表4：洁净室参数表
Table 4: Cleanroom parameter table
房间编号
Room number Room No. | 房间名称
Room name Room Name | 洁净级别
Cleanliness level Clean Class | 设计面积（m²）
Design Area(m²) Design Area | 温度(℃)
Temperature (°C). Temperature | 湿度（%RH)
Humidity (%RH) Humidity |
32016 | 换鞋
Change your shoes Shoes Changing Room | CNC | 2.1 | 18~26 | 30~70 |
32017 | 男一更
The male one is more Male Primary Changing Room | D | 2.5 | 18~26 | 45~65 |
32018 | 女一更
Female one more Female Primary Changing Room | D | 4.6 | 18~26 | 45~65 |
32019 | 洗衣间
Laundry room Gowning Cleaning Room | C | 6.9 | 18~26 | 45~65 |
32020 | 整衣间
Full walk-in closet Collation Clothes Room | C | 11.6 | 18~26 | 45~65 |
32021 | 中控室
Central control room Quality Control Room | C | 5.7 | 18~26 | 45~65 |
32022 | 洁具间
Sanitary ware room Cleaning Tools Room | C | 6.5 | 18~26 | 45~65 |
32023 | 更衣缓冲间
Locker buffer room Changing Buffer room | C | 5.9 | 18~26 | 45~65 |
32024 | 洁净走廊
Clean corridors Clean Corridor | C | 3.6 | 18~26 | 45~65 |
32025 | 物流缓冲间
Logistics buffer room Logistics Buffer Room | C | 8.6 | 18~26 | 45~65 |
32026 | 外清间
Outer clear room External Cleaning Room | CNC | 31.7 | 18~26 | 30~70 |
空调系统设计特征
Air conditioning system design features
该空调系统按照本公司洁净空调要求设计，具体设计特征可以参见空调系统KT-3-1的设计确认
The air-conditioning system is designed in accordance with the company's clean air-conditioning requirements, and the specific design features can be referred to the design confirmation of the air-conditioning system KT-3-1
空调系统关键测试项目
Key test items of air conditioning system
关键的测试项目
Key test items | 确认范围
Confirm the scope | 关键的质量特征/原理
Key quality features/principles | 在哪项测试中被确认？
In which test was it confirmed? |
洁净室悬浮粒子测试
Cleanroom particulate testing | 参见第3.3节表2规定
See Table 2 of Section 3.3 | 引入杂质影响产品成分
The introduction of impurities affects the composition of the product | 在第8.3节中执行
In Section 8Section 3 |
洁净室沉降菌测试
Cleanroom sedimentation bacteria test | | 微生物限度
Microbial limits | |
洁净室浮游菌测试
Cleanroom microbial testing | | 微生物限度
Microbial limits | |
洁净室表面微生物测试
Cleanroom surface microbial testing | | 微生物限度
Microbial limits | |
洁净室温湿度监控
Temperature and humidity monitoring in clean rooms | | 影响环境
Affect the environment | |
操作程序
Operating Procedures
标题
title | 文件编号
Document number |
空调系统标准操作规程
Standard Operating Procedures for Air Conditioning Systems | QI-GS068 F0 |
洁净区悬浮粒子监控操作程序
Clean-area particulate monitoring operating procedures | QI-QA023 F2 |
洁净区沉降菌监控操作程序
Operating procedures for monitoring sedimentation bacteria in clean areas | QI-QA021 F1 |
洁净区浮游菌监控操作程序
Operating procedures for monitoring zooplankton in clean areas | QI-QA053 F1 |
洁净区表面微生物监控操作程序
Procedures for microbial monitoring on clean area surfaces | QI-QC720 F0 |
清洁剂和消毒剂管理规程
Cleaning and disinfectant management protocols | QI-SX020 F0 |
相关的验证文件
Relevant verification documents
验证文件
Verify the documents | 文件编号
Document number | 状态
state |
DQ设计确认报告
DQ Design Validation Report | DCJH-2-XT-001DQR | 已批准并受控
Approved and controlled |
IQ安装确认报告
IQ Installation Confirmation Report | DCJH-2-XT-001IQR | 已批准并受控
Approved and controlled |
OQ运行确认报告
OQ Run Confirmation Report | DCJH-2-XT-001OQR | 已批准并受控
Approved and controlled |
方案补充/变更和偏差处理
Scenario additions/changes and deviation handling
任何验证前对本方案的修改，增加和/或删除都应以书面形式予以明确，应作出说明理由，并经原方案相同的组织批准。
Any modifications, additions and/or deletions to this protocol prior to validation shall be made clear in writing, justified and approved by the same organization as the original protocol.
如果确认过程中发现变更或偏离，应对变更或偏离的详细信息进行记录。分析偏离产生的根本原因并提出解决方法。任何变更或偏离均应在报告中被原方案相同的组织批准。如果确认中发现的偏离不需要进行处理，必须提供可接受的澄清证明。
If a change or deviation is found during the confirmation process, the details of the change or deviation should be recorded. Analyze the root cause of deviation and propose solutions. Any changes or deviations should be approved in the report by the same organization as the original program. If the deviations found in the acknowledgment do not need to be addressed, an acceptable proof of clarification must be provided.
培训
training
7.1 验证方案起草人有责任在方案批准后对本次验证相关人员进行培训，并填写培训记录。如果在验证中涉及到其他培训，培训记录的复印件附在验证报告中。
7.1 The drafter of the verification plan is responsible for training the relevant personnel of the verification after the approval of the plan and filling in the training records. If other training is involved in the validation, a copy of the training record is attached to the validation report.
7.2 参与验证的人员必须通过相应的培训并填写记录1：验证执行人员检查及资格确认表
7.2 Persons involved in the verification must pass the appropriate training and complete the Record 1: Verification Execution Check and Qualification Confirmation Form
性能确认（PQ-Tests）
Performance Validation (PQ-Tests).
PQ-1: 测试用器具状态确认
PQ-1: Confirmation of the status of the test equipment
验证前应确认验证使用的器具及设备相应关键探头仪表等已校验且在校验有效期内，并填写“记录2：仪器仪表校验状态检查结果汇总表”
Before verification, it should be confirmed that the instruments and equipment used for verification, the corresponding key probes, instruments, etc. have been calibrated and within the validity period of calibration, and fill in "Record 2:". Summary table of instrument calibration status inspection results".
PQ-2:测试物料确认
PQ-2: Test Material Confirmation
验证前应确认验证使用的物料已准备齐全且符合要求，并填写“记录3：物料确认检查表”
Before validation, you should confirm that the materials used for verification are ready and meet the requirements, and fill out "Record 3: Material Validation Checklist"
PQ-3:关键测试项目
PQ-3: Critical Test Item
8.3.1 验证测试策略和周期原理
8.3.1 Verify the test strategy and cycle principle
洁净空调系统及洁净室性能确认的测试周期按照连续三天静态[1]监测和连续三天动态[1]监测，具体不同洁净等级的验证执行要求参见下表规定
The test cycle of clean air conditioning system and clean room performance confirmation shall be based on static [1] monitoring for three consecutive days and dynamic [1] monitoring for three consecutive days, and the verification and implementation requirements for different cleanliness levels are specified in the following table
测试名称
The name of the test | 连续测试次数
Number of consecutive tests |
| Class A | Class B | Class C | Class D |
| 静态
Static | 动态
dynamic | 静态
Static | 动态
dynamic | 静态
Static | 动态
dynamic | 静态
Static | 动态
dynamic |
洁净室悬浮粒子测试
Cleanroom particulate testing | 3 days | 3 days | 3 days | 3 days | 3 days | 3 days | 3 days | N/A |
洁净室沉降菌测试
Cleanroom sedimentation bacteria test | 3 days[2] | 3 days | 3 days[2] | 3 days | 3 days[2] | 3 days | 3 days[2] | 3 days |
洁净室浮游菌测试
Cleanroom microbial testing | 3 days[2] | 3 days | 3 days[2] | 3 days | 3 days[2] | 3 days | 3 days[2] | 3 days |
洁净室表面微生物测试
Cleanroom surface microbial testing | N/A | 3 days | N/A | 3 days | N/A | 3 days | N/A | 3 days |
温湿度
Temperature and humidity | 3 days | 3 days | 3 days | 3 days | 3 days | 3 days | 3 days | 3 days |
压差
Differential pressure | 3 days | 3 days | 3 days | 3 days | 3 days | 3 days | 3 days | 3 days |
备注：[1] 静态和动态的定义参照ISO 14644-1. [2]仅作参考。
Note: [1] Static and dynamic are defined according to ISO 14644-1 [2] For informational purposes only.
8.3.2 通用要求
8.3.2 General Requirements
确保所有关联的相邻空调系统正常运作.
Ensure that all associated adjacent air conditioning systems are functioning properly
在执行PQ前，严格按照按照清洁剂和消毒剂管理规程QI-SX020进行洁净室的正常清洁消毒。
Before performing PQ, the normal cleaning and disinfection of the clean room should be carried out in strict accordance with the detergent and disinfectant management protocol QI-SX020.
静态监测过程洁净区内各个房间检测人员数量不得超过2人
During the static monitoring process, the number of inspectors in each room in the clean area shall not exceed 2
动态监测过程洁净区内最多容纳人数应根据洁净区级别、房间面积和SOP规定的要求执行。具体参见附件1.
The maximum number of people in the clean area should be implemented according to the requirements of the clean area level, room area and SOP regulations. Please refer to Annex 1 for details
8.3.3 关键测试要求及参考出处
8.3.3 Key Test Requirements and References
测试类别
Test Category | 测试要求
Testing requirements | 参考出处
Refer to the source |
温湿度
Temperature and humidity | 1.温湿度检测只测房间，测试点不低于5个，点间距不应大于2m.测点数按以下表确定：
1.The temperature and humidity detection only measures the room, the test points are not less than 5, and the spacing between the points should not be greater than 2m 房间面积≤50 m²
Room size ≤ 50 m² | 房间面积＞50m²
The room size > 50 m² | 5 | 每增加20～50 m²,增加3～5点。
For every 20~50 m² increase, 3~5 points will be added. |
2.温湿度计设置在工作高度，距地0.8m处，距吊顶、墙及地面不少于0.5m。室内测点一般布置在以下各处：
2.The temperature and humidity meter is set at a working height, 0.8m from the ground, and not less than 0.5m from the ceiling, wall and ground. Indoor measurement points are generally arranged in the following places: 送、回、排风口处；
Supply, return, exhaust outlets; 室中心
room center 3.在每个测试点让温湿度计读数稳定后，读取数据并记录在确认记录4中。
3.After the thermohygrometer reading has stabilized at each test point, the data is read and recorded in Confirmation Log 4. 4.分为动态和静态测试，静态或动态连续测试3天，每天测一次，测试点见附件2。
4. It is divided into dynamic and static tests, static or dynamic continuous tests for 3 days, once a day, and the test points are shown in Annex 2. | ISO 14644-1 |
压差
Differential pressure | 1、启动洁净室所有系统，让空调系统运行直至稳定。在所有门关闭的条件下，由平面布置图上离外界最远的房间开始由高压区向低压区依次向外检测，且最里面房间的静压差应持续到最外面房间的测试完成为止。
1. Start all systems in the clean room and let the air conditioning system run until it is stable. Under the condition that all doors are closed, the room farthest from the outside on the floor plan should be tested outward from the high-pressure area to the low-pressure area, and the static pressure difference of the innermost room should continue until the test of the outermost room is completed. 2、测量时不允许有人穿越房间。
2. No one is allowed to cross the room during the measurement. | N/A |
悬浮粒子
Suspended particles | 1.取样量：Class C, 每次采样要求至少28.3L
1. Sampling capacity: Class C, at least 28.3L per sampling 2.采样高度一般在离地面0.8m～1.5m的水平面上或工作平面0.2m.
2. The sampling height is generally 0.8m~1.5m from the ground on the horizontal plane or 0.2m on the working plane 3.采样点数量：
3. Number of sampling points: 洁净室面积A（m²）
Cleanroom area A(m²). | 测试取样点的最小值需测试的最少取样点数（N）
Minimum value of test sampling pointsMinimum number of sampling points to be tested (N) | ≤2 | 1 | ≤4 | 2 | ≤6 | 3 | ≤8 | 4 | ≤10 | 5 | ≤24 | 6 | ≤28 | 7 | ≤32 | 8 | ≤36 | 9 | ≤52 | 10 | ≤56 | 11 | ≤64 | 12 | ≤68 | 13 | ≤72 | 14 | ≤76 | 15 | ≤104 | 16 | ≤108 | 17 | ≤116 | 18 | ≤148 | 19 | ≤156 | 20 | ≤192 | 21 | ≤232 | 22 | ≤276 | 23 | ≤352 | 24 | ≤436 | 25 | ≤636 | 26 | ≤1000 | 27 | >1000 | N=27*（A/1000） | 标注1：若洁净室面积在表中两个值之间，则选取较大值。
Note 1: If the cleanroom area is between the two values in the table, select the larger value. 标注2：在单向气流的情况下，该区域可以看作是垂直气流方向的截面；在其他的所有情况中，可能会被视为洁净室或洁净区的水平投影面积
Note 2: In the case of unidirectional airflow, this area can be regarded as a cross-section in the direction of the vertical airflow; In all other cases, it may be considered as the horizontal projection area of a cleanroom or cleanroom | N：为向上取整的最少取样点数
N: is the minimum number of sample points rounded up A：为洁净室面积（m²）
A: It is the area of the clean room (m²). |
4.具体静态测试下各洁净房间取样点位数量和位置布局参见附件3.
4. See Annex 3 for the number of sampling points and location layout of each clean room under the specific static test. 关键设备和关键活动范围处增加取样点
Increase sampling points at critical equipment and critical activity areas 5.由于动态监测的关键设备和关键活动点位与静态分布点比较接近，将静态测试下附近的点位挪至关键设备和关键活动处，具体动态测试下各洁净房间取样点数量和位置布局参见附件4。
5.Due to the close proximity of the key equipment and key activity points of dynamic monitoring to the static distribution points, the nearby points under the static test are moved to the key equipment and key activities, and the number and location layout of the sampling points in each clean room under the specific dynamic test are shown in the annex4。 | 1. ISO 14644-1 附件B；
1. ISO 14644-1 Annex B; 2.医药工业洁净室（区）悬浮粒子的测试方法；
2. Test methods for suspended particles in clean rooms (areas) of pharmaceutical industry; |
浮游菌/沉降菌
Planktonic/sedimentation bacteria | 1. 浮游菌取样量：Class C，每次采样必须满足C级0.5m3；沉降菌取样时间每次不超过4小时；每天取样一次；
1. Zooplankton sampling volume: Class C, each sampling must meet the level C 0.5m3； The sampling time of sedimentation bacteria shall not exceed 4 hours each time; Samples are taken once a day; 2. 采样高度一般在离地面0.8m～1.5m的水平面上或工作平面0.2m.
2. The sampling height is generally 0.8m~1.5m above the ground on the horizontal plane or 0.2m on the working plane 3.采样点数量：
3. Number of sampling points: Class C最少取样点数量：房间面积＜40m2，按照2点进行取样；40m2≤房间面积≤100m2，按照4点进行取样，房间面积＞100m2，取样点大于6点。
Minimum number of sampling points for Class C: room area < 40 m2, sampling according to 2 points; 40m2≤ room size ≤100m2, according toSampling was carried out at 4 points, the room area was > 100m2, and the sampling point was greater than 6 points. 关键设备和关键活动范围处增加取样点
Increase sampling points at critical equipment and critical activity areas 4. 取样点布局根据医药工业洁净室（区）浮游菌的测试方法（GB/T16293-2010）附件B和沉降菌测试方法（GB/T16294-2010）附件B；
4. The layout of the sampling points is according to Annex B of the test method for planktonic bacteria in the clean room (area) of the pharmaceutical industry (GB/T16293-2010) and the test method for sedimentation bacteria (GB/T16294-2010). Annex B; 5. 具体各洁净房间取样点数量和位置布局参见附件5。
5. Please refer to Annex 5 for the number and location layout of sampling points in each clean room. | GB/T16293-2010 医药工业洁净室（区）浮游菌的测试方法
GB/T16293-2010 Test methods for plankton bacteria in clean rooms (areas) of pharmaceutical industry |
表面微生物
Surface microorganisms | 1.表面微生物检测点选择原则：参考洁净区设备台面、墙面、地面、门、关键活动区域台面进行表面微生物的测试。
1. The principle of selecting surface microbial detection points: refer to the equipment countertop, wall, floor, door, and table top of key activity areas in the clean area for surface microbial testing. 2.具体各洁净房间取样点数量和位置布局参见附件6。
2. See Annex 6 for the number and location layout of sampling points in each clean room. | N/A |
8.3.4 验证执行
8.3.4 Verification Execution
按照《慈城空调系统标准操作规程》QI-GS067正常运行净化空气系统和洁净室；
In accordance with the "Cicheng Air Conditioning System Standard Operating Regulations" QI-GS067 normal operation of the air purification system and clean room;
检测方法根据取样程序《洁净区悬浮粒子监控操作程序》QI-QA023、《洁净区沉降菌监控操作规程》QI-QA021、《洁净区浮游菌监控操作程序》QI-QA053和、《洁净区表面微生物监控操作程序》QI-QC720对悬浮粒子、浮游菌、沉降菌、表面微生物取样；
The detection method is based on the sampling program "Operation Procedures for Suspended Particle Monitoring in Clean Area" QI-QA023 and "Clean Area Operating procedures for the monitoring of sedimentation bacteria" QI-QA021, "Operating procedures for the monitoring of plankton bacteria in clean areas" QI-QA053 and "Clean Area surface microbial monitoring operation procedures》QI-QC720 sampling of suspended particles, planktonic bacteria, sedimentation bacteria, and surface microorganisms;
所有监测样品的培养按照《洁净区沉降菌监控操作规程》QI-QA021、《洁净区浮游菌监控
The culture of all monitored samples was carried out in accordance with the "Operating Procedures for the Monitoring of Sedimentation Bacteria in Clean Areas" QI-QA021 and "Monitoring of Plankton Bacteria in Clean Areas".
操作程序》QI-QA053和、《洁净区表面微生物监控操作程序》QI-QC720执行。
Operation Procedures QI-QA053 and QI-QC720 for Monitoring Microorganisms on the Surface of Clean Areas.
8.3.5 可接受标准
8.3.5 Acceptable Criteria
可接受标准参见本文件第3.3节表2
The acceptability criteria are set out in Table 2 of Section 3.3 of this document
接受标准
Acceptance criteria
完成所有性能确认的活动，PQ中规定的所有项目检查结果均符合接受标准。附上所有的数据表和适当的数据，并对验证方案完成状况进行总结。设备的可接受性决定于PQ的顺利完成并在最终报告中明确说明。
All performance validation activities are completed, and all item inspection results specified in the PQ meet the acceptance criteria. Attach all data sheets and appropriate data, and provide a summary of the completion status of the validation protocol. The acceptability of the equipment is determined by the successful completion of the PQ and is clearly stated in the final report.
记录
Recording
记录1：验证执行人员检查及培训确认表
Log 1: Verification of Execution Inspection and Training Confirmation Form
记录2：仪器仪表校验状态检查结果汇总表
Record 2: Summary table of instrument calibration status inspection results
记录3：物料确认检查表
Record 3: Material Confirmation Checklist
记录4：温湿度测试结果汇总
Log 4: Summary of temperature and humidity test results
记录5：压差测试结果汇总
Record 5: Summary of differential pressure test results
记录6：洁净区悬浮粒子测试结果汇总
Log 6: Summary of cleanroom particulate test results
记录7：洁净区浮游菌结果汇总
Log 7: Summary of plankton results in the clean area
记录8：洁净区沉降菌结果汇总
Log 8: Summary of sedimentation bacteria results in the clean area
记录9：洁净区表面微生物监控结果汇总
Log 9: Summary of microbial monitoring results on the surface of the clean area
记录10：洁净区最多容纳人数研究结果汇总
Log 10: Summary of the results of the Cleanroom Maximum Capacity Study
附件
annex
附件1：取样点数量
Annex 1: Number of sampling points
附件2：KT-3-1温湿度布点图
Appendix 2: KT-3-1 temperature and humidity distribution diagram
附件3：KT-3-1悬浮粒子静态布点图
Attachment 3: KT-3-1 static distribution diagram of suspended particles
附件4：KT-3-1悬浮粒子动态布点图
Appendix 4: KT-3-1 dynamic distribution of suspended particles
附件5：KT-3-1浮游菌/沉降菌布点图
Appendix 5: KT-3-1 Phytoplankton/sedimentation bacteria distribution diagram
附件6：KT-3-1表面菌布点图
Attachment 6: KT-3-1 surface bacterial distribution map
沉浸式翻译