Rotech RF1 to the rescue for non-compliant 2D codes

The Falsified Medicines Directive (FMD), aimed at reducing the number of falsified medicines infiltrating the legal pharmaceutical supply chain within Europe, was implemented in 2011. From 2016 onwards manufacturers failing to comply with the directive will have to withdraw their products from the European market. A core requirement of the legislation is the serialisation of individual pharmaceutical packs, via unique codes encrypted in machine readable 2D datamatrix codes.

Richard Pether, Director at Rotech says: "This increases the burden on pharmaceutical manufacturers when it comes to coding cartons, as they have to print and verify complex datamatrix codes at high speeds, which is no mean feat. Integrating into the line a coding station that can transport the filled carton, print and inspect the code and reject problem packs can compromise line efficiency."

Whilst in theory most modern inline coders are capable of reliably producing readable 2D codes, in reality, this is not always the case. Richard Pether says: "Manufacturers are typically finding that continuous ink jets (CIJs) are not up to the challenge, because they struggle to consistently produce 2D codes that meet the ISO/IEC 15415 quality specification."

Even where manufacturers are using thermal inkjet printers (TIJs), datamatrix barcoding requires near-perfect presentation of a carton to the printer in order to achieve the highest verification grade. Richard notes: "Accurate carton feeding is crucial to consistent print quality, and with an online system, the necessary accuracy will rarely be achieved without the addition of an extra line element that controls the carton during print and inspection. This can have serious space implications and revalidation issues."

For many pharmaceutical operations, the answer to these issues could lie in Rotech's RF1 Pharma system, a modular system that incorporates printing, labelling (if required) and inspection with Rotech's automatic stack-to-stack feeding technology at its core.

Complying with legislation

Richard says: "Companies are coming to us because they see this as a way of complying with the new legislation without impacting the production line. We have already supplied multiple RF1 Pharma systems into the pharmaceutical industry worldwide."

One of these systems was supplied to multinational generics and OTC manufacturer PharmaSwiss for its Belgrade factory in Serbia. The company says:"The Rotech RF1 is a unique solution for pharmaceutical printing. This was the only machine that met all requirements."

Several South Korean pharmaceutical businesses, among them Kun Wha Pharmaceutical Co, Kolmar Pharmaceutical and Yu Yu Pharma, have also invested in RF1 Pharma systems from Rotech. Kun Wha describes the machine as "a high performance system for GS1 datamatrix serialisation", whilst Kolmar Pharmaceutical praises its ease of use, saying "it is simple to set up with one sensor controlling everything."

Offline overprinting systems come into their own where a large amount of text is required or the print is required to meet an exacting standard, such as the 2D datamatrix code on a pharmaceutical carton. By taking this process offline, the cartons are brought to the line ready printed and inspected, eliminating any delays due to coding issues. The potential for rejects is reduced because the carton can be presented to the printer in the most favourable orientation.

The RF1 Pharma is the highest specification machine in Rotech's RF1 range, and is fitted, as standard, with an inline diverter-flap reject system for automatic removal of reject cartons, advanced carton tracking software and a shingling (accumulation) conveyor to maintain high throughput. Integral inspection of printed information and pharmacode verifies that datamatrix codes and human readable information such as expiry dates and lot codes are correct. The flexible system can code onto a range of pharmaceutical packaging formats, including cartons, wallets, sleeves and crash-lock cartons, at speeds of up to 200 packs per minute. It can handle pack sizes from 60×70mm up to 350×350mm.

Depending on the application, the system can be fitted with either a thermal inkjet or a thermal transfer printer. In some scenarios, a system incorporating both technologies may be configured, as Richard explains: "We've had customers who wanted thermal inkjet for printing on the flap of a carton, which is a matte, varnish-free surface, yet wanted thermal transfer for coding the main body of the pack, which is a smooth, glossy surface. The RF1 is designed in such a way that it is flexible enough to accommodate both printing technologies."

To learn more about the RF1 Pharma system, please visit www.rotechmachines.com.