Hilary Ayshford visited Richter Gedeon's recently expanded facility in Dorog to get the inside story behind the plant automation
When Hungarian pharmaceutical company Richter Gedeon decided on a major expansion of its steroid product manufacturing facilities, including the building of two additional production lines within an existing building at its site in Dorog, it required a great deal of careful planning.
Founded in 1901 and with its headquarters in Budapest, Richter Gedeon develops, manufactures and markets finished drugs, APIs and intermediates - around 100 different products in all - and its traditional expertise in steroid chemistry makes it a leading global player in the gynaecological field.
As a large proportion of its output is exported to all parts of the world, a fundamental requirement was that the entire automation solution had to be cGMP and 21CFR 210-211 compliant.
'The production must be controlled by an automation system that is capable of handling the registration and integration of all planning, control and monitoring tasks,' said Lorant Kovacs, head of the steroid plant. 'Furthermore, we wanted to be as flexible as possible when it came to integrating new improvements into our plant. This puts some requirements on the visualisation in the control room, on the field equipment and especially on the batch system.'
Further requirements were the ability to use Richter Gedeon's existing software modules to reduce the time to start-up and - crucially - that production had to begin within nine months.
Following a feasibility study in March 2003, based around customer requirements for the manufacture of a specific product, detailed planning started in January 2004 and construction was underway a few months later, involving around 100 different facilities, including 50 autoclaves and another 50 pieces of highly specialised equipment, two manufacturing halls plus the tank farm.
But as with the best laid plans, it all went awry in September 2004, when the product for which the plant was designed was discontinued and Richter Gedeon was asked to manufacture an entirely different product involving seven chemical steps, two chromatography steps, crystallisation and micronisation.
As a result all the plans for process control, automation of the tank farm etc had to be revised. When contracts were awarded at the end of November 2004, the task of automation in both the new projects and the existing plant fell to ABB, which had supplied Richter Gedeon with control systems for more than a decade.
In November the starting gun was fired and with time now of the essence, the construction, the technological development and the process control were all running in parallel on the same site. But despite the apparent chaos, by June 2005 the intermediate plant was up and running, chromatography was in place by September, the cleanroom was functioning in January 2006 and in March the product samples were delivered.
'It was a parallel world - everyone was working at the same time. Things were happening before the ink was even dry on the drawings. Sometimes we were doing things and the designer was coming and writing it down the way we had done it,' recalled Kovacs
ABB's solution to Richter Gedeon's exacting requirements was to use its 21CFR 11 compliant extended automation System 800xA for both the new and existing plants, as it offers an evolution path from its existing DCS systems using Advant technology. Not only does this mean that existing libraries can be use, but the HMI will be familiar and operator retraining is minimal.
'That has helped greatly with the operation of the plant because people who have been working for five or six years with the old system took to the new system like ducks to water,' said Kovacs. 'They felt immediately at home, rather than needing several months of retraining.'
To achieve the required flexibility, fieldbus technology based on Profibus and 800xA Batch Management was used. The choice of a fieldbus technology was critical in finishing the project on time. The reduced cabling alone provided an estimated time saving of 2.5-3 months. It also made maximum use of the limited space available within the existing building.
High availability of the plant was another requirement, which was solved with complete redundancy of controllers, operator stations, servers and control networks using Gigabit Ethernet. In addition the whole building is an intrinsic safe area, which puts specific requirements on the equipment.
The signals from the field are collected by redundant S800 Remote I/O modules or, in case of harsh environments, by intrinsic safe S900 Remote I/Os. The S900 Remote I/O is placed inside ABB's preconfigured, stainless steel field housings with ATEX Zone 1 approval. These are used within the plant as well as outside the buildings at the tank farm.
The remote I/Os and the drives are connected to the redundant AC 800M controllers via redundant Profibus DP lines. Finally, the Profibus PA field devices are connected via the linking device LD 800P, the DP/PA converter. The usage of FB 900 Fieldbus Barriers, which split up the fieldbus trunk into four branches, combines cost-savings with fulfillment of increased safety EEx e requirements.
The production management is based on 800xA Batch Management with redundant batch servers. Historical values are archived by 800xA Information Management and are available at any time. To increase the flexibility of operations, operator stations are not only placed in the central control room, but also in the intrinsic safe areas at the production site, where appropriate mobile Bartec terminals are used. 800xA Operations, the operator console software, makes the entire information system wide available.
But because plant operators, maintenance engineers, production engineers, process engineers and plant managers want different visibility at their terminals with a different screen format, each job function can have a personalised display. This is accomplished by password-protected logon codes, all of which are FDA compliant (21CFR 11). The system also creates a full audit trail automatically, so when the documented batch record is produced, there is a full record of who did what and when.
But for a pharmaceutical plant like Richter Gedeon's the main advantage of the 800xA extended automation technology is that all the functions it could ever need are incorporated into a single package with a common operating environment: batch management, motor control centres, energy management, asset optimisation, safety systems, real-time production intelligence are all built into the system.
The software is loaded from a DVD into the system in its entirety and the functions for which licences have been purchased are switched on. If additional functions are needed in the future, the user need only apply for a licence and activate that software element. This ensures continuity of production as there is no need to stop the system, install new software, test it and start up again.
'Where previously there was a processing control system, a separate electrical control system and a separate power management system, you can now pull those together using common hardware,' explained Peter Fox, vice president, automation technologies division (UK). 'In one solution, as we have here, within the 21 controllers not only are the process controllers running the sequences and recipes but also the electrical control running the drives and motors associated with that process unit.'
This has a knock-on benefit in terms of productivity gains. With a traditional system, it can take 30 seconds for a pump to start up from the time the operator gives the command. But using the intelligent motor control system, it takes less than two seconds. 'In a batch chemical plant if you can save 28 seconds every time you start or stop a pump it is possible to get a lot more production through the plant and have a lot more control over your product,' Fox said.
The fully compliant Batch Manager is capable of automatic routing selection, so in a manifolded plant the system will look across the plant at what equipment is available, what is off-line or not available for use, select a route through the plant and then make the product in the optimal way.
The manufacturing management system will incorporate the manual operations too, displaying at the appropriate point the Standard Operating Procedures and feeding the data back into the system where it is logged within the network batch records.
Real-time production intelligence is also part of the 800xA, carrying out breakdown analysis, logging stoppages by type and enabling the user to carry out analysis as to why maximum production rate is not being met.
The investment at Richter Gedeon amounted to US$35m, of which the cost of the process control was around $5m. And despite switching products in midstream, the increase in the process control costs was kept to just an additional 15%.
'The road to the success relied not on the scientific product or on the project management techniques but on the very strong friendly co-operation as partners,' stressed Kovacs. 'Richter was successful in explaining to the partners, and the partners understood the final objectives of the project.'