Advanced Technologies for Bioburden Monitoring in Compliance with EU GMP Annex 1 Guidelines
EducationalHow to manage the revision of cGMPs Annex 01 for sterile products
2025-06-04 | 02:00 PM - 02:15 PM | TPD Room
Information
As regulatory expectations evolve, the pharmaceutical industry faces increasing pressure to adopt advanced, data-driven strategies for contamination control. The revised EU GMP Annex 1 underscores this shift by emphasizing continuous environmental and utility monitoring as a core component of contamination control strategy (CCS). In alignment with these principles, the implementation of automated technologies for bioburden monitoring has become essential to ensure compliance, improve process control, and safeguard product quality.
This presentation focuses on the application of flow cytometry and integrated optical detection modules as cutting-edge solutions for real-time monitoring of Water for Injection (WFI) and airborne particles. These methods significantly outperform traditional culture-based techniques, offering advantages such as near-instantaneous detection, enhanced sensitivity, and minimal human intervention. Their ability to support continuous, real-time data acquisition ensures robust process understanding and faster deviation response—key expectations under Annex 1.
In addition to regulatory and operational benefits, automated bioburden monitoring systems offer notable sustainability advantages. They reduce the consumption of water, media, and single-use plastics while lowering energy and labor demands—contributing to greener, more efficient manufacturing processes.
Attendees will explore how these technologies can be validated, integrated, and scaled across facilities, with practical insights into achieving both regulatory compliance and long-term sustainability through innovation.
