2023年12月24日发(作者：)
Qualification protocol of Compressed air
system
压缩空气系统确认方案
Prepared by起草： Date日期：
Reviewed by审阅： Date日期：
Approved by批准： Date日期：
Qualification protocol of Compressed air system压缩空气系统验证方案 共 12 页 第 2 页
Table of contents
目 录
1.0 Instruction引言 ................................................................................. 3
1.1 Summarize概述 ............................................................................ 3
1.2 State of Equipment设备的基本情况 ............................................... 3
2.0 Purpose验证目的 .............................................................................. 4
3.0 Responsibility验证职责 .................................................................... 4
3.1 Validation team验证小组 ............................................................... 4
3.2 Equipment department设备部 ....................................................... 5
3.3 Quality department质量部 ............................................................. 5
4.0 Validation scope验证范围 ................................................................ 6
5.0 Validation content验证内容 .............................................................. 6
5.1 Installation Qualification(IQ)安装确认 ............................................. 6
5.2 Operation Qualification(OQ)运行确认 ............................................ 9
5.3 Performance Qualification性能确认 ............................................ 10
5.4 Re-validation and re-validation period拟定再验证及验证周期 ..... 11
5.5 Conclusion 验证方案结论 ............................................................ 12
6.0 Approval of validation protocol验证方案最终批准 ........................ 12
Qualification protocol of Compressed air system压缩空气系统验证方案 共 12 页 第 3 页
Content正文
1.0 Instruction引言：
1.1 Summarize概述：Compressed air met Criteria was provided for
manufacturing process produced from air compressor in this Compressed air
system and cleaning treated. 本压缩空气处理系统是通过空压机制取的压缩空气，经过净化处理后为生产工艺提供合格的洁净空气。
System process 系统流程：
Air→Air compressor→Compressed air→Compressed air tank→pre-filter(Class C) →Refrigeration Air Dryer→Filter(Class T) →Filter(Class A)
→Filter(Class H) →Cleaning air.
空气→空压机→压缩空气→贮气罐→前置过滤器（C级）→冷冻式干燥机→空气过滤器（T级）→空气过滤器（A级）→空气过滤器（H级）→洁净空气。
1.2 State of Equipment设备的基本情况：
Item项目
No编号
Name名称
Model型号
Series系列号
Manufacturer
生产厂家
release date
出厂日期
Contact联系人
Arrival date
到货日期
Owner
Department
使用部门
Position
放置地点
Owner
管理员
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 4 页
Services name
服务单位名称
Services address服务单位地址
Tel联系电话
Checked by检查人： Reviewed by复核人：
Date检查日期： Date复核日期：
2.0 Purpose验证目的：
2.1 Checking the air compressed system and ensure the qualification of
installation、operation、 performance to meet designed criteria 检查并确认该压缩空气处理系统安装、运行、性能等各项技术指标符合设计要求。
2.2 Ensure the archive of relatively data and file to meet the requirement
of GMP. 确保相关资料和文件的存档管理符合GMP要求。
2.3 Inspect compressed air if it's meet the requirement of manufacture.检查处理后的压缩空气是否达到生产要求。
3.0 Responsibility验证职责：
3.1 Validation team验证小组：
3.1.1 Responsible for approval of protocol负责验证方案审批。
3.1.2 Responsible to coordinate the work of validation, ensure the
implement of this protocol effectively.负责验证的协调工作以保证本验证方案规定项目的顺利实施。
3.1.3 Responsible for approval of validation report.负责验证报告的审批。
3.1.4 Responsible for signing and issue the certification of validation负责验证证书的发放。
3.1.5 Responsible for affirmed the period of validation负责验证周期的确认。
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3.2 Equipment department设备部：
3.2.1 Responsible for draft the protocl负责验证方案的起草。
3.2.2 Responsible for installing,adjusting the equipment and recording.负责设备的安装、调试并作好相应记录。
3.2.3 Responsible for the calibration of equipment and meter.负责仪器仪表的校正。
3.2.4 Responsible for collected all validation data and submit to the
validation team. 负责收集各项验证记录，报验证小组。
3.2.5 If this protocol need to change because of specific cause,
Equipment department should be responsible to fill 'the application and
approval form of protocol change.若因特殊原因需变更原验证方案时，应负责填写“验证方案变更申请及批准书”，报验证小组批准。
3.2.6 Responsible for providing mainly parameter of equipment.负责提供与设备有关的主要参数。
3.2.7 Responsible for operation、cleaning and maintenance of equipment.负责设备的操作、清洗和维护保养。
3.2.8 Responsible for implement of this protocol.负责验证方案的实施。
3.2.9 Responsible for identified the re-validation period and protocol.负责拟定再验证方案及周期。
3.3 Quality department质量部：
3.3.1 The representative of Quality department should be involved in the
approval of validation protocol and report.质量部负责人参与验证方案、验证报告的审阅。
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3.3.2 QA was responsible to supervise the validation 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
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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。
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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
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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
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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
Qualification protocol of Compressed air system压缩空气系统验证方案 共 12 页 第 11
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细菌数，同时用5.3.1.1.1剩余纯化水100ml做空白，所得细菌总数减去空白。
5.3.1.1.4 Visual inspect the remaining samples 其余样品进行目检。
5.3.1.2 Acceptance critera确认标准：
5.3.1.2.1 Particular matter微粒：No visual foreign matter in the sample.样品目测无可见杂质。
5.3.1.2.2 Oiliness含油：No oil contamination in the sample.样品目测无油污。
5.3.1.2.3 Total count of bacterial 细菌数： ≤ 1CFU/m3。
5.3.1.3 Record确认记录：
Position Times
使用点位置 检测次数
Particular
matter颗粒
Oiliness油污
Total count of Results
bacterial 细菌数 结果
Tested by测试人： Reviewed by确认人：
Date测试日期： Date确认日期：
5.4 Re-validation and re-validation period拟定再验证及验证周期：
Re-validation will be performed as this protocol or supplement protocol
drafted per actual Situation when there were major change or maintenance in
this equipment, and any exception in manufacture process, and any trouble in
the utilities etc to ensure applicability and repeatability of this equipment. 当设备和装置发生较大变更或做大检修后，在日常验证中发现重要的工艺特性出现异常，公用工程发现故障以等情况下，应按照期前验证采用的方法对设备进行
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再验证，或根据实际情况修订补充验证方案后进行“再验证”，以确认设备的适应性和重现性。
Re-validation period should be identified per the requirement of
process and operation status of this equipment by Equipment
Department( See the Validation master plan). 设备部根据工艺要求、设备运行情况拟定验证周期(见“验证主计划” )。
5.5 Conclusion 验证方案结论：
Conclusion should be decided per validation applicable,
Analysis and summarize this problem occurred in validation process. 根据验证结果，做出验证是否通过的结论，如适用，对验证中发生的问题进行分析总结。
Conclusion see the validation report验证结论见验证报告。
6.0 Approval of validation protocol验证方案最终批准：
This validation protocol is effectively after approved by relatively
department manager, Quality Director. 验证方案最终由相关部门经理，质量总监批准后生效。
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