ISO-Compliant Validation of Dynamic Image Analysis for Particle Characterization > 자유게시판

Ensuring accuracy, reproducibility, and traceability through a methodical validation protocol aligned with ISO requirements to ensure accuracy, reproducibility, and traceability of results. This technique is widely applied across pharmaceutical, food, and materials science sectors to characterize particle size, shape, and distribution in real time. To meet ISO compliance, particularly under ISO 13322-1 and ISO 13322-2 and the ISO, organizations must establish a comprehensive validation framework.

Initiate validation by specifying the method’s purpose and defining measurable performance targets. This includes identifying the parameters to be measured, such as PSD, elongation ratio, sphericity, and aggregate formation, and determining acceptable tolerances for each. The method must be fit for purpose, meaning it should reliably produce results within specified limits under normal operating conditions.

The instrument requires calibration against accredited reference materials linked to national or global benchmarks. For dynamic image analysis, this often involves using particles with known size and shape, such as silica beads, calibrated polymer particles, or monodisperse latex spheres, to verify the system’s ability to accurately capture and measure images. Calibration should be performed regularly and documented, 粒子径測定 with records maintained for audit purposes.

Evaluate both precision and accuracy by conducting repeated trials under standardized operational settings. Reproducibility testing should be conducted across multiple operators, instruments, and days to assess within-laboratory variability. Accuracy can be verified by comparing results against a reference method, such as laser diffraction or microscopy, where appropriate. The difference between the dynamic image analysis results and the reference values should fall within predefined acceptance criteria.

Another indispensable phase is evaluating method ruggedness. This involves deliberately introducing small variations in method parameters—such as lighting intensity, flow rate, or focus settings—to determine how sensitive the method is to operational changes. A robust method will produce consistent results even when minor deviations occur, indicating reliability in routine use.

The measurement range and minimum detectable concentration must be empirically determined. This includes determining the smallest and largest particle sizes the system can reliably measure, as well as the the threshold concentration below which signals are indistinguishable from noise.

All validation activities require meticulous and traceable documentation. All protocols, raw data, calculations, and conclusions must be recorded in a standardized, traceable, and verifiable manner. A validation report should summarize the intended purpose, execution steps, outcomes, and final assessment, and include statements of compliance with applicable ISO standards. Any deviations or anomalies encountered during testing must be investigated and resolved before the method is approved for routine use.

Staff must be adequately trained in sampling, instrument use, and result analysis. Human error can significantly affect outcomes, so regular skill verification and documented work instructions are required. Continuous monitoring and ongoing validation checks need to be implemented to ensure the method remains valid over time, especially after instrument maintenance, software updates, or changes in sample matrix.

IEC 17025 accreditation must demonstrate that their validation activities are integrated into a quality management system. This ensures that validation is not a one-time event but a sustained commitment to quality.

Adopting these validated procedures in accordance with applicable ISO requirements, organizations can confidently validate dynamic image analysis methods, ensuring their results are reliable, audit-ready, and fit for compliance-driven industries.