An Integrated Process Analytical Technology (PAT) Approach for Process Dynamics-Related Measurement Error Evaluation and Process Design Space Development of a Pharmaceutical Powder Blending Bed

2014 ◽  
Vol 19 (1) ◽  
pp. 215-226 ◽  
Author(s):  
Huiquan Wu ◽  
Maury White ◽  
Mansoor Khan
Keyword(s):  
Measurement Error ◽  
Process Design ◽  
Design Space ◽  
Process Analytical Technology ◽  
Integrated Process ◽  
Error Evaluation ◽  
Process Dynamics ◽  
Powder Blending ◽  
Pharmaceutical Powder ◽  
Analytical Technology

scholarly journals Process Design of Continuous Powder Blending Using Residence Time Distribution and Feeding Models

Pharmaceutics ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 1119
Author(s):  
Martin Gyürkés ◽  
Lajos Madarász ◽  
Ákos Köte ◽  
András Domokos ◽  
Dániel Mészáros ◽  
...  
Keyword(s):  
Residence Time ◽  
Process Design ◽  
Time Distribution ◽  
Residence Time Distribution ◽  
Process Analytical Technology ◽  
Active Pharmaceutical Ingredient ◽  
Process Dynamics ◽  
Powder Blending ◽  
Line Process ◽  
Continuous Powder Blending

The present paper reports a thorough continuous powder blending process design of acetylsalicylic acid (ASA) and microcrystalline cellulose (MCC) based on the Process Analytical Technology (PAT) guideline. A NIR-based method was applied using multivariate data analysis to achieve in-line process monitoring. The process dynamics were described with residence time distribution (RTD) models to achieve deep process understanding. The RTD was determined using the active pharmaceutical ingredient (API) as a tracer with multiple designs of experiment (DoE) studies to determine the effect of critical process parameters (CPPs) on the process dynamics. To achieve quality control through material diversion from feeding data, soft sensor-based process control tools were designed using the RTD model. The operation block model of the system was designed to select feasible experimental setups using the RTD model, and feeder characterizations as digital twins, therefore visualizing the output of theoretical setups. The concept significantly reduces the material and instrumental costs of process design and implementation.

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