Standard Operating Procedure for Granulation in Capsule Formulations

Purpose

The purpose of this SOP is to establish procedures for the granulation process in the formulation of capsules, ensuring uniformity, consistency, and adherence to quality standards.

Scope

This SOP applies to all personnel involved in the capsule formulation process, including formulation scientists, operators, and quality assurance personnel.

Responsibilities

• Formulation Scientist: Responsible for developing the granulation process parameters.
• Operators: Responsible for executing the granulation process according to the established procedures.
• Quality Assurance: Responsible for monitoring and ensuring compliance with the granulation SOP.

Procedure

1. Review the formulation recipe to ensure that all required ingredients and their respective quantities are accurately documented.
2. Verify that all equipment, including granulators and drying equipment, is clean, sanitized, and calibrated before initiating the process.
3. Weigh and dispense each ingredient accurately, following Good Manufacturing Practices (GMP) and the approved formulation recipe.
4. Transfer the weighed ingredients to the granulator, following the specified order of addition and process parameters.
5. Initiate the granulation process, adjusting parameters such as impeller speed, binder addition rate, and granulation time as per the formulation requirements.
6. Monitor the granulation process to ensure the formation of granules with the desired characteristics, such as size, density, and moisture content.
7. Perform in-process checks, such as granule size analysis or moisture content determination, to assess the granulation’s