Monitoring for the pharmaceutical industry
Wireless monitoring of temperature, humidity, CO2 and differential pressure in production, cleanrooms, GMP warehouses and QC laboratories. We supply the system, the documentation and the validation.
What does GMP require of temperature monitoring?
GMP requires the environmental conditions that affect product quality to be under control and documented. In practice this means continuous measurement, alarms on deviation and a log that cannot be altered. The system must be able to be validated, and the measurements must be traceable to an accredited calibration.
Areas we monitor
From raw material store to finished goods. Same system, different requirements.
Pharmaceutical production
Temperature and humidity in production areas, process equipment and intermediate storage. Alarms before the batch is at risk.
Read more →
GMP warehouses and distribution
Raw material stores, finished goods stores and cold rooms under GDP. Mapping documents that the whole room holds.
Read more →
Cleanrooms and pressure cascades
Differential pressure between zones, airlocks and isolators. One or two channels per sensor.
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QC laboratories
Refrigerators and freezers down to -30 with an Emerald Bluetooth sensor. Colder than that, and in warming cabinets, we use Emerald with a Pt100 probe.
Read more →
Cell and gene therapy
Liquid nitrogen tanks down to -196 degrees, ULT freezers and CO2 incubators. Samples that cannot be made again.
Read more →
Cold chain and transport
Cool bags, boxes and transport between sites. Emerald measures the whole way and is read via a phone.
Read more →Without documentation, the medicine is declared unfit for use
If the environment goes outside the limits and you cannot document for how long, there is no discussion. And then the bill is not a new logging system. It is the value of the entire stock, plus the deviation you have to explain afterwards.
Friday evening
The compressor fails, or a door does not close. Nobody is in the building.
Monday morning
The damage is done, and nobody can say how long it went on.
At audit
The answer is a paper log with an empty field. That is not an answer.
What the solution looks like
Wireless sensors at every piece of equipment, one gateway for the whole building, and software that keeps calling until someone acknowledges.
Measures around the clock
Temperature, humidity, CO2 and differential pressure. The sensor sits inside the equipment, the data logger outside.
Calls on deviation
Call, text message and email to the person on call. If they do not answer, it moves on to the next.
Stores everything
Every measurement, every alarm and every acknowledgement with name and timestamp, in a log that cannot be altered.
Delivers the documentation
Choose a period and export the report as PDF or CSV. Ready before anyone asks for it.
Everything is wireless
No cables through GMP walls and no breaching of cleanroom zones. Two wireless technologies, each with its own job.
LoRaWAN
Data logger to gateway
Ultra-long range and low power consumption. One gateway handles up to 50 data loggers and 100 to 200 sensors.
Bluetooth
Sensor to data logger
Used for the sensing itself, not for the gateway. Emerald is a Bluetooth sensor that pairs wirelessly with the data logger and can sit inside the equipment.
Wi-Fi
Smaller installations and fast logging
Cobalt XS Wi-Fi for smaller installations, or when a logging interval faster than 1 minute is needed.
One system across sites
OCEAView brings production, storage, cleanrooms and laboratories together on one screen. Cloud or on your own servers with LDAP. You decide.
All measuring points live
Every refrigerator, every freezer, every cleanroom. Green is normal, red is a deviation.
Limits drawn into the graph
Yellow lines are warnings, red are alarms. Min, max and average are calculated for the period.
Three levels up and three down
Each limit can have its own delay, so an airlock in use does not trigger an alarm.
The documentation your QA asks for
We supply the system, the documentation and the validation. You set the scope based on your SOPs, and we carry out the work on our own or together with your QA.
Audit trail
Every measurement, every alarm, every acknowledgement with timestamp and user. Cannot be altered.
Traceable certificates
Every sensor is supplied calibrated with a certificate, and the calibration data is stored in the sensor itself.
Reports in one click
Choose a period, export the report as PDF or CSV. Ready before anyone asks for it.
Requirements we support
GMP, GDP, EU GMP Annex 11, FDA 21 CFR Part 11 and ALCOA data integrity.
Accredited calibration
Calibration is carried out by accredited partners, DFM and Dickson. Every sensor comes with a traceable certificate, and the certificate can be retrieved directly in OCEAView.
The system itself shows which sensors are due for calibration, based on the intervals you have defined. With sensor exchange, we swap the sensors in your calibration rotation for freshly calibrated sensors. No downtime, no gaps in the graph.
See how calibration worksDFM
Denmark's national metrology institute. DANAK accredited to ISO/IEC 17025.
Dickson
The manufacturer's own COFRAC-accredited laboratory.
Sensor exchange
Recalibration without downtime: a newly calibrated sensor in, the old one returned.
We don't make the equipment. We make it fit you.
Djurhuus IT has been in the industry since 2000 and since 2018 has supplied monitoring to hospitals, laboratories and pharmaceutical production in Denmark. We are the Danish distributor of DICKSON, which builds the data loggers, sensors and software.
What we do is everything between the equipment and your day-to-day work. We come out and look at your premises, assess where the sensors should go and how many are needed. We install, set up alarm limits and on-call rotas together with you and train your staff to use the system.
Afterwards we look after it. Calibration on time via accredited partners, sensor exchange without downtime, and a phone answered by someone who knows your installation.
More about Djurhuus IT →DICKSON
The manufacturer. Builds hardware, sensors and OCEAView. French and American production, its own accredited calibration laboratories.
Djurhuus IT
Distributor in Denmark since 2018, in the industry since 2000. Consultancy, design, installation, configuration, training, validation, calibration management and service.
You
Owner of the system. You set limits, SOPs and validation scope. We supply, configure, validate and maintain it for you.
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 →Certifications and standards
The equipment is manufactured and calibrated to recognised standards. The certificates are held by DICKSON and can be requested.
ISO/IEC 17025
Accredited calibration. Traceable certificates for every single sensor.
ISO 9001
Quality management at the manufacturer.
CE, FCC and IC
The units are approved for use in the EU and North America.
21 CFR Part 11
Electronic records and signatures are supported in OCEAView.
Frequently asked questions
Are FMS and EMS the same?
Yes. Facility Monitoring System and Environmental Monitoring System cover the same thing: a system that measures, logs and raises alarms on temperature, humidity, CO2 and pressure. The only difference is which term the industry uses.
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.
Do you do the accredited calibration yourselves?
No. It is carried out by accredited partners, DFM and Dickson. We handle planning, sensor exchange, certificates and making sure intervals are kept.
How many sensors can one gateway handle?
Around 50 data loggers and 100 to 200 sensors, depending on the setup. The range is up to 15 km in open air, 1 to 2 km in a production building and considerably less in basements.
Can we run OCEAView on our own servers?
Yes. On-premises runs on your own servers with LDAP user management, and you control version updates yourselves, so the qualification holds.
Can the system monitor third-party equipment?
Yes. Universal Smart-Sensor reads 4-20 mA, 0-5 V and 0-10 V, so particle counters, oxygen monitors and cell production equipment can sit in the same system.
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