Original Article from www.rotronic.com
Rotronic has released launched our next generation server based Environmental Monitoring System (RMS), but here we take a look at our traditional system that is still fully supported and widely used in the pharmaceutical industry and beyond.
The German pharmaceutical manufacturer Dr. R. Pfleger GmbH requires specialist cleanroom environments for many areas of production and development. It is vital for the company to monitor and verify pressure conditions as well as humidity and temperature data in its cleanrooms. To meet this need,the company uses validated Rotronic data loggers from the Hygrolog HL-NT series.
Together with the Rotronic validated HW4 monitoring software, these data loggers deliver important information on the environments that have an influence on the production of pharmaceutical products.
The Rotronic monitoring system has stood the test of time in the market over many years and undergone continuous development. The HW4 software forms the heart of the system. It visualises and saves all data, configurations and user events and also triggers alarms. Its audit trail logs all data and activities in compliance with FDA21 CFR Part 11 and GAMP5. Rotronic calibrated, qualified and validated Dr. R. Pfleger GmbH’s monitoring system according to GMP requirements.
Overall control and regulation
The management system forms the basis for operation, monitoring and control of the technical facilities as well as for data and message management. Apart from the technical installations, the validated clean room monitoring system is implemented
directly in FIS (OPC interface).
HygroLog HL-NT data logger – The central acquisition unit is a HygroLog-HL-NT data logger. It provides digital inputs for HygroClip humidity and temperature probes as well as Pt100 and 4…20 mA devices.
The data logger is also equipped with a memory card which not only stores the measurement of data but also all the events in the instrument itself.
The digital HygroClip2 climate probes provide class leading precision and long-term stability. All calibration and adjustment data is stored internally. Their standard accuracy ex works is ±0.8 %rh and ±0.1 K, for more demanding tasks, sensors with an accuracy of ±0.5 %rh can be supplied.
Sophisticated Software – The HW4 software saves the measurement data, alarms and events in a protected binary format. Any manipulations are detected and the data record is then marked as corrupt. Instruments are organised in groups and shown in the room layout. Colour changes make alarms and disturbances easy to recognise.
Evaluation and archiving
A data file is created for every measuring point. Mean Kinetic Temperature values are calculated from this raw data. The evaluation also contains alarm times and deviations and is presented in the form of a table with statistical values. Thanks to the high level of integration of the hardware in HW4, virtually all Rotronic instruments can be implemented in the existing monitoring system.
The monitoring system implemented by Rotronic offers a consistent solution, since all main and secondary installations and the monitoring system itself are integrated in the FIS management system, they can be monitored and controlled via a central software platform.
Dr. R. Pfleger GmbH
- Medium-sized pharmaceutical company located in the city of Bamberg,
- The company is entirely owned by the Doktor Robert Pfleger-Foundation
- The company now markets over 30 medicinal products
- Primary focus on urological, gynaecological, and dermatological indication
For more information on any of our products please visit the Rotronic website.