Standard Operating Procedure for Use of Surfactants in Powders Production

1) Purpose

The purpose of this SOP is to provide guidelines for the proper use of surfactants in the manufacturing of powders within the pharmaceutical industry. Surfactants are used to improve wetting, dispersion, and solubility of active pharmaceutical ingredients (APIs) in powder formulations.

2) Scope

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

3) Responsibilities

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

4) Procedure

1. Surfactant Selection:
   1. Consult the formulation or process development team to determine the suitable surfactant based on product requirements.
   2. Verify the availability and suitability of the selected surfactant for the intended powders processing.
2. Preparation and Addition of Surfactant:
   1. Prepare the surfactant solution or dispersion according to the specified concentration and method (e.g., aqueous or organic solvent).
   2. Add the surfactant solution to the powder formulation gradually while mixing to ensure uniform distribution.
3. Mixing and Processing:
   1. Mix the surfactant with the powder blend thoroughly to ensure homogeneity and effective wetting of APIs.
   2. Proceed with further processing steps as per the standard operating procedures (e.g., granulation, blending).
4. Quality Control Checks:
   1. Perform tests such as dissolution testing to evaluate the surfactant’s impact on API solubility and dissolution rate.
   2. Conduct additional tests as required to assess powder flow properties and uniformity.
5. Cleaning and Maintenance:
   1. Clean the equipment used for surfactant preparation and addition to prevent cross-contamination.
   2. Perform routine maintenance of equipment as per manufacturer’s guidelines.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Batch Records, Surfactant Preparation Logs, Quality Inspection Reports

7) Reference, if any

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

8) SOP Version

Version 1.0