Comment from Wenan Lu
AnonymousOtherIndividual
Summary: The commenter is seeking technical clarification regarding the calculation of the Area Effect Threshold (AET) for filters in specific manufacturing configurations. They are asking whether the dilution factor should be based on the buffer tank volume or the total batch volume when a filter is positioned before a buffer tank that feeds multiple filling lines.
It would be helpful to further clarify the AET calculation. Specifically, is the example provided in 877 Example AET Calculation applicable only to a filter located upstream of a bulk tank (i.e., for bulk filtration), or can it also be applied to a filter positioned before a filling assembly—for example, where a 1 L buffer tank is used but the overall batch volume is 100 L?
In this configuration, the buffer tank feeds multiple filling lines. Therefore, should the dilution factor used for the AET calculation be based on the 1 L buffer volume, or on the full 100 L batch volume when the filter is located before the buffer tank?