'Multitasking' of a packaging line
Kugler: Turnkey supplier in the expanding Eastern European market
By now GMP regulations already have global validity. With Belupo in Croatia these requirements regarding quality and safety are top priority.
Belupo is the leading pharmaceutical company in Croatia in sales of drugs having effect on the cardiovascular and dermatological systems and the second largest manufacturer of pharmaceuticals in Croatia. The core activity of Belupo, who is marking the 33rd anniversary of its activity at the end of 2004, is manufacturing and sale of pharmaceutical preparations and cosmetics; Belupo is a joint-stock company (d.d.) whose head office in Koprivnica. Through its organization and working methods the company is following the latest trends in business operation both on domestic and foreign markets. Continuous emphasis on strategic development and export activities, investing in the system of assurance and quality control, professional training of its employees, and investing in the manufacturing capacities and programs, Belupo has found its place among the leading manufacturers of pharmaceuticals in Central and south-eastern Europe.
The existing demand for drugs as well as promising product launches make the company grow and further invest. In order to be up to the coming challenges, the most important proviso for the design of a new packaging line is “flexibility”. As turnkey supplier, Kugler implemented a comprehensive packaging line on which complete dermatological liquids program will be filled. The modular design of the Kugler line allows for extensions to other liquid and semi-liquid drugs with new format ranges at any time.
Flexibility – it’s more than just a buzzword, here it stands for filling volumes of 1 ml to 1000 ml and for the application of all regular types of closures. At present, generics are filled into glass and plastic bottles with volumes of 10 ml to 500 ml on the Kugler line. The beginning of the packaging line is formed by a turntable onto which the containers are loaded. First of all, the cGMP certified hygiene characteristics in the primary packaging area are provided for by a Kugler rinsing machine. Here, the bottles are turned over by 180° and air rinsed. The air is exhausted at the bottleneck and plastic bottles are additionally deionized to avoid static charging. Next is the linear filling and capping machine Kugler Linoline which operates with a two-step conveyor rake.
Safety through 100% in-process inspection
Before the filling, the bottles are weighed on a tare weigher. Then the filling is done in two time-saving steps of 50% each. For checking and for self-optimization of the filling unit, the gross weight of the filled containers is then determined. Depending on the product, a plug or a spray pump is then inserted. Since the dip tubes of the spray pumps have a tendency to coil, they have to be drawn straight mechanically before being inserted into the bottle – a feature that only Kugler had been able to offer the customer. Then the containers line up to get either a crimp cap, a screw cap or a pilfer proof cap. Checking devices on all closing units and a reject system ensure process reliability. And, furthermore, the entire filling and capping unit is suitable for laminar flow.
The KUGLER Linoline monoblock machine is followed by a labeling machine supplied by Kugler, which applies labels to the containers and prints batch numbers and expiry dates onto the labels. Here too, the highest checking demands are placed: Print quality and Pharmacode are checked, and the presence of the label on the bottle is verified. Then the containers arrive at a cartoner with an upstream storage turntable.
In order to be able to package also suppositories and blisters on the cartoner, a special product infeed system has been integrated to allow for additional manual loading of these products. At this point, spoons are automatically added to some bottles arriving “regularly” via the filling line, and all bottles are fitted with package inserts. After that, further process inspections take place: This time the Pharmacode on the carton and on the package insert is checked and eventually the carton is embossed with a batch number. A multipack machine arranges the cartons in groups of 10 and wraps them in foil, and finally these are tightened into ready-to-ship multipacks in a heat tunnel.
Quick format changeover, flexible design
Aside from the flexibility of the packaging line, which can process any regular type of closure, quick product changeover is of particular importance for its cost-efficient operation with many different patent free drugs. Kugler has developed into a leading specialist in this area: Servomotors are used at many points, so that format changeover can largely be done “at the push of a button”. All format parts are fitted with quick-change chucks. And it is also very important for quick format changeover that the working stations are easy to access. A product changeover on the Kugler line can be carried out in a total of 30 minutes. The dosing accuracy is +/- 0.5 1 %. With the integrated weighing stations, the line offers 100% in-process inspection according to CFR 21 Part 11.
Acting as sole contact, Kugler had taken full responsibility for the planning and implementation, which also included the layout of the line within the given premises. The entire project duration was seven months until the acceptance of the line in November 2003, including three weeks of installation on site in Croatia. Belupo expressed a high level of satisfaction with the overall performance of Kugler in terms of project handling, delivery reliability, and startup – which was a special commendation given the complexity of the packaging line.
Prepared for expansion
Belupo is well on the way to filling a wide gap in the market: Medical care in Croatia will be further expanded; there is a demand for safe, effective, and at the same time low-cost drugs. As of May 2004, because of the eastern enlargement of the EU, Belupo will benefit from further improving health standards in markets the company is already established in. And, last but not least, from the flu weather in Eastern Europe, while in Croatia the sun is shining once again.