How Fujirebio meets stringent temperature control requirements

Published 2022-08-12

Fujirebio has 50 years of experience in providing in vitro diagnostic (IVD) solutions. The company is involved in everything from developing and manufacturing to selling robust IVD products worldwide. The entire operation is permeated by strict requirements to ensure that all medical raw materials are stored at exactly the right temperature at all times. To meet these legal requirements, Fujirebio uses the testo Saveris 1 monitoring system.

The report team from Nordtec meets Facility Manager Alexander Gatara on site at Fujirebio’s premises in Gothenburg to see how testo Saveris 1 helps Alexander and his colleagues in their daily work.

What exactly do you do here at Fujirebio?
– We produce reagents for chemical analysis,” says Alexander. “The big players in medical technology use our raw material to perform tests with their analytical instruments, which they develop and sell to hospital laboratories,” says Alexander Gatara.

– We also use the raw material ourselves, to produce our own analysis kits. They are used to diagnose a wide range of conditions, both for research and clinical use.

Can you describe your Saveris system?
– There are many donors, over 30 of them. All are wirelessly connected to 5 converters, which in turn are connected to the Ethernet network. Via a switch, the values are transmitted to a computer and the Saveris base station.

– The software is on a virtual computer, so I can go in and look at the values from any computer. If I’m on call and at home when an alert comes in via text or email, I can log in and see what’s wrong.

– This allows me to directly assess the urgency of the problem. For example, if a freezer is currently being defrosted, it is not surprising that the temperature rises.

– All the devices we use also have a device manager and they also receive alarms via SMS when a measured value is not within the limit values. Then we have to go and check what is wrong.

– But we have huge restrictions on who can be inside the system. It’s just me and one other person. So when someone needs to get a report, one of us does it. It is possible to introduce different access levels in the system and allow more users, but we haven’t done that yet.

Are there requirements from authorities?
– This is a heavily regulated activity and the Medical Products Agency, among others, carries out inspections. It is important for temperature levels to be recorded, for alarms to be sent out to the right people and so on. Customers also have specific requirements, so they can also come and visit us to inspect our processes.

Are you satisfied with testo Saveris 1?
– I am very happy. I don’t really see anything missing.

What is the procedure for calibrating measuring equipment?
– We don’t actually disassemble any sensors and send them off for calibration. I calibrate them myself on site using a specific method to meet all the requirements of our business. All sensors are checked once a year. If the deviations are too large, I make an adjustment and then recalibrate. Everything is, of course, documented according to the instructions developed for the activity.

– “Almost all Saveris sensors can be adjusted, so it shouldn’t be a problem,” Mattias adds. Otherwise, you would have to rely on calibration protocols and add or subtract the measurement deviation manually at each reading.

– We also bought the adjustment software for the testo Saveris 1 just to be able to calibrate and adjust on our own.

What are the main advantages of the monitoring system?
– It is a large, complex system with many sensors, yet it is easy to manage. In addition, I can create the necessary reports at any time and at least once a month we run a report on the whole system.

What do you measure?
– We measure temperature values in refrigerators and freezers where we store the raw material, i.e. the reagent materials we produce here. In the freezers, we keep -75°C and the sensors are inserted through tight seals. Looking at the system as a whole, we have sensors that measure everything from -196°C to +65°C.

Which measurement quantities?
– We only measure temperature. We have freezers, cold rooms and even a cryogenic freezer for living cells. They are then used to make cultures in the lab, which we use in the raw material.

How was temperature monitoring managed before testo Saveris 1?
– A long time ago, we only used the freezers and refrigerators’ own sensors. They were connected to a system that sent alarms to Securitas. We could not see temperature levels before and after the event that triggered the alarm and we could not document the temperature levels over time.

– So there was no history. But now it’s 8 or 9 years since we installed the testo Saveris 1 and we have gradually expanded it with more and more sensors. Now it has grown really big.