Sterilization pouch with internal and external indicators

Abstract

A sterilizable pouch having both internal and external sterilization record indicators to indicate whether attempted steam sterilization of the pouch and contents was successful or unsuccessful. The pouch preferably has one indicium in each indicator responsive to multi-parameter sterilization by steam, and another indicium in each indicator responsive to gas sterilization, such as using ethylene oxide.

1 . A method of providing a visual indication of successful or unsuccessful exposure to a proper sterilization cycle for the contents of a package having a pouch formed from a generally planar polymer layer and a paper member joined together by a marginal seal extending around a portion of a perimeter of the package and wherein the pouch can be sealed, the method comprising the steps of: 
 a) providing a first indicator located on the package and exterior of the pouch; and    b) providing a second indicator located on the package and interior of the pouch, wherein the second indicator includes a multi-parameter sterilization chemical indicia responsive to a steam sterilization process and further wherein both the external and internal indicators undergo a visual change to a desired ending color when the package is subjected to complete sterilization conditions, and further wherein only the first indicator undergoes a visual change to the desired ending color when the package is subjected to incomplete sterilization conditions.    
     
     
         2 . The method of  claim 1  wherein the visual change is a change to a designated end color and wherein the second indicator will not undergo a complete color change to the designated end color in the event the interior of the pouch is not subjected to complete sterilization conditions when steam is used as the sterilizing medium.  
     
     
         3 . The method of  claim 2  wherein the first indicator includes a multi-parameter sterilization chemical indicator and a color change to the designated end color of the first indicator without the second indicator changing to the designated end color indicates that sterilization was attempted, but was incomplete when the package is subjected to steam as the sterilizing medium.  
     
     
         4 . The method of  claim 1  wherein the first indicator includes a multi-parameter sterilization chemical indicia responsive to a steam sterilization process and the method further comprises the additional steps of: 
 c) subjecting the package to a sterilization process using steam as the sterilizing medium; and  
 d) observing the first and second indicators.  
 
     
     
         5 . The method of  claim 1  wherein the first indicator includes a multi-parameter sterilization chemical indicia responsive to a steam sterilization process and the method further comprises the additional steps of: 
 c) subjecting the package to complete sterilization conditions using steam as the sterilizing medium; and  
 d) causing both the first and second indicators to undergo a visual change to the desired ending color.  
 
     
     
         6 . The method of  claim 1  wherein the first indicator includes a multi-parameter sterilization chemical indicia responsive to a steam sterilization process and the method further comprises the additional steps of: 
 c) subjecting the package to incomplete sterilization conditions; and  
 d) causing at most the first indicator to undergo a visual change to the desired ending color, without the second indicator undergoing a visual change to the desired ending color.  
 
     
     
         7 . The method of  claim 1  wherein the first and second indicators are responsive to at least one of steam sterilization and gas sterilization.  
     
     
         8 . The method of  claim 1  wherein the first and second indicators each include a first indicium responsive to steam sterilization and a second indicium responsive to gas sterilization.  
     
     
         9 . The method of  claim 8  wherein the gas sterilization comprises using ethylene oxide.  
     
     
         10 . The method of  claim 1  wherein the first and second indicators each comprise multi-parameter sterilization chemical indicium responsive to a complete sterilization process that maintains the package at a predetermined temperature for a predetermined time in the presence of steam as a sterilizing medium.  
     
     
         11 . The method of  claim 10  wherein the first and second indicators each comprise a first sterilization chemical indicium and a second sterilization chemical indicium, with the first sterilization chemical indicium responsive to steam and the second sterilization chemical indicium responsive to ethylene oxide.  
     
     
         12 . A sterilizable package comprising: 
 a) a generally planar polymer layer; and    b) a paper member joined together by a marginal seal extending around a portion of a perimeter of the package and an adhesive region foldable against the polymer layer to form a pouch;    c) a first indicator located on the package and exterior of the pouch; and    d) a second indicator located on the package and interior of the pouch    wherein the second indicator includes a multi-parameter sterilization chemical indicium responsive to a steam sterilization process such that the second indicator undergoes a visual change to a desired ending color when the package is subjected to complete multi-parameter sterilization conditions using steam as a sterilizing medium.    
     
     
         13 . The package of  claim 12  wherein at most only the first indicator will undergo a visual change to the desired ending color when the package is subjected to incomplete steam sterilization conditions.  
     
     
         14 . The sterilizable package of  claim 12  wherein the first indicator comprises a steam sterilization indicium  
     
     
         15 . The sterilizable package of  claim 12  wherein the first and second indicators each comprise a gas sterilization indicium.  
     
     
         16 . The sterilizable package of  claim 15  wherein the gas sterilization indicia are responsive to sterilization using ethylene oxide.  
     
     
         17 . A method of providing a visual indication of successful or unsuccessful steam sterilization of the contents of a package of the type having a generally planar non-porous membrane and a porous membrane joined together by a marginal seal extending around a portion of a perimeter of the package and an adhesive region on an extension of one of the porous and non-porous membranes which is foldable against the other of the non-porous and porous membranes to form a sealed pouch, the method comprising: 
 a) providing a first indicator located on the package and exterior of the pouch wherein the first indicator includes a multi-parameter sterilization chemical indicium responsive to a steam sterilization process;    b) providing a second indicator located on the package and interior of the pouch wherein the second indicator includes a multi-parameter sterilization chemical indicium responsive to a steam sterilization process;    c) subjecting the package to a sterilization process using steam; and    d) observing the first and second indicators    wherein the multi-parameter sterilization chemical indicium of both the first and second indicators undergo a visual change to a desired ending color when the package is subjected to complete multi-parameter steam sterilization conditions, while at most only the multi-parameter sterilization chemical indicium of the first indicator will undergo a visual change to the desired ending color when the package is subjected to incomplete steam sterilization conditions.    
     
     
         18 . The method of  claim 17  wherein the non-porous membrane is a polymer layer.  
     
     
         19 . The method of  claim 17  wherein the porous membrane is a paper member.  
     
     
         20 . The method of  claim 17  wherein the multi-parameter sterilization conditions conform to ANSI/AAMI/ISO 11140-1: 2005, “Sterilization of healthcare products—Chemical Indicators—Part 1: General Requirements” as promulgated by the American National Standards Institute and the Association for the Advancement of Medical Instrumentation.  
     
     
         21 . The method of  claim 17  wherein the multi-parameter sterilization conditions conform to ISO/TC 198, Sterilization of Healthcare Products as promulgated by The International Organization for Standardization.  
     
     
         22 . The method of  claim 17  wherein the first and second indicators each include a separate indicium responsive to ethylene oxide sterilization  
     
     
         23 . A sterilization package comprising: 
 a first package layer;    a second package layer coupled to the first package layer with a perimeter seal extending around a portion of the package to define a pouch with a sealable opening;    a first indicator located on the package and exterior of the pouch;    a second indicator located on the package and interior of the pouch, the second indicator including a multi-parameter sterilization indicium responsive to a sterilizing medium in the pouch; and    a barrier seal that joins a portion of the first package layer to a portion of the second package layer proximate the second indicator, the barrier seal configured to block contents of the package from the second indicator.    
     
     
         24 . The sterilization package of  claim 23 , wherein the barrier seal is not connected to the perimeter seal and allows passage of the sterilizing medium in the pouch to the second indicator.  
     
     
         25 . The sterilization package of  claim 23 , wherein the perimeter seal is proximate to the perimeter of the package.  
     
     
         26 . The sterilization package of  claim 23 , wherein the multi-parameter sterilization indicium changes from a first color to a second color when the interior of the pouch is subjected to complete sterilization conditions with respect to at least two sterilization process variables selected from the group consisting of time, temperature, and presence of sterilizing medium.  
     
     
         27 . The sterilization package of  claim 23 , wherein only the first indicator or neither of the first and second indicators changes color when the package is subjected to incomplete sterilization conditions.  
     
     
         28 . The sterilization package of  claim 23 , wherein the first and second indicators each includes a first indicium responsive to steam sterilization and a second indicium responsive to gas sterilization.  
     
     
         29 . The sterilization package of  claim 28 , wherein the second indicium is responsive to ethylene oxide sterilization.  
     
     
         30 . The sterilization package of  claim 23 , wherein the first indicator is between the first and second package layers.  
     
     
         31 . The sterilization package of  claim 23 , wherein at least one of the first and second package layers comprises an adhesive region for securing the second package layer to the first package layer to close the opening to seal the contents within the pouch.  
     
     
         32 . The sterilization package of  claim 23 , wherein the first and second package layers are separate members, and the first packaging layer comprising paper and the second package layer comprising a polymeric material.  
     
     
         33 . A sterilization package comprising: 
 a first package layer;    a second package layer coupled to the first package layer with a seal to define a pouch, the second package layer securable to the first package layer to seal contents within the pouch;    a first indicator located on the package and exterior of the pouch; and    a second indictor located on the package and interior of the pouch, the second indicator including a multi-variable sterilization indicium responsive to a sterilization process, wherein the second indicator changes from a first color to a second color when the package is subjected to complete sterilization conditions with respect to at least two sterilization process variables selected from the group consisting of time, temperature, and presence of sterilizing medium.    
     
     
         34 . The sterilization package of  claim 33 , wherein only the first indicator or neither of the first and second indicators changes color when the package is subjected to complete sterilization conditions for fewer than two of the sterilization process variables.  
     
     
         35 . The sterilization package of  claim 33 , wherein the first and second indicators each includes a first indicium responsive to steam sterilization and a second indicium responsive to gas sterilization.  
     
     
         36 . The sterilization package of  claim 35 , wherein the second indicium is responsive to ethylene oxide sterilization.  
     
     
         37 . The sterilization package of  claim 33 , wherein the first indicator includes a multi-variable sterilization indicium responsive to the sterilization process.  
     
     
         38 . The sterilization package of  claim 33 , and further comprising: 
 a barrier seal that joins the first and second package layers, the barrier seal configured to allow passage of steam or gas to the second indicator and block contact of the contents of the package with the second indicator.    
     
     
         39 . The sterilization package of  claim 38 , wherein the barrier seal is not connected to the seal.  
     
     
         40 . A sterilization package comprising: 
 a generally planar polymeric layer;    a paper layer coupled to the first package layer with a perimeter seal extending around a portion of a perimeter of the package to define a pouch, the second package layer including an adhesive region foldable against the polymer layer to seal the pouch;    a first gas sterilization indicium responsive to gas sterilization printed on the paper layer exterior of the pouch;    a first steam sterilization indicium responsive to steam sterilization printed on the paper layer exterior of the pouch;    a second gas sterilization indicium responsive to gas sterilization printed on the paper layer interior of the pouch; and    a second steam sterilization indicium responsive to steam sterilization printed on the paper layer interior of the pouch, the second steam sterilization indicium comprising a multi-variable steam sterilization indicium that changes color when the package is subjected to complete steam sterilization conditions with respect to at least two steam sterilization process variables selected from the group consisting of time, temperature, and presence of steam.    
     
     
         41 . The sterilization package of  claim 40 , wherein the first steam sterilization indicium also comprises a multi-variable steam sterilization indicium.  
     
     
         42 . The sterilization package of  claim 40 , wherein at least one of the first and second gas sterilization indicia comprises a multi-variable steam gas sterilization indicium that changes color when the package is subjected to complete gas sterilization conditions with respect to at least two gas sterilization process variables selected from the group consisting of time, temperature, and presence of sterilizing gas.  
     
     
         43 . The sterilization package of  claim 42 , wherein only the first gas sterilization indicium or neither of the first and second gas sterilization indicia changes color when the package is subjected to complete gas sterilization conditions for fewer than two of the gas sterilization process variables.  
     
     
         44 . The sterilization package of  claim 40 , wherein only the first steam sterilization indicium or neither of the first and second steam sterilization indicia changes color when the package is subjected to complete gas sterilization conditions for fewer than two of the gas sterilization process variables.  
     
     
         45 . The sterilization package of  claim 40 , wherein the first and second indicia are responsive to ethylene oxide sterilization.  
     
     
         46 . The sterilization package of  claim 40 , and further comprising: 
 a first barrier seal that joins the first and second package layers proximate the second gas sterilization indicium, the first barrier seal configured to allow passage of sterilizing gas to the second gas sterilization indicium and block the contents of the package from the second gas sterilization indicium; and    a second barrier seal that joins the first and second package layers proximate the second steam sterilization indicium, the second barrier seal configured to allow passage of steam to the second steam sterilization indicium and block the contents of the package from the second steam sterilization indicium.    
     
     
         47 . The sterilization package of  claim 46 , wherein at least one of the first and second barrier seals is not connected to the perimeter seal.