Standard Operating Procedure for Friability Testing in Granules

1) Purpose

The purpose of this SOP is to outline the procedure for conducting friability testing on granule formulations in the pharmaceutical industry to assess their resistance to abrasion and mechanical stress.

2) Scope

This SOP applies to all personnel involved in friability testing of granule formulations within the pharmaceutical quality control (QC) department.

3) Responsibilities

Analytical Chemist: Responsible for performing friability testing and documenting results.
Quality Assurance (QA) Department: Responsible for reviewing and approving the friability testing procedure and results.

4) Procedure

1. Sample Collection:
   1. Select representative samples from different batches or lots according to the sampling plan.
   2. Weigh each sample accurately using a calibrated balance.
2. Apparatus Setup:
   1. Prepare the friability testing apparatus according to manufacturer specifications.
   2. Calibrate the apparatus as per standard operating procedures.
3. Testing:
   1. Place the pre-weighed sample into the friability testing drum.
   2. Set the rotation speed and testing duration as per specifications (typically 100 rotations for 4 minutes).
   3. After completion of the test, remove the granules from the drum and carefully brush off any loose dust.
4. Measurement:
   1. Weigh the granules after friability testing.
   2. Calculate the percentage friability using the formula:
   3. Friability (%) = [(Initial Weight - Final Weight) / Initial Weight] × 100
   4. Where:
      • Initial Weight is the weight of the sample before testing.
      • Final Weight is the weight of the sample after testing.
5. Acceptance Criteria:
   1. Compare the calculated friability with established acceptance criteria.
   2. Evaluate the mechanical strength and abrasion resistance of the granules based on the friability value.
6. Reporting:
   1. Document the friability test results in the appropriate logbook or electronic system.
   2. Include any deviations noted during testing and actions taken.
7. Documentation:
   1. Maintain accurate records of all friability testing activities, including raw data, calculations, and reports.
   2. File documentation following Good Documentation Practices (GDP).

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
GDP: Good Documentation Practices

6) Documents, if any

Friability Testing Protocol, Test Results, Friability Report

7) Reference, if any

Pharmacopeial guidelines for friability testing of pharmaceutical granules.

8) SOP Version

Version 1.0