IFTPS Retort - Processing - Guidelines - 02 - 13 - 14 PDF

IFTPSGuidelinesforConductingThermalProcessingStudies
IssueDate:March13,2014
SupersedesDate:New i
Institute For Thermal Processing Specialists
GUIDELINESFORCONDUCTINGTHERMALPROCESSINGSTUDIES
Thefollowingrecommendationsaretobeconsideredvoluntaryguidelines.Theserecommendations
donotprecludetheapplicationofothermethodsandequipmentforconductingthermalprocessing
studies.TheseguidelineshavebeendevelopedbyconsensusoftheInstituteforThermalProcessing
Specialistsandshouldbegivenseriousconsiderationforadoptionasmethodologybyindividuals
performingthermalprocessingstudies.
TheInstituteforThermalProcessingSpecialistsisanonprofitorganizationestablishedexclusivelyfor
thepurposeoffosteringeducationandtrainingforthosepersonsinterestedinprocedures,techniques
andregulatoryrequirementsforthermalprocessingofalltypesoffoodorothermaterials,andforthe
communicationofinformationamongitsmembersandotherorganizations.
ThisdocumentisacompilationandrestructuringofpreviouslypublishedIFTPSguidancedocuments.
Priordocumentsweremodifiedtofollowacommonformatandwerealsoupdatedtoreflectcurrent
practices.Commonsectionsamongstpreviouslypublisheddocuments,suchasRetortSurvey,were
placedintoseparatechapters.InformationwasaddedtoChaptersonTemperatureDistribution,Heat
TransferDistribution,andHeatPenetrationtoproviderecommendationsregardingDataAnalyses,
SuccessCriteria,andRisks,IssuesandOtherConsiderations.
Hyperlinkshavebeenembeddedthroughoutthedocumenttoassistthereaderinnavigatingbetween
differentchapters.Hyperlinksmaybeidentifiedasunderlined,bluetext.
Instructionsforfollowinghyperlinksindocuments
TofollowalinktothepointbeingreferencedPressCTRLkey+leftclickonthemousetomoveto
referenceditem.NotethattheinstructiontoCTRL+clickwillalsoshowwhenthecursorisplaced
withinahyperlink.
ToreturntotheplaceinthedocumentwhereyouwerereadingPressALTkey+backarrow(Alt+)
(notethatusingthebackspacekeywillnotwork).

SupersedesDate:New ii

This document was approved for publication in March, 2014 by the IFTPS Board of
Directors.

Institute For Thermal Processing Specialists
304 Stone Rd. W., Ste. 301, Guelph. ON N1G 4W4
P: 519 824 6774 F: 519 824 6642 info@iftps.org
www.iftps.org

SupersedesDate:New iii
TABLE OF CONTENTS
Chapter 1 Definitions
Chapter 2 Test Equipment and Standardization/Calibration
Chapter 3 Documenting Processing Equipment and Test Conditions
Chapter 4 Conducting Temperature Distribution Studies
Chapter 5 Conducting Heat Transfer Distribution Studies
Chapter 6 Conducting Heat Penetration Studies
Appendices
A. LiteratureCited
B. DocumentingProcessingEquipmentandTestConditions
C. TemperatureDistributionDataMonitoring/CollectionPointsbyRetortType
D. HeatPenetrationDocumentationChecklist

SupersedesDate:New 11
1 DEFINITIONS
Thischapterprovidesdefinitionscommonlyusedforthermalprocessingstudies.
TERM DEFINITION
BallastContainers
Thesearecontainersusedtofilltheretortduringthermalprocessingstudiesto
simulateproductionconditions.Typically,ballastcontainersforheatpenetration,
temperaturedistributionandheattransferdistributionstudiesarethesametype,
shapeandsizeofcontainersasusedfortheintendedprocess.Insomeretort
systems,e.g.,multibasketbatchretorts,ballastcontainersmaynotneedtobethe
sameinbasketsnotcontainingheatpenetrationandheattransferdistribution
probes.Materialusedforfillingcontainersmaybethetestproduct,oranysuitable
materialhavingheatingcharacteristicssimilartothatofthetestproduct,orinsome
circumstances,water(e.g.,temperaturedistribution).
BrokenHeating
Heattransfercharacteristicofsomefoods,particularlythosewithstarches,where
theheattransferratechangesduetoachangeintheproductasaresultofproduct
heating.Thechangeinheattransferratemayrepresentachangefromheating
primarilybyconvectiontoheatingbyconduction.
Calibration
Tocheck,adjust,ordeterminebycomparisonwithatraceablestandardthe
graduationsofaquantitativemeasuringinstrument.
Cassettes/Trays/Racks
Ameansbywhichfilledpackagesareheld/carriedinaretort.Cassettes/trays/racks
maybeloadedintocubes,baskets,orothermeanstoconveyfilledpackagesinto
andoutofaretort.
ColdSpotHeatPenetration
Thecoldspotforheatpenetrationstudiesisdeterminedexperimentallyand
representstheslowestheatinglocationwithinthecontainer.Inthecaseofnon
homogenousfoods,theslowestheatingfoodparticleintheslowestheatinglocation
withinthecontainerwouldbeconsideredtobethecoldspot.
ColdSpotTemperature
Distribution
Thecoldspotfortemperaturedistributionisgenerallythatareaoftheretortwhich
isthelastareaintheretorttoreachaminimumprocessingtemperatureduring
comeup.
ColdSpotHeatTransfer
Distribution
Theslow/slowertoheatlocation(s)forHeatTransferDistributionisgenerallythe
location(s)intheretortwhereheattransferintotheproductistheslowest.Thisis
indicatedbythelocationwiththelargestf
h
value.
ComeUpTime(CUT)
Comeuptime(CUT)isdefinedasthetimerequirementforthereferenceTIDtoread
atorabovetheminimumprocesstemperatureANDallTMDstoreadwithin1F
(0.5C)ofminimumprocesstemperaturewithin1minuteofstartingtheholdtime.
CommercialSterility
Commercialsterilityisdefinedastheconditionachievedbyapplicationofheat,or
othertreatmentsthatrenderstheproductfreeofviablemicroorganismshaving
publichealthsignificanceaswellasmicroorganismsofnonhealthsignificance
capableofreproducinginfoodundernormalnonrefrigeratedconditionsofstorage
anddistribution.
ComputerControlSystem
Computerusedforautomationofelectromechanicalprocesses.Alsoreferredtoasa
ProgrammableLogicController(PLC).
Conduction
Atypeofheattransferthatmaybecharacterizedasonewhereagitationofthe
packagewiththefooddoesnotimpacttheheattransferrate.
Convection
Atypeofheattransferthatmaybecharacterizedasonewhereagitationofthe
packagewiththefooddoesimpact(positively)theheattransferrate.
CratelessRetort
Anonagitating(i.e.,still)batchretortwhereincansaresterilizedinsaturatedsteam
asajumblepack,withoutbaskets,traysorcassettes.Loadingisbydroppingcans
fromtheretorttopintoacushionofwaterandcansareunloadedbygravity
droppingoutthebottomintoawatercanalwithadragchaintodryingandpacking.
CriticalFactors
USFDA21CFRPart113definescriticalfactorsasanyproperty,characteristic,
condition,aspect,orotherparameter,variationofwhichmayaffectthescheduled
processandtheattainmentofcommercialsterility.Criticalfactorsmayinclude
physicalandchemicalaspects/parametersassociatedwiththecontainer,the
product,theretortandprocessingconditions.
f
h
Thetimefortheheatpenetrationcurvetotraverseonelogcycle.Alsoreferredtoas
theheatingrateindex.
Fill,Drained,andNet
Weights
FillWeightmeanstheweightofsolidproductinthecontainerbeforeprocessingand
doesnotincludetheweightofthepackageorcoverliquid(ifapplicable);Drained
Weightistheweightofsolidsafterprocessing;andNetWeightofaproductrefersto
theweightofallproductinthecontainerincludinganycoverliquidminustheweight
ofthecontainer.
FlowMeter Aninstrument/device/sensorthatmeasuresfluidflowrate.
HeatPenetration
StudiesconductedtodetermineandestablishaScheduledProcess.Heat
Penetrationstudiesaretypicallyconductedunderworstcaseconditionsfor
product,package,location,andretortparameters.
HeatTransferDistribution
Heattransferdistributionstudiesareusedtoestablishtheabilityofaretortprocess
touniformlymixanddistributetheheattransfermediumespeciallywhentheheat
transferintoproductmayberatelimiting.
HeatInputUnit(HIU)
Appropriatematerialsuchasapolymer,clay,orfoodproductwith
repeatable/definitivethermophysicalproperties,andcapableofbeingusedforheat
transferdistributionstudies.
HeatPenetrationCurve
Plotofthelogarithmicdifferencebetweeneitherretorttemperatureandproduct
temperature(heatingcurve)orproducttemperatureandcoolingmedium
temperature(coolingcurve)versustime.
HermeticSeal
Theconditionwhichexcludestheingressofmicroorganisms,filthorother
environmentalcontaminantsthatcouldrendertheproductunfitforconsumptionor
whichcouldreducethequalityoftheproducttoalevellessthanintended.
InitialTemperature
Theaveragetemperatureofthecontentsofthecoldestcontainertobeprocessedat
thetimethesterilizationcyclebegins.
LowAcidCannedFood
(LACF)
Anyfood,otherthanalcoholicbeverages,withapH>4.6andawateractivity(a
w
)
greaterthan0.85packagedinahermeticallysealedcontainersthatarethermally
processedandstoredatambienttemperatures.
LoadingPattern/Map
Adepictionshowinglocationsofprobesand/orprobedcontainers(e.g.,temperature
distribution,heatpenetration,andheattransferdistribution)withinaretortload.
Nesting/Shingling
Conditionthatoccurswhenmorethanonecontainerisstackedfullyorpartiallyon
topofanothercontainer.Inthecaseofpouches,thisisreferredtoasshingling.
Nesting/shinglingmaynegativelyimpactheattransfer/heatpenetration.
Overpressure
Pressureinexcessofthatcorrespondingtosaturatedsteamvaporpressureata
giventemperatureandwhencorrectedforaltitude.Overpressuremaybenecessary
tomaintainpackageintegrityduringtheprocess.
PackingGland(StuffingBox)
SoftrubberorothermaterialthatisusedtocreateatightsealaroundTMDs/PMDs
thatassistsinprovidingameanstopenetratetheretortshellwithoutallowing
processmediatoleaktoatmosphere(ifapplicable).
pH
Ameasureofacidityoralkalinity.Chemically,pHisdefinedasthenegativelogof
thehydrogenionconcentration.
PipingandInstrumentation
Diagram(P&ID)
Diagramwhichshowsthepipingoftheprocessflowtogetherwiththeinstalled
equipmentandinstrumentation.
Plenum/Shroud
Inasteam/airretort,theplenum/shroudisthespacebetweentheretortshelland
theportionoftheretortholdingthebaskets/cassettes.Thefunctionofthe
plenum/shroud,usuallyinconjunctionwithafan,facilitatesmovementofsteam/air
throughtheretortandretortload.
Pocketspace Spacewithinacassette/rack/traytoholdapackage.
PressureControlSensing
Device
Instrumentusedtocontrolpressureinsidetheretort.
PressureIndicatingDevice
(PID)
Instrumentusedtomonitorpressureinsidetheretort,e.g.,pressuregaugeor
pressuretransmitterwithelectronicdisplay.
PressureMeasuringDevice
(PMD)
Pressuresensorplacedwithin(ormountedon)theretorttoaccuratelymonitor
pressuresattainedandmaintainedthroughouttheappliedprocess.
ProcessDeviation
Achangeinanycriticalfactorofthescheduledprocessthatreducesthesterilizing
valueoftheprocess,orwhichraisesaquestionregardingthepublichealthsafety
and/orcommercialsterilityoftheproductlot/batch.
ProcessEstablishment
Scientificproceduretodeterminetheadequateprocesstimeandtemperatures
requiredtoproducecommerciallysterilecannedproducts.
ResistanceTemperature
Detector(RTD)
Thermometrysystembasedonthepositivechangeintheresistanceofametal
sensingelement(commonlyplatinum)withincreasingtemperature.
Retort
Anyclosedvesselorotherequipmentusedforthermalprocessing.Mayalsoreferto
theactofapplyingathermalprocesstoacannedfoodinaclosedpressurizedvessel.
Mayalsobereferredtoasasterilizer.Thetermsretortandsterilizerareoften
usedinterchangeably.
RetortContinuous
Rotary/ReelandSpiral
Cooker/CoolerRetorts
InContinuousRotary/ReelandSpiralCookerCoolerretorts,cansenterandexitthe
processingvesselthroughmechanicalpressurelocks.Onceinthevessel,cansmove
throughaspiraltrackmountedonareelthatisrotatinginsideahorizontal
cylindricalshell.Inonerevolutionofthereel,cansrollbygravityalongthebottom
partofthearc(approximately90120),whichprovidesmostoftheproductmixing
withinthecan.Thecansareessentiallystaticastheypassthroughtheremainderof
thearc(approximately240270).
RetortHydrostatic
Aretortinwhichtotalpressureinthesterilizationsectionisdeterminedand
maintainedbythehydrostaticpressureofinletandoutletwatercolumns.Packages
arecontinuouslyconveyedthroughthemachine.
Separator/DividerSheet
Separator/dividersheetsareusedtoseparatelayersofpackagesinabasket/crate.
Thesetypicallycontainperforations/holestohelpfacilitatefreemovementofthe
heattransfermedium.Materialsofconstructioncanvarymetal/stainlesssteel,
rubber,plastic,andsoforth.
ScheduledProcess
Theprocessdefinedbytheprocessorasadequateundertheconditionsof
manufactureforagivenproducttoachievecommercialsterility.
Should
Shouldisusedinthisdocumenttoindicatearecommendationoroptionfor
consideration.
SimpleHeating
Heattransfercharacteristicofsomefoodswheretheheattransferrateisrelatively
constantduringproductheating.
SlipRing
Adevicethatallowsfortransferofthethermocouplevoltagesignalfromarotating
environmenttoastationaryelectricalcontactoutsideofaretort.
Steam/AirFlowIndicator
Indicatorlocatedintheretortshelltodeterminethedirectionandtomeasureflow
(cubicfeetperminutecfm)ofprocessmedia.
Steam/AirRatio
Thesteam/airratio(forisothermal/isobaricconditionsofthecooksegment)is
calculatedbyvolumebydeterminingtheamountofsteampressureatacertain
temperatureplustheatmosphericpressureatsealevelanddividingthatvalueby
thetotalabsoluteTotalPressureofSteamandAir/Nitrogenasindicatedbythe
retortgaugepressureplustheatmosphericpressure.Forexample,usingthesteam
tables,at240F(115.6C),theabsolutesaturatedsteampressureatsealevelis
24.968psia/1.722bar(or10.272psigand0.708bargauge).Foraprocesswitha
gaugepressureof15psig(1.034bargauge),theabsolutepressureatsealevelis
29.696psia(2.048bar).Thiswouldequatetoasteam/airmixturethatis84%
saturatedsteam(i.e.,24.968/29.696X100%or1.722/2.048X100%)and16%
overpressureair(i.e.29.69624.968/29.696X100%).Notethatthealtitudeofthe
processingfacilityshouldbeconsideredwhenconvertinggaugepressuretoabsolute
pressure.
Steam/AirRetort Asteam/airretortisabatchretortthatusesair/nitrogentoprovideoverpressure.
Steam/AirRetortForced
FlowSteam/AirRetort
Inaforcedflowretort,amixingfaninducesaforcedconvectionoftheprocess
heatingmediabydrawingthesteam/airmixturethroughtheproductandcirculating
itthroughareturnplenum.Steamisintroducedbetweenbasketswhileairover
pressureisintroducedintothereturnplenumcavity.
Steam/AirRetortAir
MakeupSteam/AirRetort
Inthistypeofretort,smallventvalvesontheretortremainopenafterdesired
temperatureandpressureareachievedandprovidecontinuousventingoftheretort
duringtheheatingperiod.Airisreintroducedintotheretortasneededtosatisfy
overpressurerequirementswhilesteamissimultaneouslyaddedtomaintain
temperature.
Steam/AirRetortPositive
FlowSteam/AirRetort
Inthistypeofretort,acontinuousflowofsteamandairarepassedthroughthe
vesseltocreateahomogeneousmixturethroughouttheretort.Thiscreatesan
overpressureconditionintheretortandresultsincontinuousventingofthe
steam/airmixturethuscreatingflowpastthecontainers.
Sterilizer SeedefinitionaboveforRetort.
SufficientSampling
Frequency(DataCollection)
Asusedinthisdocument,sufficientsamplingfrequencyisdeterminedbythe
processorandshouldbefrequentenoughtoconfirmthatthemeasuredparameter
iswithincontrol.
TemperatureControl
SensingDevice
Deviceusedforcontrollingtemperatureinaretort.
TemperatureIndicating
Device(TID)
Deviceusedformonitoringtemperature,includingthermometers,thermocouples,
RTDsandthermistorsandgenerallyreferredtoastheofficialorreference
temperaturemonitoringdeviceonaretortsystem.AMercuryinGlass(MIG)
thermometerisanexampleofaTID.
TemperatureMeasuring
Device(TMD)
Deviceusedformeasuringtemperature,includingthermometers,thermocouples,
RTDs,wirelessdataloggers,andthermistors.
TemperatureUniformityand
Stability
Verificationoftemperatureacross/withintheretortload(uniformity)andovertime
(stability)oftheprocessparticularlyduringCook/Hold.
Thermistor
TMDmanufacturedfromsemiconductormaterialswhichexhibitslargechangesin
resistanceproportionaltosmallchangesintemperature.Thermistorsaremore
sensitivetotemperaturechangesthanthermocouplesorRTDsandarecapableof
detectingrelativelysmallchangesintemperature.
Thermocouple
TMDcomposedoftwodissimilarmetalswhicharejoinedtogethertoformtwo
junctions.Whenonejunctioniskeptatanelevatedtemperatureascomparedtothe
other,asmallthermoelectricvoltageorelectromotiveforce(emf)isgenerated
whichisproportionaltothedifferenceintemperaturebetweenthetwojunctions.
TemperatureDistribution
Studiesconductedinasterilizer(retort)usingdistributedtemperaturemeasuring
devices(TMD)toestablishventingprocedures,ventingschedules,comeup
requirements,andtemperaturestabilityanduniformity,whicharenecessaryto
establishheatingandcoolingperformance(i.e.,temperatureuniformity)throughout
theretort.Temperaturedistributionstudiesaretypicallyperformedusingactual
productionretortconditionsorparameters.
Tray/Rack SeeCassette/Tray/Rackabove
Validation
Therearemultipledefinitionsofthewordvalidation.Inthecontextofthis
guidelinedocument,validationisassumedtomeanatleasttwosuccessiveand
successfulreplicatestudiesthatmeetestablishedsuccess/acceptancecriteria.
Vent/Venting
Aventisadevice/valvethroughwhichairisremovedfromaretort.Ventingisthe
processbywhichairisremoved.
Verification
Inthecontextofthisguidancedocument,verificationisassumedtomeanreplicate
studiesthatareintendedtoconfirmaprocess.Verificationmayalsobeusedto
indicateconfirmationofthecalibrationstatusofprocessmeasurementdevicesused
tocollectthermalprocessdata.
WaterActivity(a
w
)
Wateractivity(a
w
)isdefinedastheratioofthepartialpressureofwaterabovea
foodtothewatervaporpressureofpurewateratagiventemperature(a
w
=p/p
o
).
WaterCascadeRetort
Awatercascaderetortisdefinedasonewhereasmallamountofprocesswateris
drawnfromthebottomoftheretortbyahighcapacitypumpanddistributed
throughmetalplate(s)ormanifold(s)inthetopoftheretort.Thisprocesswater
cascadesdownovertheretortcassettes,cagesorracksinarainwaterorshower
fashion,passingovertheproductcontainersonthewaybacktothebottomofthe
retortwhereitisrecirculatedthroughtheheatinganddistributionsystem.
Processingwatermaybeheatedusingoneormoredirectorindirectheating
methodsincludingheatexchangers,directsteaminjection,orviasteamdistribution
pipesorspreaders.
WaterImmersionRetort
Awaterimmersionretortisdefinedasonewhereprocesswaterissometimes
heatedinaseparatevesselandoncetheprocesswaterreachesthedesired
processingtemperature,isdroppedintotheprocessingvessel.Waterisre
circulatedduringprocessing.Sufficientwatertocompletelycoverthepackagesmay
beused.Inothercases,packagesmayonlybepartiallycoveredwithwaterduring
processing.
WaterSprayRetort
Awatersprayretortisdefinedasonewhereacontrolledamountofprocesswateris
drawnfromthebottomoftheretortbyahighcapacitypumpanddistributed
throughspraynozzleslocatedalongthetopandsidesoftheretort.Thisprocess
waterissprayedovertheretortcassettes,cagesorracksinahighpressuremist
fashionpassingovertheproductcontainersonthewaybacktothebottomofthe
retortwhereitisrecirculatedthroughtheheatinganddistributionsystem.
Processingwatermaybeheatedusingoneormoredirectorindirectheating
methodsincludingheatexchangers,directsteaminjection,orsteamdistribution
pipesorspreaders.
Asensor/measuringdevicethatisselfcontained(i.e.,doesnotrequirewires).These
WirelessDatalogger devicestypicallyrequireprogrammingpriortouseandcollecteddataarethen
downloadedortransmittedforanalysesafteruse.
%CV
Thecoefficientofvarianceismathematicallycalculatedbydividingthestandard
deviationofasetofnumbersbytheaverageofthesamesetofnumbersandthen
multiplyingthatquotientby100.(%CV=standarddeviation/average*100)

2 TESTEQUIPMENTANDCALIBRATIONOFTESTEQUIPMENT
SCOPE
2.1. Theguidelinesinthischapterapplytoequipmentusedtocollectthermalprocessdatainany
retortsystem.Theguidelinesapplytobothinternalandexternalmeasuringanddatacollection
systems.Testequipmentusedforcollectingthermalprocessdatashouldbesuitableforthe
purposeofthestudiesbeingconducted.Devicestocollecttemperaturedistribution,heat
transferdistribution,andheatpenetrationdata,ingeneral,shouldbecalibratedrelativetothe
expectedtestconditionsandrangespriortoconductingthermalprocessstudies.Ideally,
devicesshouldalsobecalibrateduponcompletionofthermalprocessstudies.Processefficacy
andsuccesscriteriaofthermalprocessingstudiesmaynotbemetifsensorsandmeasuring
devicesareinaccuratelycalibrated.
2.2. Biologicalindicatorsarenotaddressedinthischapter.
OBJECTIVE
2.3. Theobjectiveofthisdocumentistoprovideguidancewithregardtocalibrationoftest
equipmentusedtocollectthermalprocessdata.
TOOLS,EQUIPMENT,INSTRUMENTATION
2.4. DataAcquisitionSystemThedataacquisitionsystemshouldbecalibratedpriortouse.It
shouldalsobeequippedwithsufficientchannelstoaccuratelymonitorandrecord
temperature/pressurewithintheprocessdeliverysystem.Manualrecordingofdatamaybe
usedifasufficientsamplingfrequencycanbemaintained.
2.5. TemperatureMeasuringDevice(TMD)TMDsmaybethermocouples,wirelessdataloggers,or
othersimilardevices.AllTMDsmustbeofsufficientaccuracy,size,andlength,andinsufficient
quantity,toadequatelyandaccuratelymonitortheprocessenvironment.
2.6. PressureIndicatingDevicesOperationalgauges,electronicindicators,and/orwirelessdata
loggersmaybeusedtomonitorpressuresassociatedwiththeretortoperationduringatest.
Thesedevicesshouldbecalibratedpriortothestartofdatacollection.Typicalpressure
measurementscouldinclude:retortvesselpressure,steamlinepressure,andotherline
pressuresthatmaybecriticaltotheprocess.
2.7. ReferenceTemperatureIndicatingDevice(TID)ThismaybearetortMercuryInGlass(MIG)
thermometerorothervalidreferencetemperaturemeasuringdeviceincludingadigital
thermometerofsufficientaccuracyandprecision.
2.8. PackingGland(StuffingBox)Thisisneededforentryofleadwiresintotheretortwhenwired
datacollectiondevicesareused.Materialsusedshouldbesoftenoughtoprovideatightseal
withoutovertighteninganddamagingtheTMDs.ExamplesincludeNeopreneorother
syntheticmaterials.
2.9. SlipRingThisallowsfortransferofthermocoupleoutputsfromarotatingenvironmenttoa
stationaryelectricalcontactoutsideoftheretort.
2.10. FlowMetersWhereapplicable,flowmetersmaybeusedtomeasureflowofprocesswater
duringcomeup,heating,andcoolinginthosesystemsusingcirculatingpumps.Flowmeters
maybeusedtomeasurevolumeorvelocityofairflowinthosesystemsusingairforagitation
ofheatingandcoolingmedia.
2.11. StopwatchThisisneededtoverifyrotationrate/speedinsystemsthathaveagitationand/or
continuouscontainerhandling.
2.12. HeatInputUnit(HIU)Anappropriatematerialtosimulatetheproductbeingstudiedinheat
transferdistributionstudies.PackagedproductmayalsobeusedasanHIU.

METHODSFORTESTEQUIPMENTSTANDARDIZATION
2.13. RetortTemperatureIndicatingDevice(TID)Thereferencetemperaturemeasurementdevice
mustconformtoapplicableregulations.Forexample,USFDAregulation21CFRPart113
establishestherequirementthattemperatureindicatingdevicesandreferencedevicesmustbe
testedagainstareferencedeviceforwhichtheaccuracyistraceabletoaNationalInstituteof
StandardsandTechnology(NIST),orothermetrologyinstitute.Thereferencedeviceistypically
calibratedforaccuracyagainstaknowncertifiedreferencedeviceatleastannually.The
preferenceistohavetheRetortTIDcalibratedneartothetimedataarecollected.Thelast
calibrationcheckdateshouldbeincludedinthestudydocumentation.
2.14. MeasurementSystem(s)Measurementsystemsincludeasapplicable:thermocouples/TMDs
(withextensionwiresasapplicable),dataacquisitionsystem,pressuremeasurementdevices,
andflowmeters.Therecommendationsofthedataloggingequipmentmanufacturershouldbe
followedoraninstrumentprofessionalshouldbeconsultedregardingthecorrectgrounding
techniquetouse.
TMDStandardization/Calibration
2.14.1. Priortoconductingthermalprocessstudies,standardizationorcalibrationoftest
equipmentshouldbeperformed.Thermocouplesideallywouldbecalibratedinthetest
retort(s).Allthermocouples,extensions,connectionsandthespecificdataloggershould
beassembledastheywillbeusedundertheactualtestconditions.Considerationfor
conductingduplicatecalibrationstudiespriortoconductingcriticalthermalprocessing
studiesisrecommended.
2.14.2. AnacceptablemethodofcalibrationistobundleallTMDsandlocatetheminclose
proximitytotheknownaccuratereferenceTID,takingcarenottoinhibitflowoftheheat
transfermediumacrossthereferenceTID.Theretortisbroughtuptothesame
sterilizationsetpointtemperatureandpressureasdefinedforthetestandtheretortis
allowedtoequilibrate.Equilibrationtimemaybedependentuponthespecificretort
and/orretorttype.ThetemperaturedifferencesbetweenthereferenceTIDandTMDsare
thencalculatedanddocumented.Thesedifferencesmaybeappliedascorrectionfactors
foreachTMD.Atypicalrangeofcorrectionfactorsforthermocouplesisusuallynotmore
than12F(0.61.2C).LargecorrectionfactorsmayindicateanissuewiththeTMDthat
meritsinvestigationandcorrectiveactionspriortouseinthermalprocessingstudies.
NonthermocoupleTMDssuchaswirelessdataloggersshouldbewithinmanufacturers
specificationsatthetimeoftheiruseprovidedthosespecificationsareconsistentwith
conditionsofintendeduseoftheTMD.
2.14.3. Alternatively,TMDsmaybecalibratedofflineinanestablishedcalibrationprogram
withinthetemperaturerangetobeusedduringdatacollection.Thedifferencebetween
theTMDsagainsttheknownaccuratereferencedeviceshouldbecalculatedand
documentedaspartofthestudydata.Thisdifferencemaybeappliedascorrection
factorsforeachTMD.
2.14.4. VerificationofthecalibrationofallTMDsaftercompletingthermalprocessingstudiesis
recommended.Offsetswhicharesubstantiallydifferentthantheprestudyvaluesshould
beevaluatedrelativetothedatathatwerecollected.
PressureMeasurementDevicesVariousmethodsareavailabletocalibratepressure
measurementdevices.Traditionalcalibratedandtraceabledeadweighttesters(ortheir
electronicanalogs)arerecommendedtobeusedastheprimaryreferencestandardagainst
whichpressuregauges,transmittersanddataloggingdevicesshouldbecalibrated.
Regardlessofmethodused,standardizationresultsshouldbedocumentedaspartofthe
overallstudydatapackagewherepressureispartoftheprocess.Accuracyofpressure
measurementsystemsshouldpreferablybe1%ofthecalibratedandtraceablepressure
referencestandardsused,intheplannedworkingoroperatingpressurerangeofthe
processesinwhichtheyaretobeused.Inaddition,theaccuracyshouldsatisfythe
applicablefollowingconsiderations:
2.14.5. Forsteam/airretortprocesses,theaccuracyofpressuremeasurementsshouldnotresult
incalculatedintrinsic(unsafe)SteamAirRatios1%(i.e.richerinsteam)fortheactual
processvalue.
2.14.6. Fornonoverpressureretortsystems(primarilysaturatedsteam),theaccuracyof
pressuremeasurementsshouldnotresultinanoverestimate(unsafe)errorofthe
equivalentsaturatedsteamtemperature(correctedforsealevel)of0.2F
o
(0.1C
o
),if
processtemperaturesareplannedtobecalculatedfrompressurevaluesforany
evaluationorconsideration.
FlowMetersAnumberofmethodsmaybeusedtocalibrateflowmeters.Regardlessof
methodused,standardizationresultsshouldbedocumentedaspartoftheoverallstudy
datapackage.
2.14.7. Fluidflowratesareoftendeterminedbyflowmetersorindirectlybyrevolutionsper
minutes(RPM)offans,pumpsormotorsforknown/fixedcrosssectionflowareas.
2.14.8. Flowmeters(usuallymechanicalorelectronic),directcontactornoncontact,have
becomeincreasinglyspecializedandcomplicatedandmanufacturershavesetup
specializedflowtestbenchestoprovidecalibrationservicesfortheirflowmeters.
2.14.9. Periodically(e.g.,annually),factoryelectronicflowsensoroutputshouldbeverifiedwith
volumetric,gravimetricorotherapproaches(e.g.,tachometers,velocitymeters,currentor
voltagedraw)andresultscomparedtocalibrationdata.Recalibrationwouldbeneededif
theverificationresultsarenotconsistentwiththecalibrationdata.
2.14.10. Basedonthewayflowismeasuredorimputed,processfluidflowsensoraccuracy
shouldbecalibratedforuseinproductionorvalidationintheoperatingrangeofthe
processandvalidationsshouldfactorinknownoffsets,errorsandcalibration
inaccuracies.Processefficacyandsuccesscriteriaofthermalprocessingstudiesmaynot
bemetifflowmetersareinaccuratelycalibrated.
StopwatchesStopwatchestypicallyarereceivedcalibratedwithanexpirationdatefromthe
stopwatchequipmentsupplier.
NonproductbasedHeatInputUnits(HIU)EachHIUusedinheattransferdistributionstudies
musthaveauniqueidentity.
2.14.11. Usingeitherapilotscaleretortorthetestretort,astandardizationtestforacomplete
setofHIU(e.g.,1224separateunits)shouldbemadeusingexpectedoperating
parameters(i.e.,temperatureandpressure)toestablishabaselinefortheheating
performanceasmeasuredbytheheatingrateindex(i.e.,f
h
)priortouseandperiodically
duringtheirlifeexpectancy.
2.14.12. AllHIUswithinasetshouldbeincloseproximitytooneanotherduringthe
standardization/calibrationstudy.
2.14.13. AllTMDsusedinconjunctionwithHIUsmustbecalibratedpriortocalibratingtheHIU.
2.14.14. Areasonablemeansofdeterminingacceptablestandardizationfortheuseofasetof
HIUsinheattransferdistributionstudiesatanytimeduringtheirlifeexpectancyisto
utilizethestatisticalmeasureofcoefficientofvarianceofthef
h
oftheHIUs(%CV=
standarddeviation/average*100%).Avalueoflessthanorequalto1%wouldbe
acceptableforasetofHIUstobeusedtocollectheattransferdistributiondata.
2.14.15. Inaddition,eachindividualnonproductbasedHIUwithinasetshouldalwaysbewithin
1%ofitshistoricalperformanceasmeasuredbyf
h
forthesame
standardization/calibrationprocess.Oncethe%CVexceeds1%foragivenHIUrelativeto
itsestablishedbaseline,considerationforremovingitfromserviceshouldbemade.A
rationaleforusinganHIUthatfallsoutsideofthisrecommendationcouldbebasedonits
performanceinaspecificstudyprovidedthedatacollectedmeetthesuccesscriteria
established(i.e.,f
h
%CV5%inaheattransferdistributionstudy).
ProductbasedHIUProductshouldberepresentativeoftheproductheatingtype(e.g.,
conduction,convection)tobestudiedduringheattransferdistributiontests.

RISKS,ISSUES,ANDOTHERCONSIDERATIONS
2.15. Tomeetthecalibrationcriterianotedabove(section2.14)andtoensureaccuracyoftest
results,considerationshouldbegiventominimizingerrorsinherentinanycomponentofthe
temperaturemeasuringsystem.Forexample,useofspeciallimitsoferror(SLE)wireor
premiumgradethermocouplewireshouldbeusedtomakethermocouples.Theuseof3or4
wirehighaccuracyRTDcanhelptoreduceintrinsicerror.
2.16. ThermocoupleCalibration:Thermocouplesshouldbecalibratedagainstatraceablecalibration
standard(e.g.,thermometer,RTD,thermistor).Inaccuraciesintemperaturemeasurements
mayresultinerrorsinthermalprocessstudies;hence,frequentcalibrationisessentialto
providereliabledata.Factorsaffectingcalibrationinclude:wornordirtysliprings,improper
junctions,metaloxidation,multipleconnectorsononethermocoupleandinadequatedata
acquisitionsystemcoldjunctioncompensation.Asaconsequence,thermocouplesshouldbe
calibratedinplaceaspartofthecompletedataacquisitionsystem.Someprecautionswhen
usingthermocouplebaseddataacquisitionsystemsinclude:minimizingmultipleconnections
onthesamewire,cleaningallconnections,groundingthethermocouplesandrecordingdevice,
slittingthermocoupleouterandinnerinsulationoutsidetheretorttopreventfloodingofdata
loggerordatarecordingdevice(4,8),andusingproperlyinsulatedthermocouplewires.
2.17. HIUTheconsiderationsdiscussedbelowapplytoHIUsotherthanpackagedproduct.
2.17.1. InherentvariationsassociatedwithanyHIUsmustbeconsideredwhenselectingthe
specifictypeofHIU,e.g.,polymerbasedsolidmaterial,bentonitesuspensions,andoils.In
addition,thedesignandgeometryofanHIUmustalsobeconsidered.
2.17.2. Thenatureoftheprocessenvironment(temperatureandpressure)maydictatetheHIU
material.Thematerialselectedmustwithstandtheoperatingconditionsrepeatedlyand
reliably.
2.17.3. ThegeometricdesignoftheHIUsshouldconsiderthepackage(s)generalshapeinall
dimensionsandplacementwithinthepackageholdingsystem(e.g.,rack,trays,baskets)in
ordertomimicpotentialflowrestrictionsoftheprocessmedia.Typically,theHIUsshould
bedesignedtoconformtotheshapeofcontainersformingtheballast.
2.17.4. ThethermalpropertiesoftheHIUsshouldbeverifiedbeforeandaftertheirlastuseto
ensurethattheirpropertiesremainunchanged.Sincematerialthermaldiffusivityrelates
indirectlytoheatingrateindex(i.e.,f
h
),thermalpropertyverificationcouldbeintheform
ofheatingratedeterminationofallHIUsunderspecificheatingconditionsbeforeandafter
atest.
2.17.5. Factorsthatcaninfluencestandardization/calibrationoftheHIUmaterialsinclude:
machiningtolerances,seals,airandwaterresiduesintheTMDwells,andheatdegradation
oftheHIUuponrepeateduse.
2.17.6. HIUssuchasbentonitesuspensionsatdifferentconcentrationsexhibitdifferentheating
characteristicsresultinginconvectionandconduction(simpleorbrokenheating)profiles.
Preparationstepsshouldbeconsistentfrombatchtobatchtominimizeinherenterrors
(13,14).
2.18. Whenactualpackagedproductisbeingusedtocollectheattransferdistributionorheat
penetrationdata,acriticalassumptionisthatitisuniformacrossalltestpackages.Any
intrinsicvariabilityintheproductwouldbebuiltintothedatacollectedduringitsuseinspecific
thermalprocessingstudiessuchasheatpenetrationorheattransferdistributiontests.This
intrinsicvariabilitywould/couldeventuallyaffectProcessEstablishmentormeetingHeat
TransferDistributionSuccessCriteria.

DOCUMENTATION
Calibrationorstandardizationresultsshouldbeincludedinstudydocumentation.Alistingofrecords
requiredbyUSFDAregardingcalibrationrecordsfortemperatureindicatingandreferencedevicescan
befoundin21CFRPart113.100.

3 DOCUMENTINGPROCESSINGEQUIPMENTANDTESTCONDITIONS
Itisimportanttoestablishproperdocumentationregardingtheprocessingequipmentusedforthermal
processingstudiesincluding:temperaturedistribution,heattransferdistribution,andheatpenetration.
Whileprocessingequipmentsurveysarenotapartofdatacollectionperse,theyareimportantin
identifyingretortsthatareusedforthermalprocessingstudies,documentingstudytestconditions,as
wellashelpingplantmanagementrealizethatprojectsoutsidetheretortroommayhaveaneffecton
processingoperations.
Surveysshouldbeperiodicallyperformedonallretortstoensurethattheyremainconsistentlyand
properlyinstalledtopreviouslydocumentedconditions.Thesemayalsobeanimportantpartofa
plantschangecontrolprogram.NotethatUSDArequiresannualsurveysorauditsofretortsystems.
SCOPE
Theguidelinesinthischapterareapplicabletoanyretortsystem.Thelisteditemsforaprocessingroom
surveyshouldnotbeconsideredasbeingallinclusive.Somelisteditemsmaynotbeapplicabletothe
particularretort/processingsystembeingdocumented.

OBJECTIVES
Theobjectivesofconductingaretort/processingsurveyinclude:
3.1. Documentationoftestretort(s).
3.2. Providingdocumentationtoaidintheidentificationandsometimestheselectionofretortsfor
temperaturedistribution,heattransferdistribution,andheatpenetrationstudies.
3.3. Documentationofasexistingconditionsthatmaythenbeusedaspartofanoverallchange
controlprogram.
ITEMSTOINCLUDEINTHESURVEY
Retort
3.4. ShellPhysicaldimensionsoftheretortandcapacity(e.g.,numberofbaskets,cassettes,
dividers,etc.).Secureifpossible,theretortmanufacturersorfactoryblueprintsoftheretort
andallattendantpiping,aswellas,anyalterationssincetheretortwasoriginallyinstalled.
3.5. ControlsProcesscontrolsandinstallationvariationsfromoneretorttoanother(ifany)inthe
selectedtestretortgroup
3.6. LocationofInstrumentationincludinginstrumentwellsSize,shapeandlocationofwell(s)
usedtolocatesensors.
3.7. ReferenceTemperatureIndicatingDevice(TID)Type,locationandcalibrationstatus.
3.7.1. Whereused,Mercuryinglass(MIG)thermometerlocation,temperaturerangeand
increments,lengthofscale,calibrationdate,andlengthofinsertion,i.e.,thelengthofthe
sensingbulbthatisinsideeithertheretortshellorinstrumentwell.
3.7.2. ElectronicTIDtype(e.g.,RTD,thermocouple,thermistor,etc.),range,responsetime,
location,andlengthofinsertion.Ifapplicable,recordifthereferenceTIDislocated
directlyintheheattransfermedium.
3.8. TemperatureControlSensingDeviceTypeandlocationofthetemperaturecontrolsensing
device.DescribelocationofcontrolsensorinrelationtotheTIDsensorandtothesteam
distributor.Ifapplicable,recordifthetemperaturecontrolsensorislocateddirectlyintheheat
transfermedium.
3.9. PressureControlSensingDeviceTypeandlocationofthepressurecontrolsensingdevice.
3.10. Overflow/purge/vents(airremoval)
3.10.1. Valvetypeandsize
3.10.2. Pipesizeandconnectionstodrainheadersorchannels
3.10.3. Ventslocationandsizeofpipes,typeandsizeofvalves
3.10.4. Ventmanifoldormanifoldheaderslocationandsizeofallpipesandconnectingpipes
3.10.5. Bleeders,mufflerslocation,number,sizeandconstruction
3.10.6. Safetyvalvessize,typeandlocation
3.10.7. Additionalpipingorequipmentsuchascondensateremovalsystems,etc.
3.11. PressureIndicatingDevice/SensorNotetype,rangeandlocationofpressuresensorsand
gauges.
3.12. Drainsincludingwaterleveldumps,overflows,condensateremoval
3.12.1. Valvetypeandsize
3.12.2. Pipesizeandlength
3.12.3. Noteifcheckvalvesareused
3.12.4. Notelocationofthecondensateremovalsysteminrelationtocriticalzones,e.g.,relation
ofcondensatedraintothebottomofthecookshellinacontinuousrotary/reelandspiral
cooker.
3.13. Steamsupplytotheretorts
3.13.1. Boilercapacity(horsepower,BTUrating),pressure,andmethodoffiring(gas,oil,coal,
dualcapacity).
3.13.2. Headerpressure.Thisisimportanttodeterminethatadequatesteampressureand
volumeisavailablefortheretortingsystem.Thispartofthesurveyshouldbeperformed
duringbothpeakuseandoffloadhours.
3.13.3. Pipesizeandlength,valvesizeandtypes,pressureregulatorsorreducers,pipefittings
includingsteambypasspipes,fromthemainsteamlinetothetestretort(s)
3.13.4. Sizeofallconnectingsteampipestothemainline,notingallequipmentusingsteam
(e.g.,blanchers,exhaustboxes,etc.).
3.14. SteamIntroductionintotheRetort
3.14.1. Typeandspecificationsforthesteamdistributionsystemincludingconfiguration(e.g.,
fishtail,cross,inline,etc.),steamflowpiping,size,numberandlocationofsteaminjection
perforations
3.14.2. Steaminjectionchamber(ifapplicable)
3.14.3. Steaminjectionpointssize,typeandlocation
3.14.4. Steamspreaderornozzleshape,size,locationandconfiguration,number,sizeand
locationofholesinpipe,sizeofT,oranyotherpipefittings.
3.14.5. Describetheheatingmedium(e.g.,steam,hotwater)andtemperature.
3.14.6. Describethecoolingmedium(e.g.,recirculatedrefrigeratedwater,ambientwellwater,
evaporativecoolingtowersorpondsinrecirculatingcoolingwatercircuits).
3.15. Airornitrogensupplytoandintotheretorts
3.15.1. Compressortype,capacityandoperatingpressure
3.15.2. Typeandsizeoffilter,dryerandtank
3.15.3. Linesize,pressure,filtersanddryersforinstrumentair
3.15.4. Processairheaderlinesize(s),pressureandpressureregulation,ifused
3.15.5. Entrylocationandinletsize,controlvalvesizeandtype,pressuresettingandflowrate
duringtesting.Availabilitytosupplyinstruments.Indicateifairisheatedorairlinesarein
closeproximitytosteamorwaterlines.
3.15.6. ForOverpressureRetortsLocationandsizeofpipesandvalves(typeandsize)and
methodofcontrol.
3.16. Watersupplytoandintotheretorts
3.16.1. Processwatersupplysource,quality,temperature,andcontrols,ifapplicable
3.16.2. Coolingwatersupplysource,quality(includingmicrobialcontrolmethods),temperature,
andcontrols,ifapplicable
3.16.3. Useofanyalternatemethodsofheatingprocessingwater
3.16.4. Describethemethodusedtoheatandcooltheprocessingwaterincludingtype(e.g.,
heatexchanger,coolingtower,etc.)
3.16.5. Locationandsizeofpipes,valvesizeandtype,pumpand/orspreadersize,typeand
location(ifapplicable)
3.16.6. Waterlevelindicatorswhereapplicable,type(e.g.,sightglass,petcock,electronic,etc.)
andlocation
3.17. Dependingupontheretortsystem,documentthefollowing:
3.17.1. Whereapplicable,waterrecirculationsystemincludingpumptypeandcapacity,location
andsizesandfiltersofinlet/outletports,recirculationlinesize,flowmetertypeand
capacity,outputratesatoperatingconditions(e.g.,gpmorL/min),rpm,pipediameterfor
pumpinletandoutletandhorsepowerrating,impellersize
3.17.2. Airflow,orificesize,pressuresettingandflowrate,ifapplicable
3.17.3. Pressureand/orflowswitchestype,location,andtrippointsetting,ifapplicable
3.18. ForSteam/AirRetorts
3.18.1. Typeanddescriptionofcirculationandmixingsystemforsteam/airmixing;bleeder(s)
size,typeandlocation
3.18.2. AirPlenumandfanshroud(ifapplicable)
3.18.3. Distance(length)fromretortshelltoplenummaterialifdesignedasashellinshell.
3.18.4. Detailsonfanshrouddesignandconnectiontotheplenum
3.19. ForWaterSprayandWaterCascadingRetorts
3.19.1. Waterspreader(s)size,typeandlocation
3.19.2. Waterrecirculationsystempumptypeandcapacity,impellersize,motorsize,location
andsizesandfiltersofinlet/outletports,recirculationlinesize,typeandcapacityofflow
meter
3.19.3. Steaminjectionpointssize,typeandlocation
3.19.4. Heatexchangeruse,sizeandtype
3.19.5. WaterdistributionPlate(s)(WaterCascade)
3.19.6. Locationofwaterinletpipetomanifold(e.g.,top/centerofretortshell,top/rearofretort
shell)
3.19.7. Dimensionsofmanifoldandmaterialofconstruction
3.19.8. Number,sizeandlocation(holepattern)ofholesinwaterdistributionplate;percent
openareaoftheholesinthewaterdistributionplateshouldbecalculated(Water
Cascade)
3.19.9. Waterdistributionpipes(WaterSprayRetorts)
3.19.10. Entrancelocationofentranceofwaterinletpipeintoretortshell
3.19.11. Locationofwaterdistributionpipesinrelationtocircumferenceofretortinterior
3.19.12. Lengthofpipes,dotheyextendthelengthoftheretort?
3.19.13. Number,sizeandlocationofholesinpipes
3.19.14. Ifconnectedtonozzles,describethenozzletype.Arenozzlesfixedorcapableof
oscillation?Describeifnozzlesrestrictdiameteroftheopenings.
3.19.15. Describewaterflowrate,e.g.,litersperminute,gallonperminute,etc.
3.19.16. Processwaterretentionchannelortroughinbottomofretort
3.19.17. Noteifandhowprocesswaterisretainedforcoolingorreuse
3.19.18. Length,widthanddepthofwaterchannelortrough
3.19.19. Amountofwater(litersorgallons)atstartofprocessandhowitiscontrolledand
measured.
3.19.20. Ifapplicable,locationofsteamdistributorsorspreadersinrelationtochannelor
trough.
3.20. RotationalEquipmentrotationalspeedindicatoranddrivesystem
3.21. RecordingDeviceRecorderorrecorder/controllertypeanddescriptionincluding:resolution,
parametersrecorded,andcalibrationstatus.
3.22. RetortLoadingConsiderations/LoadingEquipment
3.22.1. Containerinformationtoincludematerial,sizeanddimensions,orientationfor
processing(vertical,horizontal,jumbled),andloadingconfiguration(e.g.,layered,nested,
compartmented,offset,etc.)
3.22.2. Maximumnumberofcontainersperlayer
3.22.3. Maximumnumberofcassettes,baskets,orracksperretort
3.22.4. Cassette,basketorrackdimensions,holesize,configurationandspacinginthebase
plateandsidesofcassettes,basketsorracks
3.22.5. Separatorsheetdimension,holesizeincludingopenarea,configuration,andspacing
3.22.6. Partialloadarrangement,ifpermitted
3.22.7. Waterdisplacementrequirements(ballast)
3.22.8. Distancebetweencassettes,basketsorracks,whereapplicable
3.22.9. Orientationofthecassettes,basketsorracksintheretortduringprocessing
3.22.10. Percentopenareaofthecassettes,basketsorracks,ifused
3.22.11. Describebasketclampingdevices,whereapplicable
3.22.12. Describetopandbottomplatesholdingbaskets,whereapplicable
3.23. OtherEquipmentOthercontrolorfunctionalequipmentinstalledthatmightaffectthe
thermalprocessstudybeingconducted.Examplesofothertypesofequipmentthatshouldbe
notedinclude:
3.23.1. Samplingports
3.23.2. Waterorcondensateleveldumpvalves
3.23.3. Initialchargeandmakeupwatersystems
3.23.4. Insulationand/orjacketingofretortshell

DOCUMENTATION
Resultsandobservationsmadeshouldbedocumentedandretainedforfuturereference.Theuseof
digitalimagesmayproveuseful.

4 CONDUCTINGTEMPERATUREDISTRIBUTIONTESTS
Temperaturedistributionstudiesareconductedinasterilizer(retort)usingdistributedtemperature
measuringdevices(TMDs)toestablishventingprocedures,ventingschedules,comeuprequirements,
temperaturestabilityanduniformity,allofwhicharenecessarytoestablishreproducibleandreliable
heatingandcoolingperformancethroughouttheretort.Temperaturedistributionstudiesaretypically
performedusingestimatedproductionretortoperatingconditionsorparameters.
SCOPE
4.1. Theguidelinesinthischapterareapplicabletoconductingtemperaturedistributionstudiesin
batchsaturatedsteam,steam/air,waterimmersion,waterspray,andwatercascaderetorts
operatinginbothstillandagitatedmodes.
4.2. Cratelessretortsareexcludedfromtheguidelinesprovidedinthisdocument.
4.3. ContinuousRotary/ReelandSpiral andHydrostatic retortsareexcludedfromtheguidelinesin
thisdocument.
OBJECTIVES
4.4. Theobjectivesofconductingtemperaturedistributionstudiesinclude:
4.4.1. Establishingventingproceduresandschedules(whereapplicable),comeuprequirements,
identifyingtheexistence(ifany)ofslowesttocometoprocesstemperaturelocation(s),as
wellastemperaturestabilityanduniformityduringtheCook.
4.4.2. Temperaturedistributiondatamayalsoprovideinsightintotheimpactofchangesmade
toprocessingequipment,utilities,andotheridentifiedcriticalfactors(e.g.,packagesize,
type,loadingconfiguration,etc.).
INTRODUCTIONandBACKGROUND
4.5. Acceptabletemperaturedistributionisarequirementforprocessestablishment.
4.6. Newretortsrequiretemperaturedistributionstudies.Similarly,retortsthathaveundergone
extensiverepairredesign,orrelocationcanbeexpectedtorequiretemperaturedistribution
studies.
4.7. Considerationshouldbegiventotestingallretortsonaregularbasistoconfirmtheycontinue
toperformaspreviouslytestedanddocumented.Thereplacementornormalwearof
componentsassociatedwithmaintainingacceptabletemperaturedistributionalsowarrant
considerationforperformingtemperaturedistributionstudies.Thesecomponentsmay
include,butarenotlimitedto:watercirculatingpumps,valvesandpipesassociatedwith
steam/waterflow,steaminjectors(fishtails),airorifices,overflow/pressureregulatingvalves,
spraynozzles,heatexchangers,waterdistributionplates,andcontrolsystemchanges.
4.8. Temperaturedistributioncanvarywithindividualinstallationsofidenticalequipmentatthe
samelocation.Considerationshouldbegiventoperformingtemperaturedistributionineach
individualretorttodocumentvariationwithinindividualretorts.
4.9. Ifappropriate,informationtakenintheprocessingequipmentsurveyandanunderstandingof
plantchangecontrolprocesses,validation,andoperationproceduresmaybeusedtodevelopa
reducedtestingplan.
4.10. Demonstrationofadequatetemperaturedistributionisusuallyaprerequisiteforconducting
heattransferdistribution(whereapplicable).
MATERIALS,TOOLS,EQUIPMENT
4.11. SeeChapter2TestEquipmentandStandardizationofTestEquipment
METHODS
4.12. TestRetortSelection
4.12.1. Considerationshouldbegiventotestingallretortsinasystem.
4.12.2. Whenappropriate,areducedtestingplancanbedevelopedbasedontheinformation
takenintheprocessingequipmentsurvey(seeChapter3,DocumentingProcessing
EquipmentandTestConditions).Thereasonsforretortselectionshouldbedocumented
intestingrecords.Theretort(s)selectedshouldrepresenttheone(s)identifiedashaving
thegreatestpotentialfordiminisheddeliveryofthecriticalprocessutilitiessuchassteam,
air,andwater.Factorsthatmayhelpidentifythetestretort(s)include:retortposition
(e.g.,atthebeginningorendofalineofretorts,furthestfromsteamheader),container
configuration,dividersheetstyle,typeofheattransfermedium,andprocessingpartial
loads.
4.12.3. Theresultsoftheprocessingequipmentsurveyshouldbeverifiedforcompletenessand
accuracypriortothestartoftests.
4.13. TestRetortDocumentation
4.13.1. Testretortdocumentationmayincludephotographs,diagrams,andadescriptionofthe
operation,condition,andcalibrationstatusofsensors/measurementdevices.
4.14. LocationofTemperatureMeasuringDevicesintheretort
TMDs shouldbeplacedinthefollowinglocations:
4.14.1. AttachedorincloseproximitytothereferenceTIDprobe.
4.14.2. Attachedorincloseproximitytothetemperaturecontroldevice,unlessthereference
TIDandthecontrollerprobearelocatedtogether.
4.14.3. Locatedinatleasttwocontainersfilledwithtestmediumforthepurposeofdetermining
initialproducttemperatures.Thesecontainersshouldbelocatedinthepositionsthatare
representativeofthepotentialworstcaselocationsintheretortload.
4.14.4. Thelowestofinitialtemperaturestobeencounteredduringnormalcommercial
operationshouldbetakenintoaccountinestablishingtemperaturedistribution.The
initialtemperaturemeasuredshouldbeconsideredinthecontextofretortshelland
basket/crate/racktemperatureswhichmaybelowerorhigherthantheproduct
temperaturesandcouldhaveaneffectonthetotalheatload.
4.14.5. AnadequatenumberofTMDsareneededtoensurethattheslowesttocomeupto
temperaturelocationsareidentified.Aminimumoffive(5)TMDsperbasket/crateare
typicallyused.Theseshouldbelocatedindifferentlayersorotherwiseseparatedineach
basket/crateintheinitialphaseofthetemperaturedistributionstudy.Theintentisto
determinetheslowesttocomeuptotemperaturelocationineachbasket/crate.Note
thatadditionalstudieswithahigherconcentrationofTMDsinaparticularareaorzone
mayberequiredtoverifythattheslowestcomeuptotemperaturelocation(s)withinthe
retortloadhavebeenidentified.
4.14.6. TMDsshouldbeplacedsothosemeasuringjunctionsarenotindirectcontactwith
containersorothersurfaces.AllTMDsmustbesecurelyfastenedinplacetoprevent
damageandunplannedmovementduringtheprocess(particularlyinagitatingsystems).
4.14.7. Insubsequentstudies,wherenochangeshavebeenmadetotheequipmentand
previousstudieshaveindicatedconsistencyofcoldspotlocation(s),areducednumberof
TMDsperbasket/crate/rackmaybesufficient.
4.15. Locationofpressuresensor(s)
4.15.1. Atleastonepressuresensorshouldbelocatedintheretortshell.Iftheoperational
pressuresensorhasbeenrecentlycalibrated,itcanbeusedinplaceofatestdevice.
Pressuregaugesshouldalsobeusedtomonitorlinepressuresofsteam,air,andcooling
waterduringatest.
4.16. Locationofflowmeter(s)
4.16.1. Acalibratedflowmeter(oralternatemethod)shouldbelocatedinamannertoprovide
anaccuraterecordofthewatercirculationflowduringtheprocesscycleinsystemsusing
circulationpumps.
4.16.2. Acalibratedflowmeter(oralternatemethod)shouldbelocatedinamannertoprovide
anaccuraterecordoftheairflowduringtheprocesscycleinsystemsusingairforagitation
andmixingofprocesswater.
4.16.3. Forsteam/airretortsacalibratedflowmeter(oralternativemethod)maybelocatedin
thereturnairplenumtoprovideanaccuraterecordofthesteam/airmixtureduringthe
processcycle.Ifthecirculatingfanisequippedwithadirectional/rotationalandrpm
sensingabilityofthefanshaft,thenthedetailsofthefanmotorfromtheretortsurveywill
suffice.
4.17. RecordofMonitoredLocations(TMDMap)
4.17.1. Aschematicdrawingtoshowtheplacementofallmonitoringdeviceswithintheretort
shouldbecomepartofthedocumentationforthetemperaturedistributiontests.
4.18. PreparingRetortwithContainers
4.18.1. ContainerSizeThecontainersizeandloaddensitythatarelikelytobethemostdifficult
toachievetemperatureuniformityaretypicallyselectedfortemperaturedistribution
studies.Inmanycasesthiswillbethesmallestcontainerand/orthedensestloadinuse.
Insomecases,multiplecontainersizes,types,configurationsandorientationswillneedto
betested.
4.18.1.1. Sincetemperaturedistributionmayvarywidelywithsomesystemsdepending
uponcontainerandtype,itmaybenecessarytostudyeachdifferentcontainer/type
andloadingconditiontodevelopadifferentcomeupprofileforeachsize/typeand
loadingcondition.
4.18.2. ContainerContentsContainersmaybefilledwithwater,orthefastestheatingproduct,
forstudyingretortsthatprocessconvectionheatingproducts.Forconductionheating
products,thecontainersshouldbefilledwithproduct,starchsuspensions,orother
materialthatsimulatestheproduct.Regardlessofmaterialchosen,cautionshouldbe
exercisedwhenheatingcharacteristicsmaychangewithmultipleheatingcycles.For
waterimmersion,waterspray,orwatercascaderetortsthatuseatemperature
overshootinthecomeupprofiletohelptemperatureuniformity,useofconduction
heatingcontainersisoftentheworstcasesituation,andshouldbecarefullyconsidered.
Notethatstabilizationperiodsattheendofcomeuparenotconsideredtobeovershoots.
4.18.2.1. Forsaturatedsteamretorts,watermaybeusedforconductionheatingproducts;
howeverthecomeuptimesmaybesomewhatlongerthanwhatwilloccurwith
product.
4.18.2.2. Documentthereasonsforballastcontainercontentselectionintest
documentation.
4.18.3. ContainerPlacementConsiderationsContainersareplacedinthebasket/crateina
mannerthatisequivalenttotheworstcasesituationasseeninthecommercialoperation.
Theworstcasemaybethemaximumnumberofcontainersperlayer,actualnumberof
layers,maximumloaddensity,loadingpattern,maximumfillofpocketspace,andother
conditionsthatresultinthedensestload.Whereverticalchannellingispossible,this
conditionshouldbeconsideredinthetemperaturedistributiontestdesign.Theseaspects
mayneedtobeevaluatedthroughadditionaltestingtoensurethattheworstcasehas
beendefined.
4.18.4. ContainerOrganizationThisincludesaspectsrelatedtobaskets,dividersheets,trays,
racks,andothermeansofholdingorconfiguringpackagesintheretort.
4.18.4.1. Theseparatorordividersheetsshouldbethesameasthosetobeusedin
production.Ifmorethanonetypeofseparatorordividersheetisusedin
production,thenthedividerswiththesmallestpercentopenareashouldbeused.If
additionaldividersareusedoneitherthetoporthebottomofthecontainerload,
thisproceduremustbeduplicatedforthetest.
4.18.4.2. Foratrayorrackthatisusedtoholdand/orseparatecontainers,thedesignofthe
trayorrackthatwillbeusedinproductionmustbeusedfortemperature
distributionstudies.
4.18.4.3. Variationsinbasket/crate/rackloadingconfigurationanddesignexpectedin
productionmayneedtobetestedtodeterminewhichyieldstheworstcase
situation.Thesmallestanticipatedpartialloadandlocationofthepartialload
shouldbecomparedtofullloadconditionsnotingtheuniformityandtemperature
controlandstabilitythroughouttheretort.
4.19. ConductingtheTest
DataCollection/MonitoringPointsDependingupontheretortsystem,thefollowingshould
bemonitoredandrecordedduringtemperaturedistributionstudies.
AllRetorts
4.19.1. TemperatureandPressureControllersetpoint(s),includingifthereisanovershootset
pointforcomeupandalowersetpointforprocessing
4.19.2. ProductorBallastInitialTemperature
4.19.3. Timeprocesscyclestarts,Time=0(timezero)
4.19.4. Timeswhentheendofcomeup,startofthermalprocessing/cookstephasbeen
achieved,asindicatedbyeitherthestepchangeinacontrolprogramortheachievement
ofprocesssetpointtemperatureatboththereferenceTIDandtherecorder/controller
4.19.5. ReferenceTIDreadingsatsufficientintervalsduringtheentirecycle,includingthepoint
intimeitreachestheprocesstemperaturesetpoint.
4.19.6. Monitorrotationoragitationrateatsufficientintervalsusinganaccuratecalibrated
stopwatchorcalibrateddeviceincludinganypointswhererotationratechangesduring
processingoronacontinuouschartwhererotationoragitationisused.
4.19.7. Timeattheendofthermalprocess,andstartofcool.
4.19.8. Actualbasket/crate/rackorientationintheretort.
4.19.9. Operatingactivityofotherretortsincludingthenumberofretortsenteringcomeup
duringthestudy.
4.19.10. Numbersanddescriptionsofotherequipmentusingsteam(e.g.,blanchers)atthetime
ofthestudyandbefore,during,andaftercomeup.
Inadditiontotheabove,theseitemsshouldbemonitoredandrecordedbasedontheretort
beingstudied:
Steam/Air
4.19.11. Temperatureofairsupplyenteringtheretort.
4.19.12. Waterlevelinrelationtospreadersandlowestlevelofcontainersintheretort,if
applicable.
4.19.13. Timewhenthepressuresetpoint(s)isachieved.
4.19.14. Timeandtemperaturewhenthedrainisclosed,ifitisopenduringaportionofthevent
ifapplicable.
4.19.15. TimeandtemperaturetakenfromthereferenceTIDwhentheventcloses.
4.19.16. Airflowinscfmorlitersperminute,ifapplicableandavailable.
4.19.17. Linesteampressureatthetimeofthetestandbefore,during,andaftercomeup,if
possible.
4.19.18. Retortpressure,throughoutthetestcycleatsufficientintervalsoroncontinuouschart.
SaturatedSteam
4.19.19. Waterlevelinrelationtospreadersandlowestlevelofcontainersintheretort.
4.19.20. Timeandtemperaturewhenthedrainisclosed,ifitisopenduringaportionofthe
vent.
4.19.21. TimeandtemperaturetakenfromthereferenceTIDwhentheventcloses.
4.19.22. Linesteampressureatthetimeofthetestandbefore,during,andaftercomeup,if
possible.
4.19.23. Timesteambypassvalvecloses.
WaterSprayandWaterCascade
4.19.24. Temperatureofinitialprocesswater.
4.19.25. Waterlevelinrelationtospreadersandlowestlevelofcontainersintheretort.
4.19.26. Floworrecirculationrateofwaterasdeterminedbyflowmeterorotheracceptable
means.
WaterImmersion
4.19.29. Temperatureofinitialprocesswater.
4.19.30. Filltime(displacement)inthosesystemsdroppingwaterfromastoragedrumortank
intotheworkingprocessingvessel.
4.19.31. Waterlevelinprocessvesselinrelationtothetopsurfaceofcontainers,statedasa
minimumoranactuallevelthroughouttheprocess.
4.19.32. Floworrecirculationrateofwaterasdeterminedbyflowmeterorotheracceptable
means.
4.19.34. Airflowinscfmorlitersperminute,ifapplicableandavailable.
4.19.35. Lineairpressureatthetimeofthetestandbefore,during,andaftercomeup,if
possible.
4.20. Datalogger
4.20.1. ThedataloggershouldrecordthetemperatureofeachTMDatsufficientsampling
frequencies,typically1030seconds,throughoutthelengthofthestudy.
4.20.2. Thedataloggershouldrecordthetemperaturefromcyclestartthroughcompletionof
cooling.
4.21. Othercriticaldatacollectionpointfrequencies
4.21.1. Assumedorpotentialprocessrelatedcriticalfactorsshouldberecordedatintervalsof
sufficientfrequencytodescribeandverifyretortoperatingparametersduringthetest.
Recordingsarepartofthepermanenttestrecordsandshouldincludethetemperature
recordingchart,thepressurereadings/chart,flowraterecords,referenceTIDreadings,
andotherdatagatheredthatwereidentifiedascriticaldatacollectionpoints.
4.22. Studytimeduration
4.22.1. Thetestshouldextendforatleastaslongasneededfortheretortcontrolsystemto
stabilize,establishadefinitetemperatureprofile,andallmonitoringandTMDshave
reachedasteadystatecondition.
4.22.2. Ifdesired,retortcoolingphasetemperaturesmayberecordedthroughtheentirecooling
cycle.Thisisparticularlyimportantifproductcoolinglethalitywillbebasedonactual
retortcoolingprofilesindevelopingscheduledprocesses.
4.23. RetortTestConditions
OperatingProceduresNormalcommercialoperatingprocedurestestingtheextremesof
allowablerangestoexaminetheeffectsofloading,overpressure,andagitationshouldbe
followed.
4.23.1. Temperaturedistributionstudiesshouldberunatthemaximumretorttemperatureto
beusedforcommercialprocessing.Forexample,oneshouldnotruntemperature
distributionstudiesat250F(121C)iftheproductisprocessedat266F(130C).
Generally,temperaturedistributionstudiesshouldnotberunanyhigherorlowerthan5F
(~2.5C)fromthetemperatureatwhichproductwillbeprocessed.
4.23.2. Minimumventtemperatureandtimeisacriticalfactorforsteamretorts.The
temperatureandtimeatwhichtheventisclosedbecometheminimumventschedulefor
theprocess.
4.23.3. Partialloadingconditionsshouldbestudiedinadditiontothefullloadwherepermitted.
4.23.4. BasketrotationshouldbestudiedatorbelowtheexpectedScheduledProcessvalue.
Whereapplicable,thefollowingadditionalconditionsmaybetestedatthestandardretort
processingtemperatureusedforcommercialproduction:
Steam/Air
4.23.5. Highsteamtoairratio(LowOverpressure).
4.23.6. Lowsteamtoairratio(HighOverpressure).
WaterSpray,WaterCascade,andWaterImmersionRetorts
4.23.7. Lowflowoftheheattransfermedium.
4.24. ReplicationTodemonstratereproducibility,ataminimumduplicatetemperature
distributionstudiesshouldbeperformedforeachsituation(e.g.,containersize,containertype,
operatingtemperature,basket/crate/racksystem)withuniformandcomparableresults
obtainedfromeachtest.
4.25. Posttestinspection
4.25.1. Theconditionofthemeasuringsensors,thetestcontainers,andotherattributesofthe
retortloadshouldbeexaminedafterthecompletionoftheentiresetofstudiesto
determineifthetestresultsmayhavebeenaffectedbymovementorotherchangestothe
desiredtestsetup.
DATAANALYSES
4.26. PlotortabulatetheminimumandmaximummeasuredtemperaturesforallTMDswithinthe
retortloadateachscan/timeinterval.TheTID,Controller,andCharttemperaturesatspecific
timepointsshouldbeevaluatedrelativetotheTMDstemperature.
4.27. Evaluatethedifferencebetweentheminimummeasuredtemperatureandtheprogrammedor
setpointminimumprocesstemperatureatspecifictimepointstoestablishorconfirm
temperatureoffsetsandtoestablishcomeuptime.
4.28. IdentifythelocationoftheTMDthatwastheslowesttoachievecomeupcriteria.Identifythe
timethisTMDachievedcomeupcriteria.
4.29. IdentifytheminimumInitialTemperature.
SUCCESSCRITERIA
4.30. ComeUp
4.30.1. TheTIDshouldbeatoraboveminimumprocesstemperatureattheendofcomeup.
4.30.2. AllTMDsshouldbewithin1F(0.5C)ofminimumprocesstemperatureattheendof
comeup.
4.30.3. AllTMDsshouldbeatorabovetheminimumprocesstemperaturewithin1minuteof
startingtheholdtime.
4.31. Cook/Hold
4.31.1. AfterthestartofHold,theTIDshouldnotfallbelowtheminimumprocesstemperature.
4.31.2. AfterthefirstminuteoftheHoldphase,theuniformityandstabilityoftemperaturesis
confirmedbyhavingnoTMDtemperaturefallbelowminimumprocesstemperatureonce
thatTMDhasreachedtheminimumprocesstemperature.
4.32. CoolingIfspecificcoolingprofilesarecriticaltotheprocessdelivery,thetemperature
distributionduringcoolingmustsupportthoseprofiles.
4.33. Other
4.33.1. ThelocationofallTMDsmustbeconfirmedattheendofallstudies.AnyTMDthat
shiftedduringdatacollectionshouldbeevaluatedforimpactonstudyoutcomes.
4.33.2. Theintegrityoftestpackages/ballastshouldbeconfirmedtobeacceptable.
4.33.3. Allcriticalretortoperatingparameters(e.g.,Temperature,Rotation,Pressure,Flow,
WaterLevel,andFanSpeed)wereachievedasplannedand/orprogrammed.
4.33.4. Situationsorconditionsthatdonotmeetthesecriteriashouldbecriticallyevaluated.
4.33.5. IdentifytheminimumInitialTemperatureforwhichthetemperaturedistributionisvalid.
4.33.6. Identifyallotheraspectsoftheproduct,package,ballast,loadingpattern,andsoforth
forwhichthetemperaturedistributionisvalid.
DOCUMENTATION
Temperaturedistributionfindingsshouldbesummarizedinareport.Supportingitemsthatshouldbe
includedare:
4.34. Reason(s)forretortselection.
4.35. Resultsfromtheretortsurveyandtestretortdocumentation.
4.36. Schematicshowingplacementofallmeasuringdevicesintheretort.
4.37. Reason(s)forproductselection.
4.38. Retortcharts,operatorlogs,retortcontrolprogram,andcontrolsystemreports.
4.39. CriticalpointobservationstoincludeInitialTemperature.
4.40. Calibrationinformationforallsensors/devicesused.
4.41. Dataloggerdataforbothretortandproduct.
4.42. Graphicaldepictionsofminimum/maximumdata.

5 CONDUCTINGHEATTRANSFERDISTRIBUTIONTESTS
ThisGuidelinecoversthescientificbasisandfundamentalsforconductingHeatTransferDistribution
Studieswithemphasisoncriticalelementstobeconsidered.ThisGuidelineprovidesrationalefor
considerationstobeusedbyanenduserindecidingwhenHeatTransferDistributionStudiesare
neededinadditiontoTemperatureDistributionStudies.
SCOPE
5.1. TheguidelinesinthischapterareapplicabletoconductingHeatTransferDistributionStudiesin
steam/airretortsandmaybeappliedtowaterspray,watercascade,andwaterimmersion
retortswhereairoverpressureinexcessofthesaturatedsteampressure(correctedfor
altitude)atprocesstemperatureisused.Theseguidelinesareapplicabletoretortingsystems
operatinginbothstillandagitatedmodes.
OBJECTIVES
TheobjectivesofHeatTransferDistributionStudiesinclude:
5.2. Identificationoftheslowesttoheatlocation inaretorttotheextentthatitimpactsprocess
deliverywithintheretortloadwhenusingthesameprocess,product,package,andload
conditions.LoadConditionsinclude:Partialloadingofbaskets(e.g.,lessthanafullbasketof
trays),lessthanafullretortload(e.g.,4basketsina5basketretort),tray/racksloading(e.g.,
notallpackagelocationsfilledwithapackage),anddensityand/orpercentageofopen
volume/voidvolume.
5.3. Identificationoftherepeatabilityofthoserelativelyslowertoheatlocationsacrossretortsand
studiesusingthesameprocess,product,package,andloadconditions.
5.4. IdentificationofrecommendedlocationstoplaceHeatPenetration containersforProcess
Establishment.
5.5. Verificationoftheadequatedeliveryofthethermalprocessovertimeforagiven
product/packagecombinationandloadingcondition(s).
5.6. TemperatureDistributiontestingusuallyfocusesoncomeupandcookportionsoftheretort
cycle.Temperatureuniformityintheseportionsoftheretortcyclemaynotalwayscorrelateto
adequateheattransferintopackagesthroughouttheretort,hencetheneedforHeatTransfer
Distributionstudies.AcceptableTemperatureDistributionisrecommendedpriortoconducting
HeatTransferDistributionStudies.
5.7. HeatTransferDistributiontestingmayberecommendedwhen:
5.7.1. Anoncondensablegassuchasnitrogenorairisintroducedintotheheattransfermedium
toprovideoverpressureinexcessofthesaturatedsteampressure(correctedforaltitude)
attheCookTemperature.
5.7.2. Forheatingmediumdeliverysystems(includingtype,flow,rack,package,etc.)whenever
itispossiblethatincertainareasoftheretortloadtherateofheatenergysuppliedtothe
packageisnotinexcessoftherateatwhichthepackagecanabsorbtheheatenergy.
5.7.3. Fornewretorts,newretortprograms/controls,newproduct/package/closure
combinationsincludingtrays/racks/loadconfigurationsrequiringoverpressureairin
excessofthesaturatedsteampressureatCookTemperature.
5.7.4. AspartofanoverallChangeControlProgram.
5.7.5. Whenpartialloadsmaybeprocessedduringmanufacturing.
5.7.6. Anytimethereareconcernsthatheattransferdeliverymaybeimpactedbytheretorts
heatingmediummixinganddistributionsystemsuchasthepresenceofafan,nozzles,
shrouds/plenum,racking/traydesign,andsoforth.
5.8. HeatTransferDistributiondatamayassistinconductingdeviationanalysesprovideddataare
collectedusingactualproductandpackage.
5.9. HeatTransferDistributiondatacanbeusedaspartofanoverallongoingprogramtoverify
retortoperationsovertime.
5.10. Theeffectsofpackagelocationalongtheradiusofrotatingloadsareoftennotconsideredin
TemperatureDistributiontesting,norareeffectsoffastesttoheatpackagescomparedtothose
thatarefastesttocool.HeatTransferDistributionStudiesmayprovideinsightintopotential
effectoflocationalongtheradiusofrotatingloadsaswellaseffectsoffastertoheatandcool
packageswithintheretortload.Inaddition,insightmaybegainedonretortfanposition,
heatingmedium/airinletdesignandshrouddesign,andtheirinfluenceontheflowandmixing
oftheheatingmedium.
5.11. Ifdesired,lethalitydatacollectedusingactualpackagedproduct(vs.nonproductbasedHIUs)
maybeseparatedintothatachievedduringcomeupandcookversusthatachievedincool.
Thisinformationmaybevaluableinassessingtheeffectsonnutrientsandtheproducts
physicalstabilitythroughouttheretortload.Modificationstotheretort,package,loading
configurations,trays/racks,processingcycle,etc.toreduceorminimizethelethalitydifferential
throughouttheloadmaybethenpossible.NotethatHeatTransferDistributiondataarenot
usedforProcessEstablishment.
5.12. AspartofanoverallChangeControlprogram,HeatTransferDistributiondatacollectionshould
beconsideredwhenever:
5.12.1. Changesaremadetopackagedproductloadingsuchasnewormodifiedtrays,baskets,
etc.areintroduced.
5.12.2. Changesaremadetoloaddensity,flowrateofheattransfermedium,andshrouddesign.
5.12.3. Changesaremadetotheprimarypackage(e.g.,heavierbottle),changetopackagefill
volumeand/orheadspacevolume,etc.
5.12.4. Newformulationsareintroduced.
5.12.5. Changesaremadetoutilitiesortheretortsuchasthosedoneaspartofupgradesto
equipmentorsignificantrepairs.
5.12.6. Theamountofairoverpressureinexcessofsaturatedsteampressure(whencorrected
foraltitude)atCookTemperatureismodified.
5.12.7. Partialloadsaretobeprocessed.
5.13. HeatTransferDistributionstudies,incontrasttoHeatPenetrationstudies,mustalwaysbe
conductedintheproductionretort(s).PilotPlantRetortsorResearchSimulatorsshouldnotbe
usedforstudyingorextrapolatingHeatTransferDistributionperformance.
5.14. MicrobiologicaltechniquesarenotrecommendedforHeatTransferDistributionstudies.
5.15. Temperatureandpressuremustbeindependentlycontrolledandrecorded.
5.16. SeeIFTPSGuidelinesforConductingThermalProcessingStudies,Chapter2TestEquipment
andCalibrationofTestEquipment.
5.17. HeatTransferDistributionmeasurementsmaybeobtainedfrominstrumented/probed:
5.17.1. Productfilledpackages;or
5.17.2. NonproductbasedHIUsmadefrompolymerbasedmaterialssuchasTeflon,clayssuch
asbentonitesuspensions,andoils.Pleasereferto,Section2.14.11forcriteriaregarding
useofnonproductbasedHIUs.
5.18. Asufficientnumberofinstrumented/probedsamplestoensurethatallareasoftheretortload
arebeingstudiedandtosupportstatisticallyvalidanalysesmustbeincludedineachstudy.
METHODS
TestRetortSelection
5.19. Ingeneral,alloftheinformationtakenintheprocessingequipmentsurvey shouldbeusedto
selecttheretort(s)thatwillbeusedforHeatTransferDistributionStudies.Thereasonsfor
retortselectionshouldbedocumentedintestingrecordsorallretortsshouldbestudied.
5.20. Theretort(s)selectedshouldrepresenttheone(s)identifiedashavingthegreatestpotential
fordiminishedmixinganddeliveryoftheheattransfermedium.
5.21. HeatTransferDistributionStudiesmustbeconductedusingproductionretortsunderexpected
productionandoperatingconditions.
TestRetortDocumentation
5.22. InformationbasedondatafromtheprocessingequipmentsurveyandfromTemperature
DistributionStudiesshouldbeincludedinstudydocumentation.
5.23. Thespecificprocess,product,package,andloadconditionsbeingstudiedmustbe
documented.
BallastRetortLoad
5.24. Theballastusedmaybeproductfilledpackagesofthetypeandsizebeingevaluated.
Alternatively,othermaterialsmaybeusedprovidedtheirheatingcharacteristicsareconsistent
withtheproductbeingstudied.
5.25. Ballastpackagesshouldretaintheirheatingandphysicalcharacteristicsiftheyaretobere
used.ReuseofballastpackagesshouldbedocumentedinaTestReport.
5.26. NotethatwaterfilledpackagesgenerallyshouldnotbeusedasballastforHeatTransfer
DistributionStudiestoallowtheretortcontrolstoperformrepresentativelyforheatingmedia,
deliveryanditsreplenishmentwithintheload.
Baskets/TraysandLoadingConsiderations
5.27. Theloadingconditionsusedorexpectedtobepermittedduringmanufactureofpackaged
productmustbestudied.Thisincludesusingthebaskets,trays/racks,dividers,cassettes,etc.
thatwillhold/carryproductfilledpackages.
5.28. LoaddensitymayhaveadramaticimpactonHeatTransferDistribution.Thisisdueto
inhibitionorretardationofdistributingtheheattransfermediumthroughouttheretortload.
Therefore,optimizationwithrespecttothespecificretortsheattransfermediummixingand
distributionshouldbeconsideredwhereverpossible.Optimizationfactorstoconsiderinclude
thedesignof:
5.28.1. Trays/racks/baskets,
5.28.2. Package,
5.28.3. Numberofpackagesperlayer/rack/basket,and
5.28.4. Retortoperatingparameterssuchastemperatureandpressurevaluesandramps,timing
ofairintroduction,anyventingatthestartoftheretortcycle,orpreheatingofthe
overpressureair.
LocationsofProbedPackagedProduct/HIUintheretort
5.29. HeatTransferDistributiontestunitsareplacedinsuspectedorknownslowertoheatlocations
withintheretortload.Multiplestudiesmayberequiredtoconfidentlyidentifytheslowerto
heatlocationswithintheretortload.
5.29.1. TMDstomeasuretemperaturessurroundingthetestpackagesshouldbelocatedin
proximitytothosetestpackages.TheseTMDsaretobeusedtoaccuratelycalculatef
h
valuesofadjacenttestpackages.
5.30. TMDstomeasureproduct/HIUtemperaturestobeusedfordataanalysesshouldbesecurely
fastenedinsidethetestpackagesothatthemeasuringjunction/tipisheldinthetestpackage
coldspot.
5.31. Ataminimum,five(5)probedproductpackages/HIUsshouldbelocatedinseparatesuspected
orknownslowertoheatareasofeachbasket.Symmetryandrotationeffectsshouldalsobe
consideredwhendetermininglocationsforHeatTransferDistributiontestunits.
5.32. Allbasketsintheretortshouldcontaintestunits.
Locationofpressuresensor(s)
5.33. IndependentverificationoftotalretortpressureduringHeatTransferDistributionStudiesis
recommendedwhenpossibleandpractical.
Locationofflowmeter(s)
5.34. Independentverificationofflowratesoftheheatingmediumisrecommendedwhenpossible
andpractical.
RecordofMonitoredLocations(LoadingPattern/Map)
5.35. Aschematicdrawingtoshowtheplacementofallmonitoringdeviceswithintheretortshould
becomepartofthedocumentationforHeatTransferDistributionStudies.
RetortControlandProcessConditions
5.36. HeatTransferDistributionStudiesshouldbeconductedusingtheprocessparameterconditions
suchastemperature,pressure,mixinganddistributingtheheattransfermedium,androtation
setpointsusedduringnormalproductionormanufactureofthepackagedfoodbeingstudied.
5.36.1. Sincef
h
andtheassociated%CVareusedastheprimarymeasurestoassessadequacyof
HeatTransferDistribution,datadonotnecessarilyneedtobecollectedatthehighest
allowedoverpressurepermittedfortheproduct/packagebeingevaluated.Thisisin
contrasttoHeatPenetrationstudieswhereallworstcaseretortconditionsand
parametersmustbeused.Itisimportantthattheamountofoverpressureusedduring
HeatTransferDistributionStudiesberepresentativeoftheexpectedproductioncondition
fortheproduct/packagebeingstudied.
ConductingtheTest
5.37. DataCollection/MonitoringPointsHeatTransferDistributiontestunitsmustbelocatedin
suspectedorknownslowertoheatlocationswithintheretortload.Independentverificationof
parameterssuchascontrollingtemperature,pressure,heattransfermediumflowrates,etc.is
recommended.Locationofindependentsensorsisatthediscretionofthepersonsresponsible
forthestudydesign.
5.38. ScanFrequencyforMeasurementDevices
5.38.1. Wherepossible,measurementdevicesshouldbesettoascanfrequencysufficientto
accuratelydetermineheatingparameters(i.e.,f
h
).
5.39. Studytimeduration
5.39.1. Cookdurationsshouldbeofsufficientlengthtoadequatelydeterminef
h
valuesandto
confirmthatTemperatureDistributionsuccesscriteriaweresatisfied(SeeTemperature
Distributionsuccesscriteria).
5.40. Replication
5.40.1. Ataminimum,duplicateHeatTransferDistributionStudiesshouldbeperformedforeach
situation(e.g.,packagesize,packagetype,operatingtemperature,basket/tray/rack
system,etc.)withuniformandcomparableresultsobtainedfromeachtest.Success
Criteria mustbemetinallreplicatestudies.
5.40.2. Replicatesshouldbetruereplicatesinallrespects,includingInitialTemperature,Retort
Temperature,Pressure,rpm,andsoforth.
5.41. PreandPosttestinspections
5.41.1. SeeChapter2TestEquipmentandCalibrationofTestEquipment.
5.41.2. Thefabrication,accuracy,conditionoftheHIUs,theproductfilledtestpackages,and
otherattributesoftheretortloadshouldbeexaminedbeforeHeatTransferDistribution
areinitiatedtodetermineiftheyareacceptableforuseandHeatTransferDistribution
resultsusingthemwillnotbeadverselyaffectedbythetestingsubsystems.
5.41.3. Theconditionofthemeasuringsensors,theHIU/productfilledtestpackages,andother
attributesoftheretortloadshouldbeexaminedafterthecompletionofthetestto
determineifthetestresultsmayhavebeenaffectedbymovementofthesesensorsor
otherchangestothedesiredtestsetup.
5.41.4. Comparisonofpreandposttestfillweightstoensuretestpackageshavenotleaked
duringtesting.Considerationshouldbegiventodiscardingdatafromleakingpackages.
DATAANALYSES
5.42. Calculatef
h
valuesandtheassociated%CV
5.43. Identifytheslowertoheatlocationswithintheretortload,e.g.,f
h
distributionwithinthe
retort.
5.44. ConfirmadequateTemperatureDistributionincludingcomeuptime.
5.45. Confirmthatretortcontrolandprocessconditionswereachievedasdesigned.
5.46. IfHIUs/productfilledtestpackageshavealsobeenplacedinfastertoheatlocations,thef
h
differentialbetweenslowandfasttoheatlocationsmayalsobecompared.
5.47. DetermineproductslowerandfastertoheatlocationsfortheHIUs/productfilledtestpackage
combination.Theslowesttoheatlocationisdeterminedbasedonthelargestf
h
value.
5.48. Allsubsequentprocessdeterminationstudies,i.e.HeatPenetration,shouldbeconducted
placingtestpackagesintheknownslowesttoheatlocationsdeterminedfromHeatTransfer
Distributionstudies.
5.49. Ifdesired,determineproductslowestandfastesttocoollocations.
SUCCESSCRITERIA
HeatTransferDistributionmaybeconsideredacceptablewhen:
5.50. TemperatureDistributionsuccesscriteriahavebeenmetduringeachHeatTransfer
DistributionStudy.
5.50.1. NotethatdemonstrationofadequateTemperatureDistributionisrecommendedpriorto
conductingHeatTransferDistributionStudies.
5.51. Retortcontrolandprocessconditionsachieved/metasdesigned.
5.52. f
h
%CV5%withinandacrossreplicatestudies.Whenthisconditionismet,uniformheat
transferconditionshavebeenconfirmedandHeatPenetrationprobesmaybelocated
anywhereintheretort.
5.52.1. Intheeventthef
h
CVisfoundtobe>5%,itshouldfirstbeconfirmedthatthesensors
usedwereconsistentwithaccuracystipulations(seeChapter2HIU).AdditionalHeat
TransferDistributionstudiesneedtobeconductedtoascertainthattheslowesttoheat
locationshavebeenreliablyandconsistentlydetermined,withappropriateconfidenceand
rigor.Thereafter,allProcessEstablishmentHeatPenetrationStudiesforthetest(i.e.
product,package,process,retortandload)combinationneedtobeconductedatthe
identifiedslowesttoheatlocations.
5.52.2. Alternatively,whenthe%CVis>5%,iterativechangescouldbemadetotheretort,retort
control,loaddensity,rackdesign,etc.inanattempttoachieveanf
h
%CV5%.Once
changeshavebeencompleted,replicateHeatTransferDistributionstudiesshouldbe
conducted.Notethattemperaturedistributionstudiesareaprerequisitetoconducting
heattransferdistributionstudies.Theneedtocollecttemperaturedistributiondataafter
makingchangesshouldbeevaluatedpriortoconductingadditionalheattransfer
distributionstudies.
5.53. Verifiedthattheretortisuniformintermsofheattransfermediadistributionanddelivery
and/ortheslowesttoheatlocation(s)withintheretortloadthatmaybeusedforHeat
PenetrationstudiesforProcessEstablishmenthavebeenidentified.
5.54. Ifproductfilledpackagesareused,productfunctionalityandsealintegrityarewithinaccepted
parameters.
RISKS,ISSUES,ANDOTHERCONSIDERATIONS
5.55. HIUgeometryshouldnotinterferewiththenormalflowpatternandmixingoftheheat
transfermediumwithintheretortload.
5.56. HeatTransferDistributiondataarenotusedforProcessEstablishment.
5.57. f
h
valuesdeterminedfromHIUotherthanactualtheproduct/packagemaynotbeusedfor
deviationevaluations.
5.58. Sufficientquantityofprobedpackages/HIUtoconductavalidstatisticalevaluationofthef
h
variabilitywithinatestisrequired.Typicallythiswillrequirethatmorethan6valuesareused
tocalculateameanf
h
andtheassociatedstandarddeviationand%CV.Ingeneral,alarger
numberofvalueswillprovidemorerobustvalues.
5.59. Replicatestudiesarerecommended.Thenumberofreplicatestudieswilldependuponthe
numberofretortsbeingevaluatedandwhetheryouarestudyinganew
retort/process/package/formulationorifthisispartofaperiodic(e.g.,annual)reverification
program.WhenreplicatestudiesfailtomeetSuccessCriteriaforHeatTransferDistribution,
additionalstudiesareneeded.
5.60. Sincef
h
andtheassociated%CVareusedastheprimarymeasurestoassessadequacyofHeat
TransferDistribution,datadonotnecessarilyneedtobecollectedatthehighestallowed
overpressurefortheproduct/packagebeingstudied.ThisisincontrasttoHeatPenetration
studieswheretheworstcaseretortconditionsasdefinedbytheScheduledProcessmustbe
used.ItisimportantthattheamountofoverpressureusedduringHeatTransferDistribution
Studiesberepresentativeoftheexpectedproductionconditionfortheproduct/packagebeing
studied.
5.61. NonproductbasedHIUsmaybeapreferredoptiontoproductfilledpackageswhenthefood
beingstudiedheatsprimarilybyconduction.
DOCUMENTATION
Documentationofheattransferdistributionstudiesshouldinclude:
5.62. Reason(s)forretortselection.
5.63. Resultsfromtheretortsurveyandtestretortdocumentationincludingdigitalphotosshowing
theheatingmediadeliverysystemincludingfans,pumps,nozzles,spreaders,shrouds,andso
forth.
5.64. Schematicsand/ordigitalphotosshowingplacementofallmonitoringdevicesintheretort.
5.65. Reason(s)foruseofthespecificHIUselected,i.e.,packagedproductvs.nonproductbased
HIU.
5.66. Reason(s)foruseofthespecificBallastselected,i.e.,packagedproduct,packagedwateror
HIU.
5.67. Schematicsanddigitalphotosorpackages,HIUs,Racks,TraysandLoadsusedfortesting.
5.68. Retortcharts,operatorlogs,retortcontrolprogram,andcontrolsystemreports
5.69. Criticalfactorrecords.
5.70. Calibrationinformationforallsensors/devicesused.
5.71. RawdataforbothTemperatureandHeatTransferDistributionprobesandthatforanyother
monitoringdevicessuchaspressuresensorsthatwereusedduringthestudy.
5.72. Dataandstatisticalanalyses,retests,resultsanddiscussionaspartofaHeatTransfer
DistributionTestingReport,documentingtestingdeviations,findings,successcriteriaand
recommendationsforadditional/subsequentwork.

6 CONDUCTINGHEATPENETRATIONSTUDIES
SCOPE
Theguidelinesinthischapterapplytoconductingheatpenetrationstudiesinanyretortsystem
includingsaturatedsteam,steam/air,waterspray,watercascade,waterimmersion,andcrateless.
Batchretortsmaybeoperatedineitherthestilloragitatingmode.Considerationsforcollecting
heatpenetrationdataincontinuousrotary/reelandspiralandhydrostaticretortsareincluded.The
intentofthisdocumentistoprovideguidanceinregardstothepreparationandexecutionofheat
penetrationstudies.Suggestionsregardingdataanalysisofheatpenetrationdataarealsoprovided.

OBJECTIVES
6.1. Thepurposeofaheatpenetrationstudyistodeterminetheheatingandcoolingbehaviorofa
product/packagecombinationinaspecificretortsystemfortheestablishmentofsafethermal
processestodelivercommerciallysterileproductsandtoassistinevaluatingprocess
deviations.
6.2. Thestudymustbedesignedtoadequatelyandaccuratelyexamineallcriticalfactorsassociated
withtheproduct,packageandprocesswhichaffectheatingrates.
6.3. Beforecommencingaheatpenetrationstudy,whereapplicable,anevaluationofretort
temperaturedistribution andheattransferdistributionshouldhavebeencompleted.
6.4. Agoalinconductingthesestudiesistoidentifytheworstcasetemperatureresponseexpected
tooccurincommercialproductionasinfluencedbytheproduct,packageandprocess.
Severalproduct,process,packageandmeasurementrelatedfactorscancontributeto
variationsinthetimetemperaturedatagatheredduringaheatpenetrationtest.Establishment
ofaprocessrequiresexpertjudgmentandsoundexperimentaldatafordeterminingwhich
factorsarecriticalandtheeffectofchangingthosefactorsbothwithinandbeyondestablished
criticallimits.Thelistofitemsaddressedinthissectionisextensive,butshouldnotbeassumed
tocoverallpossiblefactors.Quantitativedataonvariabilityshouldberecordedwhere
appropriateandallpertinentdatashouldbedocumentedtobetterunderstandandaccountfor
possiblevariationsinheatpenetrationbehavior.
6.5. Product
6.5.1. Productformulationandweightvariationofingredientsshouldbeconsistentwithworst
caseproductionvalues.Changesinformulationmaynecessitateanewheatpenetration
study.
6.5.2. Fillweightusedforheatpenetrationstudiesshouldnotbelessthanthemaximum
declaredontheprocessschedule.Excessproductmaybeexpressedaspercentoverfill.
6.5.3. Solidscontentshouldbemeasuredfornonhomogeneousproductsbothbeforeandafter
processing.Solidscontentdepositedinasieveshouldbeweighedandexpressedasa
percentageoftotalweight.Note:Additionofcompressedordehydratedingredientsmay
resultinincreaseddrainedweight.
6.5.4. Notethatsolidscontentmaybeconsideredacriticalfactorforhomogeneousproducts
andshouldbemeasuredbeforeprocessing.
6.5.5. Consistencyorviscosityofsemiliquidorliquidcomponentsshouldbemeasuredbefore
andafterprocessing.Flowbehaviorwillchangewithtypeandconcentrationofthickening
agents(e.g.,starch,gums,etc.),temperatureandshearrate.Changesmaybereversible
orirreversiblewhichmaybeimportantwhenreprocessingproduct.
6.5.6. Size,shapeandweightofsolidcomponentsshouldbemeasuredbeforeandafter
processing,whenappropriate.Forexample,measuringsizeandshapeofcookedricein
productmaynotbepossibleoruseful.
6.5.7. Integrityandsizeofsolidcomponentclustersmaychangeduringprocessingandaffect
temperaturesensorplacementintheproductandcoldspotlocation.
6.5.8. Methodsofproductpreparationpriortofillingshouldsimulatecommercialpractice.For
example,blanchingmaycauseswelling,mattingorshrinkagewhichcouldinfluenceheat
penetrationcharacteristics.
6.5.9. Productmattingorclumpingmaychangeheatpenetrationcharacteristicsandinfluence
coldspotlocation.Also,cautionshouldbeexercisedwithslicedproductswhichmaystack
togetherduringprocessing.
6.5.10. Rehydrationofdriedcomponents,eitherbeforeorduringprocessing,isacriticalfactor
whichmayinfluenceheatpenetrationbehavior,aswellasprocessefficacywithrespect
tosporeinactivation.Detailsofrehydrationproceduresshouldberecordedduringthe
heatpenetrationstudy.
6.5.11. Productmayheatbyconvection,conductionormixedconvection/conduction
dependingonitsphysicalproperties.Heatingpropertiesmayalsobeinfluencedby
presence/absenceofagitationduringprocessing,headspacevolume,etc.
6.5.12. Somefoodsexhibitcomplex(broken)heatingbehavior.Productmayinitiallyheatby
convection,thenduetoaphysicalchangeintheproduct,changetoconductionheating
behavior.Forexample,forproductssuchassoupswhichcontainstarch,achangein
heatingbehaviormaybeduetostarchgelatinizationataparticulartemperature.Small
variationsinproductformulationoringredientsmaycausethetransitionfromconvection
toconductionheatingtooccuratadifferenttemperatureandrelatedtime.Specialcare
shouldbetakentoidentifyandcontrolspecificproductandprocessvariablesrelatedto
theheatingratesoftheseproducts.
6.5.13. Additionalproductcharacteristicssuchassaltcontent,wateractivity,pH,specific
gravity,concentrationofpreservatives,andmethodsofacidificationmayinfluenceheat
transferormicrobiologicalresistanceandshouldberecorded.
6.6. Container
6.6.1. Manufacturerandbrandnameinformationforthecontainershouldberecordedincase
informationrelatedtofilling,sealingorprocessingisrequired.
6.6.2. Containertype(metalcans,glassjars,retortpouches,semirigidcontainers);sizeand
dimensionsshouldberecorded.
6.6.3. Nestingoflowprofilepackagescaninfluenceheatingbehavior.Heatpenetrationstudies
wherenestingcanoccur,includingjumbledloads,shouldincludetestsconductedon
stacksofpackagesaswellasnonnestedpackages.
6.6.4. Containervacuumandheadspaceshouldberecordedforrigidcontainers.Forflexibleand
semirigidcontainers,thevolumeofresidualgasesinthecontainershouldbedetermined.
Entrappedanddissolvedgasesmaycreateaninsulatinglayerinthecontainercausinga
shiftinthecoldspotlocationandadecreaseintheheatingrate.Controlledoverpressure
duringprocessinghasbeenfoundtoreducetheseeffects.
6.6.5. Maximumthicknessofflexiblepackages(pouches)hasadirectrelationshiptothecold
spottemperaturehistorywiththickerpackagesheatingmoreslowly.Heatpenetration
studiesshouldbecarriedoutatthemaximumspecifiedandpermittedpackagethickness.
6.6.6. Containerorientation(vertical,horizontal,andspecificlocationoftop/bottomofthe
package)withintheretortmaybeacriticalfactorforsomeproduct/packagecombinations
andshouldbestudied,whereappropriate.Changesincontainerorientationmayalso
influenceventschedulesandcomeuptimeaswell.
6.6.7. Postprocessingexaminationoftestcontainersforabnormalitiesshouldbeconducted
withspecialemphasisontheslowestandfastestheatingcontainers.Itisstrongly
recommendedthatflexiblepackagesbecarefullyexaminedfollowingprocessingto
identifythethermocouplejunctionlocation.Iftheintendedsensinglocationhasshifted,it
islikelythatheatpenetrationdatacollectedarenotreliable.
6.7. MethodofFill
6.7.1. Filltemperatureoftheproductshouldbecontrolled.Itwillaffecttheinitialtemperature
whichmayinfluencesomeheatpenetrationparameters(lagfactor,retortcomeup
period).Thismayconstituteacriticalfactorforaprocess,particularlyforproductswhich
exhibitbrokenheatingbehavior.
6.7.2. Fillandnetweightsmayinfluenceheatingratesbothinstillandrotarycooks.Information
onvariabilitymaybefoundinstatisticalprocesscontrolandproductqualitycontrol
records.
6.7.3. Inmostcases,controllingheadspacebydeterminingnetweightisnotsufficientdueto
possiblevariationsinthespecificgravityofthefoodproduct.Careshouldbetakento
avoidincorporationofairwhichwouldaffecttheheadspacevacuum.Inrotaryprocesses,
containerheadspaceisacriticalfactorsincetheheadspacebubblehelpsmixtheproduct
duringagitation.
6.8. ClosingorSealing
6.8.1. Closingorsealingequipmentshouldprovideastrong,hermeticsealwhichismaintained
duringthethermalprocess.
6.8.2. Vacuumisaffectedbyvariablessuchas:headspace,producttemperature,entrappedair,
andvacuumefficiencyoftheclosingequipment.
6.8.3. Someproductssuchasvegetablesvacuumpackedincansmayhaveaminimumvacuum
asacriticalfactor.Forotherspackedinflexibleorsemirigidcontainers,vacuumsetting
willinfluencetheresidualaircontentinthepackage,alsoconstitutingacriticalfactor.
6.9. RetortSystemThetypeofretortsystemusedmayhaveasignificantinfluenceontheheating
ratesofproductsprocessedintheretort.Resultsfromaheatpenetrationtestshouldbe
reportedwithreferencetotheretorttype,heattransfermedium,agitation,andotherpre
definedconditionsexistingatthetimeoftesting.
6.9.1. Whentestingconvectionandconductionheatingproducts,retortcomeuptimeshouldbe
asshortaspossibleconsistentwithobtainingsatisfactorytemperaturedistribution.
Resultswillbeconservativewhenusinglaboratorysizeretortsorsimulatorsasthesetend
tohaveshortercomeuptimesandcoolmorequicklythanproductionretorts.However,
cautionshouldbeexercisedwhenprocessingbrokenheatingproductswherethelengthof
thecomeupperiodmayaffectthetimeatwhichtheproductheatingcharacteristics
changefromconvectiontoconduction.Thismayalsobeofconcernwherecomeuptimes
arelongerinproductionthandefinedbythedesignedprocess.
6.9.2. Laboratorysizeretortsorsimulatorsmaybeusedfordevelopmentworkonheat
penetrationbehavior.Afterdevelopment,thethermalprocessshould,ifphysically
possible,beverifiedinanappropriateproductionretort.
6.9.3. Heattransferdistributionstudiesshouldbeconductedpriortoconductingheat
penetrationstudiesforoverpressureretortsystems.
6.9.4. Rackingsystemsmaybeusedtoseparatelayersofcansorjars;constraintheexpansionof
semirigidandflexiblecontainers;providesupportandcirculationchannelsforthinprofile
containers;andensuremaximumpouchthicknessisnotexceeded.Careshouldbetaken
tounderstandtheinfluenceofaspecificrackdesignonretortperformanceandheat
transfertocontainers.
6.9.5. Stillbatchretortsystemsvaryinoperationbasedon:typeofheatingmedium(e.g.,steam,
steam/air,water);orientationoftheretort(vertical,horizontal);methodofheating
mediumagitation(fans,pumps,airinjection);andotherfactorswhichmayinfluencethe
heatingbehavior.
6.9.6. Rotationalbatchretortsystems(e.g.,axial,endoverend)aredesignedtorotate(or
oscillate)entirebasketsofproductduringprocessing.Containeragitationmayprovide
fasterratesofheatpenetrationtothecontainercoldspotascomparedtostillcooks.
6.9.7. Itisrecommendedthatdatabecollectedatsmalltimeincrements(e.g.,15secondsor
less)particularlyforlowviscosityfluidswherethecoldspotmaymoveinrelationshiptoa
fixedTMDduringrotation,producingerroneousresults.Shorttimeintervalsareimportant
withlowviscosityliquidsandbrokenheatingproductsthatchangefromconvectionto
conduction.Slightlylongertimeintervals(e.g.,30seconds)maybeacceptablefor
conductionheatingproducts.1minuteisadequateformostconductionheatingproducts,
and3minutesmaybeadequateforlargecontainersofconductionheatingproducts
wheretheprocesstimeislonger.Ingeneral,50to100datapointscollectedoverthe
collectiontimemaybesufficientformanyconductionheatingproducts.
6.9.8. SlipringconnectorsshouldbecleanedandTMDcalibrationverifiedatregularintervals.
Criticalfactorsforrotationalbatchretortsmayinclude:headspace,productconsistency,
solidstoliquidratio,initialtemperature,containersize,rotationalspeedandradiusof
rotation.
6.9.9. Continuousretortsystemsmovecontainersthroughtheprocessingvesselalongaspiral
tracklocatedattheoutsidecircumferenceofahorizontalretortshellormaybecarried
throughahydrostaticretortinchaindrivenflights.Regardlessoftheconfiguration,it
becomesdifficultorimpossibletousethermocouplestocollectheatpenetrationdatain
thesesystems.Datamaybeobtainedusingsimulatorsandthenconfirmedusingwireless
dataloggersinthecommercialvessel.
6.9.10. Heatpenetrationdata,insomecasescanbecollectedusingprocesssimulators.An
understandingofscalingorotherdifferencesbetweencommercialvesselsandtheprocess
simulatorandtheimpactonheatpenetrationisneededandshouldbedocumented.

6.10. SeeChapter2TestEquipmentandCalibrationofTestEquipment
METHODS
6.11. PositioningofTemperatureMeasuringDevices(TMDs)intheContainer
6.11.1. ThemethodofinsertingaTMDintoacontainershouldresultinanairtight,watertight
sealwhichshouldbeverifiedaftertesting.Verificationmaybeaccomplishedthrough
comparisonofcontainerweightsrecordedpreandposttesting.
6.11.2. TMDsensingjunctionsshouldbepositionedinthecoldspotofthepackage.
6.11.3. DuringinsertionoftheTMD,cautionmustbetakentoavoidphysicalchangestothe
productcomponentssuchascreatingaconductionpathwaytotheparticulatecenter.Care
shouldalsobetakentoaddresspotentialagitationcreatedbytheprobe,whichcanoccur
inrotationprocessesiftheprobeactsasastirrer.
6.11.4. ThemethodemployedformountingtheTMDintothecontainershouldnotaffectthe
containergeometrywhichcouldinfluenceheatpenetrationcharacteristics.
6.11.5. FlexibleorrigidTMDsmaybeinsertedintorigid,flexibleorsemirigidcontainersusing
compressionfittingsorpackingglands.Forflexiblecontainers,NFPA(4)provides
illustrationsofthermocouplepositioningintoasolidparticulateandseveralthermocouple
positioningdevicestoensurethethermocoupleremainsinafixedpositionwithinthe
container.
6.11.6. ThemostappropriateTMDdeviceforaparticularapplicationwilldependuponthe
product,rackingsystem,containertypeandsealingequipment.
6.11.7. Leakagemaybedetectedbyweighingthecontainerbeforeandafterprocessingto
determinechangesingrossweight.Ifthereisleakagecausedbyimproperlymounted
TMDsorthefailureofahermeticseal,datacollectedforthatcontainershouldbe
discarded.
6.12. TypeandPlacementofContainers
6.12.1. Thetypeandsizeofcontainerusedintheheatpenetrationstudyshouldbethesameas
thatusedforthecommercialproduct.
6.12.2. Therackingandloadingofrigid(e.g.,cans),semirigid(e.g.,plasticbottles,traysand
cups)andflexible(e.g.,pouches)containersshouldsimulatecommercialpractice.
6.12.3. Testcontainersshouldbeplacedattheslowestheatinglocation(s)intheretort,as
determinedbytemperatureandheattransferdistributionstudies.
6.13. TemperatureoftheHeatingMedium
6.13.1. TMDstomeasuretheheatingmediumshouldbepositionedsoastopreventdirect
contactwithracksorcontainersandidentifiedaccordingtotheirspecificlocationsinthe
retort.
6.13.2. AminimumoftwoTMDsarerecommendedforretorttemperaturemeasurement:one
situatedclosetothesensingbulboftheretortreferenceTID,theotherlocatednearthe
testcontainers.
6.13.3. Inaddition,atleastoneTMDshouldbeplacednearthesensorforthetemperature
controllerwhenthatlocationisremotefromthelocationofthereferenceTID.
6.14. RetortPressureWorsecaseoverpressureconditionsshouldbeusedwhencollectingheat
penetrationdata.
6.14.1. Overpressureconditionsduringprocessingwillinfluencepackageexpansionby
constrainingtheexpansionofheadspacegases.Thismaybebeneficialbyimprovingheat
transfertofoodinflexibleandsemirigidcontainersordetrimentalbyrestrictingthesize
oftheheadspacebubbleinrotaryprocesses.
6.14.2. Coolingwithoutoverpressuremayresultindepressurizationwithinacontaineratthe
endofaprocess,leadingtoaccelerateddecreasesintemperatureforfluidfoods.Glass
packagesmayalsobreakifoverpressureisnotproperlymaintainedduringcooling.
6.15. ColdSpotDetermination
6.15.1. Thelocationoftheslowestheatingorcoldspotinacontaineriscriticaltoestablishinga
processandshouldbedeterminedexperimentally.Acoldspotlocationstudyshouldbe
completedtodeterminetheslowestheatinglocationforaspecific
product/package/processcombination.Usually,thecoldspotlocationwillbedetermined
fromaseriesofheatpenetrationtestsemployingseveralcontainerswithTMDsinsertedat
differentlocations.Alternatively,morethanoneTMDpercontainermaybeused;
however,multipleTMDsmayinfluenceheatingbehavior,especiallyforproductsinsmaller
containers(6).Careandjudgementbasedonanumberofpreliminaryexperiments,must
beexercisedtoensurethecoldspotlocationhasbeenidentified.
6.16. InitialProductTemperature
6.16.1. Measurementofinitialproducttemperatureshouldbetakenimmediatelypriorto
testing.
6.17. NumberofContainersperTestRun
6.17.1. Aheatpenetrationtestshouldevaluateatleast10workingTMDsforeachtestrun(6).If
theretortcannotaccommodatethisquantity,thenumberofreplicatetestrunsshouldbe
increased.
6.18. NumberofTestRuns
6.18.1. Replicationofheatpenetrationtestrunsisimportantinordertoobtainresultswhich
accountforruntorun,product,containerandprocessvariability.
6.18.2. Afterinitialcoldspotdeterminationtestsarecompletedandallcriticalfactorshavebeen
determined,atleasttwofullreplicationsofeachtestarerecommended.Shouldresults
fromthesetestsshowvariation,aminimumofathirdtestisrecommended.
6.18.3. Variationintheresultsisexpectedandquitecommon,especiallyforproductswhichare
nonhomogeneousorexhibitcomplexheatingbehavior.Variabilityisgenerallyevaluated
basedonplotsoftheheatingandcoolingcurvesand/orlethalitycalculationsandshould
beconsideredwhenidentifyingorpredictingtheslowestheatingbehaviorofaprocess.

DATAANALYSES
6.19. Variousmethodsareavailableforanalyzingheatpenetrationdata(4,6,7,and8).Regardless
ofthemethodused,awarenessofthepotentialpros/consforeachmethodshouldbe
understoodandaddressed.
RISKS,ISSUESANDOTHERCONSIDERATIONS
6.20. Useofselfcontained(i.e.,wirelessdataloggers)TMDsshouldbeevaluatedforaccuracy,
reliability,andapplicabilitypriortouseastheproducttemperaturemeasuringdevicesforheat
penetrationstudies.Insomecasesthesedevicesmayprovidebenefitsoverusingwired
thermocouples,e.g.,inagitatingretortssuchascontinuousrotarysterilizers,batchretorts
operatedinanagitatingmode,andhydrostaticretorts.
6.21. Ecklund(5)reportedcorrectionfactorsforheatpenetrationdatatocompensateforerrors
associatedwiththeuseofnonprojecting,stainlesssteelreceptacles.Whilenotreportedinthe
literature,thismayalsobeaconcernwithotherfittings.
6.22. TypeofConnectorsandAssociatedErrors:Connectorsusedinathermocouplecircuitare
fittingsattachedtoathermocouplewithinwhichelectricalconnectionsaremade.Severaltypes
ofconnectorsareavailableforspecificapplicationsandthermocoupletype.Cautionmustbe
exercisedtoavoidcertainsourcesoferrorwhichmaybeassociatedwiththeuseofconnectors
andextensionwires.Theseinclude:disparitybetweenthermocouples,connectorsand
extensionwires;temperaturedifferencesbetweentwowirejunctions;andreversedpolarityat
thethermocoupleextensionwirejunction.Thermocoupleconnectorsshouldbecleaned
frequentlytoremoveoxidationfromcontactstoassuregoodelectricalcontactandprevent
errorsinthermocouplereadings.SimilarconcernsshouldbeaddressedwhenusingRTDsand
thermistors.
DOCUMENTATION
Thefollowingprovidesasummaryofdetailswhichmaybeincorporatedinachecklistand
documentedintheirentiretyorpartiallyasdeemedappropriateforaspecificstudy.Other
factorsnotlistedinthissectionmayalsoberelevant.
6.23. PretestDocumentation
6.23.1. Productcharacteristics
6.23.2. Productname,formorstyleandpackingmedium
6.23.3. Netweightandvolume
6.23.4. Consistencyofviscosityoftheliquidcomponent
6.23.5. Size,shapeandweightofsolidcomponents
6.23.6. Sizeofsolidcomponentclusters
6.23.7. pHofsolidandliquidcomponents
6.23.8. Methodsofpreparationpriortofilling(ingredientmixingmethods,specialequipment,
etc.)
6.23.9. Mattingtendency
6.23.10. Rehydrationofcomponents
6.23.11. Acidificationprocedures
6.23.12. Othercharacteristics(e.g.,%solids,density,etc.)
6.24. ContainerDescription
6.24.1. Containermaterial(brandnameandmanufacturer)
6.24.2. Type,sizeandinsidedimensions
6.24.3. Containertestidentificationcode
6.24.4. Maximumthickness(flexiblecontainer)
6.24.5. Grossweightofcontainer
6.24.6. Containernestingcharacteristics
6.24.7. Slowestheatingorcoldspotlocationincontainer
6.25. DataAcquisitionEquipmentandMethodology
6.25.1. Identificationofdataloggingsystem
6.25.2. TMDsandconnectorplugmaintenance
6.25.3. TMDsandconnectorsnumbered
6.25.4. Electricalgroundchecked(usingthermocouples)
6.25.5. CalibrationofTMDsplacedinheatingmedium
6.25.6. Type,length,manufacturerandidentificationcodeofTMDsandconnectors
6.25.7. TMDlocationincontainer
6.25.8. PositioningtechniqueforTMDs
6.26. FillMethod
6.26.1. Filltemperatureofproduct
6.26.2. Fillweightofproduct
6.26.3. Headspace
6.26.4. Fillingmethod(comparisontocommercialprocess)
6.26.5. Sealingoperations
6.26.6. Typeofsealingequipment
6.26.7. Time,temperature,pressureandvacuumsettings(ifapplicable0
6.26.8. Gasevacuationmethod
6.26.9. Canvacuum
6.26.10. Volumeofresidualgases(i.e.,flexiblecontainers)
6.27. RetortSystem
6.27.1. Retortsystemstillorrotary,typeofagitation(endoverend,axial,oscillatory,none)
6.27.2. Retortidentificationnumber
6.27.3. Reeldiameter(numberofcontainerpositions)androtationalspeed
6.27.4. Heatingmedium(steam,steam/air,waterimmersion,waterspray/cascade)andflow
rate
6.27.5. Circulationmethodforwateroroverpressuremedia
6.27.6. Temperaturedistributionrecords
6.27.7. Whereapplicable,heattransferdistributionrecords
6.27.8. Retortventingschedule
6.27.9. Packagepositionstudydataforbatchrotaryretorts
6.28. LoadingofRetort
6.28.1. Loadingorrackingsystemdetails
6.28.2. Containerorientation
6.28.3. Locationofthermocouplesforretorttemperature
6.28.4. Useofballastcontainerstoensurefullyloadedretort(applicabletosomeretortsystems)
6.28.5. Selectedtimeintervalfordataloggingsystem
6.28.6. Locationoftestcontainersinretort(slowestheatingzone)
6.29. AdditionalInformation
6.29.1. Date
6.29.2. Testidentification
6.29.3. Processorandlocation
6.29.4. Individual(s)performingheatpenetrationtest
6.30. TestPhaseDocumentation
6.30.1. Testrunidentification
6.30.2. Initialtemperatureofproductatthestartofheating
6.30.3. Rotationspeed(ifapplicable)
6.30.4. Timeheatingstarts
6.30.5. Timeventclosedandtemperature,ifapplicable
6.30.6. Timeretortreachessetpointtemperature(t
c
)
6.30.7. TemperatureindicatedonreferenceTIDandwhencookstarts
6.30.8. Pressurefromacalibratedpressuregaugeortransducer
6.30.9. Timeprocessbegins
6.30.10. Timecoolingbegins(pressurecooling,ifapplicable)
6.30.11. Coolingwatertemperature
6.30.12. Timecoolingends
6.30.13. Anyprocessirregularitiesorinconsistencies
6.31. PostTestDocumentation
6.31.1. Containerlocationandorientation
6.31.2. Containernetandgrossweightcheckforleakage
6.31.3. Thicknessofcontainer(flexiblepouches)
6.31.4. Measurementofcontainervacuumorresidualaircontent(ifapplicable)
6.31.5. LocationoftheTMDandwhetherornotitisimpaledinafoodparticle
6.31.6. Postprocessingproductcharacteristics(e.g.,syrupstrength,appearance,viscosity,
headspace,drainedweight,pH,consistency,shrinkage,matting,clumping,etc.)

SupersedesDate:New AppendixA1
APPENDIXASELECTEDBIBIOGRAPHY
Thefollowingreferencesrepresentaselectionofpublicationsthatmayprovidemoreinsightand
informationregardingthermalprocessingstudies.

1. Pflug,I.JandBerryM.R.1987.UsingThermocouplestoMeasureTemperatureduringRetortor
AutoclaveValidation.J.FoodProtection.Vol50(11):975981.
2. Tung,M.AandBritt,I.J.1995.FoodMaterialScienceandFoodProcessEngineering:Keysto
ProductQualityandSafety.FoodResearchInternational.Vol28(1):101108.
3. Tung,M.A.Britt,I.J.andRamaswamy,H.S.1990.FoodSterilizationinSteam/AirRetorts.Food
Technology.44(12)105109.
4. NFPA1985.GuidelinesforThermalProcessDevelopmentforFoodsPackagedinFlexible
Containers.NationalFoodProcessorsAssociation,Washington,DC.
5. Ecklund,O.F.1956.Correctionfactorsforheatpenetrationthermocouples.FoodTechnol.
10(1):4344.
6. Pflug,I.J.1975.ProceduresforCarryingOutaHeatPenetrationTestandAnalysisofthe
ResultingData.UniversityofMinnesota,Minneapolis,MN.
7. CFPRA1977.GuidelinesfortheEstablishmentofScheduledHeatProcessesforLowAcidFoods.
TechnicalManualNo.3.CampdenFoodPreservationResearchAssociation,ChippingCampden,
Gloucestershire,UK.
8. ASTM.1988.StandardGuideforUseintheEstablishmentofThermalProcessesforFoods
PackagedinFlexibleContainers.F116888.AmericanSocietyforTestingandMaterials,
Philadelphia,PA.
9. Bee,G.R.andPark,D.K.1978.Heatpenetrationmeasurementforthermalprocessdesign.
FoodTechnol.32(6):5658.
10. Ball,C.O.1923.ThermalProcessTimeforCannedFood,BulletinoftheNationalResearch
Council,Washington,DC.Vol.7,Part1,Number37.
11. Ball,C.O.1927.Theoryandpracticeinprocessing.TheCanner,64(5),27.
12. BallC.O.andOlsenF.C.W.1957.SterilizationinFoodTechnology.Theory,Practiceand
Calculation.NewYork,McGrawHillBookCo.
13. Jackson,J.M.andOlson,F.C.W.1940.Thermalprocessingofcannedfoodsintincontainers.IV.
Studiesofthemechanismsofheattransferwithinthecontainer.FoodResearch.5(4):409420.
14. Niekamp,A.,Unklesbay,K.,Unklesbay,N.,andEllersieck,M.1984.Thermalpropertiesof
bentonitewaterdispersionsusedformodellingfoods.J.FoodScience.49(1):2831.

SupersedesDate:New AppendixB1
APPENDIXBDocumentingProcessingEquipmentandTestConditionsWorksheet
Wherepossible,drawings,schematics,picturesoftheretortandassociatedequipmentcouldbebeneficialtoincludewhendocumentingtest
retortsandtestretortconditions.Thefollowingtableisanexampleofaworksheetthatmaybeusedtodocumentprocessingequipmentand
testconditions.Thisexamplemaybemodifiedasneeded.
SurveyInformation
Date________________Location_________________Doneby_____________________
Altitude___________________Heightabovesealevel_____________________
TYPEOFRETORT
ContinuousReelHydrostatSaturatedSteamBatchSteam/AirBatchWaterSprayBatchWaterCascade
BatchWaterImmersionBatchCratelessOther(Describe)___________________________
PRODUCTINFORMATION(optional)
ProductName__________________________
ProductHeatingSimple,ConvectionSimple,ConductionBrokenOther(describe)_______________
ContainerMaterial________Dimensions_________OrientationforprocessingVerticalHorizontalJumbled
Fill/Net/DrainedWeight_____________________
Listproductcriticalfactors,targets,andlimits_____________________________________________
PACKAGEINFORMATION(optional)
TypeofpackageRigidSemiRigidFlexiblePaperboardOther,describe____________________________
Materialofconstruction(describe)______________________________________________________________
Formetalcans2pc3pcSideseamconstruction___________________________________
LoadingPatternsJumblePackArrayedOther(describe)_____________________________________
PackageInformation,continued
Seal/ClosureType_______________
ContainerVacuumYesNoIfyes,allowedlimits___________________________________
RETORTOPERATION
Throughput(CPM)___________________________________Containers/load_______________________
CookTemperatureSetpoint________________PressureSetpointduringCook______________________
RotationSetpoint_____________________________
PartialLoadsYesNoIfyes,describeallowedconditions________________________________________________________
___________________________________________________________________________________________________________
Whereapplicable,includeretortcontrolprogram.
ForWaterImmersionFullImmersionPartialImmersionWaterrecirculationrate_________________
ForWaterSprayNumberandtypeofnozzles_______________________________FlowRate___________________
ForWaterCascadeNumberandtypeofspreader/manifold_________________________FlowRate_______________
ForSteam/AirFanlocation___________________FanRPM_________________ShroudYesNo
Preheatingofoverpressureair/nitrogenYesNoIfyes,describehowheated,howcontrolled,andtowhattemperature
______________________________________________________________________________________________________
Steam/AirRatio___________________IsventingpartoftheprocessYesNoIfyes,whenisventclosed_______________
LOADINGCONSIDERATIONS(wherepossiblesecuredrawings,schematics,pictures)
LoadingConfigurationLayeredNestedCompartmentedOffsetOther(describe)_______________________________
Loadingconsiderations,continued
Waterdisplacementrequirements(ballast)_________________________________________________________________
Cassette,Basket,orRackDimensions_____________________Distancebetween(ifapplicable)______________________
Orientationinretortduringprocessing_________________________Percentopenarea________________
Separator/DividerTraysMaterialofconstruction___________________________HoleSize(ifapplicable)________________
Percentopenarea______________________________
HoleOpenArea,SpacingandPatternBaseplate________________Sidesofcassettes/baskets/rack___________________________
Separator/dividerSheets_________________________
RETORTSPECIFICS(wherepossiblesecurefactoryblueprints/schematicsoftheretortandallattendantpipingaswellasanyalterationssincethe
retortwasinstalled)
Manufacturer________________________DateInstalled_______________PhysicalDimensionsofshell________________
CapacityContinuousReel:Zone1_________Zone2__________Zone3_________Zone4________Cooker_________
Cooler_________PressureCooler__________Total_________
CapacityHydrostatic:Preheat______________Sterilization______________Cooling_____________Total__________
Numberofflights________________________
CapacityBatch:No.ofBaskets/CratesperRetort____________No.ofpackagesperload________________
CapacityCrateless:Maximumnumberofcontainersperload__________________________________
HeatTransferMedium:SaturatedSteamSteam/AirWaterOther_________________
MethodofHeatingHeatTransferMedium(describe)_____________________________________________________
Retortspecifics,continued
CoolingMedium:AmbientwellwaterChilledwaterOther(describe)____________________________________
Methodofprocesswatermicrobialcontrol_______________________________________________
Methodofdistributing/mixingheattransfermedium:FanPump(s)Airplenum/shroudNozzlesNotApplicable
Other(describe)_______________________________
Controls(e.g.,PLC,ComputerControl,etc.)(Describe):
_________________________________________________________________________________________
Noteanydifferencesbetweenretortsinthetestgroup.
Listofallcontrolling/sensingdevices(notethatideallyaschematic/drawingshouldbeavailable):___________________________
___________________________________________________________________________________________________________
Rotation:YesNoContinuousReelRPM___________________________HydrostaticCPM________________________
BatchRPM_______________________________BatchOscillatory_________________________
VentsType_________________________Size________________________Location__________________________________
Pipesizeandconnectiontodrainheadersorchannels____________________________________
Ventmanifold/manifoldheaderLocation__________________Pipesize(s)includingconnectingpipes______________________
Bleeders/MufflersNumber__________Size(s)_______________________Location(s)__________________________________
Construction_______________________________________________________________
DrainsValveType__________________ValveSize________________Pipesize___________PipeLength______________
Connectionstodrainheadersorchannels____________________________________Location(s)___________________________
Retortspecifics,continued
CondensateRemovalSystem(s)Type________________________Size_______________________Location_______________
CheckValvesYesNoIfyes,Size______________________Type_____________________Location(s)__________________
SafetyValvesSize__________________Type__________________________Location(s)_____________________________
CenteringguidesorbafflespresentYesNoIfyes,indicatelocation_____________________________________________
Waterrecirculationsystem(ifapplicable)Pumptype_____________PumpSize___________PumpCapacity_______________
Inlet/outletportLocations__________________Size_______________Filters_____________________Recirculationlinesize_________
Flowmeter(ifapplicable)type__________________Capacity______________
Horsepower_________Pipediameterforpumpinlet___________andforpumpoutlet____________
UTILITIESTO/FROMRETORT
SteamSupply
BoilerCapacity____________MethodofFiring____________________Pressure_______________
Steamheaderpressure(peakusage)_____________________PipeSize______________Length___________________
Steamheaderpressure(offloadhourusage)_____________________
Steaminjectionchamber(ifapplicable)________________________________
ValveType___________ValveSize________________
Pipefittingsincludingsteambypasspipesfrommainlinetoretort(presence,type,size)_________________________________________
Sizeofallconnectingsteampipestothemainline_________________________________________________________________________
Noteallequipmentusingsteamfromsamesupplyline______________________________________________________________________
Utilitiesto/fromretort,continued
PressureReducingValve/RegulatorYesNoIfyes,typeandpressureintoretort_____________________________________________
SizeandTypeofValveforSteamentryintoRetort_____________________________________________________________________________
SteamdistributionsysteminretortNumber,locationandsizeofsteamspreaders/distributors______________________________________
SteaminjectionpointsSize___________Type_______________________Location(s)__________________________________
SteamspreaderornozzleShape________________Size______________Location(s)________________________________
Configuration___________________________Numberof_________________Sizeandlocationinpipe_________________________
SizeofT_____________________Sizeofotherpipefittings__________________________________________
WaterSupply(wherepossible,attachaP&ID)
Waterpressuretoretort_______________________________________Watertemperaturetoretort_____________
WaterdistributionsysteminretortNumber,sizeandlocationofwaterspreaders/manifolds_______________________________________
_____________________________________________________________________________________________________________________
ProcessWaterSupplySource__________________Quality____________Temperature_______Controls(ifany)____________________
CoolingwatersupplySource_____________Quality______________Temperature_______Controls(ifany)________________________
Methodofheatingprocessingwater(describe)____________________________________________________________
HeatexchangerSize______________Type__________________
PumpSize________Type__________Location____________________
Air/NitrogenSupply
CompressorType______________________________Capacity__________________OperatingPressure____________________________
Utilitiesto/fromretort,continued
FilterType________________________FilterSize____________________DryerType___________________DryerSize________________
TankType______________________TankSize_______________________________
LineSize____________Pressure___________Filtersanddryersforinstrumentair_______________________________________________
ProcessairheaderLinesize_____________Pressure_______________Regulation(ifapplicable)________________
EntryLocation______________________InletSize_________________
ControlValveSize____________________Type______________________Pressuresetting____________Flowrate_______________
Indicateavailabilitytosupplyinstruments_________________________________________________________________________________
AirheatedYesNoIndicateifairlinesareincloseproximitytosteamorwaterlines____________________________________________
ForOverpressurePipelocation(s)_______________Pipesize________________Valvetype______________Valvesize______________
Methodofcontrol(describe)____________________________________________
SENSORS
Temperature
TypeofReferenceTID____________________________ModelofTID_______________________Location(s)_________________________
Range______________________________Responsetime__________________Lengthofinsertion_________________________
Lengthofscale(MIG)_______________________________Increments(MIG)___________________________________
CalibrationstatusDatelastcalibrated_________________Nextcalibrationdate______________________
Size,shape,locationofwells____________________________________________________________________________________________
Sensors,continued
TemperatureControlSensingDeviceType__________________Location_________________RelationshiptoTID____________________
ForWaterSprayandWaterCascadeIsthisdeviceinthewaterspray/cascadeYesNo
ForSteam/AirIsthisdeviceintheretortorintheair(return)plenumRetortAirreturn/plenum
Pressure
TypeofPID_________________________________ModelofPID___________________________Location(s)_________________________
Range___________________________________CalibrationstatusDatelastcalibrated_____________
Nextcalibrationdate____________________
Water
Waterlevelindicatortype(ifapplicable)____________________________________Location(s)_______________________________
Other
RotationsensorType__________________________Location____________________________Drivesystem_____________________
Throughput/speedsensorType____________________________Location________________________
Typeandsizeofflowmeter_________________________________Location(s)______________________________
RECORDINGDEVICES
Recorder/RecorderControllerType_______________________Resolution__________________________
Parametersrecorded_________________________________________Calibrationstatus___________________________
ListProcesscriticalfactorsandtheirassociatedlimits___________________________________________________________________
________________________________________________________________________________________________________________
WATERSPRAYANDWATERCASCADERETORTTheseareitemsthatmaynotbecoveredinotherareasofthesurvey.
WaterSpreader(s)Type_____________Size________________Location_________________________
WaterrecirculationsystemPumpType______________PumpCapacity________________PumpImpellerSize______________
PumpMotorsize___________________
Inlet/OutletportLocation___________________Size______________________
Waterflowrate______________________________
ProcesswaterretentionchannelortroughinbottomofretortYesNoIfyes,Length________Width______Waterdepth________
ProcesswaterretainedforcoolingYesNo
ProcesswaterretainedforreuseYesNo
Amountofprocesswateratstartofprocess____________Controlledby____________________Measuredby_____________________
Steamdistributors(ifapplicable)Locationinrelationtochannelortrough____________________________________________
WaterDistributionPlate(s)WaterCascadeonlyInletpipetomanifoldlocation:Top/centerofretortshellTop/rearofretortshell
Dimensionsofmanifold__________________________MaterialofConstruction________________________________
Numberofholes____________Sizeofholes__________Location(holepattern)________________________________________________
Percentopenarea________________________________
Waterdistributionpipes(WaterSprayonly)Locationofwaterinletpipetoretortshell__________________________________________
Locationofwaterdistributionpipesinrelationtocircumferenceofinteriorofretort_______________________________________________
Waterspray/cascaderetorts,continued
Lengthofpipes(dotheyextendlengthofshell)_______________________________________
Numberofholes_____________Sizeofholes__________________Locationofholes_____________________________
NozzlesType(ifapplicable)___________________________FixedOscillatoryOther(describe)_________________________
RestrictholeopeningYesNoIfyes,howmuch______________________________________________________
STEAM/AIRRETORTS
AirplenumandfanshroudDistance(length)fromretortshelltoplenumifdesignedasashellinshell____________
Ifnotdesignedasshellinshell,describe:_______________________________________________________________________
Fanshrouddetails(describe)_____________________________
SupersedesDate:NewAppendixC1
APPENDIXCTemperatureDistributionDataCollection/MonitoringPoints
Thefollowingtableisacompilationofsuggesteddatacollection/monitoringpointswhen
collectingtemperaturedistributiondataindifferenttypesofretorts.
DataCollection/MonitoringPoints
RetortType
ST SA WS WC WI
TemperatureandPressureControllersetpoint(s),includingifthereisan
overshootsetpointforcomeupandalowersetpointforprocessing
( ( ( ( (
ProductorBallastInitialTemperature. ( ( ( ( (
Timeprocesscyclestarts,Time0. ( ( ( ( (
Timewhentheendofcomeup,startofthermalprocessing/cookstephasbeen
achieved,asindicatedbyeitherthestepchangeinacontrolprogramorthe
achievementofprocesssetpointtemperatureatboththereferenceTIDandthe
recorder/controller.
( ( ( ( (
ReferenceTIDreadingsatsufficientintervalsduringtheentirecycle,includingthe
pointintimeitreachestheprocesstemperaturesetpoint.
( ( ( ( (
Monitorrotationoragitationrateatsufficientintervalsusinganaccurate
calibratedstopwatchorcalibrateddeviceincludinganypointswhererotationrate
changesduringprocessingoronacontinuouschartwhererotationoragitationis
used.
( ( ( ( (
Timeattheendofthermalprocessandstartofcool. ( ( ( ( (
Actualbasket/crate/rackorientationintheretort. ( ( ( ( (
Operatingactivityofotherretortsincludingthenumberofretortsenteringcome
upduringthestudy.
( ( ( ( (
Numbersanddescriptionsofotherequipmentusingsteam(e.g.,blanchers)atthe
timeofthestudyandbefore,during,andaftercomeup.
( ( ( ( (
Temperatureofairsupplyenteringtheretort. (
Waterlevelinrelationtospreadersandlowestlevelofcontainersintheretort. ( ( (
Timewhenthepressuresetpoint(s)isachieved. ( ( ( (
Timeandtemperaturewhenthedrainisclosed,ifitisopenduringaportionofthe
vent.
( (
Timeandtemperature,iforwhentheventcloses,takenfromthereferenceTID. ( (
Airflowinscfmorlitersperminute,ifapplicableandavailable. ( (
Linesteampressureatthetimeofthetestandbefore,during,andaftercomeup,
ifpossible.
( (
Retortpressure,throughoutthetestcycleatsufficientintervalsoroncontinuous
chart.
( ( ( (
Timesteambypassvalvecloses. (
Temperatureofinitialprocesswater. ( ( (
Floworrecirculationrateofwaterasdeterminedbyflowmeterorother
acceptablemeans.
( ( (
Filltime(displacement)inthosesystemsdroppingwaterfromastoragedrumor
tankintotheworkingprocessingvessel.
(
Waterlevelinprocessvesselinrelationtothetopsurfaceofcontainers,statedas
aminimumoranactuallevelthroughouttheprocess.
(
Lineairpressureatthetimeofthetestandbefore,during,andaftercomeup,if
possible.
(
STSaturatedSteamSASteam/AirWSWaterSprayWCWaterCascade
WIWaterImmersion
SupersedesDate:New AppendixD1
APPENDIXDHeatPenetrationDocumentationChecklist
ThefollowingtableisanexampleofachecklistthatmaybeusedforHeatPenetrationStudies.Thisexamplemaybemodifiedas
needed.
PreTestDocumentation
Item/Parameter Data DoneBy
Productcharacteristics
Productname,form,style,packingmedium
Netweightandvolume
Consistencyorviscosityoftheliquidcomponent
Size,shape,andweightofsolidcomponents
Sizeofsolidcomponentclusters
pHofsolidandliquidcomponents
Methodsofpreparationpriortofilling(e.g.,ingredient
mixingmethods,specialequipment,etc.)

Mattingtendency
Rehydrationofcomponents
Acidificationprocedures
Othercharacteristics(e.g.,%solids,density,etc.)
ContainerDescription
Containermaterial(brandnameand
manufacturer)

Type,Size,andInsidedimensions
Containertestidentificationcode
Maximumthickness(flexible
container)

Grossweightofcontainer
Containernestingcharacteristics
Slowestheatingorcoldspotlocation
incontainer

DataAcquisitionEquipmentandMethodology
Identificationofdataloggingsystem
TMDtypeandwhereapplicable,
connectorplugmaintenance

Type,length,manufacturerand
identificationcodeofTMDsand
connectors

Electricalgroundchecked(using
thermocouples)

CalibrationofTMDsplacedin
heatingmedium

TMDlocationincontainer
PositioningtechniqueforTMDs
FillMethod
Filltemperatureofproduct
Fillweightofproduct
Headspace
Fillingmethod(comparisonto
commercialprocess)

Sealingoperations
Typeofsealingequipment
Time,temperature,pressure,and
vacuumsetting(ifapplicable)

Gasevacuationmethod
Canvacuum
Volumeofresidualgases(i.e.,
flexiblecontainer)

RetortSystem
Retortsystemstillorrotary,type
ofagitation(endoverend,axial,
oscillatory,none)

Retortidentificationnumber
Reeldiameter(numberofcontainer
positions)androtationalspeed

Heatingmedium(steam,steam/air,
waterimmersion,water
spray/cascade,hydrostatic)andflow
rate

Circulationmethodforwateror
overpressuremedia

Temperaturedistributionrecords
Heattransferdistributionrecords(if
applicable)

Retortventingschedule
Packagestudypositionforbatch
retorts

LoadingofRetort
Loadingorrackingsystemdetails
Containerorientation
LocationofTMDsforretort
temperature

Useofballastcontainerstoensure
fullyloadedretort(applicablefor
someretortsystems)

Selectedtimeintervalfordata
loggingsystem

Locationoftestcontainersinretort
AdditionalInformation
Date
Testidentification
Processorandlocation
Individualsperformingtest
TestPhaseDocumentation
Testrunidentification
Initialtemperatureofproductatthe
startofheating

Rotationspeed(ifapplicable)
Timeheatingstarts
Timeventclosedandtemperature,if
applicable

Timeretortreachessetpoint
temperature(t
c
)

Temperatureindicatedonreference
TIDwhencookstarts

Pressurefromacalibratedpressure
gaugeortransducer

Timeprocessbegins
Coolingwatertemperature
Timecoolingbegins(pressure
cooling,ifapplicable)

Timecoolingends
Anyprocessirregularitiesor
inconsistencies

PostTestDocumentation
Containerlocationandorientation
Containernetandgrossweight
checkforleakage

Thicknessofcontainer(i.e.,flexible
pouches)

Measurementofcontainervacuum
orresidualaircontent(ifapplicable)

LocationoftheTMDandwhetheror
notitisimpaledinafoodparticle(if
applicable)

Postprocessingproduct
characteristics(e.g.,syrupstrength,
appearance,viscosity,etc.)

IFTPS Retort - Processing - Guidelines - 02 - 13 - 14 PDF

Caricato da

Informazioni sul documento

Descrizione originale:

Titolo originale

Copyright

Formati disponibili

Condividi questo documento

Condividi o incorpora il documento

Opzioni di condivisione

Hai trovato utile questo documento?

Questo contenuto è inappropriato?

Copyright:

Formati disponibili

IFTPS Retort - Processing - Guidelines - 02 - 13 - 14 PDF

Caricato da

Copyright:

Formati disponibili

IFTPSGuidelinesforConductingThermalProcessingStudies

Institute For Thermal Processing Specialists

Potrebbero piacerti anche