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AUTOMATION
3,600 units pass through production line in one hour reliable the OMRON FHV7 inspection
The producer has the legally required manufacturing license for medicinal products system was. As part of the challenge
as well as the GMP certificate. The Good Manufacturing Practices (GMP) certification testing, we deliberately introduced
guarantees process integrity in drug production and conformity with applicable mislabels, all of which were reliably
regulations. When it comes to filling and packaging the drugs, Steierl-Pharma uses a detected – but with a throughput of
production line designed for around 3,600 units per hour. several 10,000 labels, not a single good
It consists of a filling and capping machine, a labeller and a packaging machine. label was incorrectly read as a bad label,”
The line ensures a continuous and seamless process consisting of filling and closing reports Wegner.
the bottles with a dropper insert and a screw cap. The closed bottles then leave the Even a single faulty unit could cause
cleanroom and enter the labeller, where they are labelled and then packed in a folding a lot of trouble in the GMP environment.
box together with an information leaflet in the packaging machine. By using the new camera, such situations
do not occur, and the machine outages
Avoiding unintentional machine stops and read errors caused by the incorrect reading of actual
In 2019, a project team at Steierl-Pharma began initial considerations to introduce a good units can also be prevented.
replacement for an already older labelling machine. “The labelling machine used until Another advantage of the OMRON
then already had a smart camera-based inspection system to check the identity of the camera is the software, which is intuitive
label and the variable data (batch name and expiration date). This however had two to use and does not require lengthy
drawbacks: firstly, labels were repeatedly misread as bad labels, and secondly, bad training. “I also really like the option of
units were not rejected, but the labelling process was stopped. This meant that when a customisable user interface, and so do
the machine stopped, the bottles backed up into the filling machine and the packaging the users. There is only one window in
machine ran empty. “So, we had a bottleneck in our process,” reports Steffen Wegner, which, for example, the target code, batch
MD of Steierl-Pharma GmbH. designation and expiration date can be
entered. Code verification and OCV can
Precision and speed also be performed. It’s all very clear and
Wegner explains: “That’s why we worked with the manufacturer HERMA to find a simple,” explains Wegner.
suitable inspection system. The focus here was on high reliability and pricing.” The aim The software runs on any current
was to develop a labelling machine that on the one hand met the high requirements Windows system and communicates
in the GMP area, but on the other hand, also ran without interruption during regular directly with the FHV7 via the local
operation. One of the main criteria was that the new inspection system should work network. Wegner also praises the high
particularly precisely - bad units such as an incorrect or illegible barcode as well as batch inspection speed of the OMRON system.
or expiry date errors should be detected reliably, the keyword being sensitivity. The complex individual inspection of a
Steierl-Pharma wanted a high level of specificity; the system should only detect label takes just 80 milliseconds: “That’s
actual bad units as such and eject them from the process. That’s not all - with an output impressively fast.”
of around 60 labels per minute, the inspection system only has a time window in the
range of milliseconds for the complex inspection tasks. Inspection system and support
“We are very satisfied with both the
FHV7 smart camera supports testing and quality control new labeller and especially OMRON’s
The central component here is the inspection system. Wegner explains: “We decided on inspection technology. In a highly regulated
the OMRON FHV7 smart camera after a test on our label material on site, supported by environment such as the pharmaceutical
an OMRON application engineer. We were effectively supported by OMRON throughout industry, manufacturers must be able to
the entire development process up to commissioning and qualification of the machine fully rely on the technology that is used
and beyond.” With the help of the FHV7, the HERMA labelling machine at Steierl- – also to be able to successfully complete
Pharma checks the identity of the label based on the pharmaceutical code and verifies the qualification. This is the case with us,”
batch and expiration via OCV (optical character validation) for compliance with the Wegner sums up. “The cooperation with
specifications. the sales and application team was, and is,
The FHV7 series smart camera provides illumination and image processing also excellent.”
functionality for enhanced visual inspections. Due to its world-first, multi-colour light Since the company has had such a
and a powerful high-resolution 12-megapixel camera, only a single FHV7 camera is good experience with OMRON, an existing
needed to perform high-precision visual inspections of the production line. packaging machine will be converted to
During the performance qualification, the project managers involved were surprised Omron inspection technology in the near
by the extremely high specificity of the FHV7. “We could not believe how extremely future. n
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