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31.4m3÷10m3/min=3.1mins
And during the validation, exhaust 5mins and air circulation 25mins. 验证过程中，排气5分钟且循环25分钟。
6.2.1.3 The air flow direction test will use the smog to observe the smog flow direction and take the photograph.
气体流向测试使用烟雾弹来观察烟雾的流向，并拍成照片。
6.2.2 温度均匀性确认Temperature uniformity qualification
6.2.2.1 During the qualification process, the purpose is to find the coldest point and test the temperature uniformity of the aeration room.
在这个确认过程中，目的是为了寻找冷点及测试解析室的温度均匀性。
6.2.2.2 The temperature low limited is 34℃, and set temperature 40℃ during the operational qualification, all temperature of the sensors must be not less than 34℃, and the temperature range must be less than 16℃.
温度最低限为34℃，在操作确认过程中设定温度为40℃，所有温度传感器的温度不低于34℃，温度波动范围在16℃以内。
6.2.2.3 The temperature was monitored by the temperature sensors, the guideline requires a minimum of one temperature sensor for every 2.5m3 of aeration area. Because every aeration room volume is 31.4m3, and we use sixteen sensors to
monitor the aeration room temperature (but no fewer than 13 must operate throughout the process). The temperature sensor placement diagram, please the attachment 2. 温度通过温度传感器来监测，要求每2.5 m3的解析空间最少放置一个温度传感器。由于每个解析室的空间为31.4m3，所以我们用16个传感器来监测解析室温度（整个操作过程不能低于13个温度传感器），温度传感器的放置图见附件2。
6.2.2.4 When the temperature of the aeration room reach to set temperature, start to aerate and when the temperature is steady, then go on running 2 hours and stop running, then read the temperature sensor data and analyze data to find the coldest point and make the temperature trend observe the temperature uniformity.
当解析室的温度达到设定温度时，开始解析，当温度稳定继续运行2小时后停止，读取温度传感器数据并分析数据以发现最低温度点，并做温度趋势图观察温度的均一性。
7. 主要接受标准Summary of Acceptance Criteria
7.1 Records audit confirms that all record parameters for the operational qualification
processes conform to the process specification proposed above. 记录审核确认所有操作确认过程参数符合上面提供的工艺规格说明。
7.2 Temperature range of operational qualification is less than 34℃ at any given time.
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操作确认中任何时间的解析温度范围不得低于34℃。
8. 鉴定证明Certification of Qualification
8.1 Upon completion of the study, a final report summary will be compiled which will summarize the results of the qualification and contain all documentations and data. All documents must be maintained in a controlled, permanent record. The documentation will include but may not be limited to:
完成鉴定后编辑最终总结报告，最后总结报告包括鉴定结果和所有的文件和数据。所有的文件都须要受控，永久保存。文件必须包括但不限制以下：
8.1.1. Equipment documentations and Calibration Certification
设备文件资料及校正证书
8.1.2 Aeration time and temperature
解析时间和温度
8.1.3 Rate of change of air and air flow direction
空气换气速率和气体流向
8.1.4 Sensor Placement diagrams
传感器放置图
8.1.5 Aeration data and temperature trend of aeration room records
解析数据和解析室温度趋势图
8.1.6 Data and trend of temperature sensors
温度传感器数据和趋势图
9. 后续验证Subsequent Validation
9.1 In accordance with ANSI/AAMI/ISO 11135:1994, validation includes commissioning and performance qualification, and commissioning includes IQ and OQ, after finishing the IQ and OQ, we should do the performance qualification next step.
根据ANSI/AAMI/ISO 11135:1994要求，验证包括试运行和性能鉴定，试运行包括安装鉴定和操作鉴定，在完成安装和操作鉴定后，下个阶段将做性能鉴定。
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Attachment 1: Air flow direction trend
Inlet duct Exhaust fan Inlet duct
Outlet duct Outlet duct Entrance
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Attachment 2: Temperature sensors placement of operational qualification
1底 2中 3中 4底 5中
6底 7中 8底 9中 10底 11中
12底 13中 14中 15底 16中
Entrance
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Signature of approval and acknowledgement of protocol review and acceptance of activities defined therein:
Prepared By: __________________________________________ Date: ___________
ETO Sterilization Process Engineer
Accepted By: ___________________________________________ Date: ___________
ETO Sterilization Assurance Engineer
Accepted By: ____________________________________________Date: ___________
Sterilization Manager
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