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 gel-forming agents or diluents, depending on the need.
• Mix thoroughly to ensure homogeneity after any adjustments.

4.3 Documentation

• Record the viscosity values, any adjustments made, and the final readings in the batch manufacturing record (BMR).
• Document all viscosity measurements in the viscosity log.

5) Abbreviations, if any

• QA: Quality Assurance
• BMR: Batch Manufacturing Record

6) Documents, if any

• Batch Manufacturing Record (BMR)
• Viscosity Log

7) References, if any

• USP 39 – Viscosity Testing in Pharmaceutical Preparations

8) SOP Version

Version 1.0

Annexure

Viscosity Log Template

  

    
Date
    
Formulation
    
Viscosity (cP)
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Formulation Name
    
Viscosity
    
Operator Name
    
QA Name