There has not been wholesale adoption of Controlled Not Classified (CNC) manufacturing spaces when using closed systems, despite the significant energy savings and efficiency gains that this approach represents. Biomanufacturing spaces remain, for the most part, under traditional environmental controls for sterile manufacturing areas.
The objective of this effort is to generate an empirical assessment of the benefits, liabilities, and requirements needed to establish the use of CNC as industry standard for manufacturing operations. Establishing laboratory-determined parameters and controls for CNC spaces is an integral part of the strategy. The aim is to drive standardization of this approach to facilitate adoption.
This project could accelerate the adoption of cutting-edge CNC technologies, enabling precision manufacturing and reducing production lead times by documenting proposed changes.
This project highlights implementing Controlled Non‑Classified (CNC) spaces supported by closed‑system manufacturing to reduce HVAC energy use, environmental monitoring, and gowning labor/material costs, enabling a smaller, more flexible, multi‑product facility with faster changeovers, increased capacity, and stronger supply continuity.
Future deliverable: White paper clearly defining the expectations, criteria, and practical requirements for standard controls in CNC spaces. The objective is to find the optimal balance between the flexibility of CNC spaces with acceptable standards that could be implemented across the industry to set a baseline for operational acceptability.
Torres, J., Presenter, Controlled Non-Classified Manufacturing Spaces, NIIMBL National Meeting, Washington, DC, June 24, 2025.
Login to the NIIMBL member portal to access additional project information, including presentations, progress updates, reports, and more.
Not yet a member? Learn more about which level of NIIMBL membership is right for you and your organization.
Eli Lilly and Company
Genentech, Inc.
Sartorius Stedim
