Standard Operating Procedure for Use of Glidants in Powders Production

1) Purpose

The purpose of this SOP is to provide guidelines for the proper use of glidants in the manufacturing of powders within the pharmaceutical industry. Glidants are additives that improve the flow properties of powders by reducing interparticle friction and cohesion.

2) Scope

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

3) Responsibilities

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

4) Procedure

1. Glidant Selection:
   1. Consult the formulation or process development team to determine the suitable glidant based on powder characteristics and requirements.
   2. Verify the availability and suitability of the selected glidant for the intended powders processing.
2. Preparation and Addition of Glidant:
   1. Prepare the glidant blend or dispersion according to the specified concentration and method (e.g., dry blending).
   2. Add the glidant blend to the powder formulation gradually while mixing to ensure uniform distribution.
3. Mixing and Processing:
   1. Mix the glidant with the powder blend thoroughly to ensure homogeneity and effective reduction of friction between particles.
   2. Ensure proper blending time and conditions to achieve desired flow properties.
4. Quality Control Checks:
   1. Perform flowability testing to evaluate the impact of glidant on powder flow properties.
   2. Conduct additional tests as necessary to assess uniformity and consistency of the powder blend.
5. Cleaning and Maintenance:
   1. Clean the equipment used for glidant 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, Glidant Preparation Logs, Quality Inspection Reports

7) Reference, if any

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

8) SOP Version

Version 1.0