sectional area is at least equal to the totalcross-sectional area of all connecting retort manifoldpipes from all retorts venting simultaneously. Timingof the process shall not begin until the retort has beenproperly vented and the processing temperature hasbeen reached. Some typical installations and operatingprocedures reflecting the requirements of this sectionfor venting still retorts are given in paragraph

(a)(12)(i)(a) through (d) and (ii)(a) and (b) of thissection.

(i) Venting horizontal retorts. (a) Venting throughmultiple 1-inch vents discharging directly toatmosphere.

Specifications. One 1-inch vent for every 5 feet ofretort length, equipped with a gate or plug cock valveand discharging to atmosphere; end vents not morethan 21/2 feet from ends of retort.

Venting method. Vent valves should be wide open forat least 5 minutes and to at least 225 °F, or at least 7minutes and to at least 220 °F.

(b) Venting through multiple 1-inch vents dischargingthrough a manifold to atmosphere.

Specifications. One 1-inch vent for every 5 feet ofretort length; and vents not over 21/2 feet from ends ofretort: Size of manifold-for retorts less than 15 feet inlength, 21/2 inches; for retorts 15 feet and over inlength, 3 inches.

Venting method. Manifold vent gate or plug cockvalve should be wide open for at least 6 minutes and toat least 225 °F, or for at least 8 minutes and to at least220 °F.

(c) Venting through water spreaders.

Size of vent and vent valve. For retorts less than 15feet in length, 2 inches; for retorts 15 feet and over inlength, 21/2 inches.

Size of water spreader. For retorts less than 15 feet inlength, 11/2 inches; for retorts 15 feet and over inlength, 2 inches. The number of holes should be suchthat their total cross-sectional area is approximatelyequal to the cross-sectional area of the vent pipe inlet.

Venting method. Water spreader vent gate or plugcock valve should be wide open for at least 5 minutesand to at least 225 °F, or for at least 7 minutes and toat least 220 °F.

(d) Venting through a single 21/2-inch top vent (forretorts not exceeding 15 feet in length).

Specifications: A 21/2-inch vent equipped with a 21/2-inch gate or plug cock valve and located within 2 feetof the center of the retort.

Venting method: Vent gate or plug cock valve shouldbe wide open for at least 4 minutes and to at least 220°F.

(ii) Venting vertical retorts. (a) Venting through a11/2-inch overflow.

Specifications. A 11/2-inch overflow pipe equippedwith a 11/2-inch gate or plug cock valve and with notmore than 6 feet of 11/2-inch pipe beyond the valvebefore break to the atmosphere or to a manifold header.

Venting method. Vent gate or plug cock valve shouldbe wide open for at least 4 minutes and to at least 218°F, or for at least 5 minutes and to at least 215 °F.

(b) Venting through a single 1-inch side or top vent.

Specifications. A 1-inch vent in lid or top side,equipped with a 1-inch gate or plug cock valve anddischarging directly into the atmosphere or to amanifold header.

Venting method. Vent gate or plug cock valve shouldbe wide open for at least 5 minutes and to at least 230°F, or for at least 7 minutes and to at least 220 °F.

(iii) Other installations and operating procedures thatdeviate from the above specifications may be used ifthere is evidence in the form of heat distribution data,which shall be kept on file, that they accomplishadequate venting of air.

(13) Critical factors. Critical factors specified in thescheduled process shall be measured and recorded onthe processing record at intervals of sufficientfrequency to ensure that the factors are within thelimits specified in the scheduled process.

(i) When maximum fill-in or drained weight isspecified in the scheduled process, it shall be measuredand recorded at intervals of sufficient frequency toensure that the weight of the product does not exceedthe maximum for the given container size specified inthe scheduled process.

(ii) Closing machine vacuum in vacuum-packedproducts shall be observed and recorded at intervals ofsufficient frequency to ensure that the vacuum is asspecified in the scheduled process.

(iii) Such measurements and recordings should bemade at intervals not to exceed 15 minutes.

(iv) When the product style results in stratification orlayering of the primary product in the containers, thepositioning of containers in the retort shall beaccording to the scheduled process.

(b) Equipment and procedures for pressure processingin water in still retorts-(1) Indicating mercury-in-glassthermometer. Each retort shall be equipped with atleast one mercury-in-glass thermometer whosedivisions are easily readable to 1 °F and whosetemperature range does not exceed 17 °F per inch ofgraduated scale. Thermometers shall be tested for

accuracy against a known accurate standardthermometer upon installation and at least once a yearthereafter, or more frequently if necessary, to ensuretheir accuracy. Records of thermometer accuracychecks which specify date, standard used, methodused, and person performing the test should bemaintained. Each thermometer should have a tag, seal,or other means of identity that includes the date whenit was last tested for accuracy. A thermometer that hasa divided mercury column or that cannot be adjusted tothe standard shall be repaired or replaced before furtheruse of the retort. Thermometers shall be installedwhere they can be accurately and easily read. Bulbs ofindicating thermometers shall be located in such aposition that they are beneath the surface of the waterthroughout the process. On horizontal retorts, this entryshould be made in the side at the center, and thethermometer bulbs shall be inserted directly into theretort shell. In both vertical and horizontal retorts, thethermometer bulbs shall extend directly into the watera minimum of at least 2 inches without a separablewell or sleeve. The mercury thermometer-not therecorder chart-shall be the reference instrument forindicating the processing temperature.

(2) Temperature-recording device. Each still retortshall have an accurate temperature-recording device.Graduations on the temperature-recording devices shallnot exceed 2 °F within a range of 10 °F of theprocessing temperature. Each chart shall have aworking scale of not more than 55 °F per inch within arange of 20 °F of the processing temperature. Thetemperature chart shall be adjusted to agree as nearlyas possible with, but to be in no event higher than, theknown accurate mercury-in-glass thermometer duringthe process time. A means of preventing unauthorizedchanges in adjustment shall be provided. A lock, or anotice from management posted at or near therecording device which provides a warning that onlyauthorized persons are permitted to make adjustments,is a satisfactory means for preventing unauthorizedchanges. The recorder may be combined with thesteam controller and may be a recording-controllinginstrument. The recording-thermometer bulb should belocated adjacent to the bulb of the mercury-in-glassthermometer, except in the case of a vertical retortequipped with a combination recorder-controller. Insuch vertical retorts, the temperature recorder-controlbulb shall be located at the bottom of the retort belowthe lowest crate rest in such a position that the steamdoes not strike it directly. In horizontal retorts, thetemperature recorder-control bulb shall be locatedbetween the water surface and the horizontal planepassing through the center of the retort so that there isno opportunity for direct steam impingement on thecontrol bulb. Air-operated temperature controllers

should have adequate filter systems to ensure a supplyof clean, dry air.

(3) Pressure gages. (i) Each retort should be equippedwith a pressure gage, which should be graduated indivisions of 2 pounds or less.

(ii) Each retort should have an adjustable pressurerelief or control valve of a capacity sufficient toprevent an undesired increase in retort pressure whenthe water valve is wide open and should be installed inthe overflow line.

(4) Steam controller. Each retort shall be equippedwith an automatic steam controller to maintain theretort temperature. This may be a recording-controllinginstrument when combined with a recordingthermometer.

(5) Steam introduction. Steam shall be distributed inthe bottom of the retort in a manner adequate toprovide uniform heat distribution throughout the retort.In vertical retorts, uniform steam distribution can beachieved by any of several methods. In horizontalretorts, the steam distributor shall run the length of thebottom of the retort with perforations distributeduniformly along the upper part of the pipe.

(6) Crate supports. A bottom crate support shall beused in vertical still retorts. Baffle plates shall not beused in the bottom of the retort. Centering guidesshould be installed so as to ensure that there is about a11/2-inch clearance between the side wall of the crateand the retort wall.

(7) Stacking equipment and position of containers.Crates, trays, gondolas, etc., for holding containersshall be made of strap iron, adequately perforated sheetmetal, or other suitable material. When perforatedsheet metal is used for the bottoms, the perforationsshould be approximately the equivalent of 1-inch holeson 2-inch centers. If divider plates are used betweenthe layers of containers, they should be perforated asabove. The positioning of containers in the retort, whenspecified in the scheduled process, shall be inaccordance with that process. Dividers, racks, trays, orother means of positioning of flexible containers shallbe designed and employed to ensure even circulationof heating medium around all containers in the retort.

(8) Drain valve. A nonclogging, water-tight valve shallbe used. Screens should be installed over all drainopenings.

(9) Water level indicator. There shall be a means ofdetermining the water level in the retort during

operation, e.g., by using a gage, water glass, orpetcock(s). Water shall cover the top layer ofcontainers during the entire come-up-time andprocessing periods and should cover the top layer ofcontainers during the cooling periods. The operatorshall check and record the water level at intervalssufficient to ensure its adequacy.

(10)(i) Air supply and controls. In both horizontal andvertical still retorts for pressure processing in water, ameans shall be provided for introducing compressed airat the proper pressure and rate. The proper pressureshall be controlled by an automatic pressure controlunit. A check valve shall be provided in the air supplyline to prevent water from entering the system. Air orwater circulation shall be maintained continuouslyduring the come-up-time and during processing andcooling periods; the adequacy of the air or watercirculation for uniform heat distribution within theretort shall be established in accordance withprocedures recognized by a competent processingauthority and records shall be kept on file; if air is usedto promote circulation, it shall be introduced into thesteam line at a point between the retort and the steamcontrol valve at the bottom of the retort.

(ii) Water circulation. When a water circulating systemis used for heat distribution, is shall be installed in sucha manner that water will be drawn from the bottom ofthe retort through a suction manifold and dischargedthrough a spreader which extends the length of the topof the retort. The holes in the water spreader shall beuniformly distributed and should have an aggregatearea not greater than the cross-section area of the outletline from the pump. The suction outlets should beprotected with nonclogging screens to keep debris fromentering the circulating system. The pump shall beequipped with a pilot light or other signaling device towarn the operator when it is not running, and with ableeder to remove air when starting operations.Alternative methods for circulation of water in theretort may be used when established by a competentauthority as adequate for even heat distribution.

(11) Cooling water supply. In vertical retorts thecooling water should be introduced at the top of theretort between the water and container levels ; inhorizontal retorts the cooling water should beintroduced into the suction side of the pump. A checkvalve should be included in the cooling water line.

(12) Retort headspace. The headspace necessary tocontrol the air pressure should be maintained betweenthe water level and the top of the retort shell.

(13) Vertical and horizontal still retorts. Vertical and

horizontal still retorts should follow the arrangementsin the diagrams below in this paragraph. Otherinstallation and operating procedures that deviate fromthese arrangements may be used, as long as there isevidence in the form of heat distribution data or othersuitable information, which shall be kept on file, thatdemonstrates that the heat distribution is adequate.

Legend for Vertical and Horizontal Still Retorts

A-Water line.

B-Steam line.

C-Temperature control.

D-Overflow line.

E1-Drain line.

E2-Screens.

F-Check valves.

G-Line from hot water storage.

H-Suction line and manifold.

I-Circulating pump.

J-Petcocks.

K-Recirculating line.

L-Steam distributor.

M-Temperature-controller bulb.

N-Thermometer.

O-Water spreader.

P-Safety valve.

Q-Vent valve for steam processing.

R-Pressure gage.

S-Inlet air control.

T-Pressure control.

U-Air line.

V-To pressure control instrument.

W-To temperature control instrument.

X-Wing nuts.

Y1-Crate support.

Y2-Crate guides.

Z-Constant flow orifice valve.

Z1-Constant flow orifice valve used during come-up.

Z2-Constant flow orifice valve used during cook.



(ii) Closing machine vacuum in vacuum-packedproducts shall be observed and recorded at intervals of

sufficient frequency to ensure that the vacuum is asspecified in the scheduled process.


(iv) When the product style results in stratification orlayering of the primary product in the containers, thepositioning of containers in the retort shall beaccording to the scheduled process.

(c) Equipment and procedures for pressure processingin steam in continuous agitating retorts-(1) Indicatingmercury-in-glass thermometer. Each retort shall beequipped with at least one mercury-in-glassthermometer whose divisions are easily readable to 1°F and whose temperature range does not exceed 17°F per inch of graduated scale. Thermometers shall betested for accuracy against a known accurate standardthermometer upon installation and at least once a yearthereafter, or more frequently if necessary, to ensuretheir accuracy. Records of thermometer accuracychecks which specify date, standard used, methodused, and person performing the test should bemaintained. Each thermometer should have a tag, seal,or other means of identity that includes the date onwhich it was last tested for accuracy. A thermometerthat has a divided mercury column or that cannot beadjusted to the standard shall be repaired or replacedbefore further use of the retort. Thermometers shall beinstalled where they can be accurately and easily read.Bulbs in indicating thermometers shall be installedeither within the retort shell or in external wellsattached to the retort. External wells or pipes shall beconnected to the retort through at least a 3/4-inchdiameter opening, and equipped with a \1/16\-inch orlarger bleeder opening so located as to provide a fullflow of steam past the length of the thermometer bulb.The bleeders for external wells shall emit steamcontinuously during the entire processing period. Themercury thermometer-not the recorder chart-shall bethe reference instrument for indicating the processingtemperature.

(2) Temperature-recording device. Each retort shallhave an accurate temperature-recording device.Graduations on the temperature-recording devices shallnot exceed 2 °F within a range of 10 °F of theprocessing temperature. Each chart shall have aworking scale of not more than 55 °F per inch within arange of 20 °F of the processing temperature. Thetemperature chart shall be adjusted to agree as nearlyas possible with, but to be in no event higher than, theknown accurate mercury-in-glass thermometer during

the process time. A means of preventing unauthorizedchanges in adjustment shall be provided. A lock, or anotice from management posted at or near therecording device that provides a warning that onlyauthorized persons are permitted to make adjustments,is a satisfactory means of preventing unauthorizedchanges. The recorder may be combined with thesteam controller and may be a recording-controllinginstrument. The temperature-recorder bulb shall beinstalled either within the retort shell or in a wellattached to the shell. Each temperature-recorder bulbwell shall have a \1/16\-inch or larger bleederopening emitting steam continuously during theprocessing period. Air-operated temperature controllersshould have adequate filter systems to ensure a supplyof clean, dry air.

(3) Pressure gages. Each retort should be equippedwith a pressure gage that should be graduated indivisions of 2 pounds or less.

(4) Steam controller. Each retort shall be equippedwith an automatic steam controller to maintain theretort temperature. This may be a recording-controllinginstrument when combined with a recordingthermometer. A steam controller activated by the steampressure of the retort is acceptable if it is carefullymaintained mechanically so that it operatessatisfactorily.

(5) Bleeders. Bleeders, except those for thermometerwells, shall be one-eight inch or larger and shall bewide open during the entire process, including thecome-up-time. Bleeders shall be located withinapproximately 1 foot of the outermost location ofcontainers at each end along the top of the retort;additional bleeders shall be located not more than 8feet apart along the top of the retort. All bleeders shallbe arranged so that the operator can observe that theyare functioning properly. The condensate bleeder shallbe checked with sufficient frequency to ensureadequate removal of condensate or shall be equippedwith an automatic alarm system(s) that would serve asa continuous monitor of condensate-bleederfunctioning. Visual checks should be done at intervalsof not more than 15 minutes. A record of such checksshould be kept to show that the bleeder is functioningproperly.

(6) Venting and condensate removal. Vents shall belocated in that portion of the retort opposite the steaminlet. Air shall be removed before processing is started.Heat distribution data or documentary proof from themanufacturer or from a competent processingauthority, demonstrating that adequate venting isachieved, shall be kept on file. At the time steam is

turned on, the drain should be opened for a timesufficient to remove steam condensate from the retort,and provision shall be made for continuing drainage ofcondensate during the retort operation. The condensatebleeder in the bottom of the shell serves as an indicatorof continuous condensate removal.

(7) Retort speed timing. The rotational speed of theretort shall be specified in the scheduled process. Thespeed shall be adjusted and recorded when the retort isstarted, at any time a speed change is made, and atintervals of sufficient frequency to ensure that theretort speed is maintained as specified in the scheduledprocess. These adjustments and recordings should bemade every 4 hours or less. Alternatively, a recordingtachometer may be used to provide a continuous recordof the speed. A means of preventing unauthorizedspeed changes on retorts shall be provided. A lock, or anotice from management posted at or near the speedadjustment device that provides a warning that onlyauthorized persons are permitted to make adjustments,is a satisfactory means of preventing unauthorizedchanges.

(8) Emergency stops. If a retort jams or breaks downduring processing operations, necessitating cooling theretort for repairs, the retort shall be operated in such away that ensures that the product is commerciallysterile, or the retort is to be cooled promptly and allcontainers either reprocessed, repacked andreprocessed, or discarded. When operated as a stillretort, all containers shall be given a full still retortprocess before the retort is cooled. If, in such anemergency, a scheduled still process or another processestablished 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 intransfer valves between cooker shells of a continuousretort at the time of breakdown shall either bereprocessed, repacked and reprocessed, or discarded.

(ii) Both the time at which the reel stopped and thetime the retort was used for a still retort process, if soused, shall be marked on the recording chart andentered on the other production records required in thischapter. If the alternative procedure of prompt coolingis followed, the subsequent handling methods used forthe containers in the retort at the time of stopping andcooling shall be entered on the production records.

(9) Temperature drop. If the temperature of thecontinuous retort drops below the temperaturespecified in the scheduled process while containers are

in the retort, the retort reel shall be stopped promptly.An automatic device should be used to stop the reelwhen the temperature drops below the specifiedprocess temperature. Before the reel is restarted, allcontainers in the retort shall be given a completescheduled still retort process if the temperature dropwas 10 °F or more below the specified temperature, oralternatively, container entry to the retort shall bestopped and the reel restarted to empty the retort. Thedischarged containers shall be either reprocessed,repacked and reprocessed, or discarded. Both the timeat which the reel stopped and the time the retort wasused for a still retort process, if so used, shall bemarked on the recording chart and entered on the otherproduction records required in this chapter. If thealternative procedure of emptying the retort isfollowed, the subsequent handing methods used for thecontainers in the retort at the time of the temperaturedrop shall be entered on the production records. If thetemperature drop was less than 10 °F, a scheduledauthorized emergency still process approved by aqualified person(s) having expert knowledge ofthermal processing requirements may be used beforerestarting the retort reel. Alternatively, container entryto the retort shall be stopped and an authorizedemergency agitating process may be used beforecontainer entry to the retort is restarted. Whenemergency procedures are used, no containers mayenter the retort and the process and procedures usedshall be noted on the production records.

(10) Critical factors. Critical factors specified in thescheduled process shall be measured and recorded onthe processing record at intervals of sufficientfrequency to ensure that the factors are within thelimits specified in the scheduled process. Theminimum headspace of containers, if specified in thescheduled process, shall be measured and recorded atintervals of sufficient frequency to ensure that theheadspace is as specified in the scheduled process. Theheadspace of solder-tipped, lapseam (vent hole) cansmay be measured by net weight determinations. Theheadspace of double seamed cans may also bemeasured by net weight determinations forhomogenous liquids, taking into account the specificcan end profile and other factors which affect theheadspace, if proof of the accuracy of suchmeasurements is maintained and the procedure andresultant headspace is in accordance with the scheduledprocess. When the product consistency is specified inthe scheduled process, the consistency of the productshall be determined by objective measurements on theproduct taken from the filler before processing andrecorded at intervals of sufficient frequency to ensurethat the consistency is as specified in the scheduledprocess. Minimum closing machine vacuum in

vacuum-packed products, maximum fill-in or drainedweight, minimum net weight, and percent solids shallbe as specified in the scheduled process for all productswhen deviations from such specifications may affectthe scheduled process. All measurements andrecordings of critical factors should be made atintervals not to exceed 15 minutes.

(d) Equipment and procedures for pressure processingin steam in discontinuous agitating retorts-(1)Indicating mercury-in-glass thermometer. Each retortshall be equipped with at least one mercury-in-glassthermometer whose divisions are easily readable to 1°F and whose temperature range does not exceed 17°F per inch of graduated scale. Thermometers shall betested for accuracy against a known accurate standardthermometer upon installation and at least once a yearthereafter, or more frequently if necessary, to ensuretheir accuracy. Records of thermometer accuracychecks which specify date, standard used, methodused, and person performing the test should bemaintained. Each thermometer should have a tag, seal,or other means of identity that includes the date onwhich it was last tested for accuracy. A thermometerthat has a divided mercury column or that cannot beadjusted to the standard shall be repaired or replacedbefore further use of the retort. Thermometers shall beinstalled where they can be accurately and easily read.Bulbs of indicating thermometers shall be installedeither within the retort shell or in external wellsattached to the retort. External wells or pipes shall beconnected to the retort through at least a 3/4-inch-diameter opening, and equipped with a \1/16\-inch orlarger bleeder opening so located as to provide a fullflow of steam past the length of the thermometer bulb.The bleeder for external wells shall emit steamcontinuously during the entire processing period. Themercury thermometer-not the recorder chart-shall bethe reference instrument for indicating the processingtemperature.

(2) Temperature-recording device. Each retort shallhave an accurate temperature-recording device.Graduations on the temperature-recording devices shallnot exceed 2 °F within a range of 10 °F of theprocessing temperature. Each chart shall have aworking scale of not more than 55 °F per inch within arange of 20 °F of the processing temperature. Thetemperature chart shall be adjusted to agree as nearlyas possible with, but to be in no event higher than, theknown accurate mercury-in-glass thermometer duringthe process time. A means of preventing unauthorizedchanges in adjustment shall be provided. A lock, or anotice from management posted at or near therecording device that provides a warning that only

authorized persons are permitted to make adjustments,is a satisfactory means for preventing unauthorizedchanges. The recorder may be combined with thesteam controller and may be a recording-controllinginstrument. The temperature-recorder bulb shall beinstalled either within the retort shell or in a wellattached to the shell. Each temperature-recorder bulbwell shall have a \1/16\-inch or larger bleederopening emitting steam continuously during theprocessing period. Air-operated temperature controllersshould have adequate filter systems to ensure a supplyof clean, dry air.

(3) Pressure gages. Each retort should be equippedwith a pressure gage, which should be graduated indivisions of 2 pounds or less.

(4) Steam controller. Each retort shall be equippedwith an automatic steam controller to maintain theretort temperature. This may be a recording-controllinginstrument when combined with a recordingthermometer. A steam controller activated by the steampressure of the retort is acceptable if it is mechanicallymaintained so that it operates satisfactorily.

(5) Bleeders. Bleeders, except those for thermometerwells, shall be one-eighth inch or larger and shall bewide open during the entire process, including thecome-up-time. Bleeders shall be located withinapproximately 1 foot of the outermost location ofcontainers, at each end along the top of the retort;additional bleeders shall be located not more than 8feet apart along the top. Bleeders may be installed atpositions other than those specified above, as long asthere is evidence in the form of heat distribution datathat they accomplish adequate removal of air andcirculation of heat within the retort. In retorts havingtop steam inlet and bottom venting, a bleeder shall beinstalled in the bottom of the retort to removecondensate. All bleeders shall be arranged in a waythat enables the operator to observe that they arefunctioning properly.

(6) Venting and condensate removal. The air in eachretort shall be removed before processing is started.Heat distribution data or documentary proof from themanufacturer or from a competent processingauthority, demonstrating that adequate venting isachieved, shall be kept on file. At the time steam isturned on, the drain should be opened for a timesufficient to remove steam condensate from the retortand provision should be made for containing drainageof condensate during the retort operation.

(7) Retort speed timing. The rotational speed of theretort shall be specified in the schedules process. The

speed shall be adjusted, as necessary, to ensure that thespeed is as specified in the scheduled process. Therotational speed as well as the process time shall berecorded for each retort load processed. Alternatively,a recording tachometer may be used to provide acontinuous record of the speed. A means of preventingunauthorized speed changes on retorts shall beprovided. A lock, or a notice from management postedat or near the speed-adjustment device that provides awarning that only authorized persons are permitted tomake adjustments, is a satisfactory means ofpreventing unauthorized changes.

(8) Critical factors. Critical factors specified in theschedules process shall be measured and recorded onthe processing record at intervals of sufficientfrequency to ensure that the factors are within thelimits specified in the scheduled process. Theminimum headspace of containers in each retort load tobe processed, if specified in the scheduled process,shall be measured and recorded at intervals ofsufficient frequency to ensure that the headspace is asspecified in the scheduled process. The headspace ofsolder-tipped, lap seam (vent hole) cans may bemeasured by net weight determinations. When theproduct consistency is specified in the scheduledprocess, the consistency of the product shall bedetermined by objective measurements on the producttaken from the filler before processing and recorded atintervals of sufficient frequency to ensure that theconsistency is as specified in the scheduled process.Minimum closing machine vacuum in vacuum-packedproducts, maximum fill-in or drained weight, minimumnet weight, and percent solids shall be as specified inthe scheduled process for all products for whichdeviations from such specifications may affect thescheduled process. All measurements and recordings ofcritical factors should be made at intervals not toexceed 15 minutes.

(e) Equipment and procedures for pressure processingin water in discontinuous agitating retorts-(1)Indicating mercury-in-glass thermometer. Each retortshall be equipped with at least one mercury-in-glassthermometer whose divisions are easily readable to 1°F and whose temperature range does not exceed 17°F per inch of graduated scale. Thermometers shall betested for accuracy against a known accurate standardthermometer upon installation and at least once a yearthereafter, or more frequently if necessary, to ensuretheir accuracy. Records of thermometer accuracychecks which specify date, standard use, method used,and person performing the test should be maintained.Each thermometer should have a tag, seal, or othermeans of identity that includes the date on which it waslast tested for accuracy. A thermometer that has a

divided mercury column or that cannot be adjusted tothe standard shall be repaired or replaced before furtheruse of the retort. Thermometers shall be installedwhere they can be accurately and easily read. Bulbs ofindicating thermometers shall be installed either withinthe retort shell or in external wells attached to theretort. The mercury thermometer-not the recorderchart-shall be the reference instrument for indicatingthe processing temperature.

(2) Temperature-recording device. Each retort shallhave an accurate temperature-recording device.Graduations on the temperature-recording devices shallnot exceed 2 °F within a range of 10 °F of theprocessing temperature. Each chart shall have aworking scale of not more than 55 °F per inch within arange of 20 °F of the processing temperature. Thetemperature chart shall be adjusted to agree as nearlyas possible with, but to be in no event higher than, theknown accurate mercury-in-glass thermometer duringthe process time. A means of preventing unauthorizedchanges in adjustment shall be provided. A lock, or anotice from management posted at or near therecording device that provides a warning that onlyauthorized persons are permitted to make adjustment,is a satisfactory means for preventing unauthorizedchanges. This recorder may be combined with thesteam controller and may be a recording-controllinginstrument. The temperature-recorder bulb shall beinstalled either within the retort shell or in a wellattached to the shell. Air-operated temperaturecontrollers should have adequate filter systems toensure a supply of clean dry air.

(3) Pressure gages. Each retort should be equippedwith a pressure gage which should be graduated indivisions of 2 pounds or less.

(4) Steam controller. Each retort shall be equippedwith an automatic steam controller to maintain theretort temperature. This may be a recording-controllinginstrument when combined with a recordingthermometer.

(5) Retort speed timing. The rotational speed of theretort shall be specified in the scheduled process. Thespeed shall be adjusted, as necessary, to ensure that thespeed is as specified in the scheduled process. Therotational speed as well as the process time shall berecorded for each retort load processed. Alternatively,a recording tachometer may be used to provide acontinuous record of the speed. A means of preventingunauthorized speed changes shall be provided. A lock,or a notice from management posted at or near thespeed adjustment device that provides a warning thatonly authorized persons are permitted to make

adjustment, is a satisfactory means of preventingunauthorized changes.

(6) Air supply and controls. Means shall be providedfor introducing compressed air at the proper pressureand rate, which shall be controlled by an automaticpressure control unit. A check valve shall be providedin the air supply line to prevent water from entering thesystem.

(7) Critical factors. Critical factors specified in thescheduled process shall be measured and recorded onthe processing record at intervals of sufficientfrequency to ensure that the factors are within thelimits specified in the scheduled process. Theminimum headspace of containers, if specified in thescheduled process, shall be measured and recorded atintervals of sufficient frequency to ensure that theheadspace is as specified in the scheduled process. Theheadspace of solder-tipped, lap seam (vent hole) cansmay be measured by net weight determinations. Whenthe product consistency is specified in the scheduledprocess, the consistency of the product shall bedetermined by objective measurements on the producttaken from the filler before processing and recorded atintervals of sufficient frequency to ensure that theconsistency is as specified in the scheduled process.Minimum closing machine vaccum in vacuum-packedproducts, maximum fill-in or drained weight, minimumnet weight, and percent solids shall be as specified inthe scheduled process for all products when deviationsfrom such specifications may affect the scheduledprocess. All measurements and recordings of criticalfactors should be made at intervals not to exceed 15minutes.

(f) Equipment and procedures for pressure processingin steam in hydrostatic retorts-(1) Indicating mercury-in-glass thermometer. Each retort shall be equippedwith at least one mercury-in-glass thermometer whosedivisions are easily readable to 1 °F and whosetemperature range does not exceed 17 °F per inch ofgraduated scale. Thermometer shall be tested foraccuracy against a known accurate standardthermometer upon installation and at least once a yearthereafter, or more frequently if necessary, to ensuretheir accuracy. Records of thermometer accuracychecks which specify date, standard used, methodused, and person performing the test should bemaintained. Each thermometer should have a tag, seal,or other means of identity that includes the date onwhich it was last tested for accuracy. A thermometerthat has a divided mercury column or that cannot beadjusted to the standard shall be repaired or replaced

before further use of the retort. Thermometers shall beinstalled where they can be accurately and easily read.The thermometer shall be located in the steam domenear the steam-water interface. When the scheduledprocess specifies maintenance of particulartemperatures in the hydrostatic water legs, a mercury-in-glass thermometer shall be located in eachhydrostatic water leg in a position near the bottomautomatic recorder. The mercury thermometer-not therecorder chart-shall be the references instrument forindicating the processing temperature.

(2) Temperature-recording device. Each retort shallhave an accurate temperature-recording device.Graduations on the temperature-recording devices shallnot exceed 2 °F within a range of 10 °F of theprocessing temperature. Each chart shall have aworking scale of not more than 55 °F per inch within arange of 20 °F of the processing temperature. Thetemperature chart shall be adjusted to agree as nearlyas possible with, but to be in no event higher than, theknown accurate mercury-in-glass thermometer duringthe process time. A means of preventing unauthorizedchanges in adjustment shall be provided. A lock, or anotice from management posted at or near therecording device that provides a warning that onlyauthorized persons are permitted to make adjustments,is a satisfactory means for preventing unauthorizedchanges. The recorder may be combined with thesteam controller and may be a recording-controllinginstrument. The temperature-recorder bulb shall beinstalled either within the steam dome or in a wellattached to the dome. Each temperature-recorder bulbwell shall have a \1/16\-inch or larger bleederopening which emits steam continuously during theprocessing period. Additional temperature-recorderbulbs shall be installed in the hydrostatic water legs ifthe scheduled process specified maintenance ofparticular temperatures in the hydrostatic water legs.Air-operated temperature controllers should haveadequate filter systems to ensure a supply of clean dryair.

(3) Pressure gages. Each retort should be equippedwith a pressure gage which should be graduated indivisions of 2 pounds or less.

(4) Recording of temperatures. Temperatures indicatedby the mercury-in-glass thermometer or thermometersshall be entered on a suitable form during processingoperations. Temperatures shall be recorded by anaccurate automatic recorder or recorders at thefollowing points:

(i) In the steam chamber between the steam-waterinterface and the lowest container position.

(ii) Near the top and the bottom of each hydrostaticwater leg if the scheduled process specifiesmaintenance of particular temperatures in the legs.

(5) Steam controller. Each retort shall be equippedwith an automatic steam controller to maintain theretort temperature. This may be a recording-controllinginstrument when combined with a recordingthermometer. A steam controller activated by the steampressure of the retort is acceptable if it is carefullymechanically maintained so that it operatessatisfactorily.

(6) Venting. Before the start of processing operations,the retort steam chamber or chambers shall be ventedto ensure removal of air.

(7) Bleeders. Bleeder openings 1/4-inch or larger shallbe located at the top of the steam chamber or chambersopposite the point of steam entry. Bleeders shall bewide open and shall emit steam continuously duringthe entire process, including the come-up-time. Allbleeders shall be arranged in such a way that theoperator can observe that they are functioningproperly.

(8) Retort speed. The speed of the container-conveyorchain shall be specified in the scheduled process andshall be determined and recorded at the start ofprocessing and at intervals of sufficient frequency toensure that the retort speed is maintained as specified.The speed should be determined and recorded every 4hours. An automatic device should be used to stop thechain when the temperature drops below that specifiedin the scheduled process. A means of preventingunauthorized speed changes shall be provided. A lock,or a notice from management posted at or near thespeed-adjusting device that provides a warning thatonly authorized persons are permitted to makeadjustments, is a satisfactory means of preventingunauthorized changes.



(ii) Closing machine vacuum in vacuum-packedproducts shall be observed and recorded at intervals ofsufficient frequency to ensure that the vacuum is asspecified in the scheduled process.


(g) Aseptic processing and packaging systems-(1)Product sterilizer-(i) Equipment-(a) Temperature-indicating device. Each product sterilizer shall beequipped with at least one mercury-in-glassthermometer or an equivalent temperature-indicatingdevice, such as a thermocouple-recorder. Mercury-in-glass thermometers shall have divisions that are easilyreadable to 1 °F and whose temperature range does notexceed 17 °F per inch of graduated scale.Thermometers and temperature-indicating devicesshall be tested for accuracy against a known accuratestandard thermometer upon installation and at leastonce a year thereafter, or more frequently if necessary,to ensure their accuracy. Records of accuracy checkswhich specify date, standard used, method used, andperson performing the test should be maintained. Eachthermometer and temperature-indicating device shouldhave a tag, seal, or other means of identity thatincludes the date on which it was last tested foraccuracy. A thermometer that has a divided mercurycolumn or that cannot be adjusted to essentialagreement with the standard shall be repaired orreplaced. Thermometers and temperature-indicatingdevices shall be installed where they can be accuratelyand easily read. The temperature-indicating deviceshall be the reference instrument for indicating theprocessing temperature.

(b) Temperature-recording device. There shall be anaccurate temperature recording device on each productsterilizer. The device shall be installed in the product atthe holding-tube outlet between the holding tube andthe inlet to the cooler. Temperature-recording devicesshall have graduations that do not exceed 2 °F within arange of 10 °F of the processing temperature. Eachchart shall have a working scale of not more than 55°F per inch within a range of 20 °F of the desiredproduct-sterilization temperature. The temperaturechart shall be adjusted to agree as nearly as possiblewith, but to be in no event higher than, a knownaccurate mercury-in-glass thermometer. A means ofpreventing unauthorized changes in adjustment shall beprovided. A lock; or a notice from management postedat or near the recording device that provides a warningthat only authorized persons are permitted to makeadjustments, is a satisfactory means for preventingunauthorized changes.

(c) Temperature recorder-controller. An accuratetemperature recorder-controller shall be located in theproduct sterilizer at the final heater outlet. It shall becapable of ensuring that the desired productsterilization temperature is maintained. The chartgraduations shall not exceed 2 °F within a range of 10°F of the desired product sterilization temperature.Air-operated temperature controllers should haveadequate filter systems to ensure a supply of clean, dryair.

(d) Product-to-product regenerators. When a product-to-product regenerator is used to heat the coldunsterilized product entering the sterilizer by means ofa heat exchange system, it shall be designed, operated,and controlled so that the pressure of the sterilizedproduct in the regenerator is greater than the pressureof any unsterilized product in the regenerator to ensurethat any leakage in the regenerator is from thesterilized product into the unsterilized product.

(e) Differential pressure recorder-controller. When aproduct-to-product regenerator is used, there shall bean accurate differential pressure recorder-controllerinstalled on the regenerator. The scale divisions shallnot exceed 2 pounds per square inch on the workingscale of not more than 20 pounds per square inch perinch. The controller shall be tested for accuracy againsta known accurate standard pressure indicator uponinstallation and at least once every 3 months ofoperation thereafter, or more frequently if necessary, toensure its accuracy. One pressure sensor shall beinstalled at the sterilized product regenerator outlet andthe other pressure sensor shall be installed at theunsterilized product regenerator inlet.

(f) Metering pump. A metering pump shall be locatedupstream from the holding tube and shall be operatedto maintain the required rate of product flow. A meansof preventing unauthorized speed changes shall beprovided. A lock, or a notice from management postedat or near the speed-adjusting device that provides awarning that only authorized persons are permitted tomake adjustments, is a satisfactory means ofpreventing unauthorized changes.

(g) Product holding tube. The product-sterilizingholding tube shall be designed to give continousholding of every particle of food for at least theminimum holding time specified in the scheduledprocess. The holding tube shall be designed so that noportion of the tube between the product inlet and theproduct outlet can be heated, and it must be slopedupward at least 0.25 inch per foot.

(h) Flow-diversion systems. If a processor elects toinstall a flow-diversion system, it should be installed inthe product piping located between the product coolerand the product filler or aseptic surge tank and shouldbe designed to divert flow away from the filler oraseptic surge tank automatically. Controls and/orwarning systems should be designed and installed withnecessary sensors and actuators to operate wheneverthe sterilizing temperature in the holding tube orpressure differential in the product regenerator dropsbelow specified limits. Flow-diversion systems shouldbe designed and operated in accordance withrecommendations of an aseptic processing andpackaging authority.

(i) Equipment downstream from the holding tube.Product coolers, aseptic surge tanks, or any otherequipment downstream from the holding tube, withrotating or reciprocating shafts, valve stems,instrument connections, or other such points, aresubject to potential entry of microorganisms into theproduct. Such locations in the system should beequipped with steam seals or other effective barriers atthe potential access points. Appropriate means shouldbe provided to permit the operator to monitor theperformance of the seals or barriers during operations.

(ii) Operation-(a) Startup. Before the start of asepticprocessing operations the product sterilizer and allproduct-contact surfaces downstream shall be broughtto a condition of commercial sterility.

(b) Temperature drop in product-sterilizing holdingtube. When product temperature in the holding tubedrops below the temperature specified in the scheduledprocess, product flow should be diverted away fromthe filler or aseptic surge tank by means of a flow-diversion system. If for any reason product subjected toa temperature drop below the scheduled process isfilled into containers, the product shall be segregatedfrom product that received the scheduled process. Theprocessing deviation shall be handled in accordancewith §113.89. The product holding tube and anyfurther system portions affected shall be returned to acondition of commercial sterility before product flow isresumed to the filler or to the aseptic surge tank.

(c) Loss of proper pressures in the regenerator. Whena regenerator is used, the product may lose sterilitywhenever the pressure of sterilized product in theregenerator is less than 1 pound per square inch greaterthan the pressure of unsterilized product in theregenerator. In this case, product flow should bediverted away from the filler or aseptic surge tank bymeans of the flow-diversion system. If for any reason

the product is filled into containers, the product shallbe segregated from product that received the scheduledprocess and shall be reprocessed or destroyed. Productflow to the filler or to the aseptic surge tank shall notbe resumed until the cause of the improper pressurerelationships in the regenerator has been corrected andthe affected system(s) has been returned to a conditionof commercial sterility.

(d) Loss of sterile air pressure or other protection levelin the aseptic surge tank. When an aseptic surge tank isused, conditions of commercial sterility may be lostwhen the sterile air overpressure or other means ofprotection drops below the scheduled process value.Product flow to and/or from the aseptic surge tank shallnot be resumed until the potentially contaminatedproduct in the tank is removed, and the aseptic surgetank has been returned to a condition of commercialsterility.

(e) Records. Readings at the following points shall beobserved and recorded at the start of aseptic packagingoperations and at intervals of sufficient frequency toensure that these values are as specified in thescheduled process: Temperature-indicating device inholding tube outlet; temperature recorder in holdingtube outlet; temperature recorder-controller at finalheater outlet; differential pressure recorder-controller,if a product-to-product regenerator is used; productflow rate as established by the metering pump or asdetermined by filling and closing rates and, if anaseptic surge tank is used, sterile air pressure or otherprotection means; and proper performance of seamseals or other similar devices. The measurements andrecordings should be made at intervals not to exceed 1hour.

(2) Container sterilizing, filling, and closing operation-(i) Equipment-(a) Recording device. The container andclosure sterilization system and product filling andclosing system shall be instrumented to demonstratethat the required sterilization is being accomplishedcontinuously. Automatic recording devices shall beused to record, when applicable, the sterilization mediaflow 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 eitherto give the retention time of containers, and closures ifapplicable, in the sterilizing environment specified inthe scheduled process, or to control the sterilizationcycle at the rate specified in the scheduled process. Ameans of preventing unauthorized speed changes mustbe provided. A lock, or a notice from managementposted at or near the speed adjusting device that

provides a warning that only authorized persons arepermitted to make adjustments, is a satisfactory meansof preventing unauthorized changes.

(ii) Operation-(a) Startup. Before the start ofpackaging operations, both the container and closuresterilizing system and the product filling and closingsystem shall be brought to a condition of commercialsterility.

(b) Loss of sterility. A system shall be provided to stoppackaging operations, or alternatively to ensuresegregation of any product packaged when thepackaging conditions fall below scheduled processes.Compliance with this requirement may beaccomplished by diverting product away from thefiller, by preventing containers from entering the filler,or by other suitable means. In the event product ispackaged under conditions below those specified in thescheduled process, all such product shall be segregatedand handled in accordance with §113.89. In the eventof loss of sterility, the system(s) shall be returned to acondition of commercial sterility before resumingpackaging operations.

(c) Records. Observations and measurements ofoperating conditions shall be made and recorded atintervals of sufficient frequency to ensure thatcommercial sterility of the food product is beingachieved; such measurements shall include thesterilization media flow rates, temperatures, thecontainer and closure rates (if applicable) through thesterilizing system, and the sterilization conditions if abatch system is used for container sterilization. Themeasurements and recordings should be made atintervals not to exceed 1 hour.

(3) Incubation. Incubation tests should be conductedon a representative sample of containers of productfrom each code; records of the test results should bemaintained.

(4) Critical factors. Critical factors specified in thescheduled process shall be measured and recorded onthe processing record at intervals of sufficientfrequency to ensure that the factors are within thelimits specified in the scheduled process. Suchmeasurements and recordings should be done atintervals not to exceed 15 minutes.

(h) Equipment and procedures for flame sterilizers.The container conveyor speed shall be specified in thescheduled process. The container conveyor speed shallbe measured and recorded at the start of operations andat intervals of sufficient frequency to ensure that theconveyor speed is as specified in the scheduled

process. Such measurements and recordings should bedone at 1-hour intervals. Alternatively, recordingtachometer may be used to provide a continuous recordof the speed. A means of preventing changes in flameintensity and unauthorized speed changes on theconveyor shall be provided. A lock, or a notice frommanagement posted at or near the speed adjustingdevice that provides a warning that only authorizedpersons are permitted to make adjustments, is asatisfactory means of preventing unauthorized changes.The surface temperature of at least one container fromeach conveyor channel shall be measured and recordedat the entry and at the end of the holding period atintervals of sufficient frequency to ensure that thetemperatures specified in the scheduled process aremaintained. Such measurements and recordings shouldbe done at intervals not to exceed 15 minutes.

(1) Process interruption. In the event of processinterruption wherein the temperature of the productmay have dropped, an authorized, scheduledemergency plan approved by a qualified person havingexpert knowledge of the process requirements may beused.


(i) Equipment and procedures for thermal processingof foods wherein critical factors such as water activityare used in conjunction with thermal processing. Themethods and controls used for the manufacture,processing, and packing of such foods shall be asestablished in the scheduled process and shall beoperated or administered in a manner adequate toensure that the product is safe. The time andtemperature of processing and other critical factorsspecified in the scheduled process shall be measuredwith instruments having the accuracy anddependability adequate to ensure that the requirementsof the scheduled process are met. All measurementsshall be made and recorded at intervals of sufficientfrequency to ensure that the critical factors are withinthe limits specified in the scheduled process.

(j) Other systems. All systems, whether or notspecifically mentioned in this part, for the thermalprocessing of low-acid foods in hermetically sealedcontainers shall conform to the applicable requirementsof this part and the methods and controls used for themanufacture, processing, and packing of these foodsshall be as established in the scheduled process. Thesesystems shall be operated or administered in a manner

adequate to ensure that commercial sterility isachieved. Critical factors specified in the scheduledprocess shall be measured and recorded at intervals ofsufficient frequency to ensure that the critical factorsare within the limits specified in the scheduled process.

[44 FR 16215, Mar. 16, 1979, as amended at 62 FR31722, June 11, 1997]

21 cfr ubpartD_P 113

Subpart D-Control of Components, Food ProductContainers, Closures, and In-Process Materials

21 cfr 113.60

§ 113.60 Containers.

(a) Closures. Regular observations shall be maintainedduring production runs for gross closure defects. Anysuch defects shall be recorded and corrective actiontaken and recorded. At intervals of sufficient frequencyto ensure proper closure, the operator, closuresupervisor, or other qualified container closureinspection person shall visually examine either the topseam of a can randomly selected from each seaminghead or the closure of any other type of container beingused and shall record the observations made. Fordouble-seam cans, each can should be examined forcutover or sharpness, skidding or deadheading, falseseam, droop at the crossover or lap, and condition ofinside of countersink wall for evidence of brokenchuck. Such measurements and recordings should bemade at intervals not to exceed 30 minutes. Additionalvisual closure inspections shall be made immediatelyfollowing a jam in a closing machine, after closingmachine adjustment, or after startup of a machinefollowing a prolonged shutdown. All pertinentobservations shall be recorded. When irregularities arefound, the corrective action shall be recorded.

(1) Teardown examinations for double-seam cans shallbe performed by a qualified individual and the resultstherefrom shall be recorded at intervals of sufficientfrequency on enough containers from each seamingstation to ensure maintenance of seam integrity. Suchexaminations and recordings should be made atintervals not to exceed 4 hours. The results of theteardown examinations shall be recorded and thecorrective action taken, if any, shall be noted.

(i) Required and optional can seam measurements:

(a) Micrometer measurement system:

______________________________________________________________________________ RequiredOptional______________________________________________________________________________Cover hookOverlap (by

calculation).Body hookCountersink.Width (length, height)......................Tightness (observation for wrinkle)......................Thickness......................______________________________________________________________________________

(b) Seam scope or projector:

______________________________________________________________________________ RequiredOptional______________________________________________________________________________Body hookWidth (length,

height).OverlapCover hook.Tightness (observation for wrinkle)Countersink.Thickness by micrometer.....................______________________________________________________________________________

(c) Can double seam terminology:

(1) "Crossover": The portion of a double seam at the lap.

(2) "Cutover": A fracture, sharp bend, or break in the metalat the top of the inside portion of the double seam.

(3) "Deadhead": A seam which is incomplete due to chuckspinning in the countersink.

(4) "Droop": Smooth projection of double seam belowbottom of normal seam.

(5) "False seam": A small seam breakdown where thecover hook and the body hook are not overlapped.

(6) "Lap": Two thicknesses of material bondedtogether.

(ii) Two measurements at different locations, excludingthe side seam, shall be made for each double seamcharacteristic if a seam scope or seam projector is used.When a micrometer is used, three measurements shallbe made at points approximately 120° apart, excludingthe side seam.

(iii) Overlap length can be calculated by the followingformula:

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, capperefficiency must be checked by a measurement of thecold water vacuum. This shall be done before actualfilling operations, and the results shall be recorded.

(3) For closures other than double seams and glasscontainers, appropriate detailed inspections and testsshall be conducted by qualified personnel at intervalsof sufficient frequency to ensure proper closingmachine performance and consistently reliablehermetic seal production. Records of such tests shall bemaintained.

(b) Cooling water. Container cooling water shall bechlorinated or otherwise sanitized as necessary forcooling canals and for recirculated water supplies.There should be a measurable residual of the sanitizeremployed at the water discharge point of the containercooler.

(c) Coding. Each hermetically sealed container of low-acid processed food shall be marked with anidentifying code that shall be permanently visible tothe naked eye. When the container does not permit thecode to be embossed or inked, the label may be legiblyperforated or otherwise marked, if the label is securelyaffixed to the product container. The requiredidentification shall identify in code the establishmentwhere packed, the product contained therein, the yearpacked, the day packed, and the period during whichpacked. The packing period code shall be changed withsufficient frequency to enable ready identification oflots during their sale and distribution. Codes may bechanged on the basis of one of the following: intervalsof 4 to 5 hours; personnel shift changes; or batches, aslong as the containers that constitute the batch do notextend over a period of more than one personnel shift.

(d) Postprocess handling. When cans are handled onbelt conveyors, the conveyors should be so constructedas to minimize contact by the belt with the doubleseam, i.e., cans should not be rolled on the doubleseam. All worn and frayed belting, can retarders,cushions, etc. should be replaced with new nonporousmaterial. All tracks and belts that come into contactwith the can seams should be thoroughly scrubbed andsanitized at intervals of sufficient frequency to avoidproduct contamination. Automatic equipment used inhandling filled containers should be so designed andoperated as to preserve the can seam or other containerclosure integrity.

21 cfr ubpartE_P 113

Subpart E-Production and Process Controls

21 cfr 113.81

§ 113.81 Product preparation.

(a) Before using raw materials and ingredientssusceptible to microbiological contamination, theprocessor shall ensure that those materials andingredients are suitable for use in processing low-acidfood. Compliance with this requirement may beaccomplished by receiving the raw materials andingredients under a supplier's guarantee that they aresuitable for use, by examining them for theirmicrobiological condition, or by other acceptablemeans.

(b) Blanching by heat, when required in the preparationof food for canning, should be effected by heating thefood to the required temperature, holding it at thistemperature for the required time, and then eitherrapidly cooling the food or passing it to subsequentprocessing without delay. Thermophilic growth andcontamination in blanchers should be minimized by theuse of adequate operating temperatures and bycleaning. If the blanched food product is washed beforefilling, potable water should be used.

(c) The filling of containers, either mechanically or byhand, shall be controlled so as to ensure that the fillingrequirements specified in the scheduled process aremet.

(d) The exhausting of containers for the removal of airshall be controlled so as to meet the conditions forwhich the process was designed. Compliance with therequirement may be accomplished by heat exhausting,mechanical exhausting, hot brining, or steam injection.

(e) When the maintenance of pH (above 4.6) of anormally low-acid food is a basis for a scheduledprocess, there shall be careful supervision to ensurethat the equilibrium pH of the finished product meetsthat of the scheduled process. The methodologydescribed in §114.90 of this chapter should be used.

(f) When the scheduled process sets forth criticalfactors to prevent the growth of microorganisms notdestroyed by the thermal process, the factors shall becarefully controlled to ensure that the limits establishedin the scheduled process are not exceeded. Whennormally low-acid foods require sufficient solute topermit safe processing at low temperatures, such as in

boiling water, there shall be careful supervision toensure that the equilibrium water activity (a w) of thefinished product meets that of the scheduled process.The scheduled thermal processes for foods having anaw greater than 0.85 and less than the aw that wouldallow the growth of spores of microorganisms ofpublic health significance shall be sufficient to renderthe food free of microorganisms capable ofreproducing in the food under normal nonrefrigeratedconditions of storage and distribution.

21 cfr 113.83

§ 113.83 Establishing scheduled processes.

Scheduled processes for low-acid foods shall beestablished by qualified persons having expertknowledge of thermal processing requirements forlow-acid foods in hermetically sealed containers andhaving adequate facilities for making suchdeterminations. The type, range, and combination ofvariations encountered in commercial production shallbe adequately provided for in establishing thescheduled process. Critical factors, e.g., minimumheadspace, consistency, maximum fill-in or drainedweight, aw, etc., that may affect the scheduled process,shall be specified in the scheduled process. Acceptablescientific methods of establishing heat sterilizationprocesses shall include, when necessary, but shall notbe limited to, microbial thermal death time data,process calculations based on product heat penetrationdata, and inoculated packs. Calculation shall beperformed according to procedures recognized bycompetent processing authorities. If incubation testsare necessary for process confirmation, they shallinclude containers from test trials and from actualcommercial production runs during the period ofinstituting the process. The incubation tests forconfirmation of the scheduled processes should includethe containers from the test trials and a number ofcontainers from each of four or more actualcommercial production runs. The number of containersfrom actual commercial production runs should bedetermined on the basis of recognized scientificmethods to be of a size sufficient to ensure theadequacy of the process. Complete records covering allaspects of the establishment of the process andassociated incubation tests shall be prepared and shallbe permanently retained by the person or organizationmaking the determination.

21 cfr 113.87

§ 113.87 Operations in the thermal processingroom.

(a) Operating processes and retort venting proceduresto be used for each product and container size beingpacked shall either be posted in a conspicuous placenear the processing equipment or be made readilyavailable to the retort or processing system operatorand any duly authorized employee of the Food andDrug Administration. Scheduled processes must bemade readily available to the supervisor and any dulyauthorized employee of the Food and DrugAdministration.

(b) A system for product traffic control in the retortroom shall be established to prevent unretorted productfrom 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 containsany retorted food product, be plainly andconspicuously marked with a heat-sensitive indicator,or by other effective means that will indicate visually,to thermal processing personnel, those units that havebeen retorted. A visual check shall be performed todetermine whether or not the appropriate change hasoccurred in the heat-sensitive indicator as a result ofretorting for all retort baskets, trucks, cars, or crates, toensure that each unit of product has been retorted. Awritten record of these checks should be made.

(c) The initial temperature of the contents of thecontainers to be processed shall be determined andrecorded with sufficient frequency to ensure that thetemperature of the product is no lower than theminimum initial temperature specified in the scheduledprocess. For those operations that use water during thefilling of the retort or during processing, provisionshall be made to ensure that the water will not, beforethe start of each thermal process, lower the initialtemperature of the product below that specified in thescheduled process.

(d) Timing devices used in recording thermal processtime information shall be accurate to the extent neededto ensure that the processing time and venting timespecified in the scheduled process are achieved. Pocketor wrist watches are not considered satisfactory fortiming purposes. Digital clocks may be used if theoperating process and the venting schedule have a 1-minute or greater safety factor over the scheduledprocess.

(e) Clock times on recording-temperature charts shouldreasonably correspond to the time of day on the writtenprocessing records to provide correlation of theserecords.

(f) The steam supply to the thermal processing systemshall be adequate to the extent needed to ensure thatsufficient steam pressure is maintained during thermalprocessing, regardless of other demands of steam bythe plant.

(g) If mufflers are used on bleeders or vent systems,evidence that the bleeders or vents are operated in amanner that does not significantly impede the removalof air shall be kept on file. This evidence may be in theform of heat distribution data or other satisfactoryevidence such as a letter from the manufacturer, thedesigner, or a competent processing authority.

21 cfr 113.89

§ 113.89 Deviations in processing, venting, orcontrol of critical factors.

Whenever any process is less than the scheduledprocess or when critical factors are out of control forany low-acid food or container system as disclosedfrom records by processor check or otherwise, thecommerical processor of that low-acid food shall eitherfully reprocess that portion of the production involved,keeping full records of the reprocessing conditions or,alternatively, must set aside that portion of the productinvolved for further evaluation as to any potentialpublic health significance. Such evaluation shall bemade by a competent processing authority and shall bein accordance with procedures recognized bycompetent processing authorities as being adequate todetect any potential hazard to public health. Unless thisevaluation demonstrates that the product had beengiven a thermal process that rendered it free ofmicroorganisms of potential public health significance,the product set aside shall be either fully reprocessed torender it commercially sterile or destroyed. A recordshall be made of the evaluation procedures used andthe results. Either upon completion of full reprocessingand the attainment of commerical sterility or after thedetermination that no significant potential for publichealth hazard exists, that portion of the productinvolved may be shipped in normal distribution.Otherwise, the portion of the product involved shall bedestroyed. All process deviations involving a failure tosatisfy the minimum requirements of the scheduledprocess, including emergencies arising from a jam or

breakdown of a continuous agitating retortnecessitating cooling the retort for repairs, shall berecorded and made the subject of a separate file (or alog identifying the appropriate data) detailing thosedeviations and the actions taken.

21 cfr ubpartF_P 113

Subpart F-Records and Reports

21 cfr 113.100

§ 113.100 Processing and production records.

(a) Processing and production information shall beentered at the time it is observed by the retort orprocessing system operator, or other designated person,on forms that include the product, the code number, thedate, the retort or processing system number, the sizeof container, the approximate number of containers percoding interval, the initial temperature, the actualprocessing time, the mercury-in-glass and recordingthermometer readings, and other appropriateprocessing data. Closing machine vacuum in vacuum-packed products, maximum fill-in or drained weight, orother critical factors specified in the scheduled processshall also be recorded. In addition, the followingrecords shall be maintained:

(1) Still retorts. Time steam on; time temperature up toprocessing temperature; time steam off; venting timeand temperature to which vented.

(2) Agitating retorts. Functioning of condensatebleeder; retort speed; and, when specified in thescheduled process, headspace, consistency, maximumdrained weight, minimum net weight, and percentsolids.

(3) Hydrostatic retorts. The temperature in the steamchamber between the steam-water interface and thelowest container position; speed of the containerconveyor chain; and, when the scheduled processspecifies maintenance of particular temperatures in thehydrostatic water legs, the temperatures near the topand the bottom of each hydrostatic water leg.

(4) Aseptic processing and packaging systems. Producttemperature in the holding tube outlet as indicated bythe temperature-indicating device and the temperature

recorder; product temperature in the final heater outletas indicated by the temperature recorder-controller;differential pressure as indicated by the differentialpressure recorder-controller, if a product-to-productregenerator is used; product flow rate, as determinedby the metering pump or by filling and closing rates;sterilization media flow rate or temperature or both;retention time of containers, and closures whenapplicable, in the sterilizing environment; and, when abatch system is used for container and/or closuresterilization, sterilization cycle times and temperatures.

(5) Flame sterilizers. Container conveyor speed;surface temperature at the beginning and at the end ofthe holding period; nature of container.

(6) Food preservation methods wherein critical factorssuch as water activity are used in conjunction withthermal processing. Product formulation and scheduledprocesses used, including the thermal process, itsassociated critical factors, as well as other criticalfactors, and results of aw determinations.

(7) Other systems. Critical factors specified in theformulation of the product or in the scheduled process.

(b) Recording thermometer charts shall beidentified by date, retort number, and other dataas necessary, so they can be correlated with thewritten record of lots processed. Each entry onthe processing and production records shall bemade by the retort or processing system operator,or other designated person, at the time thespecific retort or processing system condition oroperation occurs, and this retort or processingsystem operator or other designated person shallsign or initial each record form. Not later that 1working day after the actual process, and beforeshipment or release for distribution, arepresentative of plant management who isqualified by suitable training or experience shallreview all processing and production records forcompleteness and to ensure that the productreceived the scheduled process. The records,including the recording thermometer chart(s),shall be signed or initialed and dated by thereviewer.

(c) Written records of all container closureexaminations shall specify the product code, the dateand time of container closure inspections, themeasurements obtained, and all corrective actionstaken. Records shall be signed or initialed by thecontainer closure inspector and reviewed bymanagement with sufficient frequency to ensure thatthe containers are hermetically sealed.

(d) Records shall be maintained to identify the initialdistribution of the finished product to facilitate, whennecessary, the segregation of specific food lots thatmay have become contaminated or otherwise renderedunfit for their intended use.

(e) Copies of all records provided for in this part,except those required under §113.83 establishingscheduled processes, shall be retained at the processingplant for a period of not less than 1 year from the dateof manufacture, and at the processing plant or otherreasonably accessible location for an additional 2years. If, during the first year of the 3-year record-retention period, the processing plant is closed for aprolonged period between seasonal packs, the recordsmay be transferred to some other reasonably accessiblelocation at the end of the seasonal pack.

Pt. 114

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