Particle Loss in Transport Tubing: How to Address the New Annex 1 Requirement

On Demand | Duration: approx 60 min

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.

What you'll learn:

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)

Webinar Presented By:

Serena Steidl

EMEA Advisory Project Coordinator, Particle Measuring Systems

Serena has a strong scientific background in Microbiology and Biotechnology. She worked in several pharmaceutical companies to support quality control departments. She is especially skilled in quality assurance procedures and has excellent knowledge of cGMP guidelines. She started her career as a quality technician, and over the years, she moved into management positions, working in immuno-chemical, chemical, and microbiological departments. She played a key role in many projects, such as: disinfectants strategy, environmental sampling plan definition, lean scheduling and release of products, product stability management, method and process validation, and change control. In PMS, she splits her time between Sterility Assurance and Risk Assessments for Environmental Monitoring.

Get the experts in Particle Measuring Systems’ Advisory team to do your risk assessment for tubing particle loss.
Particle loss in transport tubing can occur due to a combination of various external factors. To assess the risk and potential impact on the finished product, it is crucial to conduct particle transportation tests. The primary objective of these tests is twofold: first, to quantify the resultant particle losses within a remote sampling system, and second, to provide documented evidence characterizing the efficiency of viable and non-viable monitoring processes. By addressing these aspects, manufacturers can gain valuable insights into the particle transportation dynamics in their remote systems and ensure appropriate measures are taken to maintain product quality.

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