It’s time to get compliant: Three considerations when choosing a serialisation solution for your factory
27th October, 2016
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The pharmaceutical industry is one of the most heavily regulated, with new requirements continually being introduced. The upcoming European Falsified Medicines Directive (FMD) is the latest high-profile piece of legislation in the EU, but with many companies also operating in the wider global market, the specific demands of individual countries also need to be taken into consideration.
With the wide variety of equipment and operating software available, companies face a myriad of choices in selecting the most appropriate solution for their particular requirements. Our team of technical experts list the key factors that must be considered when implementing a fully compliant coding solution.
The capability of your equipment
In terms of the actual performance of each coder, it is vital that the machines are able to process and output the data quickly enough to keep up with the overall speed of the packing line. Clearly this is a necessary requirement for direct printing but it has particular implications for print and apply label operations.
For serialisation to be guaranteed in the print and apply process, the label needs to be applied to the pack immediately after it is printed – what is commonly known as ‘last label’ capability. Unlike the ICE Vulcan which is designed to print at a speed which matches the packaging line without ever missing a pack, regardless of line throughput, build back and pack size, some labelling systems demand that a number of labels are printed into a reservoir between the print engine and the point of application. As a result, the operating software will have to be adjusted to take this into account, which adds to the complexity of product and batch changes and increases the risk of errors.
The versatility of your design and networking software
Each coder must be able to produce a wholly transparent ‘audit trail’ – this provides confirmation of what the coder did at any particular time, how this was implemented, and who carried out the task.
Coder networking software such as CLARiNET allows important data to be transferred easily throughout the packing and distribution operation so that it is highly accessible for inclusion into any reporting procedures.
The strength and reliability of your support network
With most companies operating across many countries and continents, it is vital that their coding partner can offer the appropriate levels of support in every region.
Fast response will be critical since any downtime to the coder will have a hugely detrimental effect on production. It is also important that the service provider has the fullest levels of knowledge about the entire coding system so that the operation is able to function consistently and reliably and that all software is fully supported.
The advantages of common platforms and operating systems, such as those offered by ICE, are also apparent when considering support. Common platforms across different systems and print technologies increase familiarity and confidence for both operators and engineers.
Multilingual systems with good diagnostics and the facility for remote diagnostics, data archiving and parameter cloning have been shown to have a significant impact on downtime and error reduction.
Here at ICE, we offer comprehensive training days at our head office in Nottingham, to ensure that operators can get the most out of the advanced technology built into our printers and software, in order to improve line efficiency.
The application of accurate legible variable data is critical to the quality and traceability of a pharmaceutical product and whilst serialisation has increased the complexity of the process, the basic requirements remain the same.
If implemented effectively serialisation should have no negative impact on productivity or manufacturing costs. In fact, it is possible to use the requirement to strengthen existing processes and provide efficiency gains and ROI justifications comparable to those used when seeking general productivity improvements.
To find out more about our Print and Apply labelling solutions, visit the ICE Vulcan product page, to learn more about our suite of label printing software products, visit the CLARiSUITE software page or call us on 01159 640144.