SOP for Formulating Isotonic Nasal Sprays

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