包装印刷packing inspect project(英文版)

n更多企业学院： 中小企业管理全能版183套讲座+89700份资料总经理、高层管理49套讲座+16388份资料中层管理学院46套讲座+6020份资料国学智慧、易经46套讲座人力资源学院56套讲座+27123份资料各阶段员工培训学院77套讲座+ 324份资料员工管理企业学院67套讲座+ 8720份资料工厂生产管理学院52套讲座+ 13920份资料财务管理学院53套讲座+ 17945份资料销售经理学院56套讲座+ 14350份资料销售人员培训学院72套讲座+ 4879份资料XXX Group Corp.Medical Polymer products Co., LTD Packing inspect projectName: the arts and crafts inspection of packingDocuments serial No: VP-002draftsmanexamine and approveratifierSignDateCollect sign dept.Collection sign Date Catalogue1. Purpose2. Context of inspection3. Results analysis and appraise4. Final approval5. Organization of inspection6. Duty and divide the work1. 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 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 inner packing, we carry out the inspections in order to approve of measuring up the requirements of medical device instruction(MDD93/42/EEC).2. Inspect contentsThe 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 general 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 inspection of single packing:5) Biological compatibility inspection of single packing:6) Toxicity inspection of single packing7) Label system inspection of single packing1)Preliminary contaminated Inspection of single packing: omnivorously holding samples 10 PCS( triple bags 250ml with lot ,) 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-the 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 lot , , and 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 conveniently after sterilization with lot , , and 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 single packing: take out 5 pieces conveniently with lot , , and 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 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 by pressing the plastic container against sheets of blue litmus paper and observing the development of pink spots on the paper. The detail information refers to ISO3826:1993 plastic collapsible containers for human blood and blood components.5) Biological compatibility inspection of single packing: take out 5 pieces conveniently after sterilization with lot , , and and send to inspect center.The methods of experiments refer to ISO10993-1:1997 biological appraise of medical device the first part: appraise and test.6) Toxicity inspection of single packing: take out 5 pieces conveniently after sterilization with lot , , and and send to inspect center. The method of experiments refers to ISO3826:1993 plastic collapsible containers for human blood and blood components.7) Label system inspection of single packingTake out 5 pieces conveniently label stuck with lot , , , inspect one by one according to EN980 package and symbol of medical polymer products including:(1) General demandsa) The symbol indicated on package should be instruct to shipments, storage, tearing open and usageb) 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 packing 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 packinga) Products name. style or specificationb) The manufacture name, address and brandsc) Production lot or date:d) “non-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 inspection1. 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 material, we carry out the inspections as following:1) Non-ventilate inspection of single packing:2) Prevent bacterium inspection of single packing:3) Agglutinate of seal inspection of single 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 , , 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 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 , , 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) 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 , , 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 agglutinate of seal inspection of single packing:Groups ParameterSeal temperatureConvey speed1200High2210High3220High . 3.The final 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 organization4.1 Inspection principal: Cheng Yunliang Workshop member: Zhang Yanhong Dong Lujing Dou XiaojieManufacture departments member: Tian Xuefei Zhao Zhendong Li Xiouying Zhang Cuiyan4.2 Duty and divide the workWorkshop: charge the records of process of production; strictly control the process of productionManufacture departments: harmonize and do correspondent documents in the process of inspection.5.Works schedule: In vision, the work will be finished in Mar, 2003.XXX Group Corp.Medical Polymer products Co., LTD Packing inspect reportsName: the arts and crafts inspection of packingDocuments serial No: VP-002draftsmanexamine and approveratifierSignDateCollect sign dept.Collection sign Date Catalogue1. Summarize2. Packing inspection project3. Contents of inspection in single package4. Contents of inspection in over-package5. Conclusion of inspection6. Attachment documents1. SummarizeThe disposable Plastic Blood bags 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 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 (MDD93/42/EEC).2. Inspect projectThe inspect project is compiled by Technology Dept with collect signed by several of departments, and authorized by administer.3. Inspect carrying into executionAccording to packing inspect project, we composed inspection groups to inspect items as following:3.1Preliminary contaminated Inspection of single packing:Description and type: 250 ml triple bags, lot number , , and :Inspect reference: GB15980-1995 the disposable medical products hygiene standards Inspect results: measure up requirements Inspect reports: the reports about preliminary contaminated inspection of single packing3.2 Non-ventilate inspection of single packing:Description and type: 250 ml triple bags, lot number , , and :Inspect reference: EN868-1-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 non-ventilate inspection of single packing.3.3 Prevent bacterium inspection of single packing:Description and type: 250 ml triple bags, lot number , , and :Inspect reference: EN868-1-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 prevent bacterium inspection of single packing:3.4 Resistance to leakage inspection of single packing:Description and type: 250 ml triple bags, lot number , , and :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 packing:3.5 Biological compatibility inspection of single packing:Description and type: 250 ml triple bags, lot number , , and :Inspect reference: PRENAISO10993-1:1997 biological appraise of medical deviceInspect results: measure up requirementsInspect reports: the reports about biological compatibility inspection of single packing:3.6 Toxicity inspection of single packingDescription and type: 250 ml triple bags, lot number , , and :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 packingDescription and type: 250 ml triple bags, lot number , , and :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 of single packing:4. The inspection of over-package4.1 Non-ventilate inspection of over-package:Lot number: , , :Inspect reference: EN868-1-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 non-ventilate inspection of over-package4.2 Prevent bacterium inspection of over-package inspection of over-package:Lot number: , , :Inspect reference: EN868-1-Medical Device sterilized packing material