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