Craig Stobie, the Global life sciences sector manager at Domino Printing Sciences plc, discusses how complex coding applications require a holistic approach involving end users, OEMs and equipment suppliers.
The CIP-13 legislation that came into force in France at the start of 2011 requires external packaging of every pharmaceutical product to carry much more information than before:
- A data-matrix bar code made up of the 13-digit CIP-13 code plus three lines of human-readable text: the CIP-13 code, batch number and expiration date.
- Prescribed drugs must also carry a preprinted vignette sticker to facilitate reimbursements.
CIP-13 is a sign of things to come. In future we will see much more such legislation, as a glance at other markets illustrates: Turkey's ITS scheme, which is already in force, and the proposed pan-European EFPIA scheme both combine a data matrix code with four lines of human-readable text, the former to facilitate simple serialisation, the latter for more complex serialisation. The recently-ratified EU Falsified Medicines Directive also points in this direction, decreeing that within three years all pharmaceutical packaging must incorporate a unique pack identifier.
Of the currently-installed coding devices, significant numbers are not compatible with the new legislation, so the clock is now ticking for manufacturers who have not yet updated their lines to meet French or Turkish requirements. Updating packaging lines to conform to new regulations calls for close co-operation between end users and equipment suppliers to ensure compliance, performance and a long service life. When equipment is supplied under an OEM agreement — as is generally the case for new lines — the relationship between the manufacturers of all equipment (host machine, coding and inspection devices) and the end user makes managing the project even more important. So what should you bear in mind to guarantee a smooth transition and minimal downtime?
Reassuringly, the first thing to realise is that the coding and packaging industries have considerable experience of OEM relationships and know what to do and what not to do. As integration between packaging and coding specialisations has become more technically sophisticated, OEM agreements enable companies to incorporate the best technology into their systems without developing it themselves from the ground up. Unlike OEM deals involving off-the-shelf products — a re-badging agreement between two PC suppliers, for example — all parties recognise that the OEM arrangement is more than simply a channel to market with a simple buyer/seller dynamic, but a three-way relationship in which a third party, the end user, produces the profits. Like a stool, it needs all three legs to work.
This makes understanding and co-ordinating the interests and capabilities of the three parties fundamental to the health of an OEM relationship, so from the outset you need to establish who is in charge; in other words, who will receive the telephone call if a problem arises? It is especially important when the project involves installing a whole new system rather than simply retrofitting an enhancement. Will the OEM partner take full responsibility for specifying and delivering a fully-functioning system? Or will they subcontract validation and installation to the manufacturer of the equipment, who will take responsibility for key stages such as Factory Acceptance Testing (at the OEM) and Site Acceptance Testing (at the customer)?
Whoever takes ultimate responsibility must appreciate the holistic nature of a complex project. How important this is was brought home to Domino recently during a thorough evaluation of exactly what services the company provides. The exercise — which gave rise, among other things, to the company's new Do more initiative — confirmed that complex integration and technical expertise is at least as important as product installation and maintenance, and that much of our role involves 'innovating at the customer interface' and engineering local solutions to problems on site.
Implementing a holistic approach
In practice, this means identifying the different factors that influence a project and understanding how they interact. Taking the CIP-13 regulations as an example, it brings together IT, materials science, packaging design and coding technology. Where serialisation is required, a unique tracking number needs not only to be generated and printed on each pack, but also scanned to verify its readability. The information is more comprehensive, and its presentation more sophisticated, which impacts on the physical design of the label, the choice of coding technology and its suitability for the packaging materials involved. Even in less complex applications, a number of factors must be taken into account to ensure that packaging performs its dual role of physically protecting the product (through the right choice of materials) and protecting the brand itself (through measures to prevent counterfeiting or increase shelf appeal).
The holistic approach involves, and is the product of, other factors that make for a successful OEM relationship. Experience is crucial, of course, because the more experience each party has, both as individual companies and as a partnership, the more likely they are to have encountered and solved any problems previously. Technical resources likewise; you need to be confident that as well as possessing expertise they have the engineers to apply it. Training is also important - a major change to production such as CIP-13 calls for the workforce to gain new skills.
Follow the link to read more about the initiative known as 'Domino. Do More'.