Media fill simulation

Quality Assurance
1

What are the challenges during media fill??

2

Media fill challenge study, usually covers:

  1. Speed challenge
  2. Planned Power shutdown
  3. Turn off then turn on machine after 10 min
    4.Operator fatigue
    5.Open the entry door of powder filling room so that, differential pressure of the room goes below standard differential pressure
  4. extending filling duration

A.Manufacturing bulk and filtration bulk hold time
B.Hold time of the stoppers, SS items, all other components for 48 hrs after sterilization.
C.Depyrogenated vials before filling hold time

Note: Ideally common regular interventions should be covered during media fill, however the challenge studies are covered at the end session inorder to define the root case.
we should not conduct some stupid challenges which may have greater risk to the media, as Media is more susceptible to contamination.

Thanks