Standard Operating Procedure (SOP) for Operational Check of Friability Test Apparatus

1.0 Purpose:

The purpose of this SOP is to outline the step-by-step procedure for conducting an operational check on the Friability Test Apparatus to ensure its proper functionality and accuracy in pharmaceutical testing.

2.0 Scope:

This SOP is applicable to all personnel involved in the operation and maintenance of the Friability Test Apparatus in the pharmaceutical laboratory.

3.0 Responsibilities:

3.1 Lab Technician:

Responsibilities of Lab Technician:

3.1 Pre-Operational Preparations:

• 3.1.1 Ensure personal protective equipment (PPE) is worn, including lab coat and gloves.
• 3.1.2 Verify that the Friability Test Apparatus is clean and free from any residues.
• 3.1.3 Check and confirm the calibration status of the apparatus.

3.2 Set-Up:

• 3.2.1 Properly place the friability drum inside the apparatus and secure it in place.
• 3.2.2 Verify that the rotational speed control is set to the standard operating speed (usually 25 rpm).
• 3.2.3 Ensure that the drum is adequately lubricated if required by the manufacturer.

3.3 Calibration Check:

• 3.3.1 Load a known number of test tablets (placebo tablets or as per standard requirements) into the drum.
• 3.3.2 Set the testing time as per the standard procedure (usually 4 minutes).
• 3.3.3 Start the apparatus and monitor for any irregularities during the test.

3.4 Visual Inspection:

• 3.4.1 Observe the tablets during the test to ensure there is no damage or breakage beyond the acceptable limit.
• 3.4.2 Vigilantly monitor the drum for smooth rotation without abnormal noise or vibration.

3.5 Post-Operational Checks:

• 3.5.1 Stop the apparatus after the completion of the test duration.
• 3.5.2 Carefully remove the tablets from the drum.
• 3.5.3 Inspect the tablets for any signs of excessive friability.

3.6 Documentation:

• 3.6.1 Record the results of the operational check accurately.
• 3.6.2 Document any observations or deviations from the standard procedure.
• 3.6.3 Report any issues or deviations to the appropriate personnel promptly.

4.0 Review and Approval:

• The Lab Technician is responsible for presenting the recorded results to the Quality Assurance (QA) Officer for review and approval.

3.2 Quality Assurance (QA) Officer:

Responsibilities of QA Officer:

3.2.1 Pre-Operational Preparations:

• 3.2.1.1 Confirm that the Lab Technician has adhered to the required personal protective equipment (PPE) guidelines.
• 3.2.1.2 Verify the cleanliness of the Friability Test Apparatus and the status of its calibration.

3.2.2 Set-Up:

• 3.2.2.1 Ensure the Lab Technician has correctly placed the friability drum inside the apparatus and secured it in place.
• 3.2.2.2 Verify that the rotational speed control is set to the standard operating speed.
• 3.2.2.3 Confirm proper lubrication of the drum if required.

3.2.3 Calibration Check:

• 3.2.3.1 Review the documented calibration check, ensuring compliance with the established standards.
• 3.2.3.2 Check for any anomalies or deviations during the calibration check.

3.2.4 Visual Inspection:

• 3.2.4.1 Evaluate the Lab Technician’s observations during the visual inspection of tablets for damage or breakage.
• 3.2.4.2 Confirm the Lab Technician’s assessment of the drum’s rotation for smooth operation.

3.2.5 Post-Operational Checks:

• 3.2.5.1 Scrutinize the Lab Technician’s documentation of the post-operational checks, including tablet inspection and any identified issues.
• 3.2.5.2 Determine the severity of any deviations and assess the need for corrective actions.

3.2.6 Documentation Review:

• 3.2.6.1 Thoroughly review all recorded results and documentation for completeness and accuracy.
• 3.2.6.2 Cross-reference the findings with established quality standards and procedural requirements.

3.2.7 Approval Process:

• 3.2.7.1 Provide final approval for the operational check if all parameters meet the specified criteria.
• 3.2.7.2 If deviations are identified, collaborate with relevant personnel to initiate corrective actions.

4.0 Record Keeping:

• Ensure all records related to the operational check are appropriately filed and maintained.

4.0 Equipment and Materials:

• Friability Test Apparatus
• Test tablets (placebo tablets or as per standard requirements)

5.0 Procedure:

5.1 Pre-Operational Preparations:

5.1.1 Personal Protective Equipment (PPE) Verification:

• 5.1.1.1 Prior to initiating any activity, ensure that the Lab Technician verifies the use of appropriate PPE, including lab coat and gloves.
• 5.1.1.2 Confirm that PPE is in good condition and free from any damage.

5.1.2 Apparatus Cleanliness:

• 5.1.2.1 Inspect the Friability Test Apparatus for cleanliness and absence of residues from previous tests.
• 5.1.2.2 If any residues are detected, clean the apparatus following the approved cleaning procedure.

5.3 Calibration Status Check:

• 5.3.3.1 Verify the calibration status of the Friability Test Apparatus.
• 5.3.3.2 Ensure that the calibration is up-to-date as per the established schedule.

5.4 Readiness Confirmation:

• 5.4.4.1 Confirm that all necessary materials and tools for the operational check are available.
• 5.4.4.2 Check the availability of the required number of placebo tablets or test tablets for the calibration check.

5.5 Safety Checks:

• 5.5.5.1 Ensure that emergency equipment, such as fire extinguishers and first aid kits, is readily accessible.
• 5.5.5.2 Confirm the availability and functionality of emergency exits.

5.6 Documentation Review:

• 5.6.6.1 Check the Operational Check Log to ensure that the last operational check details and any relevant notes are reviewed.
• 5.6.6.2 Verify that any outstanding issues from the previous operational checks are appropriately addressed.

5.2 Set-Up:

Set-Up Procedure:

5.2.1 Placement of Friability Drum:

• Open the apparatus and place the friability drum inside.
• Ensure the drum is securely positioned and locked in place according to the manufacturer’s guidelines.

5.2.2 Rotational Speed Control:

• Verify that the rotational speed control is set to the standard operating speed (typically 25 rpm).
• If adjustments are necessary, follow the equipment manual guidelines for setting the correct speed.

5.2.3 Lubrication Check:

• Confirm whether the friability drum requires lubrication, following the manufacturer’s recommendations.
• If lubrication is needed, apply the appropriate lubricant as instructed.

5.2.4 Power On:

• Switch on the power to the Friability Test Apparatus.
• Ensure that the apparatus powers up without any abnormal sounds or vibrations.

5.2.5 System Check:

• Run a brief system check to verify that all components are functioning correctly.
• Check for any error messages or abnormalities on the display panel.

5.2.6 Ready Status Confirmation:

• Confirm that the apparatus is in a ready state for the operational check.
• Ensure that the set-up process is completed in accordance with the equipment specifications.

5.2.7 Calibration Verification:

• Double-check that the apparatus is calibrated, referring to the calibration certificate or the calibration log.
• If the calibration is not within the acceptable range, address the issue before proceeding.

5.3 Calibration Check:

Calibration Check Procedure:

5.3.1 Load Test Tablets:

• Place a known number of test tablets (placebo tablets or as per standard requirements) into the friability drum.
• Confirm that the tablet load adheres to the specified quantity for the calibration check.

5.3.2 Set Testing Time:

• Set the testing time on the Friability Test Apparatus as per the standard procedure (usually 4 minutes).
• Ensure that the testing time is accurately inputted and displayed.

5.3.3 Initiate Apparatus:

• Start the Friability Test Apparatus to initiate the calibration check.
• Observe the apparatus during operation to ensure proper functioning.

5.3.4 Monitor Tablet Condition:

• Continuously monitor the test tablets during the calibration check for signs of damage or breakage.
• Note any deviations from the expected tablet condition.

5.3.5 Stop Apparatus:

• Stop the apparatus after the completion of the specified testing time.
• Ensure that the apparatus comes to a complete stop before proceeding.

5.3.6 Tablet Inspection:

• Carefully remove the test tablets from the drum.
• Inspect the tablets for any signs of excessive friability, such as chipping or breakage.

5.3.7 Record Results:

• Record the results of the calibration check in the Operational Check Log.
• Include details such as tablet condition, testing time, and any deviations observed.

5.3.8 Report Deviations:

• If any deviations are identified during the calibration check, report them to the designated personnel immediately.
• Document any corrective actions taken to address the deviations.

5.4 Visual Inspection:

Visual Inspection Procedure:

5.4.1 Tablet Observation:

• Initiate the operational check of the Friability Test Apparatus as per the established procedure.
• Continuously observe the test tablets inside the drum during the testing period.

5.4.2 Damage Assessment:

• Evaluate each tablet for signs of damage, including chipping, breakage, or excessive wear.
• Record any observed damage and categorize it based on severity.

5.4.3 Drum Rotation Monitoring:

• Monitor the rotation of the friability drum for smooth and consistent movement.
• Check for any abnormal noise or vibration that may indicate issues with the apparatus.

5.4.4 Stop Apparatus:

• Stop the Friability Test Apparatus after the completion of the testing period.
• Ensure that the apparatus comes to a complete stop before proceeding.

5.4.5 Tablet Removal:

• Carefully remove the test tablets from the drum for closer inspection.
• Handle the tablets with care to avoid additional damage during removal.

5.4.6 Detailed Inspection:

• Examine each tablet individually for any finer details not visible during the operational check.
• Note any additional observations or deviations discovered during the detailed inspection.

5.4.7 Record Results:

• Record the results of the visual inspection in the Operational Check Log.
• Include details such as observed damage, drum rotation assessment, and any deviations noted.

5.4.8 Report Deviations:

• If any significant deviations are identified during the visual inspection, report them to the designated personnel promptly.
• Document any corrective actions taken to address the observed deviations.

5.5 Post-Operational Checks:

Post-Operational Checks Procedure:

5.5.1 Stop Apparatus:

• Stop the Friability Test Apparatus immediately after the completion of the specified testing time.
• Ensure that the apparatus comes to a complete stop before proceeding with post-operational checks.

5.5.2 Tablet Removal:

• Carefully remove the test tablets from the friability drum.
• Handle the tablets with care to prevent additional damage during removal.

5.5.3 Visual Inspection:

• Conduct a visual inspection of each tablet for signs of damage, chipping, or excessive wear.
• Record any observed damage and categorize it based on severity.

5.5.4 Drum Inspection:

• Inspect the friability drum for any residual tablet fragments or unusual wear.
• Clean the drum if necessary, following the approved cleaning procedure.

5.5.5 Functional Checks:

• Verify that the Friability Test Apparatus is functioning correctly, with no abnormal noise or vibrations.
• Confirm that all components are in proper working order.

5.5.6 Review Documentation:

• Review the documentation in the Operational Check Log for completeness and accuracy.
• Cross-reference the results of post-operational checks with visual inspection findings.

5.5.7 Record Results:

• Record the results of post-operational checks in the Operational Check Log.
• Include details such as observed tablet conditions, drum inspection results, and any deviations noted.

5.5.8 Report Deviations:

• If any significant deviations are identified during post-operational checks, report them to designated personnel promptly.
• Document any corrective actions taken to address the observed deviations.

5.6 Documentation:

Documentation Procedure:

5.6.1 Operational Check Log:

• Create a dedicated Operational Check Log for the Friability Test Apparatus.
• Include fields for date, technician’s name, apparatus identification, and calibration details.

5.6.2 Pre-Operational Documentation:

• Record the verification of personal protective equipment (PPE) usage by the Lab Technician.
• Document the cleanliness check of the apparatus and the confirmation of its calibration status.

5.6.3 Set-Up Documentation:

• Log details of the placement and securing of the friability drum.
• Document the verification of rotational speed control and lubrication status.

5.6.4 Calibration Check Documentation:

• Record the specifics of the calibration check, including the number of test tablets, testing time, and any deviations observed.
• Document the QA Officer’s review and approval of the calibration check.

5.6.5 Visual Inspection Documentation:

• Record observations during the visual inspection, including tablet condition and drum rotation assessment.
• Document any issues or deviations identified during the visual inspection.

5.6.6 Post-Operational Checks Documentation:

• Document results of post-operational checks, including tablet conditions, drum inspection, and functional checks.
• Record any deviations noted and any corrective actions taken.

5.6.7 Record Review and Approval:

• The Lab Technician must review recorded results for completeness and accuracy.
• The QA Officer reviews and approves the documented results in the Operational Check Log.

5.6.8 Corrections and Amendments:

• If errors are identified in the documentation, make corrections using the approved correction procedure.
• Clearly indicate any amendments made and the reason for the correction.

5.6.9 Record Retention:

• Establish a record retention system according to regulatory requirements.
• Clearly label and file records for easy retrieval during audits.

5.7 Training and Communication:

• Train personnel on the proper documentation procedures outlined in this SOP.
• Communicate any updates or changes to the documentation process promptly.

6.0 Review and Approval:

• The recorded results and any noted deviations must be reviewed and approved by the QA Officer.

7.0 Records:

Record Creation:

7.1 Operational Check Log:

• Create a dedicated Operational Check Log for the Friability Test Apparatus.
• Include fields for date, technician’s name, apparatus identification, and any relevant calibration details.

7.2 Pre-Operational Preparations:

• Document the Lab Technician’s verification of personal protective equipment (PPE) usage.
• Record the confirmation of apparatus cleanliness and calibration status.

7.3 Set-Up:

• Log details of the correct placement and securing of the friability drum.
• Include information on the verification of rotational speed and lubrication.

7.4 Calibration Check:

• Record the specifics of the calibration check, such as the number of test tablets, testing time, and any deviations observed.
• Highlight the QA Officer’s review and approval of the calibration check.

7.5 Visual Inspection:

• Document the Lab Technician’s observations during visual inspections of tablets and drum rotation.
• Note any issues identified during the visual inspection.

7.6 Post-Operational Checks:

• Record the results of post-operational checks, including tablet inspections and any corrective actions taken.
• Include details of the QA Officer’s review and approval of the post-operational checks.

7.7 Documentation Review:

• Regularly review records for completeness, accuracy, and adherence to established standards.
• Document any discrepancies or corrective actions taken during the review process.

7.8 Record Retention:

• Establish a systematic filing system for easy retrieval and long-term storage of operational check records.
• Define a retention period for records in accordance with regulatory requirements.

7.9 Accessibility:

• Ensure that all relevant personnel have access to the records when necessary.
• Implement security measures to protect the confidentiality and integrity of the records.

8.0 Training and Communication:

• Train personnel on the proper documentation procedures outlined in this SOP.
• Communicate any updates or changes to the records management process promptly.

8.0 References:

• Include any relevant reference documents or standards applicable to the friability testing.

9.0 Revision History:

• Maintain a record of revisions made to this SOP.

10.0 Attachments:

Attach any supporting documents, calibration certificates, or test procedures relevant to the Friability Test Apparatus.

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