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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