Validating rapid micro methods

28-Nov-2017 17:33

The development of a meaningful strategy for the implementation of rapid microbiological methods requires a certain level of knowledge, skills and competencies on the subject, including the scientific, regulatory and business expectations when assessing and validating RMM technologies.

Important end of the story is the road map to regulatory acceptance of this Rapid Sterility Test, now approved by FDA CDER, FDA CBER, MHRA and by the European Medicines Agency for a number of Novartis sterile products.Against this background, the safety of such new technologies, products and applications becomes more importance.One important topic in the focus of risk assessment and safety is the contamination with microorganisms and mycoplasmas and their detection, prevention and control.The Encyclopedia of Rapid Microbiological Methods is a culmination of many years of research, development and implementation of new technologies by a number of industry sectors, including pharmaceuticals, medical device, cosmetic and personal care, health and clinical, food and beverage, and municipal water, as well as government agencies and their subsidiaries, including bio-defense laboratories, first responders and homeland security.

Furthermore, support for novel ways in which to conduct microbiological assays is becoming the norm for both regulatory agencies and pharmacopoeias, as demonstrated in recent initiatives and guidance documents provided by the FDA, EMEA, USP and Ph. The encyclopedia attempts to pull together the opinions of these organizations, suppliers of new microbiology platforms, and the laboratories and endusers of the technologies that will be discussed within its pages.provides an overview of microbiological methods and opportunities for industry, regulatory and pharmacopoeial perspectives, and validation strategies.To meet zero-tolerance levels, detection methods need to be sensitive down to a single pathogen in a prescribed sample.