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RF Compliance Takes The Complexity Out Of Serialisation

1st December 2017

Offline coding and marking specialist Rotech has launched a new generation coding system for pharmaceutical manufacturers looking to ensure compliance with the FMD (Falsified Medicines Directive).

With the ability to generate, print and verify serialised 2D codes on cartons, the RF Compliance offers an instant, simple and reliable solution for pharmaceutical manufacturers who are wondering how to meet the 2019 FMD deadline.

The FMD, aimed at reducing the number of falsified medicines infiltrating the legal pharmaceutical supply chain within Europe, was transposed into UK law in 2013.

Once implemented in February 2019, the regulation will require the serialisation of individual pharmaceutical packs, via unique codes encrypted in machine readable 2D datamatrix codes. Manufacturers failing to comply with the directive will have to withdraw their products from the European market.

“Pharmaceutical manufacturers are all too aware of the need to comply with FMD; the challenge they face is how to comply. The complexity of some of the available online solutions is daunting not just from an integration and operational point of view, but also because of the cost involved. Our aim, in engineering this latest system, was to take the headache out of compliance. The RF Compliance is an easy-to-operate, stand-alone system that doesn’t interfere with production or compromise line efficiency,” says Richard Pether, Director at Rotech.

The RF Compliance succeeds Rotech’s RF1 Pharma system, combining the modularity and automatic stack-to-stack feeding technology of the first generation offline coder with a state-of-the-art chassis and advanced controls that enable integrated printing, serialisation and inspection capabilities.

“Essentially, the system generates a unique code for each pack and transmits the codes to the printer on a carton-by-carton basis. Immediately after printing, an integrated camera automatically inspects the datamatrix barcode, OCR text and pharmacode. Linking all of these processes allows for maximum efficiency and ensures each individual pack is fully compliant.

Whilst in theory most modern inline coders are capable of reliably producing readable 2D codes, in practice, there are several compelling arguments for taking the process offline.

Firstly, datamatrix barcoding requires near perfect presentation of a carton to the printer in order to achieve the highest verification grade. “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,” says Richard.

Secondly, integrating into the line a coding station that can print and verify complex datamatrix codes at high speeds can compromise line efficiency. Offline overprinting systems such as the RF Compliance offer a way of complying with the new legislation without impacting the production line.

“By taking this process offline, the cartons are brought to the line ready printed and inspected, eliminating any delays due to coding issues,” says Richard.

Thirdly, whilst continuous inkjet (CIJ) is the printing technology of choice when coding online, the reality is that many CIJ coders struggle to consistently produce 2D codes that meet the ISO/IEC 15415 quality specification. The RF Compliance is supplied as standard with a thermal inkjet (TIJ) printer for superior print quality and simple, no-mess operation.

A prototype of the RF Compliance was previewed at this year’s PPMA, and now Rotech is scaling up production of this high specification machine.

The RF Compliance comes complete with a full validation package, an inline diverter-flap reject system for automatic removal of reject cartons 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. Operator control is via a 12 inch Siemens HMI and the electrical panel is incorporated within the main machine for easy access.

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 60x70mm up to 350x350mm.