Table Of Content

Validation of Food Preservation Processes Based on Novel Technologies This pageintentionallyleftblank Validation of Food Preservation Processes Based on Novel Technologies Editedby TATIANA KOUTCHMA Guelph Research and DevelopmentCenter,Agriculture and Agri-Food Canada, ON, Canada AcademicPressisanimprintofElsevier 125LondonWall,LondonEC2Y5AS,UnitedKingdom 525BStreet,Suite1650,SanDiego,CA92101,UnitedStates 50HampshireStreet,5thFloor,Cambridge,MA02139,UnitedStates TheBoulevard,LangfordLane,Kidlington,OxfordOX51GB,UnitedKingdom Copyright©2022ElsevierInc.Allrightsreserved. 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Practitionersandresearchersmustalwaysrelyontheirownexperienceandknowledgein evaluatingandusinganyinformation,methods,compounds,orexperimentsdescribed herein.Inusingsuchinformationormethodstheyshouldbemindfuloftheirownsafety andthesafetyofothers,includingpartiesforwhomtheyhaveaprofessionalresponsibility. Tothefullestextentofthelaw,neitherthePublishernortheauthors,contributors,or editors,assumeanyliabilityforanyinjuryand/ordamagetopersonsorpropertyasamatter ofproductsliability,negligenceorotherwise,orfromanyuseoroperationofanymethods, products,instructions,orideascontainedinthematerialherein. BritishLibraryCataloguing-in-PublicationData AcataloguerecordforthisbookisavailablefromtheBritishLibrary LibraryofCongressCataloging-in-PublicationData AcatalogrecordforthisbookisavailablefromtheLibraryofCongress ISBN:978-0-12-815888-3 ForInformationonallAcademicPresspublications visitourwebsiteathttps://www.elsevier.com/books-and-journals Publisher:CharlotteCockle AcquisitionsEditor:NinaRosadeAraujoBandeira EditorialProjectManager:RachelPomery ProductionProjectManager:R.VijayBharath CoverDesigner:VictoriaPearson TypesetbyMPSLimited,Chennai,India Dedication In the memory of my mother Nina M. Kuchma who died in 2020. This page intentionallyleftblank Contents Listofcontributors xi Preface xiii Introduction xvii 1. General principles and approaches of food process validation 1 TatianaKoutchmaandLarryKeener 1.1 Generalprinciplesandapproachesoffoodprocessvalidation 1 1.1.1 Validationconceptandterminology 1 1.1.2 Verificationversusvalidationversusmonitoring 5 1.1.3 Validationatdifferentphasesofprocessdevelopment 6 1.1.4 Scale-upprocess 7 1.1.5 Keycomponentsofvalidationprocedures 9 1.1.6 Physicalvalidation 9 1.1.7 Microbiologicalvalidation 10 1.1.8 Qualityvalidation 18 1.1.9 Equipmentvalidation 21 1.1.10 Cleaningandsanitationvalidation 22 1.1.11 Facilityrequirements 23 1.1.12 Documentation 24 1.1.13 Roleofprocessauthorityintheeraofemergentnoveland nonthermalpreservationtechnologies 24 1.1.14 Requirementsforprocessingauthorities[21CFR113.83and113.89] 26 1.2 Conclusions 29 References 29 2. Validation ofhigh hydrostatic pressure process 31 TatianaKoutchmaandKeithWarriner 2.1 Historyandintroductiontohigh-pressureprocessingtechnology forfoods 31 2.2 FundamentalsofHHP 32 2.2.1 HHPprincipleofoperation 32 2.2.2 HHPcommercialapplications 33 2.2.3 HHPmicrobiologicaleffects 35 2.2.4 HHPqualityeffects 41 2.2.5 HHPeffectsonallergens 42 2.2.6 HHPeffectsonpatulinmycotoxin 42 vii viii Contents 2.2.7 HHPeffectsonenzymes 44 2.3 HHPcriticalproductandprocessparameters 44 2.3.1 Productparameters 44 2.3.2 Processparameters 51 2.4 Packaging 56 2.4.1 Requirementsandtypesofpackages 56 2.4.2 Foodcontactcompliance 59 2.4.3 Packagingvalidation 59 2.5 HHPcommercialsystems 60 2.5.1 Design 60 2.5.2 Pressurevessels 60 2.5.3 CommercialHHPmanufacturers 62 2.5.4 Scalabilityofpilotandcommercial-scaleHHPprocesses 66 2.5.5 CalibrationandmaintenanceofHHPsystems 68 2.6 Internationalregulatoryrequirements 69 2.6.1 AustraliaandNewZealand 69 2.6.2 Canada 71 2.6.3 EuropeanUnion 72 2.6.4 UnitedStates 73 2.7 Microbiologicalchallengetesting 74 2.7.1 Shelf-lifevalidation 77 2.7.2 Safetyvalidation 79 2.7.3 Surrogateorganisms 81 2.8 CommercialHHPtrials 84 2.8.1 Juices 84 2.8.2 Meats 86 2.8.3 Delisalads,hashbrowns,herbs,andgravybase 88 2.9 ResponsibilitiesforcontractofHHPfacility 89 2.9.1 Deviationfromthevalidatedprocess 90 2.10 FutureprospectsandgapsinHHPtechnologydevelopment 90 References 91 Furtherreading 97 3. Case study of validation of high hydrostatic pressure processing of fruit and vegetablesmoothies in PET bottles 99 TatianaKoutchmaandKeithWarriner 3.1 Productdescription 99 3.2 Packaging 99 3.3 HPPunit 100 3.4 Methodology 100 Contents ix 3.5 Samplingplan 100 3.6 Testprocedures 102 3.7 Sourceofpathogens 102 3.8 Cultivation,enumeration,andenrichmentprotocolsformodelmicrobes 103 3.9 HPPoperationprocedure 105 3.10 Results 106 3.11 Conclusion 112 References 112 4. Validation oflight-based processes 113 TatianaKoutchma 4.1 Historyandintroductiontofundamentalsofultravioletlightandpulsed lighttechnologyforfoodapplications 113 4.2 ContinuousUV,pulsed,andLEDlightsources 115 4.3 Internationalregulatoryrequirements 118 4.3.1 USFoodandDrugAdministration:foodadditiveapproach 118 4.3.2 Novelfoodregulations 122 4.4 ValidationofUVlighttechnologiesforsurfacetreatment 123 4.4.1 UVdisinfectionefficiencyofsurfacesandlimitingfactors 124 4.4.2 Advantagesanddisadvantagesofhigh-intensitypulses 126 4.4.3 Establishingstepsandvalidationofsurfacetreatmentprocess 126 4.4.4 Criticalprocessandcontrolparameters 130 4.4.5 CommercialUVandpulsedlightsystemsforsurfacetreatment 130 4.4.6 CasestudiesofpulsedandcontinuousUVsurfacetreatment 131 4.5 ValidationofUVlightpreservationprocessesforliquidproducts andbeverages 133 4.5.1 RequirementsforUVCpreservationofbeverages 134 4.5.2 EstablishmentofpreservationreductionequivalentUVCdose 137 4.5.3 PrinciplesofvalidationofUVCpreservationprocessforliquids andbeverages 141 4.5.4 ValidationofcommercialUVequipmentandprocesscontrols 160 4.6 Conclusion 165 References 165 5. Case study of validation of ultraviolet light pasteurizationof sugar syrups 169 TatianaKoutchma 5.1 Evaluationofultravioletdoseincommercialultravioletsystem 169 5.1.1 Experimentalapproach 169 5.1.2 Results 176