会社のニュース Modular Cleanroom Commissioning: Step-by-Step Guide to Successful System Startup

Commissioning a modular cleanroom is a rigorous, multi-phase process that validates every component performs to design specifications, ensuring regulatory compliance and operational reliability. Unlike traditional construction, modular systems offer advantages in faster validation due to factory-tested components, but require meticulous planning to integrate all systems seamlessly.

Before any testing begins, a comprehensive pre-commissioning checklist ensures all foundational elements are in place. This includes verifying correct installation of modular wall panels, ceiling grids, and flooring systems, with proper alignment and gasket sealing. Utility connections—electrical, plumbing, and compressed air—are pressure-tested and leak-checked. HVAC systems undergo preliminary airflow balancing, with each fan filter unit (FFU) run continuously for 72 hours to stabilize performance. Documentation reviews confirm all equipment has valid calibration certificates and material safety data sheets (MSDS) are on file.

The core of cleanroom commissioning focuses on validating environmental controls. Particle counting tests measure airborne contaminants using calibrated laser counters at multiple heights and locations, ensuring compliance with ISO classification standards (ISO 14644-1). Temperature and humidity mapping uses data loggers placed strategically throughout the space, verifying uniform conditions within ±0.5°C and ±2% RH of setpoints. Pressure differential testing confirms proper cascade relationships between zones, with differential pressures maintained at ≥12.5 Pa between adjacent cleanroom classifications.

Modular cleanrooms rely on integrated systems that must function harmoniously. Air change rate tests calculate ventilation effectiveness by measuring tracer gas decay times, ensuring sufficient air exchange rates meet industry standards. Filter integrity tests (DOP/PAO) challenge HEPA/ULPA filters with aerosolized particles to detect leaks, critical for maintaining sterile conditions. Alarm systems are triggered intentionally to verify proper notification protocols, and emergency shutdown procedures are tested to ensure safe de-energization of equipment.