Flexible and foolproof
Versatility was essential on a Croatian job for German packaging specialist Kugler

As one of central Europe’s leading pharmaceutical manufacturers,Croatian company Belupo wanted the best from its new packaging line. German packaging specialist Kugler obliged with a highly flexible “multitasking” design.

Belupo is the second-largest manufacturer of pharmaceuticals in Croatia, and the country’s leading manufacturer of drugs for the cardiovascular system and dermatology. Manufacturing and sales of pharmaceutical preparations and cosmetics are the company’s core activities.
Based in Koprivnica, Belupo will be 33 years old at the end of 2004, but this joint-stock (d.d.) company has a very modern outlook. In its organization and working methods Belupo follows the latest business trends in both domestic and foreign markets. Continuous emphasis on strategic development and exports, quality assurance and quality control systems, professional training for its employees and investment in manufacturing technology have all helped to make Belupo one of the leading manufacturers of pharmaceuticals in central and south-eastern Europe.
Strong demand for existing drugs and planned product launches required Belupo to build a new filling line for liquid and semi-liquid dermatological products. It was essential that the new line should be extremely flexible, as well as operating to the highest standards of quality and safety. The company turned to Kugler, a business unit of the German Optima Packaging Group, as a specialist turnkey supplier. To Kugler, flexibility is not just a buzzword: the new line can fill volumes of 1 ml to 1,000 ml and handle all standard closure types. At the moment it is used for product volumes of 10–500 ml in both glass and plastic bottles, but its modular design will allow Belupo to change products and packaging types at any time in the future. With its integrated weighing stations, the new line offers 100% in-process inspection according to CFR 21 Part 11.

100 percent in-process inspection
At the beginning of the packaging line is a turntable onto which the containers are loaded. Next, a Kugler rinsing machine maintains the cGMP-certified hygiene characteristics of the primary packaging area. The containers are turned upside down and air-rinsed. The exhaust air, along with any possible contamination, is removed from the bottleneck, and plastic bottles are additionally deionized to eliminate static charge. Next is the Kugler Linoline linear filling and capping machine, which operates with a two-step conveyor rake. Before filling, the bottles are weighed on a tare weigher. Next, the filling itself is carried out in two time-saving steps of 50 percent each. A second weighing completes the filling process and allows the control system to check and optimize the filling volume. The dosing accuracy is 60.1 percent.
After filling, each container needs to be closed with a stopper or spray pump, depending on the product. Since the dip tubes of the spray pumps have a tendency to coil, the capping machine draws them straight before fitting them to the container — a feature that only Kugler was able to offer the customer. Finally a crimp cap, screw cap or tamper-proof cap is added. At every stage, containers are checked for correct closure and rejected if there are any defects. The entire filling and capping unit is suitable for laminar-flow air extraction.
The monobloc Linoline machine is followed by a labeling machine, also supplied by Kugler, which applies labels to the containers and prints batch numbers and expiry dates. Here too, the highest quality standards are maintained. The machine checks the print quality and the Pharmacode, and verifies the presence of the label on the container.
Next, the containers arrive at a cartoner with an upstream storage turntable. So that the cartoner can also handle suppositories and blister packs, Kugler designed a special product feed system that allows these products to be loaded manually. Spoons are automatically added to the packaging of those bottles that require them, and all packages are supplied with inserts. A final inspection stage checks the Pharmacode on the carton and the pack insert, before the carton is embossed with a batch number. A multipack machine arranges the cartons in groups of 10 and wraps them in foil. The batches of cartons are then assembled into ready-to-ship multipacks and shrinkwrapped in a heated tunnel.
As well as the flexibility of the packaging line, with its ability to handle any common type of closure, quick product changeover is of particular importance to this manufacturer of generic drugs. Kugler is something of a specialist in this area.
Many changeover tasks are automated through the use of servomotors, so that they can be carried out at the press of a button. All format parts are fitted with quick-change chucks, and — just as important for quick format changes — all the workstations feature easy access. As a result, product changeover takes just 30 minutes.
Kugler took full responsibility for all planning and implementation, including the layout of the line at Belupo’s site. The entire project duration was seven months, including three weeks of installation on site in Croatia, and the line was accepted by the client in November 2003. Belupo was highly satisfied with Kugler’s overall performance in terms of project handling, delivery reliability, and startup — a special achievement given the complexity of this system.
Belupo, meanwhile, is well on its way to filling a wide gap in the market, as medical care in Croatia expands further and the demand grows for drugs that are safe and effective, yet low in cost. And as Croatia approaches membership of the European Union, things can only get better.