Fluid sterilant injection sterilization device and method

Abstract

A method for sterilizing a container is provided where a penetrable septum of a sealed empty device is penetrated with an injection member. A fluid sterilant is then injected through the injection member and into an interior chamber of the device. The fluid sterilant is allowed to reside within the chamber a sufficient amount of time to render the chamber either sterile or bactericidal. Product can then be introduced through the septum into the sterile or bactericidal chamber. The resulting penetration aperture is then resealed to hermetically seal the product within the chamber.

1 . A method comprising the following steps:
 (i) penetrating a penetrable septum of a sealed empty device with an injection member;   (ii) introducing a fluid sterilant through the injection member and into an interior chamber of the device;   (iii) allowing the fluid sterilant to reside within the chamber a sufficient amount of time to render the chamber either sterile or bactericidal;   (iv) introducing a product through the septum and into the sterile or bactericidal chamber; and   (v) resealing the resulting penetration aperture to hermetically seal the product within the chamber.   
     
     
         2 . A method as defined in  claim 1 , further comprising withdrawing fluid sterilant from the chamber prior to introducing the product into the chamber. 
     
     
         3 . A method as defined in  claim 2 , wherein the withdrawing step includes drawing a vacuum through a device inserted through the penetrable septum. 
     
     
         4 . A method as defined in  claim 3 , wherein the device is defined by the injection member. 
     
     
         5 . A method as defined in  claim 3 , wherein the device inserted through the penetrable septum is a needle. 
     
     
         6 . A method as defined in  claim 1 , wherein the step of introducing the product includes introducing the product through the injection member. 
     
     
         7 . A method as defined in  claim 1 , wherein the step of introducing the product includes penetrating the penetrable septum with a filling member and introducing a product through the filing member and into the sterile or bactericidal chamber 
     
     
         8 . A method as defined in  claim 1 , wherein the fluid sterilant is nitric oxide. 
     
     
         9 . A method as defined in  claim 1 , further comprising sterilizing or decontaminating a penetrable surface of the septum prior to at least one of steps (i) and (iv). 
     
     
         10 . A method as defined in  claim 9 , wherein the sterilizing or decontaminating of the penetrable surface includes applying a fluid sterilant or radiation to the penetrable surface. 
     
     
         11 . A method as defined in  claim 10 , wherein the fluid sterilant is VHP and the radiation is UV. 
     
     
         12 . A method as defined in  claim 1 , further comprising introducing an overpressure of sterile air or other gas during at least one of steps (i), (ii), (iv) and (v). 
     
     
         13 . A method as defined in  claim 1 , wherein the resealing step includes applying a liquid sealant to the resulting penetration aperture. 
     
     
         14 . A method as defined in  claim 13 , wherein the resealing step further includes applying radiation or energy to the liquid sealant to cure the liquid sealant from a liquid to a solid phase. 
     
     
         15 . A method as defined in  claim 14 , wherein the radiation or energy is UV. 
     
     
         16 . A method as defined in  claim 1 , wherein the resealing step includes applying radiation or energy to the septum at the resulting penetration aperture and thermally resealing the penetration aperture. 
     
     
         17 . An apparatus comprising:
 a device including a sealed empty chamber and a penetrable septum in communication with the chamber; and   a source of fluid sterilant in communication with an injection member for penetrating the septum and introducing a fluid sterilant through the injection member and into the chamber of the device, and allowing the fluid sterilant to reside within the chamber a sufficient amount of time to render the chamber either sterile or bactericidal.   
     
     
         18 . An apparatus as defined in  claim 17 , further comprising:
 a source of product to be filled into the chamber and coupled in fluid communication with one of (a) the injection member and (b) a filling member for penetrating the penetrable septum with the filling member, for introducing the product therethrough and into the sterile or bactericidal chamber.   
     
     
         19 . An apparatus as defined in  claim 18 , further comprising a resealing station for resealing the resulting penetration aperture to hermetically seal the product within the chamber. 
     
     
         20 . A device as defined in  claim 18 , further including a source of liquid sealant for dispensing the liquid sealant onto the resulting penetration aperture and resealing the septum. 
     
     
         21 . A device as defined in  claim 20 , further including a radiation or energy source for transmitting radiation or energy onto the liquid sealant to cure the sealant from a liquid to a solid phase. 
     
     
         22 . A device as defined in  claim 19 , wherein the resealing station includes a radiation or energy source for applying radiation or energy to the septum at the resulting penetration aperture and thermally resealing the penetration aperture. 
     
     
         23 . An apparatus comprising:
 a device including a sealed empty chamber and a penetrable septum in communication with the chamber; and   first means for penetrating the penetrable septum and introducing a fluid sterilant through the penetrable septum and into the chamber of the device, and allowing the fluid sterilant to reside within the chamber a sufficient amount of time to render the chamber either sterile or bactericidal.   
     
     
         24 . An apparatus as defined in  claim 23 , further comprising second means for introducing a product through the penetrable septum and into the sterile or bactericidal chamber. 
     
     
         25 . An apparatus as defined in  claim 24 , further comprising third means for resealing the resulting penetration aperture. 
     
     
         26 . An apparatus as defined in  claim 24 , further comprising fourth means for either sterilizing or decontaminating a penetrable surface of the septum prior to penetrating it with either the first means or the second means. 
     
     
         27 . An apparatus as defined in  claim 26 , wherein the first means is an injection member and source of fluid sterilant coupled in fluid communication thereto; the second means is one of the injection member and a filling member, and a source of product coupled in fluid communication thereto; the third means is either liquid sealant or radiation; and the fourth means is fluid sterilant or radiation.