Ondrej Kruk, Business Unit Manager LPA, Videojet Technologies, looks at the challenges faced by labelling systems as regulatory demands become increasingly stringent
The pharmaceutical packaging industry is held to exacting standards. Such standards are expected to grow in complexity due to the globalisation of its customer base and drug serialisation requirements deployed across a number of countries. The coding and marking of pharmaceutical products are crucial to ensure reliable product identification which helps companies fight counterfeiting and most importantly help prevent errors in administering drugs to patients.
The European Union’s Directive 2011/62/EU, which is expected to come into force in 2017, will require all pharmaceutical products distributed within the EU to have a serialisation number, or unique code, printed or attached onto each pack to enable suppliers to track and trace the product back to its manufacturing source. Serialisation can take the form of linear barcodes, two dimensional bar codes or even radio frequency identification (RFID). Similar regulations are already in place in other countries such as the US, China, India, and Turkey.
As pharmaceutical product regulations change, so does the threat of an increase in coding errors
As pharmaceutical product regulations change, so does the threat of an increase in coding errors, compounded by other marking challenges that can be a source of frustration and can slow down the speed and productivity of packaging operations. This is because in addition to improved marking legibility requirements, increases in variable data to code and faster production lines, manufacturers also have to find solutions to accommodate new flexible packaging coming to the market, which presents its own challenges.
As a result, manufacturers came under pressure to apply barcode labels onto all pharmaceutical goods being supplied to retail outlets, including outer casing. Historically, when it came to applying labels onto outer cases, manufacturers would either pre-print labels offline from a print room and apply them by hand or use a traditional labelling machine. Subsequently, they started using specially built applicator systems, taking labels from a desktop printer and automatically applying them to the cartons.
The evolution from manual to automated application of labels resulted in a complex piece of machinery
The evolution from manual to automated application of labels resulted in a complex piece of machinery incorporating the actual labelling machine with an unwind/rewind assembly, a separate print engine inserted into the base of the system and a label applicator – as such, the first Print and Apply Labelling (LPA) system was invented. However, LPA systems had problems as the technology necessitated constant manual adjustments due to either machine parts breaking down or labels being spoiled, misaligned or stuck in the machinery. This resulted in a high level of unscheduled downtime, frustration among operators and loss of production time and cost.
More than two decades later, pharmaceutical production managers are still facing pressure to reduce operational costs and improve productivity and efficiency. Manufacturers not only have to juggle the requirements of their supply chain partners but they must also comply with local and international coding, labelling, and pharmaceutical safety standards and regulations. In the outer casing industry, for example, legible information and unique codes have to be printed on every outer package for traceability purposes.
The foundations of LPA design haven’t changed since their inception despite the huge progress made in modern technology and significant design improvements which have been missing to reduce downtime and improve coding quality at high throughput rates.
With so much pressure to maximise productivity, reduce operational costs and improve business growth, pressure on pharmaceutical manufacturers will intensify. In the next article, the specific needs of the pharmaceutical industry are explored.
Ondrej Kruk is a Business Unit Manager at Videojet Technologies. His main responsibility at the company is the global commercial leadership of the Print and Apply Labeling (LPA), Large Character Marking (LCM) and software business units. Kruk has 10 years of business experience, four of them in the product identification and digital printing industry. In his previous role, as global manager of the Product Decoration Business at Videojet, he was able to turn a North American business unit into a global business by leveraging the capabilities of an industrial technology to revitalise a product category in the consumer goods market. Prior to Videojet, he was an Associate at A T Kearney, a global management consulting firm.