Standard Operating Procedure for Particle Size Analysis
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for performing particle size analysis of pharmaceutical formulations, including Intramuscular (IM) and Subcutaneous (SC) injections, to ensure uniformity and consistency of the product.
2) Scope
This SOP applies to all personnel involved in the particle size analysis of pharmaceutical formulations within the pharmaceutical manufacturing facility. It includes procedures for sample preparation, measurement, and data analysis.
3) Responsibilities
– Analytical Development Team: Responsible for conducting particle size analysis and ensuring accurate results.
– Quality Control (QC) Department: Responsible for verifying and documenting particle size data.
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory requirements.
4) Procedure
4.1 Equipment and Materials
4.1.1 Ensure that all equipment used for particle size analysis, such as laser diffraction analyzers, is calibrated and maintained.
4.1.2 Prepare all necessary materials, including samples, solvents, and dispersants.
4.2 Sample Preparation
4.2.1 Obtain representative samples of the formulation as per the sampling plan.
4.2.2 Prepare the sample by dispersing it in an appropriate solvent or dispersant to ensure a uniform suspension.
4.2.3 Sonicate the sample if necessary to break up any agglomerates.
4.3 Measurement
4.3.1 Set up the particle size analyzer according to the manufacturer’s instructions.
4.3.2 Load the prepared sample into the analyzer.
4.3.3 Perform the measurement according to the specified method (e.g., laser diffraction, dynamic light scattering).
4.3.4 Record the particle size distribution data.
4.4 Data Analysis
4.4.1 Analyze the data to determine key parameters such as mean particle size, D10, D50, and D90.
4.4.2 Compare the results against predefined specifications to ensure compliance.
4.5 Documentation
4.5.1 Document all measurement data, including raw data and calculated parameters, in the particle size analysis logbook or electronic database.
4.5.2 Ensure that all records are reviewed and approved by the QC department.
4.6 Reporting
4.6.1 Prepare a particle size analysis report summarizing the methodology, results, and any observations.
4.6.2 Submit the report to the QA department for review and approval.
4.7 Troubleshooting
4.7.1 If the results do not meet specifications, investigate potential causes such as equipment malfunction or sample preparation errors.
4.7.2 Repeat the analysis if necessary, following corrective actions.
5) Abbreviations, if any
– IM: Intramuscular
– SC: Subcutaneous
– QC: Quality Control
– QA: Quality Assurance
6) Documents, if any
– Particle Size Analysis Logbook
– Calibration Records
– Particle Size Analysis Reports
7) Reference, if any
– USP <429> Light Diffraction Measurement of Particle Size
– ISO 13320:2009 Particle Size Analysis – Laser Diffraction Methods
8) SOP Version
Version 1.0
