Pathology Department Cleanroom Solutions

In medical diagnosis, pathology cleanrooms are critical for ensuring accurate results by preventing sample contamination and protecting staff. This simplified guide outlines key requirements and solutions for these specialized environments.​

Pathology cleanrooms differ from other industries, focusing on preventing cross-contamination and ensuring biosafety. They typically follow ISO 14644 standards (ISO 7-8), with additional biosafety level 2 (BSL-2) requirements for handling infectious materials.​

Key standards include:​

• WHO's biosafety guidelines and China's "Pathology Department Construction Guidelines"​
• Sampling rooms: ≥15㎡, 15+ air changes/hour, HEPA-filtered exhaust, negative pressure​
• Molecular labs: Strict zoning (reagent prep, sample handling, amplification, analysis) with pressure gradients (≥5Pa)​
• General areas (sectioning/staining): 10-12 air changes/hour, focus on dust control​
• Layout must follow one-way flow for samples and separate paths for personnel, with dedicated changing areas between zones.​

• Modular construction with smooth, easy-to-clean surfaces (color steel walls, seamless PVC/epoxy floors)​
• Three-stage air filtration (G4 → F8 → H13 HEPA) removing 99.97% of ≥0.3μm particles​
• 100% fresh air systems for high-risk areas to prevent cross-contamination​
• Specialized equipment: Class II biosafety cabinets (0.38-0.5m/s airflow), chemical fume hoods (0.5-0.6m/s)​

• Activated carbon filters for formaldehyde/xylene (≥90% efficiency)​
• Separate equipment for molecular lab zones; no cross-use​
• Leak-proof reagent storage with chemical segregation​
• Strict cleaning protocols: Daily surface cleaning, weekly disinfection (500mg/L chlorine or 0.5% peracetic acid)​

• Real-time monitoring of temperature (20-24℃), humidity (40-60%), pressure, and particles​
• Energy optimization: Variable speed fans, heat recovery (30%+ energy savings)​
• Regular maintenance: Annual HEPA filter testing, performance verification​
• Staff protocols: Training, restricted access, proper PPE, and health monitoring​

• Smart monitoring via IoT and sensor technology​
• Modular designs for flexible scaling​
• Eco-friendly materials and reagents
• Human-centric features: Ergonomic workstations, improved lighting​

Pathology cleanrooms require balanced attention to contamination control, safety, and efficiency. By combining proper design, technology, and protocols, these environments protect both samples and staff while ensuring diagnostic accuracy.​