How to Validate Dynamic Image Analysis Methods According to ISO Standards > 자유게시판

Implementing a structured and meticulous validation process for dynamic image analysis under ISO guidelines 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 series for particle size analysis and the ISO, organizations must establish a comprehensive validation framework.

The first step is to define the intended use of the method and establish clear performance criteria. This includes identifying the parameters to be measured, such as size distribution, shape factors, 動的画像解析 roundness, and particle clustering, 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 glass or polystyrene spheres, to verify the system’s ability to accurately capture and measure images. Calibration should be performed on a scheduled basis with verifiable logs, 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 different technicians, devices, and time periods to assess within-laboratory variability. Accuracy can be verified by comparing results against a reference method, such as dry sieving or optical microscopy, where appropriate. The difference between the dynamic image analysis results and the reference values should fall within predefined acceptance criteria.

Robustness testing is another critical component. This involves deliberately introducing small variations in method parameters—such as illumination levels, suspension flow speed, or lens focal distance—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 method’s range and limit of detection must also be established. This includes determining the the minimal and maximal particle dimensions the instrument can resolve, as well as the lowest concentration at which particles can be detected without interference from background noise or artifacts.

Documentation is essential throughout the validation process. All protocols, raw data, calculations, and conclusions must be recorded in a well-organized, reviewable, and compliant documentation. A validation report should summarize the objectives, methods, results, and conclusions, 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 competency assessments and standard operating procedures must be in place. 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.

Finally, laboratories seeking ISO. This ensures that validation is not a one-time event but a ongoing dedication to excellence.

By following these steps and adhering to the principles outlined in relevant ISO standards, organizations can confidently validate dynamic image analysis methods, ensuring their results are scientifically sound, legally defensible, and suitable for use in regulated environments.