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 DS was established which was delineated in the green region in fig.
Neha Chavan is a Gpcb Scientist for Glatt Air Techniques, Pharmaceutical Services Division and has been a frequent speaker and presenter at pharmaceutical conferences. When X 2 at low level and X 3 at high level, spray drying increased hence fines increased while X 2 at a high level and X 3 at a low level, agglomeration increased.
Using a systematic approach to select critical process parameters.
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Overall, gpxg coating zone increases from lab to pilot scale. Trials were performed to understand behavior of process parameters on pellets quality. Risk priority numbers RPNs were calculated as the product of occurrence, severity and detectability scores. Hydroxypropyl cellulose HPC is used in the formulation as a matrix forming polymer, Microcrystalline Cellulose MCC as the diluent and the pellet former and Propranolol as the Model drug. Prior to optimization, historical data were analyzed and several screening DoE analyses were done.
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.
Analysis of particle coating by spouted bed process. Blackie Academic and Professional; The ypcg coefficient Response surface plot showing the influence of process variables on -a fines, b agglomerates, and c assay Assay was significantly influenced by the linear models of spray rate X 2. The development of the product is normally done in 6″ Wurster with the batch size 0.
The resulting equation for all three responses Y 1 finesY 2 agglomerates and Y 3 assay are presented below:. Quality Risk Management Q9.
The RPN must be calculated for each cause of failure.
Each formulation was pelletized in GPCG 1. 11.1 design matrix comprising 10 experimental runs including 2 centre points was constructed. X 2 and X 3 were the most critical process parameters found affecting on yielded and assay of pellets while X 3 has less impact. Spray rate above optimum over wet the pellets while atomization air pressure increased at same spray rate reduced droplet size and reduced agglomerates generation.
Meurice Research and Development a.s.b.l.
For assay, results were observed in the range of As shown in table 6 predicted and experimentally determined values for Y 1Y 2 and Y 3 were comparable. Yield is an important quality attributes. Wurster column base area considered for theoretical factor calculation in scaling up activity.
The aim of this study was to investigate the influence of process parameters gpvg the pellets quality using an experimental design and risk mitigation performed based on QbD principles for quality product. The quadratic response surface of CQAs as a function of selected variables was given in fig.
Screening of design of experiments Prior to optimization, historical data were analyzed and several screening DoE analyses were done. Hence, value of correlation coefficients found less than 0. The model predicts that process variables represented by flag in fig.
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The correlation coefficients R gpcgg for all three responses indicated good fits to the raw data. SEM images of enteric coated pellets of-a F13, b F14, c F17 and d F19 The agglomerates Y 2 formation was equally influenced by the linear models of spray rate X 2atomization air pressure X 3 and spray rate-atomization air pressure X 2 X 3.
S T P Pharm Sci ;9: 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. Nowadays USFDA also demanding for a scientific approach for scale activity based on development batches.
That space defines the arranges of each CPP, taking into account multivariate interactions. It is not difficult to imagine the example of an extreme shift of a process parameter having a minor impact on a CQA, whether measurable or not . This study indicated that atomization air pressure governed the fines generations, as pressure increased, fines generation increased proportionately.
The influence of liquid spray rate and atomizing pressure on the size of spray droplets and spheroids.