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ValidationofFood PreservationProcesses

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ValidationofFood PreservationProcesses BasedonNovel Technologies

GuelphResearchandDevelopmentCenter,Agriculture andAgri-FoodCanada,ON,Canada

AcademicPressisanimprintofElsevier

125LondonWall,LondonEC2Y5AS,UnitedKingdom 525BStreet,Suite1650,SanDiego,CA92101,UnitedStates 50HampshireStreet,5thFloor,Cambridge,MA02139,UnitedStates TheBoulevard,LangfordLane,Kidlington,OxfordOX51GB,UnitedKingdom

Copyright©2022ElsevierInc.Allrightsreserved.

Nopartofthispublicationmaybereproducedortransmittedinanyformorbyanymeans, electronicormechanical,includingphotocopying,recording,oranyinformationstorageand retrievalsystem,withoutpermissioninwritingfromthepublisher.Detailsonhowtoseek permission,furtherinformationaboutthePublisher’spermissionspoliciesandour arrangementswithorganizationssuchastheCopyrightClearanceCenterandtheCopyright LicensingAgency,canbefoundatourwebsite: www.elsevier.com/permissions.

Thisbookandtheindividualcontributionscontainedinitareprotectedundercopyrightby thePublisher(otherthanasmaybenotedherein).

Notices

Knowledgeandbestpracticeinthisfieldareconstantlychanging.Asnewresearchand experiencebroadenourunderstanding,changesinresearchmethods,professionalpractices, ormedicaltreatmentmaybecomenecessary.

Practitionersandresearchersmustalwaysrelyontheirownexperienceandknowledgein evaluatingandusinganyinformation,methods,compounds,orexperimentsdescribed herein.Inusingsuchinformationormethodstheyshouldbemindfuloftheirownsafety andthesafetyofothers,includingpartiesforwhomtheyhaveaprofessionalresponsibility.

Tothefullestextentofthelaw,neitherthePublishernortheauthors,contributors,or editors,assumeanyliabilityforanyinjuryand/ordamagetopersonsorpropertyasamatter ofproductsliability,negligenceorotherwise,orfromanyuseoroperationofanymethods, products,instructions,orideascontainedinthematerialherein.

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1.Generalprinciplesandapproachesoffoodprocessvalidation1

TatianaKoutchmaandLarryKeener

1.1 Generalprinciplesandapproachesoffoodprocessvalidation1

1.1.1 Validationconceptandterminology1

1.1.2 Verificationversusvalidationversusmonitoring5

1.1.3 Validationatdifferentphasesofprocessdevelopment6

1.1.4 Scale-upprocess7

1.1.5 Keycomponentsofvalidationprocedures9

1.1.6 Physicalvalidation9

1.1.7 Microbiologicalvalidation10

1.1.8 Qualityvalidation18

1.1.9 Equipmentvalidation21

1.1.10 Cleaningandsanitationvalidation22

1.1.11 Facilityrequirements23

1.1.12 Documentation24

1.1.13 Roleofprocessauthorityintheeraofemergentnoveland nonthermalpreservationtechnologies24

1.1.14 Requirementsforprocessingauthorities[21CFR113.83and113.89]26

1.2 Conclusions29 References29

2.Validationofhighhydrostaticpressureprocess31

TatianaKoutchmaandKeithWarriner

2.1 Historyandintroductiontohigh-pressureprocessingtechnology forfoods31

2.2 FundamentalsofHHP32

2.2.1 HHPprincipleofoperation32

2.2.2 HHPcommercialapplications33

2.2.3 HHPmicrobiologicaleffects35

2.2.4 HHPqualityeffects41

2.2.5 HHPeffectsonallergens42

2.2.6 HHPeffectsonpatulinmycotoxin42

2.2.7 HHPeffectsonenzymes44

2.3 HHPcriticalproductandprocessparameters44

2.3.1 Productparameters44

2.3.2 Processparameters51

2.4 Packaging56

2.4.1 Requirementsandtypesofpackages56

2.4.2 Foodcontactcompliance59

2.4.3 Packagingvalidation59

2.5 HHPcommercialsystems60

2.5.1 Design60

2.5.2 Pressurevessels60

2.5.3 CommercialHHPmanufacturers62

2.5.4 Scalabilityofpilotandcommercial-scaleHHPprocesses66

2.5.5 CalibrationandmaintenanceofHHPsystems68

2.6 Internationalregulatoryrequirements69

2.6.1 AustraliaandNewZealand69

2.6.2 Canada71

2.6.3 EuropeanUnion72

2.6.4 UnitedStates73

2.7 Microbiologicalchallengetesting74

2.7.1 Shelf-lifevalidation77

2.7.2 Safetyvalidation79

2.7.3 Surrogateorganisms81

2.8 CommercialHHPtrials84

2.8.1 Juices84

2.8.2 Meats86

2.8.3 Delisalads,hashbrowns,herbs,andgravybase88

2.9 ResponsibilitiesforcontractofHHPfacility89

2.9.1 Deviationfromthevalidatedprocess90

2.10 FutureprospectsandgapsinHHPtechnologydevelopment90 References91 Furtherreading97

3.Casestudyofvalidationofhighhydrostaticpressureprocessing offruitandvegetablesmoothiesinPETbottles99

TatianaKoutchmaandKeithWarriner

3.1 Productdescription99

3.2 Packaging99

3.3 HPPunit100

3.4 Methodology100

3.5 Samplingplan100

3.6 Testprocedures102

3.7 Sourceofpathogens102

3.8 Cultivation,enumeration,andenrichmentprotocolsformodelmicrobes103

3.9 HPPoperationprocedure105

3.10 Results106

3.11 Conclusion112 References112

4.Validationoflight-basedprocesses113

TatianaKoutchma

4.1 Historyandintroductiontofundamentalsofultravioletlightandpulsed lighttechnologyforfoodapplications113

4.2 ContinuousUV,pulsed,andLEDlightsources115

4.3 Internationalregulatoryrequirements118

4.3.1 USFoodandDrugAdministration:foodadditiveapproach118

4.3.2 Novelfoodregulations122

4.4 ValidationofUVlighttechnologiesforsurfacetreatment123

4.4.1 UVdisinfectionefficiencyofsurfacesandlimitingfactors124

4.4.2 Advantagesanddisadvantagesofhigh-intensitypulses126

4.4.3 Establishingstepsandvalidationofsurfacetreatmentprocess126

4.4.4 Criticalprocessandcontrolparameters130

4.4.5 CommercialUVandpulsedlightsystemsforsurfacetreatment130

4.4.6 CasestudiesofpulsedandcontinuousUVsurfacetreatment131

4.5 ValidationofUVlightpreservationprocessesforliquidproducts andbeverages133

4.5.1 RequirementsforUVCpreservationofbeverages134

4.5.2 EstablishmentofpreservationreductionequivalentUVCdose137

4.5.3 PrinciplesofvalidationofUVCpreservationprocessforliquids andbeverages141

4.5.4 ValidationofcommercialUVequipmentandprocesscontrols160

4.6 Conclusion165 References165

5.Casestudyofvalidationofultravioletlightpasteurizationof sugarsyrups169

TatianaKoutchma

5.1 Evaluationofultravioletdoseincommercialultravioletsystem169

5.1.1 Experimentalapproach169

5.1.2 Results176

5.1.3 MathematicalmodelingofUVfluencerate184

5.1.4 Conclusions191

5.2 UVdoseverificationstudiesincommercial-scalesystem192

5.2.1 Background192

5.2.2 Materialsandmethodologies193

5.2.3 Results198

5.2.4 Conclusion207

5.3 UVinactivationofpathogenicandspoilageorganismsinliquidsucrose207

5.3.1 Methodology208

5.3.2 Results210

5.3.3 Conclusions213 References214

6.Overviewofothernovelprocessesandvalidationapproaches215 TatianaKoutchma

6.1 Introduction215

6.2 Radiation,regulations,andvalidation215

6.2.1 Gammarays216

6.2.2 X-raysande-beams217

6.2.3 Safetyofirradiation218

6.2.4 Validationandverificationoffoodirradiationprocess218

6.2.5 Irradiationfacility221

6.2.6 Internationalregulationsandstandards221

6.3 Advancedradiativeandelectromagneticheatingtechnologies223

6.3.1 Infrared224

6.3.2 Ohmic224

6.3.3 Magneticinduction225

6.3.4 Microwave226

6.3.5 Radiofrequency226

6.3.6 Validationprinciplesofmicrowaveandradiofrequencyheating229

6.4 Coldatmosphericplasma235

6.4.1 Validationchallenges236

6.4.2 Regulationsandcommercialization238 References239 Conclusions241 Index 247

Listofcontributors

LarryKeener

InternationalProductSafetyConsultants,Seattle,WA,UnitedStates

TatianaKoutchma

NovelFoodProcessingTechnologies,AgricultureandAgri-FoodCanada,Guelph, ON,Canada

KeithWarriner

FoodScienceDepartment,UniversityofGuelph,Guelph,ON,Canada;Centerfor PublicHealthandZoonosesCanada

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Preface

Withthefast-growingdemandsinmildheatandcoldfoodpreservation andsanitationmarkets,novelprocessingtechnologieshavebeenemerging infoodproductionforextendingproducts’ shelf-lifeandeliminating foodbornepathogens.Ascience-basedstandardizedvalidationprocessisa criticalcomponentinassessingtheefficacyofnoveltechnologiesasa microbialcontrolmeasureaccordingtofoodregulationsandsuccessful commercialization.Whilethelongerhistoryofvalidationofthermaltechnologiesresultedinadvancingstandardmethodologies,theapproachesfor thevalidationofnonthermaltechnologiesarenotestablishedandarecurrentlyunderdevelopment.Amonganumberoftechnologiesthatare presentlyinvestigatedforpremiumfoodprocessing,highhydrostaticpressure(HHP)andultraviolet(UV-C)lightarenonthermalalternativesto pasteurizationapprovedbyinternationalregulatoryagenciesandrecognizedasthesimplestandenvironmentallyfriendlywaystodestroypathogenicandspoilageorganismswithlowerimpactonqualityandnutrition valuesandsensoryattributesofmanyproducts.

Despitenumerouspublicationsthatareavailableonscientific,technological,andengineeringaspectsofnonthermalprocessingapplicationsfor foodtreatment,norecentmonographexiststhatwouldintegratefundamentalknowledgeaboutprinciplesandscientificapproachesoffoodprocessvalidationonallstagesofprocessdevelopmentand commercialization.Theneedforclearknowledgeandunderstandingof validationstepsofnonthermalprocessesisvital.Thisbookisafirst attempttosummarizeexistingscientificexperienceofvalidationoftraditionalthermalandnonthermaltechnologies,suchascanningorradiation, andrecommendkeyactivitiesforbenchtop,pilot,prototype,andcommercialvalidationofHPPandUVsystemsforthetreatmentofvarietyof foodproducts.Theobjectiveandfocusofthismanuscriptistoreview definitions,principles,andpracticalapproachesoffoodprocessvalidation andsummarizetheexperienceofthermalprocessingandofafewcommerciallyavailablenovelprocessesthathavebeenusingHPPtechnology, recentlyultravioletlightandothernoveltechnologiesforsafetyandpreservationoperations.Theaspectsexploredincludeavailableprocessapplicationsforliquidandsolidfoods,criticalproductandprocesscontrol parametersforeachtechnology,microbialchallengestudiesincluding

selectionandrecommendationofsurrogates,andconsiderationforprocedurestomeasureandcontrolthedeliveryoftherequirednovelprocess, quality,andequipmentvalidation.Inaddition,sanitarydesignandequipmentscalabilitywillbediscussedtofacilitatetheimplementationofnonthermaltechnologiesandmitigaterisksduringfoodproduction.

Theintroductionchapterstartswithreexaminingthehistoryofthermalprocessvalidationandverificationandexistingpracticalmethodsand approachesofthermalpreservationprocessestablishmentandvalidation. Also,newchallengesofdevelopment,validation,andcommercialimplementationofnovelnonthermalprocessescomparedtothermalprocessing areoutlinedincludingproductionbenefitsandreviewoffundamental principles.

In Chapter1,GeneralPrinciplesandApproachesofFoodProcess Validation,generalconceptanddefinitions,structure,keycomponents, andapproachestoprocessvalidationarepresentedanddiscussedindetail. Thisincludesphysical,microbiologicalsafety,quality,andequipmentvalidationwithelementsofcleaning,calibrationandanalyticalparts,andvalidationoffacilities.Thegeneralguidelinesforeachkeycomponentofthe validationprocessaregivenalongwiththebasicoutlineofobjectivesand criticalproceduresofprocessandequipmentvalidation.Essentialroleand requirementsforprocessauthorityarepresentedinthischapter.

Thefocusof Chapter2,ValidationofHighHydrostaticPressure Process,isthevalidationofHHPprocessofHPPthatisusedfornonthermalpasteurization.ThefundamentalprinciplesofHPPalongwithessentialpracticalconsiderationsintermsofcriticalproductandprocess parameters,packaging,microbialchallengestudies,andothertestingand scalingupissuesarediscussedindetailstoassistHPPenduserstoaccelerateprocessinnovation.

Thegoalof Chapter3,CaseStudyofValidationofHighHydrostatic PressureProcessingofFruitandVegetableSmoothiesinPETBottles. Chapter4 istodiscussValidationofLight-BasedProcesses,suchascontinuousUV-Clight,pulsedlight,andLEDs,forthetreatmentofsurfaces andliquidproductsandprovideguidelinesfortechnologyimplementation.Informationregardinginternationalregulatoryrequirementsonlight technologiesissummarizedandwillbehelpfulindeterminingvalidation objectivesandscope. Chapter5,CaseStudyofValidationofUltraviolet LightPasteurizationofSugarSyrups,presentsthemethodologyandvalidationofmicrobiologicalefficacyofcommercialUVtreatmentofsugar syrups.

Chapter6,OverviewofOtherNovelProcessesandValidation Approaches,isfocusedontheoverviewandbriefdiscussionofprinciples, commercialapplications,andmainvalidationapproachesoftwocommerciallyavailablegroupoftechnologies,suchasionizingirradiationand advancedmicrowaveheatingandemergingtreatmentusingcoldatmosphericplasma.Prosandconsofeachtechnologywillbepresentedalong withstatusupdateonregulatoryapprovalsandvalidationprocedures.Due tothephysicalnatureofthosetechnologies,theapproachesforprocess validationdifferandfacedifferenttechnicalchallenges.Forthisreason, differentapproachescanbeusedtodemonstrateanddocumentthetargetedperformance.

Notallnonthermaltechnologiesandvalidationissueswerediscussed inthisbook.Ingeneral,thebookcontentisaimedtoassistandprovide recommendationsforfoodprocessors,technologydevelopers,equipment manufacturers,regulatoryinspectors,andextensionspecialistsduringthe commercializationofnoveltechnologies.Moreover,thesuggestionsfor validationprotocolsandreportscanbehelpfulforintendedaudience. However,thisbookrepresentsthemostcomprehensiveandambitious steponthesubjectofvalidationofnoveltechnologiesforfoodsthatexists todate.Also,theimportantstepforwardhasbeenmadeinscientific understandingoftheneedsandpracticaltasksforthefuture.

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NovelFoodProcessingTechnologies,AgricultureandAgri-FoodCanada,Guelph,ON,Canada

1.Historyofthermalprocessvalidationandverification

1.1Approachestothermalprocessvalidation

Throughoutthehistoryoffoodprocessing,theapplicationofpreservation technologieshasbeentraditionallyassociatedwithfourfundamental concepts:

1. Applicationofthermalenergytoelevateproducttemperaturesto achievelong-termorextendedsafety,stability,orpreservation;

2. Removalofthermalenergytoreduceproducttemperatureandextend shelf-life;

3. Removalofwaterfromproductstructureortoacidifyfoodsandthus achieveanextendedshelf-life;

4. Applicationofpackagingorasteprequiredformaintainingofproduct propertiesachievedafterprocessingduringstorage.

Theapplicationofthermalenergytoelevatetheproducttemperature hasbeenoneofthekeyprocessesinthefood-processingindustry,which oftenaimstoproducecommerciallysterilefoodproductsandpasteurized productsofoptimalquality.

Dependingontheproducttype solidorliquid beingprocessedand theshelf-liferequired,thermalpreservationcanbeaccomplishedintwo ways.Inthecaseofsolidfoods,heatisappliedtoafilled,sealedcontainer, andinthecaseofliquids,thesterilizationorpasteurizationofproducts cantakeplaceoutsideoftheirfinalcontainerandbeforefillinginaclean orasepticenvironment.

Sterilizationandpasteurizationoperationsrely,respectively,oneliminationandreductionofthemostresistantpathogensofpublichealthsignificanceandspoilagemicroflora.Commercialsterilityisdefinedas:the conditionachievedbyapplicationofheatwhichrendersfoodfreefrom viablemicroorganisms,includingthoseofknownpublichealthsignificance,capableofgrowinginthefoodatthetemperaturesatwhichthe foodislikelytobeheldduringdistributionandstorage(USDepartment ofHealth,1994).Theterm “pasteurization” wasoriginallydefinedasa

processofmildheattreatmenttoreducesignificantlyorkillthenumber ofpathogenicandspoilagemicroorganisms.Thedefinitionofatraditional pasteurizationprocessreliedonlyonthermaltreatmentandisachievedby exposingfoodstoheatforacertainamountoftime.Unlikesterilization, afterpasteurizationthefoodisnotfreeofmicroorganismssinceheattreatmentisnotsevereenoughtokillheat-resistantsporesthatcansurvivethe processandmaybepresent.Thereforeadditionalformsofpreservation suchasrefrigeration(e.g.,milk),atmospheremodification(e.g.,vacuum packagingofmeatsandcheeses),additionofantimicrobialpreservatives (e.g.,sodiumchloride,sodiumnitrite,ascorbicacid,sorbicacid,andsulfur dioxide),orcombinationsofthesetechniques,arerequiredforproduct stabilizationduringdistribution.

Sinceintroducingpreservationprinciplesinfoodprocessingatthestart ofthe19thcentury,thefoodindustryandscientificcommunityhave accumulatedcriticalknowledgefortheestablishmentandvalidationof thermalandothertraditionalprocessesthatincludes:

1. Establishedorganismofpublichealthconcernfordifferentgroupsof productssuchaslow-acidproducts,milk,andjuices;

2. Wellunderstoodandknownkineticsofmicrobialdestructionandits parametersofthermalresistance(z),decimalreductiontime(DT),and lethality;

3. Knowledgeofproductheatingandheattransferingivenprocessing systems;

4. Establishingofequivalentsafetyofdifferentprocessingsystems expressedin “lethality” terms.

Processvalidationisnecessarytogiveanassurancethatcommercial sterility,pasteurization,orotherrelatedfoodsafetyobjectives(FSOs)that havebeenachievedintestconditionsalsowillbedeliveredinallsubsequentproductionconditions.Historically,therearetwoapproachestothe validationofthermalprocesses.

1. Thefirstapproachhasbeentousedirectmicrobialkillmeasurements involvinginoculationstudieswithsporeorbacterialcellsuspensions withknownheatdestruction/resistancecharacteristicsorothermicrobialchallengetests.

2. Thesecondapproachinvolvesthecollectionandrecordingoftime andtemperaturedatahistoryinthetestedproductusingspecialized data-loggingsystems,andmorerecentlyin-processdata-loggingwith smalldataloggersthatcanpassthroughthecontinuousprocess,and collectdataforsubsequentanalysisandinterpretation.

Inbothcasessomeformofmathematicalmodelinghasbeenusedto interpretthedatainthecontextofFSOsand/orcommercialsterility.The mathematicalmodelsforinterpretationofthedataaredesignedtoreflect theappropriatedeathkineticsofthetargetmarkerorganisms. Mathematicalmodelssuchastheapplicationof D and z valuesinthe developmentofthermalprocessinghaveprovenextremelyuseful.The modelsalsoprovideawayofintegratingtheoveralllethaleffectofthe thermalprocess,enablingprocessesofdifferenttimesandtemperaturehistorytobecomparedonacommonbasisoflethalityequivalence. Lethalityisanessentialelementofprocessestablishmentandvalidation thathasbeendevelopedforthermallyprocessedfoods.Itprovidesthe abilitytoexpressprocessdeliveryintermsofunitsoflethalityandto understandtheequivalentsafetyofdifferentprocessingsystems.Byincorporatingboththekineticsofthedestructionoftheorganismofpublic healthconcernandthemathematicalmodelingofheatingcurvesthethermalprocessingindustrydevelopedthetermsofprocessvaluessuchas “sterilizationvalue” (FT)andpasteurizationvalue(PT).Whenthesterilizationvalue(FT)hasareferencetemperatureof121.1°Citiscalledan Fo, andpasteurizationvalue(PT)withareferencetemperatureof72°Cis called Po.Thesterilizationandpasteurizationvaluesarethemeasurement ofthenumberofminutesthatwouldresultinthesameeffectivenessof theprocessiftheproducthadbeenheldat121.1°Cor72°C/90°C, respectively.A “worstcase” approachbychoosingsamplesthatreceived thelowesttime temperaturetreatmenttoestablishasafeprocessistraditionallyusedinthermalprocessing.Thisapproachaimingatgivinga greaterassuranceofprocesssafetyoftenresultsinavastmajorityofoverprocessedproductsandleadstolowerqualityasaresult.

Theabilitytounderstandtheequivalentefficacyofthermalprocesses isimportantwhenitcomestocommercialapplicationsandcompliance withassociatedinternationalregulatoryrequirements.Also,itisevident thatthevalidationtemplatedevelopedovermanyyearsforactivitiessuch ascanning,andasepticapplicationscouldserveasa “blueprint” forother applicationsofnovelprocessingtechnologies.

1.2Establishmentofthepreservationprocess

Thecriticalproduct,process,andstorageconditiondifferencesbetween targetmicroorganismsthataretobeconsideredtoestablishpasteurization orsterilizationpreservationspecificationsaresummarizedin Table1.1.

Table1.1 Criticalproduct,process,andstorageconditionsfortheestablishmentofpreservationspecifications.

PasteurizationSterilization

Productparameters

pH , 3.53.5 , pH , 4.6pH . 4.6pH . 4.6

Aw . 0.86

Processparameters

Temperature,°C65 72 . 65 . 65 . 121

Additional hurdles NoRefrigerationAntimicrobials, Aw

Targetmicroorganisms

Pathogenic

SpoilageMolds,yeastsLacticbacteria,yeasts, molds

Geobacillus spp. Bacilluscereus

StorageAmbientRefrigeratedconditionsAmbienttemperature

PackagingHermeticallysealedflexiblecontainersHermeticallysealedflexible containers

Ageneralapproachtotheestablishmentofprocessingtechnologies includes:

1. Identificationoftheorganismofconcernofpublichealthsignificance;

2. Identificationandselectionoftheappropriatetargetend-pointor microbialreduction;

3. Developmentofaconservativeestimationoftheabilityoftheprocess toconsistentlydeliverthetargetend-pointorspecificlogreduction;

4. Quantitativevalidation(microbiologicalormathematically)ofthe lethaltreatmentdelivered;

5. Listofthecriticalfactorsandproceduresusedtocontrolthedelivery oftherequiredprocess.

Forthedesignofa “preservationspecification” tomeetrequiredspecificlogarithmicmicrobialreduction(SLR)innumbersoftargetmicroorganisms,processingtime Fp ortargetprocessvalueistraditionallydefined bytheinitialloadoftargetorganisms(No),theend-pointoftheprocess (NF),andthelogarithmicresistanceoftargetbacteriaunderdefinedconditions(DT)asgivenin Eq.(1).

5 DT ðlogNo logNF Þ 5 ðSLRÞ xDT (1)

where DT isadecimalreductiontime(min)atthereferencetemperature ofathermalprocess.

Databasescontainingkineticinactivationparametersforvarioustarget pathogenicandspoilagemicroorganismsareneededfortheestablishment ofprocessingtimeandcriticalpreservationprocessparameters.

Eq.(2)estimatestheaccumulatedlethality F,sterilization(F0),orpasteurizationvalue(P0)ofathermalprocess,whenthereferencetemperatureand z valuesaredefinedforspecificmicroorganismsandproducts

where T (°C)isatemperatureand t istime(min). Tref isareferencetemperatureofthethermalprocess. Z isbacterialcellsorthespore’sthermal resistance(°C)atthereferencetemperature.

Thevalidationoftheprocessingtimeunderactualproductionconditionsrequirestheaccumulationofaminimumprocessvalueunderworst caseconditions(cold-spot,lowprocesstemperature,etc.)of Fo.Themeasuredoractualtreatmenttime Fp undersimilarworstcaseconditionsthat isrequiredtoachieveatargetSLRshouldmeetthecondition(3)thatis:

. Fp (3)

Fp

Theprocedureofestablishingaprocessandthenvalidatingitseffectivenessisdependentontheprocessingsystemusedandthefoodproduct beingproduced.However,allassumptionsassociatedwithhistorical experimentalprocedureswillneedtobeverifiedfortheirapplicabilityto thenewapplication.Theprocessorneedstomakesurethatasufficiently verifiedapproachisusedtocollecttheneededinformationnecessaryto understandtheprocessdeliveredandifthetargetend-pointwasachieved.

Theconclusionsandrecommendationsthatexistfortheestablishment andvalidationofthermalpasteurizationandsterilizationtreatmentcanbe modifiedandadoptedfornovelthermalornonthermalprocesses.Itwill benecessarytodeterminemicrobialinactivationkineticsandrateconstantsthataresimilarto D-and z valuesandintegratedprocesslethalityto determineprocessequivalency.

2.Nonthermaltechnologiesandchallengesofvalidationof novelprocessescomparedtothermalprocessing

2.1Reviewoffundamentalprinciples

Overthelastfewdecades,thefifth “alternative” processingconceptcalled “novelprocessingtechnologies” startedtoemergegloballyinfoodproduction.Inthehistoryoftechnologydevelopment,noveloremerging technologiesarethosecontemporarytechnicalinnovationswhichrepresentprogressivedevelopmentswithinafieldforacompetitiveadvantage. Inthefoodindustry,asaresultofmoderndemandsforfoodsthatare fresher,healthier,morenatural,orminimallyprocessedandadditive-free, novelprocessingtechniquesarecurrentlyunderbroaddevelopmentand implementation.Theuseofnoveltechnologiesultimatelybringsthe advantageoftheproductionoffoodswithbetterqualityandhighernutrientcontentsduetoreducedthermalandchemicalabuse,superiorsafety attributesduringextendedshelf-life,andatareasonablecostfortheconsumer.Foodsafetyisoneoftheessentialcomponentsthatdrivesthe developmentofnoveltechnologiessuchasphysicalmicrobialintervention toreduce,control,oreliminatefoodbornepathogensfromfoodproducts andcontactsurfaces.Additionally,novelprocessingtechnologieshave potentialtobeusedastoolstotailorfoodswithbetterquality,addedor enhancedfunctionalandnutritionalvalues,tolowerthecarbonfootprint, andsubstantiallyreducewatervolumesusedinheattransferprocesses.As anexample,novelprocessingmethodsarebeingexploredtopotentially

createhypoallergenicproducts,andhavebeentestedtoaltertheallergen reactivityofcomponentsoffoodmatrices.

Thisfifth “novel” processingconceptincludesadvancedthermaland nonthermalhigh-technologymethodsbasedontheutilizationofmechanical,electrical,andelectromagneticenergy,andcombinedapplications approaches.So-callednovelfoodswithnohistoryofconsumptionthat maybeproducedbynovelprocesseshavestartedtoemergeinthemarket andoftencanreplacetraditionalstylefoods.Forexample,old-styleham treatedbyhighhydrostaticpressure(HHP)orfreshappleciderpasteurized usingultraviolet(UV)lightforbetterproductsafetyaredescribedasnovel foods.

Food-processingtechniquesthatcanbeusedforthereductionof microbialloadsincluderemovalandinactivationapproaches.Known removalunitoperationsincludefiltration,centrifugation,andseparation, whichbelongtothegroupofhydrodynamicprocessesthataredrivenby ahydrostaticorhydrodynamicpressuregradient.Unitoperationsthatare usingmicrobialinactivationincludeanumberofphysicalmethodsand chemicalagentscapableofpronouncedbactericidaland/orsporicidal effects.Asummaryofdifferenttechniquesthathavebeenexploredand theirfundamentalprinciplestodeliveralethalmicrobialtreatmentispresentedin Table1.2

Therearetypicallynumerousunknownsassociatedwiththesafeuse ofnovelpreservationtechnologiesintheproductionoffoodsandbeveragesintendedforhumanconsumption.Duetodifferentfundamental principlesandperformancecapabilitiesofnoveltechnologies,novelprocessesdifferfromtraditionalthermalprocessingintermsofthetypesof foodcategoriesthatcanbetreated,microbialefficacyandmicrobial destructionmodes,desiredandundesiredeffectsonfoodcompositionand quality,andtheireconomicandenvironmentalimpacts.Additionally,the fullcommercializationandproductionpotentialofnovelthermaland nonthermaltechnologiesandfood-processingoperationsbasedontheir useisnotbeingrealizedduetoalackofinformedandendorsedguidance regardinghowtoimplementthepropertechnologyvalidationanddemonstrateitssafety.Beforeanovelprocesscanbeusedandtheresulting productcanbesold,thoroughreviewsoftheimpactoncomposition, quality,andnutrition,andevaluationsofthesafetyofthenovelprocess andconsequentlynovelfoodshavetobeconductedbyfoodindustryprofessionalsandregulatoryagencies.Asaresult,theincrementaldevelopmentsofnoveltechnologiesforavarietyoffoodapplicationshaveledto

Table1.2 Food-processingunitoperationsandfundamentalprinciplesoftraditionalandnovelprocessingtechnologies.

Microbialreduction principle

PhysicalmechanismofactionDrivingforceProcessAdditionalbactericidal modes

RemovalMomentumtransferPressuredifferenceFiltration

Separation

Centrifugation

ThermalinactivationHeattransferTemperaturedifferenceBlanching

Drying

Heatpasteurization

Heatsterilization

ElectromagneticenergyTemperaturedifferenceInfraredheating

Microwaveheating(MWH)

Radiofrequency

ElectricalenergyTemperaturedifferenceOhmicheating

Conductionheating

Momentumtransferandheat generation TemperaturedifferencePressure-assistedthermal sterilization

Pressureand compressionheating

Momentumtransferandheat generation TemperatureUltrasonicationCavitation

Localtemperature increase

Nonthermal inactivation

ElectromagneticenergyChargedparticles

Electronstransfer

UVlightphotontransfer

Irradiation

Electronbeams

UVenergy

SupercriticalfluidconditionsConcentrationPressureandCO2

MomentumtransferHydrodynamicpressurein liquids

Temperatureincrease

MomentumtransferHydrodynamicpressurewaves insolids

Freeradicals

Highpenetrating power

PressurehomogenizationTemperature Cavitation

Highhydrodynamicpressure/ shockwaves

Shearstress

MomentumtransferHydrostaticpressureinliquids andsolids HHP (Continued)

Table1.2 (Continued)

Microbialreduction principle PhysicalmechanismofactionDrivingforceProcessAdditionalbactericidal modes

PulsedenergyElectricalfieldsHighvoltagegradientPulsedelectricfields(PEFs)Temperature

ElectromagneticenergyLightandUVphotonstransferPulsedlightTemperature

MomentumtransferPressurePressurecycling

PlasmaElectricalorelectromagnetic energy Chargedparticlesandphoton transfer AtmosphericplasmaLightphotons Freeradicals

Chargedparticles

ChemicalOxidationConcentrationOzone

Carbondioxide

Ionexchange

Chlorination pHadjustment

OsmoticpressureSoluteconcentrationWateractivityBoundwater

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