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Now the industry extraction and concentration equipment in pharmaceutical machinery industry has achieved the scale of production, variety, production strength and yield level of different, but there is a chance to the development of large-scale professional production industry, but with the trade and economic integration GMP internationalization and international norms, promote the pharmaceutical equipment to strengthen drug GMP the production enterprises obtain better functional concept of urgent needs, GMP become a hot technology equipment and competitiveness of domestic and foreign trade. GMP pharmaceutical water preparation plant has the following requirements:
1. The structure design should be simple, practical, reliable and easy to assemble and disassemble.
2, For the convenience of disassembly and assembly, replacement, cleaning parts, standardized design enforcement agencies, in order to maximize the use of universal, systematic components.
3. A smooth surface inside and outside the equipment requires strong, no dead ends, easy to clean and disinfect. The surface of the parts should be chrome plated, surface treated, corrosion resistant and rustproof. Avoid external coating devices to prevent flaking.
4. The preparation of water purification equipment should be made of low-carbon stainless steel or other effective materials that do not pollute water quality. The preparation of water purification equipment should be cleaned and cleaned regularly.
5, The injection of water contact material must be of high quality, low carbon stainless steel (316L stainless steel, etc.) or other contaminated water proved to be wrong material. The equipment for preparing water for injection should be cleaned and cleaned regularly to ensure that there is no effect.
6, Purified water storage period should not exceed 24 hours, the box should be stainless steel or validation, non-toxic and corrosion resistance, so that other materials do not leak contaminated ions. The vent shall be protected from a hydrophobic filter that does not fall off the fiber. At this stage, no temperature and pressure sensors such as water pollution parameters have been formed. Tanks should be cleaned regularly, sterilized and sterilized, as well as cleaned, sterilized, validated.
7. Transportation of pharmaceutical water
1) Purified water and water should be removed, cleaned and sterilized. Stainless steel pump is convenient. Compressed air and nitrogen should be purified at the time of the injection of pure water and water with compressed air or nitrogen pressure.
2) Purified water should be transported by pipeline. Piping design shall be concise, blinding and death shall be avoided. The pipe shall be made of stainless steel pipe or verified with no poison, corrosion resistance, etc. no leakage pollution ion shall be used. The valve shall be sanitary, with no dead ends, and purified water shall be marked.
3) Transport purified water and injection water pipeline, the pump should be cleaned regularly, disinfection and sterilization, after verification can be put into use.
8, The design of pressure vessel, shall be authorized qualified personnel units, according to the national standard of People's Republic of China China "steel pressure vessel" (gb150-80) and "pressure vessel safety technology supervision regulation" of the relevant provisions.