Standard Operating Procedure for Water Activity Testing in Aerosols
1) Purpose
The purpose of this SOP is to outline procedures for conducting water activity testing on aerosol products to assess moisture content and stability.
2) Scope
This SOP applies to water activity testing performed on aerosol products manufactured by [Company Name] to ensure product quality, stability, and compliance with regulatory requirements.
3) Responsibilities
Quality Control (QC) Team: Perform water activity testing according to approved protocols and acceptance criteria.
Production Team: Provide aerosol samples for testing and coordinate sample collection.
Regulatory Affairs: Review and approve water activity 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 Label samples with unique identifiers and store under specified conditions (e.g., room temperature) prior to testing.
4.1.3 Minimize sample exposure to ambient conditions to prevent moisture absorption or loss.
4.2 Water Activity Measurement:
4.2.1 Calibrate the water activity meter according to manufacturer instructions using standard calibration solutions.
4.2.2 Place aerosol samples into the water activity meter chamber and allow equilibration to reach thermal stability.
4.2.3
4.3 Acceptance Criteria:
4.3.1 Establish acceptance criteria for water activity levels based on product specifications and regulatory requirements.
4.3.2 Compare water activity readings against predefined acceptance criteria to determine compliance.
4.3.3 Record and document all test results, including raw data, calculations, and interpretations.
4.4 Reporting and Documentation:
4.4.1 Prepare detailed water activity test reports summarizing testing methods, results, and conclusions.
4.4.2 Review and approve test reports by designated personnel to ensure accuracy and compliance with SOPs.
4.4.3 Maintain records of all water activity testing activities, including sample preparation, equipment calibration, and approval documentation.
4.5 Non-Conformance Handling:
4.5.1 Initiate non-conformance reports (NCRs) for aerosol products that fail water activity testing or exceed acceptance criteria.
4.5.2 Investigate root causes of non-conformance and implement corrective actions to prevent recurrence.
4.5.3 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
Water Activity Testing Protocol
Water Activity Test Reports
Calibration Records for Water Activity Meter
Non-Conformance Reports (NCRs)
Approval Records and Documentation
7) Reference, if any
USP Chapter
ISO 7218: Microbiology of food and animal feeding stuffs – General requirements and guidance for microbiological examinations
ICH Q2: Validation of Analytical Procedures
8) SOP Version
Version 1.0