The production of labels for pharmaceutical products involves mastering various technical and organisational challenges. As part of a broad range of services, Eukerdruck GmbH & Co. KG, Marburg, has specialised in the production of labels for the pharmaceutical industry for over 60 years.
The Mägerlein family, who took over the commercial print shop founded at the beginning of the 20th century in 1950, today runs the Company in its third generation. Together with Manfred Mägerlein, his sons Dietrich and Robert Mägerlein form the management team and continue the family tradition. In addition to standard products such as labels, package inserts and mini-brochures, the company also specialises in Focus on patient alert cards and Outsert 2in1 solutions. Here, machines that are unique in Germany and therefore innovative product solutions are used together with the customer.
Special challenge pharmaceuticals
The consistent use of specifications, which serve as the basis for the creation of production orders at the label manufacturer and for the incoming goods inspection at the pharmaceutical customers, should standardise the production properties and conditions and make them reproducible for all orders. The production conditions take into account the GMP specifications. They should be observed during the production of the labels as if the Labelling a pharmaceutical product is. At Euker, the GMP rules are implemented both in organisational measures and in electronic controls.
The organisational measures relate to cleanliness and hygiene in the production areas and at the workplaces, the „Line Clearance“, training and education. For example, when the printed labels are rewound, any missing parts or copies to be sorted out are cut out of the web using the carrier tape. The good ends of the label web are glued together in such a way that they cannot cause any interference when the labels are dispensed on the customer's system.
Of course, the machine operators carry out regular in-process checks, the results of which are documented. Monitoring the production processes and product quality at every stage of production results in high-quality finished products.
The electronic quality controls include a comparison of the supplied data with the order data, a 100% comparison of the first and last labels of a production run against the print release and a 100% inline camera monitoring of the rewound labels.
Media check system
To compare the printed labels against the print approval, which is usually available as a PDF file, Euker uses the Media check system in. To do this, the labels are scanned and compared electronically pixel by pixel against the PDF file. The deviations are then assessed by trained quality control staff. Logs are created for this comparison, which clearly show which deviations were identified by the system and how they were assessed by the employees.
Traceability
All steps from order acceptance, receipt of the print data or the assignment of the print data to the order, to the creation of the printing plates, printing, rewinding and packaging through to dispatch are documented in a production log. The documentation is done electronically and then archived.
In addition to the delivery note and the delivery certificate, customers also receive a reel mirror, which provides information on the arrangement of the webs on the reel and the sequence of the reels produced. Should an error occur, it can be localised in this way. The affected rolls could be sorted out. The rest of the delivery could be processed by the customer.
These measures ensure that Complete traceability This makes it possible to identify the print data, materials, tools and machines used, the employees involved and the underlying specifications even years after production and delivery.
Possible applications
The labels produced cover all areas of application. Ampoules and syringes, for example, require small labels that can hold all the necessary information and still reserve space for the variable data that the customer prints when dispensing. The material must be selected so that the labels fit easily around the small ampoules and cannot come off again.
Pharmaceutical labels can also be applied to folding cartons as Tamper evidence be used. On the one hand, they should be easy to open, which is why the labels are perforated. On the other hand, it must not be possible to remove the labels, or only with visible traces on the folding carton.
As the possible applications of labels in the pharmaceutical industry are very diverse, Euker's experts advise customers on the selection of the right labelling. right materials for the corresponding application areas or for the technical design of the labels. The range of services also includes the creation of print data, drawings and specifications.
Euker processes around 20,000 orders from all over the world every year at two locations in Marburg. Perfect service from the idea to the finished product is the company's philosophy. The company has made a name for itself in the pharmaceutical industry for many decades. It also offers solutions for the food and cosmetics industries.
