Layout design and decoration of pharmaceutical GMP workshop
Pharmaceutical GMP pharmaceutical cleanroom design, selection and installation should meet production requirements, be easy to clean, disinfect or sterilize, facilitate production operation and repair and maintenance, and prevent errors or reduce pollution; the surface of equipment in direct contact should be smooth and smooth , Easy to clean or sterilize, Corrosion resistant, design...
Text label: Design and decoration of pharmaceutical GMP workshop, GMP workshop layout, pharmaceutical pharmaceutical cleanroom decoration
Pharmaceutical GMP workshop layout design and decoration
Pharmaceutical GMP workshop design, selection and installation should meet production requirements, be easy to clean, disinfect or sterilize, facilitate production operation and repair and maintenance, and prevent errors or reduce pollution; the surface of equipment in direct contact should be smooth and smooth , easy to clean or sterilize, corrosion-resistant, lubricants, coolants, etc. used in the equipment shall not cause pollution to medicines or containers; the main fixed pipes connected to the equipment shall be marked with the name and flow direction of the materials in the pipes; the preparation and storage of purified water and water for injection and distribution should be able to prevent the growth and contamination of microorganisms, the materials used for storage tanks and conveying pipelines should be resistant to corrosion, the design of pipelines should avoid dead corners and blind pipes, and the cleaning and sterilization cycles should be specified for storage tanks and pipelines. Ventilation of water for injection storage equipment The mouth should be equipped with a hydrophobic sterilizing filter that does not fall off fibers; the storage of water for injection can be stored at 70 °C with a heat preservation cycle or below 4 °C; instruments, meters, measuring tools, weighing instruments, etc. used for production and inspection, their scope of application And the precision should meet the production and inspection requirements, have obvious qualification marks, and check regularly.
The equipment layout in the workshop is as consistent as possible with the technological process, and the technological process is used as much as possible to make the material flow automatically, so as to avoid the phenomenon of intermediates and products and cross round-trip; The main equipment such as reactors are arranged in the middle layer, and the storage tank and heavy equipment are arranged in the lowest layer; the equipments that are related to each other during operation should be arranged close to each other, except for maintaining the necessary distance to take into account the reasonable operating range, the convenience of pedestrians, In addition to the transportation of materials, consideration should also be given to setting aside a certain amount of raw materials, semi-finished products, and finished products around the equipment. If necessary, it can be used as a general maintenance site. It is also necessary to consider the minimum width of the equipment handling channel and leave workshops. Expansion location; equipment layout should be as symmetrical as possible, the same or similar equipment should be arranged centrally, and the possibility and convenience of mutual exchange should be considered to give full play to the potential of the equipment; about the distance between the equipment and the wall, the distance between the equipment There are certain specifications for the standard of the equipment and the standards for the passages and sidewalks for transporting equipment, which should be followed in the design. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and GMP workshops.
Under the principle of not affecting the technological process, the centralized arrangement of higher equipment can simplify the three-dimensional layout of the workshop and avoid the waste of building volume caused by the disparity of equipment height; Vibrating equipment, such as compressors and centrifuges, should be arranged on the ground floor of the factory building as much as possible to reduce the load and vibration of the factory building. These devices should be avoided from being installed on the operating table. Placed on the upper side of the beam, the perforation of the equipment must avoid the main beam; the operating table must be considered uniformly to avoid the random repetition of the platform pillars, so as to save the area occupied by the factory buildings; the entrances and exits of the factory buildings, traffic roads, and stairs must be carefully designed and Arrangement; when arranging equipment, the possibility of installation, maintenance and disassembly of the equipment and the methods and methods must be considered.
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