Standard Operating Procedure for Preparation of Lyophilized Formulations for Ophthalmic Use

1) Purpose

This SOP outlines the procedure for preparing lyophilized formulations intended for ophthalmic use, ensuring product sterility, stability, and compatibility with the ocular environment.

2) Scope

This SOP applies to formulation scientists, production operators, and QA personnel involved in the preparation of lyophilized ophthalmic products.

3) Responsibilities

• Formulation Scientists: Responsible for developing formulations that are safe and effective for ocular administration.
• Operators: Responsible for preparing the formulation as outlined in the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying sterility and proper documentation of the ophthalmic product.

4) Procedure

4.1 Formulation Development

4.1.1 Criteria for Ophthalmic Formulations

• 4.1.1.1 The formulation should be isotonic with tears and pH-adjusted for compatibility with the eye.
• 4.1.1.2 Common excipients include stabilizers, buffering agents, and preservatives compatible with ocular tissues.

4.2 Preparation and Lyophilization

4.2.1 Solution Preparation

• 4.2.1.1 Weigh the required ingredients as per the BMR.
• 4.2.1.2 Dissolve the ingredients in a suitable buffer solution and stir until fully dissolved.

4.2.2 Sterile Filtration and Filling

• 4.2.2.1 Filter the solution through a sterile 0.22-micron filter to ensure sterility.
• 4.2.2.2 Aseptically fill the sterile ophthalmic containers and freeze before lyophilization.

4.3 Lyophilization and Reconstitution

• 4.3.1 Transfer the containers to the lyophilizer and follow the lyophilization