MDI Particle Size Analysis Procedures
1) Purpose
The purpose of this SOP is to establish the procedures for particle size analysis of metered-dose inhalers (MDIs) to ensure proper aerosol performance and drug delivery efficiency.
2) Scope
This SOP applies to all personnel involved in the particle size analysis of MDIs at the manufacturing facility, including laboratory technicians and quality control staff.
3) Responsibilities
The responsibilities for this SOP include performing particle size analysis accurately, documenting results, and ensuring compliance with regulatory standards. Specific roles include:
Laboratory Technicians: Conduct particle size analysis as specified.
Quality Control Staff: Review and document the results of particle size analysis.
4) Procedure
4.1 Sample Preparation
4.1.1 Collect MDI samples from each batch following the sampling plan.
4.1.2 Ensure samples are properly labeled and stored prior to analysis.
4.2 Equipment Setup
4.2.1 Set up the particle size analyzer according to the manufacturer’s instructions.
4.2.2 Calibrate the equipment using standard reference materials.
4.3 Analysis Procedure
4.3.1 Prepare the MDI sample for analysis by shaking or priming as necessary.
4.3.2 Introduce the sample into the particle
4.3.3 Record the particle size distribution data.
4.3.4 Perform multiple analyses to ensure consistency and accuracy.
4.4 Data Recording
4.4.1 Document all particle size distribution results in the analysis logbook.
4.4.2 Ensure data integrity and compliance with Good Laboratory Practice (GLP) guidelines.
4.5 Review and Analysis
4.5.1 Analyze the particle size data to ensure it meets acceptance criteria.
4.5.2 Review results and prepare a particle size analysis report.
4.6 Reporting
4.6.1 Submit particle size analysis reports to the quality assurance department for approval.
4.6.2 Update the particle size analysis schedule as required.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
GLP: Good Laboratory Practice
6) Documents, if any
Particle size analysis logs, equipment calibration records, and analysis reports should be maintained.
7) Reference, if any
Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for particle size analysis standards.
8) SOP Version
Version 1.0
