Continuous Processing in Secondary Production

Chemical Engineering in the Pharmaceutical Industry: R&D to Manufacturing

Volumn , Issue , 2010, Pages 837-851

  Warman, Martin ^a  

^a VERTEX PHARMACEUTICALS   (United States)

Author keywords

Continuous blender, previously described as "variability reduction ratio" (VRR) device; Continuous processing in secondary production online measurement of variability; GMC 30 NIR control strategy

Indexed keywords

EID: 84889475149     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470882221.ch43     Document Type: Chapter

References (29)

1. Kossik J. Think Small: Pharmaceutical Facility Could Boost Capacity and Slash Costs by Trading in Certain Batch Operations for Continuous Versions. Pharmamag.com, article ID/ DDAS-SEX 52B
2. Factory shift: new prescription for drug makers: update the plants. Wall Street J. September 3, 2003
3. US Food and Drug Administration, Center for Drug Evaluation and Research, Guidance for Industry PAT-A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, August 2003. http://www.fda.gov/cder/guidance/ 5815dft.htm
4. US, Food and Drug Administration, Center for Drug Evaluation and Research, PharmaceuticalcGMPSfor the 21st Century-A Risk-Based Approach: Second Progress Report and Implementation Plan, September 2004. http://www.fda.gov/Drugs/ DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPfor-Drugs/UCM071836
5. Leuenberger H. Moist agglomeration of pharmaceutical powders (size enlargement of particulate material)-the production of granules by moist agglomeration of powders in mixers/ kneaders. In: Chulia D, Deleuil M, PourcelotY, editors. Powder Technology and Pharmaceutical Processes, Handbook of Powder Technology, Vol. 9, Elsevier, Amsterdam, 1994, pp. 377-389
6. Laurent BFC, Bridgwater J. Convection and segregation in a horizontal mixer. Powder Technol. 2002;123:9-18
7. Laurent BFC, Bridgwater J. Performance of single and sizebladed powder mixers. Chem. Eng. Sci. 2002;57: 1695-1709
8. Laurent BFC, Bridgwater J. Influence of agitator design on powder flow. Chem. Eng. Sci. 2002;57:3781-3793
9. Marikh K, Berthiaux H, Mizonov V, Barantseva E. Experimental study of the stirring conditions taking place in a pilot plant continuous mixer of particulate solids. Powder Technol. 2005;157:138-143
10. Williams J, Rahman M. Prediction of the performance of continuous mixers for particulate solids using residence time distributions, Part I: Theoretical. Powder Technol. 1971;5: 87-92.
11. Beaudry JP. Blender efficiency. Chem. Eng. 1948;55:112-113.
12. Williams J, Rahman M. Prediction of the performance of continuous mixers for particulate solids using residence time distributions, Part II: Experimental. Powder Technol. 1971;5: 307-316
13. Harwood C, Walanski K, Luebcke E, Swanstrom C. The performance of continuous mixers for dry powders. Powder Technol. 1975;11:289-296
14. Portillo PM, Ierapetritou MG, Muzzio FJ. Characterization of continuous convective powder mixing processes. Powder Technol. 2008;182:368-378
15. Warman M. Using near infrared spectroscopy to unlock the pharmaceutical blending process. Am. Pharm. Rev. 2004; 7(2):54-57
16. Koblitz T, Ehrhardt L. Continuous Variable-Frequency Fluid Bed Drying of Pharmaceutical Granulations, Pharmaceutical Technology, March 1985
17. Leunberger H. New trends in the production of pharmaceutical granules: batch vs. continuous processing. Eur. J. Pharm. Biopharm. 2001;52:289-296
18. Mollan MJ, Jr., Lodaya M. Continuous Processing in Pharmaceutical Manufacturing (white paper), PharmaManufacturing. com, http://www.pharmamanufacturing.com/whitepapers/ 2004/11.html
19. Paul S, Knoch A, Lee G. Continuous Granulation: Review. PZ Prisma, 1997;4:112-124
20. Lindberg NO. Some experiences of continuous wet granulation. Acta Pharm. Suec. 1988;25:239-246
21. Appelgren C, Eskilson C, Medical L. A novel method for the granulation and coating of pharmacologically active substances. Drug Dev. Ind. Pharm. 1990;16(15):2345-2351
22. Jones PL, Rawley AT. Dielectric drying. Drying Technol. 1996;14(5):1063-1098
23. Lindberg NO, Turfvesson C, Olbjer L. Extrusion of an effervescent granulation with a twin screw extruder. Drug Dev Ind. Pharm. 1987;13:1891-1913
24. Gamlen M, Eardly C. Continuous Granulation using a Baker Perkins MP50 (multipurpose) extruder. Drug Dev. Ind. Pharm. 1986;12:1710-1713
25. Ghebre-Sellassie I, et al. Continuous Production of Pharmaceutical Granulation. United States Patent US 6,499,984 B1 Dec. 31, 2002
26. Lodaya M, Mollan M, Ghebre-Sellassie I. Twin screw wet granulation. In: Ghebre-Sellassie I, Martin C,editors. Pharmaceutical Extrusion Technology, Drugs and the Pharmaceutical Sciences Series, Vol. 133, Marcel Dekker, 2003
27. Rey L. Some leading edge prospects in lyophilization. Am. Pharm. Rev. 2003;6(2):32-44
28. US Food and Drug Administration Center for Drug Evaluation and Research, 21 Code of Federal Regulations, Parts 210 and 211 Current Good Manufacturing Practice for Manufacturing, Processing, Packing, or Holding of Drugs, http://www.fda.gov/ cder/dmpq/cgmpregs.htm
29. ASTM E2537: Standard Guide for the Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing