SICK’s Glare sensor providing tamper evidence for medicinal product packaging at Bosch Packaging Technology

The Glare by SICK is offering ‘bright’ prospects in the battle against
falsification and tampering in the field of medicinal product packaging. The
innovative Glare sensor was developed in response to the aims of the ‘Packaging
– Tamper verification features for medicinal product packaging’ standard. Bosch
Packaging Technology is successfully using the Glare in its CPS serialisation
solutions and is achieving 100% reliability in detecting transparent
tamper-evident safety labels, which are applied by machine.

Falsified medicinal products are a global problem. Popular medicines and
highly priced medicines are at particular risk. Experts estimate that more than
one in ten preparations worldwide is falsified; for medications available
online, the level is believed to be over 50 per cent. Studies suggest that
buyers who wish to remain anonymous when making purchases via the Internet
could even expect a falsification rate of up to 95 per cent, based on all of
the products available on the web.

Tamper evidence:
Transparent labels show when folding cartons have been opened

Standard EN 16679:2014 is a supplement to the Falsified Medicines Directive
(FMD) 2011/62/EU. This enhancement of the standard will ensure the genuineness
and verifiability of individual packs, and thus prevent falsified or adulterated
medication and lifestyle preparations from entering legitimate distribution
channels. EN 16679:2014 recommends a range of sealing options that would
prevent packs from being opened and closed again without leaving evidence, and
would guarantee maximum protection against tampering. Alongside fibre-tear
labels, which are irreversibly damaged on opening, and foil ‘VOID’ stickers
that reveal previously invisible text or patterns once they are detached,
tamper-evident safety features have proved themselves effective in practice.

Daniel Sanwald, product manager at Bosch Packaging Technology explains these
are transparent, self-adhesive sealing labels with perforations across the
opening flaps of folding cartons.

As a form of protection against prior opening, transparent seals neither
affect the pack design nor cover up the required wording or markings on the packaging.
The damage to the perforation when first opened is instantly visible. According
to Sanwald, as an element of their CPS folding box printing and verification
systems, they offer a tamper-evident function as an optional module that can
very easily be retrofitted to existing packaging and serialisation solutions.
For most packs, there are two label dispensers that attach the safety labels to
the two opening flaps. In order to identify errors in dispensing or attaching
the labels immediately, 100 per cent reliable detection of the applied labels
was essential.

Glare – when glare
characteristics make the difference

Although glare is a property, which often interferes with the function
of sensors, for the Glare it is an advantageous characteristic of the object or
surface that can be enormously useful. Delta-S-Technology facilitates reliable
detection. The Glare has a sensing distance of 50mm and features two receiver
fields and eight transmitter axes. The red-light LEDs transmit in various
directions and create a light spot size of approximately 10 mmx 13mm. This
arrangement renders the sensor invulnerable to vibrations during machine
operation and to any wobbling of the objects as they pass the sensor, thus
ensuring reliable detection of glare changes between label and pack.

Referring to the ease with which the glare sensor can be integrated into
a system, Sanwald says it is also important that the Glare should not require
time-consuming configuration, or need additional illumination or protection
against ambient light. During operation, the Glare distinguishes between
directional and diffuse reflections, using an intelligent algorithm to evaluate
the received signal in terms of its spatial distribution. By simultaneously
observing the dynamic transitions between glare states, the Glare also achieves
good signal quality.

IO-Link: The
efficient option

The Glare can optionally be integrated into the machine controller via
IO-Link. This allows the sensor to be adjusted via the controller and a wide
range of process data can be supplied during operation; this data can then be processed
for specific purposes in the PLC or on the user interface. As required in a pharma
environment, the configuration data is stored centrally in the machine controller.
It can be transferred to the sensor when switching to a different pack or when
changing devices. In addition, the Glare will send an error message to the
operator when it encounters contamination such as dust on the pack.

Now a reality: Automatic
aggregation of pharma packages

In the process of combining packages in track-and-trace containers, SICK’s
DeltaPac MultiTask photoelectric sensor can be relied upon to accurately count
units without any interruptions to the product flow. Moreover, where automatic
aggregation is concerned, it makes all the difference. Once the packages have
been labelled and sealed ready for sale, they are combined (both physically and
in terms of data) in bundles in the aggregation module. DeltaPac counts the
packages by detecting the leading edges. Simultaneously, a Lector62x image-based
code reader reads the labels on the individual packages. After this, the bundle
is taken to a robot module for outer packaging. When full, the outer packaging
is forwarded to a pallet handling machine.

Sanwald says each stage of the aggregation process is verified
seamlessly. In the ERP system, this produces a complete aggregation structure,
which is similar to a pyramid and maps all stages of the bundling process,
thereby supporting seamless track and trace. Identification of the packages
with the Lector62x and reliable counting with DeltaPac maximise process
reliability and enable a product to be tracked and traced at any time and at
any stage throughout the entire production, packaging, and logistics process.

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