GMP dust-free workshop process water
GMP dust-free workshop process water
The materials of storage tanks, pipes and pipe fittings for the storage and transportation of purified water in the GMP workshop shall be corrosion-resistant, easy to sterilize, and shall be made of high-quality stainless steel with polished inner walls or other materials that do not pollute purified water. Install hydrophobic filters that do not shed fibers; Purified water transport...
Text label: GMP pharmaceutical cleanroom design, GMP workshop installation, process water in clean workshop
GMP dust-free pharmaceutical cleanroom process water
The materials of storage tanks, pipes and pipe fittings for the storage and transportation of purified water in the GMP workshop shall be corrosion-resistant, easy to sterilize, and shall be made of high-quality stainless steel with polished inner walls or other materials that do not pollute purified water. Install a hydrophobic filter that does not shed fibers; the purified water delivery pipeline should adopt a circulation method, and there should be no dead corners where water is retained and difficult to clean during design and installation. The length of the branch pipe should not be greater than 3 times the diameter of the branch pipe. The purified water terminal purification device should be set close to the point of use; the purified water storage and transportation system should be cleaned and disinfected.
The preparation method of water for injection should ensure that its water quality conforms to the current water for injection standards. High-quality stainless steel pipes or other materials that do not pollute the water for injection, the ventilation of the storage tank should be equipped with a hydrophobic sterilizing filter that does not shed fibers; the water for injection pipeline system should adopt a circulation method, and the design and installation should not appear to be stagnant and difficult to use. In the dead corner of the cleaning, the flow rate of the recycled water in the circulating main pipe should not be less than 1m/s, the circulating temperature can be kept above 70 °C, the length of the non-circulating branch pipe should not be greater than 3 times the diameter of the branch pipe, and the water for injection terminal purification device should be installed close to the use. On-line cleaning and on-line disinfection facilities should be set up in the water for injection storage and delivery system. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and dust-free workshops.
The main pipes of the process pipelines should be laid in the technical interlayer or the technical interlayer. The pipelines that need to be dismantled, washed and disinfected should be laid openly. The corrosive material pipes should be laid openly. When it needs to cross the technical interlayer, reliable safety measures should be adopted. Measures; during the design and installation of the process pipeline, there should be no places where the conveying medium is stagnant and difficult to clean; under the premise of meeting the process requirements, the process pipeline should be short; the process pipeline system should be provided with purge ports, drain ports and sampling The direct contact industrial gas purification device should be selected according to the gas source and production process requirements for gas purity, and the gas terminal purification device should be set close to the gas use point; pipelines, pipe fittings and valves should be based on the physical and chemical properties of the conveyed materials. The working conditions are selected, the materials and valves used should meet the process requirements, and the materials should not be adsorbed and polluted; the pipeline materials for conveying sterile media should be made of high-quality stainless steel with polished inner walls or other materials that do not pollute materials; the dry pipe for conveying process materials Soft pipes should not be used, and brittle materials such as cast iron, ceramics, and glass should not be used. When materials with poor plasticity are used, reinforcement and protection measures should be taken. Adaptation; in addition to meeting the process requirements, the valves and pipe fittings on the process pipeline should also adopt a structure that is convenient for disassembly, cleaning and maintenance; the pipeline and equipment should be connected by metal pipes, and when using hoses, metal hoses should be used.
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