Turning media fill data into stronger aseptic control in an Annex 1 era

Media fills provide an important demonstration of aseptic process performance, as the information gathered during a simulation gives manufacturers a stronger understanding of how the process behaves over time.

As companies must now translate their media fill processes to meet Annex 1 expectations, the way this information is reviewed can provide valuable insight into aseptic process control.

That means reviewing all of the evidence gathered during the simulation run. The incubation result remains important, but it only presents one part of the picture. It’s important to review the rest of the information surrounding it to help determine whether the process behaved as expected and where control may need to be strengthened.

Key signals may emerge as a result of recurring operator observation, environmental trend, process alarm or protocol deviation, even when the final result is acceptable. When reviewed over time, this information can help contribute to a deeper understanding of aseptic performance and help inform future media fill programs. 

In an article with Biopharma Boardroom, Chad hafer, Director of MSAT at Kindeva, explores how manufacturers harness the evidence gathered during media fills to help build greater process confidence. He examines how data review can support aseptic control and how media fill programs can remain practical and defensible in the Annex 1 era.

Read the full article to explore how manufacturers can turn media fill data into stronger aseptic process control.