Standard Operating Procedure for Lotion Viscosity Testing

1) Purpose

The purpose of this SOP is to outline the procedure for conducting viscosity testing of lotions to ensure consistent product quality and performance.

2) Scope

This SOP applies to all personnel involved in the viscosity testing of lotions within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities for executing this SOP are as follows:

Laboratory Analysts:

• Perform viscosity tests according to this SOP and document results accurately.
• Ensure all viscosity testing equipment is calibrated and maintained.

Quality Control Personnel:

• Review and verify viscosity test results for accuracy and compliance with specifications.

Quality Assurance Personnel:

• Ensure that the viscosity testing program complies with regulatory requirements.

4) Procedure

4.1 Pre-Testing Preparation:

• Ensure the viscometer is calibrated and in good working condition.
• Prepare the lotion samples according to the specified sampling plan.
• Bring the lotion samples to the specified temperature for testing, typically 25°C.

4.2 Viscosity Testing Process:

1. Equipment Setup:
   • Set up the viscometer according to the manufacturer’s instructions.
   • Select the appropriate spindle and speed for the lotion being tested.
   • Verify that the viscometer is level and properly secured.
2. Sample Preparation:
   • Stir the lotion sample gently to ensure uniformity.
   • Transfer an adequate amount of lotion into the viscometer sample container.
3. Conducting the Test:
   1. Immerse the spindle into the lotion sample, ensuring it is fully submerged without touching the bottom or sides of the container.
   2. Start the viscometer and allow it to run for the specified duration to reach a stable reading.
   3. Record the viscosity reading displayed on the viscometer.
   4. Repeat the test as required to obtain an average value, ensuring consistent conditions for each test.
4. Post-Test Activities:
   • Clean the viscometer spindle and sample container thoroughly after each test.
   • Document the test results in the laboratory logbook and batch record.

4.3 Documentation:

• Record the viscosity readings, test conditions, and any observations in the laboratory logbook.
• Ensure all documentation is complete and accurate, including the batch number and test date.

4.4 Review and Evaluation:

• Compare the viscosity results with the product specifications to determine if the lotion meets the required standards.
• Document any deviations and investigate the cause.

5) Abbreviations, if any

RPM: Revolutions Per Minute

6) Documents, if any

• Laboratory Logbook
• Batch Record
• Viscometer Calibration Records

7) Reference, if any

• USP <912> Viscosity – Rotational Methods
• Manufacturer’s instructions for the specific viscometer model used

8) SOP Version

Version 1.0