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Research Journal of Pharmacy and Technology
Year : 2019, Volume : 12, Issue : 2
First page : ( 805) Last page : ( 811)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2019.00140.9

Equipment Qualification of a New Laboratory Tray Dryer

Patil Bahubali N., Tippavajhala Vamshi Krishna, Pai K Girish*

Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Karnataka, State, India

*Corresponding Author E-mail: girish.pai@manipal.edu

Online published on 18 April, 2019.

Abstract

This qualification study deals with the Installation and Qualification of a New Tray Dryer. Granules in the pharmaceutical industry are dried using the different equipment like Fluid Bed Dryer, Belt Dryer, Tray Dryer, Vacuum Tray Dryer, Spray Dryer and Rotary Dryer. In this case, the study was conducted on the newly installed laboratory Tray Dryer. Various documentation requirements like User Requirement Specification, Factory Acceptance Test, Site Acceptance Test, Installation Qualification, Operational Qualification and Performance Qualification were carried out for the equipment. Calibration of measuring devices, the prepared granules were dried using the tray drier and noted the time required to dry the granules. Equipment qualification of newly installed laboratory Tray Dryer was performed meeting all the qualification parameters.

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Keywords

Tray Dryer, User Requirement Specification, Installation Qualification, Operational Qualification and Performance Qualification.

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