SOP on Operation of Tablet Hardness Tester

Title: Operation of Tablet Hardness Tester

  • Purpose: This SOP outlines the Operation of tablet hardness tester to measure the hardness or breaking force of tablets accurately.
  • Scope: This SOP applies to all personnel involved in tablet hardness testing using the designated tablet hardness tester in the laboratory.
  • Equipment and Materials:
    • Tablet hardness tester
    • Tablets to be tested
    • Test log or record sheet
    • Cleaning materials (lint-free cloth, brush, cleaning solution)
    • Personal protective equipment (PPE) (lab coat, gloves, safety glasses)
  • Pre-Operational Checks:
  • A. Equipment Preparation:
    • Ensure that the tablet hardness tester is clean, calibrated, and in proper working condition.
    • Check that the instrument is connected to a stable power source.
    • Ensure that all necessary accessories (e.g., measuring probe, sample holder) are in place.
  • B. Tablet Preparation:
    • Select representative tablets for testing according to the applicable specifications or requirements.
    • Check that the tablets are intact, free from defects or damage, and suitable for testing.
    • Avoid handling tablets directly with bare hands to prevent contamination or damage.
  • Operation Procedure:
  • A. Instrument Setup:
    • Power on the tablet hardness tester and allow it to warm up, if required, according to the manufacturer’s instructions.
    • Set the appropriate testing parameters, including the desired measurement units (e.g., Newton, kilogram, pound).
    • Ensure that the testing method (e.g., single-punch, multi-punch) is correctly selected for the tablets being tested.
  • B. Calibration (if applicable):
    • Perform the necessary calibration procedures as per the manufacturer’s instructions.
    • Verify and record the calibration details, including the calibration date and any correction factors applied.
  • C. Tablet Testing:
    • Place the tablet carefully in the sample holder or on the testing platform, ensuring proper alignment.
    • Close or secure the sample holder or platform to stabilize the tablet for testing.
    • Initiate the tablet hardness test according to the instrument’s operating procedure.
    • Record the hardness or breaking force measurement displayed by the instrument.
    • Repeat the test for each tablet (10 Nos), following the same procedure consistently.
  • D. Cleaning and Maintenance:
    • After testing, clean the tablet hardness tester using a lint-free cloth or brush and a suitable cleaning solution, if necessary.
    • Ensure that all surfaces, accessories, and components are thoroughly cleaned and dried.
    • Perform routine maintenance procedures, such as lubrication or component replacement, as recommended by the manufacturer.
Operation of Tablet Hardness Tester
  • Documentation:
  • A. Test Record:
    • Document all relevant information, including the date, test equipment details, tablet identification, and hardness measurements.
    • Record any observations, deviations, or abnormalities encountered during testing.
  • B. Storage:
    • Store the test records and any associated documentation in a secure location as per the laboratory’s recordkeeping procedures.
    • Maintain records for the required duration based on regulatory or quality management requirements.
  • Safety Precautions:
    • Adhere to the laboratory’s safety procedures and wear appropriate personal protective equipment (PPE) during testing.
    • Handle the tablet hardness tester with care to avoid accidental damage or injury.
  • Training and Qualification (if Applicable):
    • Ensure that all personnel performing tablet hardness testing are trained on this SOP and familiar with the specific tablet hardness tester used.
    • Conduct periodic refresher training to keep operators updated on any changes or new procedures.

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