Media Fill
A process simulation in which sterile growth medium replaces product, filled and incubated to show that the aseptic process can produce sterile units.
It must simulate the worst case
Maximum campaign duration, interventions, shift changes, operator count and line speed — not an easy demonstration run. A media fill that avoids interventions proves nothing about a line that has them.
Acceptance
Zero contaminated units for runs up to 5,000 filled, with defined action on any positive: investigation, requalification and assessment of product filled since the last successful simulation.
Related terms
Where this applies
Oncology Injectables
Need help applying this?
Stancor Pharma engineers answer specification questions directly. Contact us.