Particle Loss in Transport Tubing: How to Address the Annex 1 Requirement
This webinar, after going through the factors that may affect loss in transport tubing, will present case studies about the impact of particle loss in monitoring applications where the use of tubing becomes a standard error.
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Included in the release of EU GMP Annex 1:2022, there is a requirement to review the tubing used in particle counter applications. Most of the existing installations do not comply with this requirement.
This webinar, after going through the factors that may affect loss in transport tubing, will present case studies about the impact of particle loss in monitoring applications where the use of tubing becomes a standard error as the shift of data from regular is more critical than the absoluteness of the result as a singular event. Furthermore, we will show how to measure and statistically estimate the amount of loss, and, how to manage the impact through the interpretation of trended data relative to product risk in the case that tubing losses occur.
Key learning points:
- EU GMP Annex 1 requirements for tubing in particle counters applications
- Factors that may effect loss in transport tubing
- Case studies about the impact of particle loss in monitoring applications
- How to measure and statistically estimate the amount of loss
- How to manage the impact through the interpretation of trended data
Who should attend:
- QC (micro managers and/or supervisors)
- QA (on the floor for filling lines)
- Project Managers
- QP and Plant Managers
- Production Supervisors and Managers
- Engineering (MS&T Engineers)
Speakers
Serena Steidl
EMEA Advisory Project Coordinator, Particle Measuring Systems
Serena is a microbiologist with a strong background in biotech and pharma manufacturing. She has supported QC and QA teams across multiple GMP-regulated facilities, with expertise in sterility assurance, risk assessment, and environmental monitoring. Her experience spans immuno-chemical, chemical, and microbiological laboratories, where she has led key initiatives by delivering practical solutions that align with global cGMP guidelines. At Particle Measuring Systems, she focuses on contamination control strategies that support cleanroom compliance.
