401 Application of PAT in the Manufacturing Setting

Wednesday, October 31, 2012: 8:30 AM
Allegheny II (Westin )
Description:
This section focuses on the use of Process Analytical Technologies to monitor, control, and gain a better understanding of Pharmaceutical manufacturing processes at commercial scales (drug products and drug substances (APIs)). Authors are encouraged to submit papers discussing case studies, research, and value-added applications of PAT in manufacturing settings as well as challenges overcome and lessons learned while implementing PAT in pharmaceutical manufacturing operations.

Sponsor:
Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsor(s):
Systems and Process Control (10B)

Chair:
Stelios Tsinontides
Email: stsinont@cephalon.com

Co-Chair:
Sharmista Chatterjee
Email: sharmista.chatterjee@fda.hhs.gov

- indicates paper has an Extended Abstract file available on CD.

File available
8:30 AM
(401a) Process Understanding Tools in PAT Implementations
Joao Machado, Tiago Robalo, Pedro Felizardo and Jose Menezes

8:55 AM
Break
File available
9:20 AM
(401c) An Integrated Process Analytical Technology (PAT) Approach to Examine the Effect of Temperature On Nucleation Kinetics of a Dynamic Pharmaceutical Co-Precipitation Process
Huiquan Wu, Maury White, Ryan Foringer and Mansoor A Khan

9:45 AM
(401d) Making PAT an Integral and Sustained Part of Manufacturing Operations
John O'Reilly

10:10 AM
(401e) Design and Implementation of An Efficient Control System in a Continuous Pharmaceutical Manufacturing Process Via Roller Compaction
Ravendra Singh, Marianthi Ierapetritou and Rohit Ramachandran

10:35 AM
(401f) Near Infrared Spectroscopy (NIRS): An Enabling Tool for Pharmaceutical Quality by Design (QbD)
K. Geoffrey Wu, Suhas Patankar, Lane V. Christensen, Robert A. Lionberger and Lawrence X. Yu
See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
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