Standard Operating Procedure for Hydrogel Preparation

1) Purpose

The purpose of this SOP is to provide a standardized procedure for the preparation of hydrogel in the pharmaceutical industry to ensure consistency, quality, and compliance with regulatory standards.

2) Scope

This SOP applies to all personnel involved in the manufacturing of hydrogel in the pharmaceutical production facility.

3) Responsibilities

Production Manager: Oversee the hydrogel preparation process and ensure compliance with the SOP.
Production Staff: Follow the procedure as outlined in the SOP.
Quality Control (QC) Personnel: Verify that the hydrogel meets specified quality standards.

4) Procedure

4.1 Preparation and Setup
4.1.1 Ensure all equipment and work areas are clean and sanitized according to the relevant cleaning SOP.
4.1.2 Gather all required raw materials and verify their quality and quantity against the batch record.

4.2 Mixing Process
4.2.1 Add the required amount of deionized water into the mixing vessel.
4.2.2 Gradually add the gelling agent while continuously stirring to avoid lump formation.
4.2.3 Adjust the pH of the mixture as required, using appropriate pH adjusting agents.

4.3 Heating and Homogenization
4.3.1 Heat the mixture to the specified temperature under continuous stirring.
4.3.2 Maintain the