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.
Unique Requirements and Standards
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.
Core Solutions
Hardware
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)
Contamination Control
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)
Lean Operations
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
Future Trends
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.
Your message must be between 20-3,000 characters!