MEVAC Five – Design and Implementation of an Integrated Water and Steam Distribution System in Compliance with GMP Standards

A complete water and steam piping system was installed in line with pharmaceutical GMP standards, using orbital automated welding to ensure the highest level of quality and hygienic performance.

1-     The Purified Water Loop was installed with a total length of 600 meters and a diameter of 1 inch. This loop distributes purified water for cleaning and manufacturing processes. The design ensures continuous turbulent flow to avoid any microbial growth or sedimentation. The piping was installed with a proper slope for complete drainage, and the system is operated with regular hot water or chemical sanitization cycles. The entire loop underwent qualification (IQ/OQ/PQ) to guarantee compliance with pharmaceutical requirements.

2-     The Water for Injection (WFI) Loop was executed with a total length of 400 meters and a diameter of 1 inch. WFI is produced via multi-effect distillation or vapor compression systems and distributed in a hot loop operation mode (70–80 °C) to maintain sterility. The piping network was designed with a hygienic slope for condensate removal, preventing water stagnation. Routine monitoring is performed, including conductivity, TOC (Total Organic Carbon), and endotoxin tests, to ensure consistent water quality.

3-     The Pure Steam System was installed with a total length of 300 meters Clean Steam and a diameter of 1 inch, including all necessary accessories. Pure steam is mainly used for sterilization of autoclaves, process equipment, and water systems. The piping is designed with a slope for efficient condensate drainage. The system is equipped with steam traps, separators, sanitary sample valves, condensate return lines, sanitary valves, and filters. Regular testing is carried out to verify steam quality, including non-condensable gases, dryness fraction, and superheat values, in compliance with pharmaceutical industry standards.