SOP for Preparation of Preservative-Free Nasal Sprays

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