DUBAI, United Arab Emirates — In early Q2 2023, the life science division of Merck Millipore launched a new and innovative product aimed at the pharmaceutical industry: the Milliflex Rapid System 2.0.
The product is the perfect rapid solution for bioburden and sterility testing needs.
Sterility testing is a mandatory release test for all drug products in the pharmaceutical industry purported to be sterile (EP 6.3, chapter 2.6.1, EP 7.0, chapter 5.1.9/ USP). The traditional sterility test requires an incubation time of at least 14 days to get the result. However, by changing the traditional test approach from liquid media incubation to solid nutrient media, and the detection from visual inspection to an automated bioluminescence assay, the Milliflex® Rapid System 2.0 reduces the time-to-result substantially down to 5 days.
The Milliflex Rapid System 2.0 can be used as a standalone test system or within a networked environment. 21 CFR PART 11 compliance ready. It has the ability to detect microorganisms up to four times earlier than the current traditional method. Its intelligent technology recognizes and counts grown micro-colonies of viable microorganisms. Filtered onto the system filter down to 1 colony forming unit (1 CFU), the Milliflex Rapid Sterility Test has also been successfully validated and implemented by various pharmaceutical companies over the years.
The Milliflex Rapid System 2.0 achieves highly consistent and reliable results. It can clearly distinguish between mixed microbial growth of slow-growing and fast-growing microorganisms, variances in colony size and adenosine triphosphate (ATP) content in filtrable samples.
Commenting on behalf of Merck Life Science, Dr. Robert Nadaskay – Biomonitoring in Middle East & Pakistan; said:
“I am proud to share with our customers, that Milliflex Rapid 2.0 was recently launched in the Middle East region. Having a strong validation and implementation support, this system allows to finalize the Sterility Testing within five days. It provides a significant advantage in order to shorten the time to result in comparison to the traditional 14 days.”
The product will be displayed on the booth of Gulf Scientific Corporation, their main distributor in UAE and the GCC, during the ArabLab event, one of the largest trade shows and exhibitions that focuses on laboratory and analytical technology, instrumentation, equipment, and services.