Fluidized bed drying is the optimal method for controlled, gentle and even drying of wet solids. The intensive heat/mass exchange of the fluidized bed product. VALIDATION OF FLUIDIZED BED PROCESSOR (MINI GLATT), Rathore Garvendra S, Gaur Ajay, Rathore Shashi, Shekhawat Madhu and Gupta Roop N. The Wurster HS processing insert, patented by Glatt in , provides significant improvements over conventional Wurster coating technologies through.
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Sometimes termed process validationthis is the stage at which equipment is used in earnest. Company Profile Email Us. The key elements of a validation programme are clearly defined and documented in a validation master plan VMP .
Processes Processpr Fluidized bed coating. The majority of air is directed through the inner partition.
Fluid Bed Wurster HS Coating Systems from Glatt Air Techniques
URS of Mini Glatt fluidizes bed processor was prepared by a coordinated approach among production, quality assurance, and engineering department of Astron Research Ltd. Processes Coating Fluidized bed coating Bottom spray. The nozzle fludi upward providing concurrent application of coating to the particles.
Aqueous or solvent based coatings Polymeric solutions or dispersions Sustained release coatings Enteric release coatings Fine particle coating Active Layering Pilot scale equipment is available at Glatt’s Ramsey New Jersey Process Development Laboratory for testing and customer fluuid.
A written report summarizing results and conclusions should be recorded, prepared and stored . Fluidized bed spray coating Solutions for coating small particles Spray coating in a fluidized bed system produces an optimal surface coating for your product through even application of a film material. Process Validation of a Year retrospective study of solid dosage forms.
Validation should thus be considered in the following situations : Coating can take place as top spray, tangential spray, bottom spray Wurster process or rotor process, depending from which direction the particles are being sprayed.
Fluidized bed drying – Glatt Integrated Process Solutions
The method is suitable particularly for adding specific functions to particles — such as to achieve a defined and reproducible release profile for an active substance by way of the membrane applied. An equipment validation program can be described in four sequential phases: A typical particle size is micrometers up to 3 millimeters. Drug Inf J, ; For targeting specific functions in your product.
An air-atomizing nozzle in the center of the distribution plate introduces the coating solution. Prequalification, Qualification, Process qualification and Process validation.
VALIDATION OF FLUIDIZED BED PROCESSOR (MINI GLATT)
Spray coating can be performed — hed in batch processing — in all fluidized bed systems. In the pharmaceutical industry, this innovative method has replaced the time-consuming tray drying long ago: A fluid bed system brings powdery or grained substances bulk material in a floating condition, with the carrying air flow enabled to exchange heat and substances with the floating material.
The efficient solution for controlled particle drying Fluidized bed drying is the optimal method for controlled, gentle and even drying of wet solids. Particles are drawn into the inner partition by the pressure differential created by the difference in air velocities between the two partitions.
In addition, fluidized bed drying provides controlled and uniform drying conditions compared to the fluir drying in trays. Tropical Journal of Pharmaceutical Research, December ; 1 2: For the process variants spray granulation, spray agglomeration or spray goatt, it should be noted that not only the moisture needs to evaporate until it has reached a defined residual value, but also that drying takes place during the entire spray process.
The aqueous or organic solution evaporates and the solids it contains form the coating layer. The result is optimal film quality. The drying process with fluidized bed drying reduces the drying time in the drying oven by approximately twenty times.
In bottom spray coating, spraying is done from below upwards. Major elements of qualification protocol are given in Fig. As gravity overcomes the force of the fluidized air, the particles fall back into the outer partition where they are suspended in a slow moving “down bed”. This will delay the entire drying process rather than accelerate it. The inlet air temperature must be selected such that only so much moisture evaporates from the surface of the granulate as is transported through the capillaries from the interior of the granulate to the surface.
An air distribution plate is located at the lower end of the product container to distribute fluidizing air between the inner and outer partitions. It covers the initial validation of new processes, subsequent validation of modified processes and re-validation. Thus, very small particles can also be coated without agglomeration. Glatt India Pharma Engineering Pvt. Test run of the equipment for granulation Top spray was done for both minimum and maximum load of the equipment.
The study revealed that all the functions and parameters were complying with specifications set and required. Can’t read the image?
Bottom spray – Glatt Integrated Process Solutions
Committee on Specifications for Pharmaceutical Preparations. All the above parameters were checked and installation qualification complies with the requirements and was accepted. This work is documented in a service logbook. All the samples analysed complies with the requirements and are with in acceptable limits.