Lonza wanted to achieve paperless quality control (QC) laboratories using automated digital systems. As part of this ambition, Lonza sought an end-to-end (E2E) automated solution to optimize environmental monitoring (EM) at four of its Cell & Gene Manufacturing sites across North America, Europe, and Asia.

Lonza successfully integrated the MODA-EM® Module with Rapid Micro Biosystems' Growth Direct® System, combining paperless processes with automated microbial enumeration for pharmaceutical QC. To our knowledge, the project was the first industry implementation of an E2E automated incubation and read-out process for EM.

Impact: As a result of the integration, Lonza achieved:

• More accurate testing: Lonza reduced human error and improved data integrity.
• Faster processes: the E2E solution reduced time-to-detection and TTR to <72 hours (down from up to 8 days previously).
• Better compliance: Increased automation and standardization resulted in greater synergy across data management, aiding compliance and facilitating cost savings.

"This project provides a valuable blueprint for the industry to emulate," commented Willem Dullaers, Lonza Associate Director of Strategy, Innovation, and Systems. 

A smoother road towards regulatory acceptance

Make your validation journey a smooth transition by working with a partner with proven technology and experience. At RMB, we have developed a validation pathway that simplifies the adaptation from compendial methods to RMM:

Comprehensive support: RMB provides end-to-end support, from initial feasibility studies to full-scale deployment. No matter the size of your operations, our team of experts assist with every step of the validation process. Read about Lonza’s customer journey working with RMB: Building a Digitalized End-to-End Process for Environmental Monitoring.

Proven technology: Our Growth Direct® system has been validated and proven in various applications, including environmental monitoring and bioburden testing. The robustness and accuracy of the technology have been demonstrated through an extensive body of peer-reviewed research, providing a solid foundation for sterility testing validation.

By following RMB’s tried and tested validation pathways, you can transition to RMM with confidence.

Building a Digitalized End-to-end Process for Environmental Monitoring - Download Whitepaper.