277786 Investigation of the Impact of Mode of Operation (Batch vs Flow) On Design Space Map
277786 Investigation of the Impact of Mode of Operation (Batch vs Flow) On Design Space Map
Wednesday, October 31, 2012: 12:55 PM
Allegheny II (Westin )
This talk will discuss how the mode of operation (batch vs flow) impacts the design space map for impurities thus impacting the robustness of the process. A specific case study involving a reaction model will be used for this investigation that builds upon previous work on failure mode analysis in continuous processes (Wong etal 2011). There are three impurities of interest formed in this reaction. A reaction kinetic model developed from batch experiments is used to design for both batch and flow processes. The key questions that this investigation addresses is:
- How much does the mode of operation impact the size of the design space?
- Is the link between the uncertainties due to routine variability and model uncertainty and the output impurity levels same or different depending on the mode of operations?
- Can certain generalizations be drawn based on the results of this case study?
[1] Sze-Wing Wong, Prashant Kokitkar, K. Derek Berglund, Martin D Johnson, and Shekhar K. Viswanath, Failure Mode Analysis of Continuous Process with Process Models, AIChE Annual Meeting, MN 2011
See more of this Session: Application of Quality by Design in API Process Development
See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture