Standard Operating Procedure (SOP)

1. Purpose

This SOP outlines the procedures for cleaning the Friability Test Apparatus to ensure its proper functioning, prevent contamination between tests, and maintain compliance with laboratory standards.

2. Scope

This procedure applies to all laboratory personnel responsible for the cleaning, maintenance, and use of the Friability Test Apparatus in [Organization/Department Name].

3. Definitions

• Friability Test Apparatus: A device used for testing the mechanical strength of tablets or other solid dosage forms by rotating them in a drum at a specified speed and time.

4. Responsibilities

• Laboratory Analysts: Responsible for the cleaning and inspection of the apparatus before and after each use.

• Supervisors/Managers: Ensure all personnel are trained to follow this SOP and maintain the equipment.

• Maintenance Team: Conduct regular checks and assist in equipment servicing, as needed.

5. Materials and Equipment

• Clean, lint-free cloths or wipes

• Distilled water

• Isopropyl alcohol (70%)

• Mild detergent (if necessary)

• Soft brush (for hard-to-reach areas)

• Non-abrasive sponge

• Vacuum cleaner (if required for cleaning powder residues)

• Gloves (PPE)

• Personal protective equipment (PPE)

6. Procedure

6.1 Pre-Cleaning Setup

• Ensure the apparatus is turned off and unplugged from the power source before cleaning.

• Wear appropriate PPE such as gloves, lab coat, and safety goggles.

6.2 Cleaning Process

6.2.1 Cleaning the Drum

• Use a vacuum cleaner to remove any powder or loose tablet debris from inside the drum.

• If necessary, wipe the inside of the drum with a clean, lint-free cloth dampened with distilled water.

• For stubborn residues, use a mild detergent solution (non-abrasive) to clean the surface.

• After cleaning with detergent, wipe the drum thoroughly with a cloth dampened with distilled water to remove all detergent residue.

• Dry the drum completely using a lint-free cloth.

6.2.2 Cleaning the Pan and Rotating Mechanism

• Clean the pan and rotating mechanism using a soft, non-abrasive cloth dampened with distilled water or isopropyl alcohol (70%) to remove any tablet dust or residue.

• For hard-to-reach areas, use a soft brush to dislodge debris.

• Ensure the pan is completely dry before reassembling it.

6.2.3 Cleaning the Control Panel

• Wipe the control panel with a soft, dry cloth to remove any dust or surface contamination.

• Avoid using any liquid directly on the control panel. If necessary, dampen the cloth with isopropyl alcohol (70%) for cleaning.

6.3 Post-Cleaning Inspection

• After cleaning, inspect all parts of the apparatus for any signs of wear, corrosion, or damage.

• Ensure all components are securely reassembled and properly aligned.

6.4 Final Drying and Reassembly

• Allow all parts to air dry completely before reassembling the apparatus.

• Ensure the apparatus is correctly reassembled, with all components tightly secured and functional.

7. Documentation

• Record the date and time of cleaning in the Cleaning Logbook or relevant electronic system.

• Document any observations, such as issues encountered during cleaning or parts that require maintenance or replacement.

8. Precautions

• Always use distilled water to avoid contamination from minerals or impurities.

• Do not use abrasive materials or harsh chemicals, as they can damage the apparatus.

• Ensure the apparatus is fully dry before reassembling to avoid electrical or mechanical malfunctions.

• Do not use excessive force when cleaning delicate parts to avoid damage.

9. Frequency of Cleaning

• Clean the Friability Test Apparatus after each use.

• Perform a more thorough cleaning and inspection weekly or as necessary.

10. References

• USP (United States Pharmacopeia) Monographs

• Internal Quality Control Documents

• Manufacturer’s Manual for Friability Test Apparatus

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