Reliably mark and serialize whilst saving space

Reliably serializing a wide variety of pharmaceuticals packaging involving small quantities and producing country-specific layouts just in time – this is the challenge that has been overcome at Iscador, a Swiss pharmaceuticals manufacturer. The mid-sized company is equipped to meet both current and future challenges with a solution from Atlantic Zeiser.

Iscador, which specializes in anthroposophic mistletoe compounds for tumor therapy, only produces small lot sizes (80 to 2,000 packages), but does so in a wide range of variants for different countries, dose sizes and combinations for markets inside and outside the EU. This means that it must hold a very large number of different packaging types in reserve. But storage space in Basel, a chemicals and pharmaceuticals center, is extremely expensive. “To avoid storage costs, we do all package printing in-house,” says Björn Stehle, head of merchandise logistics and packaging at Iscador. “That is why we decided to use a solution from Atlantic Zeiser for late stage customization and serialization. Other well-known pharmaceuticals manufacturers have already expressed great interest in how we do those things.” MEDTRACKER, the serialization and production management software application, plays a central role.

Produce more efficiently and react flexibly to new market requirements

At base, the Swiss pharmaceuticals manufacturer was interested in solving multiple problems at once: the country-specific marking of packages in small lot sizes, the reliable serialization required by individual target markets, and the mapping of internal cold chain logistics for a process that is safe overall, including data management – all in as little space as possible. “The printing and software solution not only saves us valuable storage space, but also cuts logistical costs. We have reduced printing rejects to almost zero and achieved shorter throughput times, so we produce more efficiently overall. Another advantage is that the solution can be flexibly configured so that it can be changed and adapted to new market requirements within a very short time. The fact that we will be working with a new sales partner in the future and serving other markets makes this especially important for us,” says Björn Stehle, head of merchandise logistics and packaging at Iscador.

Many folding carton variants – complex marking

The variety of folding cartons at Iscador is enormous. It holds stocks of 118 different formats for Switzerland alone, alongside 72 for Germany and 40 each for Austrian, Italian, Swedish, South Korean, South African, and United Arab Emirates markets. The number of different packaging varieties that must be held ready is correspondingly high. “In finding a solution, it was important that it be able to print packaging with country-specific labels quickly, flexibly, and – of particular importance – without long reset times, since we only produce small lot sizes,” Stehle says.

Added to all this are the requirements of serialization that vary for different target markets, such as South Korea. It must be possible to reliably generate, print, check, control, and manage the serialization codes. “Thus far, the serialization codes have been printed on a cartridge printer. Up to 30% were rejected. On top of that, there were the unnecessary downtimes to correct the problems,” Stehle recalls.

Gaplessly documenting the cold chain

Another peculiarity of Iscador is the cold chain. The Swiss company produces ampules with liquid injections of various active agents and concentrations. The refrigerated goods must be stored at temperatures between 2 and 8 degrees Celsius. That is why the actual packaging takes place under cold clean-room conditions. The ampules of various concentrations are placed in inlays and packaged in the folding carton with the insert appropriate for the target country. Before MEDTRACKER was introduced, dual control was necessary. “We must document the maintenance of the cold chain for the receiving wholesaler. This made organizing the corresponding data management a central challenge for the new Atlantic Zeiser solution,” says Stehle.

Ruling out product confusion during the packaging process

This begins even before packaging itself, with packaging preparation: Each order must be allocated to the correct folding carton which has received country-specific labelling and inserts and to the associated ampules with various active agent concentrations. Only then can packaging be carried out in the clean room. “To rule out confusion of items during packaging preparation, we used to need numerous checks, often involving dual control. But even that was never 100% reliable, and it took a lot of time,” Stehle says.

Software solution for data management reliably maps processes

Iscador can now dispense with multiple dual controls. Almost the entire packaging and serialization process, including internal cold chain logistics, is now monitored and controlled by MEDTRACKER software. In addition to the incorporation of corresponding hardware, MEDTRACKER receives from a hand-held scanner all data relevant to process reliability. This allows errors in packaging preparation to be avoided. The software continues to receive all relevant data for documenting maintenance of the cold chain up to the point of pharmaceuticals shipment, including any necessary aggregation, so that a reliable process results.

The MEDTRACKER serialization software also ensures  flexible, audit-proof generation, distribution, printing, aggregation, and tracing of codes for all applicable international legal regulations. If the spectrum of requirements changes, the software can be adapted easily by way of parameterization. But that is not all; unlike many conventional software options, MEDTRACKER is a generic database application with the full functionality of a production management platform that allows all necessary hardware module process steps and functions to be defined, monitored, and adapted relatively freely, at any time, and without programming or updates. It forms the foundation for extremely safe and reliable processes.

Serialization and late-stage customization on a single system

Another significant increase in efficiency results from the combination of MEDTRACKER with the DIGILINE Compact printing system, also from Atlantic Zeiser. The DIGILINE Compact allows quick format changes and short set-up times, which is ideal for Iscador’s small lot sizes and its many country variants. The system is equipped with an OMEGA drop-on-demand UV inkjet printer; piezoelectric impulses in the DoD print head cause tiny droplets of ink to fall through microscopic openings onto the folding cartons, where they are cured under UV light in a fraction of a second. This ensures brilliant print and the highest level of no-fade properties and resistance to abrasion, light, moisture, and disinfectants. These properties mean that the system can, in addition to providing country-specific marking and serialization, print other coding, so that at Iscador, late stage customization and serialization can be performed in a single step and just in time. “Instead of keeping various folding cartons in storage, we only print a folding carton format with all the country-specific and other information, including serialization code, exactly when they are needed. We can now dispense with cartridge printers, and we have a reliable, compact solution that gives us the best printing quality,” Stehle says.

Quickly develop new markets

That is why there are good reasons for the pharmaceuticals manufacturer’s interest: “Thanks to the software solution from Atlantic Zeiser, we have a data management system that ensures the process reliability of late stage customization and serialization, including maintenance of the cold chain until shipment. We are thus already prepared for any future requirements with respect to coding and serialization, and can service any market within a short time. We are optimally equipped to work with new sales partners,” Stehle says.