MechChem Africa March-April 2022

FHV7 smart camera delivers reliable GMP-compliant drug labelling Steierl-Pharma, a pharmaceutical company from Bavaria in Germany that specialises in naturopathy, has modernised and optimised its labelling processes with an inspection system based on the OMRON FHV7 smart camera. Steierl-Pharma’s MD, Steffen Wegner, tells the story.

H ardly any other industry is subject to the high quality requirements and legal regulations as those of 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, which can be up to five years. Labels carry important information including the name of the drug, the active ingredients and the manufacturer, along with variable data such as expiration date, lot number and serialisation information. Establishing a valid labelling process is therefore key. At the same time, theprocesses shouldalsobeasefficient, fast, andsustainable as possible. Steierl-Pharma relies on the support of OMRON automation experts in this regard. By using a new labelling system with smart camera technology, Steierl-Pharma can now reliably label its pharmaceuticals at high process speeds. The labels are printed with variable data onbatchdesignation, expiration

date and, if required, the dispensing notice: “Sample not for sale”. Steierl-Pharma is amedium-sizedpharma- ceutical company in the field of naturopathy and produces liquid doses of its medicines in cylindrical glass containers. Company prod- ucts include: medicines for the musculoskel- etal system; for lowering blood pressure; for relieving migraines; for skin diseases; or for treating flu-like infections. The producer has the legally required manufacturing license formedicinal products as well as Good Manufacturing Practices (GMP) certification, soas toguaranteeprocess integrity in drug production and conformity with applicable regulations. When it comes to filling and packaging medicines, Steierl- Pharma uses a production line designed for around 3 600 units per hour. This line consists of a filling and capping machine, a labeller and a packaging machine. The line ensures a continuous and seamless process consisting of filling and closing the bottles with a dropper insert and a screw cap.

The closed bottles then leave the cleanroom and enter the labeller, where they are labelled and then packed at the packaging machine into a folding box together with an informa- tion leaflet. Unintentional machine stops and read errors In 2019, a project team at Steierl-Pharma began to consider a replacement for an older labellingmachine. “The labellingmachineused until then already had a smart camera-based inspection system to check the identity of the label and the variable data – batch name and expiration date. This, however, had two drawbacks: first, labels were repeatedly mis - read as bad labels, and second, bad unitswere not rejected, even when the labelling process was stopped. Thismeant thatwhenthemachinestopped, the bottles backed up into the fillingmachine, while the packaging machine ran empty. “So we had a ‘bottleneck’ in our process,” reports Wegner. Hecontinues: “That’swhyweworked

Steierl-Pharma production line consists of a filling and capping machine, a labeller and a packaging machine.

34 ¦ MechChem Africa • March-April 2022