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Tamper-Evident-Labelling

Manipulation protection for drugs

Tamper-evident labeling with sealing labels for folding boxes - what you should know about it


According to the World Health Organization (WHO), every second drug that is obtained on the Internet is counterfeit. Counterfeit drugs pose enormous health risks for the consumer. Active ingredients are often left out or replaced by ineffective or even harmful substances - this can be life-threatening for the consumer. The trade in counterfeit drugs causes enormous economic and reputational damage for drug manufacturers.

The Falsified Medicines Directive 2011/62 / EU of the European Union aims to counteract the problem. The guideline contains two security features: The serialization is usually guaranteed by, for example, a 2D data matrix code and an individual serial number as well as the application of protection against tampering. The guideline gives manufacturers and contract packers a great deal of leeway with regard to the implementation of tamper protection. One direction is now specified by DIN EN 16679.

Options for checking tampering with drug packaging

There are four options:

  • Special folding box construction

  • Folding boxes sealed with glue

  • Foil wrapping of the folding box

  • Sealing labels

Sealing labels are usually the most economical solution, as no changes need to be made to the folding box packaging.


Tamper-evident labels - the right label adhesive

Round or rectangular, transparent labels are mostly used as tamper-evident labels. The decisive factor here is the label adhesive. This must be highly resistant to various solvents, mechanical manipulation, high temperatures and water - only then is protection against counterfeiting guaranteed.

The label must not be able to be peeled off the folding box without leaving any residue. Either it leaves a residue on the label or the cardboard surface of the folding box is destroyed. The seal label must not be resealable. The adhesives are already available for almost all surfaces. The tamper-evident labels from b + b can be used for a wide variety of packaging surfaces.




The right labeling

When using seal labeling to protect against manipulation, a number of relevant factors must be taken into account:

  • Reliable separation of the folding boxes from one another This can be done, for example, by the system's conveyor belt.

  • Precise application of the seal label This can be ensured by fixing the folding box.

  • Required labeling speed The labeling speed must at least correspond to the line speed of production.

  • Position of the tuck-in flaps to be labeled The tuck-in flaps of the folding boxes can be in different positions.

Possible positions of the tuck-in flaps:





The labeling process:

With tamper-evident labeling, around 50% of the label is applied to the folding box - the other half protrudes beyond the body of the folding box. With the help of a pressure roller or strip, the label can be precisely ironed onto the other side of the folding box.


Tamper-evident labeling with standardized machines

The pharmaceutical industry is faced with complex labeling requirements like hardly any other industry. Complete traceability, measures against counterfeit medicines such as serialization and manipulation features as well as reliable product labeling pose major challenges for manufacturers and contract packers.

Manufacturers and contract packers often decide inevitably to meet the labeling requirements for expensive special machines. However, this is usually not necessary. Due to the modular design of the b + b machines, individual labeling requirements can be implemented economically. With the right level of standardization, cost benefits can be achieved. In accordance with the concept of mass customization, you will receive a solution tailored to your requirements.

The solution can consist of different modules. The modules include:

  • Labeler

  • Printing systems

  • Control and inspection units

  • Reject stations

  • Inlet and outlet buffers


The labeller

The core module of the tamper-evident system is the labeler. The actual labeling process of the tamper-evident label is carried out through this. Different folding box formats can also be labeled by simply changing the format.

Due to the modular design, the labeler can be retrofitted at any time, as can the installation of additional labeling stations. In this way, manufacturers and contract packers can use b + b labelers to react quickly and safely to the constantly growing labeling requirements in the pharmaceutical industry.

The printing system

The application of variable data can be done either directly on the folding box or on the label.

The right printing process depends on various conditions:

  • Product format

  • Product surface or label material

  • Size and type of labels

  • Production speed

The printing module is integrated into the labeling system. Here we use print modules from well-known partners. Existing systems can also be retrofitted with one or more pressure modules without any problems. This gives the user the opportunity to react flexibly and inexpensively to increasing labeling requirements.



Printing on the folding box
Printing on the folding box

Printing the data matrix code and the serial number:





The control unit

Different control systems are used depending on the application and requirements. If the data matrix code is actually to be read, camera systems, appropriate sensors or scanners are integrated into the system.

A label presence check can also be carried out using appropriate sensors on all four sides. If only a print presence check is to be carried out, simple contrast or color sensors are sufficient.

Retrofitting for existing systems is possible at any time. Defective products can then be ejected from the production line if required.



Kameraprüfsystem für den Druck
Kameraprüfsystem für den Druck

The reject station

In the event of a damaged or non-functional label, the labeled product is removed from the production line. Insensitive products are transported from the conveyor belt by means of air pressure and collected in a closed container. If faulty labels are to be sorted out before they are applied to the label, this can be made possible by a label ejection. This is mostly the case with expensive products.


Implementation of the guideline through the serialization module - the complete solution from a single source

In addition to the hardware to make your products counterfeit-proof, b + b also supplies the necessary software. This also has a modular structure. It can be adapted to existing and future requirements without major investments. Be it the adaptation for the management of production lines or locations as well as the adaptation to new coding and aggregation regulations or an expansion of the machine park.

Our b + b site server and its modules ensure a smooth and standardized data exchange between higher-level data systems, the individual line components and the reporting of the family tree of your products.

In addition, this software package also serves as a platform for production management. An almost infinite number of hardware components from various manufacturers for automation, coding and aggregation can be controlled and managed in parallel. You can find more information about the serialization of your products at www.bb-trace.com.

Any questions? Or would you like to send us an inquiry?

Then please contact us. Our contacts are at your disposal.