Standard Operating Procedure for Particle Size Distribution in Creams
1) Purpose
The purpose of this SOP is to outline the procedures for determining the particle size distribution in creams to ensure consistency and quality of the product.
2) Scope
This SOP applies to all personnel involved in the quality control testing of creams, including laboratory technicians, analytical chemists, and quality assurance (QA) personnel. It covers procedures for sample preparation, particle size analysis, and documentation.
3) Responsibilities
It is the responsibility of laboratory technicians to prepare and analyze samples, analytical chemists to validate the particle size analysis method, and QA personnel to review and approve the test results.
4) Procedure
4.1 Preparation for Particle Size Analysis
4.1.1 Review the batch record and sampling plan to determine the number of samples to be analyzed.
4.1.2 Ensure all particle size analysis equipment (e.g., laser diffraction analyzer, microscope) is calibrated and in proper working condition.
4.1.3 Prepare all necessary reagents and dispersants according to the validated method.
4.1.4 Label all sample containers with necessary information, including sample ID, batch number, and date of preparation.
4.1.5 Wear appropriate personal protective equipment (PPE) such as gloves, lab coat, and safety glasses to avoid contamination.
4.2 Sample Preparation
4.2.1 Weigh an appropriate amount of cream sample
4.2.2 Disperse the cream sample in a suitable dispersant to ensure complete separation of particles.
4.2.3 Use ultrasonic treatment or mechanical stirring to achieve uniform dispersion, if necessary.
4.2.4 Prepare a blank solution and standard samples for calibration, following the same procedure as for the sample.
4.3 Particle Size Analysis
4.3.1 Set up the particle size analyzer according to the validated method parameters.
4.3.2 Introduce the prepared sample dispersion into the analyzer for measurement.
4.3.3 Run the analysis according to the validated method, ensuring the system suitability criteria are met.
4.3.4 Record the particle size distribution data, including parameters such as D10, D50, and D90, which represent the particle sizes at the 10th, 50th, and 90th percentiles, respectively.
4.3.5 Calculate the mean particle size and polydispersity index (PDI) to assess the uniformity of the particle size distribution.
4.4 Quality Control
4.4.1 Perform the particle size analysis in duplicate or triplicate to ensure accuracy and precision.
4.4.2 Include quality control (QC) samples and reference standards in the analysis run to verify the reliability of the results.
4.4.3 Compare the particle size distribution results with the specification limits to determine if the batch meets the required criteria.
4.5 Documentation and Review
4.5.1 Document all details of the particle size analysis procedure, including sample preparation, instrument settings, and calculation of results, in the particle size analysis log or laboratory notebook.
4.5.2 Review the particle size distribution data and ensure all results are within the specified acceptance criteria.
4.5.3 Submit the particle size analysis results for review and approval by QA personnel.
4.5.4 Maintain records of the particle size analysis results according to company policy and regulatory requirements for future reference and audits.
5) Abbreviations, if any
QA: Quality Assurance
PPE: Personal Protective Equipment
PDI: Polydispersity Index
SOP: Standard Operating Procedure
6) Documents, if any
Batch Records
Sampling Plan
Particle Size Analysis Log
Calibration Curve Documentation
7) Reference, if any
ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology
USP (United States Pharmacopeia) General Chapter on Particle Size Distribution
8) SOP Version
Version 1.0