Cold chain · Pharma & vaccines

    Catch the freeze that quietly kills a vaccine.

    Everyone guards the 8 °C ceiling — but distribution studies have found 14–35% of fridges and shipments exposed vaccines to freezing, and a few minutes below 0 °C against a cold-pack or reefer wall destroys potency with nothing for the receiver to see. Navixy puts calibrated logging inside the carrier, alerts on the freeze side and the rate of change, and turns the trip into a GDP-ready record.

    EN 12830 · ISO-17025 calibrated loggingFreeze + heat excursion alertsMKT & time-out-of-rangeExports to your QA / QMS
    Two sensors, one vaccine shipment — only one sees the freeze
    Reefer return-air sensorreads in range

    The unit's air sensor sits in the airflow, not the load — it never dips below 2 °C.

    In-carrier product probefreeze · potency at risk

    Pressed against a cold-pack or the reefer wall, the vial hits −1.4 °C — invisible to the receiver.

    Guard both ends of the band — and prove it

    A vaccine corridor has a floor as well as a ceiling. Navixy watches the freeze side most monitoring ignores, measures from inside the load, and assembles the qualified record a GDP audit actually asks for.

    The record an auditor follows, not one you assemble the night before

    Mean kinetic temperature, time above the ceiling, and time below freezing on one defensible record — built on a schedule with IoT Query and exported to your QA system, so a freeze event is logged, explained, and dispositioned instead of discovered.

    Shipment RX-204 · vaccine · 2–8 °C
    GDP record
    Condition · cold store → clinicboth bounds watched
    Mean kinetic temp
    4.1 °C
    Time above 8 °C
    0 min
    Time below 0 °C
    6 min
    Disposition
    QA review

    Alert on the freeze side, not just the ceiling

    IoT Logic watches the lower 0 °C bound and the rate of change toward it, so a cold-pack or a stuck heater trips an alert before the vial is damaged — not at receiving.

    EN 12830 · ISO-17025 · ±0.5 °C
    ~345 d on-board log

    Calibrated, certified, gap-free logging

    Use BLE loggers certified to EN 12830 with ISO-17025-calibrated probes that hold ~345 days on-board, so a cellular dead zone never leaves a hole in the audit trail.

    Measure the vial, not the airflow

    The reefer's return-air sensor reads the air, not the product. Navixy ingests an independent probe placed in the carrier — where the freeze actually happens.

    Mean kinetic temperature
    4.1 °Cvs 5.6 °C simple mean

    Weights heat exposure the way stability does — the number a GDP audit asks for.

    Mean kinetic temperature, not a simple average

    MKT weights exposure the way stability data does, so the number on the report reflects real potency risk — the metric GDP and stability budgets are written in.

    Glass vaccine vials with blue caps resting on frozen gel packs inside a white insulated medical cooler, cold vapor rising
    In-carrier probe−1.4 °C
    30%+
    of injectable drugs are freeze-sensitive (industry estimate)
    From cold store to clinic

    The freeze usually happens on the way to the clinic

    Frozen gel packs added for the last leg are the most common cause of an accidental freeze: a vial resting against a brick of −20 °C coolant drops below 0 °C while the box's air still reads 4 °C. A calibrated probe travelling with the product — not on the wall — is what turns that invisible event into an alert and a line on the record.

    • Calibrated probe inside the carrier, beside the product
    • Freeze-side and rate-of-change alerts before damage, not after
    • Custody and condition handed to the clinic as one record
    How excursions are caught in real time
    Anatomy of a freeze excursion

    A 2–8 °C vaccine load brushes the cold wall — and is pulled back before potency is lost

    The trace runs the GDP corridor until a cold-pack contact drives the product probe below freezing. Watch the rate-of-change alert fire on the dive, the handler reposition the load, and the trip resolve into a record that logs the time below 0 °C.

    GDP corridor · 2–8 °Clive shipment telemetry
    8 °C2 °C
    Pharma DCLine-haulCold-pack legClinic
    Condition timeline
    • Departure — box pre-conditioned to 4 °C, in range
    • Gel pack added for the last mile; probe begins to dive
    • Rate-of-change alert fires before 0 °C is crossed
    • Freeze: −1.4 °C — handler repositions the vials off the pack
    • Back in range; time below 0 °C logged automatically
    • Condition record sealed and routed to QA
    Proof of condition
    Min product temp
    −1.4 °C
    Min product temp
    Time below 0 °C
    6 min
    Time below 0 °C
    Disposition
    QA review
    Disposition
    How it's built

    From a vial in a box to a released record, in four moves

    The same composable platform that runs fleet and field operations, configured for a GDP cold chain — buildable on hardware you already approve.

    1. 01

      Sense in the load

      A BLE logger certified to EN 12830 with an ISO-17025-calibrated probe travels inside the carrier, sampling every 1–5 minutes and logging on-board so dead zones leave no gaps.

    2. 02

      Decide on both bounds

      IoT Logic evaluates each reading against the floor and the ceiling and the rate of change between readings — value('temperature',0,'valid') vs the previous index — so a freeze is caught on the way down.

    3. 03

      Act before damage

      The handler nearest the load is alerted to reposition or adjust, with an escalation ladder behind it, while the vials can still be saved.

    4. 04

      Prove with the right metric

      IoT Query rolls up MKT, time-above and time-below-freezing, excursions, and chain of custody into a qualified record, exported to your QA system over the API.

    Hardware & integrations

    Calibrated sensors, certified logging, your QA system

    Pharma needs traceable calibration and a record with no holes. Navixy normalizes EN 12830 / ISO-17025 BLE loggers, 1-Wire probes, door, and GPS into one data model on 2,500+ device models, then pushes the proof straight into the systems your quality team already runs.

    • EN 12830-certified BLE loggers with ISO-17025-calibrated probes (±0.5 °C class) and on-board logging that survives dead zones
    • No rip-and-replace: keep your GPS trackers and add the calibrated cargo probe your lanes need
    • Freeze-side, ceiling, and rate-of-change rules run identically across mixed device fleets
    • Push MKT, time-out-of-range, and chain of custody to your QMS / QA over an open API and webhooks — and ship it white-label
    Calibrated probe
    EN 12830 · in-carrier
    On-board log
    store & forward
    IoT Logic
    freeze + rate rule
    IoT Query
    MKT · time-out-of-range
    Your QMS / QA
    open API

    Every reading is calibratable and traceable end to end — the chain a Good Distribution Practice auditor follows from the vial to the released record.

    FAQ

    What pharma teams ask about freeze and proof

    Because freezing is the more common — and more silent — failure. A PATH/WHO systematic review (Matthias et al., Vaccine 2007) found 14–35% of fridges or shipments exposed vaccine to freezing, and in studies that examined every distribution segment, 75–100% of shipments saw at least one freeze event. A brief freeze against a cold-pack or the reefer wall can destroy potency with no visible change, so a load that looks fine arrives worthless unless something was watching the floor.

    Prove your vaccines never froze — not just that they never cooked

    Tell us your products, lanes, and GDP requirements. We'll map the calibrated sensors, the freeze-side and rate-of-change IoT Logic rules, and the MKT / time-out-of-range records for your pharma cold chain — and show you the proof your quality team and customers will trust.