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Streamline New Product Introductions with Master Soils
Author: Rizwan Sharnez

“New Perspectives on Cleaning” is an ongoing series of articles dedicated to cleaning process development, validation, and monitoring. This column addresses scientific principles, strategies, and approaches associated with cleaning that are faced in everyday work situations. Reader questions, comments, and suggestions are requested for future discussion topics. These can be submitted to either the column coordinator Rizwan Sharnez at rsharnez@amgen.com or to journal coordinating editor Susan Haigney at shaigney@advanstar.com.

SUMMARY
This article addresses issues related to cleaning that impact clean-in-place (CIP) cycle development, new product introductions (NPIs), and validation of multiproduct equipment. These operations present some unique and complex challenges. A relatively simple strategy for overcoming these challenges is presented. The strategy is based on using worst-case non-process soils to facilitate cycle development and streamline cleaning validation. The non-process soils are formulated with representative raw materials and are designed to provide an optimal worst-case cleaning challenge.

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