Page 26 - Energize March 2022

NEWS

Drug labelling process optimised

with modern inspection technology

Reliable drug production requires fast and GMP-compliant labelling

teierl-Pharma GmbH from
Herrsching in Bavaria, Germany,
Srelies on the support of OMRON
automation experts in this regard. By using
a new labelling system with smart camera
technology, Steierl-Pharma can label its
pharmaceuticals with high process speed
and reliability. These labels are printed
with variable data on batch designation,
expiration date and if required, the
dispensing notice “Sample not for sale”.
Hardly any other industry is subject
to such high-quality requirements and
legal regulations as pharmaceutical
companies. This applies to active
ingredients, production and storage as
well as to the labelling process. The labels
must be robust and stick reliably for the
usability period of the drug of up to five It consists of a filling and capping machine, a labeller and a packaging machine. The line
years. Labels carry important information ensures a continuous and seamless process consisting of filling and closing the bottles with
such as the name of the drug, active a dropper insert and a screw cap. The closed bottles then leave the cleanroom and enter
ingredient(s), manufacturer, and variable the labeller, where they are labelled and then packed in a folding box together with an
data such as expiration date, lot number, information leaflet in the packaging machine.
and serialization information. Establishing In 2019, a project team at Steierl-Pharma began initial considerations to introduce a
a valid labelling process is key. At the same replacement for an older labelling machine. “The labelling machine used until then already
time, the processes should also be as had a smart camera-based inspection system to check the identity of the label and the
efficient, fast and sustainable as possible. variable data (batch name and expiration date). This however had two drawbacks: firstly,
Steierl-Pharma is a medium-sized labels were repeatedly misread as bad labels, and secondly, bad units were not rejected, but
pharmaceutical company in the field of the labelling process was stopped. This meant that when the machine stopped, the bottles
naturopathy and produces medicines in backed up into the filling machine and the packaging machine ran empty. “So, we had a
liquid dosage form, in cylindrical glass ‘bottleneck’ in our process,” reports Steffen Wegner, Managing Director of Steierl-Pharma
containers. The product range of the GmbH.
company includes medicines for the Wegner explains: “That’s why we worked with the manufacturer HERMA to find a
musculoskeletal system, for lowering suitable inspection system. The focus here was on high reliability and pricing.” The aim was
blood pressure, for relieving migraines to develop a labelling machine that on the one hand met the high requirements in the GMP
or skin diseases, or for treating flu-like area, but on the other hand, also ran without interruption during regular operation. One of
infections. the central criteria was that the new inspection system should work particularly precisely
The producer has the legally required - bad units such as an incorrect or illegible barcode as well as batch or expiry date errors
manufacturing license for medicinal should be detected reliably, the keyword being sensitivity.
products as well as the GMP certificate. Steierl-Pharma wanted a high level of specificity, the system should only detect actual
The Good Manufacturing Practices (GMP) bad units as such and eject them from the process. That’s not all, with an output of
certification guarantees process integrity around 60 labels per minute, the inspection system only has a time window in the range of
in drug production and conformity with milliseconds for the complex inspection tasks.
applicable regulations. When it comes to The central component here is the inspection system. Wegner explains: “We decided
filling and packaging the drugs, Steierl- on the OMRON FHV7 smart camera after a test on our label material on site, supported by
Pharma uses a production line designed an OMRON application engineer. We were effectively supported by OMRON throughout
for around 3600 units per hour. the entire development process up to commissioning and qualification of the machine

energize | March 2022 | 24