Temperature excursions
Temperature-sensitive biologics, mRNA vaccines, and cell therapies degrade outside their qualified ranges. A single unmonitored deviation can void a shipment and trigger a recall under USP <1079> and EU GDP guidelines.
← All industries
Pharma & Life Sciences
Cold chain integrity, cryptographically verified.
Vaccines, biologics, clinical trial materials, and controlled substances move through corridors where one excursion can void an entire shipment. Journey Protector captures sensor-grade evidence at the device, signs it at source, and delivers a chain of custody that holds up in regulatory audits.
The Problem
Where today's chain of custody breaks down
Serialisation and traceability under DSCSA
The US Drug Supply Chain Security Act requires unit-level serialisation, transaction history, and verification across the dispenser network. Pen-and-paper handoffs and paper logs no longer satisfy these requirements.
Audit-readiness for FDA 21 CFR Part 11
Electronic records of cold chain conditions must be attributable, legible, contemporaneous, original, and accurate (ALCOA). Most temperature loggers were not designed for this evidentiary bar.
Clinical trial chain of custody
Investigational medicinal products under ICH GCP Section 5.13 require verifiable handling records from sponsor to investigator site. Lost samples or unverifiable conditions can invalidate trial arms.
The Platform
A purpose-built sensor platform for regulated cold chain.
Continuous monitoring across 10 modalities
Temperature, humidity, shock, GPS, acoustic, gas, light, barometric, RF environment, and tamper detection. Every reading is signed at the hardware level with Ed25519 before it leaves the device.
Append-only evidence chain
Every measurement is hashed into an append-only record with optional blockchain anchoring. Post-hoc editing is cryptographically detectable, which is the standard regulators are moving toward.
Real-time exception alerts
AI risk engine learns the baseline for your specific routes and lanes. Excursions, route deviations, or sensor anomalies trigger alerts in real time, not on arrival.
Air, sea, road, courier
Tested across IATA TTSL airfreight, reefer container ocean lanes, refrigerated road, and specialist courier. One platform across modes, one evidence chain across handoffs.
Compliance
Built around the frameworks that matter
Every framework below is a real standard or regulation. Journey Protector's evidence chain is designed to feed each one with the data it actually requires, not just the data that's easy to collect.
DSCSADrug Supply Chain Security ActUnited States
FDA 21 CFR Part 11Electronic Records & SignaturesUnited States
EU GDPGood Distribution PracticeEuropean Union
USP <1079>Storage & Shipping RequirementsUnited States Pharmacopeia
IATA CEIV PharmaCenter of Excellence for Independent ValidatorsGlobal air freight
ICH GCPGood Clinical PracticeGlobal trials
WHO PQSPerformance, Quality & SafetyGlobal health programmes
In Practice
Where this gets deployed
mRNA vaccine distribution
Continuous ultra-low temperature monitoring with rate-of-change analysis. Detects gradual freezer drift hours before it crosses the threshold, not after.
Clinical trial sample shipping
Signed evidence chain from investigator site to central lab. Tamper-detection on the container itself, not just the outer packaging.
Biologic and cell therapy logistics
Tracking through narrow temperature corridors with multi-sensor fusion to distinguish handling events from real excursions.
Controlled substance transit
GPS, geofencing, and tamper detection combined for Schedule II and equivalent regulatory needs.
Built for Pharma.
Ready to talk specifics?
Our team can scope a pilot on your real routes, with your real cargo, on your real timelines. We don't sell a platform you have to integrate. We deploy it for you.