GMP purification workshop engineering piping system
GMP purification workshop engineering piping system
The GMP purification workshop piping system is mainly used for the transportation and distribution of process water, process gas, and prepared liquid medicine, such as water for injection, purified water, pure steam, clean compressed gas, etc.; For enterprises producing sealing machines, the pipeline distribution system is especially...
Text label: GMP purification workshop piping system, clean engineering design and installation
GMP purification workshop engineering piping system
The GMP purification workshop piping system is mainly used for the transportation and distribution of process water, process gas, and prepared liquid medicine, such as water for injection, purified water, pure steam, clean compressed gas, etc.; For enterprises producing sealing machines, the pipeline distribution system is particularly important. The distribution system pipelines should be designed with a reasonable inclination, the flow of the branch pipelines, and the pressure on the machine should be balanced and balanced, and each distribution pipeline should be effective. Independent control facilities and equipped with a detection system, from the concentration distribution to the end of potting, all material transportation should be completed through a closed pipeline system. According to the design scheme of the system, the pipeline system is divided into lengthened pipe fittings and ordinary pipe fittings according to the welding method, and 316L pipe fittings and 304L pipe fittings according to the material; according to the different types of process water, there are many kinds of valves. During the operation of the system, the valve used has no pollution to the process water, no shedding, and the valve material has good chemical inertness. The structure of the valve should not be conducive to the retention of microorganisms and impurities, and will not support the growth of microorganisms; it is used in small volume injection. The valve on the liquid pipeline should be a clean diaphragm valve.
In the process piping system of the GMP purification workshop, the piping accessories generally include sanitary diaphragm valves, thermometers, pressure gauges, rotating cleaning balls, stainless steel filters, etc. The water transportation in the pharmaceutical water system mainly relies on clean centrifugal pumps, According to the range of flow and head that can be achieved, it can be divided into single-stage centrifugal pump and multi-stage centrifugal pump. In the clean area, the main pipe should go through the technical interlayer, the branch pipe should be vertical to the point of use, the direction should be as short as possible, the pipe fittings should be as few as possible, and the horizontal pipe should be avoided. Connect the pipeline, try to use short flat joints; avoid setting up a steel platform in the clean area, use stainless steel with polished outer surface instead of general steel, and the platform should be hollowed out; the pipeline in the clean area should try to avoid using supports and hangers, if necessary, should be used Sanitary support and hanger; open pipes in the clean area, if heat preservation and anti-scalding are required, the outer casing should be made of stainless steel. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP purification workshops and clean engineering.
During the installation and construction of the pipeline, dust and sundries will adhere to or enter the inner and outer surfaces of the pipeline. The pipeline is cleaned with dry and sterile filtered compressed air for several times to remove the dust remaining in the pipeline system. The debris is blown out of the system; the cleaning solution is pumped into the pipeline system and circulated for about 20 minutes. During this period, all valves and discharge ports in the process water system should be closed at least 3 times; The liquid is completely drained. Passivation of pipelines in GMP purification pharmaceutical cleanroom: use water for injection and analytically pure nitric acid to prepare 8% acid solution, circulate at 49-52 °C for 60 minutes, and then discharge; rinse with normal temperature water for injection, and the time is not less than 30 minutes; finally rinse until The resistivity of the inlet and outlet is the same as that of the water for injection; the pipeline is generally sterilized by saturated circulating steam.
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