Vaginal Dosage Forms: SOP for Gel Homogenizer

SOP for Gel Homogenizer

Operation and Maintenance of Gel Homogenizer

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the gel homogenizer to ensure effective homogenization of gel formulations.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the gel homogenizer in the manufacturing facility.

3) Responsibilities

It is the responsibility of production operators, maintenance staff, and quality control personnel to follow this SOP to ensure proper operation and maintenance of the gel homogenizer.

4) Procedure

4.1 Preparation

  1. Ensure the work area and equipment are clean and sanitized before starting the homogenization process.
  2. Verify the availability and integrity of gel formulations ready for homogenization.
  3. Inspect the gel homogenizer, including homogenization chamber and motor, to ensure they are clean and operational.
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4.2 Homogenization Process

  1. Set up the homogenization parameters such as speed, pressure, and homogenization cycle time according to product specifications.
  2. Load the gel formulation into the homogenization chamber and start the homogenization process.
  3. Monitor the homogenization process to ensure uniform mixing and particle size reduction of gel formulations.

4.3 Cleaning and Maintenance

  1. Stop the gel homogenizer after completing the homogenization batch.
  2. Disassemble the homogenization chamber and clean all parts thoroughly to remove any gel residues.
  3. Perform routine maintenance tasks such as lubrication of motor bearings and
inspection of seals.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Gel formulation specification

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for gel homogenizer

8) SOP Version

Version 1.0

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