Construction of small volume injection purification plant
Construction of small volume injection purification plant
The layout of the ampoule filling and sealing linkage line in the injection purification plant includes: linear layout and L-shaped layout. The L-shaped layout equipment sets the filling system components on the operation surface, and makes the back of the equipment against the wall; equipment operation includes normal Dismantling of production operations, sampling and filling components...
Text label: Injection purification plant, purification engineering construction
Small volume injection purification plant construction
The layout of the ampoule filling and sealing linkage line in the injection purification plant includes: linear layout and L-shaped layout. The L-shaped layout equipment sets the filling system components on the operation surface, and makes the back of the equipment against the wall; equipment operation includes normal Production operations, disassembly and installation of sampling and filling parts are located in the C or B level area, and equipment maintenance and maintenance are located in the D level washing and drying room. D-level discharge; realizes the effective separation of operation area and maintenance area, personnel and logistics, reduces the pollution of maintenance to the environment, and adopts L-shaped layout to reduce the area of u200bu200bC or B-level area.
Ampoule filling and sealing linkage line is mainly composed of ampoule vertical ultrasonic cleaning machine, tunnel type sterilization dryer and ampoule filling and sealing machine. The tunnel type sterilization dryer adopts long box hot air circulation or infrared radiation heating for drying and sterilization, mainly to meet the needs of continuous production and depyrogenation sterilization. Depyrogenation sterilization of vials is an important part of aseptic filling operations. The preheating laminar flow section is mainly composed of primary air filter, preheating laminar flow box, preheating laminar flow fan, damper regulator, air hood, high efficiency filter, filter installation frame, ultrasonic transducer, dehumidification It is composed of an exhaust fan and other components. During the process of the bottle passing through the preheating section, the dehumidifying fan sucks away the hanging water outside the bottle and the humid and hot air in the heating section. The hot air from the heating section dries and preheats the bottle to ensure that the inside of the tunnel is The temperature gradient reduces the thermal shock of the vial. The drying and sterilizing laminar flow section is mainly composed of a heating box, a heating laminar flow fan, a cooling water pipe system, an electric heating pipe, a wind hood, a high-temperature high-efficiency filter, a primary filter, etc. The loss of air volume in the cavity is supplemented, and the seal is equipped with a primary filter. In order to improve air uniformity to achieve good heat uniformity, a flow equalization device is installed above the high-efficiency filter from the fan outlet and below the transmission mesh belt; according to GMP requires that after the vial is heated, the depyrogenation process needs to achieve a reduction of at least 3 logarithmic units. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for purification workshops and sterile workshops.
Use purified water or water for injection for cleaning in production to avoid recontamination of the container, and the final rinsing water should meet the requirements of water for injection; the cleaning process must be verified, and the verification parameters include ultrasonic water bath maintenance time, water bath temperature, The spray water pressure in the container, the pressure of the compressed air, the remaining water volume after the compressed air is introduced, the number of cycles, the bottle washing speed, the water pressure, the insoluble particles, the visible foreign matter in the ampoules after washing, etc. The main points of cleaning and sterilization process control are: the cleanliness observation of the bottle, the temperature observation and recording of the sterilization process, the regular replacement of air and water filter elements, and the pressure control during air and water filtration.
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