Process Analytical Technology PAT | R&D, Scale-up & Manufacturing

Process Analytical Technology (PAT)

PAT is Changing Chemical Process Development, Scale-up, and Manufacturing

Process Analytical Technology (PAT)

Process Analytical Technology in R&D
Process Analytical Technology (PAT)
In Situ Reaction Analysis Tools
Inline Particle Characterization
Heat Flow Calorimetry in PAT
Raman Spectroscopy Seminar

Applications

Measure Crystal Size Distribution
Improve Crystallization with Inline Particle Size, Shape, and Count Measurement

In-process probe-based technologies are applied to track particle size and shape changes at full concentration with no dilution or extraction necessary. By tracking the rate and degree of change to particles and crystals in real time, the correct process parameters for crystallization performance can be optimized.

Crystallization and Precipitation
Optimize Crystal Size, Yield and Purity

Optimization and scale-up of crystallization and precipitation to produce a product that consistently meets purity, yield, form and particle size specifications can be one of the biggest challenges of process development.

Chemical Process Development & Scale-Up
Design Robust and Sustainable Chemical Processes For Faster Transfer To Pilot Plant and Production

Design Robust and Sustainable Chemical Processes For Faster Transfer To Pilot Plant and Production

Impurity Profiling of Chemical Reactions
Continuous Automated Reaction Sampling Improves Productivity and Understanding for Chemists

Knowledge of impurity kinetics and mechanism of formation is important in determining reaction end-point in chemical and process development studies. Accurate, reproducible, and representative reactions samples are necessary for these studies.

Chemical Reaction Kinetics Studies
Study Chemical Reaction Rates and Measure Kinetics Inline

In situ chemical reaction kinetics studies provide an improved understanding of reaction mechanism and pathway by providing concentration dependences of reacting components in real-time. Continuous data over the course of a reaction allows for the calculation of rate laws with fewer experiments due to the comprehensive nature of the data.  Reaction Progression Kinetics Analysis (RPKA) uses in situ data under synthetically relevant concentrations and captures information throughout the whole experiment ensuring that the complete reaction behavior can be accurately described.

Continuous Flow Chemistry
Improve Safety, Reduce Cycle Time, Increase Quality and Yield

Continuous flow chemistry opens options with exothermic synthetic steps that are not possible in batch reactors, and new developments in flow reactor design provide alternatives for reactions that are mixing limited in batch reactors. This can often result in better product quality and higher yield.  When coupled with Process Analytical Technology (PAT), flow chemistry allows for rapid analysis, optimization, and scale-up of a chemical reaction.

Process Control for Exothermic Reactions
Understand and Control Grignard Reaction Development and Scale-up With Process Analytical Technology

Exothermic chemical reactions pose inherent risks, especially during scale-up. Risks include safety hazards, such as excessive pressure, contents discharge, or explosion, as well as product yield and purity degradation associated with any sharp temperature rise.  For example, inadequate control of Grignard reactions introduces safety concerns associated with the accumulation of the organic halide which, if undetected, can result in a catastrophic event leading to a runaway reaction.

Particle Size Impacts Formulations & Product Development
Measure Particles and Droplets in Solid and Liquid Formulations to Optimize Process Development

Solid and liquid formulations are influenced by particle and droplet size. Particles and droplets affect the bioavailility, stability, and manufacturability of formulations including emulsions, micro-encapsulations, suspensions, and tablets. Process analytical technology using inline particle characterization provide continuous measurements which allow researchers to measure, understand, and optimize the particle size distribution during development and ensure consistency on scale up and manufacturing.

Measure Crystal Size Distribution

In-process probe-based technologies are applied to track particle size and shape changes at full concentration with no dilution or extraction necessary. By tracking the rate and degree of change to particles and crystals in real time, the correct process parameters for crystallization performance can be optimized.

Crystallization and Precipitation

Optimization and scale-up of crystallization and precipitation to produce a product that consistently meets purity, yield, form and particle size specifications can be one of the biggest challenges of process development.

Chemical Process Development & Scale-Up

Design Robust and Sustainable Chemical Processes For Faster Transfer To Pilot Plant and Production

Impurity Profiling of Chemical Reactions

Knowledge of impurity kinetics and mechanism of formation is important in determining reaction end-point in chemical and process development studies. Accurate, reproducible, and representative reactions samples are necessary for these studies.

Chemical Reaction Kinetics Studies

In situ chemical reaction kinetics studies provide an improved understanding of reaction mechanism and pathway by providing concentration dependences of reacting components in real-time. Continuous data over the course of a reaction allows for the calculation of rate laws with fewer experiments due to the comprehensive nature of the data.  Reaction Progression Kinetics Analysis (RPKA) uses in situ data under synthetically relevant concentrations and captures information throughout the whole experiment ensuring that the complete reaction behavior can be accurately described.

Continuous Flow Chemistry

Continuous flow chemistry opens options with exothermic synthetic steps that are not possible in batch reactors, and new developments in flow reactor design provide alternatives for reactions that are mixing limited in batch reactors. This can often result in better product quality and higher yield.  When coupled with Process Analytical Technology (PAT), flow chemistry allows for rapid analysis, optimization, and scale-up of a chemical reaction.

Process Control for Exothermic Reactions

Exothermic chemical reactions pose inherent risks, especially during scale-up. Risks include safety hazards, such as excessive pressure, contents discharge, or explosion, as well as product yield and purity degradation associated with any sharp temperature rise.  For example, inadequate control of Grignard reactions introduces safety concerns associated with the accumulation of the organic halide which, if undetected, can result in a catastrophic event leading to a runaway reaction.

Particle Size Impacts Formulations & Product Development

Solid and liquid formulations are influenced by particle and droplet size. Particles and droplets affect the bioavailility, stability, and manufacturability of formulations including emulsions, micro-encapsulations, suspensions, and tablets. Process analytical technology using inline particle characterization provide continuous measurements which allow researchers to measure, understand, and optimize the particle size distribution during development and ensure consistency on scale up and manufacturing.

Publications

White Papers

Effective Crystallization Process Development
This white paper introduces the fundamentals of crystallization and presents guidelines for the design of a high quality crystallization process.
How to Optimize a Crystallization Step Using Simple Image Analysis
By quickly identifying unnecessary hold times and determining how cooling rate influences crystal growth and nucleation, the cycle time for an interme...
Process FTIR For Safe Operation of Sodium Borohydride Reduction
John O'Reilly of Roche Ireland discusses sustainable Process Analytical Technology (PAT) system using Process FTIR for the safe operation of a sodium...
In Situ Monitoring of Chemical Reactions
'How to do more with less?' is a constant topic in chemical development laboratories as researchers need to quickly and cost-effectively deliver chemi...
Rapid Analysis of Continuous Reaction Optimization Experiments
The white paper - Rapid Analysis of Continuous Reaction Optimization Experiments - discusses how to optimize chemical reactions.
Effective Design of Experiment Studies
This paper describes the Design of Experiments (DoE) approach and how it is used to identify the relationship between parameters, defining optimal set...
Risks From Rising Temperature
In chemical process scale-up, understanding temperature change and the associated heat that is accumulated by the reaction are critical to process saf...
PAT for Emulsions
Use PAT for emulsions and suspension characterization without the need for sampling or sample prep.
Monitor Tablet & Granule Disintegration
The role of in-process particle measurement to complement traditional API dissolution studies is presented. The use of particle size and count measure...
Particle Size Analysis for Process Optimization
This white paper introduces some of the most common particle size analysis approaches and how they can be deployed for the effective delivery of high...

On-Demand Webinars

Breaking Barriers to Manufacturing Innovation
Frederic Buono discusses how Boehringer Ingelheim uses continuous flow technology to break barriers in manufacturing innovation.
Crystallization Image Analysis
This presentation describes the role of image analysis in crystallization monitoring.
Flow and Batch Chemistry Monitoring
Charles Goss presents examples illustrating how GlaxoSmithKline (GSK) monitors flow and batch chemistry unit operations in both laboratory and pilot p...
Liquid-Liquid Phase Separation
This presentation describes a strategy employed to design and develop robust, scalable crystallization processes that avoids Liquid-Liquid Phase Separ...
New Tools For Continuous Flow Chemistry
Andrea Adamo of MIT and Zaiput Flow Technologies discusses new tools for continuous flow chemistry advancement.
Agglomeration & Crystallization Using Particle Measurement
This presentation details how using data from in situ particle vision and measurement tools can be used to determine particle size and shape trends re...
Lubrizol Process Development and Scale-up
This webinar focuses on how to improve process development and scale-up by leveraging calorimetry and in situ process analysis. In order to provide t...
Chemical Process Intensification Merck
Shane Grosser discusses how Merck's Process Development Intensification Laboratory develops new tools and methods to increase the speed and decrease t...

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