With more than 100 years of history, the Voigt Group is strongly anchored in the Swiss pharmaceutical market and has established itself as a key market partner. Its two subsidiaries, Voigt AG Pharma Grosshandel and Voigt Industrie Service AG (pharmaceutical pre-wholesale), offer services at the highest level in the areas of specialized trade and outsourcing solutions for customers in the pharmaceutical industry. In this respect, the Voigt Group plays an especially important role in the provision of medications for the Swiss healthcare system. The company views this responsibility as an incentive to continually optimize services and processes – for its partners, for its customers and for the Swiss population. The implementation of “VOLOGIN” (VOIGT LOGISTICS INTEGRATION) as part of the expansion of the Mittelland logistics center will combine the three current logistics centers in Romanshorn, Neuendorf and Niederbipp to form two logistics centers in the future, in Romanshorn and Niederbipp.
The Voigt Group serves as a link between the pharmaceutical industry and the specialized trade sector. It is expanding this position by including additional service offerings. The pharmaceutical industry is subject to strict regulations that are constantly being modified or expanded and thus becoming even more complex. The temperature monitoring system in the existing structure is integrated in the building management system. As a result, it is not independent from the control unit. Before the building management system was integrated in the LAN, when the new structure was put into operation, the system can only be controlled locally. Therefore, it cannot be accessed via the network or remotely. A special workplace is required in order for the system to operate and process the data. As a result, it is extremely inflexible and laborious to operate.
NEW CONSTRUCTION QUICK FACTS:
Of course, a massive and innovative logistics center of this nature operates using state-of-the-art technology. Customer requirements and new rules in the highly regulated pharmaceutical supply chain are constantly increasing. This means that the monitoring solution for the new building in Niederbipp has to be qualified and monitor both temperature and humidity in accordance with current GDP regulations to ensure the highest level of product safety and quality in all areas related to the pharmaceutical supply chain. Other important project requirements include:
In order to find a reliable partner, the Voigt Group evaluated a suitable monitoring system and the mapping services in a separate tender.
Ultimately, ELPRO won out as the provider of an affordable and complete package that included a monitoring solution with mapping services. ELPRO also had the necessary resources to implement such a large project in the short span of about five months. Opening the center on time was a mandatory requirement. ELPRO has been a key supplier for the Voigt Group for many years, so the company was already familiar with its processes, people, and requirements, and did not need additional information to get started. This allowed both parties to save an enormous amount of time.
ELPRO had the requisite knowledge and corresponding expertise to complete the project on its own and without a significant amount of involvement on the part of the Voigt Group. The formation of a small project team comprised of a project manager and validation engineer from ELPRO, the head of strategy, development and ICT and the responsible person from the Voigt Group, and the planning office, also allowed for more direct communication.
Cross-location Installation for the Highest Level of Product Safety and Quality
A solution was sought for the new building that not only met all of the requirements, but also pushed quality assurance to a new level. With its “ECOLOG Networked Monitoring for Rooms and Devices,” ELPRO offered a reliable solution that functioned across all locations and provided a high level of security. It also ensured 100% compliance with GxP and from a single source. This is because the GxP service needed for validation and qualification was part of the portfolio as well.
GxP-compliant Storage and Room Mapping Using the V Model
Temperature mapping was used to find the hottest and coldest points in a room and thus identify the ideal place for the monitoring sensors. For this purpose, the floor plan was used to place mapping data loggers in various defined locations in the room. The data loggers were calibrated, configured and clearly labeled and the mapping commenced on December 16, 2019. Installation was difficult that day because there were still many workers present in some of the locations. During this time it was not clear if the two-week mapping phase could be completed without any “movement” by the workers, for example, the opening of doors. Such “interruptions” would have distorted the results. The removal of the mapping was to happen January 6, 2020. This left no time for delays, and postponing the mapping was not an option. After the mapping phase was completed successfully, all of the data loggers were collected. The graphs were superimposed with the help of the elproVIEWER software. This made it possible to evaluate the hottest and the coldest point in the room. In the end, all of the evaluations were provided to the client in a GxP-compliant mapping report.
“Thanks to the comprehensive knowledge of ELPRO regarding how regulatory requirements must be met, our qualification project was seamless.” DR. MARKUS WICKI, HEAD OF QA/RESPONSIBLE PERSON, VOIGT INDUSTRIE SERVICE AG
With a GxP qualification using the V model, a performance qualification (PQ) was carried out after the operational qualification (OQ) was completed. As part of this process, the room was tested to determine how it functions in real conditions, i.e. with full load during normal operations. In this case, the PQ could not be carried out because a load was not available in all of the rooms when the project was completed. Therefore, the PQ was scheduled to be completed later in the summer of that same year.
As a result of the merger of the Neuendorf and Niederbipp locations and the head office in Romanshorn, a total of about 130 measurement points spread across several rooms and locations must be monitored. In Romanshorn, the proven ECOLOG-NET wireless data loggers, which communicate via the elproMONITOR software installed there, are already in use. By contrast, at the new building in Niederbipp, the ECOLOG-PRO communication and measuring modules were wired – with one control cabinet on each floor (basement, first floor, top floor).
Likewise, the recorded data is managed via the elproMONITOR software, which is installed on the server in Romanshorn.
The ECOLOG-PRO module measures the prevailing environmental conditions at regular intervals and relays these accurately to the communication module. In the case of the Voigt Group, a total of 79 sensors were installed. These sensors continuously monitor the prevailing temperature and relative humidity at the 112 measurement points (46 temperature sensors and 33 combined temperature/ relative humidity sensors, one of which is in the ATEX area). The detailed measurement values can be viewed in a report using the user-friendly and intuitive elproMONITOR software. It is also very easy to make analyses, acknowledge alarms and edit reports. Alarm notifications are emailed to the responsible person and the control center. Thanks to these immediate and repeated alarms, quick action is taken in the event of deviations. As a result, the event is still fresh, comments can be recorded, and the root cause can be better understood.
Compared with the old system, the Voigt Group saves about 20 minutes each week and about two hours each month when evaluating, printing and filing the recorded data. Thanks to the new ECOLOG monitoring solution, all of these activities are now automatic via elproMONITOR. Only in the event of a deviation does the operator need to take time to identify and evaluate an incident. Additional time and effort is saved because this evaluation can also be carried out in a GxP-compliant manner directly in the elproMONITOR software. In addition, the annual calibration service and software is less expensive compared to competing offers.
With the ELPRO monitoring solution currently installed, the Voigt Group has a very reliable system in place that emphasizes data integrity. It is also fully validated. Alarm notifications are sent repeatedly until action is taken. In this way, potential deviations are always noted and corrected. The values and reports are available immediately and are processed and archived automatically. A connection between the existing building in Niederbipp and the system installed in the new building and in Romanshorn is being planned.
“Thanks to the expert team, the project was completed efficiently, satisfactorily and on time. The ELPRO team was on site regularly and all of the necessary documents were provided by the supplier.” DR. MARKUS WICKI, HEAD OF QA/RESPONSIBLE PERSON, VOIGT INDUSTRIE SERVICE AG
Key Solution Advantages at a Glance: