Knapp test

Good morning,

I have done a Knapp test with a brevetti cea machine.

FQB/FAQ was 104% but some ampoule (total 4) with FQA more than 7 have an FBQ less than 5.
what I have to do? change parameters and repeat Knapp test?
What do you suggest?
thank you

In my opinion it is necessary to see which type of defect are these 4 samples.
If all 4 belong to the some type eg. black particles, or particles of a specific size, you should review the parameters and repeat Knapp. I they are not of the some type and however other samples similar to these 4 achieved a FQB> 7 and still a FQB> = the FQA, it is not necessary to change the parameters and repeat the knapp.

Thank you Alberto.

I have a similar difect in other ampoules that have FQA > 7 but it is not very “nice” that some reject are considered as good …
I’m wondering if there is any legislation on this issue. what do you think?
in every case we need to justify them.
thank you

Hi Silvia,
As I know there are no legislation on this issue and the questions are also depending from the inpectors. Iin general the american inspectors have more experience on manual inspection than automatic and so is better you are prepared to answer questions and be able to defend your qualification .


What is Knapp test and what its significance

The PDA presents papers on Julius Knapp’s methodology to use when validating a fully automated inspection machines (eg. Brevetti CEA, Siedenader) so this can be used for reference.
ciao Alberto

As we know,the FAQ & FBQ value must between 7 to 10 in the KNAPP-Test, so if the FBQ value less than 5, I think it need first to find the reason, then repeat the test.