Intervention during Media fill

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.

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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