US5620656A — Packaging systems for peracid sterilization proce…

Claim 1

Independent Claim 191 words

A device useful to indicate sterilization cycle exposure of an article when the sterilization cycle includes an acidic gas or vapor, comprising: a package capable of sealingly enclosing an article, the package having at least a portion with sufficient permeability to admit a sterilizing gas or vapor into contact with the article when sealingly enclosed within the package, the package being substantially bacteria impermeable when sealed; and, an indicator associated with the package and adapted to be visually observed therewith, the indicator including a pH sensitive dye and a pH adjusting agent, the indicator having a first color under ambient conditions and adapted to change color from the first color to a second color in response to acidic gas or vapor exposure, the pH adjusting agent effective to place the pH of the indicator to an acidic point about where color change from the first color to the second color begins to occur, wherein said indicator is adapted to substantially maintain the first color under ambient conditions in the absence of exposure to a sterilization cycle and to substantially maintain the second color after acidic gas or vapor exposure is terminated.

Claim 2

Independent Claim 191 words

A device useful to indicate sterilization cycle exposure of an article when the sterilization cycle includes an acidic gas or vapor, comprising: a package capable of sealingly enclosing an article, the package having at least a portion with sufficient permeability to admit a sterilizing gas or vapor into contact with the article when sealingly enclosed within the package, the package being substantially bacteria impermeable when sealed; and, an indicator associated with the package and adapted to be visually observed therewith, the indicator including a pH sensitive dye and a pH adjusting agent, the indicator having a first color under ambient conditions and adapted to change color from the first color to a second color in response to acidic gas or vapor exposure, the pH adjusting agent effective to place the pH of the indicator to an acidic point about where color change from the first color to the second color begins to occur, wherein said indicator is adapted to substantially maintain the first color under ambient conditions in the absence of exposure to a sterilization cycle and to substantially maintain the second color after acidic gas or vapor exposure is terminated.

Claim 3

Dependent Claim 20 words

The device as in claim 1 wherein the permeable package portion admits peracid and/or acetic acid vapor at reduced pressure.

Claim 4

Dependent Claim 27 words

The device as in claim 2 wherein the package permits visual observation into the package and the indicator is adapted to be sealingly enclosed within the package.

Claim 5

Dependent Claim 25 words

The device as in claim 3 wherein the permeable package portion begins to admit vapor in less than about five minutes after package exposure thereto.

Claim 6

Dependent Claim 16 words

The device as in claim 2 wherein the pH adjusting agent of the indicator is acidic.

Claim 7

Dependent Claim 41 words

The device as in claim 2 wherein the indicator includes a substrate and a dye composition, the dye composition being absorbed on the substrate and having a pH adjusted by the pH adjusting agent to between about 4.6 to about 6.5.

Claim 8

Dependent Claim 13 words

The device as in claim 6 wherein the dye composition includes Bromophenol Blue.

Claim 9

Dependent Claim 25 words

The device as in claim 1 wherein the package is adapted sealingly to enclose an article and the indicator by heat sealing or adhesive bonding.

Claim 10

Dependent Claim 149 words

A package for articles to be sterilized by a sterilization cycle including exposure to an acidic fluid, comprising: a package portion having sufficient permeability to admit a sterilizing amount of gas or vapor into the package when an article to be sterilized is enclosed therein, the package being sealable and substantially bacteria impermeable after sealing; and, a dye composition adapted to be stably carried by the package and visually observable from a position exterior to the package when sealed, the dye composition being substantially stable and capable of visually indicating whether exposure to an acidic fluid of a sterilization cycle has occurred, the dye composition including a pH sensitive dye and a pH adjusting agent, the pH sensitive dye giving a substantially stable color change in response to acetic fluid exposure, the pH adjusting agent adjusting the pH of the dye composition to between about 4.6 to about 6.5.

Claim 11

Dependent Claim 149 words

A package for articles to be sterilized by a sterilization cycle including exposure to an acidic fluid, comprising: a package portion having sufficient permeability to admit a sterilizing amount of gas or vapor into the package when an article to be sterilized is enclosed therein, the package being sealable and substantially bacteria impermeable after sealing; and, a dye composition adapted to be stably carried by the package and visually observable from a position exterior to the package when sealed, the dye composition being substantially stable and capable of visually indicating whether exposure to an acidic fluid of a sterilization cycle has occurred, the dye composition including a pH sensitive dye and a pH adjusting agent, the pH sensitive dye giving a substantially stable color change in response to acetic fluid exposure, the pH adjusting agent adjusting the pH of the dye composition to between about 4.6 to about 6.5.

Claim 12

Dependent Claim 16 words

The package as in claim 9 wherein the acidic fluid includes peracid and/or acetic acid vapor.

Claim 13

Dependent Claim 19 words

The package as in claim 10 wherein the pH sensitive dye changes color at a pH of about 4.6.

Claim 14

Dependent Claim 11 words

The package as in claim 9 further comprising: a biological indicator.

Claim 15

Dependent Claim 26 words

The package as in claim 12 wherein the biological indicator includes a selected number of viable organism spores and a carrier being inoculated with the spores.

Claim 16

Dependent Claim 12 words

The package as in claim 13 wherein the organism includes Bacillus circulans.

Claim 17

Dependent Claim 18 words

The package as in claim 9 or 12 wherein the dye composition includes Bromophenol Blue or Bromocresol Green.

Claim 18

Dependent Claim 18 words

The package as in claim 9 or 12 wherein the dye composition is affixed to a package surface.

Claim 19

Dependent Claim 131 words

A packaging system for monitoring exposure to a sterilizing process, comprising: a selected number of viable organism spores, the organism being Bacillus circulans; a carrier being inoculated with the spores; a package for the inoculated carrier, the package including at least a portion having sufficient permeability to admit a sterilizing amount of gas or vapor into contact with the spores, the package being substantially bacteria impermeable; and, an indicator associated with the package and adapted to be visually observed therewith, the indicator changing color from a first color to a different color in response to a fluid component of a sterilizing process, wherein the indicator substantially maintains the first color in the absence of acidic gas or vapor exposure and the different color after acidic gas or vapor exposure is terminated.

Claim 20

Dependent Claim 131 words

A packaging system for monitoring exposure to a sterilizing process, comprising: a selected number of viable organism spores, the organism being Bacillus circulans; a carrier being inoculated with the spores; a package for the inoculated carrier, the package including at least a portion having sufficient permeability to admit a sterilizing amount of gas or vapor into contact with the spores, the package being substantially bacteria impermeable; and, an indicator associated with the package and adapted to be visually observed therewith, the indicator changing color from a first color to a different color in response to a fluid component of a sterilizing process, wherein the indicator substantially maintains the first color in the absence of acidic gas or vapor exposure and the different color after acidic gas or vapor exposure is terminated.

Claim 21

Dependent Claim 18 words

The packaging system as in claim 17 wherein the sterilizing process component is an acidic gas or vapor.

Claim 22

Dependent Claim 114 words

A tape adapted to be affixed to biocontamination barriers for articles to be sterilized by a sterilization cycle including exposure to an acidic fluid, comprising: an elongated, flexible member having an adhesive layer on one side and a dye composition on the other side, the dye composition being substantially stable and capable of visually indicating whether exposure to an acidic fluid of a sterilization cycle has occurred, the dye composition including a pH sensitive dye and a pH adjusting agent, the pH sensitive dye giving a substantially stable color change in response to acetic fluid exposure, the pH adjusting agent adjusting the pH of the dye composition to between about 4.6 to about 6.5.

Claim 23

Dependent Claim 114 words

A tape adapted to be affixed to biocontamination barriers for articles to be sterilized by a sterilization cycle including exposure to an acidic fluid, comprising: an elongated, flexible member having an adhesive layer on one side and a dye composition on the other side, the dye composition being substantially stable and capable of visually indicating whether exposure to an acidic fluid of a sterilization cycle has occurred, the dye composition including a pH sensitive dye and a pH adjusting agent, the pH sensitive dye giving a substantially stable color change in response to acetic fluid exposure, the pH adjusting agent adjusting the pH of the dye composition to between about 4.6 to about 6.5.

Claim 24

Dependent Claim 16 words

The tape as in claim 19 wherein the dye composition includes Bromophenol Blue or Bromocresol Green.

Claim 25

Dependent Claim 31 words

The tape as in claim 20 wherein the dye composition changes color in response to acetic acid exposure and substantially maintains the changed color after exposure to acetic acid is terminated.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2000-04-14	2000-10-14	2001-04-15	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2004-04-14	2004-10-14	2005-04-15	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2008-04-14	2008-10-14	2009-04-15	$7700.00	Window Closed / Lapsed

Packaging systems for peracid sterilization processes

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