Application of double tube plate heat exchanger in pharmaceutical water
Wheat Grass Powder,Dehydrated Cabbage Powder,Dehydrated Spinach Powder,Dehydrated Cucumber Powder Laian Xinshuyu Food Co., Ltd , https://www.xinshuyufood.com
(1) The design, selection, installation, modification and maintenance of the equipment must be in accordance with the intended use, and the risk of production pollution, cross-contamination, confusion and errors should be minimized, easy to operate, clean, maintain, and disinfected if necessary or Sterilization [Article 71, perfect terms]
(2) The surface of the production equipment in direct contact with the drug shall be smooth, smooth, easy to clean or disinfect, and resistant to corrosion. It shall not chemically react with the drug, adsorb the drug or release the substance into the drug. [Article 74, perfect terms]
(3) The materials used for purified water, water injection tanks and pipelines shall be non-toxic and corrosion-resistant; the vents of tanks shall be fitted with hydrophobic sterilizing filters that do not shed fibers; the design and installation of pipelines shall avoid dead angles and blind tubes. . [Article 98, perfect terms]
(4) The preparation, storage and distribution of purified water and water for injection should be able to prevent the growth of microorganisms. The purified water can be recycled, and the water for injection can be kept at a temperature of 70 ° C or higher. [Article 99, perfect terms]
Second, the requirements for the heat exchanger of the pharmaceutical water system are:
(1) The material contact side is made of 316L stainless steel;
(2) Designed according to hygiene requirements;
(3) Water can be completely excluded;
(4) Use sanitary connections to avoid dead ends;
(5) The surface roughness of the contact side with the product does not exceed 0.5 μm;
(6) Adopt double-tube structure design to detect leaks in time to avoid contamination of transmission medium by cooling or heating medium;
Third, the ultra-clean sanitary capillary double-tube heat exchanger has the following characteristics:
Double-tube plate heat exchangers are widely used in the heat exchange field of clean materials in pharmaceutical plants because of their structural features to prevent contamination of clean media. In addition to the above characteristics, the hygienic capillary double-tube heat exchanger developed by the company has the characteristics of high efficiency heat exchange, easy installation, easy maintenance and small floor space.
1. Clean, hygienic and anti-cross-contamination, in line with GMP requirements:
(1) The double tube plate design is adopted to effectively prevent the clean materials such as water for injection, purified water and liquid medicine from being polluted, and even if there is leakage, it can be found in time and processed in time, which fully meets the requirements of GMP;
(2) The heat exchanger components are all made of 316L, which conforms to the industry practice and will not affect the clean materials, and fully meets the requirements of GMP;
(3) The structure is completely emptied, the product side pipelines are all linear design, zero dead angle, no residue, fully comply with GMP requirements;
(4) Online cleaning (CIP), fully compliant with GMP requirements;
(5) Online sterilization (SIP), fully compliant with GMP requirements;
(6) Provide complete documentation of traceability of materials.
2. Patent design, advanced structure, fine manufacturing, high heat exchange efficiency and energy saving;
(1) Using Ø3*0.5 capillary heat exchange, the heat exchange efficiency is several times higher than that of the traditional tube heat exchanger, and the volume is greatly reduced. Under the same heat transfer conditions, the volume of the ultra-clean sanitary capillary tube-tube heat exchanger is about 1/10 or less of the volume of the conventional tube-tube heat exchanger.
Precision machining of the end face and outer circle of the baffle with a CNC machine, strictly controlling the outer diameter of the baffle, reducing the gap between the outer diameter of the baffle and the inner diameter of the shell tube to less than 0.1 mm, so that the cooling water is limited The heat exchange through the heat exchange tube reduces the amount of cooling water lost due to the gap between the outer wall of the baffle and the inner wall of the shell tube, reduces the short circuit cycle, and greatly improves the heat exchange efficiency.
The national standard requires that the gap between the baffle and the inner wall of the shell tube should not exceed 0.25 mm. In fact, since the shell tube of the conventional heat exchanger is rolled by a heat exchanger manufacturer, the roundness is insufficient. . In addition, the traditional heat exchanger has a large diameter and a long length, and the installation of the tube bundle is very inconvenient. Therefore, in order to facilitate the installation of the heat exchange tube bundle and prevent the occurrence of the jam, the manufacturer often reduces the outer diameter of the baffle and increases the baffle and The gap between the inner diameters of the shell-side tubes generally increases to 1-3 mm or more, resulting in a large amount of cooling water leaking out from this gap, which greatly reduces the heat exchange efficiency of the heat exchanger.
The multi-step process is used to precisely process the baffle plate hole to narrow the gap between the heat exchange tube and the baffle hole, and the single-side gap between the heat exchange tube and the baffle hole is controlled within 0.04 mm. Limitly avoid and reduce the amount of water lost from the gap between the heat exchange tube and the baffle hole, reduce the short circuit cycle, increase the turbulence, and thus improve the heat exchange efficiency. In the traditional tube heat exchanger manufacturing process, the national standard requires that the gap between the heat exchange tube and the baffle hole be less than or equal to 0.25 mm. In fact, the manufacturer often enlarges the gap to 0.5 in order to facilitate the tube. -1 mm, resulting in short circuit loss of cold water, severely reducing heat exchange efficiency.
3, long service life (1) overall design of the same material (tube and shell all structural parts are 316L) design, material consistency;
(2) Integrated welding molding, no temperature-sensitive deformation caused by material differences, long product life, not easy to leak;
(3) The heat exchange capillary adopts Ø3*0.5mm cold drawn capillary tube, no weld seam, high strength, no leakage, and safer to use.
(3) The overall stress relief treatment of the heat exchanger after welding, the internal stress release of the product is complete, the resistance to severe temperature changes, no deformation and no leakage, high pressure;
4, the product is easy to install, easy to maintain (1) heat exchanger with integrated structure design, without any sealing components, from the structure to achieve maintenance-free, in line with the spirit of GMP;
(2) The heat exchanger is small in size and light in weight. It can be installed on site at the point of use. The pipeline leakage can be found in time. It is very convenient to use and maintain. It does not need to be installed in the technical interlayer like the traditional large-volume heat exchanger, eliminating the need for it. Large brackets or hangers and thus increased elbows, pipes, etc., reduce installation costs.
(3) The heat exchange temperature control process can be automatically and manually, and the construction cost is completely independent. The use of traditional tube heat exchangers, in view of volume and sanitary cleaning, can only be installed in the technical interlayer. In order to realize the operation control, only the automatic control method can be adopted, and the cost of the automatic control system must increase the installation cost of at least 10,000 yuan per water point. Moreover, the installation of heat exchangers in the technical interlayer is inconvenient for maintenance, replacement and daily maintenance. It is difficult to find when the pipeline leaks, which is likely to cause product contamination.
(4) All external piping connections of the heat exchanger are connected by standard quick-install sanitary chucks, which are easy to clean and replace, and flexible and convenient to install.
5, to avoid the main problems of traditional heat exchangers (1) traditional tube heat exchangers in order to reduce the volume and increase heat transfer performance, often increase the number of heat exchange tubes to increase the heat exchange area, which often leads to water in the heat exchanger The flow rate is greatly reduced, far below the international standard of 0.914 m / s, resulting in increased opportunities for microbial contamination inside. This problem is considered in the traditional design is very small, easy to cause problems, it is not easy to be found when problems occur;
(2) The traditional tube-tube heat exchanger also has a U-tube tube-laying method. The disadvantage of this method is that it is not easy to realize full emptying inside, and it is easy to produce dead angles, and the sterilization is not thorough, which brings hidden dangers to the use safety;
(3) The traditional tube heat exchanger is manufactured by double expansion or expansion joint welding. Since it is produced by expansion and one by one, it will inevitably lead to uneven assembly stress, which is often caused during use. Repeated hot and cold exchanges lead to leakage damage, and once damaged, it is not easy to repair, and replacement is not easy.
6, serialized, standardized manufacturing, no maintenance, only need to replace the same model with the same model after retirement.