Using Residence Time Distributions (RTDs) to Address the Traceability of Raw Materials in Continuous Pharmaceutical Manufacturing

  title={Using Residence Time Distributions (RTDs) to Address the Traceability of Raw Materials in Continuous Pharmaceutical Manufacturing},
  author={William E. Engisch and Fernando J. Muzzio},
  booktitle={Journal of Pharmaceutical Innovation},
Continuous processing in pharmaceutical manufacturing is a relatively new approach that has generated significant attention. While it has been used for decades in other industries, showing significant advantages, the pharmaceutical industry has been slow in its adoption of continuous processing, primarily due to regulatory uncertainty. This paper aims to help address these concerns by introducing methods for batch definition, raw material traceability, and sensor frequency determination. All of… CONTINUE READING


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Publications referenced by this paper.
Showing 1-10 of 40 references

Characterization of feeder effects on continuous solid mixing using fourier series analysis

Y Gao, F Muzzio, M. Ierapetritou
AIChE J. 2011;57(5):1144–53 • 2016
View 1 Excerpt

Avoiding Blend Segregation in Continuous Manufacturing, presented at the IFPAC

F. Muzzio
View 1 Excerpt

Effects of powder flow properties and shear environment on the performance of continuous mixing of pharmaceutical powders

AU Vanarase, JG Osorio, FJ. Muzzio
Powder Technol • 2013
View 1 Excerpt

Continuous processing in the manufacture of active pharmaceutical ingredients and finished dosage forms: an industry perspective

P Poechlauer, J Manley, R Broxterman, B Gregertsen, M. Ridemark
Org. Process Res Dev • 2012

FDA Perspective on Continuous Manufacturing, presented at the IFPAC

S. Chatterjee
Annual Meeting, • 2012

Method for characterization of loss-inweight feeder equipment

WE Engisch, FJ Muzzio
Powder Technol • 2012
View 1 Excerpt

Continuous Manufacturing - FDA Perspective on Submissions and Implementation, presented at the PQRI Workshop on Sample Sizes for Decision Making in New Manufacturing Paradigms, Bethesda, MD

C. Moore

Continuous processing in secondary production

M. Warman
Chem. Eng. Pharm. Ind. RD Manuf., • 2011

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