Exploring Cutting-edge Control Strategies for Sustainable Manufacturing Practices in Cleanrooms

Introduction

The pharmaceutical industry is pivotal in safeguarding public health, with the global market for pharmaceutical products witnessing a remarkable 50% growth since 2010. To support this expansion, the construction and operation of pharmaceutical cleanrooms—meticulously regulated environments essential for biopharmaceutical manufacturing—have also evolved significantly. These cleanrooms are designed to meet rigorous standards, ensuring cleanliness, differential pressure, temperature, humidity, and airflow, all in compliance with Good Manufacturing Practices (GMP). The classification of cleanrooms into Class A, Class B, Class C, and Class D is fundamental, and the choice of cleanroom class depends on the production processes, facility layout, and risk assessments. GMP requirements stipulate that the production environment parameters must meet the process risk control needs of biopharmaceutical plants.

The Energy Challenge in Cleanroom Operations

While maintaining stringent cleanliness standards is vital, it comes with significant operational challenges, particularly regarding energy consumption. Cleanrooms require extensive air conditioning and ventilation systems to filter and circulate clean air continuously. Unfortunately, these systems, while crucial for maintaining prescribed environmental standards, contribute to high energy usage.  

Recent research has proposed innovative control strategies aimed at enhancing energy efficiency in biopharmaceutical cleanrooms. For instance, the study by Cheng et al. (2023) introduces a sophisticated two-part control mechanism combining feedforward and feedback systems to achieve specific pressure control objectives, thereby mitigating energy usage while preserving cleanliness standards. This model anticipates pressure levels based on variables such as room occupancy and thermal loads while actively adjusting for discrepancies between actual and target pressure levels. This hybrid approach not only stabilizes the internal environment but also maintains essential cleanliness during transitions between operational and standby modes. Similarly, Chunwang et al. (2021) emphasize the importance of real-time adaptive control systems that can optimize energy consumption without compromising sterility, revealing a growing trend in cleanroom management towards data-driven approaches. 

An essential aspect of this control strategy is managing cleanroom pressure gradients effectively. A stable pressure differential ensures clean air flows into the cleanroom while preventing the infiltration of contaminated air from adjacent areas—critical in the pharmaceutical sector, where even minimal contamination can compromise product integrity.