Abstract
This work aims to assess the impact of maintenance-oriented design on a production line in the pharmaceutical industry, which includes operations in a clean room. The case study analyses the downtimes of a production line of large volume parental solutions. The results obtained at the end of an appropriate period of observation were used to identify the main problems, in terms of maintenance time. Some of the critical issues were overcome by requiring that part of the production line be redesigned by a company specialized in the design of clean room lines. In this context, the focus of the case study is not on the technical aspects of maintenance-oriented design application, but its consequences in terms of the increase in performance. The performance of the new production line was analysed and compared with that obtained in the first phase of the study. This comparison allowed us to estimate and quantify the achieved improvements referring to system availability and consequently to a production increase quantified at more than 110,000 units per year. The impact of the maintenance-oriented design was also evaluated from an economic point of view. In particular, the production increase obtained and the corresponding economic advantages were evaluated. Through this comparison, it was possible to estimate the payback period for the investment of redesign, quantified in less than six years.
Highlights
Organizations are continuously seeking strategies to improve their operations and gain a competitive advantage
The study was performed on a production line for large volume parenteral solutions (LVPs), containing paracetamol and used in hospital settings
Comparing the data from before and after the changes, it is possible to evaluate the results in terms of the performance improvement of the system [23,24], due to the maintenance-oriented redesign of the bottling system
Summary
Organizations are continuously seeking strategies to improve their operations and gain a competitive advantage. The competitiveness is regained by implementing the dictates of their "quality management" for continuous improvements in all areas of pharmaceutical industry [2,3] All this can involve the optimization of maintenance processes directly linked to productive results in terms of defects and decreased performance. This goal can be achieved through the implementation of activities planned to increase equipment efficiency, the creation of a programme of autonomous maintenance, the establishing of a planned maintenance system, the organization of training courses for workers and the design of a plant management system This situation has led to the need for a rigorously defined performance measurement system that is able to take into account different important elements of productivity in a manufacturing process. Based on the above statements, it is clear that the pharmaceutical industry, as it is highly regulated and
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