Pure steam and water for injection in the pharmaceutical industry

摘要

Both pure steam and water for injection (WFI) are used in many areas of the pharmaceutical industry. Pure steam is mainly used for sterilizing tanks, filters and piping systems, as well as products in sterilizers. Moreover, it is used for air-moistening in cleanroom systems. WFI is used for the production of medicaments and intermediates, as well as for the final cleaning of equipment. Quality has first priority with both the production of pure steam and WFI. Therefore, limit values are defined and, with the respective measuring technique, controlled and guaranteed. Production procedures are at least judged by their quality, but that alone is no longer enough. Because increasing energy costs lead to higher operation costs, GMP aspects have to be applied in reference to the pharmaceutical security and qualified and validated procedures with reference to process and control guarantee stability. Complete documentation and simple visualization systems that are matched to the user's requirements are becoming increasingly important, since water-treatment systems are, in general, "energy provision systems."