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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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. |
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