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Pharmaceutical Manufacturing and Packing Sourcer

Look to the Future

The Falsified Medicines Directive (FMD) introduces the requirements for the outer packaging of certain medicines to include unspecified safety features, which allow wholesale distributors – and others who supply and dispense medicines to the public – to verify the authenticity of the medicine by looking at an independently resourced and populated repository of information. The directive provides for safety features comprising of a tamper-evident seal on the outer packaging and a unique identifier to be applied to certain categories of medicines; this will enable the authenticity of individual packs to be verified.

The directive states that these features must be applied – in principle – to all prescription-only medicines and to nonprescription medicines if they are at risk of counterfeiting. The exact nature of the safety features – including their characteristics and technical specifications – will be decided by the European Commission in separate legislation under a delegated act.

European Stakeholder Model

In response to this anticipated delegated act, the European Stakeholder Model (ESM) – a partnership of organisations involved in the pharmaceutical supply chain – has emerged. These companies have joined forces to develop a safe, costeffective and partnership-based pan-European medicines verification system to combat falsified medicines and ensure patient safety.

Faced with the growing and substantial threat of falsified medicines penetrating the European market, the ESM has developed an end-to-end medicine verification solution, which allows tracking and verification of medicines down to pack level from the point of manufacture, through the supply chain and to the point of being dispensed. The tracking and verification down to pack level will require the unprecedented use of a unique pack identification system. This means that individual medicine packs will be uniquely identifiable through the use of a randomised serial number. The verification system plays a pivotal role in aiding manufacturers to adhere to the 2011 EU FMD, which requires them to apply safety features to verify the authenticity and identity of individual packs of medication – due to become mandatory by 2017.

To drive implementation of the FMD, a consultation has been undertaken to define the characteristics and specifications of a unique authentic pack identifier. While these findings, which will come under the aforementioned delegated act, are not anticipated until later in 2014, it is predicted to include the adoption of a data matrix barcode, based on international standards for interoperability across the EU. Furthermore, the verification system proposed by the ESM features a data matrix code carrying four key data elements – manufacturer product code, randomised unique serial number, expiry date and batch number – which will also be required in a human readable format. The definitive way to read and verify this system is through machine vision.

Machine Vision
While machine vision is now widely used across pharma manufacturing facilities, it is often considered a ‘safeguard’ approach with regard to printed code verification, and as an alternative to periodic manual inspection of printed code quality and integrity. On adoption of the new legislative requirements, machine vision for printed human-readable code and barcode verification will need to be considered as more of an integral and essential part of the manufacturing process. It will become a prerequisite that the unique serialised numbers for individual packs will need to be stored in a central data repository. The integrity of the data held in this repository would be significantly affected by any printing errors or data management discrepancies. The importance of machine vision to identify such errors is significant, reducing the impact of releasing non-conforming packs into the supply chain and eliminating complications during the dispensing process.

Traditionally, human-readable codes and data encoded within barcodes have remained fixed between batch runs of pharmaceutical products. The significant challenge arising from the proposed ESM system is with regard to data management of the randomised unique serial number, and the synchronisation of data between the printing device and verification solution. Verification systems, which operate on fixed and repetitive data fields, require no synchronisation, as the vision system is effectively verifying the same data on each pack. The utilisation of unique serial numbers adds additional complication, as each pack essentially carries different information.

It is therefore imperative that the printing device and vision system are synchronised, to ensure the correct data is being verified for the specific pack. While in the vast majority of cases, this can be handled through specialised software, in some cases it will require additional mechanical handling of product, to ensure synchronisation is maintained.

Software Solutions
Industrial PC technology can provide vision solutions with the flexibility to cope with a wide range of data management requirements, allowing interfacing with third-party devices such as printers and control systems. High-level production management software can request the data required to verify the unique serial number, whether through database integration or simple manipulation of .csv data files.

A variety of vision inspection systems are available which offer printed text inspection and barcode verification. Omron’s Xpectia range, for example, is built upon well-established software algorithms to provide robust and reliable text and barcode verification solutions. Customisable, intuitive user interfaces and simple operational feedback aim to offer a new era of usability.

Pack Design
In addition to the unique coding requirement stipulated by the FMD, it will also be necessary to provide specific packaging safety features with regard to visual confirmation of the pack integrity. The design of future packaging media will need to be carefully considered to incorporate these tamper-evident safety features. The variation in packaging design and form for pharmaceutical products is considerable, including cartons, bottles, vials and many more. Each form will require a unique solution to ensure the tamper-evident safety function is achieved.

Once again, machine vision can play an important role in inspecting conformance with this requirement. By necessity, these safety features will be fragile, in order to provide visual identification of any tampering attempts on the product. Machine vision can be used to detect the correct application, or any damage, of the tamper-evident safety feature caused by the mechanical handling of products during production. The flexibility of machine vision, with respect to optical inspection, provides an ideal platform to inspect for all conceivable safety features. Automated inspection will undoubtedly reduce the impact of non-conforming products reaching the supply chain, eliminating issues during the final dispensing process.

Looking Ahead

Although the final details of the delegated act have yet to be formalised, forward-thinking, flexible technology platforms will allow manufacturers to adapt to changing market requirements by remaining compliant and, ultimately, ensuring patient safety.

The ability to meet the requirements of the FMD is imperative for pharma manufacturers, and upgrading machine vision systems to meet these requirements is an essential step in the process. The direction and shape of the post-2017 EU pharma supply chain is clear – if these changes are not acted upon, there is a real danger that some companies will not be able to trade in Europe.

Omron Electronics will be showcasing a wide range of machine vision solutions during the upcoming PPMA Show between 30 September and 2 October in Birmingham, UK. A range of dynamic demonstrations will be on display to highlight solutions for barcode and text verification, as well as a range of flexible product feature inspection solutions. For more information on the PPMA Show 2014, please visit or join the conversation on Twitter @PPMAshow

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Daniel Rossek is Sensing, Safety and Machine Vision Product Marketing Manager for Omron Electronics, a global service provider in the industrial automation technology sector. He has a BEng in Manufacturing Systems Engineering and over 15 years’ experience developing and applying machine vision technologies into industrial applications. Daniel began his career as a fieldbased vision application engineer and is now part of Omron’s global product management team, developing product propositions for strategic target markets.

Daniel Rossek
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