New GMP: SECESPOL deployment sterile double tube sheet heat exchanger
Updated:2011-11-09 11:42:04    By:sdhuge    Hit:2089

New Good Manufacturing Practices (GMP) standard is expected this month enacted. For the new GMP clean, sterile and many other requirements than the previous version improved a lot, for pharmaceutical companies, the industry is facing re-shuffle, and for drug companies also machines both opportunities and challenges facing the situation.

China's pharmaceutical industry about 4000 or so, each year more than 1 trillion yuan in the market. After the promulgation of the new GMP, each pharmaceutical companies to adapt to new standards, will upgrade the equipment, thus bringing the medicine machine equipment market is expected to break through 10 billion. But these new opportunities for local businesses, both domestic medicine an opportunity, but also a challenge. For a large number of technologically advanced machine drug companies, because of the implementation of the new GMP standards, as they added a lot of market opportunity, is a good development opportunity; but for some SMEs, due to technical content is insufficient to meet the new GMP standards, resulting in not only loss of new markets, but also for the original market will be lost. Therefore, after the promulgation of the new GMP, pharmaceutical companies face not only re-shuffle, the drug companies are facing the machine re-shuffle.

Pharmaceutical companies in the production process will always be water for injection and injection heating, cooling process, which for the purification of pharmaceutical companies, sterile environment is critical. Heat exchanger as injection, the core component of water for injection, sterile environment for the formation, play a crucial role. SECESPOL International Group as the world's leading experts in shell and tube heat exchangers, used in Europe advanced process design, manufacturing in accordance with EU standards, and its full line of products of high quality 316L stainless steel, with a compact, small size, heat transfer efficiency, the use of long life, security and stability, etc., are given "steam Prince" in the title. SECESPOL International Group's China headquarters, has been committed to the development of heat transfer technology and product promotion and service. After a decade of effort, is now SECESPOL series heat exchangers have been widely used in HVAC, pharmaceutical, fine chemicals, food and beverage, dairy, beer, energy and other industries or fields, the country's 30 provinces, municipalities and autonomous regions There are more than 2,000 customers, more than 200 agencies.

The relevant provisions of China's GMP standard: "Preparation of water for injection, storage and distribution should be able to prevent microbial growth and contamination. Storage tank and pipeline materials used should be non-toxic, corrosion-resistant; equipment in direct contact with the material within the surface, should not react with , does not release particles and materials adsorbed material. " That injection of water related equipment to achieve non-toxic, corrosion resistant, non-release particles, no adsorption material, withstand disinfection / sterilization of water for injection system is essential selection requirements. To meet the domestic pharmaceutical, biotechnology, the need for blood products, Shandong Hongji SECESPOL International Group earlier this year from the introduction of the P series sterile double tube sheet heat exchanger. The heat exchanger in full compliance with FDA, cGMP standards development and compliance with strict European health standards for manufacturing machinery, tube and shell are finished with high-quality 316L stainless steel, is the world's highest level of health, the most advanced shell and tube heat exchanger one device. In the settlement of the sterile conditions required under the conditions, P Series heat exchanger design principles using the smallest gap, heat transfer efficiency than conventional heat exchanger increased by 30% or more. P Series heat compared with traditional heat exchanger has the following main characteristics:

First, P Series double tube sheet heat exchanger design, to avoid cross-contamination between materials. P series ends with the heat exchanger tubes tube junction has two plates, tubes and tube plate junction leakage if it occurs, the material will flow out from the outer tube plate, cooling or heating medium from the inner tube at the outflow, effectively avoiding cross-contamination between the two materials, but also makes it easy for managers to discover the phenomenon and to take timely measures to leak. P series plate heat exchanger tube using two different processes and technology to connect between the inner tube plate and tubes connected using expansion process, effectively avoid the disclosure of production welding easily understood phenomenon, the outer tube bundle is the first plate and Expansion After the welding process, tubes and tube plate to increase the stability of the connection between. P series is an overall structure of the heat exchanger, heat exchanger and further enhance the safety of long life and stability.

Second, P Series heat exchanger material emptying design with full access to the side to avoid the generation of material remaining bacteria. Injection in the pipeline, the process flow of the container inside the device are likely to be due to bacteria and contamination. P Series heat exchanger materials in order to achieve full contact with the side emptying, the tube bundle design process more than the minimum design evacuation point to ensure the heat exchanger either vertical or horizontal installation the whole installation can be emptied; In addition, the bundle interface uses reducer quick interface, but also effectively guarantee all materials emptying.

Third, P Series Tube bundle heat exchanger surface finish is high, effective control of biofilm formation. Tube bundle surface electropolishing process. Electropolishing can be exposed with the removal of impurities and the surface layer of the surface significantly reduces the total surface area, and greatly ease the inherent mechanical polishing the surface tension. After electro-polishing treatment, the surface roughness coefficient between the 0.25μm to 0.5μm. Bring not only high surface finish is to reduce the material and bacteria attached to the base, control biofilm formation, and after polishing the surface after the formation of a layer of fine films, to enhance the corrosion resistance of the heat exchanger.

Fourth, P Series, high efficiency heat exchanger, heat transfer than the traditional 30% increase. P Series Tube bundle heat exchanger wall thickness is only 0.6mm, greatly improving the heat transfer coefficient, heat exchange tube diameter 8mm, 10mm, 12mm three sizes, the use of small diameter tubes, tubes with a minimum gap between the design and increase the unit volume of the heat transfer area. P series of heat exchangers in the process of heat exchange tube material away, heating or cooling media away shell, both as a counter-current flow direction of media designed to further enhance the heat transfer effect.

In addition, P series, sterile double tube sheet heat exchanger also has easy to install and easy maintenance features, use of different-diameter tube quick interface shell using the national standard flange, installation is very easy, installation can be installed horizontally can be vertical Direct installation, you can regular SIP / CIP cleaning and sterilization to, has good compatibility and interoperability; multi-process design, a single process, double process, the four processes, heat transfer area from 0.9 m to 15.7 m between the flexible options to meet the requirements of different conditions.

   SECESPOL sterile double tube sheet heat exchanger into our country, greatly enhanced in the pharmaceutical industry, biotechnology, blood products and other health requirements of the industries or areas of very high market competitiveness, the headquarters of China's rapid development of new opportunities, but also for the smooth implementation of our new GMP standards, so that the level of China's pharmaceutical industry to improve equipment, enhance the international competitiveness of the pharmaceutical companies do our duty.