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    Home > Medical News > Latest Medical News > Clean room design in the form of GMP in line with international standards

    Clean room design in the form of GMP in line with international standards

    • Last Update: 2014-11-08
    • Source: Internet
    • Author: User
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    With China's accession to the WTO, all walks of life inevitably develop towards nationalization As a special industry related to the national health, the pharmaceutical industry can improve the quality of Chinese medicine if it is connected with the world Zhang Zhengbing, manager of Suzhou Jiahe Environmental Technology Engineering Co., Ltd., shared his many years of design and construction experience in clean room construction in the field of medicine at the 48th national pharmaceutical opportunity International Forum The keynote speech entitled "the impact of the new GMP 2010 on the engineering construction of pharmaceutical plants" was made from three aspects: the technical upgrading of the new GMP, the important problems in the design and construction of the clean room of pharmaceutical plants, the problems in the commissioning and testing of the clean room of pharmaceutical plants, and the handling of the problems The content of the speech is detailed, practical and highly operable 1、 Mr Zhang Zhengbing, the technical upgrade of the new GMP, has listed nine aspects of the technical upgrade of GMP, namely, the standard of the new GMP classification, the occupancy status of the clean room, the air flow and wind speed of the a-area, the self purification time, the sampling amount of the a-area, etc The new gmp-2010 aseptic drug production environment requirements adopt the latest A, B, C and D classification standards of who and EU; the clean room a should use the one-way flow operation platform to maintain the environmental state of the area, and the one-way flow system must be evenly ventilated in its working area, which should have evidence to prove the state of the one-way flow system and be verified 2、 The important problems in the design and construction of clean rooms in pharmaceutical factories, especially the control of the key indexes such as temperature, humidity and cleanliness should be paid attention to in the design and construction of clean rooms in pharmaceutical factories Mr Zhang Zhengbing analyzed several important aspects of design and construction of clean room in pharmaceutical factory vividly based on his practical work 1 Temperature and humidity control in clean room of pharmaceutical factory the temperature and humidity in clean room of pharmaceutical factory shall meet the quality requirements of pharmaceutical production, and the air conditioning system shall be controlled according to the requirements of pharmaceutical production to ensure the requirements of temperature and humidity in clean room 2 Cleanliness control of clean room in pharmaceutical factory the cleanliness of clean room can be divided into four levels: A, B, C and D among them, area a is a high-risk operation area, such as: filling area, open packaging container area where rubber stopper barrel is placed in direct contact with aseptic preparation, aseptic assembly or connection operation area, etc Each grade area has its own strict requirements 3 There are corresponding requirements for the size of clean air supply according to the four cleanliness levels 4 The pollution sources and control of clean rooms in pharmaceutical plants are divided into external and internal pollution sources The external pollution sources are mainly from the outdoor fresh air and the polluted air in the surrounding non clean areas For the control of external pollution sources, the air delivered to the clean room must pass at least three-stage filtration of coarse, medium and high efficiency The second is to maintain the positive difference of the clean room and strengthen the sealing of the clean room structure to avoid the infiltration of the surrounding unclean air The internal pollution source is mainly produced by production equipment and production process, and the operators are the largest pollution source, as well as the pollution brought by equipment, appliances, raw materials, etc 5 Air distribution of clean room in pharmaceutical factory 6 Pressure difference control of clean room in pharmaceutical factory 7 Application of airlock 8 Controlled environment parameters of clean room environment designed and constructed in pharmaceutical factory are designed to meet the requirements of production process and product quality, which should not be raised too high or too strict, or unnecessary energy waste will occur Mixed flow clean room can be used in class AB clean area to reduce the energy consumption of air treatment Do not leave too much safety margin on the pressure head of the fan of the air conditioning unit, otherwise the heat load of the temperature rise of the fan is very objective Air treatment should try to eliminate and reduce the phenomenon of heat and cold counteraction Exhaust air treatment and energy recovery Frequency conversion of fan and water pump Application of LED lighting 9 The selection of A-level aseptic operation environment purification method in the selection of aseptic production plan of drugs, usually from the production technical specifications of drugs, the cost of super clean room plan, the strict regulations to be met and the level of potential hazards, etc to compare and contrast Finally, an optimal technical scheme is found out When aseptic production is involved, three different technical schemes are available for selection at present They are traditional A-level laminar flow, Rabs barrier system and isolator III problems in commissioning and testing of clean room in pharmaceutical factory and Solutions In the construction and use of clean rooms, there are often cases that the controlled environment can not meet the requirements of drug production, such as small purified air supply, unreasonable air distribution, leakage of high-efficiency filter, pressure difference can not be maintained, resulting in the cleanliness can not meet the requirements of drug production, and the air treatment process of purification air conditioning system is unreasonable, etc Common problems are as follows: in situ aerosol scanning leak detection of high efficiency filter; commissioning and stability of pressure gradient in clean room of pharmaceutical factory; the cleanliness can not meet the design requirements during commissioning; the relative humidity of clean room can not meet the requirements of production process, which is related to the specific situation of laminar flow design and construction of pharmaceutical factory, especially the impact of soft capsule process change on air flow organization (reported by the 48th National Pharmaceutical Machinery Association of yaozhi.com)
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