GMP workshop powder production
GMP workshop powder production
GMP pharmaceutical cleanroom powder is powdery granules, with small particle size and large specific surface area, easy to disperse and take effect quickly; externally applied powder has a large coverage area, which can play the role of protection and convergence at the same time; it is more convenient to store, transport and carry; The preparation process is simple, the dosage is easy to control, and it is convenient for infants and young children to take, ...
Text label: GMP pharmaceutical cleanroom purification, GMP pharmaceutical cleanroom design and installation, Zhongjing Global purification
GMP workshop powder production
GMP workshop powder is powdery granules, with small particle size and large specific surface area, easy to disperse and take effect quickly; externally applied powder has a large coverage area, which can play the role of protection and convergence at the same time; it is more convenient to store, transport and carry; The preparation process is simple, the dosage is easy to control, and it is convenient for infants and young children to take, but attention should also be paid to the influence of hygroscopicity, chemical activity, odor, irritation and the like caused by the large dispersion. It should be kept clean, doors, windows, glass, walls and ceilings should be clean and intact, equipment, pipes and pipelines should be neatly arranged and bandaged, without running, running, dripping or leaking, and meeting the relevant cleanliness requirements, check and confirm that there is no residual material on the production site ; Ambient temperature should be controlled at 18-26°C; Ambient relative humidity should be 45%-65%; Ambient light should not be lower than 300xl, and the lampshade should be well sealed; the power supply should be outside the operating room and have corresponding protection measures to ensure safe production ; The relatively clean aisle between the ingredients has a negative pressure of 12Pa.
Unpacking includes the use of vacuum cleaners or cleaning to remove dust particles on the surface of the outer packaging of materials, which is highly polluted, so the unpacking room should be located outside the GMP workshop; a transfer window or a transfer window should be set between the unpacking room and the clean area. The buffer room is used for the transfer of cleaned raw and auxiliary materials, packaging materials and other items. The transfer doors on both sides of the transfer window should have interlocking devices to prevent them from being opened at the same time, with good sealing and easy cleaning; the size and structure of the transfer window should be Meet the size and weight needs of the delivered items. Facilities such as capturing and vacuuming should be installed in the batching room. The technical parameters of the batching equipment should be verified and confirmed. The air inlet of the batching room should have a suitable filter device, and the air outlet should have a device to prevent air from backflowing; 'clearance certificate, whether the relative humidity and pressure difference meet the production requirements, and record the temperature, relative humidity, and pressure difference in the clean area; check whether the turnover containers and production tools used are clean and damaged; check whether the vacuum system is clean; The stainless steel barrels are stored and sealed, and the status marks are attached to the inside and outside of the container, ready for use, and then transferred to the next process. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and clean workshops.
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