标准编号:	GB 50457-2019
中文名称:	医药工业洁净厂房设计标准
英文名称:	Code for design of pharmaceutical industry clean room
行业分类:	GB    国家标准
发布机构:	中华人民共和国住房和城乡建设部
发布日期:	2019-08-12
实施日期:	2019-12-1
标准状态:	现行
替代旧标准:	GB 50457-2008 医药工业洁净厂房设计规范
翻译语言:	英文
文件格式:	PDF
中文字符数:	50000 字
翻译价格(元):	3500.00 元
交付时间:	付款后 1 个工作日

Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.



According to the requirements of Notice on printing and distributing the development and revision plan on engineering construction standards and codes in 2013 (JIANBIAO [2013] No.6) issued by the Ministry of Housing and Urban-Rural Development of the People's Republic of China, the drafting group has formulated this standard through extensive investigation and study, careful drawing of experience from practices, and reference to relevant international and foreign advanced standards and on the basis of widely soliciting for opinions.



The main technical contents of the standard covers general provisions, terms, environmental specification of production area, location selection and general layout of plant, process design, process piping, process equipment, architecture, air purification, water supply and drainage, and electric.



The provisions printed in bold type in this standard are compulsory and must be enforced strictly.



The Ministry of Housing and Urban-Rural Development of the People’s Republic of China is in charge of the administration of this standard; China Pharmaceutical Association of Engineering Design is responsible for the routine management; and SINOPEC Shanghai Engineering Co., Ltd. is responsible for the explanation of specific technical contents. In case of any comment or suggestion during the process of implementing this standard, please send it to SINOPEC Shanghai Engineering Co., Ltd. (address: No. 769, Zhangyang Road, Shanghai 200120, China).

 

Standard for design of pharmaceutical industry clean room



1 General provisions



1.0.1 This standard is formulated with a view to implementing the relevant national policies of China in the design of pharmaceutical industry clean room, so as to ensure advanced technology, safety and reliability, quality, energy conservation and environmental protection.



1.0.2 This standard is applicable to the design of constructed, extended and renovated pharmaceutical industry clean room. Production and quality inspection facilities for biological products, toxic pharmaceuticals, psychotropic pharmaceuticals, narcotic pharmaceuticals and radioactive pharmaceuticals shall comply with the relevant regulatory provisions of the China in addition to this standard.



1.0.3 The design of pharmaceutical industry clean roomy shall create necessary conditions for construction and installation, system facility qualification, maintenance management, repair testing, and safe operation.



1.0.4 The design of pharmaceutical industry clean room shall meet the requirements of the current relevant standards of the China in addition to those of this standard,



2 Terms



2.0.1 pharmaceutical clean room



pharmaceutical production room or a confined space with controlled concentration of airborne particles and microorganisms, as well as such parameters as temperature, humidity, and pressure



2.0.2 pharmaceutical industry clean room



building containing a pharmaceutical clean room, used for pharmaceutical production and quality control



2.0.3 room for cleaning personnel



room in which the personnel are cleaned according to a certain procedure before entering into the clean room



2.0.4 room for cleaning material



room in which the materials are cleaned according to a certain procedure before entering into the clean room



2.0.5 controlled environment



specific area where pollution sources are controlled with specified methods



2.0.6 airborne particles



solid or liquid particles which, for purposes of classification of air cleanliness, suspend in the air with the size of 0.1μm to 1,000μm



2.0.7 microorganisms



bacterial or non-bacterial microscopic biological entities capable of replicating or transferring genetic material



2.0.8 particle concentration



the number of airborne particles per unit volume of air



2.0.9 microorganisms concentration



the number of microorganisms per unit volume of air



2.0.10 air cleanliness



air cleanliness class determined by the numbers of particles and microorganisms of certain particle size per unit volume of air



2.0.11 air pattern



the flow pattern and distribution status of air



2.0.12 unidirectional airflow



approximately parallel controlled airflow passing through the entire section of the clean area at a stable wind speed



2.0.13 non-unidirectional airflow



an airflow distribution in which the air fed into the clean area is mixed with the air in the area inductively



2.0.14 mixed airflow



airflow combining unidirectional and non-unidirectional airflow



2.0.15 airlock



room set up at the access to the pharmaceutical clean room for purpose of blocking airflow outside or from an adjacent room and controlling pressure difference



2.0.16 pass box



window that is set on the partition wall of the pharmaceutical clean room to transfer materials and tools, with casements that cannot be opened at the same time installed on both sides



2.0.17 clean working garment



special working garment used in the pharmaceutical clean room



2.11.18 as-built



completed facility with all powers connected and in operation, but without production equipment, materials or operators



2.0.19 at-rest



the state with all production equipment installed in place, but without production activity or operators on site



2.0.20 in-operation



the facility operates in the specified state at the presence of specified personnel and working in the agreed state



2.0.21 high efficiency particulate air filter



air filter with a capture efficiency of over 99.95% for the particles of most permeable particle size (MPPS) under the rated air volume



2.0.22 process water



water used in the pharmaceutical production process, including drinking water, purified water, and water for injection.



2.0.23 purified water



water for medicinal purposes without any additive, prepared by distillation, ion exchange, reverse osmosis or other suitable methods, with the quality conforming to the provisions under purified water in the current Pharmacopoeia of the People's Republic of China



2.0.24 water for injection



water produced by distillation of purified water, with the quality conforming to the standard for water for injection stipulated in the current Pharmacopoeia of the People's Republic of China



2.0.25 cleanliness recovery characteristic



the time required when the clean air conditioning system starts to operate at the specified air exchange rate after the pharmaceutical clean room is polluted, until it is recovered to the inherent at-rest standard



2.0.26 recovery time



the time required for the airborne particles in the air to reach the at-rest standard after all the production operations in the pharmaceutical clean room are completed and the operators leave the site



2.0.27 sterile



without living microorganisms



2.0.28 sterile product



preparations and active ingredients with sterility test items listed in statutory pharmaceutical standards



2.0.29 non-sterile product



preparations and active ingredients with no sterility test items listed in statutory pharmaceutical standards



2.0.30 aseptic processing



a method to producing sterile products which must be conducted under aseptic control conditions



2.0.31 core(critical)area of aseptic production



area requiring special protection since the pharmaceuticals and packaging materials in direct contact with them are exposed to the environment during aseptic processing



2.0.32 aseptic processing room



pharmaceutical clean room where sterile production process is used for pharmaceuticals production and the environmental parameters are under strict control



2.0.33 sterilize



the process to make the survival probability (i.e. sterility assurance level, SAL) of microorganisms in the product not higher than 10-6



2.0.34 airborne viable particles



colonies reproduced to a number visible under suitable conditions via special culture medium with the airborne microbial particles in pharmaceutical clean room



2.0.35 sedimental viable particles



colonies reproduced to a number visible under suitable conditions via special culture medium with the living microbial particles in the pharmaceutical clean room collected by a specified method



2.0.36 validation



a series of documented activities to prove that any procedure, method, production process, equipment, material, behavior or system can indeed lead to the expected results according to the principles of the current Good manufacturing practices (GMP)



2.0.37 qualification



a series of activities to prove that the plant, facility and equipment can operate properly and achieve the expected results



3 Environmental specification of the production area



3.1 General requirements



3.1.1 The environmental parameters of the pharmaceutical production area shall comply with the requirements of the current Good manufacturing practices.



3.1.2 Particles and microorganisms shall be taken as the main control objects for the pharmaceutical clean room, and at the meantime, the environmental parameters shall also be specified, such as temperature, humidity, pressure difference, illumination, and noise.



3.1.3 There shall be no peculiar smell and substances that affect the quality of pharmaceutical and human health in the ambient air.



3.2 Specification of design requirement



3.2.1 The division of the air cleanliness classes of the pharmaceutical clean room shall meet the requirements in Table 3.2.1.



Table 3.2.1 Air cleanliness class of pharmaceutical clean room

Cleanliness class Maximum allowable number of airborne particles (pcs/m3)

At-rest In-operation

≥0.5μm ≥5.0μm ≥0.5μm ≥5.0μm

Class A 3,520 20 3,520 20

Class B 3,520 29 352,000 2,900

Class C 352,000 2,900 3,520,000 29,000

Class D 3,520,000 29,000 Not stipulated Not stipulated



3.2.2 In-operation standard for monitoring of environmental microorganisms in pharmaceutical clean rooms shall meet the requirements in Table 3.2.2.



Table 3.2.2 In-operation standard for environmental microorganisms monitoring of pharmaceutical clean room

Cleanliness

class Airborne viable particles

cfu/m3 Sedimental viable particles

(φ90 mm)

cfu/4h Surface microorganisms

Contact (φ55 mm)

cfu/dish 5 finger gloves

cfu/glove

Class A <1 <1 <1 <1

Class B 10 5 5 5

Class C 100 50 25 —

Class D 200 100 50 —



3.2.3 The air cleanliness class of relevant processes of pharmaceutical production and the environmental area shall meet the requirements of the current Good manufacturing practices and Annex A to this standard.



3.2.4 The temperature and humidity design parameters of the pharmaceutical clean room shall meet the following requirements:



1 If pharmaceutical production process and products set special requirements for temperature and humidity, they shall be determined according to the requirements of process and products;



2 If pharmaceutical production process and products set no special requirements for temperature and humidity, the temperature of the clean rooms of air cleanliness Classes A, B and C shall be 20℃ ~ 24℃, and the relative humidity shall be 45% ~ 60%; the temperature of the clean rooms of air cleanliness Class D shall be 18℃ ~ 26℃ and the relative humidity shall be 45% ~ 65%;



3 The temperature of rooms for cleaning and living of personnel shall be 16 ℃ ~ 20 ℃ in winter and 26 ℃ ~ 30 ℃ in summer.



3.2.5 The static pressure difference between clean rooms of different air cleanliness classes and that between clean room and non-clean room shall not be less than 10 Pa, and that between clean room and the outdoor atmosphere shall not be less than 10 Pa.



3.2.6 Lighting of the pharmaceutical clean room shall be set according to production requirements and shall meet the following requirements:



1 The illuminance should be 300 lx for general lighting in main working rooms;



2 The illuminance should be 200 lx for auxiliary working rooms, corridors, airlocks, and rooms for cleaning personnel and materials;



3 Local adjustment may be made as necessary for production posts with special requirements for illuminance.



3.2.7 The noise level (as-built) shall not be greater than 60 dB(A) for pharmaceutical clean rooms with non-unidirectional airflow, and that shall not be greater than 65 dB(A) for pharmaceutical clean rooms with unidirectional airflow and mixed airflow.

Foreword
1 General provisions
2 Terms
3 Environmental specification of the production area
3.1 General requirements
3.2 Specification of design requirement
4 Location selection and general layout of plant
4.1 Location selection
4.2 General layout
5 Process design
5.1 Process layout
5.2 Personnel cleaning
5.3 Material cleaning
5.4 Process water
6 Process piping
6.1 General requirements
6.2 Piping material, valve and fitting
6.3 Piping installation and insulation
6.4 Safety technology
7 Process equipment
7.1 General requirements
7.2 Design and selection
8 Architecture
8.1 General requirements
8.2 Fire protection and evacuation
8.3 Interior decoration
9 Air purification
9.1 General requirements
9.2 Clean air conditioning system
9.3 Air pattern and air supply rate
9.4 Duct and accessories
9.5 Monitoring and control
9.6 Requirements for high-potent pharmaceutical clean room
10 Water supply and drainage
10.1 General requirements
10.2 Water supply
10.3 Drainage
10.4 Fire fighting system
11 Electric
11.1 Power distribution
11.2 Illumination
11.3 Communication
11.4 Electrostatic protection and grounding
Annex A Example of classification of air cleanliness for pharmaceutical clean room
Annex B Maintenance and management of pharmaceutical clean room
Annex C Validation of pharmaceutical clean room
Explanation of wording in this standard
List of quoted standards

1 总 则
1.0.1 为在医药工业洁净厂房设计中贯彻执行国家有关方针政策。做到技术先进、安全可靠、确保质量、节能环保，制定本标准。
1.0.2 本标准适用于新建、扩建和改建的医药工业洁净厂房设计。生物制品、毒性药品、精神药品、麻醉药品以及放射性药品的生产和质量检验设施除应执行本标准外，尚应符合国家有关的监管规定。
1.0.3 医药工业洁净厂房的设计应为施工安装、系统设施验证、维护管理、检修测试和安全运行创造必要的条件。
1.0.4 医药工业洁净厂房的设计除应符合本标准外.尚应符合国家现行有关标准规范的规定。
2 术 语
2.0.1医药洁净室pharmaceutical clean room
空气悬浮粒子和微生物浓度，以及温度、湿度、压力等参数受控的医药生产房间或限定的空间。
2.0.2医药工业洁净厂房pharmaceutical industry clean room
包含医药洁净室的用于药品生产及质量控制的建筑物。
2.0.3人员净化用室 room for cleaning personnel
人员在进入医药洁净室之前按一定程序进行净化的房间。
2.0.4物料净化用室 room for cleaning material
物料在进入医药洁净室之前按一定程序进行净化的房间。
2.0.5 受控环境 controlled environment
以规定方法对污染源进行控制的特定区域。
2.0.6悬浮粒子 airborne particles
用于空气洁净度分级的空气悬浮粒子尺寸范围在0.1μm～1000μm的固体和液体粒子。
2.0.7 微生物 microorganisms
能够复制或传递基因物质的细菌或非细菌的微小生物实体。
2.0.8 含尘浓度particle concentration
单位体积空气中：悬浮粒子的数量。
2.0.9 含菌浓度 microorganisms concentration
单位体积空气中微生物的数量。
2.0.10空气洁净度 air cleanliness
以单位体积空气中某种粒径的粒子数量和微生物的数量来区分的空气洁净程度。
2.0.11 气流流型 air pattern
空气的流动形态和分布状态。
2.0.12 单向流 unidirectional airflow
通过洁净区整个断面、风速稳定，大致平行的受控气流。
2.0.13非单向流 non-unidirectional airflow
送入洁净区的空气以诱导方式与区内空气混合的一种气流分布。
2.0.14混合流 mixed airflow
单向流和非单向流组合的气流。
2.0.15 气锁 airlock
在医药洁净室出入口，为了阻隔室外或邻室气流、控制压差而设置的房间。
2.0.16传递柜(窗)pass box
在医药洁净室隔墙上设置的传递物料和工器具的窗口，两侧装有不能同时开启的窗扇。
2.0.17 洁净工作服 clean working garment
医药洁净室内使用的专用工作服。
2.11.18空态 as-built
设施已经建成，所有动力接通并运行，但无生产设备、物料及人员。
2.0.19静态 at-rest
所有生产设备已经安装就位，但没有生产活动且无操作人员在现场的状态。
2.0.20 动态 in-operation
设施以规定的状态运行，有规定的人员在场，并在商定的状态下工作。
2.0.21高效空气过滤器high efficiency particulate air filter
在额定风量下，按最易穿透粒径(MPPS)粒子的捕集效率在99.95％以上的空气过滤器。
2.0.22医药工艺用水process water
医药生产工艺过程中使用的水，包括生活饮用水、纯化水、注射用水。
2.0.23纯化水purified water
蒸馏法、离子交换法、反渗透或其他适宜的方法制得的，不含任何附加剂，供药用的水，其质量符合现行《中华人民共和国药典》纯化水项下的规定。
2.0.24注射用水 water for injection
纯化水经蒸馏制得的水，其质量符合现行《中华人民共和国药典》注射用水项下的规定。
2.0.25 自净时间 cleanliness recovery characteristic
医药洁净室被污染后，净化空气调节系统在规定的换气次数条件下开始运行，直至恢复到固有的静态标准时所需时间。
2.0.26恢复时间 recovery time
医药洁净室生产操作全部结束、操作人员撤出现场，空气中的悬浮粒子达到静态标准时所需时间。
2.0.27无菌 sterile
没有活体微生物存在。
2.0.28无菌药品 sterile product
法定药品标准中列有无菌检查项目的制剂和原料药。
2.0.29非无菌药品 non-sterile product
法定药品标准中未列有无菌检查项目的制剂和原料药。
2.0.30无菌生产工艺 aseptic processing
必须在无菌控制条件下生产无菌药品的方法。
2.0.31无菌生产核心区 core(critical)area of aseptic pro-duction
无菌生产工艺过程中，药品和与药品直接接触的包装材料暴露于环境中从而需要特别保护的区域。
2.0.32无菌生产洁净室 aseptic processing room
采用无菌生产工艺进行药品生产，并且环境参数受到严格控制的医药洁净室。
2.0.33灭菌 sterilize
使产品中微生物的存活概率(即无菌保证水平，SAL)不高于10-6的过程。
2.0.34浮游菌 airborne viable particles
医药洁净室内悬浮在空气中的活微生物粒子，通过专门的培养基，在适宜的生长条件下，繁殖到可见的菌落数。
2.0.35沉降菌 sedimental viable particles
用特定的方法收集医药洁净室内空气中的活微生物粒子，通过专门的培养基，在适宜的生长条件下，繁殖到可见的菌落数。
2.0.36 验证 validation
根据现行《药品生产质量管理规范》(GMP)的原则，证明任何程序、方法、生产工艺、设备、物料、行为或系统确实能导致预期结果的有文件证明的一系列活动。
2.0.37确认 qualification
证明厂房、设施、设备能正确运行并达到预期结果的一系列活动。
3生产区域的环境参数
3.1一般规定
3.1.1 药品生产区域的环境参数应符合现行《药品生产质量管理规范》的规定。
3.1.2医药洁净室应以微粒和微生物为主要控制对象，同时尚应规定环境的温度、湿度、压差、照度、噪声等参数。
3.1.3 环境空气中不应有异味以及影响药品质量和人体健康的物质。
3.2环境参数的设计要求
3.2.1 医药洁净室的空气洁净度级别划分应符合表3.2.1的规定。
表3.2.1 医药洁净室空气洁净度级别
洁净度
级别 悬浮粒子最大允许数(个/m3)
静态 动态
≥0.5μm ≥5.0μm ≥0.5μm ≥5.0μm
A级 3520 20 3520 20
B级 3520 29 352000 2900
C级 352000 2900 3520000 29000
D级 3520000 29000 不做规定 不做规定

3.2.2 医药洁净室环境微生物监测的动态标准应符合表3.2.2的规定。
表3.2.2 医药洁净室环境微生物监测的动态标准
洁净度
级别 浮游菌
cfu/m3 沉降菌
(φ90mm)
cfu/4h 表面微生物
接触(φ55mm)
cfu/碟 5指手套
cfu/手套
A级 <1 <1 <1 <1
B级 10 5 5 5
C级 100 50 25 —
D级 200 100 50 —


3.2.3药品生产有关工序和环境区域的空气洁净度级别，应符合现行《药品生产质量管理规范》和本标准附录A的规定。
3.2.4 医药洁净室的温度和湿度设计参数应符合下列规定：
1药品生产工艺及产品对温度和湿度有特殊要求时，应根据工艺及产品要求确定；
2药品生产工艺及产品对温度和湿度无特殊要求时，空气洁净度A级、B级、C级的医药洁净室温度应为20℃～24℃，相对湿度应为45％～60％；空气洁净度D级的医药洁净室温度应为18℃～26℃，相对湿度应为45％～65％；
3人员净化及生活用室的温度，冬季应为16℃~20℃，夏季应为26℃～30℃。
3.2.5 不同空气洁净度级别的医药洁净室之间以及洁净室与非洁净室之间的空气静压差不应小于10Pa，医药洁净室与室外大气的静压差不应小于10Pa。
3.2.6 医药洁净室的照明应根据生产要求设置，并应符合下列规定：
1主要工作室一般照明的照度值宜为300lx；
2辅助工作室、走廊、气锁、人员净化和物料净化用室的照度值宜为200lx；
3 对照度有特殊要求的生产岗位可根据需要局部调整。
3.2.7非单向流医药洁净室的噪声级(空态)不应大于60dB(A)，单向流和混合流医药洁净室的噪声级(空态)不应大于65dB(A)。
3.2.8仓储区的温度、湿度和照明应符合下列规定：
1常温保存的环境，其温度范围应为10℃～30℃；
2 阴凉保存的环境，其温度范围应为小于或等于20℃；
3凉暗保存的环境，其温度范围应为小于或等于20℃，并应避免直射光照；
4低温保存的环境，其温度范围应为2℃～10℃；
5储存环境的相对湿度宜为35％～75％；
6贮存物品有特殊要求时，应按物品性质确定环境的温度、湿度参数。
4厂址选择和总平面布置
4.1厂址选择
4.1.1 厂区位置的选择应经技术经济方案比较后确定，并应符合下列规定：
1 应设置在大气含尘、含菌浓度低、自然环境较好的区域；
2应远离铁路、码头、机场、交通要道，以及散发大量粉尘和有害气体的工厂、仓储、堆场，远离严重空气污染、水质污染、振动或噪声干扰的区域；不能远离以上区域时，应位于其全年最小频率风向的下风侧。
4.1.2 医药工业洁净厂房净化空气调节系统的新风口与交通主干道近基地侧道路红线之间的距离宜大于50m。
4.2总平面布置
4.2.1 厂区的总平面布置应符合国家有关工业企业总平面设计要求、满足环境保护的要求，同时应避免交叉污染。
4.2.2厂区应按生产、行政、生活、辅助等不同使用功能合理分区布局。
4.2.3 医药工业洁净厂房应布置在厂区内环境清洁，且人流、物流不穿越或少穿越的地段，并应根据药品生产特点布局。
兼有原料药和制剂生产的药厂，原料药生产区应位于制剂生产区全年最小频率风向的上风侧。三废处理、锅炉房等有较严重污染的区域，应位于厂区全年最小频率风向的上风侧。
4.2.4青霉素类等高致敏性药品的生产厂房，应位于其他医药生产厂房全年最小频率风向的上风侧。
4.2.5多条生产线、多个生产车间组合布置的联合厂房，应合理组织人流、物流的走向，同时满足生产工艺流程的要求和消防安全的要求。
4.2.6厂区内设动物房时，动物房宜位于其他医药工业洁净厂房全年最小频率风向的上风侧。
4.2.7厂区内应设置消防车道。消防车道的设置应符合现行国家标准《建筑设计防火规范》GB 50016的有关规定。
4.2.8厂区内主要道路的设置应符合人流、物流分流的原则。医药工业洁净厂房周围的道路面层应采用整体性好、发尘少的材料。
4.2.9医药工业洁净厂房周围应绿化。厂区内空地应采用绿化、碎石或硬地覆盖。厂区内不应种植易散发花粉或对药品生产产生不良影响的植物。
5工艺设计
5.1工艺布局
5.1.1 医药工业洁净厂房的工艺布局应满足下列基本要求：
1应满足药品生产工艺的要求；
2应满足空气洁净度级别的要求。
5.1.2工艺布局应防止人流和物流之间的交叉污染，并满足下列基本要求：
1 应分别设置人员和物料进出生产区域的出入口。对在生产过程中易造成污染的物料应设置专用出入口。
2应分别设置人员和物料进入医药洁净室前的净化用室和设施。
3 医药洁净室内工艺设备和设施的设置应满足生产工艺和空气洁净度级别要求。生产和储存的区域不得用作非本区域内工作人员的通道。
4输送人员和物料的电梯宜分开设置。电梯不宜设置在医药洁净室内。当工艺需要必须在医药洁净室内设置物料垂直输送的装置时，则应采取措施确保医药洁净室的空气洁净度级别不受影响，并避免交叉污染。
5 医药工业洁净厂房内物料传递路线应符合工艺生产流程需要，短捷顺畅。
5.1.3在符合工艺条件的前提下，医药工业洁净厂房内各种固定技术设施的布置应根据净化空气调节系统的要求综合协调。
5.1.4 医药洁净室的布置应符合下列规定：
1在满足生产工艺和噪声要求的前提下，空气洁净度级别高的医药洁净室宜靠近空调机房布置，空气洁净度级别相同的工序和医药洁净室的布置宜相对集中；
2 不同空气洁净度级别医药洁净室之间的人员出入和物料传送应有防止污染的措施。
5.1.5 医药工业洁净厂房内，宜靠近生产区设置与生产规模相适应的原辅料、半成品和成品存放区域。存放区域内宜设置待验区和合格品区，也可采取控制物料待检和合格状态的措施。不合格品应设置专区存放。
5.1.6 高致敏性药品(青霉素类)、生物制品(如卡介苗类和结核菌素类)、血液制品的生产厂房应独立设置，其生产设施和设备应专用。
5.1.7 生产β-内酰胺结构类药品、性激素类避孕药品、含不同核素的放射性药品生产区必须与其他药品生产区严格分开。
5.1.8炭疽杆菌、肉毒梭状芽孢杆菌、破伤风梭状芽孢杆菌应使用专用生产设施生产。
5.1.9某些激素类、细胞毒性类、高活性化学药品生产区应使用专用生产设施。特殊情况下，当采取特别防护措施并经过必要的验证，上述药品制剂则可通过阶段性生产方式共用同一生产设施。
5.1.10下列药品生产区之间应分开布置：
1 中药材的前处理、提取和浓缩等生产区与其制剂生产区；
2动物脏器、组织的洗涤或处理等生产区与其制剂生产区；
3原料药生产区与其制剂生产区。
5.1.11 下列生物制品的原料和成品，不得同时在同一生产区域内加工和灌装：
1 生产用菌毒种与非生产用菌毒种；
2生产用细胞与非生产用细胞；
3强毒制品与非强毒制品；
4死毒制品与活毒制品；
5脱毒前制品与脱毒后制品；
6活疫苗与灭活疫苗；
7不同种类的人血液制品；
8预防类与治疗类制品。
5.1.12原辅料取样区应单独设置，取样环境的空气洁净度级别应与被取样物料的生产环境相同。无菌物料的取样应满足无菌生产工艺的要求，并应设置相应的物料和人员净化用室。特殊药品的取样区应专用。
5.1.13原辅料称量室应专门设计，产尘量大的称量操作应具有粉尘控制的措施。称量室的空气洁净度级别应与生产环境相同。
5.1.14直接接触物料的设备、容器及工器具的清洗间的设置应符合下列规定：
1清洗间应单独设置，清洗间的空气洁净度级别不应低于D级。空气洁净度为A/B级的医药洁净室内不得设置清洗间。
2不便移动的设备应设置在线清洗、在线灭菌设施。A/B级医药洁净室内的在线清洗、在线灭菌设施的下水及蒸汽凝水必须排出本区域外。
3清洗后的物品应在清洁干燥通风的条件下存放。A/B级医药洁净室内使用的物品清洗后应及时灭菌，灭菌后的存放应保证其无菌状态不被破坏。
5.1.15医药洁净室的清洁工具洗涤、存放应设置单独的房间，其空气洁净度级别不应低于D级。A/B级医药洁净室内不应设置清洁工具的洗涤间，清洁工具不宜在A/B级医药洁净室内存放。在A/B级区域内存放的清洁工具必须经过灭菌处理。
5.1.16洁净工作服洗涤、干燥和整理应符合下列规定：
1洗衣间宜单独设置。洁净工作服的洗涤、干燥和整理室，其空气洁净度级别不应低于D级；
2不同空气洁净度级别的医药洁净室内使用的工作服，应分别清洗、整理；
3 A/B级医药洁净室内使用的工作服洗涤干燥后，宜在A级送风保护下整理，并及时灭菌。
5.1.17无菌生产洁净室应专用于采用无菌生产工艺的药品的生产，不应用于其他药品的生产。
5.1.18 无菌生产洁净室应根据无菌生产工艺要求，确定核心生产区并设置必要的防护措施，避免生产过程受到污染。
5.1.19无菌生产洁净室的人流、物流设计必须合理，减少不必要的交叉影响。无菌生产洁净室内不应设置与无菌生产无关的房间。
5.1.20无菌生产洁净室应设置物品传递的通道。传入无菌生产洁净室的物品应有灭菌和消毒设施。
5.1.21 无菌生产洁净室内不应设置地漏和水斗。无菌生产洁净室所用的水应经过灭菌处理。无菌生产洁净室内的设备/器具使用完毕后应移出本区域清洗，并经过灭菌后进入。采用在线清洗/在线消毒的生产设备，其下水/凝水应直接排出无菌生产洁净室外。
s.1.22无菌生产洁净室内设备通气口应设置除菌过滤器。灭菌产生的水蒸气应排出无菌生产洁净室。
5.1.23 无菌生产洁净室应设置环境消毒/灭菌设施，以降低环境的微生物负荷。无菌生产洁净室内使用的清洗剂/消毒剂应经过灭菌/除菌处理。
5.1.24无菌生产洁净室的净化更衣设施应满足本标准第5.2.2条、第5.2.4条的要求。
5.1.25 质量控制实验室的布置和空气洁净度级别应符合下列规定：
1 质量控制实验室应与药品生产区严格分开。无菌检查、微生物检查、抗生素微生物检定、放射性同位素检定和阳性对照实验室等应分开设置。
2 各微生物实验室的设置应符合下列规定：
1)无菌检查实验应在B级背景下的A级单向流洁净区域完成，或在D级背景下的隔离器中进行；
2)微生物限度检查实验应在D级背景下的B级单向流洁净区域进行；
3)阳性对照试验和抗生素微生物检定试验应根据所处理对象的危害程度分类及其生物安全要求，在相应等级的生物安全实验室内进行；
4)各微生物实验室应根据各自的空气洁净度要求，设置相应的人员净化和物料净化设施，并应有效避免互相干扰。
3有特殊要求的分析仪器应设置专门的仪器室并有相应的措施。
4实验动物房应当与其他区域严格分开，并应具有独立的空气处理设施和动物专用通道。
5.1.26 医药工业洁净厂房应设置防止昆虫和其他动物进入的设施。
5.2 人员净化
5.2.1 医药工业洁净厂房内人员净化用室和生活用室的设置应符合下列规定：
1人员净化用室应根据药品生产工艺和空气洁净度级别要求设置。不同空气洁净度级别的医药洁净室的人员净化用室宜分别设置。
2人员净化用室应设置存雨具、换鞋、存外衣、洗手、更换洁净工作服等设施。
3盥洗室、休息室等生活用室可根据需要设置，但不得对药品生产造成不良影响。
5.2.2人员净化用室和生活用室的设计应符合下列规定：
1人员净化用室入口处应设置净鞋设施。
2存外衣区域应单独设置，存衣柜应根据设计人数每人一柜。
3人员净化用室应按气锁设计，脱外衣和穿洁净衣的区域应分开。必要时，可将进入和离开医药洁净室的更衣间分开设置。
4人员净化用室的空气净化要求应符合本标准第9.2.13条的规定。
5厕所和浴室不得设置在医药洁净室内，且不得与生产区和仓储区直接相通。
6青霉素等高致敏性药品、某些甾体药品、高活性药品及其他有毒有害药品的人员净化用室，应采取防止有毒有害物质被人体带出人员净化用室的措施。
5.2.3 医药工业洁净厂房内人员净化用室和生活用室的面积，应根据不同生产工艺要求和工作人员数量确定。