Learn how Genera Research enhanced production of their bone regeneration therapy and reduced risks with automated temperature monitoring and wireless data loggers.
In our area, the main challenge every day is to monitor the temperature conditions in the chambers outside the laboratory’s working hours.
"The temperature is often visually read by laboratory staff and the readings are manually entered into the temperature list, which is a very time-consuming process.
Eupry is a real refreshment in the Croatian market. We are delighted with its ease of use and alarm functions. All data is traceable and easy to follow and we are especially pleased with the fast calibration service that is also a part of the service."
Dora Adanic Chief Operating Officer at Genera Research
The main challenges in temperature monitoring
The temperature monitoring method that was used previously by Genera Research was digital thermometers that needed to be read visually, while laboratory staff had to enter a certain value in the predicted temperature list twice during the laboratory’s working hours.
The whole procedure was very time-consuming and there was no possibility of monitoring the temperature between the reading interval and without the presence of laboratory staff.
Genera Research was, therefore, looking for a solution with the following features:
About Genera Research Ltd
- Genera Research is a privately owned company located in the Republic of Croatia Zagreb area. The company’s activity is mainly based on the production of high-quality therapeutic proteins using recombinant DNA technology.
- The company operates in Kalinovica near Sveta Nedjelja, where a GMP production plant is located and produces bone-morphogenic protein BMP6 – the active substance of the cure OSTEOGROW, which is being tested in clinical studies in orthopaedic surgery.
- This drug is given to patients in the form of an autologous blood clot of the patient and phase II of the drug’s clinical development has been completed.
The solution for Genera Research facility
Wide temperature range for the most sensitive substances
Genera Research uses Eupry data loggers placed in incubators, freezers and refrigerators, where sensitive substances for the production of OSTEOGROW cure are stored.
The Eupry systems used, operate in the temperature range from -50° C to 50° C and from -196° C to 150° C.
Real-time data availability
Temperature data is always available to laboratory staff in the online temperature monitoring application.
Reporting deviations via free SMS messages and e-mail notifications was extremely important to the staff in case of physical absence or accidental failures – such as left open doors of cooling devices, sudden breakdowns or power outages.
Minimized data compliance procedures
OSTEOGROW is manufactured in accordance with GMP guidelines, which require a prescribed temperature monitoring procedure, accompanied by a written record of the temperature deviations.
The Eupry system enables the generation of temperature reports and fast data export in accordance with regulatory requirements and 21 CFR, part 11 guidelines.
The whole process is fully automated, which reduces the need for physical handling and minimizes the risk of human error.
Carefree work of laboratory staff
Eupry data loggers are installed on-site and connected to the existing Wi-Fi network, which allows the staff of Genera Research to easily move the device in case of need.
An additional advantage is that there is no interruption of work because when re-calibrating the device, it is not physically taken to the laboratory, but you only change the sensor, which is previously calibrated.
The process of temperature monitoring with the Eupry system is significantly simplified since all data is stored in the online application that displays temperature fluctuations and allows the data, charts and reports export based on data stored for up to 5 years.
Eupry has proven to be a safe solution for maintaining the optimum temperature in cooling devices with valuable substances for the production of a new innovative cure for the regeneration of bone defects.
The benefits of implementing Eupry in our lab work are numerous
First of all, it’s a time saver! Compared with manual temperature monitoring, Eupry saves us more than 500 working hours yearly, which allows us to use that time for other important tasks, increasing the productivity of lab personnel. Secondly, automated temperature monitoring and recording allow us to relax during the weekend or out of working hours, knowing that the temperature is automatically recorded and easily monitored via the Eupry app.
Also, alarm notifications are a reliable tool to react in real-time if temperature deviation occurs.
Lastly, with the audit trail, it is easy to process the non-conformity or to prove that everything was within set parameters, so we can have the report ready in compliance with GMP requirements.
says Dora Adanic.
A special thank you to Genera Research for enlightening us on your very crucial area of work and to Sartorius Croatia for facilitating the story.