Standard Operating Procedure for Monitoring Viscosity of Nasal Gels and Suspensions

1) Purpose

The purpose of this SOP is to establish a procedure for monitoring and controlling the viscosity of nasal gels and suspensions to ensure product consistency and proper administration.

2) Scope

This SOP applies to all personnel involved in the preparation, testing, and quality control of nasal gels and suspensions at [Company Name].

3) Responsibilities

• Operators: Responsible for measuring viscosity during the formulation process.
• QA: Verifies viscosity values and ensures they meet product specifications.

4) Procedure

4.1 Viscosity Measurement

4.1.1 Equipment Setup

• Ensure the viscometer is calibrated and properly set up before testing.
• Prepare the appropriate spindle size based on the viscosity range of the formulation.

4.1.2 Sampling

• Take a representative sample of the nasal gel or suspension for viscosity testing.

4.1.3 Testing Procedure

• Set the viscometer at the appropriate speed and temperature for the test as per formulation requirements.
• Record the viscosity values (in cP or mPa·s) and check for consistency with formulation specifications.

4.2 Viscosity Adjustment

4.2.1 Adjustment Methods

• If the viscosity falls outside the target range, adjust the formulation by adding more