Standard Operating Procedure for Mixing and Homogenization Techniques in Lyophilized Formulations

1) Purpose

This SOP describes the methods and techniques for mixing and homogenizing components in lyophilized formulations to ensure uniformity and proper dispersion of active ingredients and excipients.

2) Scope

This SOP applies to the formulation development team, production operators, and QA staff involved in the mixing and homogenization of raw materials in lyophilized formulations.

3) Responsibilities

• Operators: Responsible for following the mixing and homogenization procedures as outlined in the BMR.
• Formulation Scientists: Responsible for selecting appropriate mixing methods based on formulation characteristics.
• QA: Responsible for verifying process parameters and documenting results.

4) Procedure

4.1 Equipment Setup

• 4.1.1 Ensure that all equipment (e.g., mechanical mixers, homogenizers) is cleaned and calibrated before use.
• 4.1.2 Set up the equipment in the designated area following safety protocols.

4.2 Mixing Procedure

4.2.1 Weighing and Addition of Materials

• 4.2.1.1 Weigh all raw materials as per the formulation instructions and add them to the mixing vessel.

4.2.2 Mixing Process

• 4.2.2.1 Use the specified mixing speed and duration as per the formulation record.
• 4.2.2.2 Monitor the temperature during mixing to avoid overheating, which may affect the stability of the components.

4.3 Homogenization Process

4.3.1 Homogenization Settings

• 4.3.1.1 Homogenize the solution to achieve uniform particle size