Mixing and Homogenization Procedure

1) Purpose

The purpose of this SOP is to outline the procedure for mixing and homogenizing vaginal dosage forms to ensure uniformity and consistency.

2) Scope

This SOP applies to personnel involved in the mixing and homogenization processes of vaginal dosage forms at the pharmaceutical facility.

3) Responsibilities

The Manufacturing Department is responsible for adhering to this SOP and ensuring that all mixing and homogenization processes are performed according to the defined procedures.

4) Procedure

4.1 Equipment Preparation

1. Verify the cleanliness and operational status of the mixing equipment.
2. Set up the equipment according to the formulation requirements.

4.2 Material Transfer

1. Transfer the pre-weighed raw materials into the mixing vessel.
2. Ensure accurate measurement of each ingredient as per the formulation recipe.

4.3 Mixing Process

1. Initiate the mixing process using specified parameters (e.g., speed, time).
2. Monitor the mixing to achieve uniform distribution of ingredients.

4.4 Homogenization

1. Homogenize the mixture to ensure consistent particle size and distribution.
2. Adjust homogenization parameters as needed to achieve desired product characteristics.

4.5 Cleaning and Sanitization

1. Clean and sanitize the equipment after completion of mixing and homogenization.
2. Document cleaning procedures and verify cleanliness before next use.

4.6 Batch Record Documentation

1. Complete all necessary batch records and documentation related to mixing and homogenization.
2. Review and verify the accuracy of all entries prior to submission for approval.

5) Abbreviations, if any

None

6) Documents, if any

Formulation recipe, batch record, equipment cleaning log

7) Reference, if any

USP Chapter 797: Pharmaceutical Compounding – Sterile Preparations, FDA Guidance for Industry: Aseptic Processing

8) SOP Version

Version 1.0