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,” 

Cleanroom Equipment and Supplies

Equipment

Facility Design and Engineering

Peer-Reviewed Research

Quality Assurance/Quality Control

Quality Systems

Standard Operating Procedures

Pharmaceutical Technology-09-02-2018

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.