A Strategy For Implementing Rapid Microbial Methods

By Gilberto Dalmaso, Sterility Assurance Consulting, A&L Co

Rapid Microbiology

PURPOSE

The purpose of this white paper is to present a strategy to be used and applied for rapid microbiological methods (RMM).

INTRODUCTION

There is a real and growing need in the pharmaceutical microbiology to introduce new analytical methods that can meet the requirements of the pharmaceutical industry. The current microbiological technologies are based on the 19th century. The continued use of these conventional methods proves how successful they have been in the pharmaceutical industry. Changes in the industry are beginning to happen. Technology-driven solutions to drug development and manufacture are beginning to take shape. The main regulatory agencies have recently published a series of guidelines with the purpose to facilitate innovation in the pharmaceutical industries.