Merck KGaA, based in Darmstadt, Germany, has introduced the M-Trace Software & Mobile App, designed to digitise sterility testing in microbial quality control.

The offering aims to enhance process safety by automatically documenting each step of the testing workflow, thereby minimising deviations, false positives and human error.

Sterility testing is a critical component of the pharmaceutical industry’s quality control process, ensuring that products such as vaccines and injectables are contaminant-free.

Microbial contamination poses significant risks, potentially exposing patients to harmful pathogens or toxins, leading to severe health consequences or even death.

It can also result in drug degradation, affecting the product’s potency.

The M-Trace software provides pharmaceutical manufacturers with a tool to address safety concerns by alerting them to any errors detected during the testing process.

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It also offers a fully digital solution for maintaining documentation compliance.

The software creates detailed reports that improve data analytics capabilities, facilitating the tracking of trends and simplifying investigations into out-of-specification results.

The company’s portfolio includes AI-powered software for digital chemistry and drug discovery, such as AIDDISON and SYNTHIA retrosynthesis software.

Merck offers tools that digitise traditionally manual processes, including the Digital Reference Materials ChemisTwin platform and cell counting systems MilliCell DCI and Scepter 3.0.

Merck Science & Lab Solutions Life Science business head Jean-Charles Wirth stated: “Microbiological quality control labs are critical to ensuring the safety of sterile medicine. Here, the consequences of noncompliance can be very serious.

“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.”

The latest development comes after Merck announced an investment of more than €300m ($320.8m) in a new Life Science Research Center at its global headquarters in Darmstadt, Germany.