Crystallization

Biopharmaceutical and chemical companies are under pressure to develop scalable crystallization processes faster - at lower costs and with higher quality.  Companies must control crystallization conditions to improve cycle times and optimize product quality.  With the incorporation of Process Analytical Technology (PAT), scientists can quickly measure solution and particle phase behavior in situ without pulling samples.

A well-designed crystallization process can be scaled successfully to production scale - giving the desired crystal size distribution, yield, and purity.

Crystallization applications include:

• Laboratory Batch Crystallization - Design scalable batch crystallization processes by providing critical insight to crystal shape, oil formation, secondary nucleation, and batch-to-batch consistency
• Crystallization Kinetics Modeling and Control - Measure, understand, and control crystal nucleation, growth, agglomeration, and attrition phenomenon with inline particle characterization and reaction analysis technology
• Continuous Crystallization - Achieve a high volume of product with a target particle size distribution using real time particle characterization tools
• Scale-up - Avoid crystallization scale-up problems such as batch-to-batch inconsistencies in the crystal size distribution, yield losses, and purity profile which have a significant impact on product quality and downstream process efficiency
• Downstream Processing - Troubleshoot and optimize downstream concerns, such as long filtration times, incomplete washing or drying, inconsistent powder flow, or formulation inconsistency
• Production Crystallization - Use Process Analytical Technology (PAT) to increase yield and capacity while achieving repeatable product particle size, purity, and bulk density while reducing cycle times and eliminating failed product
• Supersaturation - Measure and control the driving force for crystallization processes
• Metastable Zone Width Determination (MZWD) - Develop robust crystallization process by quickly characterizing with the solubility curve and metastable zone early in development
• Wet Milling - Ensure the desired particle distribution and detect wet milling endpoints in real time , without the need for sampling, with inline particle characterization
  

The METTLER TOLEDO suite of advanced crystallization tools are used to:

• Speed development times with real time measurements
• Gain confidence in scalability and efficiency
• Control percentage yield
• Optimize percentage throughput
• Improve percentage capacity
• Enhance price premium based on chemical product quality
  
  

LinkedIn Crystallization Community


METTLER TOLEDO works closely with our customers to ensure they receive the maximum benefits offered by our advanced Process Analytical Technology (PAT), including:

• FBRM^® for quantitative measurement tracking inline changes to particles and particle structures as they actually exist without sampling.  FBRM tracks real time changes in particle dimension, shape, and count.  After purchasing Lasentec in 2001, METTLER TOLEDO has become the world leader for inline particle system characterization.
• PVM^®   for real-time particle and droplet imaging and understanding of particle size and shape
• ReactIR^TM FT-IR spectroscopy for in situ monitoring and control of relative supersaturation
• Automated Lab Reactors for precise monitoring and control of the critical process variables in the crystallization step.