Standard Operating Procedure for Use of Disintegrants in Powders Production

1) Purpose

The purpose of this SOP is to provide guidelines for the proper use of disintegrants in the manufacturing of powders within the pharmaceutical industry. Disintegrants are essential additives that promote the rapid breakup of tablets or granules into smaller particles upon exposure to moisture, ensuring effective drug dissolution and absorption.

2) Scope

This SOP applies to all personnel involved in the powders production within the pharmaceutical manufacturing department, particularly those handling and using disintegrants.

3) Responsibilities

Production Operator: Responsible for adding disintegrants as per batch requirements and following SOPs.
Quality Control (QC) Analyst: Responsible for monitoring disintegration parameters and conducting quality checks.

4) Procedure

1. Disintegrant Selection:
   1. Consult the formulation or process development team to determine the suitable disintegrant based on product requirements (e.g., tablet or powder formulation).
   2. Verify the availability and suitability of the selected disintegrant for the intended powders processing.
2. Preparation and Addition of Disintegrant:
   1. Prepare the disintegrant blend or solution according to the specified concentration and method (e.g., dry blending, wet granulation).
   2. Add the disintegrant blend to the powder formulation gradually while mixing to ensure uniform distribution.
3. Mixing and Granulation:
   1. Mix the disintegrant with the powder blend thoroughly to ensure homogeneity and effective dispersion.
   2. If applicable, proceed with granulation using the chosen technique (e.g., wet granulation) following the standard procedures.
4. Quality Control Checks:
   1. Perform disintegration testing to evaluate the disintegrant’s effectiveness in promoting tablet or powder breakup.
   2. Conduct additional tests such as dissolution testing if applicable to assess drug release properties.
5. Cleaning and Maintenance:
   1. Clean the equipment used for disintegrant preparation and addition to prevent cross-contamination.
   2. Perform routine maintenance as per equipment manufacturer’s guidelines.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Batch Records, Disintegration Testing Logs, Quality Inspection Reports

7) Reference, if any

Pharmacopoeial guidelines (e.g., USP, EP) for disintegrant use in pharmaceutical powders production.

8) SOP Version

Version 1.0