SOP FOR OPERATION AND CALIBRATION OF TABLET HARDNESS TESTER

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OPERATION AND CALIBRATION OF TABLET HARDNESS TESTER

GMP Compliant | Pharmacopoeial Methods | QA/QC Laboratory

1. Purpose

To define the procedure for the operation, calibration, and maintenance of the tablet hardness tester to ensure accurate, reliable, and reproducible measurement of tablet mechanical strength in accordance with pharmacopeial and regulatory requirements.

2. Scope

This SOP applies to all tablet hardness testers used for routine quality control, in-process testing, and stability studies of tablets in the pharmaceutical laboratory.

3. Responsibilities

  • Analyst: Perform hardness testing, calibration, and record results accurately.
  • QC Supervisor: Verify calibration and test data, approve results.
  • QA: Ensure compliance, review deviations, approve final records.

4. Safety Precautions

  • Wear PPE (lab coat, gloves, goggles).
  • Handle tablets carefully to avoid damage and spillage.
  • Follow electrical safety while operating the instrument.
  • Dispose of broken tablets appropriately.

5. Equipment Description

  • Tablet hardness tester (digital or analog)
  • Calibration weights or reference hardness standard tablets
  • Glass or stainless-steel force application plates (as per instrument)
  • Cleaning materials (soft cloth, alcohol)

6. Calibration Procedure

6.1 Verification with Reference Standard

  1. Switch ON the hardness tester and allow it to warm up if required.
  2. Ensure the instrument is clean and free of dust or debris.
  3. Place the reference standard tablet (with known hardness value) between the compression jaws.
  4. Apply pressure until the tablet breaks and record the reading.
  5. Repeat at least 3 times using different tablets or reference points.
  6. Calculate mean value and % deviation from reference.
  7. Acceptance: Reading within ±5% of the reference standard value.

6.2 Mechanical / Load Verification (for digital testers)

  1. Use calibrated weights (if manufacturer recommends) or reference load standard.
  2. Apply known load and verify displayed value matches within tolerance.
  3. Repeat three times and record data.
  4. Acceptance: ±5% of applied load.

7. Operational Procedure

7.1 Sample Preparation

  1. Select tablets randomly from batch (usually 10 tablets per batch unless method specifies otherwise).
  2. Check tablets for defects or coating irregularities; discard damaged ones.
  3. Bring tablets to room temperature if stored in controlled conditions.

7.2 Hardness Measurement

  1. Switch ON the hardness tester.
  2. Place the first tablet between the jaws or platens as per instrument design.
  3. Start compression slowly until tablet fractures.
  4. Record the hardness value displayed (N, kg/cm², or kp as per instrument).
  5. Remove broken tablet carefully and repeat for remaining tablets.
  6. Calculate mean, standard deviation, and %RSD of all measurements.

7.3 Post-Test Procedure

  1. Clean the instrument jaws/platens using soft cloth and alcohol if required.
  2. Switch OFF the instrument.
  3. Dispose broken tablets as per SOP.
  4. Store instrument in dust-free area.

8. Acceptance Criteria

  • Hardness of tablets should be within the range specified in the method.
  • %RSD of measurements should not exceed 5%.
  • Calibration checks should be within ±5% of reference standards.

9. Documentation and Records

  • Record calibration data, operational results, and calculations in the instrument logbook.
  • QA approval required for all calibration and test results.
  • Maintain records according to company policy for retention period.

10. Troubleshooting & Preventive Maintenance

  • Check for uneven or sticky jaws if readings fluctuate.
  • Ensure instrument is level on bench to prevent measurement errors.
  • Clean platens regularly to avoid residue buildup.
  • Verify calibration periodically and after any mechanical service.
  • Report any abnormal readings or mechanical issues to QC Supervisor immediately.

Prepared By: ____________________

Reviewed By: ____________________

Approved By: ____________________

Effective Date: ____________________

SOP No.: __________    Revision No.: _____

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