Cyber-Resilient Cold Chain Monitoring for Temperature-Sensitive Pharmaceuticals

Ensuring data integrity in pharmaceutical cold chains is increasingly challenging due to cybersecurity risks, regulatory requirements, and patient safety concerns. This study proposes a secure and interoperable monitoring architecture that integrates low-cost IoT sensors (ESP32 with DS18B20 probes) with a permissioned blockchain (Hyperledger Fabric v2.5) to enable real-time, tamper-evident data management. The framework uses SHA-256 hashing, Ed25519 digital signatures, smart contracts for anomaly detection, and HL7 FHIR standards for health system interoperability. Validation with over 5,000 timestamped records demonstrated 100% tamper-evidence, sub-2-second latency, and compliance with FDA, EU GDP, and WHO guidelines. Results indicate the approach can reduce therapeutic spoilage by up to 28%, improving traceability, pharmacovigilance, and resilience in pharmaceutical supply chains.