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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