Media fill protocol describes the objective, procedure and acceptance criteria for media fill study. Here we try to mentioned the key elements of media fill protocol as a media fill protocol template.
Objective of the study
- To evaluate the aseptic process simulation (media fill)
- To know the key points in designing a media fill protocol to meet regulatory expectations
- To learn how failures have to be evaluated and which consequences they have
The key elements of media fill protocol
- Number and frequency of runs
- Medium culture (to replace the product)
- Number of units filled
- Container (vial) size
- Fill volume
- Line speed (or filling speed)
- Duration of fill
- Operators shifts
- Monitoring activities
- Interventions –both routine and non-routine-
- Incubation method
- Acceptance criteria
Number and frequency of runs
In start up simulation at least three consecutive separate successful runs should be performed (it is recommended they are performed in different days). For on-going simulation, a routine semi-annual qualification is recommended (one run) Extraordinary media fill should be performed after all changes to a product or line changes evaluated as a potential danger for the aseptic process.
Number of units filled
Number of units filled should reflect the real batch size; it is allowed to fill a lowest number of units provided that the number of units filled is sufficient to reflect the effect of potential operator fatigue and adequately represents the maximum number of interventions. Some regulations suggest the number of units to be filled in consideration of batch production size.
Read also: What is Media Fill? Why It is Necessary?