Particle loss in sample tubing recently gained new visibility with the changes to EU GMP Annex 1, requiring that all tubing, used for particle counter applications, be “qualified”. The understanding of tubing losses forms a foundational component in how the data can be transformed into useful information and applied to the site Contamination Control Strategy (CCS), through improved, timely, responses to alert and action events, and quality decisions.
This study presents results from guidance presented in ISO/TR 14644-21, and testing conducted using traceable instruments and particle sizes across varied configurations. Key variables: tubing length, number of bends, internal diameter, and material—were systematically evaluated to assess their influence on particle transit in controlled environments.
Findings highlight changes in sampling setup significantly impact particle transmission efficiencies, particularly for larger particles and more complex configurations. The results support a risk-based approach to system qualification and emphasize the need for configuration control to meet evolving regulatory expectations regarding data traceability and integrity. As regulatory agencies increase scrutiny on environmental monitoring systems, understanding these variables becomes essential for designing defensible monitoring strategies.
This presentation offers guidance for optimizing sampling configurations and enhancing compliance, through a better understanding of the variables and resulting data.
Key Learning Objectives
- Explain the significance of particle loss in sample tubing
- Identify key variables that influence particle transmission efficiency in sampling configurations
- Apply a risk-based approach to the qualification of environmental monitoring systems
