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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.
摘要：
本研究调查了活性药物成分（API）工厂内全面生产维护（TPM）和以可靠性为中心的维护（RCM）策略的要求，关系和实施。本研究旨在研究TPM和可靠性工程的工具和技术，然后将设计模型部署到API工厂。涉及定义精益六西格玛阶段设计的案例研究，Measure,分析,设计,并验证用于构建API站点TPM试点计划。数据是通过采访X公司的本地和全球工程团队收集的。进程运行时，编制了停机时间和工厂可用性指标，并提出并验证了全面生产维护和可靠性的新设计。设计了一个维护框架，以最佳方式纳入全面生产维护，可靠性和运营卓越，重点是整体设备效率（OEE），实现计划维护活动减少33%，纠正维护减少70%，维护清洁减少了50%，离心机的试点维护区域的OEE增加了20％，工厂可用性增加了200和6小时。这项研究强调了全面生产维护作为有效维护策略的关键组成部分及其改变维护实践的潜力的重要性。基于此研究和结果,建议将TPM应用于任何API制造组织。该研究的局限性在于它是单站点案例研究。这项研究的新颖性基于对可靠性工程的重视，以从制造计划中删除非增值维护时间。本研究中设计和实施的全面生产维护和可靠性模型在文献中是独一无二的，工程专业人员和学者可以利用它来了解TPM的好处。
