Eye drops GMP dust-free plant equipment requirements

Eye drops GMP dust-free plant equipment requirements

Water and steam in the GMP pharmaceutical cleanroom for eye drops production are usually transported by pipelines. The rationality of the layout is closely related to the production, management, safety and operation; the dry pipelines should not use flexible pipelines, cast iron, glass, ceramics, etc. Brittle materials, when the plasticity is more...

Text label: GMP workshop for eye drops, equipment requirements for dust-free workshop

Eye drops GMP dust-free plant and equipment requirements

Water and steam in the GMP workshop for eye drops production are usually transported by pipelines. The rationality of the layout is closely related to the production, management, safety and operation; the dry pipelines should not use flexible pipelines, cast iron, glass, ceramics, etc. For brittle materials, when using materials with poor plasticity, there should be reinforcement and protection measures; the dry pipe system should be provided with necessary purging ports, drain ports and sampling ports; technical

The connection of drying pipes in the interlayer and technical channel should be welded; in areas with clean air requirements, the drying pipeline of the process pipeline should be laid in the technical interlayer, technical channel or technical ceiling; pipes not related to GMP dust-free workshops It is not easy to pass through the dust-free pharmaceutical cleanroom, and the pipes should be made of stainless steel. In addition to meeting the process requirements, valves and pipe fittings should adopt a structure that is easy to disassemble, easy to clean, and easy to repair; the dust-free pharmaceutical cleanroom should minimize the laying of pipes, and the necessary pipes should be arranged neatly. , minimize valves, pipe fittings and pipes; pipes passing through the walls, floors and ceilings of the factory building should be laid in the casing, the pipe sections in the casing should not have welding, threads and flanges, and there should be reliable connections between the pipes and the casing. sealing measures.

The water for injection piping system in process water should be made of high-quality low-carbon stainless steel, and welded or flanged connections should be used as much as possible; elbows and other branch pipes or dead pipes that can cause long-term retention should be minimized; continuous circulation should be used for pipelines The closed system should be maintained at a suitable temperature in the pipeline, and it should not be connected with other pipeline systems; the water pipeline should be equipped with cleaning, disinfection and sterilization facilities. The water supply and drainage devices must meet the production requirements to ensure the water consumption and water quality requirements of each process. The drainage equipment must meet the specified requirements and must not cause water accumulation. The drainage floor drain should be S-shaped. Hot water should be provided in the toilets for personnel purification. , hot water pipes should be laid; the drainage equipment in the GMP workshop and the equipment connected to the gravity return pipeline must be equipped with a water seal device below the discharge outlet; there should be less floor drains in the 10,000 GMP workshop, if the setting requires materials that are not easy to corrode, The inner surface is smooth and clean, there is a sealing cover, it is not easy to scale, it is easy to open, it can prevent backflow, and it can be sterilized if necessary. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and dust-free workshops.

The commonly used equipment in the GMP workshop for the production of eye drops are: weighing apparatus, electronic balance, tray torsion balance, stirring equipment, glass, enamel products and stainless steel appliances, various filters of filter paper, microporous membrane, filling device, multi-effect Distilled water, autoclave. In order to prevent the contamination of raw materials, semi-finished products, finished products, packaging containers and materials by leakage of lubricating oil and coolant, the transmission parts of the equipment should be well sealed; in order to prevent cross-contamination, the transmission belt used for material transfer should not pass through different clean areas. It should be transmitted in sections on both sides of the partition wall; in order to prevent the noise and vibration generated by the transmission equipment, muffler and anti-vibration devices should be installed respectively to improve the production environment.

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