XXXX医疗器械有限公司验证报告
验证报告名称： 验证报告编号： 验证完成日期： 有 效 期：
验证报告申请人: 签字日期: 年
验证报告审批人: 签字日期: 年 日
日
月 月
验 证 方 案 审 批 表
验证小组成员名单
环氧乙烷灭菌过程验证方案
一、验证目的：
1. 20 m3环氧乙烷灭菌器灭菌工艺的验证（首次验证），按照规定的程序评价灭菌周期所采用的
工艺技术参数是否达到要求 二、验证小组人员组成：
1.组长：（结果批准） 2.组员：（操作员）、（生产安排）、 （设备管理）、厂家工程师、（确认实施）、微生物试验） 三、验证依据
GB18279-2000 医疗器械 环氧乙烷灭菌确认与常规控制 GB18282-2000 医疗保健产品灭菌 化学指示物 GB18281.1-2000 环氧乙烷灭菌用生物指示物 GB/T19633-2005 最终灭菌医疗器械的包装
GB15980-1995 一次性使用医疗用品卫生标准
ISO11135-1 ：2007 医疗器械灭菌过程开发、确认和常规控制要求 ISO11135-2：2008 ISO11135-1应用指南
四、验证产品名称：
详见附录1产品信息（包装/体积/密度） 五、验证过程 （一） 验证对象
对我公司新购置的20 m3环氧乙烷灭菌器进行首次确认。其中包括灭菌柜的安装确认IQ、灭菌柜的操作鉴定OQ、环氧乙烷灭菌工艺确认PQ
验证内容
1. 基准被灭菌物品的选择与确定 2. 验证前的准备工作 3. 菌柜的安装确认IQ 4. 灭菌柜的操作鉴定OQ 5. 环氧乙烷灭菌工艺确认PQ 6. 验证过程中的审核；
7. 验证报告、作业文件的批准； 8. 验证方案及验证数据
基准被灭菌物品的选择与确定
一、定义：
规定的被灭菌物品，接近于可代表最难达到灭菌的产品组合。（GB18279-2000-3.20） 二、选择基准：
选取一种产品作为基准灭菌物品，以此种产品满载模式作为验证时的装载模式。 本次验证选取麻醉包满载的模式做为验证时的装载模式。理由有以下几点：
1、产品构造复杂，配件中有医用高分子类产品、玻璃制品以及织物类产品等 2、麻醉包为双层塑盒包装
3、麻醉包为本公司批量生产较大的三类产品，相对于其它产品，风险较大
因此麻醉包满载可视为最难达到灭菌的产品组合，选取其作为基准被灭菌物品。 （制作IPCD时把菌片放入最难灭菌的玻璃注射器内） 三、产品分析：详见附录1产品信息（包装/体积/密度） 按主要原材料分： 1、按包装形式分： 外包装： 单包装：
2、残留量分析： 四、对比结果：
1、包装型式、材料对灭菌剂的阻隔性： 2、医疗器械风险分析分类： 3、解析困难程度：
五、结论：
综合以上因素，选择麻醉包产品作为本次灭均确认的基准被灭菌物品。麻醉包满载的装载方式可代表其余产品的任何方式的混合装载。
环氧乙烷灭菌工艺验证时间计划
1. 环氧乙烷灭菌验证人员资格确认
灭菌柜的安装鉴定
Installation Qualification of Sterilization
根据ISO11135-1：2007和GB18279-2000标准(《医疗器械的灭菌――环氧乙烷灭菌的验证及日常控制》)的要求，对灭菌柜进行有效的安装鉴定，证明灭菌柜有效的完成了安装过程，并可正常投入运行，满足ISO11135-1：2007的要求。
According to ISO11135-1：2007 and the standard of GB18279-2000 (Medical devices –Validation and routine control of ethylene oxide sterilization) requirements, did the effective IQ of sterilization chamber, to demonstrate that the sterilization chamber had been finished the effective installation process, and can run normally, meet the requirements of ISO11135-1：2007.
在做灭菌柜的安装鉴定时，主要做以下三方面的鉴定：
There are three qualification items of IQ of sterilization chamber:
1. 系统安装的检查：检查设备是否安装正确、是否符合设计的要求，是否能正常工作。
System installation check: check the correctness of the equipment and the design of equipment is right or wrong and can run or not.
2.资料收集：安装测试前，要保证所有设备资料和仪表校正证书都应具有，并收集起来、妥善保管。（见附1 仪器校准确认）
Information collect: make sure we have all documents and calibration certificates, collect and appropriate storage before doing the installation test.
3.安装测试：测试设备的具体功能是否能够正常使用，能否达到规定的要求。
Installation test: test the equipment detail function can use normally or not, and whether fits the regulate requirement.
3.1系统安装的检查System installation check: 3.1.1安装的正确性The correctness of installation
Performed by:
Verified by:
1.2安装的完整、准确性The integrality and veracity of installation
Performed by:
Verified by:
1.3电器控制系统安装Electric controlling system installation
Performed by: Verified by:
1.4计算机系统安装Computer system installation
Performed by:
Verified by:
2.资料收集Information collect:
2.1设备相关文件资料收集Collect all interrelated documents:
2.2仪表证书收集Collect all calibration certificates
Performed by:
Verified by:
3.安装测试Installation test:
3.1辅助设备的运行测试A．ssistant equipment r．．．．．．．．．．．．．．．．．．u．n test．．．．．
Performed by:
Verified by:
3.2计算机系统的运行测试Computer system run test
Performed by:
Verified by:
结论：经过安装鉴定，灭菌柜及各个辅助部件（真空系统、循环系统、加热系统、压缩空气系统、电器控制系统，蒸气系统）资料均齐备、正确安装、系统位置准确，设备设计图纸、技术资料及相关资料齐全；符合ISO11135-1:2007的要求，仪表校正证书见附件1。
Conclusion：After finishing the installation qualification, the sterilization chamber and each assistant part’s (vacuum system, cycle system, heating system, compress air system, electric controlling system, steam system) documents are complete and install correctly, system position nicety, the blueprint of equipment, technique documents and interrelated documents also are collected, and it meets the requirements of 5.2 of ISO11135-1994, the calibration certificates as follows attachment 1.
Prepared By: __________________________________________ Date: ___________
ETO Sterilization Process Engineer
Accepted By: ___________________________________________ Date: ___________
ETO Sterilization Assurance Engineer
Accepted By: ____________________________________________Date: ___________
Sterilization Manager3
附件1
灭菌柜的操作鉴定
Operational Qualification of Sterilization
根据ISO11135-1:2007和GB18279-2000标准(《医疗器械的灭菌――环氧乙烷灭菌的验证及日常控制》)的要求，对灭菌柜进行有效的操作鉴定，证明安装过程的有效性，设备可正常投入运行，并满足ISO11135-1:2007的要求。
According to ISO11135-1:2007 and the standard of GB18279-2000 (Medical devices –Validation and routine control of ethylene oxide sterilization) requirements, did the effective OQ of sterilization chamber, to demonstrate that installation process of the sterilization chamber is effective, the equipment can run normally, and meet the requirements of ISO11135-1:2007.
在做灭菌柜的操作鉴定时，主要做以下五方面的鉴定：
There are five qualification items of OQ of sterilization chamber:
1. 真空速率测试：通过抽真空，设定参数来计算真空速率大小。
Vacuum speed test: to calculate the vacuum speed by setting vacuum parameter during the vacuum process.
2. 压力泄露测试：通过在负压和正压下进行保压，来观察和计算柜体的泄露速率。
Pressure leak test: to observe and calculate the leak speed of chamber by keeping pressure during the subatmospheric and superatmospheric process.
3. 温度均匀性测试：确定整个灭菌区域内的温度监测分布点数，来测试灭菌柜的温度均匀性。
Temperature uniformity test: to determine the temperature in a number of locations distributed throughout the sterilization area to test the temperature uniformity of sterilization chamber.
4. 湿度测试：通过给灭菌柜加湿来证明加湿系统工作的有效性和计算湿度与压力的变化关系。
Humidity test: to determine the validity of humidity injection system and calculate the variety relation between humidity and pressure by injecting humidity into the sterilization chamber.
详细内容如下：
Particular content as follows:
1真空速率测试Vacuum speed test
1.1设置抽真空参数-50KP，记录达到各个参数值所用的时间，计算真空速率。
Set the vacuum parameter -50KP， record the time that reach to the setting parameters, and calculate the vacuum speed.
1.2 物理参数运行结果The run results of physical parameters
1.3 数据记录见附件1
The data record as follows attachment 1.
Performed by:
Verified by
2压力泄露测试Pressure leakage test 2．1根据ISO11135-1:2007，.做柜体负压和正压的泄露测试；设定负压为-50KP，保压60分钟；正压50KP，保压60分钟，观察并计算在保压阶段内的泄露速率。
Accords with the requirements of ISO11135-1:2007, do the leak test of the chamber during the subatmospheric and superatmospheric process; subatmospheric: -50KP, keep pressure 60mins; superatmospheric: 50KP, keep pressure 60mins, observe and calculate the leak speed of the sterilization chamber of the keeping pressure process.
2．2物理参数运行结果The run results of physical parameters
The data record as follows attachment 7.
Performed by:
Verified by
3温度均匀性测试Temperature uniformity test
3.1内壁温度均匀性Inner wall temperature uniformity
3．1．.1根据ISO11135-1：2007，在空载的条件下小于和等于1 m3的灭菌柜，需要3个温度传感器来监测灭菌柜的温度，大于3m3的灭菌柜，每增加1 m3，增加1个温度传感器； 1 m3至少需要使用3个温度传感器来监测灭菌柜的温度（实际上使用20个温度传感器），温度传感器的放置图见附件3。
Accords with the requirements of ISO11135-1：2007, the volume of sterilization chamber is no more than 1 m3, should use 3ea temperature sensors to monitor the sterilization chamber temperature, add a minimum of one temperature sensor for adding 3m3 of sterilization chamber if the chamber volume is more than 1 m3 during the empty loading condition; and it need 3ea temperature sensors at least to
monitor the sterilization chamber temperature of 1 m3 sterilization chamber (in fact, we used 20ea temperature sensors), the temperature sensor placement diagram, please see the attachment 4.
3.1.2设定灭菌温度50℃，并记录分析数据。
Set the sterilization temperature 50℃, record and analyze data. 3.1.3 物理参数运行结果 The run results of physical parameters 3.1.4 数据记录及温度趋势图，灭菌数据及趋势图见附件2
Data and temperature trend, sterilization data and trend as follows attachment 2 2.2.5 通过操作鉴定，灭菌柜内壁温度均匀性较好。
The inner wall temperature uniformity of sterilization chamber is good by the operational qualification.
Performed by:
Verified by
灭菌室箱壁温度均匀性确认
附件2
灭菌室箱壁温度均匀性布点示意图
附件3
3.2空间温度均匀性Space temperature uniformity
3.2.1根据ISO11135-1:2007，.在空载的条件下小于和等于3 m3的灭菌柜，需要3个温度传感器来监测灭菌柜的温度，大于3m3的灭菌柜，每增加1 m3，增加1个温度传感器； 20m3至少需要使用20个温度传感器来监测灭菌柜的温度（实际上使用20个温度传感器），温度传感器的放置图见附件5。
Accords with the requirements of ISO11135-1:2007, the volume of sterilization chamber is no more than 3 m3, should use 3 ea temperature sensors to monitor the sterilization chamber temperature, add a minimum of one temperature sensor for adding 20m3 of sterilization chamber if the chamber volume is more than 5 m3 during the empty loading condition; and it need 20ea temperature sensors at least to monitor the sterilization chamber temperature of 1m3 sterilization chamber (in fact, we used 20ea temperature sensors), the temperature sensor placement diagram, please see the attachment 5.
3.2.2设定灭菌温度50℃，并记录分析数据。
Set the sterilization temperature 50℃, record and analyze data.
3.2.3 物理参数运行结果 The run results of physical parameters
3.2.4 数据记录及温度趋势图，灭菌数据及趋势图见附件4。
Data and temperature trend, sterilization data and trend as follows attachment 4.
3.2.5通过操作鉴定，灭菌柜空间温度均匀性较好。
The space temperature uniformity of sterilization chamber is good by the operational qualification.
Performed by:
Verified by
灭菌室空间温度均匀性确认
灭菌室空间温度均匀性布点示意图
附件5
4.湿度测试Humidity uniformity:
4.1 在温度为的条件下，给灭菌柜加湿，记录湿度从30%RH升到80%RH的压力变化。并保持一段时间，检测湿度均匀性，温度传感器的放置图见附件6
Inject humidity into the sterilization chamber when the temperature of chamber is and pressure is , record the pressure variety when the humidity rises from 30%RH to 80%RH.. record and analyze data，the Humidity sensor placement diagram, please see the attachment 6. 4.2 物理参数运行结果The run results of physical parameters 年 月 日
附件6
灭菌室湿度测试布点示意图
Performed by:
Verified by
环氧乙烷灭菌工艺确认
PQ of Sterilization Chamber Of ETO Department
根据ISO11135-1:2007和GB18279-2000标准《(医疗器械的灭菌――环氧乙烷灭菌的验证及日常控制》)的要求，对灭菌柜进行工艺鉴定，证明工艺有效，并满足ISO11135-1:2007的要求。
According to ISO11135-1:2007 and the standard of GB18279-2000 (Medical devices –Validation and routine control of ethylene oxide sterilization) requirements, did the effectivePQ of sterilization chamber, the equipment can run normally, and meet the requirements of ISO11135-1:2007.
1灭菌实施方案针对新的EO灭菌罐进行如下确认：
Project in allusion to new Sterilization as follows
微生物运转性能合格性确认以表明灭菌工艺满足产品的灭菌要求。
BI test met the Sterilization requirements
1.1负载温度/湿度均匀性确认
Temperature/Humidity uniformity test 实施1次test 1
● 产品装载状态下的温度分布测定，最高温度与最低温度差在10℃以内
The run results temperature
1.2微生物性能的确认BI test
验证方法：Validation method
⑴ 半时循环法half cycle test：
本方法是在除时间外所有其它过程参数不变情况下，确定无存活菌的EO最短作用时间,应再重复1次实验来证实该最短灭菌时间，两次实验均应表明生物指示剂上无菌生长。规定作用时间应至少为最短灭菌时间的2倍。
This method is that keeping all parameters in same condition except time; ensure that after the shortest EO sterilization time, no bacteria survive, and repeat once same test to certify thisshortest sterilization time. 2 times test should show that there are no bacteria in BI. Accordingto regulation the normal sterilization time should be at least 2 times of the shortest sterilization time.
⑵按上述灭菌工艺进行验证，生物指示剂全为阴性，重复两次。
Follow above sterilization techniques to do the validation, BI are negative. Repeat twice. ⑶ 亚致死周期试验sub lethal cycle test ：按前面得到的验证参数，其中灭菌时间缩短为60/120分 钟（A/B）进行亚致死周期试验，当生物指示剂部分为阴性，试验完成。
According to above validationparameters, reduce the sterilization time to be 60/120 mins for sub lethal cycle test, when some of BI showed negative, test is finished. ⑷ 全周期试验Full cycle test：按前面得到的验证参数进行全周期试验。 Follow above validation parameters to do full cycle test.
验证和结论Validation and result
2、负载温度/湿度均匀性确认Temperature/Humidity validation when products is in chamber
2.1.1根据ISO11135-2007，.在负载的条件下小于和等于3 m3的灭菌柜，需要3个温度传感器来监测灭菌柜的温度，大于3 m3的灭菌柜，每增加1 m3，增加1个温度传感器；20m3的灭菌柜至少需要使用20个温度传感器8个湿度传感器来监测灭菌柜的温度（实际上使用20个温度传感器8个湿度传感器），温度传感器的放置图见附件1。
Accords with the requirements of ISO11135-2007, the volume of sterilization chamber is no more than 3 m3, should use 3ea temperature sensors to monitor the sterilization chamber temperature, add a minimum of one temperature sensor for adding 1m3 of sterilization chamber if the chamber volume is more than 3 m3 during the empty loading condition; and it need 3ea temperature sensors at least to monitor the sterilization chamber temperature of 20 m3 sterilization chamber (in fact, we used 20ea temperature sensors), the temperature sensor placement diagram, please see the attachment1.
2.1.2设定灭菌温度 ℃，并记录分析数据。
Set the sterilization temperature ℃, record and analyze data.
2.1.3 物理参数运行结果 The run results of physical parameters(A) 1st
灭菌室负载温度均匀性试验确认表
2.1.4 数据记录及温度/湿度趋势图，灭菌数据及趋势图见附件2。
Data and temperature trend, sterilization data and trend as follows attachment 2
2.1.5 通过操作鉴定，灭菌柜负载温度均匀性较好。
The space temperature uniformity of sterilization chamber is good by the operational qualification. Performed by:
Verified by：
灭菌室负载温度均匀性验证温度传感器布点图示意图
Drawing about distribution of temperature sensors for
temperature uniformity validation in autoclave
图1
3微生物性能确认BI Validation
对环氧乙烷灭菌设备在灭菌周期中的灭菌工艺及灭菌过程的有效性进行确认。
Validation of biological performance is the validation of validity of sterilization process with autoclave in sterilization cycle.
3．1 根据IS011135-1:2007标准，在进行微生物性能确认时，采用对环氧乙烷具有较强耐药性的枯草杆菌作为灭菌指示剂，其原始微生物含量为 cfu；在预热阶段开始前，按均匀分布原则，将40片灭菌指示剂安放在灭菌负载中，其分布方式如附件2所示。
According to ISO11135-1:2007, Atcc7372, which is strong against ETO gas, is used as our biological indicator during the validation of biological performance. The original biological organism content is cfu. Before preheated process, according to uniformity distribution rule, we put 40pc BI into the chamber, the distribution drawing is in attached document 2.
根据灭菌负载的产品构造、包装形式及其在灭菌器内的分布方式，确定微生物性能确认时的相关灭菌工艺如下：According to products structure, package form and distribution in the
chamber, we decide the relative sterilization techniques as following:
产品 Product
灭菌工序的灭菌Sterilization process condition
Performed by:
Verified by
3．2．1 为证明灭菌过程的有效性，采用半周期法，在保持上述灭菌工艺不变的条件下，
将灭菌作用时间进行变化，并将不同灭菌作用时间的灭菌指示剂在无菌环境下进行培养，按培养后灭菌指示剂有无细菌生长的结果作为对灭菌过程及灭菌工艺有效性的评判。详细数据如表一所示：To certify the validity of sterilization process, we use half cycle method; keep
above sterilization techniques, change sterilization time, and culture BI which is used in different sterilization time in sterile environment, after that evaluating the validity of
sterilization techniques according to the result if BI has bacteria or not after cultivation. For details please see table 1.
表一Table 1
(生物指示物长菌时间记录见附件3)
(BI bacteria appearance record see attached document 3)
从表一的结果可以说明：在上述灭菌工艺参数下，在灭菌负载的产品构造、包装形式
及负载分布形式保持不变的条件下,灭菌过程是有效的；灭菌作用的临界时间（最短有效灭菌时间）为 min。
From the result of table 1, in these sterilization parameters, if the product structure, package form and load distribution keep in the same conditions, the sterilization process is validity. The sterilization critical time for this product (shortest effective sterilization time)
is 180mins.
综上所述，经过对本套20ｍ
3
环氧乙烷灭菌器进行交付试验和性能确认后，全套设备的
验证结果和验证过程符合ISO11135-1:2007。
To summarized, after validating this autoclave (20m3) about installation,
operation and performance validation, this autoclave validation process and result are accordance with ISO11135-1:2007.
另：采用表一微生物性能确认取得的数据，按照半时循环法，由此推荐产品灭菌作用时间为 min，以确保灭菌有效性。
Additionally, this result is got from half cycle method; we recommend for product A, the sterilization time is mins for total cycle to guarantee the validity sterilization.
3．2．2为证明灭菌过程的有效性，采用半周期法，在保持上述灭菌工艺不变的条件下，将灭菌作用时间进行变化，并将不同灭菌作用时间的灭菌指示剂在无菌环境下进行培养，按培养后灭菌指示剂有无细菌生长的结果作为对灭菌过程及灭菌工艺有效性的评判。详细数据如表二所示：
To certify the validity of sterilization process, we use half cycle method; keep above
sterilization techniques, change sterilization time, and culture BI which is used in different sterilization time in sterile environment, after that evaluating the validity of sterilization techniques according to the result if BI has bacteria or not after cultivation. For details please see table 2.
IPCD布点图
图2
附件3 Attachment 3
生物指示物长菌时间记录
BI record
灭菌工艺确认
XXXX医疗器械有限公司 特殊工序验证资料——环氧乙烷灭菌验证
记录号：HS/CQ1202-2 格式批准： 批准日期：2010.01.03 保存年限：5年
34
XXXX医疗器械有限公司验证报告
验证报告名称： 验证报告编号： 验证完成日期： 有 效 期：
验证报告申请人: 签字日期: 年
验证报告审批人: 签字日期: 年 日
日
月 月
验 证 方 案 审 批 表
验证小组成员名单
环氧乙烷灭菌过程验证方案
一、验证目的：
1. 20 m3环氧乙烷灭菌器灭菌工艺的验证（首次验证），按照规定的程序评价灭菌周期所采用的
工艺技术参数是否达到要求 二、验证小组人员组成：
1.组长：（结果批准） 2.组员：（操作员）、（生产安排）、 （设备管理）、厂家工程师、（确认实施）、微生物试验） 三、验证依据
GB18279-2000 医疗器械 环氧乙烷灭菌确认与常规控制 GB18282-2000 医疗保健产品灭菌 化学指示物 GB18281.1-2000 环氧乙烷灭菌用生物指示物 GB/T19633-2005 最终灭菌医疗器械的包装
GB15980-1995 一次性使用医疗用品卫生标准
ISO11135-1 ：2007 医疗器械灭菌过程开发、确认和常规控制要求 ISO11135-2：2008 ISO11135-1应用指南
四、验证产品名称：
详见附录1产品信息（包装/体积/密度） 五、验证过程 （一） 验证对象
对我公司新购置的20 m3环氧乙烷灭菌器进行首次确认。其中包括灭菌柜的安装确认IQ、灭菌柜的操作鉴定OQ、环氧乙烷灭菌工艺确认PQ
验证内容
1. 基准被灭菌物品的选择与确定 2. 验证前的准备工作 3. 菌柜的安装确认IQ 4. 灭菌柜的操作鉴定OQ 5. 环氧乙烷灭菌工艺确认PQ 6. 验证过程中的审核；
7. 验证报告、作业文件的批准； 8. 验证方案及验证数据
基准被灭菌物品的选择与确定
一、定义：
规定的被灭菌物品，接近于可代表最难达到灭菌的产品组合。（GB18279-2000-3.20） 二、选择基准：
选取一种产品作为基准灭菌物品，以此种产品满载模式作为验证时的装载模式。 本次验证选取麻醉包满载的模式做为验证时的装载模式。理由有以下几点：
1、产品构造复杂，配件中有医用高分子类产品、玻璃制品以及织物类产品等 2、麻醉包为双层塑盒包装
3、麻醉包为本公司批量生产较大的三类产品，相对于其它产品，风险较大
因此麻醉包满载可视为最难达到灭菌的产品组合，选取其作为基准被灭菌物品。 （制作IPCD时把菌片放入最难灭菌的玻璃注射器内） 三、产品分析：详见附录1产品信息（包装/体积/密度） 按主要原材料分： 1、按包装形式分： 外包装： 单包装：
2、残留量分析： 四、对比结果：
1、包装型式、材料对灭菌剂的阻隔性： 2、医疗器械风险分析分类： 3、解析困难程度：
五、结论：
综合以上因素，选择麻醉包产品作为本次灭均确认的基准被灭菌物品。麻醉包满载的装载方式可代表其余产品的任何方式的混合装载。
环氧乙烷灭菌工艺验证时间计划
1. 环氧乙烷灭菌验证人员资格确认
灭菌柜的安装鉴定
Installation Qualification of Sterilization
根据ISO11135-1：2007和GB18279-2000标准(《医疗器械的灭菌――环氧乙烷灭菌的验证及日常控制》)的要求，对灭菌柜进行有效的安装鉴定，证明灭菌柜有效的完成了安装过程，并可正常投入运行，满足ISO11135-1：2007的要求。
According to ISO11135-1：2007 and the standard of GB18279-2000 (Medical devices –Validation and routine control of ethylene oxide sterilization) requirements, did the effective IQ of sterilization chamber, to demonstrate that the sterilization chamber had been finished the effective installation process, and can run normally, meet the requirements of ISO11135-1：2007.
在做灭菌柜的安装鉴定时，主要做以下三方面的鉴定：
There are three qualification items of IQ of sterilization chamber:
1. 系统安装的检查：检查设备是否安装正确、是否符合设计的要求，是否能正常工作。
System installation check: check the correctness of the equipment and the design of equipment is right or wrong and can run or not.
2.资料收集：安装测试前，要保证所有设备资料和仪表校正证书都应具有，并收集起来、妥善保管。（见附1 仪器校准确认）
Information collect: make sure we have all documents and calibration certificates, collect and appropriate storage before doing the installation test.
3.安装测试：测试设备的具体功能是否能够正常使用，能否达到规定的要求。
Installation test: test the equipment detail function can use normally or not, and whether fits the regulate requirement.
3.1系统安装的检查System installation check: 3.1.1安装的正确性The correctness of installation
Performed by:
Verified by:
1.2安装的完整、准确性The integrality and veracity of installation
Performed by:
Verified by:
1.3电器控制系统安装Electric controlling system installation
Performed by: Verified by:
1.4计算机系统安装Computer system installation
Performed by:
Verified by:
2.资料收集Information collect:
2.1设备相关文件资料收集Collect all interrelated documents:
2.2仪表证书收集Collect all calibration certificates
Performed by:
Verified by:
3.安装测试Installation test:
3.1辅助设备的运行测试A．ssistant equipment r．．．．．．．．．．．．．．．．．．u．n test．．．．．
Performed by:
Verified by:
3.2计算机系统的运行测试Computer system run test
Performed by:
Verified by:
结论：经过安装鉴定，灭菌柜及各个辅助部件（真空系统、循环系统、加热系统、压缩空气系统、电器控制系统，蒸气系统）资料均齐备、正确安装、系统位置准确，设备设计图纸、技术资料及相关资料齐全；符合ISO11135-1:2007的要求，仪表校正证书见附件1。
Conclusion：After finishing the installation qualification, the sterilization chamber and each assistant part’s (vacuum system, cycle system, heating system, compress air system, electric controlling system, steam system) documents are complete and install correctly, system position nicety, the blueprint of equipment, technique documents and interrelated documents also are collected, and it meets the requirements of 5.2 of ISO11135-1994, the calibration certificates as follows attachment 1.
Prepared By: __________________________________________ Date: ___________
ETO Sterilization Process Engineer
Accepted By: ___________________________________________ Date: ___________
ETO Sterilization Assurance Engineer
Accepted By: ____________________________________________Date: ___________
Sterilization Manager3
附件1
灭菌柜的操作鉴定
Operational Qualification of Sterilization
根据ISO11135-1:2007和GB18279-2000标准(《医疗器械的灭菌――环氧乙烷灭菌的验证及日常控制》)的要求，对灭菌柜进行有效的操作鉴定，证明安装过程的有效性，设备可正常投入运行，并满足ISO11135-1:2007的要求。
According to ISO11135-1:2007 and the standard of GB18279-2000 (Medical devices –Validation and routine control of ethylene oxide sterilization) requirements, did the effective OQ of sterilization chamber, to demonstrate that installation process of the sterilization chamber is effective, the equipment can run normally, and meet the requirements of ISO11135-1:2007.
在做灭菌柜的操作鉴定时，主要做以下五方面的鉴定：
There are five qualification items of OQ of sterilization chamber:
1. 真空速率测试：通过抽真空，设定参数来计算真空速率大小。
Vacuum speed test: to calculate the vacuum speed by setting vacuum parameter during the vacuum process.
2. 压力泄露测试：通过在负压和正压下进行保压，来观察和计算柜体的泄露速率。
Pressure leak test: to observe and calculate the leak speed of chamber by keeping pressure during the subatmospheric and superatmospheric process.
3. 温度均匀性测试：确定整个灭菌区域内的温度监测分布点数，来测试灭菌柜的温度均匀性。
Temperature uniformity test: to determine the temperature in a number of locations distributed throughout the sterilization area to test the temperature uniformity of sterilization chamber.
4. 湿度测试：通过给灭菌柜加湿来证明加湿系统工作的有效性和计算湿度与压力的变化关系。
Humidity test: to determine the validity of humidity injection system and calculate the variety relation between humidity and pressure by injecting humidity into the sterilization chamber.
详细内容如下：
Particular content as follows:
1真空速率测试Vacuum speed test
1.1设置抽真空参数-50KP，记录达到各个参数值所用的时间，计算真空速率。
Set the vacuum parameter -50KP， record the time that reach to the setting parameters, and calculate the vacuum speed.
1.2 物理参数运行结果The run results of physical parameters
1.3 数据记录见附件1
The data record as follows attachment 1.
Performed by:
Verified by
2压力泄露测试Pressure leakage test 2．1根据ISO11135-1:2007，.做柜体负压和正压的泄露测试；设定负压为-50KP，保压60分钟；正压50KP，保压60分钟，观察并计算在保压阶段内的泄露速率。
Accords with the requirements of ISO11135-1:2007, do the leak test of the chamber during the subatmospheric and superatmospheric process; subatmospheric: -50KP, keep pressure 60mins; superatmospheric: 50KP, keep pressure 60mins, observe and calculate the leak speed of the sterilization chamber of the keeping pressure process.
2．2物理参数运行结果The run results of physical parameters
The data record as follows attachment 7.
Performed by:
Verified by
3温度均匀性测试Temperature uniformity test
3.1内壁温度均匀性Inner wall temperature uniformity
3．1．.1根据ISO11135-1：2007，在空载的条件下小于和等于1 m3的灭菌柜，需要3个温度传感器来监测灭菌柜的温度，大于3m3的灭菌柜，每增加1 m3，增加1个温度传感器； 1 m3至少需要使用3个温度传感器来监测灭菌柜的温度（实际上使用20个温度传感器），温度传感器的放置图见附件3。
Accords with the requirements of ISO11135-1：2007, the volume of sterilization chamber is no more than 1 m3, should use 3ea temperature sensors to monitor the sterilization chamber temperature, add a minimum of one temperature sensor for adding 3m3 of sterilization chamber if the chamber volume is more than 1 m3 during the empty loading condition; and it need 3ea temperature sensors at least to
monitor the sterilization chamber temperature of 1 m3 sterilization chamber (in fact, we used 20ea temperature sensors), the temperature sensor placement diagram, please see the attachment 4.
3.1.2设定灭菌温度50℃，并记录分析数据。
Set the sterilization temperature 50℃, record and analyze data. 3.1.3 物理参数运行结果 The run results of physical parameters 3.1.4 数据记录及温度趋势图，灭菌数据及趋势图见附件2
Data and temperature trend, sterilization data and trend as follows attachment 2 2.2.5 通过操作鉴定，灭菌柜内壁温度均匀性较好。
The inner wall temperature uniformity of sterilization chamber is good by the operational qualification.
Performed by:
Verified by
灭菌室箱壁温度均匀性确认
附件2
灭菌室箱壁温度均匀性布点示意图
附件3
3.2空间温度均匀性Space temperature uniformity
3.2.1根据ISO11135-1:2007，.在空载的条件下小于和等于3 m3的灭菌柜，需要3个温度传感器来监测灭菌柜的温度，大于3m3的灭菌柜，每增加1 m3，增加1个温度传感器； 20m3至少需要使用20个温度传感器来监测灭菌柜的温度（实际上使用20个温度传感器），温度传感器的放置图见附件5。
Accords with the requirements of ISO11135-1:2007, the volume of sterilization chamber is no more than 3 m3, should use 3 ea temperature sensors to monitor the sterilization chamber temperature, add a minimum of one temperature sensor for adding 20m3 of sterilization chamber if the chamber volume is more than 5 m3 during the empty loading condition; and it need 20ea temperature sensors at least to monitor the sterilization chamber temperature of 1m3 sterilization chamber (in fact, we used 20ea temperature sensors), the temperature sensor placement diagram, please see the attachment 5.
3.2.2设定灭菌温度50℃，并记录分析数据。
Set the sterilization temperature 50℃, record and analyze data.
3.2.3 物理参数运行结果 The run results of physical parameters
3.2.4 数据记录及温度趋势图，灭菌数据及趋势图见附件4。
Data and temperature trend, sterilization data and trend as follows attachment 4.
3.2.5通过操作鉴定，灭菌柜空间温度均匀性较好。
The space temperature uniformity of sterilization chamber is good by the operational qualification.
Performed by:
Verified by
灭菌室空间温度均匀性确认
灭菌室空间温度均匀性布点示意图
附件5
4.湿度测试Humidity uniformity:
4.1 在温度为的条件下，给灭菌柜加湿，记录湿度从30%RH升到80%RH的压力变化。并保持一段时间，检测湿度均匀性，温度传感器的放置图见附件6
Inject humidity into the sterilization chamber when the temperature of chamber is and pressure is , record the pressure variety when the humidity rises from 30%RH to 80%RH.. record and analyze data，the Humidity sensor placement diagram, please see the attachment 6. 4.2 物理参数运行结果The run results of physical parameters 年 月 日
附件6
灭菌室湿度测试布点示意图
Performed by:
Verified by
环氧乙烷灭菌工艺确认
PQ of Sterilization Chamber Of ETO Department
根据ISO11135-1:2007和GB18279-2000标准《(医疗器械的灭菌――环氧乙烷灭菌的验证及日常控制》)的要求，对灭菌柜进行工艺鉴定，证明工艺有效，并满足ISO11135-1:2007的要求。
According to ISO11135-1:2007 and the standard of GB18279-2000 (Medical devices –Validation and routine control of ethylene oxide sterilization) requirements, did the effectivePQ of sterilization chamber, the equipment can run normally, and meet the requirements of ISO11135-1:2007.
1灭菌实施方案针对新的EO灭菌罐进行如下确认：
Project in allusion to new Sterilization as follows
微生物运转性能合格性确认以表明灭菌工艺满足产品的灭菌要求。
BI test met the Sterilization requirements
1.1负载温度/湿度均匀性确认
Temperature/Humidity uniformity test 实施1次test 1
● 产品装载状态下的温度分布测定，最高温度与最低温度差在10℃以内
The run results temperature
1.2微生物性能的确认BI test
验证方法：Validation method
⑴ 半时循环法half cycle test：
本方法是在除时间外所有其它过程参数不变情况下，确定无存活菌的EO最短作用时间,应再重复1次实验来证实该最短灭菌时间，两次实验均应表明生物指示剂上无菌生长。规定作用时间应至少为最短灭菌时间的2倍。
This method is that keeping all parameters in same condition except time; ensure that after the shortest EO sterilization time, no bacteria survive, and repeat once same test to certify thisshortest sterilization time. 2 times test should show that there are no bacteria in BI. Accordingto regulation the normal sterilization time should be at least 2 times of the shortest sterilization time.
⑵按上述灭菌工艺进行验证，生物指示剂全为阴性，重复两次。
Follow above sterilization techniques to do the validation, BI are negative. Repeat twice. ⑶ 亚致死周期试验sub lethal cycle test ：按前面得到的验证参数，其中灭菌时间缩短为60/120分 钟（A/B）进行亚致死周期试验，当生物指示剂部分为阴性，试验完成。
According to above validationparameters, reduce the sterilization time to be 60/120 mins for sub lethal cycle test, when some of BI showed negative, test is finished. ⑷ 全周期试验Full cycle test：按前面得到的验证参数进行全周期试验。 Follow above validation parameters to do full cycle test.
验证和结论Validation and result
2、负载温度/湿度均匀性确认Temperature/Humidity validation when products is in chamber
2.1.1根据ISO11135-2007，.在负载的条件下小于和等于3 m3的灭菌柜，需要3个温度传感器来监测灭菌柜的温度，大于3 m3的灭菌柜，每增加1 m3，增加1个温度传感器；20m3的灭菌柜至少需要使用20个温度传感器8个湿度传感器来监测灭菌柜的温度（实际上使用20个温度传感器8个湿度传感器），温度传感器的放置图见附件1。
Accords with the requirements of ISO11135-2007, the volume of sterilization chamber is no more than 3 m3, should use 3ea temperature sensors to monitor the sterilization chamber temperature, add a minimum of one temperature sensor for adding 1m3 of sterilization chamber if the chamber volume is more than 3 m3 during the empty loading condition; and it need 3ea temperature sensors at least to monitor the sterilization chamber temperature of 20 m3 sterilization chamber (in fact, we used 20ea temperature sensors), the temperature sensor placement diagram, please see the attachment1.
2.1.2设定灭菌温度 ℃，并记录分析数据。
Set the sterilization temperature ℃, record and analyze data.
2.1.3 物理参数运行结果 The run results of physical parameters(A) 1st
灭菌室负载温度均匀性试验确认表
2.1.4 数据记录及温度/湿度趋势图，灭菌数据及趋势图见附件2。
Data and temperature trend, sterilization data and trend as follows attachment 2
2.1.5 通过操作鉴定，灭菌柜负载温度均匀性较好。
The space temperature uniformity of sterilization chamber is good by the operational qualification. Performed by:
Verified by：
灭菌室负载温度均匀性验证温度传感器布点图示意图
Drawing about distribution of temperature sensors for
temperature uniformity validation in autoclave
图1
3微生物性能确认BI Validation
对环氧乙烷灭菌设备在灭菌周期中的灭菌工艺及灭菌过程的有效性进行确认。
Validation of biological performance is the validation of validity of sterilization process with autoclave in sterilization cycle.
3．1 根据IS011135-1:2007标准，在进行微生物性能确认时，采用对环氧乙烷具有较强耐药性的枯草杆菌作为灭菌指示剂，其原始微生物含量为 cfu；在预热阶段开始前，按均匀分布原则，将40片灭菌指示剂安放在灭菌负载中，其分布方式如附件2所示。
According to ISO11135-1:2007, Atcc7372, which is strong against ETO gas, is used as our biological indicator during the validation of biological performance. The original biological organism content is cfu. Before preheated process, according to uniformity distribution rule, we put 40pc BI into the chamber, the distribution drawing is in attached document 2.
根据灭菌负载的产品构造、包装形式及其在灭菌器内的分布方式，确定微生物性能确认时的相关灭菌工艺如下：According to products structure, package form and distribution in the
chamber, we decide the relative sterilization techniques as following:
产品 Product
灭菌工序的灭菌Sterilization process condition
Performed by:
Verified by
3．2．1 为证明灭菌过程的有效性，采用半周期法，在保持上述灭菌工艺不变的条件下，
将灭菌作用时间进行变化，并将不同灭菌作用时间的灭菌指示剂在无菌环境下进行培养，按培养后灭菌指示剂有无细菌生长的结果作为对灭菌过程及灭菌工艺有效性的评判。详细数据如表一所示：To certify the validity of sterilization process, we use half cycle method; keep
above sterilization techniques, change sterilization time, and culture BI which is used in different sterilization time in sterile environment, after that evaluating the validity of
sterilization techniques according to the result if BI has bacteria or not after cultivation. For details please see table 1.
表一Table 1
(生物指示物长菌时间记录见附件3)
(BI bacteria appearance record see attached document 3)
从表一的结果可以说明：在上述灭菌工艺参数下，在灭菌负载的产品构造、包装形式
及负载分布形式保持不变的条件下,灭菌过程是有效的；灭菌作用的临界时间（最短有效灭菌时间）为 min。
From the result of table 1, in these sterilization parameters, if the product structure, package form and load distribution keep in the same conditions, the sterilization process is validity. The sterilization critical time for this product (shortest effective sterilization time)
is 180mins.
综上所述，经过对本套20ｍ
3
环氧乙烷灭菌器进行交付试验和性能确认后，全套设备的
验证结果和验证过程符合ISO11135-1:2007。
To summarized, after validating this autoclave (20m3) about installation,
operation and performance validation, this autoclave validation process and result are accordance with ISO11135-1:2007.
另：采用表一微生物性能确认取得的数据，按照半时循环法，由此推荐产品灭菌作用时间为 min，以确保灭菌有效性。
Additionally, this result is got from half cycle method; we recommend for product A, the sterilization time is mins for total cycle to guarantee the validity sterilization.
3．2．2为证明灭菌过程的有效性，采用半周期法，在保持上述灭菌工艺不变的条件下，将灭菌作用时间进行变化，并将不同灭菌作用时间的灭菌指示剂在无菌环境下进行培养，按培养后灭菌指示剂有无细菌生长的结果作为对灭菌过程及灭菌工艺有效性的评判。详细数据如表二所示：
To certify the validity of sterilization process, we use half cycle method; keep above
sterilization techniques, change sterilization time, and culture BI which is used in different sterilization time in sterile environment, after that evaluating the validity of sterilization techniques according to the result if BI has bacteria or not after cultivation. For details please see table 2.
IPCD布点图
图2
附件3 Attachment 3
生物指示物长菌时间记录
BI record
灭菌工艺确认
XXXX医疗器械有限公司 特殊工序验证资料——环氧乙烷灭菌验证
记录号：HS/CQ1202-2 格式批准： 批准日期：2010.01.03 保存年限：5年
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