Optical inline analysis and monitoring of particle size and shape distributions for multiple applications: Scientific and industrial relevance

Emmerich, rn; Tang, Qiao; Wang, Yundong; Neubauer, Peter; Junne, Stefan; Maa, Sebastian

doi:10.1016/j.cjche.2018.11.011

Cited by 34 publications

(25 citation statements)

References 68 publications

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“…Laser scanner technology is a promising method that benefits from minimal maintenance, minimal calibration requirements, a compact size, and validity over a wide range of operating conditions [90]. It is suitable up to a volume fraction of 30% (v/v) [106], requires no sample dilution, can be used inline, and has a measurement range of 0.5-2000 µm [107]. It is ideal for monitoring during the fine emulsification of the product in the lower particle size range.…”

Section: Pat For Inline Droplet Monitoringmentioning

confidence: 99%

Process Analytical Technology for the Production of Parenteral Lipid Emulsions According to Good Manufacturing Practices

Grumbach

Czermak

2022

Processes

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The good manufacturing practices (GMP) and process analytical technology (PAT) initiatives of the US Food and Drug Administration, in conjunction with International Council for Harmonisation (ICH) quality guidelines Q8, Q9, and Q10, ensure that manufacturing processes for parenteral formulations meet the requirements of increasingly strict regulations. This involves the selection of suitable process analytics for process integration and aseptic processing. In this article, we discuss the PAT requirements for the GMP-compliant manufacturing of parenteral lipid emulsions, which can be used for clinical nutrition or for the delivery of lipophilic active ingredients. There are risks associated with the manufacturing processes, including the potential for unstable emulsions and the formation of large droplets that can induce embolisms in the patient. Parenteral emulsions are currently monitored offline using a statistical approach. Inline analytics, supplemented by measurements of zeta potential, could minimize the above risks. Laser scanning technology, ultrasound attenuation spectroscopy, and photo-optical sensors combined with image analysis may prove to be useful PAT methods. In the future, these technologies could lead to better process understanding and control, thus improving production efficiency.

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Section: Pat For Inline Droplet Monitoringmentioning

confidence: 99%

Process Analytical Technology for the Production of Parenteral Lipid Emulsions According to Good Manufacturing Practices

Grumbach

Czermak

2022

Processes

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“…With the use of FBRM, online monitoring and control methods have been greatly developed in crystallization processes. The FBRM measures only the one-dimensional chord length of crystals, which makes it difficult to apply model-based control; therefore, further development is still needed to make full use of the chord length distribution (CLD) information or to improve the transformation accuracy from CLD to CSD. , Many other measurement methods have also been developed for inline or online crystal measurement, such as online imaging, microscopy, Raman spectroscopy, and ultrasound, as reviewed in the references. ,, …”

Section: Challenges and Opportunitiesmentioning

confidence: 99%

Progress and Opportunities for Utilizing Seeding Techniques in Crystallization Processes

Zhang

Shan

Wang

et al. 2021

Org. Process Res. Dev.

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Seeding is a significant but challenging task for optimizing crystallization process operation, product quality, and process efficiency. With the development of modern crystallization technology, there have been considerable advancements in seeding techniques in recent years. This article elaborates on how seeds affect the crystallization process, clarifies the qualitative connection between seeding parameters, defines the variables and product quality attributes based on a variable-based causal graph, and analyzes various possible factors that result in seeding-technique failure based on an Ishikawa diagram. The development of seeding-technique studies and existing problems are then systematically reviewed and discussed based on the qualitative and quantitative characteristics of seeds and the factors that influence seeding efficiency. Based on extensive research accomplishments, the challenges and opportunities for utilizing seeding techniques are analyzed, and potentially valuable seeding-technique topics and directions for improving crystallization are presented. In addition, a framework to guide seed recipe design and optimization is defined by combining simulation and experimental verification.

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“…Various methods have been developed for solid particles, but certain methods can also be used for gas bubbles, although these are physically different from solid particles. A detailed overview of different methods for measuring particle size distributions can be found in [106,107].…”

Section: Bubble Size Distribution Measurementmentioning

confidence: 99%

Oxygen Mass Transfer in Biopharmaceutical Processes: Numerical and Experimental Approaches

Seidel

Maschke

Werner

et al. 2020

Chemie Ingenieur Technik

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This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. Dedicated to Prof. Dr.-Ing. Matthias Kraume on the occasion of his 65th birthday Oxygen supply in aerobic bioprocesses is of crucial importance. For this reason, this paper presents the oxygen demand of different cells and summarizes experimental and numerical possibilities for the determination of oxygen transfer in bioreactors. The focus lies on the volumetric oxygen mass transfer coefficient (k L a) calculation using computational fluid dynamics and state-of-the-art models for surface-aerated and forced-aerated bioreactors. In addition, experimental methods for the determination of the k L a value and the gas bubble size distribution are presented.

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Optical inline analysis and monitoring of particle size and shape distributions for multiple applications: Scientific and industrial relevance

Cited by 34 publications

References 68 publications

Process Analytical Technology for the Production of Parenteral Lipid Emulsions According to Good Manufacturing Practices

Process Analytical Technology for the Production of Parenteral Lipid Emulsions According to Good Manufacturing Practices

Progress and Opportunities for Utilizing Seeding Techniques in Crystallization Processes

Oxygen Mass Transfer in Biopharmaceutical Processes: Numerical and Experimental Approaches

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