Standard Operating Procedure for Preparation of Preservative-Free Nasal Sprays

1) Purpose

The purpose of this SOP is to outline the process for preparing preservative-free nasal sprays, ensuring the formulation is sterile and stable throughout its shelf life.

2) Scope

This SOP applies to all personnel involved in the formulation, preparation, and packaging of preservative-free nasal sprays at [Company Name].

3) Responsibilities

• Operators: Responsible for the accurate preparation and sterilization of preservative-free formulations.
• QA: Verifies sterilization processes and ensures that the formulation is free from preservatives.

4) Procedure

4.1 Equipment Setup

4.1.1 Equipment Inspection

• Inspect all equipment, ensuring they are clean, sterilized, and ready for use.
• Verify that the sterile filling equipment is set up correctly, and autoclaves are ready for sterilization.

4.1.2 Calibration

• Ensure that all measuring equipment is calibrated and documented in the calibration log.

4.2 Preparation of Formulation

4.2.1 Raw Material Weighing

• Weigh the raw materials (API and excipients) accurately according to the formulation requirements.
• Document all weights in the batch manufacturing record (BMR).

4.2.2 Solution Preparation

• Dissolve the API and excipients in purified water using aseptic techniques.
• Mix the solution continuously until a homogenous formulation is achieved.

4.3 Sterilization and Filtration

4.3.1 Filtration Process

• Filter the solution through a 0.22-micron sterilizing filter under aseptic conditions to remove microbial contaminants.
• Document the filtration process in the batch record.

4.3.2 Filling

• Transfer the sterilized solution into pre-sterilized nasal spray containers using a sterile filling system.
• Ensure that the filling process is performed in a Class A sterile environment.

4.4 Documentation

• Document all process steps in the batch manufacturing record (BMR) and ensure that QA personnel verify the process.

5) Abbreviations, if any

• API: Active Pharmaceutical Ingredient
• BMR: Batch Manufacturing Record
• QA: Quality Assurance

6) Documents, if any

• Batch Manufacturing Record (BMR)
• Sterilization Log

7) References, if any

• FDA Guidance for Industry – Sterile Drug Products

8) SOP Version

Version 1.0

Annexure

Sterilization Log Template

  

    
Date
    
Material
    
Sterilization Method
    
Cycle/Duration
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Material Name
    
Method
    
Details
    
Operator Name
    
QA Name