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New GMP for pharmaceutical equipment |
| Publisher: Suzhou Huanke Pharmaceutical Equipment Technology Co., Ltd Time：2023-03-03 21:20:38 Number of clicks：273 Close |
1, purified water equipment, water for injection equipment storage tank and pipeline materials should be non-toxic and corrosion-resistant.
Dead corners and blind pipes should be avoided; The preparation, storage and distribution of purified water and water for injection should be able to prevent the growth of microorganisms. Purified water can be circulated, and water for injection can be circulated at a temperature above 70 C. The new GMP puts forward higher requirements for the design of the whole purified water equipment and injection equipment, and also puts forward corresponding requirements for monitoring records during operation. In order to effectively control microbial contamination and the level of bacterial endotoxin, the design of preparation, storage and distribution system was changed from traditional water supply pipeline to circulation system, and more online monitoring and recording equipment was added and more disinfection and sterilization equipment was adopted accordingly. (1) Pretreatment equipment requirements of purified water equipment In order to prevent raw water pollution, the raw water quality of pretreatment equipment of purified water equipment must meet the national drinking water quality requirements (refer to GB 5749-2006 for standards); Multi-media filters and water softeners require automatic backwashing, regeneration and discharge; As a concentrated place of organic matter, activated carbon filtration should not only meet the above requirements, but also add steam disinfection function; Considering that the intensity of ultraviolet light is inversely proportional to time, a time and intensity recorder is required; In order to keep the water quality stable, the deionized water in the mixed bed should be recycled; (2) Requirements for preparation of purified water Purified water is generally prepared by distillation, ion exchange and reverse osmosis, and different solid preparation methods have different requirements, such as: ion exchange method adopts mixed bed, which should be able to regenerate continuously, and has measures of continuous flow at no flow rate and low flow rate to ensure continuous circulation; Using reverse osmosis method, a 3.0um water filter must be installed at the inlet of the device; If distillation is used, a multi-effect distiller should be used, and the inner wall of 316L stainless steel should be electropolished (polishing degree Ra^240 mesh) and passivated. (3) Requirements for water production of water equipment for injection People's Republic of China (PRC) Pharmacopoeia (2010 edition) makes it clear that water for injection is distilled from purified water, and pyrogen is removed by steam-water separator. The multi-effect distiller made of 316L medical grade stainless steel is adopted, and the inner wall of the 316L stainless steel material should be electropolished (polishing degree Ra<240 mesh) and passivated; Equipped with instruments for measuring, recording and automatically controlling conductivity, when the conductivity exceeds the set value, it will automatically turn to drainage. (4) Requirements for storage tanks of purified water equipment The basic requirements of storage tanks are to prevent the formation of biofilm, reduce corrosion and facilitate the disinfection of storage tanks with chemicals; The storage tank should be sealed and the inner surface should be smooth, which is helpful for thermal disinfection and chemical disinfection and can prevent the formation of biofilm. To compensate for the change of water level in storage tanks, two methods, respirator and automatic nitrogen charging, are usually adopted. Made of 316L stainless steel, the inner wall is electropolished and passivated; 0.2um hydrophobic breather filter (respirator) is installed on the storage tank and can be heated and disinfected or jacketed; Can withstand the sterilization of high temperature steam at least 121°C; The drain valve adopts stainless steel diaphragm valve; If nitrogen is filled, it must be filtered with a hydrophobic filter of 0.2um. (5) Requirements of pump for purified water equipment Adopt 316L stainless steel (immersion part), electro-polishing and passivation treatment; Sanitary chuck is used as connecting piece; The lubricant is purified water or water for injection itself; Can completely eliminate stagnant water. (6) Requirements of heat exchanger The heat exchanger is used to heat or cool water for injection, or as clean steam for cooling and condensing. Its basic requirements are as follows: made of 316L stainless steel; Design according to hygiene requirements; Electropolishing and passivation treatment; Can completely eliminate stagnant water. (7) Requirements of pipeline and distribution system Piping and distribution system should consider continuous circulation and regular cleaning and disinfection. A circulating system is easy to maintain normal operation. In order to prevent the formation of biofilm, the effluent of the delivery pump should be "turbulent", and the low flow rate should be avoided in the process of distribution and discharge; The inner wall of 316L stainless steel pipe is electropolished and passivated. The connection mode can be hot-melt argon arc welding or sectional connection of sanitary chuck; In order to remove dissolved impurities and microorganisms in the valve body, the valve adopts stainless steel PTFE diaphragm valve; The pipeline installation of distribution system should have sufficient slope and discharge point, so that the system can be completely emptied when necessary; The circulating pipeline is adopted, and the backwater flows into the storage tank and is connected in series. The length of the "blind pipe" section at the point of use valve shall not be greater than 6 times the pipe diameter for the heating system and 4 times the pipe diameter for the cooling system; The pipeline is disinfected with clean steam at a disinfection temperature of 121 C. 3. The water quality of raw water and purified water equipment should be tested regularly, and the operating parameters of purified water equipment should be recorded accordingly, giving full consideration to the regular cleaning and disinfection of pipeline distribution system. There are usually two kinds of operation modes: batch operation mode, in which water is used as a product to form a batch number, and from the perspective of safety, a certain amount of water is isolated during the test period until the test results are available; Direct-flow operation mode, continuous water supply, while preparing and using. In order to ensure that water is under control from beginning to end, it is very important to establish a regular monitoring mechanism for verification and safe use. The daily management requirements are as follows: management according to operation and maintenance procedures; Make monitoring plans for key water quality parameters and operation parameters, including calibration and implementation of key instruments; Make regular disinfection/sterilization plan and implement it; Prepare preventive maintenance plan and implementation of equipment; Management of key preparation equipment (including main parts), pipeline distribution system and change of operating conditions. |
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Suzhou Huanke Pharmaceutical Equipment Technology Co., Ltd.
Suzhou Chenglang Cleaning Equipment Co., Ltd.
Contact: Zhang Gong
Tel：15150275957
Email：285145232@qq.com
Company website： http://www.szhuanke.com
Add：No. 366, Jinxian Road, Jinjiaba Town, Wujiang District, Suzhou City, Jiangsu Province
Su ICP No. 2022043966-1
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