THE CHALLENGEA Single Excursion Spoils the Shipment
Vaccines and biologics hold their potency only inside a narrow temperature band, and a short breach in transit can ruin an entire load that still looks fine on arrival. Most operations find out at the destination, with a manual logger that has to be downloaded and read after the fact, by which point the product is already at the patient. Regulators expect a complete Good Distribution Practice record, but spreadsheet logs and uncalibrated probes do not survive an audit. The system watches product temperature live, alerts the moment it drifts, and keeps a defensible record for every shipment.
One layer of the full Telematics and GPS Tracking platform, working closely with Cold Chain Monitoring.
WHAT'S INCLUDED
Hardware and Software for Regulated Cold Chain
Calibrated BLE Sensors
Small BLE temperature and humidity sensors sit right where the product sits, with a typical tolerance of plus or minus 0.5 degrees Celsius. Each unit carries a traceable calibration certificate and supports scheduled recalibration so the data holds under audit.
GPS Gateway
A GPS gateway in the vehicle collects from every BLE sensor, adds position and time, and backhauls over cellular. One gateway serves many sensors, and the sensors move with the product as it changes vehicles or zones.
Real-Time Excursion Alerts
The gateway checks every reading against the product temperature band and trends mean kinetic temperature. A breach, or a predicted breach, fires an SMS, email, and dashboard alert that is timestamped and geotagged to the exact leg and location.
Tamper-Proof Audit Logs
Every reading is written to an append-only audit log with device identity and a trusted time source. The record cannot be edited after the fact, which is what makes it defensible when a quality team or regulator reviews the shipment.
Door-Open Sensing
A door-open sensor on the reefer or cold box logs every opening with time and place. Correlated with the temperature trace, it explains a warm spike and separates a recovered door event from a genuine product risk.
GDP Compliance Reporting
Per-shipment compliance reports are generated to align with Good Distribution Practice, ready to sign off without manually stitching spreadsheets. Excursions, durations, and acknowledgements are all captured in one record.
ARCHITECTURE
Sensor at the Product, Gateway at the Vehicle
Separating the sensor from the gateway is the core decision. Calibrated BLE sensors stay with the product across handoffs, while the GPS gateway handles position, alerting, and a complete buffered record.
BLE Sensor Layer
Independent battery-powered sensors sized for the shipment report temperature and humidity to the gateway. Multiple sensors cover multiple zones of a reefer or individual cold boxes within one vehicle.
GPS Gateway
An STM32-class MCU with a SIMCom or Quectel modem and a BLE radio runs the excursion logic, logs locally during outages, and backhauls over cellular. A backup cell keeps it logging through stops and power loss.
Compliance Backend
Readings land in an append-only store that drives alerting, the tamper-proof audit trail, and GDP report generation. Buffered data uploads after any network gap so the trace stays complete.
FAQ
Common Questions
How accurate are the temperature sensors?
Calibrated BLE temperature and humidity sensors carry a typical tolerance of plus or minus 0.5 degrees Celsius. Each sensor ships with a calibration certificate traceable to a reference standard, and scheduled recalibration is supported so the data holds up under audit.
What happens during a temperature excursion?
The gateway evaluates every reading against the product temperature band in real time. The moment a reading breaches the limit, or the mean kinetic temperature trend predicts a breach, the system raises an alert by SMS, email, and dashboard. The excursion is timestamped and geotagged so the responsible leg and location are clear.
Does this meet GDP and audit requirements?
Yes. The logging layer is designed for Good Distribution Practice. Every reading is written to a tamper-proof, append-only audit log with device identity and time source, and compliance reports are generated per shipment so an auditor or quality team can sign off without manual stitching of spreadsheets.
Why a BLE sensor and GPS gateway split instead of one device?
Splitting the sensor from the gateway lets small calibrated BLE sensors sit exactly where the product sits, inside boxes, on shelves, or in multiple zones of a reefer, while one GPS gateway handles position and cellular backhaul. One gateway serves many sensors, and a sensor can move with the product across vehicles.
Can you detect door openings during transit?
Yes. A door-open sensor on the reefer or cold box flags every opening with a timestamp and location. Correlated with the temperature trace, this explains a warm spike and separates a genuine product risk from a brief, recovered door event.
What hardware sits in the vehicle?
The GPS gateway is typically an STM32-class MCU with a SIMCom or Quectel cellular modem and a BLE radio, powered from the vehicle supply with a backup cell so it keeps logging during stops and power loss. The BLE sensors are independent battery-powered units sized for the shipment.
Does the data survive a network outage?
Yes. The gateway logs locally and buffers readings when cellular drops, then uploads the full record when the link returns. No data point is lost, which matters because a gap in the trace is itself an audit problem for a regulated shipment.
Protect Every Dose in Transit
Share your product temperature bands, lanes, and compliance needs to get a tailored approach for live product monitoring and an audit-ready record for your quality team.
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