Printed? Sealed? Check!

Step 1: Printing

There are two steps to protecting pharmaceutical packaging from falsification: First, the EU directive mandates that folding cartons be labelled with a GTIN (Global Trade Item Number), serial number, batch number and expiry date. The information is printed as plain text and also encrypted as a two-dimensional data-matrix code. The Traxeed ItemUnit-Tamper Evident gets the print data for each job from a superordinate site management system called Multi Line Manager. It labels more than five products per second at a belt speed of up to 60 metres per minute. After printing the information as plain text and code, a camera checks its readability and quality, also comparing what was actually printed with the data sent to the printer.

Step 2: Sealing

The anti-tampering device is the second part of preventing falsification. At a glance, the either pristine or damaged perforation of safety seals shows whether packaging has already been opened. That is why the ItemUnit-Tamper Evident subsequently seals folding cartons with tamper-proof safety seals. The cartons move through the Tamper Evident labeller, which – with zero contact – applies transparent plastic seals on both sides of the carton. One half of the micro-perforated label juts out and is precisely folded over the edge of the carton by a guide plate. Christian Frenz provides context: “That may sound simple. But, with over 300 folding cartons per minute, everything always has to go without a hitch!”

The Traxeed and Weber developer teams made sure that the conveyor technology and labeller in the Traxeed ItemUnit-Tamper Evident work perfectly together. After all, labelling precision and its repeatability depend on how the material is fed through the machine. The ideal coordination of components also makes it easier to handle a variety of product sizes: The Tamper Evident labeller is designed to label a range of folding cartons on two sides – from the minimum carton size of 15 x 15 x 70 millimetres up to the maximum size of 180 x 125 x 260 millimetres. The weight of the products can be anywhere between 30 and 300 grams.

“Speed and precision are important, but what impressed us the most was the small size of the machine,” says Christian Frenz. “The Weber Marking Systems device has an installation width of 300 millimetres, making it the smallest and most compact Tamper Evident labeller we could find.” Despite the tiny unit size, changing materials still has to be no-fuss. As such, the labeller completely rolls out of the ItemUnit-Tamper Evident on a sliding carriage. Workers can quickly and easily replace label rolls and conveniently perform maintenance without having to open the entire machine.

Step 3: Checking

Incorrectly labelled drug packaging must not leave production. Cameras and sensors are needed to monitor labelling because of the production speed common to the pharmaceutics industry. Sensors in the Traxeed ItemUnit Tamper Evident check the surface sheen to determine if labels were accurately applied. If this is not the case, a gust of pressurized air knocks the unit off the line.

After the target quantity has been reached, the ItemUnit-Tamper Evident tells Multi Line Manager exactly how many serial numbers were printed. From there, the data are transmitted to the EU hub, either via a business and planning logistics system (e.g. Arvato CSDB or other systems like SAP) or manually via the EMVO gateway. The hub sends the serial numbers to the verification systems (NVS) of the countries where the products will be sold. When a drug is sold, for instance at a pharmacy, the employee scans the data matrix and is immediately notified by the NVS whether the product is authentic. The serial numbers of confirmed sales are marked accordingly in the NVS databases.