BASF Automates Bulk Pharmaceuticals Production

Demand for bulk pharmaceutical products, such as caffeine, theophylline, ephedrine, and pseudoephedrine, has grown so consistently that BASF's Minden, Germany, pharmaceutical plant existed in a near-continual state of expansion to meet production requirements. By the mid-1990s, however, the site near Mittelland Canal had grown about as large as it could.

02/01/2006


AT A GLANCE

 

  • Plant optimization

  • Ability to respond to demand

  • Flexibility during unknown events

  • GMP and FDA requirements


Demand for bulk pharmaceutical products, such as caffeine, theophylline, ephedrine, and pseudoephedrine, has grown so consistently that BASF's Minden, Germany, pharmaceutical plant existed in a near-continual state of expansion to meet production requirements. By the mid-1990s, however, the site near Mittelland Canal had grown about as large as it could.

BASF's Minden plant handles liquid extraction, salt formation, distillation, hydrogenation, gas liquid reactions in loop reactors, and catalyst separation and regeneration. Facilities include a range of mixing reactors, 500-4,000-liter enameled-reactors and 500-10,000-liter stainless-steel reactors.

Stainless-steel distillation columns with 500-3,000-liter capacities have up to 36 theoretical plates. Solids separations can be handled using either pendulum-type or trailing-blade centrifuges. Drying equipment includes vacuum rotary, double-cone and fluidized bed dryers, and multiple systems are available for grinding, screening, granulation, and mixing of dry crystal and powder products. In addition, a multi-purpose plant also provides chambered equipment for chloromethylation and cyanization.

All this equipment is necessary to meet customer product specifications for separation, drying, size reduction, micronization, screening, granulation, and packaging of bulk intermediate chemicals.

Minden also employs an extensive array of quality control systems automated independently from production systems. Fully equipped laboratories provide process- and quality-control testing. All lab work is managed according to good manufacturing practices (GMP) standards.

To adapt to increased demand for BASF products and make more efficient use of existing facilities, Dr. Martin Renkhoff, director of electrical measurement-and-control technology, developed an approach based on the Wonderware InTouch supervisory control and data acquisition (SCADA) software. InTouch initially was used to optimize the company's purine plant. The application has grown from a handful to 55 InTouch workstations running the purine and ephedrine plants.

Demand response

Ruggedized, PC-based workstations for plant operators link to 140 Schneider Electric Modicon 42402 I/O PLCs, all connected via a Modbus+ DataNet over a plantwide fiber-optic computer network.

Minden plant's automation team recently embarked on a new automation program to add capabilities from the Wonderware FactorySuite client/server software bundle, including the InBatch flexible batch management system and the IndustrialSQL Server real-time relational database, to serve as the real-time relational historian.

'One of the principal reasons we added the InBatch system is because it will provide the production flexibility to react to daily market demand as well as handle unexpected plant floor events,' explains Siegfried Stutzriemer, manager of the purine facility.

'In the new system, each recipe can have a different procedure and formula and can be scheduled for production on different equipment each time a batch is produced,' Stutzriemer says. 'Ability to configure how our process equipment will be utilized can be based on the recipe and on how it is scheduled.'

Batch management activities of this system include: short-term scheduling, batch initialization, batch and unit management, and batch history and reporting, using the IndustrialSQL Server database. For BASF, an important element of the new system will be the enhanced historian features provided by InBatch and IndustrialSQL Server.

History for each batch results from capturing and storing all materials used and produced, the equipment used, the alarm events that occurred, and any operator actions and relevant process variables that were trended. While the staff at the Minden plant has always maintained GMP in its production operations—equivalent to or better than production tracking requirements of the U.S. Food and Drug Administration —the new system promises to give the facility more flexibility in using that information for optimizing production.

The IndustrialSQL Server database enables integration of data on system configuration, alarms, events, summaries, statistical quality information, batch history, and associated production data.

Minden staff— from control and process engineers to process operators, maintenance staff, production managers and quality assurance people—will have tools to view, analyze, and report on plant operations and the products manufactured.



References

  • Ajaz S. Hussain and et al., Foreword, Journal of Process Analytical Technology, Vol.1, No.1, 3 (2004)

  • E. Serris and et al., Acoustic Emission of Pharmaceutical Powders During Compaction, Powder Technology 128, No.2-3, 296-299 (Dec. 18, 2002)

  • J. Salonen and et al., Monitoring the Acoustic Activity of a Pharmaceutical Powder During Roller Compaction,

  • International Journal of Pharmaceutics 153, No.2, 257-261 (July 30 1997)

  • C. B. Scruby and L. E. Drain, “Laser Ultrasonics: Techniques and Applications,” Adam Hilger, 1990

  • I. Varghese, M.S. Thesis, “Laser Acoustic Techniques for Drug Tablet Monitoring,” Clarkson University, 2004

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