Monitoring from nitrogen to incubator
Cryo storage at -196 degrees, ULT freezers, CO2 incubators and cell production equipment. Material that is often patient-specific and cannot be produced again.
How do you monitor a liquid nitrogen tank?
With a Pt100 probe specified all the way down to -200 degrees. Liquid nitrogen holds at around -196, which is outside the range ordinary digital sensors can measure. The probe is inserted into the tank and connected to a data logger outside.
In addition to temperature, the filling system and emergency power are typically also monitored via dry contact or an analogue signal, so a technical fault raises an alarm before the level drops.
Limits and response times are set according to your own SOPs and how quickly each tank warms up.
The material may be patient-specific
In cell and gene therapy, a batch is often made from one patient's own material. If it is lost, there is no other batch on the shelf.
At the same time, the process is long. The material may sit in cryo storage for months, pass through incubators and production equipment, and go back into frozen storage. Every step must be documented, and the documentation must hang together across the whole chain.
That is why it makes sense to have the whole chain in one system rather than a logger here and a display there.
Read about nitrogen tanks and cryo freezers →
What we monitor
Liquid nitrogen tanks
Emerald with a Pt100 probe down to -200 degrees. Cryo storage with cells, tissue and patient-specific material.
Pt100 -200 to +50Read about nitrogen tanks →
ULT freezers
-80 degrees for intermediate storage and reagents. Dry contact on the door and emergency power.
Pt100 Smart-SensorRead about ULT freezers →
CO2 incubators
Temperature, humidity and CO2 in the same sensor, inserted through the access port.
Temperature, humidity and CO2 Smart-SensorRead about CO2 incubators →
Cell production equipment
Instruments such as CliniMACS Prodigy are read via their analogue output signal and appear in the same dashboard.
Universal Smart-SensorRead about third-party equipment →
Cleanrooms and isolators
Differential pressure between zones where production takes place under controlled conditions.
Differential pressure Smart-SensorRead about cleanrooms →
Emergency power and supply
UPS, compressors and gas supply via dry contact, so a technical fault raises an alarm in time.
Dry contact cableRead about alarms →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 the conditions that affect product quality to be under control. In practice: round-the-clock measurement, alarms 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 changed 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 USA or work for an American parent company.
Applies when exporting 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 set 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 lease 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 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.
An audit trail that cannot be altered
Every measurement, alarm and acknowledgement with timestamp and user. That is what an auditor asks for.
Reports in one click
Choose a period and export the report as PDF or CSV. Ready before anyone asks.
Cloud or your own servers
On-premises runs on 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 in 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 validation, on our own or in close collaboration with you, and maintain it afterwards.
Frequently asked questions
Why can't we use an ordinary sensor in the nitrogen tank?
Because ordinary digital sensors are typically only specified down to around -40 degrees. Liquid nitrogen holds at around -196. Pt100 is specified to -200 and measures reliably there.
Can we follow a batch through the whole process?
Yes. Cryo storage, incubators, production equipment and cleanrooms can sit in the same system, so the documentation for the whole process is pulled in the same report.
Can you monitor CliniMACS Prodigy and similar equipment?
Yes, via the instrument's analogue output signal. Universal Smart-Sensor reads 4-20 mA, 0-5 V and 0-10 V.
Will we be notified if the nitrogen level drops?
The system measures the temperature in the tank, and the filling system and emergency power can be connected via dry contact. The level measurement itself comes from the tank's own system, which can be read into the same dashboard.
What happens during a power failure?
The data logger keeps running on battery, and a dry contact on the emergency power raises an alarm when the system switches over.
Who is responsible for validation?
We are, on our own or in close collaboration with your QA. You set 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.
QC laboratories
Stability chambers, refrigerators and freezers without gaps in the graph.
Read more →
Cold chain and transport
A sensor in the shipment, read on a phone on receipt.
Read more →
Laboratories and research
ULT freezers, liquid nitrogen tanks and incubators in research environments.
Read more →Kom hurtigt i kontakt med den rette specialist.
Vi hjælper med alt fra nye monitoreringsløsninger til kalibrering, validering og teknisk support.
Generelle henvendelser
Nye projekter
IT & teknik
Administration
Besøg os
Måløv Byvej 229
2760 Måløv
Ring til os
+45 72 22 02 05
Man-fre, 08-16
Fortæl os, hvad du har brug for.
Vil du se, hvordan det ser ud hos jer?
Book en gennemgang. Vi kommer forbi, ser på udstyr og lokaler og rådgiver om, hvor følerne skal sidde. Derefter får du et skræddersyet forslag. Uden forpligtelser.
Book en gennemgang