Standard Operating Procedure for Specific Gravity Testing in Aerosols
1) Purpose
The purpose of this SOP is to define procedures for conducting specific gravity testing on aerosol products to ensure consistency in density and formulation.
2) Scope
This SOP applies to specific gravity testing performed on aerosol products manufactured by [Company Name] to verify product density and compliance with formulation specifications.
3) Responsibilities
Quality Control (QC) Team: Perform specific gravity testing according to approved protocols and acceptance criteria.
Production Team: Provide aerosol samples for testing and coordinate sample collection.
Regulatory Affairs: Review and approve specific gravity testing protocols to ensure compliance with regulatory guidelines.
Quality Assurance (QA) Team: Oversee adherence to SOPs and ensure documentation accuracy and completeness.
4) Procedure
4.1 Sample Collection and Preparation:
4.1.1 Collect representative samples of aerosol products from the final production batch.
4.1.2 Ensure samples are properly labeled and identified to maintain traceability.
4.1.3 Store samples under specified conditions (e.g., room temperature) prior to testing.
4.2 Equipment Setup:
4.2.1 Calibrate the specific gravity meter or balance according to manufacturer instructions using certified weights.
4.2.2 Verify instrument accuracy and precision before proceeding with testing.
4.2.3 Record calibration details and instrument settings for documentation purposes.
4.3 Testing Procedure:
4.3.1 Prepare the specific gravity meter or balance for sample analysis by zeroing or taring the instrument.
4.3.2 Carefully place aerosol samples on the instrument platform and record the mass or weight measurements.
4.3.3 Calculate specific gravity using the formula: Specific Gravity = Weight of Aerosol Product / Weight of Water (or standard reference substance).
4.4 Acceptance Criteria:
4.4.1 Establish acceptance criteria for specific gravity values based on product specifications and regulatory requirements.
4.4.2 Compare test results against predefined acceptance criteria to determine compliance.
4.4.3 Record and document all test results, including raw data, calculations, and interpretations.
4.5 Reporting and Documentation:
4.5.1 Prepare detailed specific gravity test reports summarizing testing methods, results, and conclusions.
4.5.2 Review and approve test reports by designated personnel to ensure accuracy and compliance with SOPs.
4.5.3 Maintain records of all specific gravity testing activities, including sample preparation, equipment calibration, and approval documentation.
4.6 Non-Conformance Handling:
4.6.1 Initiate non-conformance reports (NCRs) for aerosol products that fail specific gravity testing or exceed acceptance criteria.
4.6.2 Investigate root causes of non-conformance and implement corrective actions to prevent recurrence.
4.6.3 Verify effectiveness of corrective actions through retesting and document outcomes accordingly.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
NCR: Non-Conformance Report
6) Documents, if any
Specific Gravity Testing Protocol
Specific Gravity Test Reports
Equipment Calibration Records
Non-Conformance Reports (NCRs)
Approval Records and Documentation
7) Reference, if any
USP Chapter
ISO 16750: Road vehicles – Environmental conditions and testing for electrical and electronic equipment
ICH Q2: Validation of Analytical Procedures
8) SOP Version
Version 1.0
