Standard Operating Procedure for Water Activity Testing in Creams
1) Purpose
The purpose of this SOP is to define procedures for conducting water activity testing on creams. This ensures that creams have the appropriate water activity levels to maintain stability and microbiological safety.
2) Scope
This SOP applies to the Quality Control Department and personnel responsible for conducting water activity testing of creams. It covers testing methods, acceptance criteria, documentation, and reporting requirements.
3) Responsibilities
The Quality Control Manager is responsible for overseeing water activity testing activities. The Quality Control Team and Testing Technicians are responsible for executing and ensuring compliance with this SOP.
4) Procedure
4.1 Sampling
4.1.1 Select representative samples of creams from the batch for testing.
4.1.2 Ensure samples are taken aseptically and in accordance with sampling plans.
4.1.3 Label each sample with batch information and identification numbers.
4.2 Preparation of Test Samples
4.2.1 Prepare cream samples for water activity testing by homogenizing or mixing to ensure uniformity.
4.2.2 Ensure samples are handled carefully to avoid alteration of water activity levels.
4.3 Testing Method
4.3.1 Perform water activity testing using a calibrated water activity meter or device.
4.3.2 Follow manufacturer instructions and validated procedures for water activity measurement.
4.4 Measurement
4.4.1 Place cream samples into the water activity meter chamber and allow stabilization.
4.4.2 Record water activity readings from the meter display.
4.5 Acceptance Criteria
4.5.1 Establish acceptance criteria for water activity levels based on product specifications and stability requirements.
4.5.2 Compare test results against acceptance criteria to determine compliance with specified water activity levels.
4.6 Documentation and Reporting
4.6.1 Document all water activity testing activities, including sample preparation, testing methods, procedures, results, and observations.
4.6.2 Prepare water activity testing reports summarizing test conditions, results, conclusions, and recommendations.
4.6.3 Obtain approval from Quality Control Management for water activity testing reports.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
6) Documents, if any
Water Activity Testing Protocols
Water Activity Testing Reports
Non-Conforming Material Reports
7) Reference, if any
USP
Manufacturer instructions for water activity meter
8) SOP Version
Version 1.0