On-line Monitoring of Granule Growth in High Shear Granulation by an Image Processing System.

Watano, Satoru; Numa, Tetsuya; Miyanami, Kei; Osako, Yoshifumi

doi:10.1248/cpb.48.1154

Cited by 28 publications

(20 citation statements)

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“…In all cases, the pressure transmission increased almost linearly with kneading time. According to our previous study, 8,9) this implied that water dispersion increased and elastic deformation of kneaded mass became easier with elapsed time. Also, there was no obvious difference between kneading and From the results obtained, the kneading process can be explained as follows.…”

Section: Resultsmentioning

confidence: 79%

“…3b) that is usually used for wet granulation has no effect to press down the powder bed. Also, due to the high centrifugal force and upward force from agitator blade, powder bed makes a vortex flow, 4,5) which causes heavy sticking on the wall of the vessel, especially in the wet kneading of high moisture content levels and of adhesive materials.…”

mentioning

confidence: 99%

“…8,9) As previously reported, the tester consisted of a hydraulic pump, displacement sensor, upper and lower punches, cylinder, and personal computer. A cylinder having outside diameter of 40 mm, inside 11.3 mm (cross sectional area was just 1.0 cm 2 ) and height of 110 mm was placed between the upper and lower punches and 3.0 g of wet kneaded mass was fed into the cylinder.…”

mentioning

confidence: 99%

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Development of a Novel Vertical High Shear Kneader and Its Performance in Wet Kneading of Pharmaceutical Powders.

Watano

Okamoto

Tsuhari

et al. 2002

CHEMICAL & PHARMACEUTICAL BULLETIN

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Kneading of powder materials [1][2][3] has been well used in the pharmaceutical, agriculture, food, chemical, forage and fertilizer industries. Most of the cases, kneading operation is conducted just before the extrusion or molding processes, and the performance of kneading seriously affects quality of the final product or process efficiency. Therefore, it is important to quantitatively analyze and monitor the kneading process.So far, a high shear mixer has been well used for wet granulation 4) as well as for wet kneading. In the case that the high shear mixer is used for wet kneading, several advantageous points such as easy to disassemble with easy cleaning can be pointed out. However, the problems such as enormous sticking on the vessel wall or larger physical strength of extruded pellets that may cause longer dissolution time have also been known on the contrary. It is required to improve the problems of high shear mixer while keeping the advantageous points when applied to wet kneading.In this study, a multi-functional vertical high shear kneader has been newly developed and applied for wet kneading. Wet kneading of pharmaceutical powders composed of acetaminophen and excipients was conducted under various blade components and operating conditions. Dispersion of aqueous binder and compression properties of wet mass was investigated to quantitatively analyze the kneading condition. Dried pellets were then produced through a dome type extrusion granulator and a fluidized bed drier, and physical properties of the pellets were examined experimentally.Comparison between kneading performance of the novel kneader and of a conventional high shear mixer (granulator) was also conducted. ExperimentalApparatus Figure 1 shows a schematic diagram of multi-functional vertical high shear kneader (SPG-10, Fuji Paudal Co., Ltd.) developed. The vessel is a laboratory size, which has an inner diameter of 290 mm and a capacity of 10 l. The bottom of the vessel is equipped with a kneading blade that rotates horizontally. Several operating parameters such as torque of main shaft, power consumption of motor drive and temperature of kneaded mass can be continuously measured and monitored via a personal computer. Chopper blade can also be installed onto the sidewall of the vessel, if necessary. Figure 2 illustrates a newly developed kneading blade, and Fig. 3 shows appearance of various blades used. The kneading blade is composed of four parts; (a) scraper, (b) main blade, (c) dispersion blade, and (d) cap. The main blade has an edge having inclination of 20 degrees to the backward, opposite direction of the blade movement. This is designed so as to press down the wet kneaded mass, and to add high compaction force and high shear stress to the mass (typically, main agitator blade of high shear mixer (granulator) has an edge to the opposite direction of our kneading blade, thus powders are lifted up by the edge inclination). The dispersion blade equipped on the top of the main blade works to move away the wet mass to the vessel outsid...

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Section: Resultsmentioning

confidence: 79%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Development of a Novel Vertical High Shear Kneader and Its Performance in Wet Kneading of Pharmaceutical Powders.

Watano

Okamoto

Tsuhari

et al. 2002

CHEMICAL & PHARMACEUTICAL BULLETIN

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“…Hence, the change in PSD during granulation gives a direct indication of the batch progress and batch quality. Several techniques have been evaluated to monitor PSD during granulation in real-time: near infrared spectroscopy (Alcala et al, 2010;Findlay et al, 2005;Frake et al, 1997;Goebel and Steffens, 1998;Kaddour and Cuq, 2009;Luukkonen et al, 2008;Tok et al, 2008), focused beam reflectance method (Hu et al, 2008;Huang et al, 2010;Tok et al, 2008), spatial filter velocimetry (SFV) (Burggraeve et al, 2010;Lipsanen et al, 2008;Narvanen et al, 2008Narvanen et al, , 2009), image analysis (Laitinen et al, 2004;Naervanen et al, 2008;Watano and Miyanami, 1995;Watano et al 1996Watano et al , 1997Watano et al , 2000Watano et al , 2001Watano, 2001) and acoustic emission monitoring (AE) (Gamble et al, 2009;Halstensen et al, 2006;Matero et al, 2009;Tok et al, 2008;Whitaker et al, 2000). Each technique has its own advantages and shortcomings.…”

Section: Introductionmentioning

confidence: 99%

Batch statistical process control of a fluid bed granulation process using in-line spatial filter velocimetry and product temperature measurements

Burggraeve

Kerkhof²,

Hellings³

et al. 2011

European Journal of Pharmaceutical Sciences

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Fluid bed granulation is a batch process, which is characterized by the processing of raw materials for a predefined period of time, consisting of a fixed spraying phase and a subsequent drying period. The present study shows the multivariate statistical modeling and control of a fluid bed granulation process based on in-line particle size distribution (PSD) measurements (using spatial filter velocimetry) combined with continuous product temperature registration using a partial least squares (PLS) approach. Via the continuous in-line monitoring of the PSD and product temperature during granulation of various reference batches, a statistical batch model was developed allowing the real-time evaluation and acceptance or rejection of future batches. Continuously monitored PSD and product temperature process data of 10 reference batches (X-data) were used to develop a reference batch PLS model, regressing the X-data versus the batch process time (Y-data). Two PLS components captured 98.8% of the variation in the X-data block. Score control charts in which the average batch trajectory and upper and lower control limits are displayed were developed. Next, these control charts were used to monitor 4 new test batches in real-time and to immediately detect any deviations from the expected batch trajectory. By real-time evaluation of new batches using the developed control charts and by computation of contribution plots of deviating process behavior at a certain time point, batch losses or reprocessing can be prevented. Immediately after batch completion, all PSD and product temperature information (i.e., a batch progress fingerprint) was used to estimate some granule properties (density and flowability) at an early stage, which can improve batch release time. Individual PLS models relating the computed scores (X) of the reference PLS model (based on the 10 reference batches) and the density, respectively flowabililty as Y-matrix, were developed. The scores of the 4 test batches were used to examine the predictive ability of the model.

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“…However, agitating granulation process is associated with many operating parameters, which can be classified as apparatus variables (vessel shape and impeller shape), process variables (method of binder addition, wet kneading time and impeller speed) and product variables (powder properties, formulation and binder liquid volume). Both the evaluation of wet granulation and the analysis of observed behavior are very difficult.Many researchers [1][2][3][4][5][6] have studied the determination method for the critical parameters involved in wet granulation and wet kneaded mass; furthermore, they investigated the effects of such parameters on the granule size, its distribution and density. Although properties of wet granules are not directly and universally quantified by using the torque rheometry and power consumption measurements specific to respective machines, some attempts 7-9) have been carried out on the evaluation of granulation and its end point determination.…”

mentioning

confidence: 99%

Rheological Analysis and Quantitative Evaluation of Wet Kneaded Wax Matrix

Abe¹,

Suzuki²,

Ootsuki³

et al. 2004

CHEMICAL & PHARMACEUTICAL BULLETIN

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Clarification of various factors affecting the quality characteristics of product and establishment of an acceptable range of characteristics play an essential role in stable manufacturing of the sophisticated and desired products. Wet mass properties during agitating granulation process provide strong influence on the quality of final products, and this process is widely used in the pharmaceutical, the plastic and the foods industries. However, agitating granulation process is associated with many operating parameters, which can be classified as apparatus variables (vessel shape and impeller shape), process variables (method of binder addition, wet kneading time and impeller speed) and product variables (powder properties, formulation and binder liquid volume). Both the evaluation of wet granulation and the analysis of observed behavior are very difficult.Many researchers [1][2][3][4][5][6] have studied the determination method for the critical parameters involved in wet granulation and wet kneaded mass; furthermore, they investigated the effects of such parameters on the granule size, its distribution and density. Although properties of wet granules are not directly and universally quantified by using the torque rheometry and power consumption measurements specific to respective machines, some attempts 7-9) have been carried out on the evaluation of granulation and its end point determination. Nevertheless, few reports have focused on the related properties of the wet kneaded mass to the dissolution of sustained-release drug despite of the fact that many different types of sustained-release dosage forms are urgently needed by medical circles to improve clinical efficacies and relevant patient compliance. 10)Watano et al. [11][12][13] have recently demonstrated that properties of the wet kneaded mass are directly characterized by internal pressure transmissions which are determined by using a newly developed compression tester instead of the torque rheometry. Furthermore, it was also documented that the pressure transmissions were strongly associated with water dispersion among the wet kneaded mass. Despite of these available findings, however, the pressure transmissions of the wet kneaded mass are not well identified. What's worse, to make full use of the features of the wet kneaded mass for manufacturing the sustained-release dosage forms, e.g. wax matrix products, all we have to do is to address the relationship between the pressure transmissions and the drug dissolution. In the present study, the author managed to expand the pressure transmission to the form of the rheological behavior to identify the character of the transmission. Scrutinized investigations about the expanded pressure transmission disclosed the plastic property of the wet kneaded mass that turned out to be the most decisive and direct criterion in the kneading process control. It is because the kneading process subjects the powder sample to be plastic for the preparation of the extrusion granulation. From a theoretical point of view, the e...

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On-line Monitoring of Granule Growth in High Shear Granulation by an Image Processing System.

Cited by 28 publications

References 1 publication

Development of a Novel Vertical High Shear Kneader and Its Performance in Wet Kneading of Pharmaceutical Powders.

Development of a Novel Vertical High Shear Kneader and Its Performance in Wet Kneading of Pharmaceutical Powders.

Batch statistical process control of a fluid bed granulation process using in-line spatial filter velocimetry and product temperature measurements

Rheological Analysis and Quantitative Evaluation of Wet Kneaded Wax Matrix

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