I want to validate the method I am using for transfer of API and primary
packaging materials (stoppers and caps) through a dynamic pass box in
the filling area.
The materials will be transferred through the pass box from a grade C
area into the grade B filling area and they will be stored under LAF
prior their entrance into the grade A filling machine.
I am looking for a way to validate the disinfecting procedure, the
required holding time in the pass box-if any- in general to validate
the efficacy of the method and to qualify the procedure by monitoring
the pass box prior to and after the admittance of an item.
Do you have any suggestion?
Thank you in advance
21st National Road Athens-Lamia
Tel: 00 30 211 18 15 312
Fax: 00 30 210 81 61 587
e-mail:[log in to unmask]
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