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.
- 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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