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.
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.
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Eli Lilly and Company
Genentech, Inc.
Sartorius Stedim
