RF Compliance Takes The Complexity Out Of Serialisation

3 mins

Rotech team

The RF Compliance coding system allows pharmaceutical manufacturers to comply the FMD (Falsified Medicines Directive).

With the ability to generate, print and verify serialised 2D codes on cartons, the RF Compliance offers an instant, reliable and easy-to-use solution for pharmaceutical manufacturers who need to meet the 2019 FMD deadline. As an offline (or “near line”) system, the system allows for batches of cartons to be pre-printed – particularly useful for small batch runs or where product is hand packed. Furthermore, with cartons being presented to the printer under ideal conditions a perfect print will be made each time.


What is the FMD?

The Falsified Medicines Directive (FMD) aimed at reducing the number of counterfeit medicines infiltrating the legal pharmaceutical supply chain within Europe, was transposed into UK law in 2013.

Once implemented, the regulation will require individual packs to be serialised via unique codes encrypted in machine readable 2D datamatrix codes. Manufacturers who fail to meet this deadline will have to withdraw their products from the European market.


The challenge manufacturers face

Pharmaceutical manufacturers are all too aware of the need to comply with FMD; the challenge they face is how. The complexity of some of solutions is daunting not just from an integration and operational point of view, but also because of the cost. Our aim, in engineering this system was to make it much simpler. The RF Compliance is an easy-to-use, 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, combining the modularity and automatic stack-to-stack feeding technology of the first generation coder with a state-of-the-art chassis and advanced controls that enable integrated printing, serialisation and inspection.

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 inspects the barcode, OCR text and pharmacode. Linking all of these processes allows for maximum efficiency and ensures each pack is fully compliant.

FMD- Falsified Medical Records Infographic

Taking the process offline

Whilst many inline coders are capable of reliably producing readable 2D codes, there are several arguments for taking the process offline.

Firstly, datamatrix barcoding requires near perfect presentation of a carton to the printer to achieve the highest verification grade. “Accurate 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  datamatrix codes at high speeds can compromise line efficiency. Offline systems such as the RF Compliance offer a way of complying with the new legislation without impacting production.

“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 operation.

A complete solution

The RF Compliance comes complete with a full validation package, a 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.

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