Standard Operating Procedure (SOP)

1. Purpose

To define the procedure for the proper cleaning of the Tablet Hardness Tester to ensure accurate test results, prevent cross-contamination, and maintain instrument integrity.

2. Scope

This procedure applies to all laboratory personnel responsible for cleaning the Tablet Hardness Tester used in [Organization/Department Name].

3. Definitions

• Tablet Hardness Tester: An analytical device used to measure the crushing strength of tablets.

• Cleaning: Removal of dust, residue, and debris from the surfaces of the instrument.

4. Responsibilities

• Laboratory Analysts: Perform cleaning as per this SOP.

• Supervisors: Ensure compliance with the cleaning procedure.

• Quality Assurance (QA): Review cleaning records during audits or inspections.

5. Materials and Equipment

• Clean lint-free cloths

• Soft brush (non-metallic)

• Mild detergent solution (if needed)

• Distilled or purified water

• 70% Isopropyl alcohol (IPA)

• Gloves and other appropriate PPE

6. Procedure

6.1 Frequency of Cleaning

• After each use or batch testing.

• Before calibration or maintenance.

• When visibly soiled or dusty.

• As part of routine weekly maintenance.

6.2 Cleaning Steps

6.2.1 Preparation

• Ensure the Tablet Hardness Tester is powered off and unplugged before cleaning.

• Wear appropriate PPE (e.g., gloves, lab coat).

6.2.2 Dry Cleaning

• Use a soft brush to remove any loose dust, powder, or debris from the tester surfaces, particularly the plunger, anvil, and measurement area.

• Gently wipe the outer surfaces and test area with a clean, dry, lint-free cloth.

6.2.3 Wet Cleaning (if required)

• If residues remain, lightly moisten a lint-free cloth with distilled water or mild detergent solution.

• Wipe the affected areas carefully without allowing liquid to seep into electronic parts.

• Follow up with a cloth lightly moistened with 70% IPA to sanitize the surfaces, particularly contact areas.

• Allow the tester to air dry completely before re-use.

6.2.4 Special Notes

• Do not immerse any part of the hardness tester in liquid.

• Do not use abrasive cleaners, strong solvents, or excessive water.

• Pay special attention to critical measurement areas to prevent damage or misalignment.

6.3 Post-Cleaning Activities

• Inspect the Tablet Hardness Tester visually to ensure it is clean and undamaged.

• Record the cleaning activity in the cleaning logbook, including:

  • Date and time of cleaning

  • Person who performed the cleaning

  • Comments on any issues noticed during cleaning

7. Documentation

• Maintain cleaning records in the designated cleaning logbook or electronic system.

• Retain records for the period specified in the company’s documentation retention policy.

8. Precautions

• Always disconnect the power supply before cleaning.

• Avoid applying excessive force that could misalign delicate parts.

• Immediately report any instrument damage or malfunction to the supervisor.

9. References

• Manufacturer’s User Manual for the Tablet Hardness Tester

• GMP Guidelines

• Internal Equipment Maintenance SOPs

🎓 Discover one of the best Quality Assurance courses available — click below to explore the course that’s shaping future QA skills.

https://trcjw.on-app.in/app/oc/306166/trcjw