ABSTRACT

INTRODUCTION The importance of process water to a pharmaceutical manufacturing facility cannot be overstated. Production of water used for drug manufacturing is a great challenge in every aspect of design, implementation, and maintenance. Water is the most widely used material in pharmaceutical manufacturing and is often the most costly. The percentage of water in finished products varies from 0 to greater than 90%. A greater volume of water is used in cleaning and rinsing processes than in formulation in most facilities. Regardless of the water volume used in actual drug formulation, all pharmaceutical water is subject to current Good Manufacturing Practices (cGMPs) even when the water does not remain in the finished product.