Friday, 24 January 2014

Applying a risk matrix to media fills

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:

Sandle, T., Leavy, C. and Needham, G. (2012). A Risk Matrix Approach for Media Simulation Trials, Journal of Validation Technology, Vol. 18, No.4, pp70-78

If you wish to read the article, please contact Tim Sandle.

Posted by Tim Sandle