Standard Operating Procedure for Preparing Lyophilized Formulations for Nasal Delivery

1) Purpose

This SOP outlines the procedure for preparing lyophilized formulations intended for nasal delivery, ensuring product stability, effective delivery, and compatibility with nasal administration devices.

2) Scope

This SOP applies to all personnel involved in the formulation, preparation, and testing of lyophilized products designed for nasal delivery, including formulation scientists, production operators, and QA personnel.

3) Responsibilities

• Formulation Scientists: Responsible for designing the nasal lyophilized formulation and ensuring it is compatible with nasal delivery devices.
• Operators: Responsible for preparing the solution and lyophilization according to the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying product stability and ensuring proper documentation.

4) Procedure

4.1 Preparation of Nasal Lyophilized Formulation

4.1.1 Equipment Setup

• 4.1.1.1 Ensure that all equipment (e.g., mixers, pH meters) is cleaned, sanitized, and calibrated before use.
• 4.1.1.2 Maintain aseptic conditions throughout the preparation process.

4.1.2 Solution Preparation

• 4.1.2.1 Weigh the required active ingredients and excipients using a calibrated balance according to the BMR.
• 4.1.2.2 Dissolve the active ingredients in a suitable solvent (e.g., WFI) and stir until fully dissolved.

4.2 Filtration and Filling

4.2.1 Filtration

• 4.2.1.1 Filter the prepared solution using a sterile 0.22-micron filter to remove particulates.

4.2.2 Filling and Lyophilization

• 4.2.2.1 Fill sterile nasal delivery vials