Paul Lopolito is a technical services senior manager for the Life Sciences Division at STERIS.

Paul Lopolito

Cleaning validation is a regulatory requirement worldwide and an integral process step within the manufacturing of active pharmaceutical ingredients (APIs) and drug products. The approach of designing, qualifying, and monitoring a process is labeled a lifecycle approach. This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.

	Submitted: May 29, 2018
	Accepted: June 4, 2018

	Chunfen Zhang, PhD, is a scientist in the Analytical Service & Development Group; Dijana Hadziselimovic is a technical services laboratory specialist for the Life Sciences Division; Amy Thanavaro, PhD, is a group leader scientific-Analytical Services & Development; and Paul Lopolito* is a technical services senior manager for the Life Sciences Division, Paul_Lopolito@steris.com; all are at STERIS. Adeyinka Aina, PhD, MRSC, is an innovation fellow at the Pharmaceutical Manufacturing Technology Centre, University of Limerick; and Chris Edlin, PhD, is currently director of drug development and head of Pharmaceutical Sciences in Respiratory R&D for Teva Pharmaceuticals Ireland.

*To whom all correspondence should be addressed.


	Vol. 42, No. 9
	September 2018
	Pages: 42–54

	When referring to this article, please cite it as C. Zhang et. al, “Rethinking Cleaning Validation for API Manufacturing,” 

Articles

This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.