Media fill:
Media fill is a key qualification of an aseptic facility.
A media fill (Also known as a process simulation) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution.
We develop complete media fill protocol, executions, analysis of results and conclusion independently.
Our protocol includes
- Factors associated with the longest permitted run on the processing line that can pose contamination risk (e.g. operator fatigue)
- Representative number, type, and complexity of normal interventions that occur with each run, as well as non-routine interventions and events (e.g. maintenance, stoppages, equipment adjustments)
- Define allowable interventions
- Define grades of interventions
- Practise all interventions during media runs
- Lyophilisation, when applicable
- Aseptic assembly of equipment (e.g. at start-up, during processing)
- 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 useful aide in
investigating personnel behavior that could negatively affect the aseptic
manufacturing process.
Video Recording- Our Expertise in Processing
Video recording of a media fill validation may be a useful aide in investigating personnel behaviour that could negatively affect the aseptic manufacturing process.
GAMP Services 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 end software.
We can visualize the videography recording remotely during media fill.