Item-level serialisation and the race for compliance
The pharmaceutical industry is grappling with its biggest ever legislative shakeup. It will soon be a legal requirement for pharmaceutical manufacturers to make sure every bottle and pack of prescribed medication carries its own unique machine-readable code. This legislation applies to all EU countries plus Iceland, Norway, Switzerland and Liechtenstein. The deadline to reach full compliance is tabled for early 2019 – although this will be slightly later in Belgium, Italy and Greece.
Each bottle or pack of medication must be assigned its own unique identity that is traceable throughout the supply chain – from production line to patient. The unique identifier proposed by the Delegated Act for packaging is a 2D barcode carrying a serial number, product code, batch number, expiry date and an optional national reimbursement number when required. The legislation affects prescription medication only.
For the full lowdown, we recommend our short guide:
A complete guide to item-level serialisation in the pharma industry
Introducing thermal inkjet technology
Thermal inkjet is a digital coding technology that uses electrical heat to eject ink droplets and apply them to a substrate. It’s incredibly clean, fast and easy to use. Replacing ink cartridges is straightforward and you can achieve extremely high production line speeds without compromising the integrity of your coding quality.
Why is thermal inkjet so good for the pharmaceutical industry?
Speed is absolutely crucial on pharmaceutical production lines. Reducing your throughput can have a significant impact on your bottom line, while avoiding downtime is business-critical. With Domino’s G-Series range of thermal inkjet printers, production interruptions are a thing of the past. You can apply unique codes – repeat, unique codes – to up to 600 products per minute. All common 1D and 2D code formats including GS1 codes and China Code 128 are supported.
Razor sharp ink clarity, with rapid drying times
We have developed a regulation-compliant ink especially for the pharmaceutical industry. It’s called BK652 and independent reports have proven its light-fastness to be significantly above the two year industry standard. What’s more it dries in around half a second. That means you end up with high-contrast, scratch resistant codes that last for the full lifespan of your product – minimising the number of false rejects produced by machine vision systems.
Are you ready for item-level serialisation?
The move to item-level serialisation is a major operational challenge. For pharmaceutical manufacturers and packagers it means new protocols, new coding equipment and a new way of running your business. As you might expect, manufacturers across Europe are at wildly differing stages of adoption. Some are pilot testing new equipment, others are still at the research stage.
Making your move early and adopting new technology for compliance with item-level serialisation legislation is a great way to get ahead of the curve, minimising stress and operational disruption down the line. Are you ready to get started? If you would like to discuss your requirements, please contact our coding specialists for a no-obligation discussion.