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Process Validation, Area and Equipment Qualification: Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification - Tapa blanda
Sinopsis
Manufacturing area with new equipment having high capacity compared to previous one (Production Line) i.e. FBD, RMG, Co Mill and Container Mixer. Manufacturing of Metformin ER 500mg tablets is planned to do in new area with new equipment. As the size and capacity of the equipments are bigger than previous equipments, batch size of Metformin ER tablets is increasing from 0.4 mio to 0.6 mio. As the production in new area and new equipment, qualification of area, equipment, water and air was carried out as per qualification protocol. Now, further the process of optimization was performed for Metformin ER tablets by identifying the critical Process parameters i.e. standardization batch (BATCH I). Before going to start process validation, one standardization batch was taken, where the process optimization of critical parameter like mixing speed, mixing time, lubrication time was carried out; fast, 15 min, 15 min respectively the results for that. Three process validation batches (PV-1, PV-2 and PV-3) of commercial batch size were taken in which Manufacturing Process, critical parameters, Validation status of equipments & Validation criteria’s were considered.
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I had done my b.pharma from east wast college of pharmacy, Bangalore and I done my m.pharma from shri b m shah college of pharmaceutical and research, modasa. I also attended 3 national seminar related to pharmacy profession and published 2 review article and 1 research article.
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Process Validation, Area and Equipment Qualification: Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification
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LAP LAMBERT Academic Publishing, 2013
ISBN 10: 3659405086
ISBN 13: 9783659405082
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Librería: Lucky's Textbooks, Dallas, TX, Estados Unidos de America
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Process Validation, Area and Equipment Qualification Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification
Publicado por
LAP LAMBERT Academic Publishing, 2013
ISBN 10: 3659405086
ISBN 13: 9783659405082
Nuevo
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PAP. Condición: New. New Book. Shipped from UK. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000. Nº de ref. del artículo: L0-9783659405082
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Process Validation, Area and Equipment Qualification: Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification
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LAP LAMBERT Academic Publishing, 2013
ISBN 10: 3659405086
ISBN 13: 9783659405082
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Process Validation, Area and Equipment Qualification Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification
Publicado por
LAP LAMBERT Academic Publishing, 2013
ISBN 10: 3659405086
ISBN 13: 9783659405082
Nuevo
PAP
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Process Validation, Area and Equipment Qualification: Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification
Publicado por
LAP LAMBERT Academic Publishing, 2013
ISBN 10: 3659405086
ISBN 13: 9783659405082
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Process Validation, Area and Equipment Qualification: Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification
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LAP LAMBERT Academic Publishing 2013-06-12, 2013
ISBN 10: 3659405086
ISBN 13: 9783659405082
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Process Validation, Area and Equipment Qualification
Publicado por
LAP LAMBERT Academic Publishing Jun 2013, 2013
ISBN 10: 3659405086
ISBN 13: 9783659405082
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Taschenbuch
Librería: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Alemania
Calificación del vendedor: 5 de 5 estrellas
Taschenbuch. Condición: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -Manufacturing area with new equipment having high capacity compared to previous one (Production Line) i.e. FBD, RMG, Co Mill and Container Mixer. Manufacturing of Metformin ER 500mg tablets is planned to do in new area with new equipment. As the size and capacity of the equipments are bigger than previous equipments, batch size of Metformin ER tablets is increasing from 0.4 mio to 0.6 mio. As the production in new area and new equipment, qualification of area, equipment, water and air was carried out as per qualification protocol. Now, further the process of optimization was performed for Metformin ER tablets by identifying the critical Process parameters i.e. standardization batch (BATCH I). Before going to start process validation, one standardization batch was taken, where the process optimization of critical parameter like mixing speed, mixing time, lubrication time was carried out; fast, 15 min, 15 min respectively the results for that. Three process validation batches (PV-1, PV-2 and PV-3) of commercial batch size were taken in which Manufacturing Process, critical parameters, Validation status of equipments & Validation criteria's were considered. 96 pp. Englisch. Nº de ref. del artículo: 9783659405082
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Process Validation, Area and Equipment Qualification
Publicado por
LAP LAMBERT Academic Publishing, 2013
ISBN 10: 3659405086
ISBN 13: 9783659405082
Nuevo
Tapa blanda
Librería: moluna, Greven, Alemania
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Condición: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Autor/Autorin: Patel MiteshI had done my b.pharma from east wast college of pharmacy, Bangalore and I done my m.pharma from shri b m shah college of pharmaceutical and research, modasa. I also attended 3 national seminar related to pharmacy profess. Nº de ref. del artículo: 5154119
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Process Validation, Area and Equipment Qualification
Publicado por
LAP LAMBERT Academic Publishing Jun 2013, 2013
ISBN 10: 3659405086
ISBN 13: 9783659405082
Nuevo
Taschenbuch
Librería: buchversandmimpf2000, Emtmannsberg, BAYE, Alemania
Calificación del vendedor: 5 de 5 estrellas
Taschenbuch. Condición: Neu. This item is printed on demand - Print on Demand Titel. Neuware -Manufacturing area with new equipment having high capacity compared to previous one (Production Line) i.e. FBD, RMG, Co Mill and Container Mixer. Manufacturing of Metformin ER 500mg tablets is planned to do in new area with new equipment. As the size and capacity of the equipments are bigger than previous equipments, batch size of Metformin ER tablets is increasing from 0.4 mio to 0.6 mio. As the production in new area and new equipment, qualification of area, equipment, water and air was carried out as per qualification protocol. Now, further the process of optimization was performed for Metformin ER tablets by identifying the critical Process parameters i.e. standardization batch (BATCH I). Before going to start process validation, one standardization batch was taken, where the process optimization of critical parameter like mixing speed, mixing time, lubrication time was carried out; fast, 15 min, 15 min respectively the results for that. Three process validation batches (PV-1, PV-2 and PV-3) of commercial batch size were taken in which Manufacturing Process, critical parameters, Validation status of equipments & Validation criteriäs were considered.Books on Demand GmbH, Überseering 33, 22297 Hamburg 96 pp. Englisch. Nº de ref. del artículo: 9783659405082
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Process Validation, Area and Equipment Qualification : Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification
Publicado por
LAP LAMBERT Academic Publishing, 2013
ISBN 10: 3659405086
ISBN 13: 9783659405082
Nuevo
Taschenbuch
Librería: AHA-BUCH GmbH, Einbeck, Alemania
Calificación del vendedor: 5 de 5 estrellas
Taschenbuch. Condición: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - Manufacturing area with new equipment having high capacity compared to previous one (Production Line) i.e. FBD, RMG, Co Mill and Container Mixer. Manufacturing of Metformin ER 500mg tablets is planned to do in new area with new equipment. As the size and capacity of the equipments are bigger than previous equipments, batch size of Metformin ER tablets is increasing from 0.4 mio to 0.6 mio. As the production in new area and new equipment, qualification of area, equipment, water and air was carried out as per qualification protocol. Now, further the process of optimization was performed for Metformin ER tablets by identifying the critical Process parameters i.e. standardization batch (BATCH I). Before going to start process validation, one standardization batch was taken, where the process optimization of critical parameter like mixing speed, mixing time, lubrication time was carried out; fast, 15 min, 15 min respectively the results for that. Three process validation batches (PV-1, PV-2 and PV-3) of commercial batch size were taken in which Manufacturing Process, critical parameters, Validation status of equipments & Validation criteria's were considered. Nº de ref. del artículo: 9783659405082
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EUR 60,81
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Cantidad disponible: 1 disponibles