In the Land of Pusta and Lake Balaton The Hungarian Pharmaceutical Industry Is Highly Sophisticated

The Hungarian pharmaceutical industry has a long history, and it is a major factor in the country’s economy. Research plays an important role, but production technology is also very sophisticated, as the example of a recent automation project clearly shows.

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Hungarians are proud of their chemical and pharmaceutical industry which has a tradition that goes back for more than a century, and they like to draw attention to the Hungarian roots of Zsigmondy, Hevesy, Pollányi and Oláh, who won the Nobel Prize for Chemistry. A lot has happened since the end of World War II. Pharmaceutical production and exports increased significantly in the 50’s and 60’s, and a large number of license agreements with Western pharmaceutical producers were signed in the 70’s. Exports and production of generics continue to drive growth in the pharmaceutical industry.

Gedeon Richter, which has its headquarters in Budapest, is the flagship manufacturer in the Hungarian pharmaceutical industry. The company was founded back in 1901 by the pharmacist Gedeon Richter, and it is now a global player. Drugs, active ingredients and intermediates are produced and marketed at the two sites in Hungary and at plants in other countries. The portfolio includes about one hundred pharmaceutical products. Know-how in the chemistry of steroids, which was accumulated over the course of many years, has enabled the company to become one of the leading players worldwide in the market for gynecology drugs.

Recent events have demonstrated that in addition to conducting top-level research, the industry also deploys leading-edge production technology. Gedeon Richter invested more than 35 million euros in new production systems, and five million of that was spent on process automation. The contracts for three steroid production automation projects in Dorog were awarded to ABB.

American regulations set the standard in Budapest

One of the requirements for the new automation solution was that it had to fully comply with current Good Manufacturing Practice (cGMP) standards as defined in FDA regulations. These standards define methods, systems, equipment and automation for the production of pharmaceutical products. Lóránt Kovács, Steroid Production Manager, explained that “the automation system which controls production must include all of the planning, control and monitoring functions. We would also like to have maximum flexibility to upgrade our systems at a later date, and this places specific requirements on control station visualization, field devices and particularly the batch system.” It goes without saying that the Hungarians kept a close eye on costs during the course of the project. “We want to be able to reuse existing software modules. It was critical that the automation supplier was able to guarantee that production could commence within nine months after the project got underway”, added Kovács.

Andras Ujfaludi from ABB Hungary described the strategy behind the changeover from ABB Advant technology to the 800xA: “ABB has been supplying control systems to Gedeon Richter for years. We offer migration from all of our existing DCS systems to the new, state-of-the-art 800xA Extended Automation System, so the obvious solution was to use the Extended Automation System on all three projects.”

Since the 800xA fully complies with 21 CFR Part 11, cGMP validation was not an issue. Profibus-based field bus technology and 800xA batch management provided the flexibility that we were looking for.” High availability was another requirement in Hungary. This was achieved by providing complete redundancy in the controller, operator consoles and server configurations and by using gigabit Ethernet on the control networks.

The fact that the entire system is installed in an intrinsically safe area means that the equipment had to meet specific safety requirements, and this was reflected in the way in which the projects were structured. Redundant S800 I/O modules (or intrinsically safe distributed S900 I/O modules where the devices have to withstand harsh conditions) are used to acquire signals from the field. The modules are mounted in pre-configured ABB stainless steel field housings which are approved for use in Atex Zone 1. Redundant Profibus DP lines link the distributed I/O modules and the drives with the redundant AC 800M controllers. An LD 800P linking device (DP/PA converter) is used to connect the Profibus PA field devices. The use of FB 900 field bus barriers, which divide the main field bus segment into four spurs, reduces cost and meets the more stringent EEx e requirements.

Outstanding accessibility and availability

800xA-Batch Management using redundant batch servers provides the production management functionality. 800xA Information Management archives historical data which is available for recall at any time. To increase flexibility, there are operator consoles at the central control station and also in the intrinsically safe production areas where mobile Bartec terminals are used. The operator console software, 800xA Operations, provides system-wide availability of the entire information system. Operators can control the process locally no matter where they are. There was considerable time pressure during installation of the automation systems. Andras Ujfaludi explained how he was able to manage the situation. “A sophisticated engineering environment is supplied with the

800xA system, which simplifies compliance with Gedeon Richter company standards, for example faceplates and screen layouts. We were also able to use FDT/DTM technology, which makes it much easier to install distributed I/O modules and field devices. The same applies to the drives which were integrated into the 800xA system. FDT/DTM technology has better engineering capabilities, and the field bus solution reduced the cabling requirements.” The three production lines have been in operation since October 2005, and others are scheduled to go online soon. Lóránt Kovács from Gedeon Richter summarized how the new systems have enhanced production as follows: “We can react very quickly as soon as new scientific or production engineering knowledge becomes available. The new system is very flexible, and we also have the assurance that we comply with cGMP regulations.”

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