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1、PRODUCTEO sterilization Product family(Disposable oxygen cannula,Disposable oxygen mask,Disposable urine bag,Disposable pressure transducer,Disposable pressure transducer(rectal pressure)PROTOCOL NO.PQ-WSRH-VP-ET0001-2017-001 Rev.OVALIDATION PROCEDUREHalf cycle study in accordance with ISO 11135:201
2、4,B.1.2.aSTERLIZATION CYCLECycle#WSRHCHAMBERChamber#SC-CX-208AUTHORAUTHOR_Date_APPROVEDAPPROVED BYBYBeijing Winsunny Harmony Science&Technology Co.,Ltd_Date_ManagerRevisionsRevisions01st Sept.,2017NewQMRevision No.Date of IssueRevision DescriptionInitiated by目录1.0 Overview.32.0 Description of steril
3、ization validation items.42.1 Sterilization process.42.2 Description of WSRH condition sterilization validation process.63.0 References.74.0 Sterilization equipment.74.1 Use of sterilizer.74.2 Use of aeration room.75.0 Applicable sterilization product object.76.0 Validation method.86.1 Characteristi
4、cs of material and sterilization equipment.86.2 Sterilization product loading pattern.96.3 Operational Condition.96.4 Microbiological performance qualification.116.5 Physical performance qualification.136.6 EPCD qualification.136.7 EO residual aeration effectiveness qualification.146.8 Product quali
5、fication.147.0 Responsibility and authority of department involved in sterilization validation.147.1 Responsibility and authority of BEIJING WINSUNNY HARMONY SCIENCE&TECHNOLOGYCO.,LTD.148.0 The Annex.151.0 OverviewThis validation report applies to products manufactured by Beijing Winsunny Harmony Sc
6、ience&Technology Co.,Ltd and/or its affiliates and is detailed in Annx 5-1.Products will be sterilized in Chamber#SC-CX-208 at the Beijing Winsunny Harmony Science&Technology Co.,Ltd facility using Cycle#WSRH.The lethality validation will confirm that Cycle#WSRH is effective in achieving a Spore Log
7、 Reduction(SLR)of 6.0 or greater in order to verify a SLR of 12.0 or greater for a full cycle performed in Chamber#SC-CX-208,therefore confirming a minimum Sterility Assurance Level(SAL)of 10-6 according to ISO 11135:2014.This will be achieved by performing a minimum of three(3)half-cycles in Chambe
8、r#SC-CX-208.The lethality assessment will also confirm the appropriateness of the Internal and External Process Challenge Devices(IPCD)lethality resistance to the natural product bioburden.This will be achieved by performing a minimum of one(1)fractional cycle in Chamber#SC-CX-208.This report will a
9、lso include an assessment of Ethylene Oxide(EO)product residue according to ISO 10993-7:2008.A suitable heated aeration time will be determined in order to meet the ISO 10993-7:2008 requirements for Ethylene Oxide(EO)and Ethylene Chlorohydrin(ECH)product residues.A component qualification evaluation
10、 with the sterilization process will also be completed by Beijing Winsunny Harmony Science&Technology Co.,Ltd following two(2)times sterilization.This will be achieved by performing a minimum of two(2)full cycles in Chamber#SC-CX-208.2.0 Desc riptio n o f sterilizatio n validatio n items2.1 Steriliz
11、atio n pro c essIn this article,sterilization validation concerns following sterilization process.ALocation in the chartItem nameStandard sterilization condition(setting center value)AHeatingTemperature:52(-5,+5)CBKeeping heatTemperature:52(-5,+5)CTime:20402160minCVacuumRequired pressure:-60 3 KPaDL
12、eak testRequired time:10 mini 1 minEHumidifyingRequired A P:2Kpa4KpaFConditioningRequired time:30(-20,+2)minGEO injection P(Injected EO):40(-2,+8)KPaHEO ExposureRequired time:360min(-8,+2)KPaTemperature:50C(-5,+5)CIPost vacuumRequired pressure:-60+3 KPaJVacuum required pressure:-60 3 KPaFlushingAir
13、irijection required pressure:-5+3 KPaFlushing number:5 timesKAir admissionAir injection required pressure:0+3 KPaIt is a natural aerationwarehouse,the temperature will beLAerationcontrolled above 25 C.2.2 Desc riptio n o f WSRH c o nditio n sterilizatio n validatio n pro c ess3.0 Referenc es ISO1113
14、5:2014 Sterilization of health-care products Ethylene oxide Requirements for the development,validation and routine control of a sterilization process for medical devices.AAMITIR14:2009 Contract sterilization using ethylene oxide AAMI TIR16:2009 Microbial aspects of ethylene oxide sterilization EN55
15、6-1:2001 Sterilization of medical devices 一Requirements for medical devices to be designated STERILE Part 1:Requirements for terminally sterilized medical devices ISO 11737-1:2006 Sterilization of medical devices-Microbiological methods-Part 1:Determination of a population of microorganisms on produ
16、cts ISO 11737-2:2009 Sterilization of medical devices-Microbiological methods-Part 2：Tests sterility performed in the definition,validation and maintenance of a sterilization process EN ISO 10993-7:2008 Biological evaluation of medical devices-Part 7:Ethylene oxide sterilization residuals ISO 11138-
17、1:2006 Sterilization of health care products-Biological indicators-Part 1:General requirements EN ISO 11138-2:2006 Sterilization of health care products-Biological indicators-Part 2:Biological indicators for ethylene oxide sterilization processes GB 18279-1:2015 Sterilization of health care products
18、-Ethylene oxide Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices.4.0 Sterilizatio n equipment4.1 Use o f sterilizerSterilizer Type:EO sterilizerSterilizer model:HDX-20/CESterilizer number:SC-CX-208#Manufacturer:Hangzhou YOUNIKE disinfe
19、ction equipment Co.,Ltd.Chamber volume:8985 X 1355 X 1705mm,20.7m3Chamber usable volume:15 m3,Total usable volume is defined as 1.4m(L)*1.2m(W)*1.45(h)*6=15 n?.4.2 Use o f aeratio n ro o mAeration room name:Aeration roomIt is a natural aeration warehouse,the temperature will be controlled above 20 C
20、.5.0 Applic able sterilizatio n pro duc t o bjec tThe EO sterilization products of our company include Disposable oxygen cannula,Disposable oxygen mask,Disposable urine bag,Disposable pressure transducer,Disposable pressure transducer(rectal pressure).Defined those five products as a product family.
21、And according to product structure and packaging form analysis with the initial contaminated bacteria which involved in ISO 11135-2014,According to annex 5-1 conclusion.We established disposable oxygen cannula and disposable urine as master products which are worst-cases,because cannula is narrow an
22、d long,urines structure is complex.And manufacture IPCD that concrete models are showing in 6.4,and manufacture EPCD which resistance is stronger please see 6.4.after fractional cycle validation,The form of EPCD will be decided.6.0 Validatio n metho d6.1 Charac teristic s o f material and sterilizat
23、io n equipment6.1.1 All sensors in sterilizer room were calibrated in 2017,all calibration results are in acceptable scope.(See Annex 5-2 sensors calibration list)6.1.2 HTC temperature sensorTemperature measurement range of temperature sensors that will be used for this sterilization validation is-4
24、0+80C,accuracy is 土0.5C.All calibration results were within required accuracy.(See Annex 5-2 sensors calibration list)6.1.3 HTC humidity sensorHumidity measurement range of humidity sensors that will be used for this sterilization validation is 0100%RH,accuracy is 土 10%RH.All calibration results wer
25、e within the required accuracy.(See Annex 5-2 sensors calibration list)6.1.4 Electric balanceUsed for measuring EO weight,measurement range is 0+150kg,accuracy is 0.1kg.All calibration results were within the required accuracy.(See Annex 5-2 sensors calibration list)6.1.5 Steam evaporatorThe purifie
26、d water used for the chamber is clean steam produced by a steam evaporator Equipment.The steam quality refers to the Annex 5-3 Steam Quality certificate.6.1.6 IQ and OQEquipment operation(IQ)was completed in 2017:all parameters were in required scope.Operational Qualification(OQ)of preconditioning r
27、oom,Operational Qualification(OQ)of sterilizer and Operational Qualification(OQ)of aeration room were all qualified in 2017:all parameters were in required scope.6.1.7 Maintenance records in the past year.According to maintain and repair record equipment regularly.6.1.8 Characterization of sterilant
28、90%EO gas is provided by the approved supplier of Beijing Winsunny Harmony Science&Technology Co.,Ltd,each batch is provided with a quality certificate,and verified by Beijing Winsunny Harmony Science&Technology Co.,Ltd.The Gas quality refers to the Annex 5-4 EO gas Quality certificate.6.1.9 Biologi
29、cal indicatorManufacturer:FutureType of microorganism:Bacillus mophueus No.ATCC#9372.Presentation paper strip in glassine envelope,pouched in paper-laminate peel pouch#endospores/strip 106.Storage and Handling requirements:4C 25 C,30%70%.The spore strips meet the USP and ISO11138-2 requirements(D-va
30、lue should be 2.5 min).Copies of the certificates of compliance will be attached to the validation report,please refer to Annex 5-6 BI Qualitycertificate,BI use guideline refers to Annex 5-5.In the validation,if the BI is not the same lot,it is necessary to calculate the population of the used BI.6.
31、2 Sterilizatio n pro duc t lo ading patternIn accordance with the chamber size and characteristics of products,load the products for sterilization onto 1 pallets,the pallet size is 1.2m(W)X 1.4m(L)X 1.45m(H).From the Annex 5-1,the maximum density is 0.188 g/cm3(Disposable oxygen cannula,OT-MI-D),the
32、 minimum density is 0.032 g/cm3(Disposable pressure transducer(rectal pressure),OT-AP).From Annex 6-2 Load of products,there is five size of the box,and the max load is 60cm x 40cm x 35cm,max:168 cases,max load volume:14.1m.So,we choose the dummy load is using the material of the Disposable oxygen c
33、annula and other products,fill in the box(60cm x 40cm x 35cm),the weight should more than 15.75kg,and the density is more than 0.188 g/cm,total 168 cases,load volume is 14m.The concentration of EO of sterilizer cabinet is controlled by injection,it is constant.And the concentration and the temperatu
34、re are setting on upper limit in full cycle,the product of cabinet is in maximum exposed state,and this state can replace as the minim loading state.6.3 Operatio nal Co nditio nPerform the sterilization validation,half cycle run with the WSRH02 sterilization condition,fractional run with the WSRH01
35、condition,and full cycle with the WSRH03 sterilization condition respectively.WSRH routine sterilization condition and sterilization validation condition see Table 6-1.When performing the sterilization validation,the half cycle condition is to be performed a minimum of three(3)times use the max load
36、,fractional cycle a minimum of one(1)time use the max load,and full cycle a minimum of two(2)times use the max load.Table 6-1 WSRH routine sterilization condition and sterilization validation condition tableCycle NumberWSRH01WSRH02WSRH03Acceptable RangeWSRHCycle NumberFractional cycle(Lower limit)Ha
37、lf cycle(Lower limit)Full cycle(Upper limit)MinMaxRoutineAcceptable RangeMinMaxSamples10(steriletest)10(perfor mance)一一一一一IPCD38(2 sets)38(1 sets)35一EPCD38(2 sets)38(1 sets)191918Temperaturesensors20202020一一Humidity sensors8888一一一一HeatingTemperature45 C45 C55 CSetting-5 CSetting+5 C50CSetting-5 CSet
38、ting+5 CAeratio nKeep time1440mm2040min2160mmSetting-2minSetting+2min2042mm2040mm2160mmVac uumPressure arrived-60KPa-60KPa-60KPa-65Kpa-55Kpa-60KPa-65Kpa-55KpaTime to keep pressure60minlOminlOmin8min12 minlOmin8min12 minPressure change range06.0Kpa03.0Kpa03.0KpaOKpa3.0Kpa0 3.OKpaOKpa3.0KpaHumidity in
39、jec tio nSteam injection(AP)3KPa3KPa4KPa-IKPa+lKPa3KPa2KPa4KPaCo nditio ningConditioning time30min30min30minlOmin32 min30minlOmin30minHumidity afterDwell-30%90%-30%85%EO injec tio nManufacture ofEOYANANWEIYEYANANWEIYEYANANWEIYENANAYANANWEIYENANAEO injection(P)37 KPa38 KPa48KPa-2 Kg+2 Kg43Kpa38 KPa48
40、KPaEO injection(A Weight)-16.6Kg20.3 KgGas keepingGas keeping time120min170min360minSetting-2minSetting+2min360min342min362minTemperature45 C45 C55 CSetting-5 CSetting+5 C50CSetting-5 CSetting+5 CHumidity in sterilizer while sterilization(%RH)(after 15 min)50.0%RH50.0%RH50.0%RH30%RH90%RH50.0%RH30%RH
41、90%RHPo st vac uumPressure arrived-60KPa-60KPa-60KPa-65Kpa-55Kpa-60KPa-65Kpa-55KpaAir admissio nPressure of pump to close-60KPa-60KPa-60KPa-65Kpa-55Kpa-60KPa-65Kpa-55KpaRepeat times6 times6 times6times6times6 times6 times6 times6 timesPressure of air value to close-5 KPa-5 KPa-5 KPa-10 KPa-OKpa-5 KP
42、a-10 KPa-5KpaAir injec tio n and vac uumTime neededlOminlOminlOmin8min12 minlOmin8min12 minIt is a natural aeration warehouse,the temperature will be controlled above 25 C.6.4 Mic ro bio lo gic al perfo rmanc e qualific atio nRefer to ISO 11135:2014 Annex B1.2 a)Half-cycle approach,qualify the Steri
43、lity Assurance Level(SAL)after product sterilization of at least 10-6.6.4.1 Products bioburden testingTesting of products bioburden will be conducted by Beijing Winsunny Harmony Science&Technology Co.,Ltd.And the Annex6-1 is the Bioburden test report of the products.6.4.2 Preparation of PCD(process
44、challenge device)According to ISO 11135 3.28,An internal PCD is used to demonstrate that the required product SAL is achieved.A PCD located within the confines of the product or product shipper case is an internal PCD,whereas a PCD located between shipper cases or on the exterior surfaces of the loa
45、d is an external PCD.An EPCD is an item designed to be used for microbiological monitoring of routine production cycles.6.4.2.1 The IPCD of the cycle#WSRH was decided by Beijing Winsunny Harmony Science&Technology Co.,Ltd,From Annex 5-1,there are two types,one is cannula,another is bag,so we choose
46、the longest and thinnest cannula and the max surface of the bag to be the IPCDS,and after fractional cycle,we can decide the IPCD of the EO sterilization product family from the result of the fractional cycle.6.4.2.2 Preparation of PCD for validation(IPCD):Load the BI of Future inside of single prod
47、uct,the packaging configuration is same as routine products.IPCDs are prepared by Beijing Winsunny Harmony Science&Technology Co.,Ltd.IPCD1:Put 1 BI into the disposable oxygen cannula.IPCD2:Put 1 BI into the disposable urine bag.6.4.2.3 Preparation of PCD for routine control(EPCD):Load the BI of Fut
48、ure in 50mmX 90mm PE+CPP compound film pouch(0.05mm),this is the#1 EPCD,and then put the#1 into the 90mm X 150mm PE+CPP compound film pouch(0.05mm),this is the#2 EPCD,total is 2 types EPCD.And after fractional cycle,we can decide the EPCD of the EO sterilization product family from the result of the
49、 fractional cycle.6.4.3 Environment Temperature:The product is transport form clean room to sterilizer cabinet after packaging,it temperature is decided by manufacture workshop(235C).For the 3 half cycles(max load),the load will be placed in cooling storage(10C18C)for 12h to Pre-cooling,to challenge
50、 the temperature lower limit,.After Pre-cooling product will be Loading in sterilizer.6.4.4 Qualification of sterility assurance level(by half cycle method)6.4.4.1 Place 20 sets of temperature sensors,8 humidity sensors and 38 sets of IPCDs(Fractional cycle is 2 types IPCDs,half cycle use 1 decided