The Glatt’s R&D model, GPCG , for the pharmaceutical, chemical and food industry, has been introduced in India. GPCG PRO / PLUS. WST/G PRO / PLUS. Fluid bed systems. We set the standard. GPCG PRO. WSG PLUS. GPCG PLUS. WSG PRO. GRANULATING. COATING. GPCG 1. inch Wurster. 6 inch Wurster. 2 liter Granulator/Dryer/Coater. mm Rotor. 50 – g. – g. – g. – g. GPCG

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The resulting equation for all three responses Y 1 finesY 2 agglomerates and Y 3 assay are presented below: Three-dimensional surface plot fig.

Qualitative description of the Wurster-based fluid-bed coating process. Development of design space and control strategy The relationship between the process variables and CQAs were described in the design space DS.

Spray rate above optimum over wet the pellets while atomization air pressure increased at same spray rate reduced droplet size and reduced agglomerates generation. We varied the levels of all process parameters mentioned in table 1 and concluded the selected critical process parameters CPPs which needs systemic optimization plan to reduce the risk.

Prior to optimization, historical data were analyzed and several screening DoE analyses were done.

Screening of design of experiments Prior to optimization, historical data were analyzed and several screening DoE analyses were done. Additionally, ratios of air volume ggpcg plate area and spray rate to air volume maintained.

The ideal coating parameters should reduced the generation of fines, and agglomerates and maintain the uniform enteric coat quality from batch to batch.

The batch depth and mass flow density increases. Wurster column base area considered for theoretical factor calculation in scaling up activity. Air volume, spray rate and atomization air pressure, and were evaluated by conducting DoE studies to gain process understanding and remaining kept constant.


Meurice Research and Development a.s.b.l.

Chem Eng Process ;5: Hence, value of correlation coefficients found less than 0. Assay was significantly influenced by the linear models of spray rate X 2. Overall, the coating zone increases from lab to pilot scale. Scale up of pellets can be possible based on complete optimization of process variables, understanding of risk associated with variables and implementation of scale-up factor calculation provided by vendor. Statistical analysis for testing the validity of the models in summarized in table 5.

Pharmaceutical development Q8 R2Current Step 4 version; The development of the product is normally done in 6″ Wurster with the batch size 1. These values were in very close agreement and established the reliability of the optimization procedure.

In table 3, values of CPPs during lab scale and pilot scale are given. The results gpcb 4 showed that the percentage fines generation varied from 0. Quality by design i: In pellet formulation, yield is reduced either due to fine generation or agglomerates formed. The overall coating zone gcpg remain same in the pilot and commercial scale except the height of the Wurster column. RPN is a decision factor based on three ratings: Process parameters for enteric coating of preliminary trials Process parameters Values Batch Size gm Air distribution plate B Wurster column height mm Nozzle tip diameter 1.

Accurately weighed pellets 1. Failure mode scores could range from 1 to [21]. Nowadays USFDA also demanding for a scientific approach for scale activity based on development batches. The use of humidity and temperature profiles in optimizing the size of fluidized bed in a coating process. A full factorial design was applied to develop design space and determine control strategy for pantoprazole enteric coating process, have promising yield, assay and reduced process time.


Otto-von-Guericke-Universität | Lehrstuhl für Thermische Verfahrenstechnik | Equipment

Process parameters for enteric coating of preliminary trials. In scale up of pellets, physical 11 chemical parameters reproduced based on process ran as per scale up factor calculation.

Process variables that could potentially impacted enteric coating process were identified and their associated risk was evaluated based on preliminary trials.

Gpdg emission particle tracking studies of a Wurster process for coating applications. The initial risk assessment of the enteric coating process presented in fig.

Maronga SJ, Wnukowski P. The reading displayed on the screen was noted as the LOD of the sample.

The process variables categorization and risk identification performed based on previous experience and literature before conducting the preliminary gcpg. Comparatively in other trials percentage of agglomerates formation was considerably less. Therefore, the base area of Wurster column plays important role in efficient coating. Air volume cfm 46 58 70 X 2: Enteric coated pellets were placed onto a double-sided carbon tape mounted on studs and sputter-coated JFC, Jeol, Tokyo, Japan with gold.

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Therefore, variables ranked based on RPN value. The DS was established which was delineated in the green region in fig.

Using a systematic approach to select critical process parameters.