Monitoring system for the stem cell and immunology laboratory of the University Hospital Tübingen

This project involved a comprehensive upgrade of a monitoring system responsible for overseeing critical environmental parameters such as pressure and humidity. The renewal included the installation of modern particle sensors and the updating of the associated software to enable precise data collection and analysis.

The GMP manufacturing area of the University Hospital Tübingen is one of the largest of its kind in Germany and specializes in the production of stem cell preparations and medicines for innovative therapies (ATMPs) according to GMP guidelines. The joint GMP stem cell and immunology laboratory, a collaboration between Internal Medicine II and Pediatrics I, produces preparations for transplants and cellular immunotherapies. Since 2001, various stem cell products have been produced here in compliance with GMP regulations. The laboratory is JACIE-certified and holds approvals from the Paul-Ehrlich-Institut (PEI) for various processing procedures to enable safe and effective stem cell transplants.

This project marked the beginning of an ambitious modernization of the monitoring system in the joint stem cell and immunology laboratory within the Pediatric and Adolescent Medicine department. The need for renewal became clear when the existing systems no longer met current technological standards. Having gained experience through the successful outfitting of the hospital pharmacy, the company BRIEM was commissioned to plan the modernization. Upgrading existing systems always presents particular challenges. Our engineers developed a technical solution that is both functional and future-oriented.

A comprehensive upgrade of the monitoring system was carried out to monitor critical environmental parameters such as pressure and humidity. This included the installation of modern particle sensors and the updating of the associated software to enable precise data collection and analysis.

Various BRIEM MEAS panels were used to measure pressure and temperature in the cleanrooms. These panels, integrated flush into the cleanroom wall, offer convenient calibration options and are easy to clean thanks to their hygienic design. Due to their low installation depth, they can be seamlessly integrated into the existing wall system.

Outside the cleanrooms, room parameters were monitored using surface-mounted measuring devices. The sensors can be pulled out for calibration via an integrated cable. For particle measurement in GMP Class A/B areas, laser particle counters with integrated vacuum pumps were used. Additionally, virtual sensors for ft³ measurement with automatic m³ consideration were installed. All refrigerators and freezers, as well as incubators, were connected to the monitoring system with PT1000 sensors of DIN Class A. To visualize warning and alarm thresholds, three-color LED signal lights (traffic lights) were installed. These were positioned to ensure that signal messages are clearly visible from all workstations in the room. For acoustic alarms, horns with automatic mute were used. Alarms are also forwarded via an alarm forwarding module via email and SMS. The core of the monitoring system is the control cabinet combined with the specially developed BRIEM monitoring software. All sensor data, as well as control and reporting elements, are collected here and can be managed.

After completing the installation work, the entire system was re-qualified to ensure compliance with regulatory requirements and standards. As is customary in GMP environments, a maintenance contract was concluded, guaranteeing regular updates and technical support to ensure the system's longevity and reliability, and to keep it up to date at all times.

This project demonstrates how specialized technology and expertise can contribute to improving standards in medical monitoring and safety. With the introduction of the BRIEM monitoring system and its components, continuous and precise monitoring and documentation in GMP production areas are ensured. Our comprehensive service ensures that the system is used and maintained sustainably.