Process understanding: for scale-up and manufacture of active ingredients

Discussing what process understanding means to different disciplines and sectors of chemistry throughout a product's life-cycle, this handbook and ready reference reveals the factors important to all the different sectors involved inthe development and manufacture of chemicals. The resulting interdisciplinaryand general approach provides readers with the fundamental understanding necessary for a smoother technical transfer between the disciplines, leading to more efficient process development and manufacturing. The book thus shows how process understanding can also deliver a real competitive advantage within the pharmaceuticals and fine chemicals industry, and serves as an aid to meeting the stringent regulations required by the relevant authorities. INDICE: Initial manufacture for trial quantities Data requirements and understanding for process development Scale-up of chemical reactions Analytical development Pilot plant manufactures. initial manufacture at scale Contract manufacturing Equipment selection or manufacturing technology selection Secondary/formulation development Quality by Design Established Manufacture - process control Whole process design Plant design and construction

• ISBN: 978-3-527-32584-9
• Editorial: Wiley-VCH
• Encuadernacion: Cartoné
• Páginas: 380
• Fecha Publicación: 20/04/2011
• Nº Volúmenes: 1
• Idioma: Inglés