Methods for manufacturing non-glass prefilled syringes

A method of EtO sterilizing a prefilled syringe, comprising:

• providing a syringe prefilled with a sterilization-sensitive material, the sterilization-sensitive material being adversely affected when exposed to ethylene oxide (EtO) and having an initial pH within an acceptable pH range as defined by the United States Pharmacopeia;
• initiating a preprocessing stage of an EtO sterilization procedure cycle on the syringe to initiate growth of microorganisms on an exterior of the syringe;
• initiating a wash and conditioning stage of the EtO sterilization procedure cycle on the syringe to remove air from both the syringe and a treatment chamber containing the syringe;
• initiating an EtO sterilization stage of the EtO sterilization procedure cycle on the syringe within the treatment chamber to sterilize the exterior of the syringe;
• and
• initiating a wash and post exposure process of the EtO sterilization procedure cycle to remove EtO gas from the treatment chamber;
• evacuating the treatment chamber to a pressure within a range of 1-24 inches of mercury absolute (inHgA);
• wherein upon completing the EtO sterilization procedure cycle, a resultant pH of the sterilization-sensitive material remains within the acceptable pH range as defined by the United States Pharmacopeia.

A method of sterilizing a surgical kit containing a prefilled syringe, comprising:

• providing a surgical kit, the surgical kit including a procedure tray having secured therein a syringe that has a non-glass barrel prefilled with a sterilization-sensitive material, wherein the sterilization-sensitive material is a material that is adversely affected when exposed to ethylene oxide (EtO) and has an initial pH within an acceptable pH range as defined by the United States Pharmacopeia;
• initiating a preprocessing stage of an EtO sterilization procedure cycle on the surgical kit to initiate growth of microorganisms on an exterior of the syringe;
• initiating a wash and conditioning stage of the EtO sterilization procedure cycle on the surgical kit to remove air from both the syringe and a treatment chamber containing the surgical kit;
• initiating an EtO sterilization stage of the EtO sterilization procedure cycle on the surgical kit within the treatment chamber to sterilize the exterior of the syringe, wherein the wash and conditioning stage includes raising a temperature of the treatment chamber to a conditioning temperature within a range of 85-130° F.;
• and initiating a wash and post exposure stage of the EtO sterilization procedure cycle to remove EtO gas from the treatment chamber;
• wherein upon completing the EtO sterilization procedure cycle, a resultant pH of the sterilization-sensitive material remains within an acceptable pH range as defined by the United States Pharmacopeia.