GMP workshop equipment selection design and installation
GMP workshop equipment selection design and installation
The selection and design of the equipment in the GMP workshop should meet the requirements of production scale and production process. The capacity of the main equipment such as batching, mixing and sterilization for preparation production and the equipment for refining, drying and packaging of APIs should be Compatible with the production batch; equipment in the clean area,...
Text label: GMP workshop design, GMP workshop equipment selection, GMP pharmaceutical cleanroom installation
GMP workshop equipment selection design and installation
The selection and design of the equipment in the GMP pharmaceutical cleanroom should meet the requirements of production scale and production process. The capacity of the main equipment such as batching, mixing and sterilization for preparation production and the equipment for refining, drying and packaging of APIs should be It is suitable for the production batch; the equipment in the clean area should be easy to clean, disinfect or sterilize, which is convenient for production operation and repair and maintenance, and can prevent errors and reduce pollution; parts that need to be cleaned and sterilized should be easy to disassemble and assemble, Equipment that is inconvenient to disassemble and assemble should be provided with a cleaning port, the surface of the equipment should be smooth and easy to clean, and the surface of the equipment should not be coated with easily peeled off. The transmission parts should be well sealed, and the lubricants, coolants, etc. used should not contaminate the tablets or containers; the equipment used in the clean area should be as airtight as possible, and have measures to prevent dust and microbial contamination; The equipment should also meet the needs of sterilization; the closed containers used in the production of sterile preparations should be sterilized by steam, and should be cleaned and sterilized in situ.
Light and flexible material conveying tools should be designed or selected. The conveying tools in areas with different cleanliness levels should not be mixed. The conveying equipment used in the 10,000-class clean room should not pass through other lower-level areas; filter devices that can release fibers should not be used. Otherwise, a non-fiber-releasing filter device must be added, and the use of asbestos-containing filter device is prohibited; the scope of application and precision of the selected production and inspection instruments, meters, measuring instruments, weighing tools, etc. meet the quality requirements of production; The design or selection should be able to meet the relevant requirements of product verification, and test points for relevant parameters should be set reasonably. Production verification should include plant, facility and equipment installation confirmation, operation confirmation, performance confirmation and product verification; when equipment passes through different clean areas, in addition to considering In addition to fixing, reliable sealing and partitioning devices should also be used to prevent pollution; unless there are special requirements for equipment in the clean area, it is generally not suitable to install anchor bolts; for equipment that generates noise and vibration, noise reduction and vibration isolation should be used respectively. Install the device to improve the operating environment; the surface of the insulation layer of the equipment must be smooth and clean, and no particulate matter should fall off. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and sterile workshops.
Pipeline materials should be selected according to the physical and chemical properties and working conditions of the materials to be transported. The materials used should ensure that they meet the process requirements, are reliable in use, do not adsorb and pollute media, and are convenient for construction and maintenance; transport purified water, water for injection, sterile The material of the medium and finished pipes should be made of low-carbon high-quality stainless steel or other non-polluting materials; the materials of the valves and pipe fittings on the process pipes should be compatible with the materials of the pipes where they are located; the material of the open pipes introduced into the clean area should be stainless steel; In addition to meeting the technological requirements, the valves and pipe fittings used in the clean area should adopt a structure that is convenient for disassembly, cleaning and maintenance; the connection between pipes and valves should be flanges, threads or other connectors with excellent sealing performance; This kind of pipeline should be used in the design and installation to avoid the parts that are not easy to clean, and the branch pipes entering the clean room should be hidden; All kinds of pipes are marked with the name and flow direction of the materials in the pipes; the pipelines of power distribution equipment should be hidden, and the pipelines entering the room should be strictly sealed.
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