Grouping equipment for cleaning validation is a common practice for reducing execution, resources, and production downtime. Though regulatory   and industry guidelines  support the practice and provide guidance, there is a clear requirement for scientific justification.
Common industry practice is to either avoid grouping because of perceived risk or base the grouping only on a few physical characteristics (i.e., surface area and vessel size).
Equipment grouping should include equipment geometry and complexity; internal equipment components; piping diameter; and critical cleaning parameters.
The following discussion will explore concepts, considerations, and suggestions for cleaning validation (CV) equipment grouping.
Senior Global Technical Manager, Life Science (Cleaning Validation) for Ecolab in North America
Fred Ohsiek is the Sr Global Technical Manager, Life Science (Cleaning Validation) for Ecolab in North America. His main focus at Ecolab is to assist customers with cleaning validation/cleaning challenges and cleaning process optimization.
He earned his bachelor’s in chemistry from University of South Florida.
His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 22 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Boehringer Ingelheim, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk.
His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring of cleaning processes for equipment used in small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional product manufacturing.
The scope of his work involved drug substance and drug product manufacturing start-up; remediation and legacy justification; creating/improving routine monitoring programs; and increasing manufacturing capability. He has also introduced and incorporated methods to lean the CV footprint by reducing documentation and execution.
He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.