08.30 RegistrationandCoffee

09.00 Chairman’sOpeningRemarks

JamesDrinkwater,Chairman,PharmaceuticalandHealthcare

ScienceSociety

CLEANROOMDESIGNANDENGINEERING

VCCNSPOTLIGHTSESSION

09.10 EffectivecleanroomHVACsystems

• Evaluatingthecontaminationremovalefficiencyby

mechanical ventilation

• ImprovingenergyefficiencyofHVACsystems

• DevelopingtechnologiesinHVACcontrol

KoosAgricola,Contamination Control Expert, VCCN

09.50 Towardsfutureproofhigh-techfacilities

• Whatkeepspushingcontaminationcontrol?

• Distinctivetrendsinscience,technologiesandmarkets

• Newchallengesandsolutions(casestudies)forcleanroom

facility design

• Howcontaminationcontrolcouldlooklikein2050

EricStuiver,Chairman,VCCN

10.30 Morning Coffee

11.00 CFDasaToolforImplementingQualitybyDesignin

PharmaceuticalCleanroomProjects

• IntroductiontoCFD

• CFDinthelife-cycleofapharmaceuticalcleanroomproject

• CFDappliedtothedesignofnewcleanroomsystems

• CFDasatoolfortrouble-shootinganddesignforremediation

in existing systems

• HowCFDcanhelpintheCommissioningandQualification

phases

PierAngeloGalligani,Past-President,BoardMember,ASCCA

ENVIRONMENTALMONITORINGANDCONTAMINATIONCONTROL

11.40 AddressingnewGMPAnnex1requirements-selectionof

adequatecleanroomclothingthatispartofefficientQRMsystem

forasepticmanufacturingprocess

• Thedifferenttypesofrisksforqualitylinkedwithcleanroom

garments

• Elementstobeconsideredintheriskassessmentofcleanroom

clothing

• Mitigatingtheriskscomingfromcleanroomgarments

SteveMarnach,EMEATrainingManager&CriticalEnvironments

Sales and Marketing Specialist,DuPont

12.20 AligningStandardsandBestPracticeinintegratingNon-ViableandViableEnvironmentalMonitoring(EM)inGMPCleanrooms (aspartofacontaminationcontrolplan)• ApplyingISO14644-2:2015forNon-ViableEM• ApplyingQRMandnewconceptsintherevisionofISO14698(prEN17141)forViableEM

• ChallengesofintegratingNon-ViableandViableEMandrealtime vs indirect measurement

• Applying21CR11andAnnex11toqualifiedEMsystemsforcontinuous and periodic EM

ConorMurray,Chairman, IrishCleanroomSociety

13.00 NetworkingLunch

14.00 Personnel,PremisesandCleanlinessRequirementsfromaQualityRiskManagementApproach–Annex1(2008)versusDraftAnnex1(2017)• Cleanlinessrequirementstodayandinthefuture• Areoperatorsneededinthefutureandtowhatextent?• Opensystems,RABS,isolatorsorclosedprocesssystem?• Operatorsincleanrooms–Futureproblemsor…?MattsRamstorp,Professor in Cleanroom Technology,BioTekProAB

14.40 ImpactoftheEUBiocidalProductsRegulation528/2012oncleanroomdisinfection• BackgroundtoEUBiocidalProductsRegulation528/2012• Understandtheregulationinmoredetailwithregardstolife

science disinfectants• Explanationofthecurrentsituationwithregardstocommon

active ingredients• ImpactoftheBPRoncleanroomdisinfectantusersandhowto

prepare for itSiobhanMurphy,European Regulatory Specialist, Contec,Inc.

15.20 AfternoonTea

FRESENIUSKABISPOTLIGHTSESSION15.50 ContaminationControlElementsforManufacturing

UnitsandCompoundingCenters• Importanceofdesignelements(e.g.designofcleanroom&equipment)forcontaminationcontrol

• Importanceofproceduralelements(e.g.cleaning&disinfection)for contamination control

• Tools to verify implemented contamination control elementsare effective

• Challenges, case examples and areas to especially look forAlexanderStoll,Vice President, Head of Competence Centre of MicrobiologyandAsepticTechnique,FreseniusKabi

16.30 Implementationofanasepticmentoringprogram(AMP)inmanufacturingsites• Howitworks,whatarethetargetsandhowtobesuccessful• Howtosetitup,pointstoconsider,asepticmentors,howtoperformauditsforaseptictechnique

• Experiences&lessonslearnedAlanaPoloni,ManagerMicrobiology&AsepticTechnique,FreseniusKabi

17.10 Chairman’sClosingRemarksandCloseofDayOne

PharmaceuticalCleanroomTechnologyEurope DayOne|Wednesday9thOctober2019

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08.30 RegistrationandCoffee

09.00 Chairman’sOpeningRemarksJamesDrinkwater,Chairman,PharmaceuticalandHealthcareScienceSociety

CLEANROOMDESIGNANDENGINEERING

OPENINGADDRESS09.10 DevelopmentofAseptic-Containmentstrategies(ACS)for

processingofnewtoxic,potentorbio-hazardsterilemedicinalproductsandtherapies• RationalefordevelopmentofanAsepticContainmentstrategy(ACS)tositalongsidetheAnnex1ContaminationcontrolstrategyCCSrequiredforsterilemedicinalproductmanufacture

• Aseptic-ContainmentriskcharacterisationandriskcontrolcontainmentlevelsatHealthbasedexposurelevels

• ResearchintoAerosoldistributionandcontainmentinfillingsterile Toxic and Biohazard medicinal and therapy products in barrierandcombinedcleanroomtechnology

JamesDrinkwater,Chairman,PharmaceuticalandHealthcareScienceSociety

09.50 CleanroomCost,Quality,EnvironmentalSustainability–canIaffordtocompromise?Thepresentationwilldiscussthemanyoptionsopentocleanroomusers to minimise the energy consumption and operational costs ofthesehighlyenergyintensivespaces.Therearemanyefficiencyimprovementsavailablethathaveproventohavenodetrimentalimpactonthecriticalproductqualityneeds.Topicsdiscussedwillinclude:• Practical&proventoptipsyoucanapplytodaytomakeareal&significantimprovement

• HeadsuponISO14644part16• Thebusinesscasetosupportaction–illustratedwithcasestudies• FuturegamechanginginnovationincleanroomcontrolsKeithBeattie,Life Sciences Lead,EnergyEfficiencyLtd

10.30 Morning Coffee

11.00 HVAConagreenfieldfillingplantprojectfromCDtoValidation• Istheorganisationalstructureimportant?• HowcanweuseinterfaceagreementsforHVAC?• EnsuringflexibleandsimplevalidationBirgerLerche-Jorgensen,HVACResponsible,SME,ALK-AbellóNordicA/S

ENVIRONMENTALMONITORINGANDCONTAMINATIONCONTROL

11.40 Casestudy:WhathappenedinChinawiththecontaminatedWFIsystem?• Preventivemaintenanceofwatersystems• Correctiveversuspreventiveactions• Phenotypicversusgenotypicidentifications• RiskoffalsenegativetestwithendotoxinOlivierChancel,SterilityandAsepticProcessAssuranceExpert, BoehringerIngelheim

12.20 NetworkingLunch

TAKEDASPOTLIGHTSESSION

13.20 Implementationofaglobalcontamination

controlprogram–Afieldreport

• Overview:Fromtheideatotherolloutofaglobal

contaminationcontrolprogram(CCP)

• Contaminationcontrolprogramkeyelementsanddocuments

• Currentstatus/sustainphaseofthecontaminationcontrol

program

ChristophHansy,SRQCScientist,Takeda

14.00 Microbialcontaminationinvestigationtool

• Backgroundandadvantages

• Overviewandkeyelements

• Casestudy

ChristineArbesser-Rastburg,Director,GlobalMicrobiology,Takeda

14.40 AfternoonTea

15.10 Arisk-basedapproachtocleaninganddisinfection

• WillcovercurrentindustryregulationsintheUS,Europeand

Globallyrelatedtocleaninganddisinfection

• RegulatoryexpectationsincludingthelatestrevisionofAnnexI

andrecentFDAWarningLettersand483’srelatedtocleaning

and disinfection

• Cleaningfrequency,disinfectantrotation,rinsingandresidue

removal, disinfectant coverage calculations and the most

currentequipmentandmethodologiesforcleaningand

disinfectionwillbecoveredindetail

• Thetopicofsterilityrelatingtocleanroomdisinfectantsand

sporicideswillbeexplained

• Thissessionwillprovidetheabilitytodesignaneffectiverisk-

basedapproachtocleaninganddisinfection

JosephMcCall, Technical Services Specialist, STERISCorporation

15.50 Particlecontaminationmonitoringinhigh-techcleanrooms

•Particlecontaminationriskassessment

•Classificationversusmonitoringinparticlecontaminationcontrol

•Exampleofparticledepositionmonitoring

•Exampleofsurfaceparticlecontaminationcontrol

• Linkwithairbornebiocontamination

IsabelleTovena-Pecault,HeadofInternationalandEuropean

Projects,ALPHA-RLH

16.30 Chairman’sClosingRemarksandCloseofDayTwo

PharmaceuticalCleanroomTechnologyEuropeDayTwo|Thursday10thOctober2019

PharmaceuticalCleanroomTechnologyEuropeDayOne|Wednesday9thOctober2019 www.cleanroomtechnology.co.uk

Register online at www.cleanroomtechnology.co.uk

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EnvironmentalClassification,QualificationandMonitoringofGMPControlledareas

referencingISO14644-1andriskbasedGMPWorkshop Leader:

JamesDrinkwater,Chairman, PharmaceuticalandHealthcareScienceSociety

Overviewoftheworkshop:EU GMP Annex 1 differentiates Environmental classification,Qualification and risk based (holistic) monitoring of GMPcontrolled areas that are used in the manufacture of sterile medicines. ISO 14644-1 is generic forCleanroomclassificationsanditisnotalwaysclearhowtoapplyconsideringariskbasedGMP approach. Qualification extends through establishingenvironmental control through process simulations and media fills with strategies required or how to qualify Cleanrooms andBarrier technology (Isolators & RABS). EM programs require aholisticapproachconsideringriskbased/riskassessedsamplinglocationsthatareconnectedthroughallstagesofclassification,qualification and monitoring. This workshop explains therelationship and methodology for Classification, QualificationandEnvironmentalmonitoring.

Whyyoushouldattend?• ClassificationofGMPcontrolledareaswithafocuson0.5micron

particlesizesisaGMPrequirementandreferencedinAnnex1butitisnotalwaysclearonhowISO14644-1isapplied.

• Qualificationcombinesparticlesizesof0.5and5.0micronplusnottoexceedmicrobiologicallevels(surfaceandairborne)andrequiresrationale.ConsiderationprovidedtothePHSSrationale(reviewedbytheMHRA).

• Environmentalmonitoringdataiscriticaltosterileproductreleaseasevidencesterileproductshavenotbeencontaminatedfromtheprocessingenvironment.Currentbestpracticeisexplainedincluding rationales for monitoring environments that may containtoxicorbiologicallyactivesterileproductsortherapies.

Agenda:

08.30 Registration & Coffee

09.00 Workshopleaderintroduction

09.10 Session1-EnvironmentalClassificationofGMPcontrolledareas•ISO14644-1applicationinGMPcleanroomclassification•Classificationsamplingpositions–riskbased•ClassificationofCleanroomsandBarrierGMPZones–whydifferentapproachesarerequired

09.50 Session2-EnvironmentalQualification•GMPComplianceenvironmentalqualificationconsidering1m3samplevolumes

•Environmentalqualificationstart-uptostateofcontrolincludingmicrofloracharacterisation,operational monitoring

•Environmentalqualificationthroughprocesssimulations and Media Fills

10.30 CoffeeBreak

11.00 Session3-Riskbasedenvironmentalmonitoringmethods,programanddatatrending•EMriskassessmentsforsamplelocationsandsample

type •EMprograms:management,structureanddata

processing •PerspectiveonuseofRapidMicroMethods:RMM

11.40 Session4-Casestudy:EnvironmentalClassification,QualificationandRiskbasedmonitoringofavial/syringeFillinglineandrelationshipwithContaminationControlStrategy:CCSforEUGMPAnnex1compliance•OverviewofCasestudy:BiologicalproductVial/SyringeFillingLineinIsolatorBarriertechnologywithuse of pre-sterilised containers transferred to Grade AasepticprocessingzoneviaNTT:No-touch-transfertechnology

•OverviewofRationaleforEnvironmentalClassification,QualificationandMonitoringfortheAsepticprocessingfillingzonesandsurroundingCleanroom

•ApplicationofQRM:QualityRiskManagementappliedwhereapplicationvariesfromconventional/generic GMP

12.20 Closingremarks

12.30 Endofworkshop

AbouttheworkshopleaderJames Drinkwater is a pharmaceutical process engineer with additional education inpharmaceuticalmicrobiology.Havingspent10yearsin the pharma industry (Amersham-GE Healthcare)Jameshaddirector rolesatbarrier technologyandhydrogen peroxide vapor generator companies

achievingsubjectmatterexpertstatus.CurrentrolesincludeHeadofGMPcomplianceandAsepticprocesssupportforFZielGmbH,thelargestIsolatorandRABSmanufacturerinGermanyworkingonmajorfillinglineprojectsandindependentlyanelectedroleasChairmanofthePHSS:Pharmaceutical&HealthcareSciencesSociety and leader of the PHSS Aseptic processing, Aseptic-ContainmentandAnnex1focusgroups.

Aboutthecompany:At F Ziel the role includesprocess integrationofenvironmentalcontrol barrier systems with sterile product aseptic processingand support for GMP compliance including environmental controlandmonitoringriskassessments.ThePHSSisaNotforProfiteducational platform for GMP providing supportive guidance in the form of technical monographs, impact statements and Clarity on GMP guidance notes. PHSS provide workshop andtrainingcourses in theUKhavinga strongconnectionwith theUKMHRA.

HALF-DAYPRE-CONFERENCEWORKSHOPATuesday8thOctober2019

CopthorneTaraHotel,CentralLondon,UK08.30–12.30

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HALF-DAYPRE-CONFERENCEWORKSHOPBTuesday8thOctober2019

CopthorneTaraHotel,CentralLondon,UK13.30–17.30

GowningTheory andBestPracticeImplementation

Workshop Leaders: ConorMurray,Chairman, IrishCleanroomSocietyMattsRamstorp,Professor in Cleanroom Technology,

BioTekProAB

WorkshopOverview:Thiswillbeinteractiveworkshopcombiningtheoryandpractice,wherebestpracticePALdesignandconfigurationwillbeoutlinedalongwithpresentingthetheoryofgowningandselectioncriteria,coupled with participation by attendees in getting real worldexperienceofdifferentgowningtechniquesforasepticprocessingandterminalsterilisationGMPapplications.

Whyshouldyouattend:• Howtosetuserrequirements• UnderstandPAL/Gowningspaceplanningandconfiguration

fordifferentGMPclassifications• Getaninsightintothescience,experimentaldataandissues

aroundlaunderedvsreusablevslimitedusegowns• UnderstandhowGowningmaterialsareassessedand

monitoredduringuse(EM)• Gainpracticalexperienceingowninganddegowning,

AsepticvsNonAseptictechniques

Agenda:

13.30 Registration & Coffee

14.00 Openingremarksandintroductions

14.10 Session1-THEORYSettingRequirements& Gowning/PALPlanning• Settinguserrequirements•Spaceplanningdesign&configurationstomeetdifferentclassifications-establishingcontrol

•EM considerations - demonstrating control

14.50 Session2-THEORYGowningSelectionCharacteristics ofdifferenttypesGownmaterials•Testing methods•Experimental test data•Selection criteria and considerations•GowningvsDegowningdifferences

15.30 TeaBreak

16.00 Session3-THEORY&PRACTICALGowning•ImportanceofHygiene•PreparationforGowning•HandWashingtechniqueanddemonstration

16.30 Session4-PRACTICALGowningApplications•Asepticprocessingvsterminalsterilisation

applications•Gowningexercises•Degowningexercises

17.20 Closingremarks

17.30 Endofworkshop

AbouttheWorkshopLeaders:ConorMurrayhasover30years’experienceindesignand construction of cleanrooms and biosafetylabs,and since 2007 independently inanoversightand auditing role. Conor represents the NationalStandards Authority of Ireland (NSAI), as Head ofDelegation and SME at ISO TC 209 on cleanroom

standardisation. Conor is Convenor of WG-05 in CEN TC243andadvises the Irish Health Service.Conor isChairmanof theIrish Cleanrooms Society (ICS) and a past Chairman of theInternationalConfederationofContaminationControlSocieties,(ICCCS). Conor lectures internationally and gives cleanroomtrainingandeducationcoursesonbehalfoftheICS.

MattsRamstorp has beenworking formore than 30yearswithcleanlinessandhygieneasaresearcher,consultant, and educator. Matts is a Master ofScience in Chemical Engineering, Technology Doctor of Applied Biochemistry (Biotechnology)and Professor of Renewable Engineering and

ProductionHygieneatLTH,LundUniversityofTechnology.Mattshasalsopublishedanumberofbooksinthefieldofcleanroomtechnology.

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