Each and everything of mediafill

Each and everything about Mediafil

Media fills -aseptic filling process in sterile area
Media fills twice in a year
Media used SCDA 3%
dispensing
Manufacturing
Filtration - to reduce bioburden limit
Media fillingā€¦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 sizeā€¦or minimum 2 shift covered ā€¦means all the interactions are covered during media fills
Incubation - 14 days
1st 7 days stored at 20-25Ā°c
Next 7 days stored at 30-35Ā°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 investigationā€¦

4 Likes

Dear All,

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!!

Thanks