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How do you scale up and model a crystallization process from lab to industrial scale?

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Crystallization is a widely used separation and purification technique in chemical process engineering, but scaling it up from lab to industrial scale can be challenging. How do you design and optimize a crystallization process that meets your product specifications, quality, and yield? In this article, you will learn the basic steps and principles of scaling up and modeling a crystallization process, as well as some useful tools and tips to avoid common pitfalls.

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Maria Clara Ramalho Freitas

CEO Solid Consut Pharma| Entrepreneur | Research | Pharmaceutical industry

1 Define your objectives

Before you start scaling up your crystallization process, you need to have a clear idea of what you want to achieve. What are the desired properties and characteristics of your product crystals, such as size, shape, purity, and polymorphism? How much product do you need to produce per unit time and at what cost? What are the environmental and safety regulations that apply to your process? These objectives will guide your choice of crystallizer type, operating conditions, and process control strategies.

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Maria Clara Ramalho Freitas

CEO Solid Consut Pharma| Entrepreneur | Research | Pharmaceutical industry
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O quaity by design (QBD) pode ser um direcionamento para o uso racional do conhecimento técnico-científico acumulado em anos e pode fornecer informa??es necessárias para o produto final desejado. O QBD é utilizado no ciclo de vida do produto, existe uma liga??o entre o processo - design e o controle do processo. Do ICH Q8*: “a qualidade* n?o pode ser testada em produtos; ou seja, a qualidade deve ser incorporada no design.” No QBD além da gest?o da qualidade (GQ), para alcan?ar um parametro crítico do processo (critical process paramiter - CPP), um aspecto importante é a gest?o de riscos (RM). Embora o gerenciamento da qualidade estabele?a aspectos-alvo importantes do produto, o gerenciamento de riscos pode antecipar o que pode dar errado.

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Qaim Abbas

Senior Process Engineer | Digital Transformation of Manufacturing Facilities|Ammonia, Syn Gas, Gas Processing & Urea | PSM Implementation | PHA Leader| MBA| AI
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Scaling up a crystallization process involves adjusting parameters for industrial efficiency. Begin by optimizing conditions in the lab, considering factors like temperature, pressure, and solvent ratios. Conduct small-scale pilot tests to validate scalability. Use mathematical modeling to predict larger-scale outcomes. Adjust parameters based on pilot results, ensuring consistent crystal quality. Continuously monitor and refine the process during industrial scale-up, incorporating safety measures and equipment considerations for seamless integration into the production environment.

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Waqas Aslam

Senior Process Engineer/Technopreneur - Catalysing Sustainability
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Crystallisation process involves preparation of supersaturated solution followed by crystals growth via 'Ostwald Ripening'. Based upon the process requirements crystals size (size distribution), morphology and purity could be tuned by controlling cooling rate, evaporation, anti-solvent etc. 1. Choose a solvent and/or antisolvent. 2. Get the solubility curve data from lab scale experiments i.e., wt.% dissolved at different temperatures. 2. Set the operating parameters based upon desired production requirements. 3. For a precise crystals size and size distribution, the cooling rate should be controlled to maintain concentration between 'solubility' and 'cloud Point' curves i.e., 'Metastable zone'.

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2 Characterize your system

The next step is to understand the thermodynamics and kinetics of your system, which determine the solubility, supersaturation, nucleation, and growth rates of your crystals. You can use experimental methods, such as solubility measurements, phase diagrams, metastable zone width determination, and crystal growth rate measurements, to obtain these data. Alternatively, you can use empirical or mechanistic models, such as the NRTL, UNIQUAC, or Pitzer models, to estimate the thermodynamic properties of your system. You can also use population balance models, such as the MSMPR or CSTR models, to describe the crystal size distribution and morphology.

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Maria Clara Ramalho Freitas

CEO Solid Consut Pharma| Entrepreneur | Research | Pharmaceutical industry
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Conhecer o tipo de polimorfos envolvidos, se enantiotrópico ou monotrópico, auxilia na estratégia de cristaliza??o. Por exemplo se tratando de um sistema monotrópico diminuindo a temperatura, a uma composi??o constante de soluto, cineticamente, no sistema (sem discutir a zona metaestável) n?o há porque apenas uma forma cristalina nuclear e precipitar, ambas s?o possíveis. Levando em considera??o a regra de estágios de Ostwald, a diminui??o da temperatura induzirá a nuclea??o primeiro da forma metaestável, o que significa que o sistema estará mais saturado na forma metaestável no início. E como estimular o sistema para proporcionar uma forma mais estável? Usar sementes de forma estável pode ser uma solu??o.

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3 Choose your crystallizer type

Based on your objectives and system characteristics, you can select the most suitable crystallizer type for your process. There are various types of crystallizers available, such as batch, continuous, cooling, evaporative, reactive, or anti-solvent crystallizers. Each type has its own advantages and disadvantages, depending on the operating parameters, such as temperature, pressure, agitation, feed rate, residence time, and cooling or heating rate. You should consider the effects of these parameters on the crystal quality, yield, and energy efficiency of your process.

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4 Scale up your crystallizer

Once you have chosen your crystallizer type, you need to scale it up from lab to industrial scale. This involves applying geometric, dynamic, and thermodynamic similarity criteria to ensure that the performance of the large-scale crystallizer matches that of the small-scale one. You can use dimensionless numbers, such as the Reynolds, Prandtl, Nusselt, and Sherwood numbers, to compare the hydrodynamics, heat transfer, and mass transfer coefficients of the two scales. You can also use scale-up factors, such as the linear, volumetric, or power scale-up factors, to calculate the dimensions and power requirements of the large-scale crystallizer.

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Maria Clara Ramalho Freitas

CEO Solid Consut Pharma| Entrepreneur | Research | Pharmaceutical industry
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Para superar desafios e melhorar a escalabilidade, a dinamica de fluidos computacional (CFD) tem sido usada, mas se você n?o está familiarizado com este tópico aqui está a defini??o de Oxford: “A dinamica de fluidos computacional (CFD) é uma ciência que, com a ajuda computacional, produz previs?es quantitativas de fen?menos de fluxo de fluidos com base nas leis de conserva??o (conserva??o de massa, momento e energia) que governam o movimento dos fluidos”.

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5 Model your crystallizer

To optimize and control your crystallization process, you need to develop a mathematical model that captures the relevant phenomena and variables of your system. You can use different types of models, such as empirical, mechanistic, or hybrid models, depending on the level of detail and accuracy you need. You can also use different methods to solve your model, such as analytical, numerical, or simulation methods, depending on the complexity and nonlinearity of your model. You can use software tools, such as MATLAB, Aspen Plus, or gPROMS, to implement and validate your model.

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6 Test and validate your process

The final step is to test and validate your scaled-up and modeled crystallization process in the industrial setting. You need to collect data and samples from your process and compare them with your objectives and model predictions. You need to evaluate the performance indicators, such as the crystal size distribution, purity, yield, and energy consumption, of your process. You need to identify and correct any deviations or errors that may arise from scaling up or modeling errors, equipment malfunctions, or process disturbances. You need to ensure that your process is robust, reliable, and profitable.

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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How do you scale up and model a crystallization process from lab to industrial scale?

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1 Define your objectives

2 Characterize your system

3 Choose your crystallizer type

4 Scale up your crystallizer

5 Model your crystallizer

6 Test and validate your process

7 Here’s what else to consider

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