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
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 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
Contents of GB 50457-2019
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
