Design and installation of piping system in dust-free aseptic workshop
Design and installation of piping system in dust-free aseptic workshop
In the production of small-volume injections, the clean piping system of the dust-free aseptic workshop is mainly used for the transportation and distribution of process water, process gas, and prepared liquids, such as water for injection, purified water, pure steam, and clean compressed gas Wait.
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Text label: clean room design, pipe installation in sterile workshop
Dust-free aseptic pharmaceutical cleanroom piping system design and installation
In the production of small-volume injections, the clean piping system of the dust-free aseptic pharmaceutical cleanroom is mainly used for the transportation and distribution of process water, process gas, and prepared liquids, such as water for injection, purified water, pure steam, and clean compressed gas Wait.
The requirements for the design and installation of the pipeline in the dust-free sterile workshop are as follows: the equipment shall not adversely affect the quality of the products. The surface of the production equipment that is in direct contact with the product should be smooth, clean, easy to clean or corrosion-resistant, and should not react chemically with the product, absorb the product or release substances into the product; the materials used for the storage tanks and delivery pipelines for purified water and water for injection should be corrosion-resistant ; The vent of the storage tank should be equipped with a hydrophobic sterilizing filter that does not shed fibers; the design and installation of the pipeline should avoid dead pipes; the preparation, storage and distribution of purified water and water for injection should be able to prevent the growth of microorganisms, and purified water can be used Circulation, the water for injection can be used for a heat preservation cycle above 70 °C.
It is very important whether the design and selection of the piping system is reasonable, whether it meets the characteristics of process production, and whether it meets the requirements of GMP. These greatly affect the GMP certification and production of dust-free aseptic workshops. Requirements for the pipeline system of the dust-free aseptic workshop: For enterprises that use multiple independent filling and sealing machines, the pipeline distribution system is particularly important; the pipeline of the distribution system should be designed with a reasonable inclination and the flow rate of the branch pipeline. , the pressure on the machine should be balanced,
Stable, each distribution pipeline should have effective independent control facilities and be equipped with a detection system. From the concentrated distribution to the end of potting, all material transportation should be completed through a closed pipeline system.
Basic composition of the piping system of the dust-free aseptic workshop: (1) Pipe fittings: According to the design of the system, the piping system is divided into extended pipe fittings (pipe fittings with straight section ≥ 40cm) (automatic welding pipe fittings) and ordinary pipe fittings according to the welding method. Pipe fittings (zero straight section) (hand-welded pipe fittings); according to the material, it is divided into 316L pipe fittings and 304L pipe fittings. (2) Valves: According to the different types of process water in the product industry, there are many types of valves with different uses. The basic requirements for the valve of product water are that in the operation of the system, the valve used is free of pollution and shedding to the process water; the valve material has good chemical inertness; the structural form of the valve should not be conducive to the retention of microorganisms and impurities, and will not support growth of microorganisms. For valves used in small volume injection pipelines, clean diaphragm valves should be used. (3) Centrifugal pump: The transportation of water in the product water system mainly depends on the clean centrifugal pump. 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. (4) Other pipeline accessories: In the product process pipeline system, the pipeline accessories generally include sanitary diaphragm valves, pressure gauges, thermometers, rotating cleaning balls, stainless steel filters, etc.
Design principles of the piping system of the dust-free aseptic workshop: ①No dead ends, drainable and easy to clean. ② In the clean area, the supervisor should go through the technical interlayer, the branch pipe should be straight 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; the direction of the clean pipe should have priority over the general pipe and support. ③The pipe connection should be welded as much as possible, the equipment should be connected with the pipe, and the short flat joint should be used as much as possible. ④The use of support and hanger should be avoided as far as possible in the pipeline in the clean area. If necessary, sanitary support and hanger should be used. ⑤ In the clean area, steel platforms should be avoided (B and C grades are prohibited), and stainless steel (square steel or round steel) with polished outer surface should be used instead of general section steel, and the platform should be hollowed out. ⑥ The pipes are laid openly in the clean area. If thermal insulation and anti-scalding are required, the outer casing should be made of stainless steel. Zhongjing Global Purification can provide consulting, planning, design, construction, installation and transformation of dust-free workshops and sterile workshops and other supporting services.
Cleaning, passivation and sterilization of pipelines in dust-free sterile workshops: (1) Pipeline cleaning: During the installation and construction process, dust and debris will adhere or enter the inner and outer surfaces of the pipelines. becomes inevitable. The cleaning of the pipeline is generally divided into the following steps: 1. Rinse several times with dry, sterile-filtered compressed air, and blow the dust and debris remaining in the pipeline system out of the system. ②Pump the cleaning solution (purified water or water for injection) into the pipeline system and circulate for about 20 minutes. During this period, all valves and drains in the process water system should be closed at least 3 times. ③ At the end of the process, completely drain the residual cleaning fluid inside the system. (2) Passivation of pipelines: There are many methods of pipeline passivation. The following is a general method: ① Prepare 8% acid solution with water for injection and analytically pure nitric acid, and circulate at a temperature of 49~52 °C Discharge after 60min; or prepare a solution with 3% hydrofluoric acid, 20% nitric acid, and 77% water for injection, the solution temperature is 20~30°C, and circulate for 10~20min, and then discharge. ②Initial flushing: flush with water for injection at room temperature for not less than 30 minutes. ③ Rinse at the end until the resistivity of the inlet and outlet is consistent with that of the water for injection. (3) Sterilization of pipelines: Generally, saturated circulating steam is used for sterilization.
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