解析室IQOQ

IQ and OQ of Aeration Room

IQ and OQ of Aeration Room of

ETO Department

解析室的安装鉴定和操作鉴定

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TABLE OF CONTENTS

1. Purpose ………………………………………………………. …………………………..3

2. Scope …………………………………………………………….. ……………………….3

3. Specifications ……………………………………………………. ……….......................3

4. References………………………………………………………….………………...........3

5. Responsibilities……………………………………………………………………………..4

6. Procedure……………………………………………………………………………..........5

7. Summary of Acceptance Criteria………………………………………………………….7

8. Certification of Qualification…………………………....................................................7

9. Subsequent Validation…………………………………………………………………..…7

List of Attachments 附件清单

Attachment 1: Air flow direction trend………………………………………………………8 附件1：气体流向趋势图

Attachment 2: Temperature sensors placement of operational qualification……………9 附件2：操作鉴定时温度传感器放置图

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1. 目的Purpose

1.1 The purpose of IQ and OQ is to demonstrate that the aeration room temperature and air flow rate meet specification, air flow patterns will be determined, all will be done in accordance with ANSI/AAMI/ISO11135-1994, Page.12: A3.3 Aeration. 安装鉴定和操作鉴定目的是为了证明解析室的温度和气体流速满足规格，确定气流模式，所有将根据ANSI/AAMI/ISO11135-1994，第12页，A3.3解析来执行。

2. 范围Scope

2.1 This protocol applies to the aeration room IQ and OQ of ETO department. 该方案适用于ETO车间的解析室的安装鉴定及操作鉴定。

2.2 During the sterilization process, use EO mixture gas: EO/CO2: 40/60

在灭菌过程中，使用环氧乙烷混合气体：EO/CO2：40/60

3. 说明Specifications

3.1 Temperature range of aeration room: 34—50℃

解析室的温度范围：34-50℃

3.2解析室尺寸Aeration room dimensions:

Aeration room: 500cm×330cm×190cm

解析室：500cm×330cm×190cm

3.3 Temperature sensor: JR-1000

温度传感器. JR-1000

Temperature sensor of aeration room: WZP2-231 解析室的温度传感器：WZP2-231

4. 相关文件References

3.1 ANSI/AAMI ISO 11135:1994, Industrial ethylene oxide sterilization – Validation and routine control

ANSI/AAMI ISO 11135:1994，工业环氧乙烷灭菌--验证和常规控制

3.2 EN 550: 1994, Sterilization of medical devices – Validation and routine control of ethylene oxide sterilization

EN 550: 1994，医疗器械灭菌--环氧乙烷灭菌验证和常规控制

5. 职责Responsibilities:

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All personnel involved with the execution of this protocol will be trained to the requirements set forth therein and any new or modified procedures established and implemented for the successful completion of this study. Signature and date by individuals accepting this protocol will serve as documented training. Documented evidence of training for all others involved is required.

所有参与执行方案的人员都需经过先前的，任何新的，建立的修正程序和成功完成验证要求的培训。接受方案的人员签名及日期将作为文件性的培训证明，并要求相关的文件性培训记录。

5.1 ETO Sterilization Process Engineer Initiation of the protocol 起草方案

Acceptance of final report 接受最终报告

Be responsible for operational qualification and collecting all documentation involving its portion of this validation.

负责验证过程中操作鉴定及收集所有验证中涉及的文件

Equipment document collected and meters calibrated. 设备文件的收集和仪表校准

Obtain and analyse, review all test data relating to this study for accuracy and compliance with regulatory and protocol requirements

精确的获得并分析，审查所有相关的测试数据以达到规程和方案要求。

Compile and coordinate final report 编辑整理最终报告

5.2 ETO sterilization Assurance Engineer

Acceptance of final protocol 接受最终方案

5.3 ETO Manager

Acceptance of final protocol 接受最终方案

Compile a validation binder that contains all process and test data included in this study

汇编一个包含所有过程和测试数据的整套文件

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6. 程序Procedure

An equipment review should be performed to make sure the aeration equipments have passed all applicable IQ/OQ validation and therefore those equipments are capable to be used in PQ and the routine production.

执行设备审查以确保解析设备已通过可适用的IQ/OQ验证，以达到这些装置可适用于性能鉴定及日常生产。

6.1安装确认Installation Qualification

6.1.1 All applicable calibration records should be reviewed prior to the implementation of this validation study to make sure the equipments have been calibrated and are within their respective calibration expiry date.

在进行验证之前对所有的可适用的校正记录进行审查以确保所有的装置都已被校正且在有效期之内。

6.1.2 Collect all aeration rooms equipments documents and eligibility certificates, run the aeration room to check the equipments whether installed correctly and do the operation qualification to check the equipment can run normally or not.

收集所有解析室的设备的文件和合格证，运行解析室检查设备是否正确安装，进行操作确认来检查设备是否能正常运行。

6.2操作确认Operational Qualification:

6.2.1 气流测试Air flow test

6.2.1.1 The fresh air supply to the aeration room enters via an inlet duct and heat is also brought into the room via the same inlet duct, the air exhausts via an outlet duct which under the inlet duct, and on the opposite side also have inlet duct and outlet duct of the aeration room. The fresh air and heat mix in the middle of the aeration room side, the air continues to move down to the floor and the opposite side, and exhaust from the outlet duct, the air enters and exhaust direction, please see the attachment 1.

新鲜空气和热量通过同一个进气管道进入解析室,空气从进气管道下面的排气管道排出，对面一侧也有同样的进气和出气管道。新鲜的空气和热量在解析室一侧中间混合，然后流到地板和另一侧，然后从排气管道排出，空气进入和排出的方向见附件1。

6.2.1.2 Air intake duct 3600m3/h

进气口 3600m3/h

Air circulation=10 m3 per minute 空气循环= 10 m3/min

The volume of the aeration room 31.4m3 解析室容积：31.4 m3

31.4 m3÷10m3/min=3.1mins

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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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