Estudo do tempo de uso de válvulas diafragmas em linhas estéreis de inoculação e alimentação

Abstract

The study of diaphragm valves is highly important when applied in biotechnological industries, due to the fact that unlike chemical industries, ensuring a high degree of asepsis in the process is essential for the success of production. The biggest challenge faced in industrial fermentation is the guarantee of sterility, and as a result, many structural factors must be evaluated and strategically considered to promote an aseptic design. In addition to planning the industry installation area, much attention is paid to adequate instrumentation, which is when the appropriate choice of valves responsible for monitoring and controlling the process is included. Among a variety of valves, diaphragm valves are the most used in sterile processes, as they have an efficient design to guarantee sterility and also withstand the temperature and pressure variations necessary in sterilization stages. This work will address a case study from a biotechnological industry producing high-purity amino acids, focusing on the selection of two valves located at different points in the process. To determine the durability of the diaphragm valve, the behaviour during inspection intervals, the impact of temperature variations in the line, and the number of cycles performed by the valves between inspection intervals were analysed. For the valve time of use, the cleaning-in-place process was considered to have the greatest influence on durability along with the difference in diaphragm dimensions. Finally, the inspection management tool and improvement suggestions will be evaluated. It is concluded that the time of use of valves with smaller diaphragms is twice that of larger ones, affirming that diaphragm size is the most impactful factor in valve durability. Improvements in the inspection recording tool have been made to include standardization in diaphragm integrity classification.