Standard Operating Procedure for Sieving Process in Granules

1) Purpose

The purpose of this SOP is to outline the procedure for conducting the sieving process for granules in the pharmaceutical industry to ensure proper particle size distribution.

2) Scope

This SOP applies to all personnel involved in the sieving process of granules within the pharmaceutical manufacturing department.

3) Responsibilities

Production Operator: Responsible for performing the sieving process.
Quality Control (QC) Analyst: Responsible for verifying the quality aspects related to sieving.

4) Procedure

1. Equipment Setup:
   1. Check and prepare the sieve equipment as per standard operating procedures.
   2. Verify calibration status of sieves if applicable.
2. Sample Preparation:
   1. Weigh the appropriate amount of sample granules for sieving.
   2. Ensure sample is representative of the batch and properly labeled.
3. Sieving Process:
   1. Place the sieve stack properly and start the sieving machine.
   2. Allow the sieving process to continue for the specified duration.
   3. Visually inspect the sieved material for any clumps or inconsistencies.
4. Analysis and Recording:
   1. Collect the sieved material from each sieve and record the weight retained on each sieve.
   2. Calculate the particle size distribution based on the weight retained on each sieve.
5. Cleaning and Maintenance:
   1. After sieving, clean the sieves and equipment thoroughly to prevent cross-contamination.
   2. Maintain records of cleaning and maintenance activities.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Sieving Process Protocol, Sieve Calibration Records, Sieve Cleaning Log

7) Reference, if any

Pharmacopeial guidelines on particle size distribution testing for pharmaceutical granules.

8) SOP Version

Version 1.0