Being Attentive - When it comes to packaging sterile medical supplies, particularly stringent quality and safety regulations apply. To begin with, the labels have to be country-specific and language-specific, which requires a considerable amount of effort, and mistakes are even less tolerable than anywhere else. Fulfilling these wide-ranging technical packaging demands requires flexibility and stable controls in the packaging line.

Printed boxes and blister packs, patient information sheets in the various languages, compliance with legal documentation requirements, batch identification for traceability: In no other industry is the "printing appara-tus" as extensive and as important as for packaging solutions for drug products and sterile medical supplies. The labeling systems - from adhesive labels and direct printing on blister foil to laser coding for applying batch numbers and expiration dates - are a key element of the overall process and thus have a major influence on cycle times and costs. Above all, however, this type of legally compliant labeling leads to a steady reduction in batch sizes, especially when it comes to properly serving smaller markets. At the same time customers expect shorter delivery times to enable them to minimize their inventory levels.

Increasingly Protracted Changeover Times

Diminishing batch sizes arising from country-specific and customer-specific (labeling) requirements result in an increased demand for flexible delivery and print systems in order for the packaging lines used for medical sup-plies to be operated with optimal processing and cost efficiency. For instance, small batch sizes soon lead to inefficient process results if all the components of a packaging line are connected in series one after another in the conventional manner. The ratio of setup time to run time becomes disproportionate in such cases. If the same range of medical products has to be packed in blister packs for 20 or 30 European countries on a single packaging line with different labeling for each country, for example, then it does not take much to work out that with a conventional line configuration the changeover times will far exceed the run times. Line efficiency can fall below 30% in some cases, since the changeover process is not simply a matter of flicking a switch. It involves a whole series of activities, from cleaning and inspection of the line for residues, installation of the new (print) module, right through to documentation of all these activities.
One way round the time and cost dilemma outlined above is to reorganize individual sub-processes. The label-ing process in particular lends itself to this, because it is here that most of the customer-specific adaptations are required. Nevertheless, it is of course important not to overlook the many common aspects within the overall process. It stands to reason, therefore, to first work through these common aspects - for example, placing the medical contents in a thermoformed tray or blister pack - and then applying the labels later. This results in more cost-efficient batch sizes for large parts of the overall process.

Late-Stage Customization

By separating out some of the process elements, sub-processes for different batches can be bundled together, thus reducing setup times. To give a specific example, the blister packing, cartoning and printing processes can all be carried out quite separately. Bundling batches for different countries and then separating them again afterwards introduces the possibility of late stage customization, where packaging is customized at the last possible moment.
A handling module is required for this solution to store the bundled blister packs containing the various coun-try-specific batches - which are identified by machine-readable country codes - on a temporary basis and then transfer them to the identification unit when required. It goes without saying that the correct country settings must always be available, but this type of configuration change is far quicker and more economical than con-tinually resetting the entire packaging line.

Labeling System to Ensure Safety

Late stage customization not only brings about a clear improvement in cost structures for the packaging of medical supplies by increasing machine run times, but it is also a flexible just-in-time component within the packaging process as a whole which can be tailored very precisely to customer needs. The "identification" sub-process can be further optimized by using a direct printing system. This avoids the cost of stocking preprinted labeling materials. There will be virtually no effect on the print result, as the quality of direct printing systems is rapidly catching up with that of label printing systems.
The separation strategy combines the advantages of fully automatic packaging lines with the flexibility of a modular architecture. It is therefore only possible with manufacturers who can offer a seamless, yet modular integration of packaging machines, handling modules and inspection and labeling systems. The latter in particu-lar play a key role in medical applications, because the respective labeling formats themselves, for example, 2D matrix and RFID, also guarantee safety in partly separated systems as required by standards such as EN ISO 15378 (primary packaging materials in the medical and pharmaceuticals industry) and ISO 11607 (packaging of sterile medical supplies).

Automation Networks from a Single Source

Given the additional complexity of packaging lines with late-stage customization, it goes without saying that the more components that are procured from a single manufacturer, the easier the integration of the individ-ual modules will be. The added advantage for the line operator is that he or she only has to deal with one single contact, who is responsible for the project and its successful implementation and who has a detailed under-standing of the individual system components.
Thanks to a standard control system for the entire line using an industrial PC, a well integrated solution will mean that there are much fewer interfaces to control. This simplifies the running of the line and reduces train-ing and operating costs. What's more, the supplier of the integrated packaging line can create a standard vali-dation document, saving the line operator a lot of work.
Multivac demonstrated how the labeling unit closely interacts with the entire packaging line at the Achema last year. The centerpiece of the packaging line set up there was the R 245 thermoformer. An H 130 handling mod-ule was used to load the machine. The packaging machine was fitted with a direct printing system by Multivac's subsidiary MR Etikettiertechnik for online labeling. The new Multivac Vision System (MVS) for visual inspection ensures quality control, as it is optimized for the high-speed inspection of objects and surfaces and for checking completeness and accuracy in the Pick & Place area and in the final line inspection. All the components, be they connected in series or in parallel, combine to form a packaging chain in which each element interfaces safely and reliably with the next, not least thanks to the standard IPC05 industrial control.