Intervention during Media fill
Media fill is a simulation exercise conducted in aseptic processing areas to evaluate the capability of operators and the manufacturing environment to maintain sterility. The process involves filling sterile growth media into containers using the same equipment and procedures employed in the actual drug manufacturing. It provides a real-time assessment of the aseptic processes, ensuring that any potential sources of contamination are identified and rectified.
Significance of Intervention:
Intervention during media fill refers to any corrective action taken when a breach in aseptic conditions is identified. These interventions are critical to evaluate the ability of the manufacturing personnel to respond effectively and promptly to deviations from the standard operating procedures. The primary goals of intervention are to prevent microbial contamination and ensure the integrity of the final drug product.
Training and Competency:
Ensure that personnel participating in media fill exercises are adequately trained and possess the necessary skills in aseptic techniques. Conduct frequent training sessions to reinforce the significance of intervention and the correct procedures to be followed.
Monitoring and Surveillance:
Implement a strong environmental monitoring program to promptly detect any deviations from acceptable limits. Utilize advanced monitoring technologies such as viable air and surface samplers to enhance surveillance capabilities.
Immediate Response:
Establish clear protocols for immediate intervention in the event of any deviation from the aseptic conditions.
Empower personnel to promptly take corrective actions to minimize the risk of contamination.
Documentation and Investigation:
Comprehensively document all interventions, including the nature of the intervention, personnel involved, and the corrective measures taken. Conduct thorough investigations to determine the root cause of the deviation and implement corrective and preventive actions (CAPA) accordingly.
Continuous Improvement:
Regularly review and analyze intervention data to identify patterns and areas for improvement.
Implement continuous improvement initiatives based on the lessons learned from interventions.
Inherent (Routine) Intervention =18 Nos.
Machine parts assembly
Initial fill weight adjustment
Compressed Air & Vacuum Pressure adjustment.
Periodic weight checkup
Flip off seal charging.
Handling of vials by using forceps.
Handling of rubber Bungs by using forceps.
Swing conveyor movement.
Environmental Monitoring – A) Settle Plate and B) Active Air Sampling
API canister transfer.
Rubber stoppers charging.
Sensor adjustment.
Rubber stopper chute adjustment.
To remove tilted vials (filled & unfilled) from turntable
Weight adjustment.
Removal of broken and jammed vial.
Use of vacuum port for spillage removal.
Corrective (Non-Routine) Intervention=7 Nos.
Compressed Air filter replacement.
Machine Breakdown for 15 min. (Minor)
Machine Breakdown for 30 min. (Major)
Power failure for 10 minutes.
Removal of vials under the dosing disc with sterile forceps
Cleaning of choked powder dosing piston from the dosing disc
Clutch adjustment for the star wheel
Other Intervention = 7 Nos.
Maximum manpower (up to 7) filling area for 15 minutes during filling.
Operator Fatigue
Lunch and dinner.
Minimum speed.
Maximum speed.
Optimum speed.
Shift Change Over
In conclusion:
To guarantee the sterility of pharmaceutical manufacturing processes, it is crucial to intervene during media fill. By implementing effective training, monitoring, prompt response, thorough documentation, and continuous improvement, pharmaceutical manufacturers can improve their capacity to uphold aseptic conditions. Taking a proactive approach to intervention not only protects the quality of the drug product but also showcases a dedication to patient safety and adherence to regulatory standards in the ever-changing realm of pharmaceutical manufacturing.
