Medical apparatus and method for sterilizing medical apparatus

Abstract

According to embodiments, there is provided a medical apparatus including one or more sterile pre-filled syringe, one or more first protective container including the one or more sterile pre-filled syringe, wherein the first protective container may be completely or partially filled with an inert or non-inert gas, wherein the one or more first protective container is impermeable to moisture and/or sterilizing agents, and a second protective container including one or more medical components and the one or more first protective container, wherein the second protective container may be, but is not necessarily, completely or partially filled with an inert or non-inert gas. In some aspects, a package mostly impermeable to bacteria including the first and second protective containers is also completely or partially filled with an inert or non-inert gas.

1 . A process for providing a sterilized medical apparatus, the process comprising:
 Partially or completely filling a first protective container comprising one or more sterilized syringe, packaged or unpackaged, with a gas, wherein the gas is capable of creating, improving, and/or maintaining a sterile environment within a cavity of the first protective container;   Sealing the first protective container;   Packaging the first protective container within a cavity of a second protective container; and   Sterilizing the second protective container and the contents within the cavity of the second protective container.   
     
     
         2 . The process for providing a sterilized medical apparatus according to  claim 1 , wherein the gas is an inert gas. 
     
     
         3 . The process for providing a sterilized medical apparatus according to  claim 1 , further comprising pressurizing the first protective container to at or less than about 45 pounds per square inch (PSI). 
     
     
         4 . The process for providing a sterilized medical apparatus according to  claim 1 , wherein the first or second sterilized container is chosen from one or more of a tube, can, bag, bottle, glass, polymer, polyolefin, cyclic olefin copolymer, polycarbonate, silicon dioxide coated polymer, polyethylene, high density polyethylene, metal foil covered plastic, ceramic, metal, aluminum, and/or composites of two or more of said materials. 
     
     
         5 . The process for providing a sterilized medical apparatus according to  claim 1 , wherein the gas comprises one or more of argon, nitrogen, oxygen, helium, or a combination thereof. 
     
     
         6 . The process for providing a sterilized medical apparatus according to  claim 1 , further comprising capping the first protective container, the second protective container, or both. 
     
     
         7 . The process for providing a sterilized medical apparatus according to  claim 1 , wherein sealing the first protective container prevents ingress of ethylene oxide or other gaseous substance used for sterilization into the first protective container, and/or wherein sealing the second protective container prevents ingress of ethylene oxide or other gaseous substances used for sterilization into the second protective container. 
     
     
         8 . The process for providing a sterilized medical apparatus according to  claim 1 , wherein the first or second protective container comprise aluminum, steel, metal, glass, plastic, ceramic, or a combination thereof. 
     
     
         9 . The process for providing a sterilized medical apparatus according to  claim 1 , wherein the first protective container, the second protective container, or both, comprise a threaded closure, a closure that snaps open and shut, or a combination thereof. 
     
     
         10 . The process for providing a sterilized medical apparatus according to  claim 1 , wherein the first protective container, the second protective container, or both, are sealed and/or capped with a plastic seal or cap. 
     
     
         11 . The process for providing a sterilized medical apparatus according to  claim 1 , wherein the first protective container, the second protective container, or both, are sealed and/or capped with a plastic seal or cap, and wherein sealing or capping the first protective container, the second protective container, or both, is performed by applying a mechanical torque or force of less than 45 pounds per square inch (PSI). 
     
     
         12 . A medical apparatus comprising a sanitized container, wherein the sanitized container comprises metal, glass, plastic, or a combination thereof, wherein the sanitized container comprises a sterilized pre-filled syringe, wherein the sanitized container is partially or completely filled with an inert gas, oxygen, or a combination thereof, wherein the inert gas, oxygen, or a combination thereof is capable of completely or partially preventing the ingress of a sterilizing gas, and wherein the pressure of the sanitized container is equal to or less than about 45 pounds per square inch (PSI). 
     
     
         13 . The medical apparatus comprising a sanitized container according to  claim 12 , further comprising an indicator if the sterilization is compromised by ingress of a sterilizing agent or bacteria into a cavity of the sanitized container. 
     
     
         14 . The medical apparatus comprising a sanitized container according to  claim 12 , further comprising an indicator if ethylene oxide is detected inside a cavity of the sanitized container. 
     
     
         15 . The medical apparatus comprising a sanitized container according to  claim 12 , wherein the sanitized container comprises a cap, lid, or other seal for preventing ingress of ethylene oxide or other sterilizing agent into a cavity of the sanitized container. 
     
     
         16 . The medical apparatus comprising a sanitized container according to  claim 12 , wherein the plastic comprises polyethylene, polypropylene, polyolefin, cyclic olefin copolymer, polycarbonate, Silicon dioxide coated polymer, high density polyethylene, metal foil covered plastic, or a combination thereof. 
     
     
         17 . The medical apparatus comprising a sanitized container according to  claim 12 , wherein the sterilized pre-filled syringe is pre-filled with a gas, a liquid, a sterilized or sterile saline, a sterilized or sterile composition, and/or a sterilized or sterile drug composition. 
     
     
         18 . The medical apparatus comprising a sanitized container according to  claim 12 , wherein the inert gas comprises one or more of argon, nitrogen, helium, or a combination thereof. 
     
     
         19 . The medical apparatus comprising a sanitized container according to  claim 12 , wherein the sterilized container is chosen from one of a tube, can, bag, bottle, glass, polymer, or combination thereof. 
     
     
         20 . The medical apparatus comprising a sanitized container according to  claim 12 , wherein the sterilized container is sealed by a cap. 
     
     
         21 . The medical apparatus comprising a sanitized container according to  claim 12 , wherein the sanitized container comprises ceramic, metal, aluminum, or a combination thereof. 
     
     
         22 . The medical apparatus comprising a sanitized container according to  claim 12 , wherein the sterilized container comprises a threaded closure. 
     
     
         23 . The medical apparatus comprising a sanitized container according to  claim 12 , wherein the sterilized container is sealed by applying a mechanical torque of 25 to 28 pounds per square inch to a cap or other sealing mechanism. 
     
     
         24 . The medical apparatus comprising a sanitized container according to  claim 12 , wherein the sanitized container is partially or completely filled with one or more of argon, nitrogen, helium, oxygen, or a combination thereof. 
     
     
         25 . The process for providing a sterilized medical apparatus according to  claim 1 , further comprising binding, consuming, or converting a sterilizing substance within a cavity of the first protective container, the second protective container, or both. 
     
     
         26 . The process for providing a sterilized medical apparatus according to  claim 1 , further comprising adding a sterilizing substance to a cavity of the first protective container, the second protective container, or both.