New Purified Water System for the QC Laboratory

Abstract

The project consists of providing the Quality Control Laboratory with a Purified Water supply system to cover the Lab water needs for chemical testing and Laboratory equipment. Currently the laboratory uses water from another site building. A literature review was carried out to get information on the regulatory requirements for design, installation and validation of water systems. Agencies such as the Food and Drug Administration, World Health Organization, International Committee Harmonization and International Society for Pharmaceutical Engineers . Project management framework, lean Value Stream Mapping tool and cost analysis were part of the methodology used for the project implementation. The cost analysis by the Equivalent Uniform Worth analysis method determined that the most viable alternative for the project was to buy a system that can produce one gallon per minute of Purified Water. This recommendation was accepted by the management. The equipment was purchased, installed and is at the validation stage which requires 15 days of sampling and testing. The percent completion of the project is 65%. Once fully implemented, the project will comply with the objectives and benefits established. Key Terms ⎯ Cost Analysis, Lean Value Stream Mapping, Cost Analysis, Project Management Framework, Validation Requirements.