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Case study: cloud-based serialisation solution for pharma packaging

For the packaging of pharmaceutical products, Stegemann relies on serialisation solutions from Mettler-Toledo. A cloud-based software solution from tracekey solutions GmbH supports the recording and processing of serialisation orders.

Key insights:

Stegemann Lohnverpackung & Logistischer Service e.K. is a German-based company that focuses on the packaging of pharmaceutical, food, hygiene and other products.

As a contract packaging company, Stegemann is responsible for serialising packaging materials according to customer requirements and various country standards. For rolled label printing, they rely on the T11 Manual Mark & Verify from Mettler-Toledo.

Serialisation solution for various applications

The T11 system enables the creation and inspection of labels with serialised data using a single integrated system. A Smart Camera checks all data for presence and correctness. Any faulty printed labels can be identified and removed.

Stegemann receives the serial numbers of the products from their Marketing Authorization Holder (MAH). Cloud-based software from tracekey acts as the interface that receives the serial numbers. Orders are then created by Stegemann in tracekey and forwarded to PCE Line Manager Direct (PLM Direct), the Track & Trace software from Mettler-Toledo. The PLM Direct software is located on the line and imports the information required for labeling and serialisation.

After processing and reporting back the serial numbers from PLM Direct to tracekey, the serial numbers are finally sent back to the MAH for recording to the database. "The advantage is that we can configure or set the parameters ourselves, so that we can implement the requirements we receive from the customer directly into the system one-to-one," explained Nancy Fricke, responsible for GMP compliance at Stegemann.

Fricke is not only pleased with the newly created interface, but also with the entire setup process. "We have always been very satisfied with our Track & Trace solutions from Mettler-Toledo. Therefore, we were looking for software that we could connect to the existing system," Fricke continued. The decision was finally made to go with tracekey, a company providing Software as a Service (SaaS). Tracekey solutions offers Levels 4 and 5 software solutions in the cloud, helping pharmaceutical companies meet global serialisation requirements.

"Tracekey is a particularly good fit for us because we are only a small company with about 120 employees," said Fricke.

During the setup, Stegemann received support from both sides. "Mettler-Toledo understood our requirements and explained to us exactly how we could implement this project. The cooperation with tracekey was also very straightforward, as we received answers to our questions whenever we asked," said Fricke.

Stegemann's customers also like the Mettler-Toledo solutions combined with tracekey software. "We were able to keep an existing customer because we were able to create this interface exchange. Other orders were also secured. Many customers are also familiar with both our Mettler-Toledo solution and tracekey software. This provides confidence in the processes," Fricke commented.

Conformity with international standards

As a contract packaging company, it is important for Stegemann to comply with international standards. All of the track and trace systems used help meet the standards of the pharmaceutical industry, including the GS1 standard and Good Manufacturing Practice (GMP) guidelines.

Another advantage is the user friendliness of the interface. "Of course, it always depends on how experienced people are in using the software. However, the tracekey software is self-explanatory and therefore intuitive to use," added Fricke. "The interface between the Mettler-Toledo solution and tracekey software is very stable. I do not have to worry about data being lost or the system not working. This trust is very important for our daily work."

Regular service support

To ensure that the equipment and software are always up to date, Stegemann relies on service support from both sides. "We are very satisfied with the service from Mettler-Toledo. The technicians on site are always there to help us with any questions," explained Fricke.

"With a SaaS system, the main responsibility for validation and for the functioning of the system lies with the provider. However, we were happy to hand over these responsibilities. The extensive service and regular updates we receive through tracekey are wonderful."

Stegemann not only relies on the regular updates to protect the systems from failure, but is also excited about new features.

Stegemann has recognised that the greatest challenges in everyday work are the constantly growing requirements and regulations. In this context, the contract packaging company particularly appreciates the Mettler-Toledo solutions, as these are kept up to date through constant development and cover all requirements as they change.

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