Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements - Couverture rigide

Clontz, Lucia

 
9781574910629: Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements

Synopsis

This invaluable book guides readers through the microbial limit testing methodologies of the major world markets, including the US Pharmacopeia, the European Pharmacopoeia, British Pharmacopoeia, and Japanese Pharmacopoeia. It compares and contrasts various methods and provides easy-to-follow approaches to validation of these test methodologies. Packed with practical guidance on all aspects of bioburden evaluation both for product and for support mechanisms, the book covers microbial ecology, preservation of pharmaceuticals, water, equipment/surfaces and environment, Rapid Test methods, and handling of aberrant data in the lab.

Features

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Présentation de l'éditeur

This invaluable book guides readers through the microbial limit testing methodologies of the major world markets, including the US Pharmacopeia, the European Pharmacopoeia, British Pharmacopoeia, and Japanese Pharmacopoeia. It compares and contrasts various methods and provides easy-to-follow approaches to validation of these test methodologies. Packed with practical guidance on all aspects of bioburden evaluation both for product and for support mechanisms, the book covers microbial ecology, preservation of pharmaceuticals, water, equipment/surfaces and environment, Rapid Test methods, and handling of aberrant data in the lab.

Features

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Autres éditions populaires du même titre

9781420053487: Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements

Edition présentée

ISBN 10 :  1420053485 ISBN 13 :  9781420053487
Editeur : CRC Press Inc, 2008
Couverture rigide