b + b - EXPIERENCED IN ALL INDUSTRIES
TAMPER EVIDENT LABELING
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 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 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
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:
Control and inspection units
Inlet and outlet buffers
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.
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 surface or label material
Size and type of labels
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 .