Application of heat exchanger in injection water system

【Summary】:

The heat exchanger is an essential equipment for the water injection system. The structure and heat transfer effect of the heat exchanger are directly related to the long-term and healthy development of the injection manufacturer. SECESPOL-B series heat exchangers have the characteristics of high hygienic requirements, high heat exchange efficiency and small volume, and have been adopted by many pharmaceutical factories at home and abroad.
Keywords: SECESPOL injection water GMP heat exchanger     Energy saving
Heat exchanger is a must for WFI system, therefore its structure and efficiency is very important for the producer. Secespol B-line heat exchangers have high efficiency with compact design, and it also meets sanitary requirements.
Keywords: Secespol WFI GMP heat exchanger energy-saving


[Overview]:
At present, "hibernation" has become a strategy for many companies to cope with the international financial crisis, but for injection manufacturers, this is not a good choice. With the start of a new round of pharmaceutical production quality management (GMP) certification and the replacement of production licenses, it is a wise choice to make preparations before the renewal of the certificate, and successfully pass the new GMP certification to seize the opportunity.
The five-year GMP certification period for large infusion companies is approaching. The relevant person in charge of the State Food and Drug Administration said that the current GMP certification for large infusion enterprises will become increasingly strict. At present, major infusion and injection companies have turned their attention to the key equipment in the injection water system - heat exchangers.
The injection water system plays an important role in the pharmaceutical production process and is one of the main targets for the key inspection and control in the pharmaceutical certification process. In terms of its characteristics, it is highly pure and non-polluting; therefore, this also places higher demands on the choice of heat exchangers.
Shandong Hongji Heat Exchange Technology Co., Ltd. successfully introduced imported heat exchange equipment from Europe, aiming to shorten the gap between domestic medical equipment and European medical equipment, and improve the comprehensive competitiveness of domestic injection enterprises.
1 Outstanding advantages of SECESPOL-B series heat exchangers
1.1 SECESPOL-B series heat exchanger material selection basis
Water for injection is an important raw material in the preparation of pharmaceuticals such as injections, eye drops, sterile rinsing agents, etc. It is also a packaging container for filling sterile products, related equipment used in production, pipes, tools, etc. .
Since sterile products such as injections directly enter human tissues and blood for treatment, it is necessary to ensure that the sterile, pyrogen-free, insoluble particles of the production environment meet the quality standards, otherwise it will lead to different levels of potential risks and adverse consequences.
The SECESPOL-B series heat exchangers focus on the heating and cooling of the injection water system. The material is made of high-quality 316L stainless steel from Krupp Steel, which ensures the safety and operability of the entire injection water system.
Proper selection of materials is a powerful guarantee to turn a good blueprint for the design of water for injection system into reality; and an excellent and reasonable water system for injection water system can only be produced at any time and continuously after strict verification and operation management. Qualified water for injection.
Article 34 of China's GMP Regulations stipulates: “Preparation, storage and distribution of water for injection should prevent microbial growth and pollution. The materials used in storage tanks and pipelines should be non-toxic and corrosion-resistant.... The water for injection can be stored at 80. Insulation above °C, insulation cycle above 65°C or below 4°C”; Section 4.1.1(2) of the GMP Implementation Guide states: “The surface layer of the equipment in direct contact with the material, the application does not react with it, does not release particles And materials that do not adsorb material." That is, non-toxic, corrosion-resistant, non-release of particles, non-adsorbing materials, and undergoing disinfection/sterilization are the basic requirements for the selection of water for injection systems.
The high resistivity water for injection, especially under high temperature conditions, is a corrosive solvent. The equipment, pipes and fittings of the water for injection system are mainly made of stainless steel. The B-series products in the SECESPOL heat exchanger have chosen the preferred material for these requirements, 316L (00Cr17Ni14Mo2). It is manufactured in strict accordance with the EU sanitary machinery standards and is one of the world's advanced shell-and-tube heat exchangers. Whether it is from "neutrality to the transmission medium", "corrosion resistance", and "welding performance", the 316L stainless steel material is the choice of the water for the injection water system.
1.2 Advanced design concept of SECESPOL-B series heat exchanger
   The SECESPOL heat exchanger is an imported product from the European Union . The technology is sourced from the Gentsk University of Technology in Poland and the SECESPOL International Group. The production base is located in Europe, Poland.
   The SECESPOL-B series heat exchangers are based on the design of traditional double tube sheets and adopt a more advanced and reasonable design. The SECESPOL-B series heat exchangers use advanced wire-type bellows to create turbulence in the liquid outside the pipe or in the pipe, which increases the heat exchange area and improves the working efficiency.
The heat exchange tube in the Secespol- B series heat exchanger adopts the small gap design of Zui. The Zui greatly reduces the formation of the stagnant zone, and there is no dead angle, which can completely drain the accumulated water.
1.3 Surface finish of SECESPOL-B series heat exchangers
     The high surface finish can effectively eliminate the “loose land” of microbial retention and breeding. Furthermore, according to the rougher surface of the material, the pitting breakdown potential is lower, and the material is more prone to pitting corrosion in the medium. After polishing the inner surface of the material, the material particles can be reduced due to pitting corrosion. And the opportunity to pollute the quality of water for injection.
The smooth surface of the SECESPOL-B series of heat exchangers is done by electropolishing. Electropolishing removes the exposed impurities together with the surface layer, which significantly reduces the total surface area and greatly alleviates the inherent surface tension during mechanical polishing. More importantly, it can form an excellent film on the surface and enhance corrosion resistance.
1.4 SECESPOL-B series heat exchanger installation method
The SECESPOL-B series heat exchanger adopts a clamp-type quick-fit interface that is easy to disassemble and has higher hygienic precision. The sanitary joints ensure the joints due to the special connection structure and precise manufacturing process and suitable gaskets. The inner diameter is perfectly aligned and the gap can be minimized.
1.5 High efficiency heat transfer of SECESPOL-B series heat exchanger
SECESPOL-B series heat exchangers reduce the wall thickness as much as possible on the basis of ensuring safe operation. The wall thickness of each heat exchange tube is only 0.6mm, which greatly improves the heat transfer effect of hot and cold fluids. Under the same conditions, the efficiency of the traditional heat exchanger is about 5 times. Improve work efficiency and reduce the overall production cost for the majority of enterprises in the long-term operation.
1.6 Mechanical strength of SECESPOL-B series heat exchangers
SECESPOL-B series heat exchanger is all stainless steel structure, using integral welding (first expansion and welding), avoiding the possibility of dead angle and leakage; and improving the temperature and pressure resistance, pressure resistance 1.6Mpa , test pressure 3.2MPa Greatly ensure the safety of the user's production process.
1.7 Post-maintenance of SECESPOL-B series heat exchangers
The SECESPOL-B series heat exchangers have a low fouling tendency and the fouling cycle is 3-5 times that of conventional heat exchangers. Even after scaling, the cleaning of the scale is very simple. It avoids the disassembly and assembly of other heat exchangers, and can be circulated with dilute nitric acid, which is safe, convenient and inexpensive.
1.8 Models of SECESPOL-B Series Heat Exchangers
In order to better serve the domestic enterprises to provide injection technology services, SECESPOL International Group for domestic users to tailor the design of the B250, B300, B500, B1000 and other specifications, sufficient to meet the current variety of conditions.
2 Comparison of application in water for injection system
At present, in most pharmaceutical companies , there are generally three types of water-heat exchangers for water for injection systems: traditional tubular heat exchangers, plate heat exchangers, and secespol heat exchangers. The advantages of the secespol heat exchanger are illustrated below by comparison of several indicators .
project        Types of
Traditional tube
Plate type
Secespol
volume
Big
small
small
Material
Generally 304
The plate is 316L or 304
Overall 316L
Gasket
Have
Have
no
Heat transfer coefficient
1000 to 3000
3000 to 5000
3000 to 7000
Stagnation zone
Big
Larger
small
Service life
3 to 5 years
1 to 2 years replacement gasket
More than 10 years
installation
inconvenient
More convenient
Convenience
Operating cost
high
low
Lower
Customized
Non-standard
Non-standard
Fixed model
maintain
Disassembly cleaning
Disassembly cleaning
Chemical cleaning
3 conclusions
By analyzing the secespol- B series heat exchangers and comparing them with traditional tubular and plate heat exchangers , we can see that :
The heat exchanger of the plate heat exchanger has high heat transfer efficiency, small volume and light weight , and is easy to disassemble. However, due to the existence of the gasket, the probability of leakage is large, and frequent maintenance is required, and it is difficult to ensure production safety;
The traditional tubular heat exchanger has a long service life , good pressure resistance performance, low heat exchange efficiency, large volume, and inconvenient installation and maintenance.
The Secespol-B series heat exchanger combines the advantages of plate heat exchangers and traditional tube heat exchangers, and fully complies with the requirements of the National Pharmaceutical Production Quality Management Regulations 98 and GMP . And to a large extent to avoid its shortcomings, more suitable for injection water system, is a good choice for domestic users.


references:
1. "Good Manufacturing Practices 98 Edition"
2 , " GMP Specifications"
3. SECESPOL International Group Heat Exchanger Design Manual Poland: Getansk University of Technology 2006
4. "Local Corrosion of Metals" Editor-in-Chief Yang Wu    Beijing: Chemical Industry Press, 1997
5. “Practical GMP Training Course” International Pharmaceutical Business School, China Pharmaceutical University, 1997.7
6. Design and Practice of Pharmaceutical Water System Beijing: Chemical Industry Press 2001


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