Method for external sterilization of drug delivery device

A method of externally sterilizing a drug delivery device utilizing Nitrogen Dioxide (NO2) is provided, including placing the drug delivery device in a sterilization chamber, introducing into the chamber a dose of NO2 having a concentration of between about 2 and 20 milligrams per Liter by applying...

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Hauptverfasser: WU, Chia-Jung, SCHALHOUB, Kenneth G, DUE, Mads Schjoth, ABBAS, Shermeen A, SAIFAN, Rami, DEVITT, Shaun, LIU, Jessica Hai, BITONG, Anthony, MISMAR, Wael, GUIRGUIS, Malak
Format: Patent
Sprache:eng
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Zusammenfassung:A method of externally sterilizing a drug delivery device utilizing Nitrogen Dioxide (NO2) is provided, including placing the drug delivery device in a sterilization chamber, introducing into the chamber a dose of NO2 having a concentration of between about 2 and 20 milligrams per Liter by applying a vacuum level of between about 10 and 600 Torr and holding the vacuum level for a dwell time of between about 2 and 20 minutes, repeating the step of introducing into the chamber a dose of NO2 for a number of pulses between about 1 and 24, purging the sterilization chamber of at least substantially all of the NO2, and aerating the sterilization chamber.