Methods for manufacturing non-glass prefilled containers

A method of sterilizing a prefilled containers comprises assembling a non-glass container and performing at least one ethylene oxide (EtO) sterilization procedure cycle. The assembling step includes filling the non-glass container with sterilization sensitive material sealing the sterilization sensi...

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Bibliographische Detailangaben
Hauptverfasser: Carpenter, Curt, Leginski, Jessica, Kuehne, Kelley
Format: Patent
Sprache:eng
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Beschreibung
Zusammenfassung:A method of sterilizing a prefilled containers comprises assembling a non-glass container and performing at least one ethylene oxide (EtO) sterilization procedure cycle. The assembling step includes filling the non-glass container with sterilization sensitive material sealing the sterilization sensitive material within the container. The EtO sterilization procedure cycle comprises undergoing a preprocessing stage, a wash and conditioning stage, an EtO sterilization stage and a wash and post exposure stage. Upon completing the EtO sterilization procedure cycle, a resultant pH of the sterilization-sensitive material does not exceed an acceptable pH range as defined by the United States Pharmacopeia. The disclosure also discusses inserting an assembled prefilled container into a procedure tray prior to performing the EtO sterilization procedure cycle.