This chapter provides guidance for how to identify, validate, and implement rapid
microbiological methods (RMMs) for applications associated with the manufacture and …

Relying on practical examples from the authors' experience, this book provides a thorough
and modern approach to controlling and monitoring microbial contaminations during the …

As the Practical Handbook Series has gone from Dr. O'Leary's original first edition published
in 1989 to the editions published in 2009 and 2015, we have tried to expand the group of …

РЕЗЮМЕ Введение. Показана возможность выделения и количественного
определения микроорганизмов с помощью системы «Milliflex® Quantum»(«Merck» …

This chapter provides general information on the various methods used to estimate the
number of microorganisms in a given sample. The MPN method is useful in the estimation of …

FOR THE VALIDATION of alternate microbiological methods, it is necessary to demonstrate
that the accuracy of the alternate method is equivalent or non-inferior to the compendial …

Introduction. It has been shown that the Milliflex® Quantum system (Merck, Germany) that
combines a traditional method of membrane filtration and fluorescent staining of …

Standard techniques for the detection and quantification of bacteria and fungi from drugs are
not adequate for rapid (less than 24 hours) assessment of injured or uncultivated …

РЕЗЮМЕ Стандартные методы обнаружения и количественного определения
бактерий и грибов из лекарственных средств (ЛС) не подходят для быстрой оценки …