Standard Operating Procedure for Preparation of Freeze-Dried Antibiotics

1) Purpose

This SOP outlines the procedure for preparing antibiotics for freeze-drying (lyophilization), ensuring product sterility and stability throughout the process and during storage.

2) Scope

This SOP applies to all personnel involved in the preparation of freeze-dried antibiotic formulations, including formulation scientists, production operators, and QA personnel.

3) Responsibilities

• Formulation Scientists: Responsible for designing the antibiotic formulation suitable for freeze-drying.
• Operators: Responsible for preparing the antibiotic solution as per the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying the freeze-drying process and ensuring accurate documentation.

4) Procedure

4.1 Preparation of Antibiotic Solution

4.1.1 Equipment Setup

• 4.1.1.1 Ensure that all equipment (e.g., mixers, filtration systems) is cleaned, sanitized, and calibrated before use.
• 4.1.1.2 Prepare sterile containers for the antibiotic solution and maintain aseptic conditions during preparation.

4.1.2 Solution Preparation

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

4.2 Filtration and Lyophilization

4.2.1 Filtration

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

4.2.2 Filling and Lyophilization

• 4.2.2.1 Fill sterile vials with the filtered antibiotic solution and freeze at -80°C before transferring to the