Standard Operating Procedure for Mixing Time Optimization for Granules

1) Purpose

The purpose of this SOP is to outline the procedure for optimizing mixing time for granule formulations in the pharmaceutical industry to ensure uniform distribution of components.

2) Scope

This SOP applies to all personnel involved in the optimization of mixing time for granule formulations within the pharmaceutical manufacturing department.

3) Responsibilities

Production Supervisor: Responsible for conducting mixing time optimization studies.
Quality Control (QC) Analyst: Responsible for evaluating the quality aspects related to mixing time optimization.

4) Procedure

1. Initial Assessment:
   1. Review the formulation and process parameters affecting mixing.
   2. Identify critical components and their target distribution within the blend.
2. Experimental Setup:
   1. Prepare the mixer as per standard operating procedures.
   2. Set initial mixing parameters (e.g., speed, time).
3. Mixing Time Variation:
   1. Conduct mixing trials with varying times (e.g., 5 minutes, 10 minutes, 15 minutes).
   2. Ensure uniformity in sample collection across trials.
4. Sampling and Analysis:
   1. Collect samples at specified intervals during each trial.
   2. Analyze samples using appropriate analytical techniques (e.g., sieve analysis, content uniformity).
5. Data Analysis:
   1. Evaluate mixing efficiency and uniformity based on analytical results.
   2. Identify the optimal mixing time based on the desired distribution of components.
6. Documentation:
   1. Record all experimental details, including parameters, observations, and results.
   2. Document the optimized mixing time and rationale for selection.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Mixing Time Optimization Protocol, Experimental Data Sheets, Final Report on Mixing Time

7) Reference, if any

Internal company guidelines on granule mixing processes.

8) SOP Version

Version 1.0