In order to meet regulatory needs, reduce inventory and facilitate faster product release for pharma manufacturers, US based medical technology company Becton and Dickinson has launched BD FACSMicroCount System in India which will serve as a first of its kind platform for rapid microbiological testing (RMM).
RMM is done in a laboratory to check for the presence of micro-organism such as bacteria and fungi in a sample. It is required for purposes such as diagnosing diseases or discovering signs of contamination in various pharma products. It also ensures that that products are safe, meet specifications for microbial quality and comply with government regulations.
Traditional microbiological tests are usually based on the growth of the target microorganism. Common bacteria need 1 to 2 days to grow while fungi require 2 to5 days or more. Such long test periods affect product release time and bring a high inventory and risk control cost to enterprises. Besides, it causes difficulties in supervision work of governmental authorities.
Explains Rich Quashne, worldwide product manager, Becton and Dickinson,