Standardard Operating Procedure for Preparation and Sterilization of API and Excipients in Nasal Spray Formulations

1) Purpose

The purpose of this SOP is to establish the process for preparing and sterilizing active pharmaceutical ingredients (APIs) and excipients used in nasal spray formulations to ensure sterility, consistency, and product safety.

2) Scope

This SOP applies to all personnel involved in the preparation and sterilization of APIs and excipients at [Company Name]. It covers materials for sterile nasal spray formulations.

3) Responsibilities

• Operators: Responsible for preparation and sterilization of materials.
• QA: Verifies sterilization processes and documentation.
• Maintenance Team: Ensures sterilization equipment is calibrated.

4) Procedure

4.1 Equipment Preparation

4.1.1 Inspection

• Inspect sterilization equipment for cleanliness and calibration.
• Ensure autoclaves, filtration systems, or other sterilization equipment are ready for use.

4.1.2 Calibration

• Check that the equipment’s calibration log is up to date.
• Calibrate equipment if needed, based on the manufacturer’s guidelines.

4.2 API and Excipients Preparation

4.2.1 Handling of API and Excipients

• Transfer the materials to a designated sterile preparation area, ensuring no contamination occurs.
• Weigh and dispense materials in a controlled environment with aseptic techniques.

4.2.2 Sterilization Methods

• API and excipients can be sterilized using appropriate methods, including:
  • Autoclaving (for heat-resistant materials).
  • Filtration (for heat-sensitive materials).
  • Gamma irradiation (as a specialized method).
• Document the sterilization method used for each material.

4.3 Post-Sterilization Handling

4.3.1 Storage and Transfer

• Store sterilized materials in sterile containers in a controlled environment.
• Label the sterilized containers with material details, sterilization method, and date.

4.4 Documentation

• Maintain records of the sterilization process, including the sterilization log and verification of sterilization cycles.
• Ensure all documentation is signed off by the QA department.

5) Abbreviations, if any

• API: Active Pharmaceutical Ingredient

6) Documents, if any

• Sterilization Log
• Batch Manufacturing Record (BMR)

7) References, if any

• FDA Guidance on Sterility Testing

8) SOP Version

Version 1.0

Annexure

Sterilization Log Template