Each and everything about Mediafil
Media fills -aseptic filling process in sterile area
Media fills twice in a year
Media used SCDA 3%
Filtration - to reduce bioburden limit
Media filling…At slow, optimum & high speed
All types of interventions performed during of media fill
Fill volm. Min 60% of container size.
Size of runs -similar to commercial batch size…or minimum 2 shift covered …means all the interactions are covered during media fills
Incubation - 14 days
1st 7 days stored at 20-25°c
Next 7 days stored at 30-35°c
Inspection by trained microbiologist under supervision of QA.
Checking turbidity of container
Minimum 3 media fills
Compile the report.
Any failure during media fills initiates deviations nd investigation…