MilliporeSigma, the US and Canada Life Science business of Merck KGaA, has rolled out its M-Trace Software and Mobile App, a comprehensive data tracking solution to digitize sterility testing.

The software increases overall process safety by automatically documenting data for every step of the testing process. This reduces the likelihood of deviation, false positive results, and the possibility of human error.

“Microbiological quality control labs are critical to ensuring the safety of sterile medicine. Here, the consequences of noncompliance can be very serious,” said Jean-Charles Wirth, Head of Science and Lab Solutions for the Life Science business of Merck.

“Our job is to offer the solution that ensures drugs are safe and brought to market to the patients who need them the most -- so data traceability is essential. Digital innovations like M-Trace bring us one step closer to making the ‘Lab of the Future’ a reality,” Wirth added.

Sterility Testing is the last step of the quality control workflow used by the pharmaceutical industry. It ensures that products such as vaccines, ophthalmic solutions, chemotherapies, and other injectables are 100 percent free of contaminants. Microbial contamination can expose patients to pathogens/toxins that cause serious metabolic harm or lead to death. Another possible effect is drug degradation resulting in reduced potency.

M-Trace allows drug manufacturers to mitigate safety concerns by notifying of any errors spotted during the process. Furthermore, it provides a complete digital solution for documentation compliance. M-Trace generates comprehensive reports that enhance data analytics to track trends and ease investigations into out-of-specification results.

Merck is invested in enabling the ‘Lab of the Future’ through innovative workflows to revolutionize scientific research and development. To extract insights from vast amounts of data, solutions are becoming more automated, more autonomous and more continuous. Some of these technologies include AI-powered software pieces focused on digital chemistry and drug discovery, like AIDDISON AI-powered drug discovery software and SYNTHIA Retrosynthesis Software.

Other tools digitize processes that have always been manual, like the Digital Reference Materials ChemisTwin platform or cell counting systems like MilliCell DCI and Scepter 3.0. With the addition of M-Trace, Merck continues to support scientists at all stages with solutions that can increase efficiency, safety and success rates of delivering new, safer therapies for patients.