Media
trials are a regulatory requirement for aseptic processing manufacturers. Given
that not every product combination can be assessed on multi-product filling
lines, some assessment criteria is required to select the ‘worst-case’ filling
run parameters.
To
examine this, a peer reviewed paper written by Tim Sandle and colleagues discusses
the main criteria suitable for such an exercise and illustrates the application
using a case study. In doing so, the paper examines the adoption of a
risk-based matrix approach for the selection of product simulations used when
conducting media filling trials.
Here
is an extract:
“What
is less clear is where there are filling lines used for multi-product filling.
A media fill can measure clearly not every combination of vial and container
closure at each required interval; with large facilities, a rotational program
could take many years to complete (which would additionally mean that either a problematic
fill or the combination deemed to present the greatest potential contamination
risks to product would not be assessed very often). To address this issue, many
manufacturers adopt a matrix approach in order to assess the product types
deemed to be of the greatest challenge to the process or that are at a greater
risk of microbial contamination.”
The
reference for the paper is:
If you wish to read the article, please contact Tim Sandle.
Posted by Tim Sandle
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