Standard Operating Procedure for Granule Hardness Testing

1) Purpose

The purpose of this SOP is to provide guidelines for the testing of granule hardness during the manufacturing process of granules within the pharmaceutical industry. Granule hardness testing ensures that granules have sufficient mechanical strength to withstand subsequent processing steps without breaking or deforming.

2) Scope

This SOP applies to all personnel involved in the granules production within the pharmaceutical manufacturing department, particularly those responsible for performing and documenting granule hardness tests.

3) Responsibilities

Production Operator: Responsible for collecting samples for granule hardness testing and following SOPs.
Quality Control (QC) Analyst: Responsible for conducting granule hardness tests and interpreting results.

4) Procedure

1. Sample Collection:
   1. Collect representative samples of granules from the production batch at specified intervals or as per sampling plan.
   2. Ensure samples are properly labeled with batch number, date, and other relevant information.
2. Hardness Testing:
   1. Place a sufficient quantity of granules into the hardness tester.
   2. Apply a predefined force uniformly on the granules using the tester.
   3. Measure and record the hardness value in suitable units (e.g., N, kg).
3. Interpretation of Results:
   1. Compare the obtained hardness values with predefined acceptance criteria or specifications.
   2. Document results accurately in the testing record or batch documentation.
4. Reporting and Documentation:
   1. Report hardness test results to relevant personnel or departments.
   2. File and maintain testing records and documentation as per Good Documentation Practices (GDP).
5. Equipment Cleaning and Maintenance:
   1. Clean the hardness tester and other equipment used for testing 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
GDP: Good Documentation Practices

6) Documents, if any

Granule Hardness Testing Records, Batch Records, Quality Inspection Reports

7) Reference, if any

Pharmacopoeial guidelines (e.g., USP, EP) for granule hardness testing in pharmaceutical manufacturing.

8) SOP Version

Version 1.0