What the regulations require
For immunobiological medicinal products (vaccines), SanPiN 3.3686-21 (sanitary rules) requires temperature indicators and temperature recorders at all levels of the cold chain. The key requirements for the instruments are:
- temperature values recorded at an interval of no more than 1 minute;
- a unique identification number for each instrument;
- clear visual indication of an excursion, without any additional handling;
- a design that prevents falsification and resetting of readings;
- accuracy of no worse than ±0.5 °C and periodic verification of the measuring instruments;
- for insulated containers, if transport takes more than an hour, a temperature indicator in each container, with readings and the instrument number entered in the log at dispatch and at receipt.
For details, see our article on the vaccine cold chain.
Which Smartag to choose
| Task | Modification | Why |
|---|---|---|
| Insulated container, one-off shipment, a quick answer needed at receipt | Smartag mini | “OK” / “Threshold alarm” LED indication, 1–2 thresholds, delayed start |
| Transport or storage, the consignee needs a full chart | Smartag | flash drive, automatic PDF report, up to 6 thresholds, at least 700 h of recording |
| Storage with humidity monitoring, pharmacy premises | Smartag RHT | temperature and humidity in one instrument |
| Measurement inside a chamber, in a product or liquid | Smartag TZ + Smartag Zond | remote probe, electronics outside |
| Warehouse or cold room mapping | Smartag T, Smartag RHT | ±0.5 °C over −30…+40 °C, a fleet of identical verified instruments |
Workflow
- Configuration
Set the range limits and delayed start; for Smartag, also set the logging interval (1 minute for vaccines). Parameters can be specified when ordering.
- Placement
In an insulated container, place the indicator between product packages at the location recommended by the container’s thermal map — not directly against the cold packs.
- Dispatch
Enter the temperature indicator serial number in the shipping documents and the log.
- Receipt
Check the LED indication. Plug Smartag into USB and attach the PDF report to the receiving documents.
- Decision in case of an excursion
Quarantine the shipment, assess the duration and magnitude of the excursion from the chart, and request stability data from the product manufacturer.
Temperature indicator or monitoring system
| Task | Smartag | Hladverk Group monitoring system |
|---|---|---|
| Monitoring in transit | yes | — |
| Mapping | yes | — |
| 24/7 warehouse monitoring with alarms | as a supplementary tool | yes |
| Night-time alert to the person on duty | — | SMS, phone call, MAX, push |
| Independent evidence for the consignee | yes | system log and reports |
Frequently asked questions
Are temperature indicators mandatory when shipping vaccines?
Under SanPiN 3.3686-21, each insulated container must be equipped with a temperature indicator if transport takes more than an hour; the readings and indicator numbers are recorded in a log.
Can Smartag mini be reused?
No, Smartag mini is a single-use modification. If you need a temperature chart for the whole trip, choose Smartag with an automatic PDF report.
What should I do if the temperature indicator shows an excursion?
Quarantine the products, read out the data, assess the duration and magnitude of the excursion, and make a decision taking into account information from the product manufacturer.