Media Preparation and Filling Videography

media

media

Media Preparation and Filling Videography

Media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution.

  • Factors associated with the longest permitted run on the processing line that can pose Contamination risk due to operator fatigue.
  • Representative number, type, and complexity of normal interventions that occur with each run, as well as non-routine interventions and events like maintenance, stoppages, and equipment adjustments and breakdowns. Define allowable interventions
  • Define grades of interventions
  • Practise all interventions during media runs
  • Lyophilisation
  • Aseptic assembly of equipment, machines at start-up, during processing and manufacturing.
  • Number of personnel and their activities
  • ‘Worst case’ conditions, which typically involve the largest container with the widest mouth or small ampoules running at high speed with frequent jamming
  • Timings, Days, Line speed, Size of container, number of containers Video recording of a media fill test validation maybe a helpful aide in investigating personnel behaviour that could badly affect the aseptic manufacturing process.

Video Recording during batch manufacturing & filling

Video recording of a media fill validation may be a useful aide in investigating personnel behaviour that could negatively affect the aseptic manufacturing process.

Micron uses advance multi angle camera system to perform videography without human intervention.

We provide multi angle simulation video as final proof of media fill Qualification. For generating multi angle simulation video, we use high editing software. We can visualize the videography recording remotely during media fill.




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