PEF- Introduction 制药工程与 及设备基础　Pharmaceutical Equipment Fundamentals　　.ppt

Pharmaceutical Equipment Fundamentals Introduction 陈慧萍 chenhuiping@ncu.edu.cn What is Pharmaceutical Engineering? Branch of chemical engineering Focused on the design, operation and optimization of processes in pharmaceutical industries. Heavily regulated industry Life-saving characteristics of products What do Pharmaceutical Engineers do? Involved in the conception, design, construction, and operation of research facilities and manufacturing plants. Also involved in the conception, design, scale-up, manufacturing, and labeling and packaging processes in the conversion of chemical and biological materials into valuable pharmaceuticals and pharmaceutical therapies. Implement FDA regulations, validation assurance (VA), quality control, and maintain Good Manufacturing Practices (GMP) compliant facilities. The safety of the end product, they have to maintain a level of personal and environmental safety. Top 20 Pharmaceutical Companies 1. Pfizer (USA) 11. Wyeth (USA) 2. GlaxoSmithKline (UK) 12. Abbott Laboratories (USA) 3. Sanofi-Aventis (France) 13. Takeda (Japan) 4. Johnson Johnson (USA) 14. Boehringer-Ingelheim (Germany) 5. Merck Co. (USA) 15. Schering-Plough (USA) 6. AstraZenexa (UK-Sweden) 16. Bayer (Germany) 7. Novartis (Switzerland) 17. Novo Nordisk (Denmark) 8. Bristol-Myers Squibb (USA) 18. Schering AG (Germany) 9. Roche (Switzerland) 19. Sankyo Co. (Japan) 10. Eli Lilly Co. (USA) 20. Merck KGaA (Germany) ------- based on 2004 pharmaceutical revenues Top 10 Biopharmaceutical Companies 1. Amgen (USA) 6. Gilead Sciences (USA) 2. Genentech (USA) 7. MedImmune (USA) 3. Serono (Switzerland) 8. Chiron (USA) 4. Biogen Idec (USA) 9. Millennium (USA) 5. Genzyme (USA) 10. InterMune (USA) ------- based on 2004 biopharmaceutical revenues Equipment Two main categories of process equipment are proprietary and custom-designed. Proprietary equipment is designed by the manufacturer to meet performance specifications made by the user; these specifications may be