Pharmaceutical water systems are considered to be a “black box” by many organizations. In fact, these systems consist of multiple complex unit operations including, but not limited to, pretreatment systems, ion exchange units, reverse osmosis systems, membrane filtration, distillation units, distribution loops, and storage systems. Unfortunately, expanded use of instrumentation and controls has decreased “owner” understanding of systems. Frequently, the performance of individual components is not “controlled,” ultimately resulting in an unacceptable excursion. Core principles for manufacturing, operation, compliance, validation, and regulatory disciplines require, as a minimum, a basic understanding of every major component. These principles are frequently neglected for pharmaceutical water systems.
Topics associated with pharmaceutical water systems are complex and often require an understanding of scientific, engineering, and technical principles. This situation is complicated when the numerous components employed in a pharmaceutical water system are not understood to be associated with individual unit operations. By presenting the fundamentals for each unit operation it is possible to transform myriad individual components into a series of operations configured to provide and deliver an “ingredient,” pharmaceutical water, meeting compendial requirements in a fully controlled manner. Because personnel with limited background and experience may find themselves involved with technology used in pharmaceutical water systems, the unit operation approach is a logical method to achieve this objective. Further, the technical language, mathematics, and engineering drawings with symbols may be esoteric and incomprehensible for those not trained in the field.
The following images are taken from a collection of Journal of Validation Technology articles and papers featuring pharmaceutical water systems that will help engineers and non-engineers visualize the obstacles to proper validation and qualification.