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,"RMMs are now being adopted by an increasing number of pharmaceutical companies, contract manufacturers, consumer product companies and laboratories globally to reduce lead times while ensuring product safety. RMM can result in huge savings by shortening microbial hold times and drastically cutting sterility testing time.
"Pharmaceutical and consumer markets are very competitive. As these companies seek to expand and grow, they will face more and more competitive pressure. Rapid turnaround times for microbiological testing methods means that less production and fewer raw materials need to be held in quarantine, awaiting use or shipment and delivery. Fewer inventories mean less working capital and a more efficient supply chain and sales channel. RMM can also add flexibility to a company’s QA/QC programme and a faster response to excursions or errors, " he adds.
The BD FACSMicroCount system works on the proven principal of flow cytometry, which has been used extensively in clinical research applications. The samples are introduced via an automated handling system controlled by the user via a computer workstation. Each sample receives a special dye reagent that is used by the instrument to determine the presences and number of microorganisms.
Microbiology labs are typically viewed today as a cost centre, a necessity to maintain quality standards. The application of the BD FACSMicroCount allows a microbiology laboratory to contribute to the overall efficiency of the entire business raw materials can be tested and more quickly moved into production; in-process components, such as water, can be tested to ensure cleanliness; finished products can be tested and released into the supply chain faster, reducing inventory costs.
All BD instruments and reagents are backed by a world class service and support organisation with unmatched experience in microbiology and flow cytometry. BD delivers comprehensive training, application expertise, excellent technical support, and world-class field service.