Merritt J
Rexam Medical Packaging, Singapore.
Med Device Technol. 1997 Oct;8(8):22-8.
The development of an effective process requires a comprehensive understanding of two factors: the variables that can affect the process and the ability of the process to control those variables. This article examines the application of factorial designs in the qualification and validation of packaging systems. Using a case study to illustrate the concept, it describes a three-step approach that allows a reduction in the quantity of sampling compared with other experimental methods.
可能影响该流程的变量以及该流程控制这些变量的能力。本文探讨析因设计在包装系统鉴定和验证中的应用。通过一个案例研究来说明这一概念，它描述了一种三步法，与其他实验方法相比，该方法可减少抽样量。
