Media fill

Question 1

What are the limits for media fill?

Answer 1

Reference to Annex 1
The target should be zero growth

Question 2

What happens following a failed media fill?

Answer 2

Investigate to identify most probable root cause
determine and implement corrective actions
sufficient number of consecutive repeats (minimum of 3) to demonstrate returned to a state of control
review all appropriate records since previous successful media fill

Question 3

What is the purpose of aseptic media fill?

Answer 3

To demonstrate the process can be carried out aseptically without introducing contamination

Question 4

Describe how you would carry out a media fill?

Answer 4

Carryout your routine process using media instead of product challenge the worst case - all routine interventions included, all equipment streams and personal, max occupancy etc

Question 5

Are there guidelines describing the media fill process?

Answer 5

There is a section on media fills in Annex 1 which has been expanded in the 2022 version