Engineering Design Development And Practice Of Water System For Pharmaceutical Industry

The Purify water system, being the key device of Pharmaceutical water generation, must be stable and reliable to ensure the quality of Purified water. Base on study of Current Process technology and equipment, and engineering developing practice, this paper summarizes key problems and approaches to handle them on development of Purified water system engineering. This engineering development, by integrating the most advanced electrodeionization (EDI)technology,and the engineering developing idea to fulfils the requirement of the Users, The purified water system development include: Brief concept designing, Process solution selecting, Detail designing, Machine Manufacturing and installation, Commissioning and Validation activities, each steps was controlled by the idea of whole process validation Plan. The new developed Purified water system, has the advantage over the Ion-exchange system by without using ACID/ALKALI, Its self -circulation eliminates dead legs and realizes a better control of the bacteria because traditional non-continuous operation, It eliminates chemical materials and microorganism for raw water. We, together with the Customer, finished the DQ, IQ, OQ, FAT & SAT activities against the Validation Plan and supply the User a whole set of documentations. After over 30days of stable operation, the user make sure the Project fulfils the design requirement. The idea of engineering development can be a reference for diluting system and Cleaning in process system developing practice.