US 12,459,694 B2
Methods for manufacturing non-glass prefilled syringes
Kelly Kuehne, Williamston, MI (US); Curt Carpenter, Webberville, MI (US); and Jessica Leginski, Houston, TX (US)
Assigned to Medline Industries, LP, Northfield, IL (US)
Filed by Medline Industries, LP, Northfield, IL (US)
Filed on Mar. 22, 2024, as Appl. No. 18/613,254.
Application 18/613,254 is a continuation of application No. 17/855,912, filed on Jul. 1, 2022, granted, now 11,958,647.
Application 17/855,912 is a continuation of application No. 15/169,962, filed on Jun. 1, 2016, abandoned.
Prior Publication US 2024/0262554 A1, Aug. 8, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. B65B 3/00 (2006.01); A61L 2/10 (2006.01); A61L 2/20 (2006.01); A61M 5/00 (2006.01); A61M 5/31 (2006.01); A61M 5/315 (2006.01); B65B 55/02 (2006.01); B65B 55/10 (2006.01)
CPC B65B 55/10 (2013.01) [A61L 2/10 (2013.01); A61L 2/206 (2013.01); A61M 5/001 (2013.01); A61M 5/002 (2013.01); A61M 5/3129 (2013.01); A61M 5/31501 (2013.01); B65B 3/003 (2013.01); B65B 55/027 (2013.01)] 17 Claims
OG exemplary drawing
 
1. A method of EtO sterilizing a prefilled syringe, comprising:
providing a syringe prefilled with a sterilization-sensitive solution, the sterilization-sensitive solution being adversely affected when exposed to ethylene oxide (EtO) and having an initial solution pH range of 4.5-7.0;
placing the prefilled syringe into an EtO sterilizable packaging with at least one other medical equipment;
sealing the EtO sterilizable packaging with the prefilled syringe and the at least one other medical equipment therein, before performing an EtO sterilization procedure cycle;
performing the EtO sterilization procedure cycle on the EtO sterilizable packaging including the prefilled syringe and the at least one other medical equipment, the EtO sterilization procedure cycle including a preprocessing stage to initiate growth of microorganisms on an exterior of the prefilled syringe and a wash and conditioning stage to remove air from a treatment chamber containing the packaging including the prefilled syringe and the at least one other medical equipment therein, 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 an EtO sterilization stage of the EtO sterilization procedure cycle on the EtO sterilizable packaging including the prefilled syringe and the at least one other medical equipment therein within the treatment chamber to sterilize an exterior surface of the prefilled syringe; and
wherein upon completing the EtO sterilization procedure cycle, a resultant pH of the sterilization-sensitive solution remains within the initial solution pH range of 4.5-7.0.