Standard Operating Procedure (SOP)

Here is a Standard Operating Procedure (SOP) for the Operation and Calibration of Friability Test Apparatus. This SOP ensures proper operation, calibration, and maintenance of the friability testing apparatus, which is essential for evaluating the durability and resistance of tablets to mechanical stress.

1. Purpose

To provide a standardized procedure for the operation, calibration, and maintenance of the friability test apparatus, ensuring accurate and reliable results in the evaluation of the mechanical strength of tablets.

2. Scope

This SOP applies to the friability test apparatus used in the Quality Control (QC) laboratory at [Company/Facility Name] to measure the friability of tablets in accordance with the appropriate pharmacopeial guidelines (e.g., USP, EP).

3. Responsibilities

• Laboratory Technicians: Responsible for operating the friability test apparatus, performing the test, and maintaining the equipment.

• Quality Control (QC) Supervisor: Oversees the operation and calibration of the apparatus and ensures all records are maintained accurately.

• Maintenance Personnel: Responsible for servicing the apparatus, performing repairs, and ensuring the apparatus is in proper working condition.

4. Materials and Equipment

• Friability Test Apparatus (e.g., Roche Friabilator or equivalent)

• Weighing Balance (Analytical Balance)

• Tablet Samples (representative sample of the batch)

• Friability Test Cylinder (if applicable)

• Cleaning Supplies (e.g., cloth, brush)

• Record forms for documentation (e.g., test log, calibration log)

5. Procedure

5.1 Operation of Friability Test Apparatus

5.1.1 Preparation of the Apparatus

1. Clean the Apparatus:

   • Clean the friability test apparatus, including the drum or rotating cylinder, using a cloth or brush to remove any previous powder or tablet residue.

   • Ensure the drum is free from any contaminants that might affect the test.

2. Check Equipment for Proper Function:

   • Verify that the apparatus is functioning properly. Ensure the drum rotates smoothly and that there is no obstruction or mechanical malfunction.

3. Sample Preparation:

   • Weigh 10 tablets from the batch to be tested using an analytical balance. The sample should represent the overall batch.

   • Record the weight of each tablet and calculate the total weight of the 10 tablets.

5.1.2 Performing the Friability Test

1. Loading the Samples:

   • Place the 10 tablets into the friability test drum or cylinder. Ensure that the tablets are evenly distributed to prevent clumping or damage.

2. Setting the Apparatus:

   • Set the apparatus to the appropriate test parameters, usually 100 rotations (or as specified by the pharmacopoeia or product specifications).

   • Ensure the drum rotates at a consistent speed, typically around 25–30 rpm.

3. Running the Test:

   • Start the apparatus and allow the drum to rotate for the specified time (usually 100 revolutions).

   • Ensure the apparatus runs for the complete duration without interruption.

5.1.3 Post-Test Procedures

1. Weighing the Tablets After Testing:

   • After the test is completed, carefully remove the tablets from the drum.

   • Wipe off any powder from the tablets, and weigh them individually or as a group using the analytical balance.

   • Record the weight of the tablets post-test.

2. Calculating the Friability:

   • Calculate the friability percentage using the following formula:

                                                      Friability(%)=Initial Weight Initial- Weight / Final Weight​×100

   • Record the friability result. A typical acceptance criterion is that the friability of tablets should be less than 1% for tablets intended for oral use (unless otherwise specified).

5.2 Calibration of Friability Test Apparatus

5.2.1 Frequency of Calibration

• The friability test apparatus should be calibrated annually or after any major maintenance.

• Calibration should also be done if there is a noticeable malfunction or irregular readings.

5.2.2 Calibration Procedure

1. Use a Calibration Standard:

   • If a calibration standard is available, use it to verify the accuracy of the apparatus. A set of known standard tablets with a known friability value may be used to verify that the apparatus is providing consistent and reliable results.

2. Perform Test with Calibration Standard:

   • Load the calibration standard tablets into the apparatus and perform the friability test as outlined in Section 5.1.

   • Compare the calculated friability with the expected value for the calibration standard.

3. Adjust the Apparatus if Necessary:

   • If the results from the calibration standard do not meet the expected values, perform necessary adjustments as per the manufacturer’s guidelines. This may include adjusting the rotation speed, drum size, or other mechanical components.

4. Record Calibration Results:

   • Document the calibration results, including the date, calibration standard used, test results, and any adjustments made to the apparatus.

   • Maintain the calibration log for audit purposes.

5.3 Maintenance of Friability Test Apparatus

1. Routine Cleaning:

   • Clean the apparatus after each use to remove any powder residue or tablet fragments.

   • Regularly inspect the apparatus for any signs of wear or malfunction.

2. Scheduled Maintenance:

   • Perform preventive maintenance as recommended by the manufacturer, usually once every six months, including checking the mechanical components, motor, and rotating drum for smooth operation.

3. Troubleshooting:

   • If the apparatus fails to operate correctly or produces inconsistent results, check for possible mechanical issues such as obstructions in the drum or faulty rotation speed.

   • If needed, contact maintenance personnel to troubleshoot and repair the apparatus.

6. Precautions

• Always ensure that the sample tablets are weighed accurately before and after the test to ensure reliable results.

• Do not overload the drum with more than the specified number of tablets to avoid skewing the results.

• Handle the tablets carefully to avoid any damage before or after the test, as this can affect the friability results.

• Regularly check the apparatus for any mechanical or electrical issues that may affect its performance.

• Keep the testing area clean and free of external contaminants that could affect the test results.

7. Documentation and Records

• Friability Test Log: Document each test, including the batch number, tablet weight, friability percentage, and any observations.

• Calibration Log: Maintain a log for all calibration procedures, including the calibration standard used, test results, and any adjustments made to the apparatus.

• Maintenance Log: Keep a record of all maintenance activities, including the date of maintenance, issues identified, and actions taken.

8. Reference Documents

• Manufacturer’s manual for the friability test apparatus

• USP Chapter <1216> – Friability and Breaking Force of Tablets

• Pharmacopeial guidelines (e.g., USP, EP) for friability testing

• Calibration and maintenance guidelines from the apparatus manufacturer.

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