Qualification protocol of Compressed air system压缩空气系统验证方案 共 12 页 第 6 页
3.3.2 QA was responsible to supervise the validation process.QA对验证的过程实施监督
4.0 Validation scope验证范围：this protocol will validate the
Installation qualification、Operation qualification、Performance qualification of compressed air system.本方案主要对压缩空气系统的安装确认、运行确认和性能确认进行验证。
5.0 Validation content验证内容：
5.1 Installation Qualification(IQ)安装确认：Qualification the specification、installation condition or place 、installation process and end of installation of this equipment. The purpose of this phase was verify if the specification of equipment was met the requirement,if the technical data of equipment was integrity, if the equipment and meter was calibrated well. 是对欲安装设备的规格、安装条件或场所、安装过程及安装后进行确认。目的是证实设备规格是否符合要求，设备所应具有的技术资料是否齐全，仪器、仪表是否校验合格等。
5.1.1 Specification and date of equipment in the phase of IQ安装确认所需文件资料：
Equipment department should establish the archives of this equipment after factory acceptance testing, the status of archives see the following table设备部在设备开箱验收后建立设备档案，整理使用手册等技术资料，归档保存情况填于下表：
Name资料名称 Record of installation No. and Position 编号及存放处 Air compressor 空压机 Tank of compressed air贮气罐 Refrigeration air dryer冷冻式干燥机 Qualification protocol of Compressed air system压缩空气系统验证方案 共 12 页 第 7 页 and adjustment 安装调试记录 Certification of equipment or meter 仪器仪表检定记录及鉴定证书 Manual 操作手册 Documentation of equipment operation、cleaning、maintainence设备操作、清洁、维护程序草案 Purchase order设备采购单 List of equipment part备件清单 Other document其他文件 Checked by检查人： Reviewed by复核人： Date检查日期： Date复核日期： 5.1.2 Check List of critical equipment or meter and spare parts.关键性仪器仪表及备件核对登记表：
Name名称 Manufacturor生产厂家 Model型号 Units单位 Amount数量 Checked by检查人： Reviewed by复核人： Date检查日期： Date复核日期： 5.1.3 Calibration of Test equipment or meter 测试仪器仪表的校正情况检查:
5.1.3.1 Method检查方法：Inspect if there were certification of Test equipment or meter and if they were in the expiry date. 检测是否有仪器仪表校正“合格证书”，是否在校正周期内使用。
Qualification protocol of Compressed air system压缩空气系统验证方案 共 12 页 第 8 页
5.1.3.2 Acceptance Criteria确认标准: There is the certification and it should be in the expiry date, Otherwise noconformity. 有合格证书且在有效期内使用为合格；否则为不合格。
5.1.3.3 Calibration status checking and evaluation record of equipment or meter used in IQ phase. 安装确认所使用仪器仪表的校正情况检查及评价记录
Name of equipment or meter仪器仪表名称 Model型号 Is there the certification and is it in the expiry date 检查是否有合格证书且在有效期内 Reviewed by: Date日期： Remark备注 Evaluation结果评价： Checked by检查人： Date日期： 5.1.4 The technical index and spare part should be met the designed requirement. Check record see following table.设备安装后各技术指标、配套装置等，应符合设计规范要求, 检测记录确认结果见下表： Equipment设备 Air compressor 空压机 Air tank 贮气罐 Designed requirement 设计标准 Check record 检测记录 Conclusion 结果 Power电源：380V，50HZ Rated pressure额定压力：0.8MPa Volume 贮气量：1m3 Pressure meter压力表：0—1.6MPa Design Pressure设计压力：1.05MPa Safety valve安全阀：1MPa Connectingline管路连接：No leak无泄露 Pre-filter 前置过滤器 Refrigerator air Power电源380V 50HZ dryer冷冻式干Connectingline管路连接：No leak燥机 无泄露 Working pressure工作压力：0.8-1Mpa Filter(Class T)Connectingline管路连接：No leak过滤器（T级） 无泄露 Filter(Class A)Connectingline管路连接：No leak Qualification protocol of Compressed air system压缩空气系统验证方案 共 12 页 第 9 页 过滤器（A级） 无泄露 Filter(Class H)Connectingline管路连接：No leak过滤器（H级） 无泄露 Signature 确认签字 Equipment Department 设备部： Date日期： Validation Team 验证小组： Date日期： 5.1.5 Personnel Training人员培训
Training is for individuals who perform normal operations during production. This training on the validation object must be completed prior to initiation of OQ. This training documentation is to be maintained either in the validation documentation.
培训要求是针对生产中进行日常操作的个人。针对验证对象的培训必须在PQ结束前或开始时完成。培训记录保存在验证文件中。
5.2 Operation Qualification(OQ)运行确认：
5.2.1 Test conditions测试条件: all part of Air Compressor system should be operated in the normal produce status.压缩系统各部分在生产状态下运行。
5.2.2 Test Method测试方法：Test method/instrument used in OQ should be applicable with relatively qualification item.根据相关确认项目，采取对应的测试方法及仪器。
5.2.3 Test records、Acceptance and results should be filled in following table.将测试记录、确认标准及结果填入下表：
Test item 测试项目 Air compressor空压机 Refrigerator air dryer 冷冻式 干燥机 Acceptance Criteria 确认标准 Pressure Upper limit 调压上限范围：0.8MPa Pressure low limit调压下限范围：0.7MPa Ventilator风扇：Motor is Ok马达运转正常 No air leak in air tube气管无空气泄漏 Test record 测试记录 Results 确认结果 Qualification protocol of Compressed air system压缩空气系统验证方案 共 12 页 第 10
页 Drain system is Ok排水系统正常 Pressure Upper limit of coolant冷媒高压：180~250psig Pressure low limit of coolant冷媒低压：50~70psig Checked by测试人： Reviewed by确认人： Date 测试日期： Date 确认日期：
5.3 Performance Qualification性能确认：
5.3.1 Test of Particulate matter、Oiliness and Total Count of Bacteria微粒、含油和细菌数检测：
5.3.1.1Test Method( Sampling at the used place)检查方法（在压缩空气使用点取样）：
5.3.1.1.1 Take 1000 ml of Purity water, add 400ml in the suction flask, implement next step after a Visual inspection. 取1000ml纯化水，将400ml纯化水倒入抽滤瓶内，用目测法检查合格后进行下一步实验。
5.3.1.1.2 Connect above suction flask in the system, keep a working pressure, and compressed air was crossed water from the bottom of suction flask. Stop sampling and Cover with lid and sterile silver paper for test when the volume of air arrive 4 m3. Sampling three times. 将上述抽滤瓶接入系统，保持一定的压力，让气体从抽滤瓶底部缓缓通过纯化水，当通过气体量达4m3时，盖上盖子，用灭菌锡纸包好，备检。重复取样三次。
5.3.1.1.3 Test total count of bacterial with 100ml of water sample in the Laminar hood, blank test with 100ml of water 5.3.1.1.1, and total count subtract the blank.取上述方法得到的纯化水样品100ml，在层流操作台上测定