2022年验证方案 2.pdf

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1、XXX Group Corp. Medical Polymer products Co., LTD Packing inspect project Name: the arts and crafts inspection of packing Documents serial No: VP-002 draftsman examine and approve ratifier Sign Date Collect sign dept. Collection sign Date 名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心

2、整理 - - - - - - - 第 1 页，共 10 页 - - - - - - - - - Catalogue 1.Purpose 2.Context of inspection 3.Results analysis and appraise 4. Final approval 5. Organization of inspection 6. Duty and divide the work 名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 2 页，共 10 页 - - - - -

3、 - - - - 1. Inspect purpose: The disposable Plastic Blood bags made by us are packed inner package with PVC and over-package with high temperature co-ex plastic bags which are made from PP-PET material. Based on the requirements from European Community Medical Device instruction (MDD93/42/EEC),Accor

4、ding to the requirements from EN868-1-Medical Device sterilized packing material and system-the first parts: the general requirements and inspect methods, with regard to our inner packing, we carry out the inspections in order to approve of measuring up the requirements of medical device instruction

5、(MDD93/42/EEC). 2.Inspect contents The first part: the inspection of single packing . Based on the requirements from European CommunityMedical Device instruction (MDD93/42/EEC), According to the requirements from EN868-1-Medical Device sterilized packing material and system-the first parts: the gene

6、ral requirements and inspect methods, with regard to our inner packing, we carry out the inspections as following: 1) Preliminary contaminated Inspection of single packing: 2) Non-ventilate inspection of single packing: 3) Prevent bacterium inspection of single packing: 4) Assistance to-leakage insp

7、ection of single packing: 5) Biological compatibility inspection of single packing: 6) Toxicity inspection of single packing 7) Label system inspection of single packing 1)Preliminary contaminated Inspection of single packing: omnivorously holding samples 10 PCS( triple bags 250ml with lot 20030218,

8、20030219,20030220) after sterilization, the methods of inspection refer to EN1174-1/2/3:1996 the appraise of sterilization of medical device-animalcule quantity in products -the first part: essence requirements list, the appraise of sterilization of medical device- animalcule contaminated appraise-t

9、he second part:instruction of application, the appraise of sterilization of medical device- animalcule quantity in products -the third part:the confirm method instruction of inspection technical .2) Non-ventilate inspection of single packing: take out 5 pieces after sterilization conveniently with l

10、ot 2003021811, 2003021812, and 2003021813 and send to inspect center. According to the requirements from EN868-1-Medical Device sterilized packing material and system-the first parts: the general requirements and inspect methods. 3) Prevent bacterium inspection of single packing: take out 5 pieces c

11、onveniently after sterilization with lot 2003021811, 2003021812, and 2003021813 and send to inspect center. According to the requirements from EN868-1-Medical Device sterilized packing material and system-the first parts: the general requirements and inspect methods. 4) Anti-leakage inspection of si

12、ngle packing: take out 5 pieces conveniently with lot 2003021811, 2003021812, and 2003021813 and send to inspect center. When filled to nominal capacity with water as specified in ISO3696 and sealed, the plastic container shall not develop leaks under conditions of centrifugation at 5000g at 37 for

13、10 min. The plastic container is then squeezed between two plates to an internal pressure equivalent to 50kPa above atmospheric pressure at (23+5) for 10 min. No leakage is allowed on visual inspection. Note; when the plastic container is filled with anticoagulant solution, leakage may be detected b

14、y pressing the plastic container against sheets of blue litmus paper and observing the 名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 3 页，共 10 页 - - - - - - - - - development of pink spots on the paper. The detail information refers to ISO3826:1993 plastic collapsibl

15、e containers for human blood and blood components. 5) Biological compatibility inspection of single packing: take out 5 pieces conveniently after sterilization with lot 2003021811, 2003021812, and 2003021813 and send to inspect center. The methods of experiments refer to ISO10993-1:1997 biological a

16、ppraise of medical device the first part: appraise and test. 6) Toxicity inspection of single packing: take out 5 pieces conveniently after sterilization with lot 2003021811, 2003021812, and 2003021813 and send to inspect center. The method of experiments refers to ISO3826:1993 plastic collapsible c

17、ontainers for human blood and blood components. 7) Label system inspection of single packing Take out 5 pieces conveniently label stuck with lot 2003021811, 2003021812, 2003021813, inspect one by one according to EN980 package and symbol of medical polymer products including: (1) General demands a)

18、The symbol indicated on package should be instruct to shipments, storage, tearing open and usage b) The symbol indicated on package should be clear, perspicuity,fastness, It is forbidden to brush off or slur in the process of sterilization, shipments and storage. c)The symbol of parliamentary packin

19、g should be typed on the outer surface but not except for considering that removing can influence on the quality in the package. (2) The general information on the single packing a) Products name. style or specification b) The manufacture name, address and brands c) Production lot or date: d) “non -

20、sterilize” letters and/the non-sterilize symbol of drawing “ destroyed after using ” letters: e) If the single packing is broken, do not use the products. “Package broken not to use” must be indicated. f) Single use instruction/symbol design:g) Expiry date: The second part-over-package inspection 1.

21、 Inspect purpose: .Based on the requirements from European CommunityMedical Device instruction (MDD93/42/EEC), According to the requirements from EN868-1-Medical Device sterilized packing material and system-the first parts: the general requirements and inspect methods, with regard to our packing ma

22、terial, we carry out the inspections as following: 1) Non-ventilate inspection of single packing: 名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 4 页，共 10 页 - - - - - - - - - 2) Prevent bacterium inspection of single packing: 3) Agglutinate of seal inspection of singl

23、e packing: 2. Contents of inspection: 1) Non-ventilate inspection of over-package: Take off the outer packing, and take out 5 pieces conveniently with lot number 20030111, 20030120, 20030127 and send to inspect center. According to the requirements from EN868-1-Medical Device sterilized packing mate

24、rial and system-the first parts: the general requirements and inspect methods, the person who concerning will carry out Non-ventilate inspection of single packing. 2) Prevent bacterium inspection of over-package: Take off the outer packing, and take out 5 pieces conveniently with lot number 20030111

25、, 20030120, 20030127 and send to inspect center. According to the requirements from EN868-1-Medical Device sterilized packing material and system-the first parts: the general requirements and inspect methods, the person who concerning will carry out prevent bacterium inspection of single packing. 4)

26、 Agglutinate of seal inspection of over-package: according to the requirements, put the products into single packing, setting the parameter on the seal machine, each groups can seal 5 pieces with lot number 20030111, 20030120, 20030127 and send to inspect center. According to the requirements from E

27、N868-1-Medical Device sterilized packing material and system-the first parts: the general requirements and inspect methods, the person who concerning will carry out agglutinate of seal inspection of single packing: Groups ParameterSeal temperature Convey speed 1 200High 2 210High 3 220High . 3.The f

28、inal approval: The above-mentioned experiments were checked and approved by inspection groups with appraise and analysis, the eligibility documents will hand over to departments for putting into application. 3. Inspection organization 4.1 Inspection principal: Cheng Yunliang Workshop member: Zhang Y

29、anhong Dong Lujing Dou Xiaojie Manufacture departments member: Tian Xuefei Zhao Zhendong Li Xiouying Zhang Cuiyan4.2 Duty and divide the work Workshop: charge the records of process of production; strictly control the process of production Manufacture departments:harmonize and do correspondent docum

30、ents in the process of inspection. 5.Works schedule: In vision, the work will be finished in Mar, 2003. 名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 5 页，共 10 页 - - - - - - - - - XXX Group Corp. Medical Polymer products Co., LTD Packing inspect reports Name: the art

31、s and crafts inspection of packing Documents serial No: VP-002 draftsman examine and approve ratifier Sign Date Collect sign dept. Collection sign Date 名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 6 页，共 10 页 - - - - - - - - - Catalogue 1.Summarize 2.Packing inspect

32、ion project 3.Contents of inspection in single package 4.Contents of inspection in over-package 5.Conclusion of inspection 6.Attachment documents 名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 7 页，共 10 页 - - - - - - - - - 1.Summarize The disposable Plastic Blood bags

33、 made by us are packed inner package with high temperature co-ex plastic bags which are made from PP-PET material. Mid-packing usually are adopted aluminum plastic. Based on the requirements from European CommunityMedical Device instruction (MDD93/42/EEC) and BP/CX-21-07, According to the requiremen

34、ts from EN868-1-Medical Device sterilized packing material and system-the first parts: the general requirements and inspect methods, with regard to our inner packing, we carry out the inspections in order to approve of measuring up the requirements of medical device instruction (MDD93/42/EEC). 2. In

35、spect project The inspect project is compiled by Technology Dept with collect signed by several of departments, and authorized by administer. 3. Inspect carrying into execution According to packing inspect project, we composed inspection groups to inspect items as following: 3.1Preliminary contamina

36、ted Inspection of single packing: Description and type: 250 ml triple bags, lot number 20030218, 20030219, and 20030220: Inspect reference: GB15980-1995 the disposable medical products hygiene standards Inspect results: measure up requirements Inspect reports: the reports about preliminary contamina

37、ted inspection of single packing 3.2 Non-ventilate inspection of single packing: Description and type: 250 ml triple bags, lot number 20030218, 20030219, and 20030220: Inspect reference: EN868-1-Medical Device sterilized packing material and system-the first parts: the general requirements and inspe

38、ct methods Inspect results: measure up requirements Inspect reports: the reports about non-ventilate inspection of single packing. 3.3 Prevent bacterium inspection of single packing: Description and type: 250 ml triple bags, lot number 20030218, 20030219, and 20030220: Inspect reference: EN868-1-Med

39、ical Device sterilized packing material and system-the first parts: the general requirements and inspect methods Inspect results: measure up requirements Inspect reports: the reports about prevent bacterium inspection of single packing: 3.4 Resistance to leakage inspection of single packing: Descrip

40、tion and type: 250 ml triple bags, lot number 20030218, 20030219, and 20030220: Inspect reference: EN868-1:1993 Plastic collapsible containers for human blood and blood components Inspect results: measure up requirements Inspect reports: the reports about Resistance to leakage inspection of single p

41、acking: 3.5 Biological compatibility inspection of single packing: Description and type: 250 ml triple bags, lot number 20030218, 20030219, and 20030220: Inspect reference: PRENAISO10993-1:1997 biological appraise of medical device Inspect results: measure up requirements Inspect reports: the report

42、s about biological compatibility inspection of single packing: 名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 8 页，共 10 页 - - - - - - - - - 3.6 Toxicity inspection of single packing Description and type: 250 ml triple bags, lot number 20030218, 20030219, and 20030220:

43、 Inspect reference: EN868-1:1993 Plastic collapsible containers for human blood and blood components Inspect results: measure up requirements Inspect reports: the reports about toxicity inspection of single packing: 3.7 Label system inspection of single packing Description and type: 250 ml triple ba

44、gs, lot number 20030218, 20030219, and 20030220: Inspect reference: EN868-1:1993 Plastic collapsible containers for human blood and blood components and package and symbol of medical device products. Inspect results: measure up requirements Inspect reports: the reports about Label system inspection

45、of single packing: 4. The inspection of over-package 4.1 Non-ventilate inspection of over-package: Lot number: 20030218, 20030219, 20030220: Inspect reference: EN868-1-Medical Device sterilized packing material and system-the first parts: the general requirements and inspect methods Inspect results:

46、 measure up requirements Inspect reports: the reports about non-ventilate inspection of over-package 4.2 Prevent bacterium inspection of over-package inspection of over-package: Lot number: 20030218, 20030219, 20030220: Inspect reference: EN868-1-Medical Device sterilized packing material and system

47、-the first parts: the general requirements and inspect methods Inspect results: measure up requirements Inspect reports: the reports about Prevent bacterium inspection of over-package 4.3 Agglutinate of seal inspection of over-package: Lot number: 20030218, 20030219, 20030220: Inspect reference: EN8

48、68-1-Medical Device sterilized packing material and system-the first parts: the general requirements and inspect methods Inspect results: measure up requirements Inspect reports: the reports about agglutinate of seal inspection of over-package: 4. Conclusion The packing material which packed the dis

49、posable products made by us measure up to the standards through above-mentioned inspections. it is conformed with European CommunityMedical Device instruction (MDD93/42/EEC.it also can meet the expected usage. 5.Appendix 1. Packing inspect project 2. Preliminary contaminated Inspection of single pac

50、king reports: 3. Non-ventilate inspection of single packing reports: 4. Prevent bacterium inspection of single packing reports: 5. Resistance to leakage inspection of single packing reports 6. Biological compatibility inspection of single packing reports. 7. Label system inspection of single packing