Monitoring during transport
Cool bags, boxes and shipments between sites, warehouses and recipients. A sensor in the box logs all the way and is read with a phone when it arrives.
How do you document the temperature during transport?
With a data logger placed in the box together with the goods. It measures at a fixed interval all the way and stores the measurements locally, without needing a network along the way. On receipt it is read via Bluetooth with a phone, and the data goes into the same system as the rest of your measuring points.
Emerald is mainly used as a Bluetooth sensor for the data logger. It can also be used as a stand-alone logger with room for 16,000 measurements and an interval from 15 seconds to 4 hours. With an external Pt100 probe, deep-frozen and cryo transport are also covered.
Standards such as EN 12830 and HACCP are relevant for food transport. For medicinal products, GDP sets the framework.
The chain is only as strong as the link nobody measures
The warehouse is monitored. The recipient's refrigerator is monitored. What lies in between is often a box with cool packs and an expectation that it will probably be fine.
And if it goes wrong, it is rarely discovered on receipt. It is discovered when someone later has to answer what the temperature was along the way, and there is no measurement to show.
A logger in the box costs little. A shipment that has to be discarded because nobody can document it costs the entire contents.
See Emerald →
What we monitor in the chain
Cool bags and boxes
Emerald is placed in the box, measures all the way and is read with a phone on receipt.
Emerald internal sensor
Deep-frozen and cryo transport
With an external Pt100 probe, the range down to -200 degrees is covered. Probe and Emerald are calibrated as one unit.
Emerald with Pt100 probeRead about cryo →
Packing area
Temperature and humidity where the goods are packed before they leave the building.
Temperature and humidity sensor
Receiving site
Refrigerator or cold room at the recipient, so the chain is covered at both ends.
Emerald Bluetooth sensor + Cobalt XRead about GMP storage →
Documentation on receipt
Read out via Bluetooth, and the measurements go into the same report as the rest.
Temperature mappingRead about audit trail →
Standards
EN 12830 and HACCP for food transport. GDP for medicinal products.
ComplianceRead about GDP →Compliance for pharma and hospitals, explained in plain English
The rules rarely say "buy a monitoring system". They say that conditions must be under control and documented. Here is what that means in practice.
GMP
Good Manufacturing Practice
Requires that the conditions affecting product quality are under control. In practice: measurement around the clock, an alarm on deviation and a log that can be shown.
Applies to production and QCGDP
Good Distribution Practice
Requires that medicinal products are stored and transported within their temperature window. Mapping documents that the whole room stays within limits, not just the middle.
Applies to storage and transportEU GMP Annex 11
Computerised systems
Requires that the system is validated, that data cannot be changed without a trace, and that access is controlled. We carry out the validation, on our own or together with your QA.
Applies to the software itself21 CFR Part 11
Electronic records
US requirement for electronic signatures and audit trail. Relevant if you export to the USA or work for a US parent company.
Applies to exports to the USAWhere is the line between us and you?
We supply the system, the documentation and the validation itself: audit trail, traceable calibration certificates, time-stamped measurements and reports, and IQ, OQ and PQ carried out by us, on our own or in close collaboration with your QA. You determine the scope based on your own risk assessment.
Validation: who does what →OCEAView from DICKSON, set up and looked after by us
The hardware is DICKSON's. The software is DICKSON's. Everything between the equipment and your day-to-day work is ours. And once the system is in place, it is yours. You buy it, you own it, and no leasing agreement decides when you can switch, expand or stop. We take care of maintenance so it keeps running.
OCEAView
The whole setup on one screen. Watch mode gives a combined status overview of the equipment you have access to, with up to 100 units per page, and every graph can be zoomed down to the individual minute. Plan View also places the points on your own floor plan, so the person on call can see which room it concerns.
Audit trail that cannot be altered
Every measurement, alarm and acknowledgement with time stamp and user. That is what an auditor asks for.
Report in one click
Choose a period and pull the report as PDF or CSV. Ready before anyone asks.
Cloud or your own servers
On-premises runs at your site with LDAP, and you control updates yourself, so the qualification holds.
DICKSON
The manufacturer
Builds data loggers, sensors and OCEAView. French and American production, its own accredited calibration laboratories and CE, FCC and IC approved equipment.
Djurhuus IT
Distributor since 2018
We advise on placement, design the setup, install, set up alarms and on-call rotas, train your staff on the system and manage calibration afterwards.
You
Owner of the system
The system is yours. You set limits, response times and requirements according to your own SOPs. We supply the system and the documentation, handle the validation, on our own or in close collaboration with you, and maintain it afterwards.
Frequently asked questions
Does the logger need a network along the way?
No. It measures and stores locally all the way. Data is retrieved via Bluetooth with a phone when the shipment arrives.
How many measurements can it store?
16,000. With an interval of ten minutes, that covers more than a hundred days. The interval can be set from 15 seconds to 4 hours.
Can we use it for deep-frozen goods?
Yes, with an external Pt100 probe. The range down to -200 degrees is then covered, which includes cryo transport.
Can we reuse the same logger?
Yes. It is reset and used again. The calibration follows the sensor and can be documented in the same way as the fixed installations.
How does transport data get into our documentation?
The readout goes into OCEAView, so a shipment can be pulled in the same report format as a refrigerator or a cold room.
Which standards are relevant?
EN 12830 and HACCP for food transport. For medicinal products, GDP sets the framework for storage and distribution.
Other areas in pharma
Same system, different requirements. See how we monitor the rest of the chain.
GMP storage and distribution
Raw material storage, finished goods storage and cold rooms under GMP and GDP.
Read more →Cell and gene therapy
Liquid nitrogen tanks, incubators and shipments to and from the clinic.
Read more →
Wireless monitoring
Bluetooth from sensor to data logger, LoRaWAN from data logger to gateway.
Read more →Kom hurtigt i kontakt med den rette specialist.
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