Filter Validation- Bacterial Retention Testing

[DiauqS]

Hi,

Any thoughts on the following:

How Critical is Bacterial Retention Testing Validation for an Aseptic IV product (FDA, EU market)? Would extention of the Product Transfer Time need repeat validation of Bacterial retention testing? Acording to Guideline documentation its recommended does this mean it has to be done, prior to product release?

[Mokhzanni Mustapa]

Dear DiauqS,

From my experience, most established guidelines have listed out 'Bacterial Challenge test' as it requirements. However, it is only compulsory in the stage of 'Process Validation'. There is no need to re-challenge it during normal production time, because other methods such as Forward Flow test, Pressure hold test, Bubble point test, etc are sufficient enough.

Additionally, you can co-operate with 'Filter' supplier/manufacturer to do 'bacterial challenge test' for you.


Thanks,