Unit Operations Characterization Using Historical Manufacturing Performance
详细信息 查看全文
- 作者：Jerry D. Mitchell ; Kumar Abhinava ; Kristi L. Griffiths ; Bernard McGarvey ; Kevin D. Seibert ; Shanthi Sethuraman
- 刊名：Industrial & Engineering Chemistry Research
- 出版年：2008
- 出版时间：September 3, 2008
- 年：2008
- 卷：47
- 期：17
- 页码：6612-6621
- 全文大小：446K
- 年卷期：v.47,no.17(September 3, 2008)
- ISSN：1520-5045
文摘
Collecting unit operation performance data on manufacturing processes has many benefits. Besides assessing the health of assets, the data can also be analyzed to drive process improvement activities, to assist in establishing practical operating ranges for new products, and can be used to facilitate process development activities in the laboratory ultimately leading to more robust tech transfers of processes to the manufacturing facility. In this paper, we will describe how to obtain operational variability on the basis of performance data extracted from current and/or historical manufacturing unit operations and its practical uses. Although, the concept was developed initially as a small molecule process design tool, its flexibility is underscored by including an example of how a parenteral manufacturing site used it to identify and correct an issue before it translated into unplanned downtime or product loss.