b + b automation > Industries > Pharma > Tamper Evident Labeling



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 purchased over the Internet is counterfeit. Counterfeit medicines pose enormous health risks for consumers. Active ingredients are often omitted or replaced by ineffective or even harmful substances - this can be life-threatening for the consumer. The trade in counterfeit drugs causes enormous economic damage and damage to the reputation of drug manufacturers.


The counterfeiting directive 2011/62/EU (Falsified Medicines Directive, FMD) of the European Union is intended to counteract the problem. The directive contains two security features: Serialization, for example by means of a 2D matrix code and an individual serial number, and the provision of a tamper protection device. The directive gives manufacturers and contract packers a great deal of leeway in terms of implementing tamper protection. One direction is now given by DIN EN 16679. 


Possibilities for checking manipulations of pharmaceutical packaging

Four options are available:

  • Special folding box construction

  • Folding cartons closed with glue

  • Foil wrapping of the folding box

  • Sealing labels

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

Tamper evident labels - the right label adhesive

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


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

Square, transparent tamper-evident labels

Round, transparent
Tamper evident labels

Round, transparent tamper-evident labels with perforation

T-labels for tamper-evident labelling


The right labeling

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

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


Possible positions of the folding box flaps:

Bottom left and right

Top left and right

Top left and bottom right

Bottom left and top right

The labeling process:

With tamper-evident labeling, approx. 50% of the label is applied to the folding box - the other half protrudes beyond the folding box body. 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. The complete traceability, measures against counterfeit medicines such as serialization and manipulation features as well as reliable labeling of the products 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. The modular design of the b + b machines means that 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 additional labeling stations. In this way, manufacturers and contract packagers can react quickly and safely to the constantly growing labeling requirements in the pharmaceutical industry with labelers from b + b.


> More information about the b + b labelers


> TE - Fully automatic labeling machine for tamper-evident labeling

> MTE - manual labeling device for seal labeling

The printing system

The application of variable data, such as the serial number, can be done both directly on the folding box and 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.





Print the data matrix code and the serial number:


Printing on the folding box

Flat folding box with data matrix code

Printed folded box


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 by sensors and cameras.
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 removed from the production line if required.

Camera inspection system for printing

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 air pressure and collected in a sealed container. If faulty labels are to be sorted out before they are applied to the label, this can be made possible by a collecting roll. 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 exchange of data 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 .

You are looking for a turnkey solution to label your products - contact us!

b+b Automations- und Steuerungstechnik GmbH

b+b Automations- und Steuerungstechnik GmbH is your partner for innovative and reliable labelling and identification technology made to measure. In 1986 b+b was founded in Airlenbach in the Odenwald. Today the internationally operating company employs 115 people in the field of labelling technology.


Your requirements and wishes are our focus when implementing your project. From development and planning to complete implementation, our employees will provide you with optimum support.


At b+b you receive the complete solution from one source. From software, printing and dispensing systems to fully automatic labelling and identification systems. For more than 30 years b+b has been supplying complete solutions for labelling, serialisation and aggregation for companies from all industries.

email: info@bb-automation.com

phone: +49 (0) 6068 9310 0


supprt hotline: +49 (0) 6068 9310 900

support system:  report support case


b+b Automations- und Steuerungstechnik GmbH

Dieselstraße 18

64760 Oberzent


© 2019 by b+b Automations- und Steuerungstechnik GmbH. All rights reserved.

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