Energy-saving case study on the engineering design of cell therapy production workshops

Project Background:

The client is a biopharmaceutical technology company focused on R&D and clinical application of innovative drugs for tumor immunotherapy. The client plans to build a new GMP compliant production facility, including a GMP compliant production workshop for cell therapy products, QC, warehouse, and supporting facilities such as laundry, utilities, biowaste inactivation, and wastewater treatment. The biosafety level of this project is BSL-2, and the facility is designed according to NMPA GMP and EU cGMP.

This article introduces the energy-saving opportunity by analyzing the HVAC system zoning strategy of the GMP production workshop for cell therapy products.

Manufacturing Process Description:

The CAR-T production line of this project is for autologous cell production. Two completely identical production suites are designed to accommodate the production of two different products; each suite includes two sets of production units, allowing different process steps to be carried out simultaneously.

HVAC System Zoning:

For a single production suite: ① If all of the CAR-T cell operation rooms share a common HVAC system, full air exhaust shall be designed for the corresponding production units, which will increase operational energy consumption and bring inconvenience when different CAR-T production units are not producing simultaneously. ② If each CAR-T production unit has an independent HVAC system, return air can be utilized appropriately. This project adopts the second HVAC zoning strategy - air recirculation mode, with the HVAC system zoning detailed in the figure below:

Figure 1. HVAC System Zoning Plan

Conclusion:

By conducting a risk assessment, the production units, except for some rooms that require air exhaust due to the use of BSC BII type biosafety cabinets, maximize the use of recirculated air to reduce operational energy consumption. The fresh air volume of the system is reduced by 47% compared to the full exhaust mode, and the operational energy consumption of the system is reduced by 37%.

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