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Same-Day Mold Detection Becomes Reality

POSTED BY Rapid Micro Biosystems | 4 minute read

Mold contamination in cleanrooms and production areas is a major worry for pharma manufacturers, because rapidly spreading molds have traditionally been able to compromise facilities even before their presence has been fully confirmed. That’s why many industry players took great interest in the 2022 launch of RMBNucleus™ Mold Alarm by Rapid Micro Biosystems, intrigued by its potential for real-time mold detection and early intervention.

Now that a year or so has passed, you might be wondering: how well has it worked?

To answer that question, RMB researchers studied results obtained with our automated mold detection system in several Class A/B and C/D environments to simulate routine-use prior to validation then compared with data from manual/visual methods. Their findings were summarized in a technical poster presented earlier this month at the annual Parenteral Drug Association (PDA) Pharmaceutical Microbiology Conference.

Here are the key points:

  • RMBNucleus™ Mold Alarm delivers 76% faster time to detection in Class A/B cleanrooms, and 73% faster time to detection in Class C/D cleanrooms, than the manual method of detection
  • Mold detection accuracy was 100% compared to 47–65% accuracy in initial detection by human operators, resulting in improved QC Micro experience and reduced risk
  • Remediation and re-sampling can now occur within one day, reducing the possibility of additional excursions during investigation
  • While zero-tolerance policies do require identification of molds for trending, identifications can occur in parallel rather than gating other remediation activities

Real-Time Mold Detection Utilizing the Growth Direct® System

The unique combination at the heart of these improvements is the Growth Direct® System’s automated colony counting capabilities, newly upgraded with the latest version of RMBNucleus™ Mold Alarm algorithm enhancement software.

Users can now confirm the qualitative presence of mold in less than 24 hours, detecting a panel of 16 common environmental mold isolates with ≥ 95% accuracy. In software verification studies, automated mold detection was shown to detect mold when present across those 16 species within 12–24 hours, with a consistent overall count within validated testing parameters of 72 hours. The case studies described above confirm the software verification studies time-to-detection and accuracy of performance with natural environmental monitoring isolates.


The Value and Benefits of Rapid Mold Detection in the Pharmaceutical Industry

Avoiding 4-Eyes Uncertainty and Regulatory Risk

Ask Rapid: Understanding Algorithms

In environmental monitoring (EM) applications, the Growth Direct® System automatically detects the presence or absence of mold and provides the total count in 50% of the time required with traditional manual methods. Your EM testing workflow can benefit as a result, while eliminating the need for additional operator assessment and the potential for human error. This also leads to faster remediation, using validated cleaning procedures to return facilities to a decontaminated state.

To learn more, check out our webinar on rapid mold detection and proper remediation. Or contact Rapid Micro Biosystems today.

Blog by Danielle DeCesaro, Product Manager, Growth Direct® Automation at Rapid Micro Biosystems.