The European Falsified Medicines Directive continues to make waves in the pharmaceutical industry. Prescription drugs must have labelling that is completely traceable. For manufacturers, this means major upheavals in production. Track & Trace systems, such as the one from WIPOTEC-OCS, are in demand. The AP05 position indicator from SIKO GmbH, a specialist in industrial measurement and drive technology, is a useful component that further increases the process reliability of track & trace systems during format changes. A user report.
The introduction and start date of the new anti-counterfeiting directive have been known since 2016, but it was only in the last few months before it came into force that the market for corresponding „Track & Trace“ systems gained momentum. WIPOTEC-OCS, which specialises in weighing and inspection solutions including mechanical engineering for processes such as printing, reading and labelling, can only confirm this development:
„There is currently a huge pull in the market. Every company that has been producing and marketing prescription drugs since February must be able to guarantee the serialisation of medicines and have a track & trace solution integrated into their production line. Systems that can be integrated into the production line quickly and without major effort and that do not unnecessarily slow down the production process and thus impair production efficiency too much are helpful„
Daniel Anders, Product Manager Track & Trace at WIPOTEC-OCS.
With TQS, WIPOTEC-OCS has established a system for the pharmaceutical sector that is highly modular and any country-specific features in the labelling of medicines. Serialisation involves the possible process steps Printing, reading, labelling and weighing, which the TQS-HC-A machine combines. It is designed for folding cartons, which make up at least 90 per cent of medicine packaging on the European market. They are labelled on the front and/or back, optionally also on the top, and finally with a high-tech load cell WIPOTEC weighs the boxes with high precision in order to recognise whether they are fully loaded. Faulty products are automatically sorted out. If required, tamper-evident labels can also be applied to seal the packaging in a tamper-proof manner.
(Image: SIKO GmbH, Christian Fischer)
Given the often long production lines, it is important for pharmaceutical customers to have a track & trace solution that is as compact and unobtrusive as possible. In fact, the new European directive initially means high investments and the tying up of resources for pharmaceutical manufacturers. „There is no demand for a complicated system that additionally hinders processes,“ says Daniel Anders. „Acceptance on the part of the pharmaceutical industry is much greater if Track & Trace machines fit smoothly into the overall concept - and if there is an additional benefit from the expansion.“ Ultimately, a track & trace machine can simplify processes. For example, the data collected can be used to Merchandise management much easier and more convenient design. „Pharmacists will certainly only gradually become aware of these benefits once the changeover due to the new directive has been fully implemented and everything has settled down. Then it will no longer just be a prescribed measure, but manufacturers will also see the benefits for their own production.“
Monitored format change with SIKO display
A small but extremely important component on the machine provides additional Advantages for „inconspicuousness“ in the complete line: the AP05 position indicators from SIKO for a monitored format changeover, which can be used as an option. An optimised format changeover helps to facilitate batch changeovers between different pack sizes. The trend is towards smaller batches, i.e. more frequent changeovers. This means that all units usually have to be adjusted with two axes. Up to 13 SIKO displays can be installed in a TQS-HC-A. Good if these adjustments Fast, controlled and reliable can be realised.
The electronic AP05 displays are bus-compatible and can be integrated into the machine control system. From here, the new target values for the next folding carton size (which are stored in the machine control system in a recipe list for each product) are transmitted to the position indicator, which appears in its display below the current actual value. If the actual and target values match, the integrated LED lights on the position indicator switch to green. Otherwise, the LED lights up red - position not yet reached. Only when all LED indicators light up green is the machine ready for operation again, and only then can production operations be resumed with process reliability. This means that incorrect settings no longer occur. The operator can clearly see from the LED lights which adjustment points still need to be adjusted. This prevents rejects and increases process reliability. „The reliable reproducibility of the settings is important to us,“ says Daniel Anders, „so that every batch, every product receives the same precise coding and, if necessary, sealing as the previous one. The AP05 guarantees this. Another advantage: thanks to the SIKO AP05 position indicator, changeover times are minimised with a monitored Format changeover much shorter and therefore more efficient.“ This means that the drug manufacturer does not have to worry too much about this secondary process, but can instead focus on the complex line clearance and documentation required in the pharmaceutical sector for quality and safety reasons, for example.
(Image: SIKO GmbH, Christian Fischer)
Customer request for more process reliability
Until now, the TQS machines from WIPOTEC-OCS were equipped with mechanical position indicators from SIKO as standard to indicate the actual position of the axes. The monitored electronic version AP05 is compatible and can therefore be retrofitted at any time. become. The first installation of the electronic SIKO displays on the TQS-HC-A was initiated by a customer request.
„Our orange-coloured SIKO counters have been in use at WIPOTEC-OCS right from the start. When a pharmaceutical customer asked WIPOTEC for a reliable solution for the format changeover, we were delighted that the people in charge approached us straight away to realise the customer's request together with us.“
Moritz Müller, Product Manager PositionLine at SIKO
The newly equipped TQS-HC-A machines quickly convinced other WIPOTEC customers of the benefits of electronic position indicators. The reproducibility of the settings, process reliability to avoid rejects and damage to the machines, as well as a reduction in set-up times justify the initially higher investment compared to the standard mechanical version. Moritz Müller is convinced: „Once the biggest changes have been made, even more pharmaceutical manufacturers will return to the benefits of a guided and reliable format changeover. Retrofitting is possible at any time.“
Source: SIKO GmbH
