ELPRO CASE STUDY:
VOIGT LOGISTICS INTEGRATION “VOLOGIN”

A New Level of Quality and Product Safety in the Highly Regulated Pharmaceutical Supply Chain

Author: ELPRO-BUCHS AG

Update : 28th July, 2021

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 area 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 optimize its services and processes continuously – for its partners, its customers and the Swiss population.

The ultimate 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 CHALLENGE

The Voigt Group serves as a link between the pharmaceutical industry and the specialized trade sector, and it is expanding this position by including additional service offerings. The pharmaceutical industry is subject to strict regulations that are constantly modified or expanded, thus becoming even more complex. The integrated temperature monitoring system in the existing structure was in the building management system and part of the control unit. Before the integration of the building management system into the LAN, when the new structure became operational, the system could only be controlled locally. Therefore, it was not accessible via the network nor remotely. A special workplace was required in order for the system to operate and process the data. As a result, it was extremely inflexible and laborious to operate.

During the new construction, 58,000 cubic meters of soil was excavated, 50,000 tons of concrete was poured and 2,000 meters of conveyor technology were integrated in order to build the most modern logistics facility in Europe: fully automated and geared toward serialization. Each year, some 85 million packages ship from 21,000 pallet locations and 53,000 automated container locations.

Of course, a massive and innovative logistics center of this nature will utilize state-of-the-art technology. Constantly rising customer requirements and the new rules in the highly regulated pharmaceutical supply chain also meant that an environmental monitoring solution had to be found for the new building in Niederbipp. It would require one that is qualified and monitors both temperature and humidity in accordance with the current GDP regulations to ensure the highest level of product safety and quality in all areas related to the pharmaceutical supply chain.

KEY PROJECT REQUIREMENTS:

  • Convenience for the operator
  • Efficiency and a reduction of sources of errors
  • Clear processing of reports and deviations
  • A high level of data security and data integrity
  • User-friendliness and remote access
  • Complete validation and qualification
  • Adherence to the specified schedule
  • Independent project management by suppliers

THE EVALUATION PROCESS

In order to find a reliable partner, the Voigt Group evaluated a suitable environmental monitoring system and the mapping services in a separate tender. Ultimately, ELPRO BUCHS-AG won out as a provider of an affordable and complete package that included a monitoring solution with temperature mapping services. The company 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. In addition, ELPRO has been a key supplier to the Voigt Group for many years and was already familiar with the company’s processes, people, and requirements. No additional information was required, allowing both parties to save an enormous amount of time. ELPRO had the requisite expertise and corresponding knowledge to complete the project without a significant amount of involvement on the part of the Voigt Group.

“ELPRO was the only company capable of providing the enormous capacity (number of data loggers and experience with this size) to carry out the mapping of all rooms at the same time.”
– DR. MARKUS WICKI, HEAD OF QA/RESPONSIBLE PERSON, VOIGT INDUSTRIE SERVICE AG

The formation of a small project team allowed for direct communication and included a project manager and validation engineer from ELPRO; the Head of Strategy, Development and ICT; the Responsible Person from the Voigt Group; and the commissioned planning office.

THE SOLUTION

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 while maintaining 100% GXP compliance from a single source. This was because the GxP service needed for validation and qualification was part of the portfolio as well.

GxP-compliant storage and room mapping was performed 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 mapping data loggers were calibrated, configured, and clearly labeled.

Installation the day of the mapping was difficult because there were still many workers present in some of the locations. At first, it was not clear if the two-week mapping phase could be completed due to the movements of the workers, such as the opening of doors. Such “interruptions” can distort the results. Because the mapping project was to be completed by a certain date, there was no time for delays. Postponing the mapping was not an option. After the mapping phase was successfully completed, all of mapping data loggers were collected and 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. All of the evaluations were provided to the client at the end in a GxP-compliance 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

In total, 28 rooms were mapped and equipped with monitoring sensors. With a GxP qualification using the V model, a performance qualification (PQ) was performed 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, ELPRO will complete the PQ in the summer of 2021.

ELPRO ECOLOG is a modular monitoring solution that is ideal for various locations as it can expand and scale at any time. A result of the merger of the Neuendorf and Niederbipp locations, and the head office in Romanshorn, was the creation of approximately 130 monitoring points spread across several rooms and locations. In Romanshorn, the proven ECOLOG-NET™ wireless data loggers, which communicates via the elproMONITOR software installed there, was already in use. By contrast, at the new building in Niederbipp, the ECOLOG-PRO communication and measuring modules were installed with one control cabinet on each floor (basement, first floor, and top floor).

Likewise, the recorded data is managed via 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 very easy to make analyses, acknowledge alarms and edit reports. Alarm notifications are emailed to the responsible person and the control center. Through immediate and repeated alarms, quick action can be taken in the event of deviations. As a result, the event is still fresh and can be better understood and commented on.

Monitoring of Environmental Conditions with Minimal Operating Costs

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 automatic with the help of the elproMONITOR™. Only if there are deviations does the operator need to take time to identify and evaluate the occurrence. Additional time and effort is saved when this evaluation is carried out in a GxP compliant manner directly in the elproMONITOR™ software. In addition, the annual calibration service and software is inexpensive.

Advantages for the Project Partner

With the ELPRO monitoring solution installed currently, the Voigt Group has a very reliable system in place that emphasizes data integrity and can be fully validated. Alarm notifications are sent repeatedly until action is taken. In this way, potential deviations are always noted and resolved. 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 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

The advantages at a glance

  • 100 % GxP compliant monitoring solution
  • Modular, scalable and compatible with other devices
  • Easy to use
  • Fully validated in accordance with GAMP5
  • Complete audit trail
  • Automatic notifications and reports
  • Status can be viewed everywhere
  • Automatic analysis of deviations
  • GxP compliant advice and support

For more information about environmental monitoring solutions and GxP services, contact ELPRO at swiss@ELPRO.com or visit www.elpro.com.

Download a free copy of the ELPRO Case Study here.

Source : ELPRO


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