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…
What will be the action plan, if you will observe the viable counts for area and personal monitoring during microbial analysis,
however media fill pass!!