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YZ—S—051[00]F

KT-3-1洁净室系统性能确认方案
KT-3-1 Cleanroom System Performance Qualification Program

起草人 Drafter	部门 department	职务 office	签字 sign	日期 date
柴力波 Chai Libo	预灌封事业部 Pre-potting Division	暖通工程师 HVAC Engineer
审核人 Reviewers	部门 department	职务 office	签字 sign	日期 date
王彬彬 Wang Binbin	QA部 QA Department	验证主管 Verification Supervisor
刘斌伟 Liu Binwei	QC部 QC Department	QC主管 QC supervisor
崔攀 Cui Pan	预灌封事业部 Pre-potting Division	公用工程经理 Utilities Manager
韩尚池 Han Sang-chi	预灌封事业部 Pre-potting Division	总监 majordomo
批准人 Approver	部门 department	职务 office	签字 sign	日期 date
杨兰萍 Yang Lanping	QA部 QA Department	QA经理 QA Manager

宁波正力药品包装有限公司
Ningbo Zhengli Pharmaceutical Packaging Co., Ltd

目录
directory

1.0 目的 3
1.0 Purpose 3

2.0 范围 3
2.0 Scope 3

3.0 法规符合性 4
3.0 Regulatory Compliance 4

4.0 责任 10
4.0 Liability 10

5.0 空调系统描述 11
5.0 Air Conditioning System Description 11

5.1 空调系统功能描述 11
5.1 Functional description of the air conditioning system 11

5.2 空调系统设计特征 13
5.2 Air conditioning system design features 13

5.3 空调系统关键测试项目 13
5.3 Key test items of air conditioning system 13

5.4 操作程序 13
5.4 Operating Procedure 13

5.5 相关的验证文件 13
5.5 Relevant Validation Documents 13

6.0 方案补充/变更和偏差处理 13
6.0 Scheme additions/changes and deviation handling 13

7.0 培训 14
7.0 Training 14

8.0 性能确认（PQ-Tests） 14
8.0 Performance Validation (PQ-Tests) 14

8.1 PQ-1: 测试用器具状态确认 14
8.1 PQ-1: Test Equipment Status Confirmation 14

8.2 PQ-2:测试物料确认 14
8.2 PQ-2: Test Material Confirmation 14

8.3 PQ-3:关键测试项目 14
8.3 PQ-3: Key Test Item 14

9.0 接受标准 18
9.0 Acceptance Criterion 18

10.0 记录 18
10.0 Record 18

11.0 附件 18
11.0 Annex 18

验证目的
Verification Purposes

本方案的目的是提供书面文件证明慈城厂区注塑车间KT-3-1空调净化系统的性能符合GMP及设计规范需求，持续稳定的提供产品生产所需的环境。
The purpose of this program is to provide written documents to prove that the performance of the KT-3-1 air conditioning purification system in the injection molding workshop of Cicheng plant meets the requirements of GMP and design specifications, and continuously and stably provides the required environment for product production.

范围
range

本性能确认的范围适用于宁波正力药品包装有限公司慈城厂区KT-3-1空调系统和洁净室
The scope of this performance qualification is applicable to the KT-3-1 air conditioning system and clean room of Ningbo Zhengli Pharmaceutical Packaging Co., Ltd. Cicheng Plant

法规符合性
Regulatory compliance

本方案的起草是以符合以下法规、政策和本公司的验证程序要求而编制：
This program has been drafted to comply with the following regulations, policies and the requirements of the Company's verification procedures:

中国GMP现行版要求
The current version of China GMP requirements

参考以下法规:
Refer to the following regulations:

美国现行药品生产质量管理规范
Current Good Manufacturing Practice for Pharmaceuticals in United States

欧盟GMP 2008版
EU GMP 2008 edition

ISO 14644

法规标准要求分析
Analysis of regulatory and standard requirements

以下是相关法规对洁净室各级别的要求识别
The following is an identification of the requirements of the relevant regulations for each level of the cleanroom

表1：洁净区的法规定义
Table 1: Regulatory Definitions for Clean Zones

Item	China-cGMP	EU-GMP	U.S.-cGMP(Dynamic)	ISO-I4644
A	A	A	100（ISO 5）	ISO 5 (Static &Dynamic)
B	B	B	10,000 (ISO 7)	ISO 5(Static) ISO 7(Dynamic)
C	C	C	100,000 (ISO 8)	ISO 7(Static) ISO 8(Dynamic)
D	D	D	Not defined	ISO 8（static）

YZ—S—051[00]F

表1-1： A级洁净区的法规要求
Table 1-1: Regulatory requirements for Class A clean areas

A级区法规要求 Regulation Requirements for the Grade-A Zone
Regulation Requirements for the Grade-A Zone

Items

China-c GMP

EU-GMP

U.S.-c GMP

ISO-I4644

Ningbo Zhengli

洁净等级
Cleanliness level

Cleanness classification

100(Dynamic)

ISO 5 (Static &Dynamic)

(Static)

(Dynamic)

(Static)

(Dynamic)

(Static)

(Dynamic)

悬浮粒子Air borne particle
Air borne particle

0.5μm(pcs/m³)

3,520

5.0μm (pcs/m³)

Not defined

温度Temperature (℃)
Temperature (°C).

Not defined

22±4℃

相对湿度Relative humidit(RH%)
Relative humidit(RH%)

Not defined

55%±10%

不同等级相邻房间压差
Differential pressure between adjacent rooms of different grades

The pressure differential of adjacent rooms of different grades(Pa)

≥10pa

10-15pa

10-15(12.5)pa

5-20pa

≥10pa

浮游菌 Airborne microbe (pcs/m³)
Airborne microbe (pcs/^{m 3}).

Not defined

<1cfu/m³

Not defined

< 1cfu/m³

Not defined

<1cfu/m³

沉降菌 Settling microbe
Settling microbe

Not defined

<1cfu/φ90

mm·4h

Not defined

< 1cfu/φ90

mm·4h

< 1cfu/φ90

mm·4h

Not defined

<1cfu/φ90

mm·4h

<1cfu/φ90

mm·4h

(cfu/ plate)

表面微生物测试contact plates
Surface microbial testing contact plates

Not defined

< 1

Not defined

< 1

Not defined

< 1

(φ55 mm)cfu/plate

人员手套手指测试 glove print5 fingers cfu/glove
Personnel glove finger test glove print5 fingers cfu/glove

Not defined

< 1

Not defined

< 1

Not defined

< 1

表1-2： B级洁净区的法规要求
Table 1-2: Regulatory requirements for Class B clean areas

B级区法规要求- Regulation Requirements for the Grade-B Zone
Regulation Requirements for the Grade-B Zone

Items

China-c GMP

EU-GMP

U.S.-c GMP

ISO-I4644

Ningbo Zhengli

洁净等级
Cleanliness level

Cleanness classification

10,000

(Dynamic)

ISO5(Static)

(Static)

(Dynamic)

(Static)

(Dynamic)

ISO7

(Dynamic)

(Static)

(Dynamic)

悬浮粒子Air borne particle
Air borne particle

0.5μm (pcs/m³)

3,520

352,000

3,520

352,000

35,2000

3,520

352,000

5.0μm (pcs/m³)

2,900

Not defined

2900

2,900

温度Temperature (℃)
Temperature (°C).

Not defined

22±4℃

相对湿度Relative humidit(RH%)
Relative humidit(RH%)

Not defined

55%±10%

不同等级相邻房间压差
Differential pressure between adjacent rooms of different grades

The pressure differential of adjacent rooms of different grades(Pa)

≥10pa

10-15pa

10-15(12.5)Pa

5-20pa

≥10pa

浮游菌 Airborne microbe (pcs/m³)
Airborne microbe (pcs/^{m 3}).

Not defined

10cfu/m³

Not defined

10cfu/m³

Not defined

<1cfu/m³

10cfu/m³

沉降菌 Settling microbe
Settling microbe

Not defined

5cfu/

φ90mm·4h

Not defined

5cfu/

φ90mm·4h

5cfu/

φ90mm·4h

Not defined

<1cfu/φ90

mm·4h

5cfu/

φ90mm·4h

(cfu/ plate)

表面微生物测试contact plates
Surface microbial testing contact plates

Not defined

(φ55 mm)cfu/plate

人员手套手指测试
Personnel glove finger test

glove print5 fingers cfu/glove

Not defined

表1-3： C级洁净区的法规要求
Table 1-3: Regulatory requirements for Class C clean areas

C级区法规要求 Regulation Requirements for the Grade-C Zone
Regulation Requirements for the Grade-C Zone

Items

China-c GMP

EU-GMP

U.S.-c GMP

ISO-I4644

Ningbo Zhengli

洁净等级
Cleanliness level

Cleanness classification

100,000

ISO 7(Static)

(Static)

(Dynamic)

(Static)

(Dynamic)

ISO 8(Dynamic)

(Static)

(Dynamic)

悬浮粒子Air borne particle
Air borne particle

0.5μm (pcs/m³)

352,000

3,520,000

352,000

3,520,000

352,000

3,520,000

5.0μm (pcs/m³)

2,900

29,000

2,900

29,000

Not defined

2,930

2,900

29,000

温度Temperature (℃)
Temperature (°C).

Not defined

22±4℃

相对湿度Relative humidit(RH%)
Relative humidit(RH%)

Not defined

55%±10%

不同等级相邻房间压差
Differential pressure between adjacent rooms of different grades

The pressure differential of adjacent rooms of different grades(Pa)

≥10pa

10-15pa

10-15

（12.5）pa

5-20pa

≥10pa

浮游菌 Airborne microbe (pcs/m³)
Airborne microbe (pcs/^{m 3}).

Not defined

100cfu/m³

Not defined

100cfu/m³

Not defined

10cfu/m³

100cfu/m³

沉降菌 Settling microbe
Settling microbe

Not defined

50cfu/φ90mm·4h

Not defined

50cfu/φ90mm·4h

Not defined

5cfu/φ90mm·4h

50cfu/φ90mm·4h

(cfu/ plate)

表面微生物测试contact plates
Surface microbial testing contact plates

Not defined

(φ55 mm)cfu/plate

人员手套手指测试
Personnel glove finger test

glove print5 fingers cfu/glove

Not defined

表1-4： D级洁净区的法规要求
Table 1-4: Regulatory requirements for Class D clean areas

D级区法规要求-1 Regulation Requirements for the Grade-D Zone
1 Regulation Requirements for the Grade-D Zone

Items

China-c GMP

EU-GMP

U.S.-c GMP

ISO-I4644

Ningbo Zhengli

洁净等级
Cleanliness level

Cleanness classification

Not defined

ISO 8(static)

(Static)

(Dynamic)

(Static)

(Dynamic)

(Static)

(Dynamic)

悬浮粒子Air borne particle
Air borne particle

0.5μm (pcs/m³)

3,520,000

Not defined

3,520,000

Not defined

3,520,000

Not defined

5.0μm (pcs/m³)

29,000

Not defined

29,000

Not defined

29,300

29,000

Not defined

温度Temperature (℃)
Temperature (°C).

Not defined

22±4℃

相对湿度Relative humidit(RH%)
Relative humidit(RH%)

Not defined

55%±10%

不同等级相邻房间压差
Differential pressure between adjacent rooms of different grades

The pressure differential of adjacent rooms of different grades(Pa)

≥10pa

10-15pa

Not defined

5-20pa

≥10pa

浮游菌 Airborne microbe (pcs/m³)
Airborne microbe (pcs/^{m 3}).

Not defined

200cfu/m³

Not defined

200cfu/m³

Not defined

100cfu/m³

200cfu/m³

沉降菌 Settling microbe
Settling microbe

(cfu/ plate)

Not defined

100cfu/

φ90 mm·4h

Not defined

100cfu/

φ90 mm·4h

Not defined

50cfu/φ90mm·4h

100cfu/φ90mm·4h

表面微生物测试contact plates
Surface microbial testing contact plates

Not defined

(φ55 mm)cfu/plate

人员手套手指测试
Personnel glove finger test

glove print5 fingers cfu/glove

Not defined

根据上述法规和本公司要求分析，本性能确认的可接受标准依据下表（表2）要求执行。
According to the analysis of the above regulations and the requirements of the Company, the acceptability criteria for this performance confirmation are implemented in accordance with the requirements of the following table (Table 2).

表2： A/B/C/D级洁净区的验证可接受标准
Table 2: Validation Acceptance Criteria for Class A/B/C/D Clean Areas

测试项目Item Test the item		A		B		C		D
洁净等级Cleanness classification Cleanness classification		A (Static)	A(Dynamic)	B (Static)	B (Dynamic)	C(Static)	C(Dynamic)	D(Static)	D(Dynamic)
悬浮粒子Air borne particle Air borne particle	0.5μ（pcs/m³）	3,520	3,520	3,520	352,000	352,000	3,520,000	3,520,000	Not defined
悬浮粒子Air borne particle Air borne particle		5.0μ（pcs/m³）	20	20	29	2,900	2,900	29,000	29,000	Not defined
温度Temperature （℃） Temperature (°C).		22±4℃	22±4℃	22±4℃	22±4℃	22±4℃	22±4℃	22±4℃	22±4℃
相对湿度 relative humidity Relative humidity（RH%）		55%±10%	55%±10%	55%±10%	55%±10%	55%±10%	55%±10%	55%±10%	55%±10%
不同等级相邻房间压差The pressure differential of adjacent rooms of different grades(Pa) The pressure differential of adjacent rooms of different grades (Pa).		≥10pa	≥10pa	≥10pa	≥10pa	≥10pa	≥10pa	≥10pa	≥10pa
浮游菌 Plankton Airborne microbe （pcs/m³）		<1cfu/m³	<1cfu/m³	<1cfu/m³	10cfu/m³	10cfu/m³	100cfu/m³	100cfu/m³	200cfu/m³
沉降菌 Sedimentation bacteria Settling microbe （cfu/ plate）		<1cfu/φ90mm·4h	<1cfu/φ90mm·4h	<1cfu/φ90mm·4h	5cfu/ φ90mm·4h	5cfu/ φ90mm·4h	50cfu/ φ90mm·4h	50cfu/ φ90mm·4h	100cfu/ φ90mm·4h
表面微生物测试contact plates Surface microbial testing contact plates (φ55 mm) cfu/plate		Not defined	< 1	Not defined	5	Not defined	25	Not defined	50
人员监控 Personnel monitoring glove print5 fingers cfu/glove		Not defined	< 1`	Not defined	5	Not defined	Not defined	Not defined	Not defined

YZ—S—051[00]F

责任
liability

公用工程
Utilities

暖通工程师责起草性能确认方案收集验证数据，
The HVAC engineer is responsible for drafting the performance qualification plan and collecting the verification data

对确认过程中的偏差进行调查，
Investigation of deviations in the confirmation process,

并完成最终的性能确认报告。
and complete the final performance validation report.

审核验证方案，确保其符合分析和检验要求；
Review the validation scheme to ensure that it meets the analysis and inspection requirements;

组织QC部门实施性能确认相关的检验活动；
Organize the QC department to carry out inspection activities related to performance confirmation;

审核验证方案，确保其符合法规要求；
Review validation protocols to ensure compliance with regulatory requirements;

对确认过程中的偏差进行审核，
Review of deviations in the validation process,

组织QA部门支持和监控性能确认的执行；
Organize the QA department to support and monitor the execution of performance confirmations;

审核验证方案和验证报告。
Review the validation plan and validation report.

生产部门
Production department

审核验证方案，确保其符合法规要求；
Review validation protocols to ensure compliance with regulatory requirements;

QA经理
QA Manager

审阅验证方案，确保其符合法规要求；
Review validation protocols to ensure compliance with regulatory requirements;

对确认过程中的偏差、变更进行批准，
Approve deviations and changes in the confirmation process

批准验证方案和验证报告。
Approve the validation protocol and validation report.

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空调系统描述
Air conditioning system description

空调系统功能描述
Functional description of the air conditioning system

KT-3-1空调系统负责对洁净区的送风与控制。新风和回风的混合风经初效过滤器、表冷段、风机段、热水加热段、蒸汽加湿段、中效过滤器、最后通过高效过滤器送入洁净室内。具体的关键组成部分及功能概述参见下表3
The KT-3-1 air conditioning system is responsible for air supply and control in the clean area. The mixed air of fresh air and return air is sent into the clean room through the primary filter, surface cooling section, fan section, hot water heating section, steam humidification section, intermediate filter, and finally through the high-efficiency filter. An overview of the specific key components and functions is shown in Table 3 below

表3：关键组成部分及功能概述
Table 3: Overview of key components and functions

系统 system	主要部件 Main components	功能 function
空调机组 Air conditioning units	箱体 Box	用于固定箱体部件，密封，连接风口。 It is used to fix the box parts, seal and connect the tuyere.
		送风机 Blower	为空调系统提供新风。 Provide fresh air for the air conditioning system.
		初效过滤器 Primary filter	除去空气中的悬浮粒子和微生物 Removes airborne particulates and microorganisms G4 效率对粒径≥5.0μm,过滤效率90＞E≥70% G4 efficiency ≥ 5.0μm for particle size, 90>E≥70% filtration efficiency
		中效过滤器 Intermediate filter	除去空气中的悬浮粒子和微生物。 Removes airborne particulates and microorganisms. F9 效率对粒径≥0.5μm,过滤效率99＞E≥90%。 F9 Efficiency ≥ 0.5 μm for particle size, filtration efficiency 99＞E≥90%。
		表冷器 Surface cooler	冷却降低空气温度或降低空气湿度。 Cooling lowers the air temperature or lowers the humidity of the air.
		热水加热换热器 Hot water heats the heat exchanger	加热提高空气温度。 Heating raises the air temperature.
		蒸汽加湿器 Steam humidifier	空气湿度低时加湿。 Humidify when air humidity is low.
		压差计 Differential pressure gauge	用于监控过滤器的泄漏和堵塞。 It is used to monitor the leakage and clogging of the filter.
风管系统 Duct system	风管 Ducts	输送空气。 Deliver air.
		消音器 muffler	降低噪音。 Reduce noise.
		流量控制阀 Flow control valves	固定调节空气流量。 Fixedly regulated air flow.
		风管连接法兰 Duct connection flange	连接风管。 Connect the duct.
		CAV	定风量系统。 Constant airflow system.
高效过滤器 High-efficiency filters	静压箱 Static pressure box	均衡空气压力和减小噪音。 Equalize air pressure and reduce noise.
		PAO测试孔 PAO test holes	测试高效过滤器的完整性。 Test the integrity of the HEPA filter.
		高效过滤器 High-efficiency filters	除去空气中的悬浮粒子和微生物 Removes airborne particulates and microorganisms H14 效率对最易穿透粒径（MPPS）,过滤效率E〉99.995% H14 Efficiency Filtration efficiency for the most penetrating particle size (MPPS).E〉99.995%
自控系统 Automatic control system	控制柜 Control cabinets	装配控制组件,如：PLC系统 Assembling control components, e.g. PLC systems

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 0.5^m3； 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 > 100^m2, 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

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

序号 serial number	职务 office	姓名 name	签名 signature	是否通过培训 Whether or not they have passed the training
				□是 Yes □ Yes □否 No □ No
				□是 Yes □ Yes □否 No □ No No
				□是 Yes □ Yes □否 No □ No No
				□是 Yes □ Yes □否 No □ No No
				□是 Yes □ Yes □否 No □ No No
				□是 Yes □ Yes □否 No □ No
				□是 Yes □ Yes □否 No □ No No
				□是 Yes □ Yes □否 No □ No No
				□是 Yes □ Yes □否 No □ No No
				□是 Yes □ Yes □否 No □ No
				□是 Yes □ Yes □否 No □ No No
				□是 Yes □ Yes □否 No □ No No
				□是 Yes □ Yes □否 No □ No No
				□是 Yes □ Yes □否 No □ No No
				□是 Yes □ Yes □否 No □ No
				□是 Yes □ Yes □否 No □ No No

该表格可作复印
The form can be photocopied

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

序号 serial number	仪器仪表名称 The name of the instrument	编号 numbering	精度/量程 Accuracy/Range	校正日期 Correction date	有效期限 Expiration date	是否合格 Eligibility
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
						□是 □否 □ Yes □ No
记录人/日期： Recorded by/Date:
复核人/日期： Reviewer/Date:

该表格可作复印
The form can be photocopied

记录3：物料确认检查表
Record 3: Material Confirmation Checklist

序号 serial number	测试项目 Test items	批号 lot number	有效期 expiration date	接受标准 Acceptance criteria	合格/失败 Pass/Fail
1	浮游菌测试培养基平板 Plankton test medium plates			90mm	□P □F
						90mm	□P □F
						90mm	□P □F
2	沉降菌培养基平板 Sedimentation medium plates			90mm	□P □F
						90mm	□P □F
						90mm	□P □F
3	接触平板取样培养基平板 Plate of contact plate sampling medium			55mm	□P □F
						55mm	□P □F
						55mm	□P □F
备注： Remark:
记录人/日期： Recorded by/Date:
复核人/日期： Reviewer/Date:

该表格可作复印
The form can be photocopied

YZ—S—051[00]F

记录4：温湿度测试结果汇总
Record 4: Summary of temperature and humidity test results

温湿度测试记录模板如下，打印记录模板并填写数据。
The temperature and humidity test record template is as follows, print the record template and fill in the data.

YZ—S—051[00]F

测试日期时间：测试状态：□静态 □动态
Test Date & Time: Test Status: □ Static □ Dynamic

房间编号
Room number

Room No.

房间名称
Room name

Room name

面积（m²）
Area (^m2).

Area

测点数
Number of measurement points

Point quantity

测试项
Test items

Test items

测试数据
Test data

Test data

接受标准
Acceptance criteria

Acceptance criteria

通过/失败
Pass/Fail

Pass / Fail

32016

换鞋
Change your shoes

Shoes Changing Room

25.2

温度T/℃
Temperature T/°C

Point 1

Point 2

Point 3

Point 4

Point 5

18~26

□P / □F

湿度H/%RH
Humidity H/%RH

Point 1

Point 2

Point 3

Point 4

Point 5

30~70

□P / □F

32017

男一更
The male one is more

Male Primary Changing Room

9.6

温度T/℃
Temperature T/°C

Point 1

Point 2

Point 3

Point 4

Point 5

18~26

□P / □F

湿度H/%RH
Humidity H/%RH

Point 1

Point 2

Point 3

Point 4

Point 5

45~65

□P / □F

32018

女一更
Female one more

Female Primary Changing Room

11.1

温度T/℃
Temperature T/°C

Point 1

Point 2

Point 3

Point 4

Point 5

18~26

□P / □F

湿度H/%RH
Humidity H/%RH

Point 1

Point 2

Point 3

Point 4

Point 5

45~65

□P / □F

32019

洗衣间
Laundry room

Gowning Cleaning Room

7.2

温度T/℃
Temperature T/°C

Point 1

Point 2

Point 3

Point 4

Point 5

18~26

□P / □F

湿度H/%RH
Humidity H/%RH

Point 1

Point 2

Point 3

Point 4

Point 5

45~65

□P / □F

32020

整衣间
Full walk-in closet

Collation Clothes Room

9.1

温度T/℃
Temperature T/°C

Point 1

Point 2

Point 3

Point 4

Point 5

18~26

□P / □F

湿度H/%RH
Humidity H/%RH

Point 1

Point 2

Point 3

Point 4

Point 5

45~65

□P / □F

32021

中控室
Central control room

Quality Control Room

8.7

温度T/℃
Temperature T/°C

Point 1

Point 2

Point 3

Point 4

Point 5

18~26

□P / □F

湿度H/%RH
Humidity H/%RH

Point 1

Point 2

Point 3

Point 4

Point 5

45~65

□P / □F

32022

洁具间
Sanitary ware room

Cleaning Tools Room

3.6

温度T/℃
Temperature T/°C

Point 1

Point 2

Point 3

Point 4

Point 5

18~26

□P / □F

湿度H/%RH
Humidity H/%RH

Point 1

Point 2

Point 3

Point 4

Point 5

45~65

□P / □F

32023

更衣缓冲间
Locker buffer room

Changing Buffer room

14.2

温度T/℃
Temperature T/°C

Point 1

Point 2

Point 3

Point 4

Point 5

18~26

□P / □F

湿度H/%RH
Humidity H/%RH

Point 1

Point 2

Point 3

Point 4

Point 5

45~65

□P / □F

32024

洁净走廊
Clean corridors

Clean Corridor

51.3

温度T/℃
Temperature T/°C

Point 1

Point 2

Point 3

Point 4

Point 5

18~26

□P / □F

Point 6

Point 7

Point 8

Point 9

Point 10

湿度H/%RH
Humidity H/%RH

Point 1

Point 2

Point 3

Point 4

Point 5

45~65

□P / □F

Point 6

Point 7

Point 8

Point 9

Point 10

32025

物流缓冲间
Logistics buffer room

Logistics Buffer Room

7.7

温度T/℃
Temperature T/°C

Point 1

Point 2

Point 3

Point 4

Point 5

18~26

□P / □F

湿度H/%RH
Humidity H/%RH

Point 1

Point 2

Point 3

Point 4

Point 5

45~65

□P / □F

32026

外清间
Outer clear room

External Cleaning Room

9.3

温度T/℃
Temperature T/°C

Point 1

Point 2

Point 3

Point 4

Point 5

18~26

□P / □F

湿度H/%RH
Humidity H/%RH

Point 1

Point 2

Point 3

Point 4

Point 5

30~70

□P / □F

以上所有指标是否合格All above indicators are qualified ? □P / □F
All above indicators are qualified? □P / □F

备注Remark ：
Remarks:

如遇到有偏差，填写偏差报告号If there is deviation, report the number：
If there is deviation, report the number:

记录人Recorder：
Recorder:

日期Date：
Date:

复核人Reviewer ：
Reviewer:

日期Date：
Date:

该表格可作复印
The form can be photocopied

YZ—S—051[00]F

记录5：压差测试结果汇总
Record 5: Summary of differential pressure test results

压差测试记录模板如下，打印记录模板并填写数据。
The differential pressure test record template is as follows, print the record template and fill in the data.

YZ—S—051[00]F

测试日期时间：测试状态：□静态 □动态
Test Date & Time: Test Status: □ Static □ Dynamic

正压区域
Positive pressure area

Positive pressure area

相邻区域
Adjacent areas

Relative area

设计相
Design phase

对压差
to the differential pressure

Design relative pressure difference (Pa)

实测相
Measured phase

对压差
to the differential pressure

Actual relative pressure difference (Pa)

接受标准
Acceptance criteria

Acceptance criteria (Pa)

通过/失败
Pass/Fail

Pass / Fail

房间编号
Room number

Room No.

房间名称
Room name

Room name

洁净
clean

级别Clean class
Level: Clean class

设计正压
Design positive pressure

Design pressure (Pa)

房间编号
Room number

Room No.

房间名称
Room name

Room name

洁净
clean

级别Clean class
Level: Clean class

设计正压
Design positive pressure

Design pressure (Pa)

32017

男一更
The male one is more

Male Primary Changing Room

32016

换鞋
Change your shoes

Shoes Changing Room

CNC

≥10

□P / □F

32018

女一更
Female one more

Female Primary Changing Room

≥10

□P / □F

32023

更衣缓冲间
Locker buffer room

Changing Buffer room

32017

男一更
The male one is more

Male Primary Changing Room

＞0

□P / □F

32018

女一更
Female one more

Female Primary Changing Room

＞0

□P / □F

32020

整衣间
Full walk-in closet

Collation Clothes Room

＞0

□P / □F

32024

洁净走廊
Clean corridors

Clean Corridor

32021

中控室
Central control room

Quality Control Room

＞0

□P / □F

32022

洁具间
Sanitary ware room

Cleaning Tools Room

＞0

□P / □F

32023

更衣缓冲间
Locker buffer room

Changing Buffer room

＞0

□P / □F

32025

物流缓冲间
Logistics buffer room

Logistics Buffer Room

＞0

□P / □F

32027

注塑车间（三）
Injection Molding Workshop (3)

Injection Molding Workshop III

＞0

□P / □F

32028

注塑车间（一）
Injection Molding Workshop (1)

Injection Molding Workshop I

＞0

□P / □F

32025

物流缓冲间
Logistics buffer room

Logistics Buffer Room

32026

外清间
Outer clear room

External Cleaning Room

CNC

≥10

□P / □F

以上所有指标是否合格All above indicators are qualified ? □P / □F
All above indicators are qualified? □P / □F

备注Remark ：
Remarks:

如遇到有偏差，填写偏差报告号If there is deviation, report the number：
If there is deviation, report the number:

记录人Recorder：
Recorder:

日期Date：
Date:

复核人Reviewer ：
Reviewer:

日期Date：
Date:

该表格可作复印
The form can be photocopied

YZ—S—051[00]F

记录6：洁净区悬浮粒子测试结果汇总
Log 6: Summary of cleanroom particulate test results

洁净区悬浮粒子记录模板如下，打印记录模板并填写数据。
The clean area suspended particle recording template is as follows, print the recording template and fill in the data.

YZ—S—051[00]F

测试日期时间：测试状态：□静态 □动态
Test Date & Time: Test Status: □ Static □ Dynamic

房间编号
Room number

Room No.

房间名称
Room name

Room name

洁净
clean

级别
level

Clean

class

面积（m²）
Area (^m2).

Area

测点数Points
Points

测点Point
Measuring Point

测试数据（≥0.5µm）
Test data (≥ 0.5 μm).

Test data

平均值
Average

（≥0.5µm）

Average

测试数据（≥5.0µm）
Test data (≥ 5.0 μm).

Test data

平均值
Average

（≥5.0µm）

Average

通过/失败
Pass/Fail

Pass / Fail

32017

男一更
The male one is more

Male Primary Changing Room

9.6

□P / □F

32018

女一更
Female one more

Female Primary Changing Room

11.1

□P / □F

32019

洗衣间
Laundry room

Gowning Cleaning Room

7.2

□P / □F

32020

整衣间
Full walk-in closet

Collation Clothes Room

9.1

□P / □F

32021

中控室
Central control room

Quality Control Room

8.7

□P / □F

32022

洁具间
Sanitary ware room

Cleaning Tools Room

3.6

□P / □F

32023

更衣缓冲间
Locker buffer room

Changing Buffer room

14.2

□P / □F

32024

洁净走廊
Clean corridors

Clean Corridor

51.3

□P / □F

P10

32025

物流缓冲间
Logistics buffer room

Logistics Buffer Room

7.7

□P / □F

接受标准Acceptance criteria:
Acceptance criterion criteria:

洁净级别 Cleanliness level Clean class	最大粒子数0.5μm（Pcs/m³） The maximum number of particles is 0.5 μm (Pcs/^m3). Max. No. of particles 0.5μm		最大粒子数5.0μm（Pcs/m³） The maximum number of particles is 5.0 μm (Pcs/^m3). Max. No. of particles 5.0μm
洁净级别 Cleanliness level Clean class		静态 Static Static	动态 dynamic Dynamic	静态 Static Static	动态 dynamic Dynamic
C级 Class C Grade C	≤352,000	≤3,520,000	≤2,900	≤29,000
D级 Class D Grade D	≤3,520,000	N/A	≤29,000	N/A

以上所有指标是否合格All above indicators are qualified ? □P / □F
All above indicators are qualified? □P / □F

备注Remark ：
Remarks:

如遇到有偏差，填写偏差报告号If there is deviation, report the number：
If there is deviation, report the number:

记录人Recorder：
Recorder:

日期Date：
Date:

复核人Reviewer ：
Reviewer:

日期Date：
Date:

该表格可作复印
The form can be photocopied

记录7：洁净区浮游菌结果汇总
Log 7: Summary of plankton results in the clean area

洁净区浮游菌记录模板如下，打印记录模板并填写数据。
The record template of plankton in the clean area is as follows, print the record template and fill in the data.

YZ—S—051[00]F

测试日期时间：测试状态：□静态 □动态
Test Date & Time: Test Status: □ Static □ Dynamic

房间编号/
Room number/

名称
name

洁净级别
Cleanliness level

取样点
Sampling point

数量
quantity

接受标准
Acceptance criteria

对照组结果
Control group results

（cfu/m³）

取样点编号和浮游菌监测结果（cfu/m³）
Sampling point number and zooplankton monitoring results (cfu/m³).

通过/失败
Pass/Fail

□C

□D

动态C: ＜100cfu/m³
Dynamic C: <100cfu/^m3

静态C: ＜10cfu/m³
Static C: <10cfu/^m3

动态D: ＜200cfu/m³
Dynamic D: <200cfu/^m3

静态D: ＜100cfu/m³
Static D: <100cfu/^m3

对照组1
Control group 1

□P □F

对照组2
Control group 2

M10

M11

M12

平均值
average value

备注：
Remark:

如遇到有偏差，填写偏差报告号：
If there is a deviation, fill in the deviation report number:

记录人/日期：
Recorded by/Date:

复核人/日期：
Reviewer/Date:

该表格可作复印
The form can be photocopied

YZ—S—051[00]F

记录8：洁净区沉降菌结果汇总
Record 8: Summary of sedimentation bacteria in the clean area

洁净区沉降菌记录模板如下，打印记录模板并填写数据。
The sedimentation bacteria record template in the clean area is as follows, print the record template and fill in the data.

YZ—S—051[00]F

测试日期时间：测试状态：□静态 □动态
Test Date & Time: Test Status: □ Static □ Dynamic

房间编号/
Room number/

名称
name

洁净级别
Cleanliness level

取样点
Sampling point

数量
quantity

接受标准
Acceptance criteria

对照组结果
Control group results

（cfu/4h）

取样点编号和沉降菌监测结果（cfu/4h）
The number of the sampling point and the monitoring results of the sedimentation bacteria (CFU/4h).

通过/失败
Pass/Fail

□C

□D

动态C: ＜50cfu/4h
Dynamic C: <50cfu/4h

静态C: ＜5cfu/4h
Static C: <5cfu/4h

动态D: ＜100cfu/4h
Dynamic D: <100cfu/4h

静态D: ＜50cfu/4h
Static D: <50cfu/4h

对照组1
Control group 1

□P □F

对照组2
Control group 2

M10

M11

M12

平均值
average value

备注：
Remark:

如遇到有偏差，填写偏差报告号：
If there is a deviation, fill in the deviation report number:

记录人/日期：
Recorded by/Date:

复核人/日期：
Reviewer/Date:

该表格可作复印
The form can be photocopied

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

洁净区表面微生物记录模板如下，打印记录模板并填写数据。
The microbial record template on the surface of the clean area is as follows, print the record template and fill in the data.

YZ—S—051[00]F

测试日期：
Test Dates:

房间编号/名称
Room number/name

洁净级别
Cleanliness level

取样点数量
Number of sampling points

接受标准
Acceptance criteria

取样点编号和结果cfu/碟
Sampling point number and result cfu/dish

通过/失败
Pass/Fail

＜50cfu/碟
<50cfu/dish

□P □F

＜50cfu/碟
<50cfu/dish

□P □F

备注：
Remark:

如遇到有偏差，填写偏差报告号：
If there is a deviation, fill in the deviation report number:

记录人/日期：
Recorded by/Date:

复核人/日期：
Reviewer/Date:

该表格可作复印
The form can be photocopied

测试日期：
Test Dates:

房间编号/名称
Room number/name

洁净级别
Cleanliness level

取样点数量
Number of sampling points

接受标准
Acceptance criteria

取样点编号和结果cfu/碟
Sampling point number and result cfu/dish

通过/失败
Pass/Fail

＜25cfu/碟
< 25cfu/dish

□P □F

＜25cfu/碟
< 25cfu/dish

□P □F

＜25cfu/碟
< 25cfu/dish

□P □F

＜25cfu/碟
< 25cfu/dish

□P □F

＜25cfu/碟
< 25cfu/dish

□P □F

＜25cfu/碟
< 25cfu/dish

□P □F

备注：
Remark:

如遇到有偏差，填写偏差报告号：
If there is a deviation, fill in the deviation report number:

记录人/日期：
Recorded by/Date:

复核人/日期：
Reviewer/Date:

该表格可作复印
The form can be photocopied

YZ—S—051[00]F

记录10：洁净区内最多容纳人数研究结果汇总
Log 10: Summary of the results of the Maximum Capacity Study in the Clean Zone

洁净区内最多容纳人数记录模板如下，打印记录模板并填写数据。
The maximum number of people in the clean area is recorded as follows, print the record template and fill in the data.

YZ—S—051[00]F

测试日期：
Test Dates:

房间编号/名称
Room number/name

洁净级别
Cleanliness level

可接受标准
Acceptable Criteria

人员姓名
The name of the person

进出时间
In and out times

持续时间
duration

（上、下料及运输）
(Loading, unloading and transportation)

通过/失败
Pass/Fail

进入时间
Time of entry

走出时间
Step out of time

□ D

□ C

□ A

温湿度、粒子、微生物等检测项目符合规定
Temperature and humidity, particles, microorganisms and other testing items comply with the regulations

□P □F

备注：
Remark:

如遇到有偏差，填写偏差报告号：
If there is a deviation, fill in the deviation report number:

记录人/日期：
Recorded by/Date:

复核人/日期：
Reviewer/Date:

该表格可作复印
The form can be photocopied

YZ—S—051[00]F

附件1：取样点数量
Annex 1: Number of sampling points

编号
numbering

房间/层流名称
Room/laminar flow name

洁净级别
Cleanliness level

面积（m²）
Area (^m2).

温湿度
Temperature and humidity

悬浮粒子监测
Suspended particle monitoring

浮游菌
Plankton

沉降菌
Sedimentation bacteria

表面微生物
Surface microorganisms

动态最多人数
Dynamic maximum number of people

动态&静态
Dynamic & Static

取样点数量
Number of sampling points

静态
Static

动态
dynamic

取样点数量
Number of sampling points

静态&动态
Static > Dynamic

取样点数量
Number of sampling points

静态&动态
Static > Dynamic

取样点数量
Number of sampling points

动态
dynamic

取样点数量
Number of sampling points

32016

换鞋
Change your shoes

Shoes Changing Room

CNC

25.2

√

N/A

32017

男一更
The male one is more

Male Primary Changing Room

9.6

√

32018

女一更
Female one more

Female Primary Changing Room

11.1

√

32019

洗衣间
Laundry room

Gowning Cleaning Room

7.2

√

32020

整衣间
Full walk-in closet

Collation Clothes Room

9.1

√

32021

中控室
Central control room

Quality Control Room

8.7

√

32022

洁具间
Sanitary ware room

Cleaning Tools Room

3.6

√

32023

更衣缓冲间
Locker buffer room

Changing Buffer room

14.2

√

32024

洁净走廊
Clean corridors

Clean Corridor

51.3

√

32025

物流缓冲间
Logistics buffer room

Logistics Buffer Room

7.7

√

32026

外清间
Outer clear room

External Cleaning Room

CNC

9.3

√

N/A

注：动态最大人数按照平均每人每小时40m³的新风量计算并与车间最大操作人数（含QA，取样，监管人和审计检查人）相结合得出最终结果。悬浮粒子动态监测点位与静态监测点位不一致，主要为动态布点图中操作风险点位的重点布局。
Note: The dynamic maximum number of people is calculated according to the average fresh air volume of 40m3 per person per hour, and combined with the maximum number of operators in the workshop (including QA, sampling, supervisors and audit inspectors) to obtain the final result. The dynamic monitoring points of suspended particles are inconsistent with the static monitoring points, which is mainly the key layout of the operational risk points in the dynamic distribution map.