A total productive maintenance & reliability framework for an active pharmaceutical ingredient plant utilising design for Lean Six Sigma

Noel Shannon; Anna Trubetskaya; Javed Iqbal; Olivia McDermott

doi:10.1016/j.heliyon.2023.e20516

A total productive maintenance & reliability framework for an active pharmaceutical ingredient plant utilising design for Lean Six Sigma

Heliyon. 2023 Oct 17;9(10):e20516. doi: 10.1016/j.heliyon.2023.e20516. eCollection 2023 Oct.

Authors

Noel Shannon¹, Anna Trubetskaya^{1

2}, Javed Iqbal^{1

3}, Olivia McDermott⁴

Affiliations

¹ Department of Engineering, University of Limerick, Limerick, Ireland.
² Department of Biosciences and Aquaculture, Nord University, Steinkjer, Norway.
³ Department of Chemical Sciences, School of Natural Sciences, University of Limerick, Limerick, Ireland.
⁴ College of Science and Engineering, University of Galway, Galway, Ireland.

Abstract

This research investigates the requirement for and relationship and implementation of a total productive maintenance (TPM) and Reliability Centred Maintenance (RCM) strategy within an Active Pharmaceutical Ingredient (API) Plant. This research aimed to study the tools and techniques of TPM and Reliability Engineering and then deploy a designed model to an API plant. A case study involving Design for Lean Six Sigma phases of Define, Measure, Analyse, Design, and Verify was utilised to build an API site TPM pilot program. Data was collected using interviews across Company 'X's local and Global Engineering teams. Process runtime, downtime and plant availability metrics were compiled and a new design for Total Productive Maintenance and Reliability was proposed and verified. A maintenance framework was designed to optimally incorporate Total Productive Maintenance, Reliability and Operational Excellence with an emphasis on Overall Equipment Efficiency (OEE) realizing a 33 % reduction in planned maintenance activities, a 70 % reduction in Corrective Maintenance, Cleaning for Maintenance was reduced by 50 %, the pilot maintenance area of the centrifuge has its OEE increased by 20 % and plant availability increased by two hundred and 6 h. This research highlights the importance of Total Productive Maintenance as a key component of an effective maintenance strategy and its potential to transform maintenance practices. Based on this research and results, TPM is recommended to be applied to any API manufacturing organization. A limitation of the study is that it is a single-site case study. The novelty of this research is based upon the emphasis on Reliability Engineering to remove non-value add Maintenance time from the manufacturing schedule. The Total Productive Maintenance & Reliability model designed and implemented in this research is unique in the literature and can be leveraged by engineering professionals and academics to understand the benefits of TPM.

Keywords: Autonomous maintenance; Lean Six Sigma; Maintenance strategy; Manufacturing excellence; Operator care; Overall equipment effectiveness (OEE); Total productive maintenance.