Supporting AIFA Compliance with Centralized Smart Monitoring
Background
Pediatric healthcare facilities in Italy are required to maintain strict cold chain conditions to preserve the quality and safety of temperature-sensitive medications and vaccines. In large medical complexes with multiple buildings, ensuring consistent freezer performance and environmental stability can be challenging.
A pediatric healthcare facility in Naples, Italy operates across three interconnected buildings, with medical freezers distributed across different floors and departments. Manual inspections and fragmented monitoring systems made it difficult to maintain continuous oversight and comply with AIFA (Italian Medicines Agency) regulations.
To address these challenges, the facility implemented a centralized Smart Control Room (SCR) powered by the ConsolONE platform. This solution integrates cold chain monitoring, environmental sensing, energy management, and network redundancy into a single operational dashboard, enabling proactive control and regulatory compliance.
Challenges in Cold Chain Management
- Distributed Medical Freezers
Freezers located in multiple buildings complicated centralized supervision. - Limited Real-Time Data Access
Staff lacked continuous visibility into temperature, humidity, and door status. - Complex Building Infrastructure
Thick walls and long distances reduced wireless signal reliability. - Manual Monitoring Burden
Routine checks were time-consuming and vulnerable to human error.
Smart Cold Chain Monitoring Solution
The solution combines IoT sensors, smart power devices, and resilient wireless infrastructure, all integrated into the SCR platform:
Freezer & Environmental Monitoring
- TS302 Temperature Sensors
External probes and door contact inputs provide precise real-time freezer monitoring. - AM102 Environmental Sensors
Measure ambient temperature and humidity to ensure stable storage conditions.
Energy & Asset Control
- WS523 Smart Sockets
Monitor energy consumption and enable remote power control, including emergency restarts for freezers and HVAC systems.
Occupancy & Facility Insights
- VS121 AI Occupancy Sensors
Deliver people counting and space utilization data to support operational planning.
Reliable Network Connectivity
- UG65 Industrial Gateways
Collect sensor data over a redundant LoRaWAN® network with 5G backup connectivity secured via WireGuard protocol. Local data logging ensures continuous monitoring during network interruptions.
Automated alerts notify staff immediately when conditions exceed predefined thresholds, enabling rapid intervention.
Results and Benefits
- Centralized Cold Chain Visibility
Unified monitoring of freezer temperature, humidity, door status, and energy usage across all buildings. - AIFA Compliance Support
Continuous data logging and alerts help meet regulatory requirements for medical freezer storage. - Proactive Risk Prevention
Early warnings reduce medication spoilage, downtime, and operational costs. - High System Reliability
Redundant gateways and backup connectivity ensure uninterrupted monitoring. - Operational Optimization
Environmental, energy, and occupancy insights extend value beyond cold chain management.
Why Cold Chain Monitoring Matters in Pediatric Healthcare
Maintaining stable freezer conditions is critical for pediatric medications, vaccines, and biologics. A centralized, automated monitoring system improves patient safety, supports regulatory compliance, and reduces operational risk—especially in large, multi-building healthcare environments.
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