CONF-17-Philippe-Destrez.pdf

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1、ISO 22441 standard for validation of the H2O2sterilizersexplainedName:Philippe DESTREZAffiliation:ASPIntroduction2StandardsStandardsRegulationRegulationGuidelinesGuidelinesEducation and PracticesEducation and PracticesISO and EN sterilization standards3General requirementsISO 14937General requiremen

2、tsISO 11138-1Common requirementsISO/TS 22421General requirementsISO 11140-1BD Steam penetrationISO 11140-2Alternative to BDISO 11140-4BD Air removalISO 11140-5Type 2 BI and PCD for smallsteam sterilizersISO/DIS 11140-6PCD small steam sterilizersEN 867-5Ethylene oxideISO 11138-2MoistheatISO 11138-3Dr

3、y heatISO 11138-4LTSFISO 11138-5Hydrogen peroxideISO/AWI 11138-6MoistheatISO 17665-1,-2&-3Large Steam steriliersEN 285Small Steam steriliersEN 13060Dry heatISO 20857EthyleneoxideISO 11135 and ISO/TS 21387Ethylene oxideEN 1422HydrogenperoxideISO/DIS 22441Hydrogen peroxideprEN 17180LTSFISO 25424LTSFEN

4、 14180Critical devicesISO 17664-1Biological evaluationof medical devicesISO 10993-1,-7 and 17Requirementsfor packaging systemsISO 11607-1Validation of Packaging processesISO 11607-2WrapsEN 867-2Paper bags and paperEN 867-4&-3Sealable pouches and reels EN 867-5LTS/Paper and adhesivecoatingEN 867-6&7R

5、e-usable containersEN 867-8General requirementsISO 15883-1Surgical instruments,etc ISO 15883-2Human waste containers and non invasive itemsISO 15883-3&7Thermolabile endoscopesISO 15883-4Non-invasive itemsISO 15883-6Test methods for cleaningefficacyISO/TS 15883-5Sterilization ProcessSterilizersBiolog

6、ical indicatorsSteam type 2Chemical indicatorsTerminal Sterilization of healthcare products(radiation excepted)Non biologicalindicatorsSterilizers for medicalpurposes Requirements and testingPackaging requirementsand test methodsWasher-disinfectorsThermal disinfectionChemical disinfectionProcessing

7、information by Med.Device ManufacturerPackagingISO TC 198CEN TC 102 and 204Quality ManagementISO 13485Risk ManagementISO 14971Other key ISO and IEC standardsSafety for sterilizers and WD IEC 61010-2-40Storage cabinet EN 16442Storage of thermolabile endoscopesNon critical devicesISO 17664-2Microbiolo

8、gicalmethodsPopulation of microrganismsISO 11737-1Test of sterilityISO 11737-2Bacterial endotoxinISO 11737-3Guidance on 11607-1&-2ISO/TS 16775WIPWIPWIPWIPQuality of water(sterilizers and WD)ISO/TS 5111Water qualityVocabularyISO 11139TerminologyGuidanceISO 11138-7ResistometerTest equipment for BI&CII

9、SO 18472Master products-cleaningISO 17664-3(AWI)StructureStructureReplaceReplaces s+Common to Common to healthcarehealthcare facilitiesfacilities and and industryindustryContent&Scope4ISO 22441-process1.Scope2.Normative references3.Terms and definition4.Quality Management system elements5.Sterilizat

10、ion agent characterization6.Process and equipment characterization7.Product definition 8.Process definition9.Validation(IQ,OQ,PQ)10.Routine monitoring and control11.Product release from sterilization12.Maintaining process effectiveness1.1.ScopeScopeDevelopmentDevelopment,validation and routine monit

11、oring,validation and routine monitoring and control of a and control of a lowlow temperaturetemperature sterilizationsterilizationprocess for process for medicalmedical devicesdevices usingusing vaporizedvaporizedhydrogenhydrogen peroxideperoxide(VH2O2)as the(VH2O2)as the sterilizingsterilizingagent

12、agentPrion:Not Prion:Not includedincludedNote:Note:somesome VH2O2 VH2O2 sterilizerssterilizers have have processesprocesses thatthatdemonstratedemonstrate somesome levellevel of inactivation*of inactivation*Fichet G et al.Journal of Fichet G et al.Journal of microbiologicammicrobiologicam methodsmet

13、hods-20072007RogerRoger-KreuzKreuz C et al.Infection control and C et al.Infection control and hospitalhospital epidemiologyepidemiology-20092009https:/https:/ansm.sante.fransm.sante.fr/vos/vos-demarchesdemarches/industriel/liste/industriel/liste-desdes-produitsproduits-inactivantsinactivants-et et-

14、formatformat-dede-dossierdossier-pourpour-lala-revendicationrevendication-dede-performancesperformances-dinactivationdinactivationEN 17180(draft)5EN 17180(Draft)1.Scope2.Normative references3.Terms and definition4.General(Ex:sterilizer types,equipment development)(Ex:sterilizer types,equipment devel

15、opment)5.Equipment design and construction(Ex:safety,vibration)(Ex:safety,vibration)6.Indicating,monitoring,controlling and recording7.Service and local environment(Ex:Sterilant,Electrical supply)(Ex:Sterilant,Electrical supply)8.Emissions(Ex:Electromagnetic,Noise,Heat.)(Ex:Electromagnetic,Noise,Hea

16、t.)9.Test instrumentation(not fitted to the sterilizer)(not fitted to the sterilizer)10.Performance assessment(penetration with type test device,microbicidal with tests loads)(penetration with type test device,microbicidal with tests loads)11.Information to be supplied1.Scope1.ScopeThis document Thi

17、s document specifiesspecifies minimum minimum requirementsrequirements:for the performance and design of sterilizers for the performance and design of sterilizers intended to deliver a process capable of sterilizing intended to deliver a process capable of sterilizing medical medical devicesdevices;

18、for the equipment and controls of these sterilizers for the equipment and controls of these sterilizers needed for operation,control,and monitoring,needed for operation,control,and monitoring,and which can be used for validation of the and which can be used for validation of the sterilization proces

19、ses;sterilization processes;for the test equipment and test procedures used to for the test equipment and test procedures used to verify the sterilizer performance specified by this verify the sterilizer performance specified by this document.document.ISO 22441 vs EN 17180(whenpublished)6ISO 22441-p

20、rocessprENprEN 17180171801.Scope2.Normative references3.Terms and definition4.Quality Management system elements5.Sterilization agent characterization6.Process and equipment characterization7.Product definition 8.Process definition9.Validation(IQ,OQ,PQ)10.Routine monitoring and control11.Product rel

21、ease from sterilization12.Maintaining process effectiveness+ISO 22441EN17180MedicalMedical devicedeviceTest Test devicedevice2.Normative references7General requirementsISO 14937General requirementsISO 11138-1Common requirementsISO/TS 22421General requirementsISO 11140-1BD Steam penetrationISO 11140-

22、2Alternative to BDISO 11140-4BD Air removalISO 11140-5Type 2 BI and PCD for smallsteam sterilizersISO/DIS 11140-6PCD small steam sterilizersEN 867-5Ethylene oxideISO 11138-2MoistheatISO 11138-3Dry heatISO 11138-4LTSFISO 11138-5Hydrogen peroxideISO/AWI 11138-6(WIP)MoistheatISO 17665-1,-2&-3Large Stea

23、m steriliersEN 285Small Steam steriliersEN 13060Dry heatISO 20857EthyleneoxideISO 11135 and ISO/TS 21387Ethylene oxideEN 1422HydrogenperoxideISO/DIS 22441Hydrogen peroxideprEN 17180(WIP)LTSFISO 25424LTSFEN 14180Critical devicesISO 17664-1Biological evaluationof medical devicesISO 10993-1,-7 and 17Re

24、quirementsfor packaging systemsISO 11607-1Validation of Packaging processesISO 11607-2WrapsEN 867-2Paper bags and paperEN 867-4&-3Sealable pouches and reels EN 867-5LTS/Paper and adhesivecoatingEN 867-6&7Re-usable containersEN 867-8General requirementsISO 15883-1Surgical instruments,etc ISO 15883-2H

25、uman waste containers and non invasive itemsISO 15883-3&7Thermolabile endoscopesISO 15883-4Non-invasive itemsISO 15883-6Test methods for cleaningefficacyISO/TS 15883-5Sterilization ProcessSterilizersBiological indicatorsSteam type 2Terminal Sterilization of healthcare products(radiation excepted)Non

26、 biologicalindicatorsSterilizers for medicalpurposes Requirements and testingPackaging requirementsand test methodsWasher-disinfectorsThermal disinfectionChemical disinfectionProcessing information by MDM*PackagingISO TC 198CEN TC 102 and 204Quality ManagementISO 13485Risk ManagementISO 14971Other k

27、ey ISO and IEC standardsSafety for sterilizers and WD IEC 61010-2-40Storage cabinet EN 16442Storage of thermolabile endoscopesNon critical devicesISO 17664-2MicrobiologicalmethodsPopulation of microrganismsISO 11737-1Test of sterilityISO 11737-2Bacterial endotoxinISO 11737-3Guidance on 11607-1&-2ISO

28、/TS 16775Quality of water(sterilizers and WD)ISO TS 5111Water qualityVocabularyISO 11139TerminologyGuidanceISO 11138-7ResistometerTest equipment for BI&CIISO 18472*Medical device manufacturersMaster products-cleaningISO 17664-3(AWI)3.Terms and definitions8VariablesParameters and tolerancesP,TP,T C,t

29、,sterilizing agent C,t,sterilizing agent Concentration Concentration Specified value for a variableSpecified value for a variableSterilizing agent SterilantH H2 2O O2 2/H/H2 2O solution O solution Vaporized HVaporized H2 2O O2 2+H+H2 2O OPCD(process challenge device)Item providing a defined resistan

30、ce to a cleaning,disinfection Item providing a defined resistance to a cleaning,disinfection or sterilization process and used to assess performance of the or sterilization process and used to assess performance of the process(ISO 11139)process(ISO 11139)Note 1 to entry:for the purpose of this docum

31、ent,item Note 1 to entry:for the purpose of this document,item means a simulation of a product,a test device,or an means a simulation of a product,a test device,or an inoculated productinoculated product8.5 c)and 8.8 of ISO 224418.5 c)and 8.8 of ISO 22441SeeSee alsoalso PCD state of the artPCD state

32、 of the artC.Denis WFHSS 2021C.Denis WFHSS 20214.QMS elements-Typicalresponsibilities9ISO 22441-processHCF*MDM*SM*1.Scope2.Normative references3.Terms and definition4.Quality Management system elements5.Sterilization agent characterization 6.Process and equipment characterization 7.Product definitio

33、n Health care Facility with IFUs provided by Health care Facility with IFUs provided by MDMMDM 8.Process definitionSterility and compatibility testsSterility and compatibility tests 9.Validation(IQ,OQ,PQ)IQ and OQ subcontracted to the SM.IQ and OQ subcontracted to the SM.PQ by HCF or subcontracted t

34、o SM or 3rd PQ by HCF or subcontracted to SM or 3rd partyparty 10.Routine monitoring and control 11.Product release from sterilization 12.Maintaining process effectivenessrQrQ,Maintenance,Maintenance*HCF:*HCF:HealthHealth care Facilitycare Facility*MDM:Medical*MDM:Medical DeviceDevice ManufacturerMa

35、nufacturer*SM:*SM:SterilizerSterilizer ManufacturerManufacturerAccordingAccording to informative to informative annexannex E.4E.4Physics of sterilization10Adsorption,Absorption and condensation but in different ways-Steam:Release of latent heat-EO:Humidity to allow penetration of EO in spores-LTSF:E

36、ffective in liquid phase-H2O2:Adsorption and highly concentrated condensateSterilization processes are complex,multiphasic,dependent on surfaces properties and geometries.Given the growing complexity of medical devices,modeling remains challenging and microbiology test cannot be avoided Vacuum to wi

37、thdraw non-condensable gases but at various levels.Some process variables are common to sterilization modalities(P,TC,t,sterilizing agent concentration)but role and range differAltough useful there are limit to/between modalities.What is good/needed for a given process might not be appropriate for a

38、nother.Physics of sterilizationPhysics of sterilizationWFHSS 2022WFHSS 2022Daniel Daniel BeysensBeysensNicolas Nicolas LavielleLavielle5.Sterilizing agent characterisation11Microbicidal effectivenessGeobacillus stearothermophilusISO 11138-1(ISO 11138-6 when available)Effect on materialsEvolution of

39、properties after repeated exposuresBiological safety according to ISO 10993-1 and 17 Safety and the environment6.Process&equipmentcharacterisation12Process characterizationCycle Variables and parameters:Time,Pressure,TC,VH2O2 concentration(measured directly or indirectly),Equipment characterizationH

40、ardware,software,Control&Monitoring PressurePressureTimeTimeVH2O2 VH2O2 CcCcT T C CLowLow vacuumvacuumRangeRange6.3.3 The 6.3.3 The equipmentequipment specificationspecification shallshall confirmconfirm thatthat meansmeansare are providedprovided to to ensureensure thatthat a a failurefailure in a

41、control in a control functionfunctiondoesdoes not lead to a not lead to a failurefailure in in recordingrecording of process of process parametersparameterssuchsuch thatthat an ineffective process an ineffective process appearsappears effectiveeffective7.Product definition13Packaged Medical device c

42、leaned and preparedaccording to medical device manufacturer instruction for reprocessing-ISO 17664-1Packaging Validated ISO 11607-1&2H2O28.Process definition14Biological safety evaluation if neededSterility tests6 log of geobacillus thermophilus according to overkill principleat the most challenging

43、 location in the deviceX 3 at cycleFunctionality tests after#of cycles determined by Medical Device Manufacturer 9.Process validation154.Review and approval of IQ,OQ,PQ1.Installation Qualification and documentation2.Operational Qualification3.Performance Qualification For each cycleMost challenging

44、devices/load configuration 9.4.4 b)e)Packaging routine 9.4.4.c)BI 9.4.5 compliant to ISO 11138-1 or BI in PCDresponding to 8.8 CI optional9.4.5.e).If used might comply to ISO 11140-1 cycle 9.4.3x 3 9.4.11Independent Control of process parameters+response of BI or BI/PCDPCD PCD-ParagraphParagraph 8.8

45、8.89.Process validation in practice16No normative requirement from ISO 22441 for TC sensors in loadNote to 9.4.3 one or more test Note to 9.4.3 one or more test sensorssensors for for thisthis purposepurpose are are typicallytypically locatedlocated as as closelyclosely as as possible to the positio

46、ns of the respective possible to the positions of the respective sterilizationsterilization chamberchamber probesprobesNo normative requirement for H2O2concentration monitor in loadMost challenging routine loadwith BI ororBI in a PCD 8.88.8or/and or/and Challenge pack tested by the manufacturer as m

47、ore challenging than the most challenging approved routine load,with BI ororBI in a PCD 8.88.810.Routine controls17Each cycle,routine monitoring/recording and visual controlsBI/BI in PCD,CI according to applicable recommendations/rules and healthcare facilitiesprocedurePressurePressureTimeTimeVH2O2

48、VH2O2 CcCcT T C C11.Load release18According to healthcare facility proceduresParametricParametric release or BI releaserelease or BI releaseOftenOften opposedopposed but in but in factfact complementarycomplementaryNote to 11.3:Bis and CIs are widely used to support Note to 11.3:Bis and CIs are wide

49、ly used to support product release in healthcare facilitiesproduct release in healthcare facilities12.Maintaining process effectiveness19Maintenance and RecalibrationRequalification(planned or as needed)Installation requalification after relocationOperational requalificationPerformance requalificati

50、onConclusion20Compliance of a Compliance of a VH2O2 process VH2O2 process to ISO 22441to ISO 22441*HCF:Healthcare Facility*HCF:Healthcare Facility*MDM:Medical*MDM:Medical DeviceDevice ManufacturerManufacturer*SM:*SM:SterilizerSterilizer ManufacturerManufacturerISO 22441-processHCF*MDM*SM*1.Scope2.No

51、rmative references3.Terms and definition4.Quality Management system elements5.Sterilization agent characterization6.Process and equipment characterization7.Product definition(med.device load)HC Facility with IFUs provided by MDM8.Process definitionSterility and compatibility tests9.Validation(IQ,OQ,

52、PQ)IQ and OQ subcontracted to the SM.PQ by HC facility or subcontracted to SM or 3rdparty10.Routine monitoring and control11.Product release from sterilization12.Maintaining process effectivenessrQ,Maintenance subcontracted to the SMISO 22441-processHCF*MDM*SM*1.Scope2.Normative references3.Terms an

53、d definition4.Quality Management system elements5.Sterilization agent characterization 6.Process and equipment characterization 7.Product definition(med.device load)HC Facility with IFUs provided by MDM 8.Process definitionSterility and compatibility tests 9.Validation(IQ,OQ,PQ)IQ and OQ subcontracted to the SM.PQ by HC facility or subcontracted to SM or 3rdparty 10.Routine monitoring and control 11.Product release from sterilization 12.Maintaining process effectivenessrQ,Maintenance subcontracted to the SM ThankThank youyou21