Dust-free pharmaceutical cleanroom process pipeline
The pipeline that passes through the closed space of the dust-free workshop adopts seamless pipeline, no welding seam, thread, flange and clamp connection interface, and no instruments, valves and pipe fittings are installed; the casing is added outside the pipeline, and the connection between the pipeline and the casing is not provided. There should be reliable sealing measures between them; the interlayer space should be equipped with a combustible gas alarm system...
Text label: Dust-free pharmaceutical cleanroom design, dust-free workshop decoration engineering, dust-free workshop piping requirements
Dust-free workshop process piping
The pipeline that passes through the closed space of the dust-free workshop adopts seamless pipeline, no welding seam, thread, flange and clamp connection interface, and no instruments, valves and pipe fittings are installed; the casing is added outside the pipeline, and the connection between the pipeline and the casing is not provided. There should be reliable sealing measures in the interlayer space; the interlayer space is equipped with a combustible gas alarm system, which is interlocked with the interlayer ventilation system; in order to facilitate the cleaning, cleaning and disinfection of various materials and medium pipeline systems, and to verify the cleaning and disinfection effect, process pipelines The system should be provided with necessary purging ports, purge ports and sampling ports; the gas terminal purification device should be located near the gas use point to avoid pollution of the gas pipeline.
When selecting pipes and valves, they must be treated differently according to the situation. The selection of pipe material and inner wall roughness, valve form and material should meet the process requirements, and should not adsorb and pollute the conveying medium, but also provide convenience for construction and maintenance. ; The material pipeline for preparation production should be made of high-quality stainless steel. Commonly used high-quality stainless steel is 304, 304L, 316, 316L, etc. 304 and 316 steel are often used for pipelines such as conveying acidic media, liquid medicine and purified water in the production of oral liquid; In order to ensure the requirements of the production process of sterile products, high-quality ultra-low carbon stainless steel materials should be used for pipelines conveying sterile materials and water for injection, and the inner wall of the pipelines should be polished and passivated; the valves used in the production of preparations and chemical production It is very different. It requires strict control of the pollution of the valve to the preparation, and requires that the valve body should not cause the accumulation of pollutants. For example, in addition to good tightness, the stainless steel diaphragm valve also has the advantages that the valve parts do not directly contact the liquid medicine and the valve body, which is very suitable. It is also conducive to disinfection and sterilization for the transportation of sterile materials; although the flexible pipeline has the characteristics of convenient connection, optional length, and soft pipeline, it is suitable for occasions where it is not fixed, and it is not suitable as a dry pipe for process materials, especially non-metallic soft pipes. The pipe has strong adsorption, has a certain permeability, cannot be fixedly installed, is not conducive to cleaning, and is easy to age and deform, resulting in leakage of the pipeline medium; the process material dry pipe cannot use brittle materials, which are fragile, easily damaged, and not safe. It is also easy to cause environmental pollution; the cleaning methods of the pipeline system include online cleaning and disassembly cleaning. For the latter, the connection of pipes, valves, and pipe fittings can adopt a quick-opening structure, such as a clamp connection, to facilitate disassembly. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for dust-free workshops and dust-free workshops.
Ordinary flange and threaded connection are easy to accumulate liquid at the connection and breed pollutants. Therefore, for the pipelines of filtered liquid medicine, sterile liquid medicine, purified water and water for injection, the connection between them and valves and fittings The connection should be in the form of clamp connection; in addition to the material that is not easy to contaminate the medium, the sealing gasket of the flange, thread or clamp connection in contact with the material is also required to have the same inner diameter as the inner diameter of the pipeline and smooth edges to avoid liquid accumulation. , become a source of pollution; the material on the surface of the thermal insulation protective layer of the pipeline should be smooth and easy to clean, and there should be no particles falling off to prevent pollution of the dust-free workshop. The protective layer should be made of stainless steel. Subject to the daily cleaning and disinfection of the dust-free workshop, no foreign matter can be released.
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