{ENGLISH} CHAPTER 5 WATER FOR THE MANUFACTURE OF PHARMACEUTICALS – END

CHAPTER 5 WATER FOR THE MANUFACTURE OF PHARMACEUTICALS – END

9. Facilities for supplying water for pharmaceutical water

There are many use points for “purified water” and “water for injection” in a factory, and the amount used varies from hour to hour. Since selecting equipment based on peak usage is wasteful, pharmaceutical water is stored in tanks of a certain size and supplied to the use points from there.

Compared to tap water that contains chlorine, pharmaceutical water that has had impurities removed is much more susceptible to microbial growth and deterioration. Therefore, the water supply facilities for pharmaceutical water are designed to control the growth of microorganisms and maintain water quality. First, because microorganisms tend to multiply in areas where water stagnates, the supply of water is constantly circulated. For example, spray balls are installed to direct water flow to the top of the tank and the air-liquid interface, and sensor seats and branches, which are prone to stagnation, are called dead legs, and are designed so that the branches are constantly washed by turbulent flow. Water for injection, which requires stricter microbiological control than purified water, is always circulated at a high temperature (70°C or higher) and is often cooled and supplied separately at use points.

10. Design considerations

Since pharmaceutical water is used throughout a manufacturing facility, it is necessary to understand the overall operation of the facility in order to design a pharmaceutical water facility. The flow of facility construction is shown below.

Each type of equipment (pre-treatment equipment, RO membrane, EDI, UF membrane, distillation unit, etc.) can be considered only after understanding the status of pharmaceutical water usage…