home.aspx

 
.

ALTERNATIVE AND RAPID MICROBIOLOGICAL METHODS: MICROBIOLOGY OF THE 21ST CENTURY

September 12, 2019
USA (United States of America)
Today Pharmaceutical industry remains conservative for microbiology testing methods and has the reluctance to develop and to use Alternative and Rapid Microbiological Methods (RMM) supported by a number of misunderstandings and prejudgments based on the following myths RMM are not accepted by regulation authorities, RMM will never replace classical microbial methods, RMM will not offer a return on investment (ROI), Data generated from RMMs will exceed current specifications and limits involving an increase in batch rejections. Nevertheless, a movement is in progress for the use of new technologies and systems because classical microbial methods, in spite of their long return of experiences and their confidence for the regulatory point of view, have a number of disadvantages