Monitoring system for the new construction of a central sterilization facility

For the central sterilization department of Medipolis Produktion GmbH in Pharmapark Jena, a cleanroom monitoring system was required to oversee and document the TOX and NON-TOX manufacturing areas. With the centralization of production at a single site in Jena, the manufacturing area was significantly expanded, and workflows were optimized. Medipolis now employs over 500 staff across two permanent locations nationwide.

For the implementation of the project, the specialist in pharmaceutical and nursing care for the comprehensive BRIEM monitoring system was chosen. It was particularly important to the operator that the sensors fully meet the local cleanroom requirements and that the software is perfectly aligned with the existing daily production routines and related processes, featuring automatic and clear reporting.

With the holistic monitoring system from BRIEM, all of the operator's requirements can be met. The system continuously monitors environmental parameters such as pressure and temperature in 42 cleanrooms/airlocks. Additionally, particle concentration is monitored in 7 Class B cleanrooms and 15 safety cabinets according to the requirements of Annex 1, and the temperature of several cooling devices/cooling chambers is also tracked.

A detailed alarm concept was developed and implemented for alerting in case of threshold violations. Monitoring data and also fault reports from the cleanroom ventilation system (GLT) were integrated into the alarm behavior.

On-site Implementation

Various equipped BRIEM measurement panels were used for pressure and temperature measurement in the cleanrooms and integrated flush-mounted into the cleanroom walls. Room temperatures outside the cleanrooms were measured with BRIEM surface-mounted measuring devices. For particle measurement in the 15 GMP Class A areas and the 7 Class B rooms, particle counters with external pumps were used. At all measurement points, the hose lengths were kept as short as possible according to Annex 1 guidelines (<= 1 meter).

All refrigerators and freezers were connected to the monitoring system via PT1000 sensors. The sensors were mounted through device outlet boxes and blend well into the overall room design.

To visualize warning and alarm thresholds, three-color LED signal lights (traffic lights) were installed. These are also sent to responsible personnel via email and/or SMS through the integrated alarm forwarding system.

The core of the monitoring system consists of control cabinets combined with BRIEM's self-developed monitoring software. All sensor measurement data and control and alarm elements are collected here and can be managed. Alarm forwarding is handled via the alarm forwarding module, which sends alarms via email and SMS. The customer's three-stage alarm concept was implemented. Additionally, Medipolis uses various software modules, for example, to generate automated reports.

The Result

In the cleanrooms of the new production facility in Jena, Medipolis now has a highly modern, flexible, and intuitively operable monitoring system. Besides extensive support for documentation required by authorities, the system ensures that the manufacturer is always informed about the status of all critical parameters during production and can intervene at any time if necessary. Through the software, the user can switch between different operating states, allowing the system to be adapted at any time to various production processes.