Standard Operating Procedure (SOP): Operation of Friability Test Machine
Purpose:
The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the proper operation of the Friability Test Machine. This SOP ensures accurate and reliable results during the evaluation of the physical integrity of tablets or pellets.
Scope:
This SOP applies to all personnel involved in conducting friability testing in a pharmaceutical or quality control laboratory.
Responsibility:
Laboratory personnel: Responsible for performing the friability test as per this SOP.
Quality Assurance (QA): Responsible for reviewing and approving this SOP.
Procedure:
4.1. Equipment and Materials:
Friability Test Machine
Sample tablets or pellets
Balance (calibrated)
Collection pan or container
Timer or stopwatch
Cleaning materials (lint-free cloth, brush, etc.)
4.2. Pre-Operational Preparations:
4.2.1. Ensure that the friability test machine is clean and free from any residue or contaminants from previous tests.
4.2.2. Familiarize yourself with the specific operating instructions and technical specifications provided by the manufacturer for the particular model of the friability test machine being used.
4.2.3. Gather all necessary equipment and materials.
4.3. Calibration:
4.3.1. Before starting any testing, ensure that the friability test machine is properly calibrated according to the manufacturer’s instructions.
4.3.2. Verify and adjust the rotational speed of the apparatus as per the calibration requirements.
4.3.3. Check the balance for accuracy and make necessary adjustments if required.
4.3.4. Document the calibration process and results as per the laboratory’s standard operating procedures.
4.4. Sample Preparation:
4.4.1. Obtain a representative sample of tablets or pellets from the batch or lot to be tested.
4.4.2. Follow the specifications provided by the relevant pharmacopeia or internal quality control standards to determine the number of tablets or pellets required for testing.
4.4.3. Carefully handle and store the samples to prevent physical damage or exposure to environmental factors that may affect their friability.
4.5. Test Procedure:
4.5.1. Weigh the initial mass of the tablets or pellets accurately using a calibrated balance and record the weight.
4.5.2. Place the tablets or pellets into the friability test apparatus, ensuring proper alignment and positioning.
4.5.3. Close the apparatus securely to prevent any tablets or pellets from escaping during the test.
4.5.4. Start the friability test machine as per the manufacturer’s instructions and the defined test parameters (rotational speed and duration).
4.5.5. Set the timer or stopwatch to the predetermined test duration.
4.5.6. After the test cycle is completed, stop the machine and open the apparatus.
4.5.7. Remove the tablets or pellets from the apparatus, taking care not to cause additional damage or breakage.
4.5.8. Clean the collection pan or container to remove any debris or dust particles.
4.5.9. Weigh the tablets or pellets again, recording the final mass accurately.
4.6. Calculation and Interpretation of Results:
4.6.1. Calculate the percentage friability using the following formula:
Percentage Friability = [(Initial Mass – Final Mass) / Initial Mass] x 100
4.6.2. Evaluate the results according to the specified acceptance criteria mentioned in the relevant pharmacopeia or internal quality control standards.
4.6.3. Record the results, including the percentage friability for each tested sample, in a suitable format or data recording system.
4.7 Post-Test Procedures:
4.7.1. Thoroughly clean the friability test apparatus after each test, following the cleaning procedures specified in the standard operating procedures.
4.7.2. Dispose of any broken tablets or pellets and debris properly, adhering to appropriate waste disposal guidelines.
4.7.3. Store the remaining sample tablets or pellets appropriately to maintain their quality and integrity.
Records:
5.1. Maintain a record of the calibration process, including the date, equipment used, and results obtained.
5.2. Document the details of each friability test conducted, including the date, batch or lot number, sample size, initial and final mass, test parameters, and results obtained.
5.3. Retain the records in a secure and organized manner as per the laboratory’s document control procedures.
Abbreviations: (if applicable)
SOP: Standard Operating Procedure
QA: Quality Assurance
References: (if applicable)
Relevant pharmacopeia monographs or internal quality control standards for friability testing.
Manufacturer’s operating instructions and technical specifications for the specific model of the friability test machine being used.
Revision History:
Version 1.0: [Date of initial creation]
Provides the initial version of the SOP for the operation of the friability test machine.
Version 1.1: [Date of revision]
[Specify the changes made during the revision, such as updates to the procedure, clarification of steps, or addition of new sections.]
Note: Any future revisions to this SOP should be documented and approved by the appropriate personnel before implementation.