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Biomay is a biotechnology company, based in Vienna, Austria, running two production sites, specialising in the development, testing and manufacturing of plasmid DNA, recombinant proteins, mRNA and LNPs for pharmaceutical partners worldwide. Operating in a highly regulated environment, Biomay relies on strict environmental control in its laboratories, cleanrooms and storage facilities to ensure the quality, safety and consistency of its products.
Biomay has been using testo Saveris 1 since 2018 to monitor environmental conditions at its facilities. When the company built a new production site in 2022, it required a monitoring solution that could be seamlessly expanded to support the new building while maintaining the same level of reliability and compliance.
The new facility required comprehensive monitoring of rooms, cold storage cells and refrigeration equipment. In addition, the cleanroom areas demanded precise differential pressure monitoring to maintain controlled airflow and contamination control. Integrating these measurements into a centralised monitoring platform was essential to ensure continuous documentation and fast response to exceedances.
In a highly regulated environment, reliability and transparency are essential. With testo Saveris 1, we always have full confidence in our environmental data and documentation.
Pierre Lutz
Teamleader QA-Projects at Biomay AG
For the new building, Biomay again selected the testo Saveris 1 system due to its flexibility and scalability. Some existing V2 data loggers were relocated from the previous site, while the majority of monitoring points were equipped with the latest generation V3 loggers.
The monitoring network now covers critical rooms, cold storage cells and refrigeration units throughout the facility. A key aspect of the project was the integration of approximately 50 differential pressure transmitters for cleanroom monitoring. These devices simultaneously provide Ethernet communication to the testo Saveris 1 system for documentation and monitoring, while their analog outputs are used directly by the building control system for regulation and control.
The complete monitoring system was also validated by Testo, ensuring that the installation meets the strict documentation and compliance requirements of the pharmaceutical environment.
The scalable architecture of the testo Saveris 1 system supports Biomay to continuously expand its monitoring network as new requirements arise. The company regularly adds new applications, such as monitoring incubators with CO₂ sensors, integrating water leak detectors, and installing signal lights to provide visual alarm indications within the facility.
Biomay continues to operate its original site as well. There, the system was upgraded, and the cleanroom differential pressure monitoring was also integrated into testo Saveris 1 to further centralise environmental data.
Originally, Biomay implemented the system using radio communication. For later expansions, however, the company has primarily adopted Wi-Fi connectivity, allowed even greater flexibility when adding new measurement points.
With its validated monitoring infrastructure, Biomay benefits from reliable environmental documentation, improved process transparency and a system that can easily grow alongside the company’s operations.
Testo has been a reliable partner throughout our expansion. Their validation expertise and technical support ensured that the new monitoring setup was implemented smoothly and in full compliance.
Pierre Lutz
Teamleader QA-Projects at Biomay AG