Procedure for Tablet Hardness Testing
1) Purpose
The purpose of this SOP is to outline the procedure for determining the hardness of tablets to ensure they meet the required mechanical strength for packaging, handling, and usage.
2) Scope
This SOP applies to all tablet batches produced within the manufacturing facility.
3) Responsibilities
Quality Control (QC) Department: Responsible for conducting hardness testing and ensuring compliance with this SOP.
Production Department: Responsible for providing tablet samples for testing and maintaining process parameters.
4) Procedure
4.1 Sampling:
4.1.1 Collect a representative sample of tablets from different locations within a batch according to the sampling plan.
4.1.2 Ensure the sample size is adequate (e.g., 10 tablets) to obtain a uniform representation.
4.2 Equipment Preparation:
4.2.1 Calibrate the hardness tester as per the manufacturer’s instructions.
4.2.2 Ensure the tester is clean and free from previous residues.
4.3 Hardness Testing Procedure:
4.3.1 Place a tablet in the hardness tester.
4.3.2 Operate the tester to apply force on the tablet until it breaks.
4.3.3 Record the force required to break the tablet.
4.3.4 Repeat the process for all tablets in the sample.
4.4 Calculation:
4.4.1 Calculate the average hardness of the tablets.
4.4.2 Determine the standard deviation to assess the consistency of tablet hardness.
4.5 Acceptance Criteria:
4.5.1 The tablet batch is acceptable if the hardness falls within the specified range (e.g., 4-8 kg/cm²).
4.6 Documentation:
4.6.1 Document all results and calculations in the Tablet Hardness Test Record.
4.6.2 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Tablet Hardness Test Record
Calibration Record for Hardness Tester
Sampling Plan Document
7) Reference, if any
USP <1217> – Tablet Breaking Force
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0
