Diaphragm valves promote clean production in the pharmaceutical industry and strictly adhere to various regulations and standards

Diaphragm valve is one of the important equipment in the pharmaceutical industry. It is a special form of block valve, and its opening and closing parts are a diaphragm made of soft material, which can separate the valve body cavity from the valve cover cavity. According to valve experts, diaphragm valves (weir type) have the advantages of high frequency use, ultra pure to severely polluted grinding media, convenient cleaning, good liquid regulation performance, and optional flow direction. Of course, diaphragm valves also have drawbacks, such as medium pressure loss, operating pressure, and temperature limitations.

Visually speaking, a diaphragm valve is actually a "clamp" valve, with an elastic diaphragm connected to a compressed component by bolts, which is operated by the valve stem and moves up and down. When the compressed component rises, the diaphragm rises, creating a passage; When the compressed part descends, the diaphragm is pressed against the valve body weir (assuming a weir valve) or against the bottom of the contour (assuming a straight through valve). Diaphragm valves are more suitable for on-off and throttling purposes, and are mainly used in the pharmaceutical industry for pharmaceutical water use.

There are many specific regulatory regulations and directives for diaphragm valves internationally. For example, in sterile applications, the FDA even explicitly specifies the use of diaphragm valves to ensure good cleanliness. In terms of the EU GMP standard, diaphragm valves need to meet the requirements of avoiding cross contamination and facilitating equipment cleaning. Therefore, valves can be used for applications that are easy to clean, easy to disinfect, self emptying, and cavity filling.

In addition to complying with corresponding regulations and standards for the diaphragm valve product itself, it is also necessary to comply with corresponding regulations when producing, storing, and distributing pharmaceutical quality water or ultrapure steam. In order to ensure the stability and reliability of product quality, the components of pharmaceutical liquid equipment also have corresponding quality requirements. Therefore, various diaphragm valves need to be designed and developed in conjunction with corresponding pharmaceutical processes.

For example, the sealing performance of diaphragm valves and the sealing system of diaphragm valves directly affect the purity of the product. I understand that in traditional sealing systems, valves achieve sealing through the sealing profile on the diaphragm, but generally speaking, the valve body itself does not have an additional sealing profile. As the diaphragm and actuator are fixed by bolts, a circular gap will be formed on the sealing surface. The medium will penetrate through the closing action and be discharged when the valve is opened, which can cause pollution.

In response to the above situation, some valve companies have developed special sealing methods. It is reported that both the valve body and diaphragm have a sealed contour, which greatly reduces the annular gap between the diaphragm and the valve body when squeezed, thereby preventing the entry of media and significantly reducing the pump effect.

Although diaphragm valves are widely used in the pharmaceutical industry, customers still need to pay attention to some precautions when operating equipment. For example, the opening of diaphragm valves should not be arbitrarily changed in the pipeline network system. After installation and testing conditions are met, a dedicated intelligent instrument should be used to debug and adjust all diaphragm valves, and the opening of each valve should be locked to achieve hydraulic condition balance in the pipeline network. During the normal operation of the pipeline system, do not arbitrarily change the opening of the diaphragm valve, especially the opening locking device.

Also, do not install a shut-off valve again. When repairing a certain loop, the diaphragm valve on the loop can be closed. At this time, the diaphragm valve acts as a shut-off valve to cut off water flow, and after the maintenance is completed, it returns to the original locked position. Therefore, if a diaphragm valve is installed, there is no need to install a shut-off valve.

When adding (or canceling) a loop in the system, it is necessary to readjust and adjust it. When adding (or canceling) a loop in the pipeline system, except for adding (or closing) corresponding diaphragm valves, in principle, all newly installed diaphragm valves and diaphragm valves in the original system loop should be readjusted and adjusted (branch diaphragm valves in the original loop do not need to be readjusted). It is worth mentioning that in air conditioning and heating systems, the hydraulic balance of the water circulation system as the energy transmission and distribution system is very important.

Pharmaceutical water has strict requirements for cleanliness. As a device in direct contact with the medium, diaphragm valves should comply with relevant regulations to ensure the purity of the medium. In addition, relevant enterprises need to combine pharmaceutical water technology to develop equipment that meets the actual situation of the industry, in order to assist in clean production in the pharmaceutical industry.