Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology

By Matt Dean, Director of Process Architecture, AES Clean Technology Inc., and Mitchell Gonzales, Vice President of Process Technology, AES Clean Technology Inc.

Originally published on Pharma's Almanac

A cleanroom project starts with a design concept centered around the strategic goals of the biopharmaceutical manufacturer. Ideally, a cross-functional team will collaborate with the design firm, following a structured process to develop a comprehensive and compliant design that addresses present needs while offering flexibility for any future requirements. A methodical approach to designing and constructing cleanrooms is crucial to keep projects on track, especially in cases where no organized client team is provided, and the scope and process definitions are delayed and less clear than preferred. AES Clean Technology provides critical design compliance and a structured project management framework with its Compass™ Program, enabling biopharma companies to maintain a trajectory toward a right-first-time cleanroom that meets both operational and regulatory expectations. Learn about the rising demand for cleanrooms, factors driving cleanroom design, the importance of building in flexibility, the role of critical path assessments, and much more.