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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Assay was significantly influenced by the linear models of spray rate X 2. Only the unknown factor will be the mass effect. Initial risk assessment performed using FMEA tool. Therefore, the base area of Wurster column plays important role in efficient coating.
Accurately weighed pellets 1. The range of independent variables under study is shown in table 2 along with their low, medium, and high levels, which were selected based gppcg the results from preliminary experimentation. In table 3, values of CPPs during lab scale and pilot scale are given. Handbook of psychrometric charts: In trial F13 and F14, high spray level and low atomization air pressure leads to the formation of more agglomerates.
As per the literature, there are selected potential process parameters-product temperature , humidity , inlet air flow , atomization air pressure , spray rate [14,16], column height [11,] responsible for the product quality however others like nozzle tip diameter, filter bags gcg and drying time are also important based on practical experience.
Bottom spray fluidized bed processor Wurster technology supplier hpcg designs all capacity equipment in linear scale which help to make scale up activity easy.
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From the lab to pilot although there is single spray nozzle, but the nozzle is much bigger and can permit higher spray rate. Preliminary trials Initial trials were performed by varying the process parameters to understand the impact on product quality.
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 .
LOD of enteric coated pellets was targeted less than 1. The resulting equation for all three responses Y 1 finesY 2 agglomerates and Y 3 assay are presented below:. The SEM images of enteric coated pellets presented in fig.
Yield is an important quality attributes. Enteric coated pellets were placed onto a double-sided carbon tape mounted on studs and sputter-coated JFC, Jeol, Tokyo, Japan with gold. Using a systematic approach to select critical process parameters.
Meurice Research and Development a.s.b.l.
The negative coefficient Chem Eng Process ;5: Maronga SJ, Wnukowski P. Here attempt to help the industry to plan scale up activity in linear as the demand of regulatory authority to prove extrapolation of design space in commercial scale or in post-approval changes stage. A 2 3 full factorial design with two center points was performed to screen the effect of process parameters on yield and assay to explore the quadratic response surfaces and for constructing a second-order polynomial models using Design Expert Version 8.
Application of spot colour measurement for the optimization of colour coating. Additionally, ratios of air volume to plate area and spray rate to air volume maintained. Taylor and Francis; Dissolution studies Dissolution studies were carried out in two stages.
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The quadratic response surface of CQAs as a function of selected variables was given in fig. When X 2 at 11. 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. Overlay plot to EC process comprised of the overlap region of ranges for the three CQAs-a 46 cfm of air volume, b 58 cfm of air volume, c 70 cfm of air volume and d design space Fig. Experimental validation of design space The multidimensional combination and interaction of independent variables and process gpccg that have been demonstrated to provide assurance of quality is termed as the design space .
Gpfg process variables s et al. S T P Pharm Sci ;9: Qualitative description of the Wurster-based fluid-bed coating process. This study indicated that atomization air pressure governed the fines generations, as pressure increased, fines generation increased proportionately.
The pareto chart was plotted of process variables vs RPN. The variables ranked as high risk i. Spray rate, atomization air pressure, and air volume were the key coating process parameters. The results table 4 showed that the percentage gpgc generation varied from 0.
The RPN must be calculated for each cause of failure.