Monitoring in QC and stability studies
Stability chambers, refrigerators, freezers and incubators. Long studies where a gap in the curve is not just unfortunate but invalidates the study.
What monitoring does a stability study require?
That temperature and humidity are documented continuously throughout the study period, which often runs for months or years. The measurements must be traceable to an accredited calibration, and there must be no gaps in the data set.
That is why the data logger stores measurements locally, even if the connection to the gateway drops, and synchronises when it is back. And that is why a sensor due for recalibration is exchanged for a new one instead of being sent away.
Limits, acceptance criteria and study setup are defined by your QA. We supply the system and the documentation.
A gap in the curve cannot be filled in afterwards
A stability study can run for three years. If two weeks pass where a sensor was sent away for calibration, or where the connection was down without anyone noticing, those two weeks are missing for ever.
There is no way to reconstruct them. The study may be rejected, and in the worst case it has to be run again.
That is why two things are essential: that the data logger stores locally and synchronises afterwards, and that recalibration is done by exchanging the sensor on site.
How sensor exchange works →
What we monitor in QC
Stability chambers
Temperature and humidity over long periods. Both in the same sensor and in the same curve.
Temperature and humidity sensor
Refrigerators and freezers
Reference standards, samples and reagents from +2 to -40 degrees.
Emerald Bluetooth sensor + Cobalt XRead about medicine refrigerators →
ULT freezers
A ULT freezer runs at -80 degrees, so the sensor must be designed for it. We typically use an Emerald with a Pt100 probe.
Pt100 Smart-SensorRead about ULT freezers →
Incubators and ovens
Up to +200 degrees. The same Pt100 principle at the other end of the scale.
Pt100 -100 to +200
Room conditions in the laboratory
Temperature and humidity where they affect analyses and equipment.
Temperature and humidity sensor
Analytical equipment
Instruments with an analogue output are read via 4-20 mA, 0-5 V or 0-10 V.
Universal Smart-SensorRead about third-party equipment →Compliance for pharma and hospitals, explained in plain English
The rules rarely say "buy a monitoring system". They say conditions must be under control and documented. Here is what that means in practice.
GMP
Good Manufacturing Practice
Requires the conditions that affect product quality to be 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 medicines to be stored and transported within their temperature window. Mapping documents that the whole room holds, not just the middle.
Applies to warehouses and transportEU GMP Annex 11
Computerised systems
Requires the system to be validated, data not to be changeable without a trace, and access to be 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 US or work for a US parent company.
Applies when exporting to the USWhere is the line between us and you?
We supply the system, the documentation and the validation itself: audit trail, traceable calibration certificates, timestamped measurements and reports, and IQ, OQ and PQ carried out by us, on our own or in close collaboration with your QA. You define 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 complete, it is yours. You buy it, you own it, and no leasing agreement decides when you can switch, expand or stop. We handle the 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 each 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 timestamp 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 yourselves, 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
What happens if the connection drops during a study?
The data logger stores the measurements locally and synchronises when the connection is back. There is no gap in the data set.
Does the sensor have to be sent away for calibration?
No. We send a freshly calibrated sensor with a certificate, you click it in, and the old one is sent back. The study carries on in the meantime.
Can we measure both temperature and humidity at the same point?
Yes. The triple sensor and the temperature and humidity sensor both measure both at the same time, and the values sit in the same curve.
How do we document the measurements for the study report?
Choose a period and pull the report as PDF or CSV. The report contains timestamped measurements, min, max and average, and the calibration certificate can be retrieved from each individual sensor.
Can we monitor incubators up to 200 degrees?
Yes, with a Pt100 probe. The same principle as for -80 degrees, just at the other end of the scale.
Who handles validation of the system?
We do, on our own or in close collaboration with your QA. You define the scope based on your risk assessment, and we carry out IQ, OQ and PQ and deliver the documentation.
Other areas in pharma
Same system, different requirements. See how we monitor the rest of the chain.
Pharmaceutical production
Temperature, humidity and pressure in production areas, process equipment and intermediate storage.
Read more →Cell and gene therapy
Liquid nitrogen tanks, ULT freezers and incubators in one system.
Read more →
Calibration
Accredited calibration via DFM and Dickson, planned and managed by us.
Read more →Kom hurtigt i kontakt med den rette specialist.
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