What is EN ISO 18369-2:2018?

EN ISO 18369-2:2018 is a professional technical standard published by the European Committee for Standardization (CEN). It provides guidelines and requirements for determining particle size distribution of powders using laser diffraction techniques. This standard is specifically aimed at industries such as pharmaceuticals, cosmetics, and food processing where accurate measurement of particle size is crucial for product quality and performance.

The Importance of Particle Size Analysis

Particle size analysis plays a vital role in various industries as it affects the product's physical properties, stability, functionality, and overall quality. Understanding and controlling particle size distribution allows manufacturers to optimize processes, enhance product performance, and meet regulatory requirements. EN ISO 18369-2 is designed to provide a standardized methodology for particle size analysis, ensuring accurate and reliable results.

Main Features of EN ISO 18369-2:2018

This technical standard outlines specific steps and requirements for conducting particle size analysis using laser diffraction. It covers sample preparation, instrument calibration and verification, measurement procedure, data evaluation, and reporting. The key features of EN ISO 18369-2 are:

Sample Preparation: The standard provides detailed instructions on representative sampling and proper handling of powder samples prior to analysis. Adequate dispersion of particles is essential to obtain accurate results.

Instrument Calibration and Verification: EN ISO 18369-2 emphasizes the need for regular calibration and verification of the laser diffraction instrument to ensure reliable measurements. It specifies procedures and reference materials for instrument validation.

Measurement Procedure: The standard outlines the step-by-step process for measuring particle size distribution using laser diffraction technique. It covers parameters such as obscuration, measurement range, and measurement duration.

Data Evaluation and Reporting: EN ISO 18369-2 provides guidelines for data interpretation and calculation of particle size data. It also recommends the reporting format for presenting the results to ensure consistency and clarity.

Benefits of Implementing EN ISO 18369-2:2018

Adhering to EN ISO 18369-2 brings several benefits to industries involved in particle size analysis:

Standardization: By following a standardized methodology, companies can compare results across different laboratories and instruments, facilitating collaboration and ensuring consistent quality control.

Accuracy and Reliability: The requirements and guidelines outlined in EN ISO 18369-2 help minimize errors and uncertainties in particle size measurements, leading to more accurate and reliable data.

Compliance: Implementing this technical standard demonstrates a company's commitment to meeting regulatory requirements and industry best practices. It enhances credibility and facilitates product registration or approval processes.

Process Optimization: Accurate particle size analysis enables manufacturers to fine-tune their processes, leading to improved product formulations, reduced waste, and enhanced overall efficiency.

In conclusion, EN ISO 18369-2:2018 is a crucial technical standard that provides guidelines and requirements for conducting particle size analysis using laser diffraction techniques. Its implementation offers numerous advantages for industries concerned with particle size distribution, including standardization, accuracy, compliance, and process optimization. By following the procedures outlined in this standard, companies can achieve consistent and reliable results, ultimately improving product quality and performance.