Real-time process monitoring in a semi-continuous fluid-bed dryer – microwave resonance technology versus near-infrared spectroscopy

Peters, Johanna; Teske, Andreas; Taute, Wolfgang; Döscher, Claas; Höft, Michael; Knöchel, R.; Breitkreutz, Jörg

doi:10.1016/j.ijpharm.2017.12.040

Cited by 22 publications

(6 citation statements)

References 31 publications

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“…They analyzed the obtained data by MLR and PLS as a quantitative calibration model, confirming the difference between the two instruments. Unlike with previous NIRS devices, monitoring large amounts of moisture by MRT was difficult, indicating that the NIRS equipment is suitable for continuous process monitoring and control [ 247 ]. Furthermore, Figure 3 shows that PAT using NIR could be utilized for a control strategy determining the endpoint of fluidized drying process [ 248 ].…”

Section: Application Of Pat Framework For Control Strategy Of the Unit Operationsmentioning

confidence: 99%

Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Kim

et al. 2021

Pharmaceutics

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Various frameworks and methods, such as quality by design (QbD), real time release test (RTRT), and continuous process verification (CPV), have been introduced to improve drug product quality in the pharmaceutical industry. The methods recognize that an appropriate combination of process controls and predefined material attributes and intermediate quality attributes (IQAs) during processing may provide greater assurance of product quality than end-product testing. The efficient analysis method to monitor the relationship between process and quality should be used. Process analytical technology (PAT) was introduced to analyze IQAs during the process of establishing regulatory specifications and facilitating continuous manufacturing improvement. Although PAT was introduced in the pharmaceutical industry in the early 21st century, new PAT tools have been introduced during the last 20 years. In this review, we present the recent pharmaceutical PAT tools and their application in pharmaceutical unit operations. Based on unit operations, the significant IQAs monitored by PAT are presented to establish a control strategy for CPV and real time release testing (RTRT). In addition, the equipment type used in unit operation, PAT tools, multivariate statistical tools, and mathematical preprocessing are introduced, along with relevant literature. This review suggests that various PAT tools are rapidly advancing, and various IQAs are efficiently and precisely monitored in the pharmaceutical industry. Therefore, PAT could be a fundamental tool for the present QbD and CPV to improve drug product quality.

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Section: Application Of Pat Framework For Control Strategy Of the Unit Operationsmentioning

confidence: 99%

Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Kim

et al. 2021

Pharmaceutics

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“…Peters et al [106][107][108][109][110] developed a multi resonance microwave sensor, and carried out a series of laboratory and pilot scale-up studies, which could be used in the production of specific drugs (donepezil hydrochloride). Samples with different process parameters were used to establish a satisfactory moisture prediction model.…”

Section: Microwave Resonance Technologymentioning

confidence: 99%

Granulation process analysis technologies and potential applications in traditional Chinese medicine

Cui

Hou

Feng

et al. 2022

Acupuncture and Herbal Medicine

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Pharmaceutical production is changing from batch production to continuous production, during which granulation is one of the most important unit operations. The quality of mass-produced products is traditionally guaranteed by conducting off-line testing, which cannot meet the demand of continuous production for real-time monitoring of critical process parameters and critical quality attributes (CQAs) of the pharmaceutical granulation technology. Since the U.S. Food and Drug Administration proposed process analytical technology (PAT) in 2004, many PAT tools have been developed to monitor the granulation process and provide information regarding the granulation operation conditions and endpoint determination. In this article, we review the recent research and application of two PAT modes in the granulation process, namely, single CQA and multi-CQA PAT, with the aim to provide references for comprehensively improving the technological level of the pharmaceutical granulation process. Furthermore, the potential applications in traditional Chinese Medicine are discussed.

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“…As shown here and also described in literature, the residual water content is of high impact for further processing of granules and therefore can be also considered as a cMA. Different papers describe model-based approaches to predict and control the residual water content for continuous fluid bed drying processes [31,33,83,93].Within this thesis a simple drying capacity parameter is presented to estimate dryer performance at different equipment scales (see chapter 7.4).…”

Section: Summary and Qbd Learningmentioning

confidence: 99%

Continuous twin screw granulation and fluid bed drying: A mechanistic scaling approach focusing optimal tablet properties

Menth

Maus

Wagner

2020

International Journal of Pharmaceutics

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Real-time process monitoring in a semi-continuous fluid-bed dryer – microwave resonance technology versus near-infrared spectroscopy

Cited by 22 publications

References 31 publications

Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Granulation process analysis technologies and potential applications in traditional Chinese medicine

Continuous twin screw granulation and fluid bed drying: A mechanistic scaling approach focusing optimal tablet properties

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