Systematic Protocol for ISO Class 7 Cleanroom Verification in Operating Rooms: Enhancing Infection Control and Research Integration

This study presents a systematic protocol for verifying cleanroom parameters in operating rooms (ORs) under “at-rest” conditions, aligning with ISO 14644 standards, with the goal of bridging industry practices and research needs. The objective is to establish a comprehensive framework for assessing cleanroom class 7 compliance, ensuring optimal environmental conditions for infection control and patient safety. The measured microbial concentrations, room pressurisation, air temperature, relative humidity, air change rate, and particulate matter concentrations were within the recommended ranges, confirming compliance with cleanroom standards. Microbial concentrations ranged from 2 to 7 cfu/m3, well below the threshold of 35 cfu/m3, indicating excellent air cleanliness. Room pressure differentials exceeded the minimum requirement of 5 Pa, ranging from +6.86 Pa to +17.53 Pa, ensuring effective containment. Environmental conditions met stipulated guidelines, with temperatures maintained between 18.4 °C and 21.7 °C (recommended: 18 °C to 22 °C) and relative humidity between 53.6% and 58.5% (recommended: 50%–60%). These findings validate the operational readiness of the ORs and provide a benchmark for cleanroom status verification in healthcare facilities. This work supports Sustainable Development Goal (SDG) 3: Good Health and Well-being, by highlighting the importance of clean, controlled environments in reducing infection risks and improving patient outcomes. By promoting routine cleanroom verification and adherence to stringent standards, this protocol contributes to enhancing healthcare quality and fostering sustainable, healthy communities. Future studies shall consider dynamic condition assessments during surgical procedures to complement routine cleanroom verification. Such evaluations could provide valuable insights into the real-time performance of the operating environment, ensuring that cleanroom standards are maintained even under active usage conditions.