Manufacturing process validation of new bottle filling, capping, sealing and labeling line for hematology reagents

The project focuses on validating a new process line which replaced a manual line of six people. Manufacturing Process Validations are required by The Food and Drug Administration (FDA) and they consist of three stages: Installation Qualification, Process Performance Qualification and Product Performance Qualification. These stages illustrate that the product can be manufactured within specifications. It also shows the process is capable of consistently producing a finished product within the specified design parameters. The line must be effective, repeatable and accurate. Currently, the line produces twenty five thousand bottles a month. The result of this project has increased production amount by 50%, reduced the personnel working in the line by three people, and generated a constant quality product. The most important output of this project was generated when the new line was released to production. In addition, the project has established the manufacturing specifications and the monitoring system for the new process line.