Dear Forum Members
I would like to know your views and opinions regarding the validation of
the sterile filtration.
Before the dispensing into the vials, the solution is filtered with
SARTOLAB P20 plus.
The filtering is carried out in Grade A environment.
I have to study the efficacy of the filtration process.
Is it enough to use environmental organism in the test solution or the
solution has to be contaminated with Brevundimonas diminuta.
After filtration the solution is controlled microbiological test.
The SARTOLAB P 20 filter is qualified by SARTORIUS ( bubble point,
bacterium retention test and documented)
Thank you
Maria Antalffy
<mailto:antalffym@izotop.kfkipark>antalffym@izotop.kfkipark.hu
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