Procedure for Granulation Size Distribution Analysis

1) Purpose

The purpose of this SOP is to outline the procedure for determining the size distribution of granules used in pharmaceutical manufacturing to ensure consistency and quality in the final product.

2) Scope

This SOP applies to all granulation batches prepared for tablet or capsule production within the manufacturing facility.

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting size distribution testing and ensuring compliance with this SOP.
Production Department: Responsible for providing granule samples for testing and maintaining granulation process parameters.

4) Procedure

4.1 Sampling:
    4.1.1 Collect representative samples of granules from various points within the granulator according to the sampling plan.
    4.1.2 Ensure samples are taken from different depths and locations to obtain a uniform representation.

4.2 Equipment Preparation:
    4.2.1 Calibrate the sieving equipment as per the manufacturer’s instructions.
    4.2.2 Ensure all sieves are clean and free from previous residues.

4.3 Sieving Procedure:
    4.3.1 Weigh an appropriate amount of the granule sample (e.g., 100 grams).
    4.3.2 Place the sample on the top sieve of a nested set of sieves arranged by decreasing mesh size.
    4.3.3 Operate the sieve shaker for a specified period (e.g., 10 minutes) at a set amplitude.
    4.3.4 After sieving, weigh the granules retained