Efficient Engineering and Production Concepts for Products in Regulated Environments - Dream or Nightmare?

• Published in: Chemie ingenieur technik Vol. 86; no. 5; pp. 687 - 694
• Main Authors: Strube, Jochen, Ditz, Reinhard, Fröhlich, Holger, Köster, Dirk, Grützner, Thomas, Koch, Jörg, Schütte, Rüdiger
• Format: Journal Article
• Language: English
• Published: Weinheim WILEY-VCH Verlag 01.05.2014; WILEY‐VCH Verlag
• Subjects: Costs; Engineering; Filing; Flexibility; Markets; Modularization; Package units; Process design; Production methods; Standardization; Strategy
• ISSN: 0009-286X; 1522-2640
• DOI: 10.1002/cite.201300081

Manufacturing of chemical‐pharmaceutical products is moving increasingly fast on a global scale. Therefore, developing and starting up production facilities fast, with high quality, and at reasonable costs has become extremely challenging. Engineering concepts like modularization, standardization and simultaneous/parallel engineering are discussed as methods for speeding up process design and filing for regulatory approval. Transfer from batch to continuous operation mode of production is pointed out as the key‐issue in such strategies. To cope with the need for higher flexibility in customer driven supply to chemical and pharmaceutical markets, different existing engineering approaches are discussed. Additionally, a new approach based on improvement and standardization of methods for data acquisition in product and process development is presented.