Hello! We have the following basic information to your question. Media Fill: A media fill is performed to verify the sterility of the aseptic filling process. A general outlie would be as follows: • Ensure the B/F/S machine is cleaned and sterilized according to standard operating procedures. • Select a suitable growth media (TSB) or equivalent. • Batch and deliver the media into the B/F/S machine just as you would with actual product. • Adjust the filling parameters (such as fill volume and speed) to match normal production. • Run, filling vials/bottles w/media and ensure all steps are completed as they would during normal production. • Collect filled vials/bottles and incubate under appropriate conditions or as required by the protocol. 7-days followed by another 7-days or as required by the protocol. • After incubation, inspect vials/bottles for any signs of growth. • Document and compile report summarizing the results and conclusions. Smoke Study: Smoke studies are conducted to visualize airflow patterns and ensure the critical zones are protected by unidirectional airflow. • Select a suitable smoke-generating device. • You can utilize cameras/video equipment to capture the airflow patterns during the study. • Verify HVAC system is operating normally, maintaining the required air-changes rates and pressure differentials. • Introduce smoke into critical areas of the B/F/S machine (ex. fill zone). • Observe and record. • Document the results including the photos and video into the report.
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how do you do media fill and smoke study on this BFS?
Hello!
We have the following basic information to your question.
Media Fill: A media fill is performed to verify the sterility of the aseptic filling process. A general outlie would be as follows:
• Ensure the B/F/S machine is cleaned and sterilized according to standard operating procedures.
• Select a suitable growth media (TSB) or equivalent.
• Batch and deliver the media into the B/F/S machine just as you would with actual product.
• Adjust the filling parameters (such as fill volume and speed) to match normal production.
• Run, filling vials/bottles w/media and ensure all steps are completed as they would during normal production.
• Collect filled vials/bottles and incubate under appropriate conditions or as required by the protocol. 7-days followed by another 7-days or as required by the protocol.
• After incubation, inspect vials/bottles for any signs of growth.
• Document and compile report summarizing the results and conclusions.
Smoke Study: Smoke studies are conducted to visualize airflow patterns and ensure the critical zones are protected by unidirectional airflow.
• Select a suitable smoke-generating device.
• You can utilize cameras/video equipment to capture the airflow patterns during the study.
• Verify HVAC system is operating normally, maintaining the required air-changes rates and pressure differentials.
• Introduce smoke into critical areas of the B/F/S machine (ex. fill zone).
• Observe and record.
• Document the results including the photos and video into the report.
How can I learn a BFS machine?
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