STERILIZATION POUCH WITH INTERNAL AND EXTERNAL INDICATORS
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.