Table of Contents
An Industry Perspective on the Potential for Emerging Process Analytical Technologies
Agenda
Evolution of NIR/PAT Within Pfizer
PAT Applications at DP Sites
What Does the Future Hold?
Shift the Manufacturing Paradigm
Changing the Manufacturing Paradigm - Challenges
On-Line analysis of blending
Layout of Containment Blending Room
On- line NIR bin blender
PPT Slide
Saccharin Specific Absorption
Absorbance of Blend Components (Step 1)
Blend Uniformity All ingredients(Step 1)
Magnesium Stearate Uniformity (Step 2)
On-line blending - benefits
Tablet analysis by NIR transmission
NIR in Production
NIR Tablet Transmission Device
Tablet core potency - blend segregation in the bin
Automated tablet analysis
Absorbance of active tablets Vs placebos
NIR transmission Vs conc in tablets 0.1% - 2.0%
Microscopic View of Dosage Form
PPT Slide
Distribution of Lubricant in Blend
PPT Slide
MatrixNIR - Spectral Dimensions
Changing the Manufacturing Paradigm - Challenges
The “Don’t Use” Scenario
Example of “Don’t Use” - Antifungal Polymorph Conformation
The “Don’t Tell” Scenario
Control of Antibiotic Fermentation
Benefits of Improved Control
The “Win - Win” Scenario
How can we create a “Win-Win” Environment?
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