无菌制造业的积极替代:健康指数 + 韦布尔/卡普兰梅尔框架
SaiVijay Thattukolla1, SaiVinay Thattukolla2
1CSL saivijay.t1998@gmail.com.
PDA journal of pharmaceutical science and technology
|January 18, 2026
概括
一种新的维护方法使用健康指数 (HI) 和生存分析来预测设备故障,减少无菌制造中的停机时间和成本. 这种主动的方法可以确保设备的可靠性和患者的安全性,因为它可以在故障发生之前进行计划干预.
科学领域:
- 工业工程 工业工程 工业工程
- 制药制造业 制药制造业 制药制造业
- 可靠性工程可靠性工程
背景情况:
- 无菌制造需要可靠的设备来保持生产吞吐量并确保患者的安全.
- 计划外的设备故障会导致大量停机时间,成本增加和产品质量受损.
- 现有的维护策略通常依赖于反应性或基于时间的方法,这对于复杂的系统可能不是最佳的.
研究的目的:
- 提出一种实用且可重复的维护工程方法,用于在故障之前主动更换老化的设备部件.
- 将状态监测信号与生存分析相结合,以估计剩余的使用寿命 (RUL).
- 展示一个工作流程,将RUL估计转换为可执行的维护决策,在一个治理系统内.
主要方法:
- 开发了一个加权的健康指数 (HI),以总结条件信号 (振动,温度,流量等). ) 的情况.
- 已建立的生存方法,包括韦布尔和卡普兰-梅尔分析,用于估计RUL.
- 为 SAP 工厂维护 (PM) 创建了一个概念工作流映射,用于工作订单管理和记录.
主要成果:
- 韦布尔模型的形状因子约为1.8-2,捕获了磨损行为.
- 卡普兰-梅尔分析表明,在24个月后,存活概率为0.58.
- 实施HI和RUL方法将干预从反应性转移到计划性停机,显著减少了停机时间 (62.5%),成本 (84%) 和批量丢弃 (50%).
结论:
- 该研究提供了一个可重复的维护工程工作流程,结合了HI,基于生存的RUL和决策矩阵.
- 该方法在验证后可适应现有的SCADA和SAP PM基础设施.
- 优先考虑产品质量关键部件,如密封和喷雾喷嘴,预计将带来早期的好处.
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