Aseptic process simulation programme designed
Ergopharm has designed its aseptic process simulation programme ahead of the sterile line's completion, defining how media fills will be run, what interventions they must include and what result would be accepted.
A media fill replaces product with a growth medium and runs the process as it is actually run — same line speed, same operators, same interventions — then incubates every unit and looks for growth. It is the only test that assesses the whole aseptic process rather than its individual controls, and its value depends entirely on whether the simulation is honest about what happens on a real shift.
“A media fill that leaves out the awkward interventions has simulated a shift that never happens.”
The programme therefore requires that the worst-case conditions be represented: the longest permitted run, the full set of routine and non-routine interventions, shift changes, and the maximum number of personnel present. Every unit filled is incubated and inspected; the acceptance criterion is written in advance and is not adjusted after the fact.
Each operator working aseptically must participate successfully in media fills to be qualified, and requalify on a defined interval.
Key facts
- Simulates
- Line speed, operators, interventions, shift changes
- Worst case
- Longest permitted run; maximum personnel
- Assessment
- Every unit incubated and inspected
- Personnel
- Successful participation required for aseptic qualification