环氧乙烷灭菌再验证.pdf
《环氧乙烷灭菌再验证.pdf》由会员分享,可在线阅读,更多相关《环氧乙烷灭菌再验证.pdf(72页珍藏版)》请在咨信网上搜索。
1、 环氧乙烷灭菌再验证Periodical Verification of Ethylene Oxide Sterilization 目录Catalogue1.再验证计划Periodical Verification Plan2.再验证方案Periodical Verification Program3.再验证报告Periodical Verification Report4.再验证报告批准书Approval of Periodical Verification Report 1.概述General1.1 产品情况P roduct overview本灭菌过程是北京裕恒佳有限公司为其所生产的血管腔
2、内支架人工血管系统而建立。血 管腔内支架人工血管系统包括支架人工血管和与之相配合使用的送放器材。血管腔内支架人 工血管安装在送放器内,经介入方法将支架人工血管放置在人体血管病变部位,达到治疗的 目的。本产品按照我国医疗器械分类属HI类产品,本产品以无菌状态提供医疗机构进行治疗 应用。This sterilization process is specially instituted for the endovascular stent system manufactured by B eijing YuHengJia SciTech C o.Ltd.The endovascular stent
3、 system is comprised of the stent and the matched delivery system,the former of which is installed into the delivery system.Through intervention,the stent is deployed into the vascular lesions for treatment.As C ategory III product in accordance with the national classification of medical devices,th
4、is system has provided sterile to the medical institutions for treatment and application.1.2 灭菌工艺Sterilization Technology本公司采用环氧乙烷灭菌器对产品进行灭菌,以保障产品的无菌状态。灭菌柜经过一年 的使用,需要进行再次验证,以检验灭菌柜的性能是否依然满足设计要求,从而保障正常的 生产。同时,由于本公司的产品进行了重大改进,产品性能和外观变化较大,需要重新设计 装载方式及灭菌工艺。产品的部分部件对温度敏感,在高温下易出现形变并影响产品质量。因此本次灭菌工艺的设计主要以降低灭菌
5、温度为目的,其余变量为调节手段。O ur company performs sterilization on our products with ethylene oxide sterilizer to ensure that the products are sterile.After a year of service,the sterilizer has to undergo periodical verification to test whether the performance of the sterilizer satisfies the design requirements
6、 so as to guarantee normal manufacture.O n the same time,as significant improvement has happened to our products,the performance and appearance of the products have undergone great changes,which require new design of loading manners and sterilization technologies.C ertain components of our products
7、are sensitive to high temperature,under which deformation happens so as to influence the qualities of the products.Therefore,this sterilization technology is designed to reduce sterilization temperature,with other variants as regulative means.2验证目的P urpose of Verification确认系统的各种仪器仪表经过校正合格;To ensure
8、that all devices and apparatus are qualified after calibration;确认在规定的范围内操作,该系统能稳定地运行且各项指标能达到设计标准。To ensure that all operations all performed within nominal scope,that this system can operate steadily and all the indexes reach the design standards.3验证的有关人员及其职责Verification-Related Staff and Relevant R
9、esponsibilities姓名Name部门D epartment职责Responsibilities李潮Li C hao总I:C hief Engineer确认负责Validation ofresponsibilities王默然Wang Moran研发部 D evelopment D epartment确认设计 Validation ofdesign王思思Wang Sisi生产部 Manufacturing D epartment确认实施Validation ofimplementation崔娇娇C ui Jiaojiao质检部Quality Inspection D epartment确
10、认实施Validation ofimplementation4验证相关文件Verification-Related DocumentationsG B 1827 9医疗器械环氧乙烷灭菌确认和常规控制Medical devices-Ethylene O xide Sterilization-Validation and Routine C ontrolG B 1997 3.1医疗器械灭菌微生物学方法第1部分:产品上微生物总数的估计 Sterilization of Medical D evices-Microbiological Methods-P art 1:Estimation of the
11、 P opulation of Microorganisms on P roductG B 1997 3.2医疗器械灭菌微生物学方法第2部分:确认灭菌过程的无菌试验 Sterilization of medical devices-Microbiological methods一 P art 2:Tests of sterility performed in the validation of a sterilization processG B/T 14233.2-2005医用输液、输血、注射器具检验方法 第2部分:生物试验方法 Test methods for infusion,trans
12、fusion,injection equipments for medical use-P art 2:B iological test methods5验证内容Verification D etails5.1物理性能确认Validation of physical properties检测灭菌室温度均匀性、泄漏率、真空速率、加湿效果是否符合要求。To test whether the temperature uniformity,leakage rate,vacuum velocity and moist effect meet the requirements.5.2产品生物负载验证Ver
13、ification of bioburden on product 对产品初始生物负载确认,包括杂菌和真菌。The initial bioburden on product is verified,including bacteria and fungus.5.3性能验证P erformance verification5.3.1灭菌作用时间的确认Validation of sterilization exposure time5.3.1.1灭菌样品Sterilization samples灭菌样品为本公司生产的送放器内导管。样品的处理过程与产品生产过程一致。The sterilization
14、 samples are the catheters inside the delivery system produced by our company.The handling process of the samples is identical to the manufacturing process of the product.5.3.1.2生物指示物B iological indicators按照G B 18281.2医疗保健产品灭菌 生物指示物 第2部分:环氧乙烷灭菌生物指示物 的规定,采用枯草杆菌指示剂。In accordance with the provisions of
15、 Sterilization of heal th care products-Biological indicators-Part 2:Biological indicators for ethylene oxide sterilization processes,GB18281.2,the B acillus subtilis is chosen as the indicator.5.3.1.3微生物学性能确认Validation of microbial properties采用半周期法:在除时间外所有其他过程参数不变的情况下,确定无存活菌的环氧乙烷 最短作用时间。规定的灭菌作用时间应至
16、少为最短灭菌时间的2倍。为确定灭菌最短时间,应连续三次重复同一工艺参数,以证明工艺的可再现性。Half cycle method is employed.U nder the condition of constant parameters other than time,minimum exposure time of ethylene oxide with no live bacteria is determined.The sterilization exposure time shall be at least twice of the minimum sterilization ex
17、posure time.To determine the minimum exposure time,the same technological parameter shall be repeated for 3 consecutive times to ensure the reproducibility of the technology.5.3.2产品二次灭菌的确认Validation of periodical sterilization on the product本公司产品的有效期是根据包装有效作用时间进行确认的。在库房中常常有到期的产品 需要进行二次灭菌。因此,需要确定二次灭菌
18、对产品的影响。The validity period of our products is determined in accordance with the effective acting time of the packages.In the storehouse,the expired products often require periodical sterilization.Therefore,the effects of periodical sterilization on the products have to be determined.5.3.2.1灭菌产品Steri
19、le products灭菌产品为本公司生产的合格产品,在洁净间重新包装后,作为二次灭菌的产品。选用 的产品距上次灭菌时间不得超过1年。The sterile products are qualified products manufactured by our company,which will be taken as the re-sterilized products after repackaging in the clean area.The products chosen for this process shal1 be within one year from the prev
20、ious sterilization process.5.3.2.2二次灭菌确认Validation of periodical sterilization以产品环氧乙烷残留量解析时间、送放器断裂力、支架薄膜透水性和薄膜溶出物分析作 为指标,确定二次灭菌对产品的影响。应连续三次重复二次灭菌过程,以证明结果的有效性。The effects of periodical sterilization on the product are determined through the analyzing time of ethylene oxide sterilization residuals,the
21、 breaking force of the delivery system,the water permeability of the graft and the analysis of the extracts from the graft.The periodical sterilization process shall be repeated for 3 consecutive times to ensure the effectiveness of the results.北京裕恒佳科技有限公司 再验证方案Beijing Y uH eng|ia SciTech Co.Ltd Per
22、iodical Verification Program项目名称环氧乙烷灭菌P roject NameEthylene O xide Sterilization项目编号P roject No.EO-P R编制人王默然C ompilerWang Moran编制日期2007年11月2日C ompiling D ateNov 2,2007批准人李湘ApproverLi X iang批准日期2007年11月2日Approval D ateNov 2,20071灭菌器的描述D escriptions of the Sterilizer详细说明灭菌器的基本资料。包括:设备名称,设备型号,制造商,安装地点,
23、铭牌 数据。The fundamental materials of the sterilizer shall be so elaborated that the equipment name,equipment model,manufacturer,installation site,nameplate data should all be listed within.2仪器仪表检定Verification of Equipment and Apparatus在进行性能确认前,检查各控制仪表是否在校验的有效期内。检查仪表精度符合实际 要求。需检仪器要求如表2T所示。B efore the v
24、alidation of the performances,it should be checked whether all the apparatus are within the validity period of calibration so as to make sure that the precisions of the apparatus meet the requirements in practice.The apparatus to bp i nsppct.pd shal 1 meet the fol I owi ng requirements,whi ch can be
25、 referred to Table 2-1.表2-1仪器仪表检定内容Table 2-1 D etails of Verification of the Equipment and Apparatus仪器仪表名称Names of Equipment and Apparatus检定项目和要求Verification Items and Relevant Requirements3物理性能确认温度传感器(珀电阻)Temperature Sensor(P latinum resistor)温度测量范围应为0100,精度至少1%。The measurement range for temperatur
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- 环氧乙烷 灭菌 验证
1、咨信平台为文档C2C交易模式,即用户上传的文档直接被用户下载,收益归上传人(含作者)所有;本站仅是提供信息存储空间和展示预览,仅对用户上传内容的表现方式做保护处理,对上载内容不做任何修改或编辑。所展示的作品文档包括内容和图片全部来源于网络用户和作者上传投稿,我们不确定上传用户享有完全著作权,根据《信息网络传播权保护条例》,如果侵犯了您的版权、权益或隐私,请联系我们,核实后会尽快下架及时删除,并可随时和客服了解处理情况,尊重保护知识产权我们共同努力。
2、文档的总页数、文档格式和文档大小以系统显示为准(内容中显示的页数不一定正确),网站客服只以系统显示的页数、文件格式、文档大小作为仲裁依据,平台无法对文档的真实性、完整性、权威性、准确性、专业性及其观点立场做任何保证或承诺,下载前须认真查看,确认无误后再购买,务必慎重购买;若有违法违纪将进行移交司法处理,若涉侵权平台将进行基本处罚并下架。
3、本站所有内容均由用户上传,付费前请自行鉴别,如您付费,意味着您已接受本站规则且自行承担风险,本站不进行额外附加服务,虚拟产品一经售出概不退款(未进行购买下载可退充值款),文档一经付费(服务费)、不意味着购买了该文档的版权,仅供个人/单位学习、研究之用,不得用于商业用途,未经授权,严禁复制、发行、汇编、翻译或者网络传播等,侵权必究。
4、如你看到网页展示的文档有www.zixin.com.cn水印,是因预览和防盗链等技术需要对页面进行转换压缩成图而已,我们并不对上传的文档进行任何编辑或修改,文档下载后都不会有水印标识(原文档上传前个别存留的除外),下载后原文更清晰;试题试卷类文档,如果标题没有明确说明有答案则都视为没有答案,请知晓;PPT和DOC文档可被视为“模板”,允许上传人保留章节、目录结构的情况下删减部份的内容;PDF文档不管是原文档转换或图片扫描而得,本站不作要求视为允许,下载前自行私信或留言给上传者【曲****】。
5、本文档所展示的图片、画像、字体、音乐的版权可能需版权方额外授权,请谨慎使用;网站提供的党政主题相关内容(国旗、国徽、党徽--等)目的在于配合国家政策宣传,仅限个人学习分享使用,禁止用于任何广告和商用目的。
6、文档遇到问题,请及时私信或留言给本站上传会员【曲****】,需本站解决可联系【 微信客服】、【 QQ客服】,若有其他问题请点击或扫码反馈【 服务填表】;文档侵犯商业秘密、侵犯著作权、侵犯人身权等,请点击“【 版权申诉】”(推荐),意见反馈和侵权处理邮箱:1219186828@qq.com;也可以拔打客服电话:4008-655-100;投诉/维权电话:4009-655-100。