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GB 50457-2019: Code for design of pharmaceutical industry clean room
Status: Valid GB 50457: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB 50457-2019 | English | 1359 |
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Code for design of pharmaceutical industry clean room
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GB 50457-2019
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| GB 50457-2008 | English | 150 |
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Code for design of pharmaceutical industry clean room
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Basic data | Standard ID | GB 50457-2019 (GB50457-2019) | | Description (Translated English) | Code for design of pharmaceutical industry clean room | | Sector / Industry | National Standard | | Classification of Chinese Standard | P34 | | Classification of International Standard | 91.040.20 | | Word Count Estimation | 184,175 | | Date of Issue | 2019 | | Date of Implementation | 2019-12-01 | | Issuing agency(ies) | Ministry of Housing and Urban-Rural Development of the People's Republic of China; State Administration for Market Regulation | GB 50457-2019: Code for design of pharmaceutical industry clean room---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
1 General
1.0.1 This standard is formulated in order to implement the relevant national guidelines and policies in the design of clean workshops in the pharmaceutical industry, to achieve advanced technology, safety and reliability, quality assurance, energy conservation and environmental protection.
1.0.2 This standard applies to the design of new, expanded and reconstructed pharmaceutical industry clean workshops. The production and quality inspection facilities of biological products, toxic drugs, psychotropic drugs, narcotic drugs and radioactive drugs should not only implement this standard, but also comply with the relevant national regulatory regulations.
1.0.3 The design of clean workshops in the pharmaceutical industry should create necessary conditions for construction and installation, verification of system facilities, maintenance management, inspection and testing, and safe operation.
1.0.4 The design of clean workshops in the pharmaceutical industry shall not only comply with this standard, but also comply with the current relevant national standards and regulations.
2 terms
2.0.1 Pharmaceutical clean room
Airborne particle and microbial concentrations, as well as controlled pharmaceutical production rooms or limited spaces with parameters such as temperature, humidity, and pressure.
2.0.2 Pharmaceutical industry clean room
A building used for pharmaceutical production and quality control that includes pharmaceutical clean rooms.
2.0.3 room for cleaning personnel
A room where personnel are purified according to certain procedures before entering the medical clean room.
2.0.4 room for cleaning material
A room where materials are purified according to certain procedures before entering the pharmaceutical clean room.
2.0.5 controlled environment controlled environment
A specific area where pollution sources are controlled by prescribed methods.
2.0.6 suspended particles airborne particles
Solid and liquid particles in the air suspension particle size range of 0.1 μm to 1000 μm for air cleanliness classification.
2.0.7 Microorganisms
A bacterial or non-bacterial microscopic biological entity capable of replicating or transmitting genetic material.
2.0.8 particle concentration
The number of suspended particles per unit volume of air.
2.0.9 bacteria concentration microorganisms concentration
The number of microorganisms in a unit volume of air.
2.0.10 Air cleanliness
The air cleanliness is distinguished by the number of particles of a certain particle size and the number of microorganisms in a unit volume of air.
2.0.11 air flow type air pattern
Air flow form and distribution state.
2.0.12 Unidirectional airflow
Through the entire section of the clean area, the wind speed is stable, and the controlled airflow is roughly parallel.
2.0.13 non-unidirectional airflow
An airflow distribution in which the air introduced into the clean area is inductively mixed with the air in the area.
2.0.14 mixed airflow
Combination of unidirectional and non-unidirectional airflows.
2.0.15 airlock airlock
At the entrance and exit of a medical clean room, it is a room set up to block the airflow from the outside or adjacent rooms and control the pressure difference.
2.0.16 pass cabinet (window) pass box
On the partition wall of the medical clean room, the window for transferring materials and tools is equipped with windows on both sides that cannot be opened at the same time.
2.0.17 Clean working clothing clean working garment
Special work clothes used in medical clean rooms.
2.0.18 Empty as-built
The facility has been built, all power is connected and running, but there are no production equipment, materials and personnel.
2.0.19 Static at-rest
All production equipment has been installed in place, but there is no production activity and no operators are on site.
2.0.20 Dynamic in-operation
The facility is operating in the specified state, with the specified personnel present and working in the agreed state.
2.0.21 high efficiency particulate air filter high efficiency particulate air filter
Under the rated air volume, the air filter has a collection efficiency of more than 99.95% according to the most penetrable particle size (MPPS).
2.0.22 Process water for pharmaceutical process
Water used in the pharmaceutical production process, including drinking water, purified water, and water for injection.
2.0.23 purified water purified water
The quality of the water used for medicinal purposes, which is produced by distillation, ion exchange, reverse osmosis or other appropriate methods, does not contain any additives, and its quality conforms to the current regulations on purified water in the Pharmacopoeia of the People's Republic of China.
2.0.24 water for injection
The quality of purified water obtained by distillation is in line with the current regulations on water for injection in the Pharmacopoeia of the People's Republic of China.
2.0.25 Self-cleaning time cleanliness recovery characteristic
After the medical clean room is polluted, the purification air conditioning system starts to operate under the specified number of air changes until it returns to the inherent static standard.
2.0.26 recovery time recovery time
The time required for the production and operation of the medical clean room to be completed, the operators to withdraw from the site, and the suspended particles in the air to reach the static standard.
2.0.27 sterile sterile
No living microorganisms are present.
2.0.28 Sterile product
Preparations and raw materials that have sterility inspection items listed in the statutory drug standards.
2.0.29 Non-sterile drug non-sterile product
Preparations and raw materials that do not include sterility inspection items in the statutory drug standards.
2.0.30 Aseptic processing
A method of producing a sterile drug product that must be produced under aseptically controlled conditions.
2.0.31 core (critical) area of aseptic production
During the aseptic production process, the drug and the packaging materials that are in direct contact with the drug are exposed to the environment and thus require special protection.
2.0.32 aseptic processing room
Pharmaceutical clean room that adopts aseptic production process for pharmaceutical production, and the environmental parameters are strictly controlled.
2.0.33 sterilization
The process of making the survival probability of microorganisms in the product (that is, the sterility assurance level, SAL) not higher than 10-6.
2.0.34 Airborne viable particles
The living microbial particles suspended in the air in the medical clean room are propagated to visible colonies under suitable growth conditions through a special medium.
2.0.35 Sedimental viable particles
Use a specific method to collect living microbial particles in the air in a medical clean room, and propagate to a visible number of colonies through a special medium under suitable growth conditions.
2.0.36 Validation validation
A documented set of activities that demonstrates that any procedure, method, manufacturing process, equipment, material, action, or system actually leads to the intended result, in accordance with the principles of current Good Manufacturing Practice (GMP).
2.0.37 confirm qualification
A series of activities to prove that the plant, facilities and equipment can be operated correctly and achieve the expected results.
3 Environmental parameters of the production area
3.1 General provisions
3.1.1 The environmental parameters of the drug production area should comply with the provisions of the current "Good Manufacturing Practice for Drugs".
3.1.2 The pharmaceutical clean room should take particles and microorganisms as the main control objects, and at the same time, parameters such as temperature, humidity, pressure difference, illuminance, and noise of the environment should be specified.
3.1.3 There should be no peculiar smell and substances affecting the quality of medicines and human health in the ambient air.
3.2 Design requirements for environmental parameters
3.2.1 The classification of the air cleanliness level of the medical clean room shall comply with the provisions in Table 3.2.1.
Table 3.2.1 Air cleanliness level of pharmaceutical clean room
3.2.2 The dynamic standards for environmental microbial monitoring in pharmaceutical clean rooms shall comply with the provisions in Table 3.2.2.
Table 3.2.2 Dynamic standards for environmental microbial monitoring in pharmaceutical clean rooms
3.2.3 The air cleanliness level of relevant processes and environmental areas of drug production shall comply with the current "Good Manufacturing Practice for Drugs" and the provisions of Appendix A of this standard.
3.2.4 The temperature and humidity design parameters of the pharmaceutical clean room should meet the following requirements.
1 When the pharmaceutical production process and products have special requirements on temperature and humidity, it should be determined according to the process and product requirements;
2 When the pharmaceutical production process and products have no special requirements on temperature and humidity, the temperature of the pharmaceutical clean room with air cleanliness grades A, B and C should be 20°C to 24°C, and the relative humidity should be 45% to 60%. The temperature of the pharmaceutical clean room with cleanliness level D should be 18 ℃ ~ 26 ℃, and the relative humidity should be 45% ~ 65%;
3 The temperature of personnel purification and living rooms should be 16°C to 20°C in winter and 26°C to 30°C in summer.
3.2.5 The air static pressure difference between medical clean rooms of different air cleanliness levels and between clean rooms and non-clean rooms should not be less than 10Pa, and the static pressure difference between medical clean rooms and the outdoor atmosphere should not be less than 10Pa.
3.2.6 The lighting of the medical clean room should be set according to the production requirements, and should meet the following regulations.
1 The illuminance value of the general lighting in the main studio should be 300lx;
2 The illuminance value of the auxiliary working room, corridor, air lock, personnel purification room and material purification room should be.200lx;
3 The production positions with special requirements for the illumination can be adjusted locally according to the needs.
3.2.7 The noise level (empty state) of the non-unidirectional flow pharmaceutical clean room should not exceed 60dB(A), and the noise level (empty state) of the unidirectional flow and mixed flow pharmaceutical clean room should not exceed 65dB(A).
3.2.8 The temperature, humidity and lighting of the storage area shall comply with the following regulations.
1 The environment for storage at room temperature, the temperature range should be 10°C to 30°C;
2 In a cool storage environment, the temperature range should be less than or equal to 20°C;
3 In a cool and dark storage environment, the temperature range should be less than or equal to 20°C, and direct sunlight should be avoided;
4 The environment for low temperature storage, the temperature range should be 2°C to 10°C;
5 The relative humidity of the storage environment should be 35% to 75%;
6 When there are special requirements for stored items, the temperature and humidity parameters of the environment should be determined according to the nature of the items.
4 Site selection and general layout
4.1 Site selection
4.1.1 The selection of the location of the factory area shall be determined after comparing the technical and economic plans, and shall meet the following requirements;
1 It should be installed in an area with dusty atmosphere, low bacterial concentration and good natural environment;
2 Keep away from railways, wharves, airports, major traffic routes, factories, warehouses, and storage yards that emit a large amount of dust and harmful gases, and areas with severe air pollution, water pollution, vibration or noise interference; if you cannot stay away from the above areas, you should It is located on the downwind side of its annual minimum frequency wind direction.
4.1.2 The distance between the fresh air outlet of the purified air-conditioning system for clean workshops in the pharmaceutical industry and the red line of the main traffic road near the base should be greater than 50m.
4.2 General layout
4.2.1 The overall layout of the factory area should meet the general layout design requirements of relevant national industrial enterprises, meet the requirements of environmental protection, and avoid cross-contamination.
4.2.2 The factory area should be reasonably divided according to different functions such as production, administration, living, and auxiliary functions.
4.2.3 The clean workshops of the pharmaceutical industry should be arranged in areas where the environment is clean in the factory area, and where the flow of people and goods does not or rarely passes through, and should be arranged according to the characteristics of pharmaceutical production.
For pharmaceutical factories that produce both APIs and preparations, the API production area should be located on the windward side of the annual minimum frequency wind direction in the preparation production area. Areas with serious pollution, such as waste treatment and boiler rooms, should be located on the windward side of the minimum frequency wind direction throughout the year.
4.2.4 The production plant of highly allergenic drugs such as penicillins shall be located on the windward side of the annual minimum frequency wind direction of other pharmaceutical production plants.
4.2.5 The joint factory building with multiple production lines and multiple production workshops should reasonably organize the flow of people and logistics, and at the same time meet the requirements of production process and fire safety.
4.2.6 When an animal room is set up in the factory area, the animal room should be located on the windward side of the annual minimum frequency wind direction of other clean workshops in the pharmaceutical industry.
4.2.7 Fire lanes should be set up in the factory area. The setting of fire lanes shall comply with the relevant provisions of the current national standard "Code for Fire Protection Design of Buildings" GB 50016.
4.2.8 The main roads in the factory area should be set up in accordance with the principle of flow of people and logistics. The road surface around the clean workshop of the pharmaceutical industry should adopt materials with good integrity and less dust generation.
4.2.9 Greening should be done around the clean workshops of the pharmaceutical industry. The open space in the factory area should be covered with greenery, gravel or hard ground. Plants that are easy to emit pollen or have adverse effects on drug production should not be planted in the factory area.
5 process design
5.1 Process layout
5.1.1 The process layout of the pharmaceutical industry clean workshop should meet the following basic requirements.
1 It should meet the requirements of the pharmaceutical production process;
2 It should meet the requirements of air cleanliness level.
5.1.2 The process layout should prevent cross-contamination between people and goods, and meet the following basic requirements.
1 The entrances and exits for personnel and materials entering and exiting the production area shall be set up respectively. Special entrances and exits should be set up for materials that are likely to cause pollution during the production process.
2 The purification rooms and facilities before personnel and materials enter the medical clean room should be set up respectively.
3 The setting of process equipment and facilities in the pharmaceutical clean room should meet the requirements of production process and air cleanliness level. Production and storage areas shall not be used as passages for non-local workers.
4 Elevators for transporting personnel and materials should be set up separately. Elevators should not be installed in medical clean rooms. When the process needs to set up a device for vertical conveying of materials in the medical clean room, measures should be taken to ensure that the air cleanliness level of the medical clean room is not affected and cross-contamination is avoided.
5 The material transfer route in the clean workshop of the pharmaceutical industry should meet the needs of the process and production process, and be short, fast and smooth.
5.1.3 Under the premise of meeting the process conditions, the layout of various fixed technical facilities in the clean workshop of the pharmaceutical industry should be comprehensively coordinated according to the requirements of the purified air conditioning system.
5.1.4 The layout of the medical clean room should meet the following requirements;
1 Under the premise of meeting the production process and noise requirements, the medical clean room with high air cleanliness level should be arranged close to the air-conditioning machine room, and the procedures and medical clean rooms with the same air cleanliness level should be relatively concentrated;
2 There should be measures to prevent pollution for personnel access and material transfer between medical clean rooms of different air cleanliness levels.
5.1.5 In the clean workshop of the pharmaceutical industry, it is advisable to set up storage areas for raw materials, semi-finished products and finished products that are suitable for the production scale close to the production area. In the storage area, it is advisable to set up an area to be inspected and an area for qualified products, and measures to control the status of materials to be inspected and qualified can also be taken. Unqualified products should be stored in special areas.
5.1.6 The production workshops for highly allergenic drugs (penicillins), biological products (such as BCG and tuberculin) and blood products should be set up independently, and their production facilities and equipment should be dedicated.
5.1.7 The production area of β-lactam structure drugs, sex hormone contraceptive drugs, and radioactive drugs containing different nuclides must be strictly separated from other drug production areas.
5.1.8 Bacillus anthracis, Clostridium botulinum and Clostridium tetani should be produced in dedicated production facilities.
5.1.9 Certain hormone, cytotoxic and highly active chemical production areas should use dedicated production facilities. Under special circumstances, when special protective measures are taken and necessary verifications are carried out, the above-mentioned pharmaceutical preparations can share the same production facility through phased production.
5.1.10 The following pharmaceutical production areas shall be arranged separately.
1 The production area of pre-treatment, extraction and concentration of Chinese herbal medicines and its preparation production area;
2 Production areas for washing or processing animal organs and tissues and their preparations;
3 API production area and preparation production area.
5.1.11 The raw materials and finished products of the following biological products shall not be processed and filled in the same production area at the same time.
1 Bacteria and viruses for production and non-production bacteria and viruses;
2 Production cells and non-production cells;
3 strong toxic products and non-strong toxic products;
4 Dead poison products and live poison products;
5 Products before and after detoxification;
6 live vaccines and inactivated vaccines;
7 different kinds of human blood products;
8 Preventive and therapeutic products.
5.1.12 The sampling area for raw and auxiliary materials should be set separately, and the air cleanliness level of the sampling environment should be the same as the production environment of the sampled materials. Sampling of aseptic materials should meet the requirements of aseptic production process, and corresponding material and personnel purification rooms should be set up. Sampling areas for special drugs should be dedicated.
2 The setting of each microbiological laboratory shall meet the following requirements.
1) The sterility inspection experiment should be completed in a class A unidirectional flow clean area with a class B background, or in an isolator with a class D background;
2) The microbial limit inspection experiment should be carried out in the B-level unidirectional flow clean area under the D-level background;
3) The positive control test and antibiotic microbiological test should be carried out in a biosafety laboratory of the corresponding level according to the classification of the hazard degree of the treated object and its biosafety requirements;
4) Each microbiology laboratory should set up corresponding personnel purification and material purification facilities according to their respective air cleanliness requirements, and should effectively avoid mutual interference.
3 Analytical instruments with special requirements should be equipped with special instrument rooms and corresponding measures.
4 The experimental animal room should be strictly separated from other areas, and should have independent air treatment facilities and special passages for animals.
5.1.26 The clean workshops of the pharmaceutical industry should be equipped with facilities to prevent the entry of insects and other animals.
5.2 Personnel decontamination
5.2.1 The setting of personnel purification room and living room in the pharmaceutical industry clean workshop should meet the following requirements.
1 The personnel purification room should be set according to the pharmaceutical production process and air cleanliness level requirements. The personnel purification rooms of the medical clean rooms with different air cleanliness levels should be set up separately.
2 The personnel purification room should be equipped with facilities for storing rain gear, changing shoes, storing coats, washing hands, and changing clean work clothes.
3 Toilets, lounges and other living rooms can be set up according to needs, but they must not have adverse effects on the production of medicines.
5.2.2 The design of personnel purification room and living room should meet the following requirements.
1 Cleaning shoes facilities should be installed at the entrance of the personnel decontamination room.
2 The coat storage area should be set up separately, and the storage wardrobe should be one cabinet per person according to the designed number of people.
3 The personnel purification room should be designed according to the air lock, and the area for taking off coats and wearing clean clothes should be separated. If necessary, the changing rooms for entering and leaving the medical clean room can be set separately.
4 The air purification requirements of the personnel purification room shall meet the provisions of Article 9.2.13 of this standard.
5 Toilets and bathrooms shall not be set in the medical clean room, and shall not be directly connected with the production area and storage area.
6 Penicillin and other hypersensitivity...
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