alexa Abstract | VALIDATION OF FLUIDIZED BED PROCESSOR (MINI GLATT)

International Journal of Drug Development and Research
Open Access

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Abstract

Validation is a concept that has been evolving continuously since its formal appearance in the United States in 1978. An equipment validation program can be described in four sequential phases: Prequalification, Qualification, Process qualification and Process validation. Prequalification includes vendor specification, design and operation checkout. Qualification includes installation and operational check out including design qualification, installation qualification, operational qualification, performance qualification and maintenance qualification. 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. Fluidizes bed processor (Mini Glatt), a component laboratory device uses the above principle and the equipment is designed to perform drying, granulation and coating (wurster process), after a few changes over the machine tower for the relevant. The validation of Mini Glatt with respect to various functions and parameters was conducted and the study revealed that all the functions and parameters were complying with specifications set and required.

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Author(s): Rathore Garvendra S Gaur Ajay Rathore Shashi Shekhawat Madhu and Gupta Roop N

Keywords

Validation, Qualification, Fluid bed system, Mini Glatt.

 
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