Improving Equipment Availability on a Pharmaceutical Production Line by Analyzing Reliability and Maintainability

Authors: Yuniel Mendez Pupo; Jesús Cabrera Gómez
Improving Equipment Availability on a Pharmaceutical Production Line by Analyzing Reliability and Maintainability
DOI
10.25125/ijoer-aug-2026-4
DIN
IJOER-AUG-2026-4
Abstract

This research addresses the low availability of critical equipment in a physiological serum production line, characterized by frequent unscheduled shutdowns. The objective was to propose a plan to improve the availability of critical equipment, specifically in the serum filling machine, identified through a criticality and complexity analysis based on mathematical models and expert criteria. Key performance indicators such as reliability, maintainability and availability were evaluated. Initial results showed limited reliability, a high mean time to repair (10.02 h), and an availability of 89.4%, lower than the desired standard (>95%). 60% of the failures were mechanical in nature, which oriented the analysis towards the identification of causes using tools such as the Ishikawa diagram. Based on the opportunities detected, a comprehensive plan of corrective actions was designed, which included the improvement of maintenance procedures, staff training, optimization of spare parts management, implementation of condition monitoring and technological updating. The partial application of the plan showed positive results: reduction of the average repair time to 5.56 h and increase in availability to 93.59%, as well as significant improvements in the mechanical reliability of the equipment. It is concluded that the systematic implementation of the proposed plan contributes to improving the operational performance of critical equipment, increasing production efficiency and reducing economic losses in the physiological serum production line.

Keywords
Availability Improvement Reliability and Maintainability Analysis Critical Equipment Management Industrial Maintenance Failure Analysis.
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Introduction

In the industrial field, the availability of critical equipment is a determining factor in ensuring the operational efficiency and profitability of production plants [1]. In the case of the pharmaceutical industry, where quality standards and production times are demanding, any unplanned interruption can have significant repercussions on productivity and economic income. This paper presents the results of research focused on improving the availability of physiological serum production lines, specifically in a plant where unscheduled shutdowns have generated considerable economic losses and affected the fulfillment of production plans. The study focused on a serum filling machine, identified as the most critical equipment through a hierarchy analysis based on mathematical models and expert criteria. Through detailed analysis, key indicators such as maintainability, reliability, and availability were evaluated, using tools to model fault behavior and repair times [2]. The proposals for improvement presented included aspects such as the rationalization of maintenance procedures, staff training, technological modernization and inventory management. These actions seek not only to increase the availability of equipment, but also to enhance its reliability and reduce downtime, positively impacting the company's productivity and competitiveness. This work constitutes an important contribution to maintenance in the pharmaceutical industry, by combining theoretical foundations with practical solutions, supported by real data and the experience of a group of experts [3-5]. It is estimated that the implementation of its results will allow the plant to achieve higher levels of efficiency and meet national and international demands, ensuring the quality of its products and the sustainability of its operations.

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Conclusion

In summary, this study investigated a proposed plan for improving the availability of the equipment identified as the most critical in a production line of the physiological serum plant. Based on the analyses carried out and the results obtained, an action plan was proposed, the implementation of which contributed to the improvement of the availability of the critical equipment identified, which was the serum filling machine 1. Some of the actions included in the plan are being successfully implemented or are in the process of being implemented and the first results are already being observed.

  1. Serum Filling Machine 1 is regarded as the most critical and complex equipment of the serum plant.
  2. The starting values for the reliability, maintainability and availability indicators are low and can be improved. Before the proposed improvement plan was implemented, it was estimated that these values were, respectively, 75.32% for 24 hours of continuous work, 16.5% for a repair time of 2 hours and 89.4%.
  3. For the Serum Filling Machine 1, 60% of the failures recorded are mechanical in nature and the focus was on them for the identification of opportunities for improvement in availability and the allocation of corresponding corrective actions.
  4. The proposed improvement plan for Serum Filling Machine 1 sufficiently takes advantage of the identified improvement opportunities and is based on the corrective actions associated with those opportunities.
  5. The proposed availability improvement plan is in the process of being implemented and is beginning to show its first results, highlighting the increase in availability from 89.4% to 93.59%, approaching the value expected by the entity, which is 95%.
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