Reduce Machine Stops To Limit Human Intervention In Aseptic Production

University essay from Lunds universitet/Avdelningen för Biomedicinsk teknik

Abstract: Production and patient safety requirements are high in pharmaceutical industries where standards are set accordingly and controlled by e.g. the U.S. Food and Drug Administration (FDA). It is crucial that these standards are met without compromising the fact that production must run as effectively as possible, i.e. achieve Overall Equipment Efficiency (OEE), for the pharmaceutical companies to deliver the expected number of batches to retailers around the globe. Stops on the production lines are interruptions to the OEE and human interventions involving opening of protective glass doors following these stops are disturbing the sensitive aseptic production environment. Limiting the root causes of these stops would equal a higher OEE and increased patient safety. Proposals are made based on the two stop causes; Tipped Vials, 46.6\%, and Crushed Glass, 15.6\%, currently causing major interventions and delays. Belt synchronisations and material property changes suggestions are made in order to minimise the door openings with 6\% and 7\% respectively. With only a simple vial material change that helps increase line speed and eliminate crushed glass interventions the probability of door openings can be reduced by over 44\%. Focus is on long-term stability and control, both for line flow and environment, largely following the Lean philosophy. The future of aseptic production is changing and e.g. Artificial Intelligence (AI) has significant potential as enough data is extracted and prepared, correct algorithms developed and taught accordingly. As for now, solutions built on years of studies in the fields of mathematics, physics and chemistry are needed to make aseptic production standards in the pharmaceutical industry even more efficient and, as always, with the interest of the patient as main priority.

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