Standard Operating Procedure for Formulating Isotonic Nasal Sprays

1) Purpose

The purpose of this SOP is to provide detailed instructions for formulating isotonic nasal sprays to ensure optimal osmolality and patient safety.

2) Scope

This SOP applies to all personnel involved in the formulation of isotonic nasal sprays at [Company Name].

3) Responsibilities

• Operators: Responsible for preparing isotonic solutions according to formulation guidelines.
• QA: Verifies osmolality and ensures compliance with formulation standards.

4) Procedure

4.1 Preparation of Isotonic Solution

4.1.1 Equipment Setup

• Ensure all measuring and mixing equipment is clean and calibrated.
• Prepare an osmolality meter to measure the isotonicity of the formulation.

4.1.2 Mixing the Solution

• Weigh the correct amount of sodium chloride or other tonicity agents as specified in the formulation.
• Dissolve the agents in the required amount of purified water using aseptic techniques.

4.2 Osmolality Testing

4.2.1 Measuring Osmolality

• Use a calibrated osmolality meter to test the solution’s osmolality.
• If the value is within the target range (270-330 mOsm/kg), proceed to the next steps. If not, adjust the formulation by adding purified water or additional tonicity agents.

4.2.2 Documentation

• Record the osmolality readings in the osmolality testing log, and verify with the QA department.

4.3 Final Filtration and Packaging

4.3.1 Filtration

• Filter the isotonic nasal spray solution through a 0.22-micron filter before packaging to ensure sterility.

4.3.2 Packaging

• Transfer the filtered solution into sterilized nasal spray containers using aseptic techniques.
• Label the containers with batch number, formulation name, and production date.

5) Abbreviations, if any

• QA: Quality Assurance

6) Documents, if any

• Osmolality Testing Log
• Batch Manufacturing Record (BMR)

7) References, if any

• USP 39 – Tonicity of Solutions

8) SOP Version

Version 1.0

Annexure

Osmolality Testing Log Template

  

    
Date
    
Formulation
    
Osmolality (mOsm/kg)
    
Operator Initials
    
QA Approval
  
  

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