APPARATUS AND METHOD FOR LEAK TESTING OF A STERILE UNIT

The present invention relates to a dosing device and to a method for checking the leaktightness of a sterile assembly (3) which comprises at least one storage vessel (30) filled with a sterile fluid (31) and having an inflow attachment (32) and a discharge attachment (33), said method comprising the...

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Bibliographische Detailangaben
Hauptverfasser: HOLEY, Daniel, BRAEUNINGER, Marc, KAUDER, Florian, KUCHENBROD, Michael
Format: Patent
Sprache:eng ; fre ; ger
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Beschreibung
Zusammenfassung:The present invention relates to a dosing device and to a method for checking the leaktightness of a sterile assembly (3) which comprises at least one storage vessel (30) filled with a sterile fluid (31) and having an inflow attachment (32) and a discharge attachment (33), said method comprising the steps of: mounting the sterile assembly (3) in a dosing device (1) for dosing the sterile fluid (31), wherein the dosing device (1) comprises a pressure-testing device (4), connecting the pressure-testing device (4) to the storage vessel (3) of the sterile assembly (3) and at the same time interrupting all other connections to the storage vessel (3), pressurizing the sterile fluid (31) in the storage vessel (3) by means of a pressure-testing medium (40) of the pressure-testing device for a predetermined period of time, and checking the sterile assembly (3) for leaks.