環(huán)氧乙烷滅菌英文報(bào)告

1、Sh Shanghai Yuxing Medical Device Co.,ETO Sterilizationpage - 1 -The sterilization protocol is conducted by Yuxing Medical Device Co., Product: PTFE Injection Needle, Disposable Biopsy Forceps，Sterilization Equipment：HDX-63 # sterilizerProtocol No： BVP(PQ)-SHAED-20140501Rev A/0ETO Sterilization Vali

2、dation ReportCustomer Name: Wilson Instruments (SHANGHAI) Co.,.Product Name: Disposable injection needle, Biopsy Forceps,Oval/BasketType GrasForcepsProtocol Code: BVP(PQ)-SHAED-20140501Sterilization validation method: Half-cycle validation methodSterilizer: 3#Shanghai Yuxing Medical Device Co.,Autho

3、r:Date:Reviewed by：Date：Authorized by：Date：Wilson Instruments (SHANGHAI) Co.,.Reviewed by：Date：Authorized：Date：Revision0First EditionQMRev.Issue dateDescriptionIssued bySh Shanghai Yuxing Medical Device Co.,ETO Sterilizationpage - 2 -The sterilization protocol is conducted by Yuxing Medical Device C

4、o., Product: PTFE Injection Needle, Disposable Biopsy Forceps，Sterilization Equipment：HDX-63 # sterilizerProtocol No： BVP(PQ)-SHAED-20140501Rev A/0CONTENT1. Validation Purpose32. Sterilization Validation Item Description32.1 Confirmation process description32.2 Description of Validation process for

5、sterilization43. References44. Sterilization Equipment54.1 Pre-conditioning Room54.2 Sterilizer54.3 Aeration chamber65.Products to be sterilized66. Confirm Project and Confirmation process scheduling86.1 Validate the item before conducting the sterilization condition to the product86.1.1 Validate th

6、e accuracy of the detector and meter for sterilization86.1.2 The IQ and OQ of the sterilizer86.1.3 The IQ and OQ for the electric controlling system and computer controlling system96.1.4 The validation of the compliance of the raw material and indicator used in the sterilization process96.1.5 Valida

7、tion of the Initial Bioburden of the product96.1.6 The validation of the most difficult point of the product to be sterilized 10 6.1.7The validation of the consistency of PCD106.1.8 Validation of the products loading pattern116.1.9 Validation of the uniformity of the loading temperature and humidity

8、, the effects of pre-conditioning and the allocation of IPCDEPCD during the sterilization process.126.1.10 Validation of the set value of the sterilization operation condition 136.2 The sterilization condition of the product166.2.1 Fractional cycle166.2.2 Half-cycle176.2.3Full-cycle186.36.4Validatio

9、n of the aeration of EO residual19Summary of the sterilization parameter20. 217.8. Routine sterilization238.1 Routine sterilization detection238.2 The release of the product249. Sterilization revalidation24Sh Shanghai Yuxing Medical Device Co.,ETO Sterilizationpage - 3 -The sterilization protocol is

10、 conducted by Yuxing Medical Device Co., Product: PTFE Injection Needle, Disposable Biopsy Forceps，Sterilization Equipment：HDX-63 # sterilizerProtocol No： BVP(PQ)-SHAED-20140501Rev A/01 Validation PurposeEstablish EO sterilization condition for PTFE injection needle and biopsy forceps of Wilson Inst

11、ruments(SHANGHAI) Co.,., sterilized in the HDX-6 sterilizer (#3 sterilizer) in Shanghai Yuxing Medical DeviceCo., according to the requirement of ISO11135-1:2007 and GB18279:2000 standard, validate theeffectiveness, reproducibility, scientific of the product, to ensure that the SAL of the sterilized

12、 product is10-6 and the adaptability of the product meets the requirement.The sterilization validation will run for one time physical cycle, one time fractional cycle, three times half-cycle and three times full-cycles.2.Sterilization Validation Item Description2.1 Confirmation process descriptionIn

13、stallation Qualification Operational Qualification Performance Qualification（Half-cycle method）Physical performance Qualification Initial Pollutant Test Temperature and humidity distribution in the productSelect the appropriate BI/PCD Performance TestingRun one time fractional cycle Establish reprod

14、ucibility sterilizationRun three times half-cycleRun three times full-cyclesISValidated process (Reporting)Residual EO testPackaging Performance TestingMicrobial properties QualificationSh Shanghai Yuxing Medical Device Co.,ETO Sterilizationpage -4 -The sterilization protocol is conducted by Yuxing

15、Medical Device Co., Product: PTFE Injection Needle, Disposable Biopsy Forceps，Sterilization Equipment：HDX-63 # sterilizerProtocol No： BVP(PQ)-SHAED-20140501Rev A/02.2 Description of Validation process for sterilization3. ReferencesSterilizerEN 1422:1997+A1:2009Sterilizers for medical purposes Ethyle

16、ne oxide sterilizers Requirements and testValidation and ControlISO 11135-1:2007Sterilization of health care products Ethylene oxidePart 1: Requirements for development, validation and routine control of a sterilization process for medical devicesProcedureRemarkPreconditioningThis process can be con

17、ducted either in the preconditioning chamber or in a sterilization chamber, mainly for heating and humidifying the product from normal to a predetermined status. Therefore, there is a large range of pressure variation. The data of this step is showed as heating and insulation.VacuumThis process for

18、assisting the effects of EO injection, and specific pressure is mainly determined by the products packaging performance, The data of this step is showed as pre-vacuum.Pressure-keeThis process is checking equipments leaking status, and The data of this step is showedas keepressure.Humidification and

19、humidity balanceIn this step, the temperature may rise for the humidification, so this process temperature will be higher. However during the moisture equilibrium, pressure and humidity may decrease, for the water is absorbed by carton. The data of this step is showed as humidification.EO injectionT

20、his step is EO injection. The pressure will slowly rise. The data of this step is showedas EO injection.SterilizationIn this step, the pressure will decrease due to the penetration of EO into the product. The data of this step is showed as sterilization for in this process the temperature and humidi

21、ty are relatively balanced.In this protocol, the pre-set the product sterilization short cycle: 180min, half-cycle:240min, full cycle: 480min.FlushingThis process is to remove EO, and flush more than three times, lasts for over 30min. Thedata of this step is showed as flushing process.Cabinet ventil

22、ationThis process is to remove EO, and flush more than three times, lasts for over 30min. The data of this step is showed as the end of flushing process.Sh Shanghai Yuxing Medical Device Co.,ETO Sterilizationpage -5 -The sterilization protocol is conducted by Yuxing Medical Device Co., Product: PTFE

23、 Injection Needle, Disposable Biopsy Forceps，Sterilization Equipment：HDX-63 # sterilizerProtocol No： BVP(PQ)-SHAED-20140501Rev A/04.Sterilization Equipment4.1 Pre-conditioning RoomAccording to the actual situation, the pre-conditioning is conducted in the sterilizer.4.2 SterilizerName: HDX ETO Steri

24、lizerRequirement for packagingISO 11607-1:2006Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systemsISO 11607-2:2006Packaging for terminally sterilized medical devices- Part 2：Validation requirements for for, sealing and

25、assembly processesInitial contaminating bacteria testISO 11737-1:2006Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on productsSterilization of medical devices-Microbiological methods- Part 2: Tests of sterility performed in the valid

26、ation of a sterilization processSterilityO 11737-2:2006Biological IndicatorISO 11138-2:2006Sterilization of health care products - Biological indicators - Part 2 ：Biological indicators for ethylene oxide sterilization processesChemical IndicatorISO 11140-1:2005Sterilization of health care products -

27、 Chemical indicators- Part 1： General requirementsEthylene OxideYY/T 0822-2011Liquefied gas sterilization with ethylene oxideEvaluation of residuals of EOISO 10993-7:2008Biological evaluation of medical devices -Part 7： Ethylene oxide sterilization residualsProduction process controllingYY 0033-2000

28、Management practices of manufacturing sterile medical devicesProcess validationGHTF-SG3-N99-10： 2004Quality Management Systems - Process ValidationGuidanceSh Shanghai Yuxing Medical Device Co.,ETO Sterilizationpage - 6 -The sterilization protocol is conducted by Yuxing Medical Device Co., Product: P

29、TFE Injection Needle, Disposable Biopsy Forceps，Sterilization Equipment：HDX-63 # sterilizerProtocol No： BVP(PQ)-SHAED-20140501Rev A/0M:HDX -6No: 3#Volume: 2.8m* 1.35m*1.7m (L*W*H)Inner volume 6.42m3 Effective volume：5.14m34.3Aeration chamberNatural aeration5.Products to be sterilizedProduct NameSpec

30、. & TypeQty.Lot No.MaterialsWeight (kg)Density（kg/m3）Disposable Biopsy ForcepsWS-2423B TH20140310Medical stainless steel, ABS, FEP4.8184.6Disposable Gras ForcepsWS-2423G J251403034.8184.6Disposable Retrieval BasketWS-2423G L02515140321Medical stainless steel, PTFE tube, ABS4.2161.5Disposable Sna

31、reWS-2423D T25151403134.2161.5Disposable Unguiform Gras ForcepsWS-2423G M4Q151402284.2161.5Disposable Spray CathetersWS-2423P A15140326Medical stainless steel, PTFE tube, ABS4.0153.8Disposable sheath Cytology BrushesWS-2423X A3151403254.0153.8Disposable Injection needleWS-2423P N2306151402244.2161.5

32、Sh Shanghai Yuxing Medical Device Co.,ETO Sterilizationpage - 7 -The sterilization protocol is conducted by Yuxing Medical Device Co., Product: PTFE Injection Needle, Disposable Biopsy Forceps，Sterilization Equipment：HDX-63 # sterilizerProtocol No： BVP(PQ)-SHAED-20140501Rev A/0Disposable Electrosur

33、gical SnareWS-2423D T2515140305Medical stainless steel, PTFE tube, ABS4.2161.5Disposable Hot Biopsy ForcepsWS-2423D G201402194.8184.6Disposable Coagulatio n ElectrodeWS-2423D Q151403184.5173.1Disposable Needle ElectrodeWS-2415D Z05151402204.2161.5Disposable Sphinctero tomes/Papi llotomeWS-0725D J315

34、1403274.2161.5Disposable Biopsy ValveWS-M-0150140317TPE4.0153.8Disposable Bite BlockWS-YO-0330131231PP4.0153.8Disposable Air Water ValveWS-V0-0140SCB01TPE/ABS/Silicone4.0153.8Disposable Suction ValveWS-V0-0240SCB01TPE/ABS/Silicone4.0153.8Disposable NasoBiliar y CatheterWS-0617N B-110140322PTFE Tube4

35、.0153.8Disposable Endoscope Valves set AWS-V0-01/ WS-V0-02/ WS-M-0120SCB01TPE/ABS/Silicone4.2161.5Disposable Guide WiresWS-3545A S-1E10140405NITI WIRE, PTFE4.0153.8Sh Shanghai Yuxing Medical Device Co.,ETO Sterilizationpage - 8 -The sterilization protocol is conducted by Yuxing Medical Device Co., P

36、roduct: PTFE Injection Needle, Disposable Biopsy Forceps，Sterilization Equipment：HDX-63 # sterilizerProtocol No： BVP(PQ)-SHAED-20140501Rev A/06. Confirm Project and Confirmation process scheduling6.1 Validate the item before conducting the sterilization condition tothe product6.1.1 Validate the accu

37、racy of the detector and meter for sterilizationaValidation purpose：According to the requirement of the standard ISO11135-1:2007 article 9.2.1, in order to ensure that the sterilization process goes smoothly and the validation results are reliable and effective, validate the accuracy of sterilizatio

38、n equipment such as monitoring instruments, measuring instruments.Recognition requirements：Accuracy should be in the range of requirementsValidation Item：HTCwireless temperature sensors, HTC wireless humidity sensors, Electronics, temperature sensors, humidity sensors, Pressure Transmittersbcd efCon

39、firmation method：Collect and verify the relevant testValidation time：8th, May, 2014sSee the results：The detective device list of sterilization and The copy of the verificationValidation results：Meet the requirementscalibrationg6.1.2 The IQ and OQ of the sterilizeraValidation purpose：According to the

40、 requirement of the standard ISO 11135-1:2007 article 9. 1 and article 9. 2, ensure that the performance of the sterilization instrument meets the requirements and the validation process is conducted smoothly and the confirmation results are effective and reliable.Recognition requirements：The steril

41、izer should meet the requirement of the standard ISO 11135-1： 2007、YY 0503-2005.Validation Item：IQ and OQ validationConfirmation method：Review and audit the IQ/OQ validation report Validation time：8th, May, 2014Validation results： Meet the requirementsSee the results：Sterilizer IQ/OQ validation repo

42、rt copybc d e fgDisposable Water BottlesWS-SP-1E10140405PP, 304 stainless steel, PVC, S.I.R4.0153.8Disposable Polyp TrapsWS-S-1E10140405PE, PC, PVC4.0153.8Sh Shanghai Yuxing Medical Device Co.,ETO Sterilizationpage - 9 -The sterilization protocol is conducted by Yuxing Medical Device Co., Product: P

43、TFE Injection Needle, Disposable Biopsy Forceps，Sterilization Equipment：HDX-63 # sterilizerProtocol No： BVP(PQ)-SHAED-20140501Rev A/06.1.3 The IQ and OQ for the electric controlling system and computer controlling systemaValidation purpose：According to the requirement of the standard ISO 11135-1:200

44、7 article 9. 1 and article 9. 2, ensure that the performance of the sterilization instrument meets the requirements and the validation process is conducted smoothly and the confirmation results are effective and reliable.Recognition requirements：The installation of the electric and computer controll

45、ing system is correct. The controlling system can be operated within the controlling range and normally,Validation Item：IQ and OQ validationConfirmation method：Review and audit the IQ/OQ validation report Validation time：8th, May, 2014Validation results： Meet the requirementsSee the results：Electric

46、 and computer controlling system IQ/OQ validation report copybc d e fg6.1.4The validation of the compliance of the raw material and indicator used in the sterilizationprocessaValidation purpose：According to the requirement of the standard ISO 11135-1：2007 article 8.6、8.7、8.8 and , ensure that

47、 the raw material and indicator used in the sterilization process meets the requirements of relevant standards and appropriate BI has been chosen.bRecognition requirements：Purified waterBIChemical IndicatorEO gasMeet the requirement of national Pharmacopoeia Should meet the requirement of ISO 11138-

48、2:2006 Should meet the requirement of ISO 11138-2:2006Should meet the requirement of YY/T 0822-2011cdValidation Item： Purified water for humidification, BI, Chemical Indicator and EO gasConfirmation method: * Check the 3M BI, EO sterilization Chemical Indicator and the qualityqualification report fr

49、om the EO gasr* Test the purified water in accordance with the requirement of Pharmacopoeia Validation time：8th, May, 2014See the results： Purified water test results3M BI quality assuranceEO sterilization chemical indicator EO gas quality reportValidation results： Meet the requirementsefg6.1.5 Vali

50、dation of the Initial Bioburden of the productaValidation purpose：According to the requirement of the standard ISO 11135-1：2007 article 12.3.3, ensure that the bioburden of the product meets the requirements of the standard ISO11737 and the bioburden of the product is less than the BI, for providing

51、 the evidence for the right BI.Recognition requirements: meets the requirements of the standard ISO11737 Confirm Project：Product BioburdenValidation Item： Test the products bioburden according to the requirements of the standard ISO11737b cdSh Shanghai Yuxing Medical Device Co.,ETO Sterilizationpage

52、 - 10 -The sterilization protocol is conducted by Yuxing Medical Device Co., Product: PTFE Injection Needle, Disposable Biopsy Forceps，Sterilization Equipment：HDX-63 # sterilizerProtocol No： BVP(PQ)-SHAED-20140501Rev A/0e fgValidation time：8th, May, 2014See the results： The test report of the produc

53、ts bioburden Validation results：The products bioburden is less than BI Attention: Shanghai Yuxing Medical Device Co.,is responsible for the testing of theproducts initial biobuden and issuing the testing report.6.1.6The validation of the most difficult point of the product to be sterilizedaValidation purpose：According to the requirement of the standard ISO 11135-1：2007 article 8.6 C), find out the most difficult point of the product to be sterilized as the evidence for making PCD.Recognition requirements：Find the mos