Applications of Crystallization in API Manufacturing
Crystallization is a purification technique involving solid formation. This modules covers crystallization in detail, and solution crystallization in particular. It also looks at factors affecting solution crystallization like concentration and temperature.
What is crystallization and why is it essential in API manufacturing
Saturated, Supersaturated, and Unsaturated solutions and the solubility curve
Nucleation, seeding and crystal growth
Solubility limit, metastable zone, and super saturation.
Crystal size distribution and polymorphism
Antisolvent and reactive crystallization
Continuous and batch crystallization
A video from a manufacturer of glass line crystallizers, explaining its various parts.
Design and safety considerations
Why it matters
Crystallization plays an important role in intermediate separation/purification and final manufacturing of API. Strict control of physical properties and chemical purity of the API is critical because it has an impact on the quality and efficacy of the final pharmaceutical product. Regulatory agencies are increasingly focusing on gaps in the crystallization properties and their consistency in API manufacturing
Who is it for
This module is relevant to all employees in Engineering\, Quality Control\, Quality Assurance\, and Production of API manufacturing