Clean Room Differential Pressure Monitoring Improvements

Abstract

Manufacturing of oral solid dosage (OSD) forms, such tablets and capsules, is performed in a highly regulated environment. One of the guidelines used to provide the minimum requirements that a manufacturer must meet to assure that their products are safe for their intended use is the Good Manufacturing Practice (GMP). This practice gathers the data of the agencies that control the authorization and licensing of the manufacture and sale of food & beverages, pharmaceutical products, and others. A case study will be developed from a European Regulatory Agency recommendation to a Pharmaceutical Company to improve clean rooms differential pressure monitoring strategy, in order to meet the agency standard. Aspects and tools from Process, Automation, and Quality Engineering were used in order to comply with the standard. Additionally, a potential time saving project was identified. Key Terms ⎯ Clean Rooms, Data Historian, Differential Pressure Monitoring, Pharmaceutical.