"Security" relief - sanitary rupture disc device application in the pharmaceutical advantages

来源:    日期:2010-10-21    浏览次数1113
"Safe" Relief (For details, see http://blog.sina.com.cn/s/blog_6a9ae51e0100l4jj.html)

    In the modern pharmaceutical industry, reaction and crystallization process is the key to get qualified products, in the concentration of the material, the steps, the operation requires precise control of time, while the pressure of the process, temperature control, is very important. To avoid losing control of the reaction process, the operation failure and fire and other factors beyond its design pressure vessels and equipment, explosion, or impact on product quality after high pressure in the container safety relief valve installed on the device is essential . Equipment commonly used in the pharmaceutical safety relief valve and safety valves are generally selected disc, or a combination of both.

    For the pharmaceutical equipment, its health requirements are very demanding. To meet the requirements of cGMP or FDA, production equipment must be in strict compliance with cleaning, sterilization (CIP / SIP) requirements: equipment, wall must be smooth, smooth, corrosion resistance, no dead ends. Thus, pharmaceutical equipment interfaces are often used hygienic diaphragm valves, Tri-Clamp connection clamp flange or aseptic, to prevent Bacterial contamination purposes. But often such as pressure relief valve or bursting disc devices have caused health risks are not of equal importance.


Disc is economical and practical safety relief valve. For a long time, bursting discs are used on the installation folder structure, that folder through the flange clamping the disc between the upper and lower fixture, as shown, sealing materials and the bursting disc is separated by flat pads or O-ring. The connection structure of the more rough though the requirements to achieve the closed system, but the designation does not meet the FDA requirements for health, but the system can not meet the pharmaceutical needs of the sterile class.
       For food, beverage and other industries, can be used as shown in Figure types of health-type safety valve, the valve body from the 316L stainless steel, smooth wall, no cleaning corners, interface with health flanges, clamp or welded, special sealing materials can be resistance to CIP and SIP. Therefore, to fully meet the food and beverage production equipment health needs. However, if you use in the pharmaceutical system, the possibility still exists Bacterial contamination:

       1) imported into the spool valve distance (C) long, dead easy to form when the CIP, SIP may also be due to temperature drop of less than sterilization requirements.

      2) The safety valve in the normal state can not be completely sealed, there is always trace the leak. On the one hand, within the explosive device may accumulate in the relief work of the media channels, there are security risks; other hand, the valve core and valve seat ring into the tiny gap but breeding place for microorganisms.

  These shortcomings limit the use of the system safety valve in the pharmaceutical applications.

      Therefore, some foreign manufacturers to launch a health series (Sanitary Series) bursting disc, to resolve the above contradictions. Now with a product, for example, a brief description of what their requirements to meet the health characteristics:

    1) and the bearing disc form with Tri-Clamp, the health of this structure approved by the FDA. Bursting discs and clamp ring shape as a whole, and to achieve close contact with clamp connection. The length of the shorter clamp connector, installed in the pipe or container will not cause cleaning corners. Ring is the result of FDA approved EPDM material or more high temperature materials, to meet the pharmaceutical equipment cleaning and sterilization process requirements.

    2) special design to ensure that excess pressure in the disc can tear up when you roll up the wall after the close on the clamp to form a possible release of a large area. After tearing disc intact, without worrying about debris falling into or blockage inside the device or pressure relief valve behind the pipe.

    3) Some models of the bursting disc has a "foolproof" design, that is, the upper and lower clamp has a different groove, while the ring disc corresponding also to prevent reverse installation disc. Experimental results show that the reverse installation of bursting disc, bursting pressure may reach 5 times the normal value is very dangerous.

    4) The normal operating conditions, health-based disc complete isolation of the pharmaceutical equipment, internal and external, and therefore need to be installed after the bursting disc safety valve of the occasion, you can use the non-health-based safety valve to reduce the cost of equipment.

    5) Similarly, the price of health-type disc only hygienic safety valve. In addition to super-pressure systems often occasions, in some cases, can replace the valve and alone.

    Therefore, in the pharmaceutical system, the sanitary disc is truly "safe" pressure relief devices: not only meet the overpressure protection device, but also keep the system sterile. For the above advantages, sanitary pharmaceutical disc system at home and abroad, is widely used.