Standard Operating Procedure for Measurement of Spray Force in Aerosols
1) Purpose
The purpose of this SOP is to establish procedures for the measurement of spray force in aerosol products to ensure product performance, consistency, and compliance with regulatory requirements.
2) Scope
This SOP applies to the measurement of spray force in aerosol products at [Company Name], including testing methodologies, equipment setup, data collection, and reporting procedures.
3) Responsibilities
Quality Control (QC) Team: Perform spray force measurements as per SOP.
Production Team: Provide aerosol samples for testing and support testing activities.
Quality Assurance (QA) Team: Oversee compliance with testing procedures and review testing results.
Technical Support: Provide technical expertise and support for spray force measurement.
4) Procedure
4.1 Equipment Setup:
4.1.1 Select and calibrate a suitable force measurement device (e.g., force gauge) according to product specifications.
4.1.2 Ensure the force measurement device is capable of accurately measuring the spray force exerted by the aerosol dispenser.
4.1.3 Verify the calibration status of the force measurement device before proceeding with testing.
4.2 Sample Preparation:
4.2.1 Prepare aerosol samples for testing by ensuring they are at the specified temperature and pressure conditions.
4.2.2 Position the aerosol dispenser in a stable setup conducive to accurate force measurement.
4.2.3 Ensure proper alignment of the force measurement device with the aerosol dispenser nozzle.
4.3 Measurement of Spray Force:
4.3.1 Trigger the aerosol dispenser to discharge a spray into the force measurement device.
4.3.2 Record the maximum force exerted during the spray event as indicated by the force measurement device.
4.3.3 Repeat the measurement multiple times for each sample to ensure consistency and reliability.
4.4 Data Analysis and Interpretation:
4.4.1 Calculate the average spray force exerted by the aerosol dispenser based on the recorded measurements.
4.4.2 Compare the measured spray force values against acceptance criteria or specifications provided by regulatory guidelines or company standards.
4.4.3 Analyze any deviations from expected spray force values and investigate potential causes.
4.5 Reporting and Documentation:
4.5.1 Prepare spray force measurement reports summarizing testing methods, results, and conclusions.
4.5.2 Include graphical representations and statistical analyses of spray force data in test reports.
4.5.3 Review and approve spray force measurement reports by designated personnel before release.
4.6 Compliance and Documentation:
4.6.1 Ensure compliance with regulatory requirements and company standards for spray force measurement.
4.6.2 Maintain records of spray force measurement activities, including procedures, raw data, and analysis reports.
4.6.3 Archive spray force measurement records in a controlled environment to ensure data integrity and traceability.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Spray Force Measurement Reports
Calibration and Verification Records for Force Measurement Device
Training Records for Personnel
Audit Reports and Corrective Action Plans
7) Reference, if any
FDA Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products
ISO Standards for Aerosol Spray Force Measurement
Company-Specific Testing Method Validation Protocols
8) SOP Version
Version 1.0
