Biological indicator package having improved usability features

Abstract

A biological indicator package includes an intermediate support member, a vapor permeable pouch, a biological indicator contained in the pouch, and a tab. The pouch protrudes from a first side of the intermediate support member. The biological indicator includes an organism carrier and a spore loaded onto the carrier. The tab protrudes from a second side of the intermediate support member. The tab includes a tab front layer and a tab back layer. The tab front layer or the tab back layer, or both, may have a tab adhesive layer configured to adhere the tab front layer to the tab back layer. The tab adhesive layer is configured to enable peeling apart of the tab front layer away from the tab back layer to expose the tab adhesive layer. The tab adhesive layer, once exposed, is configured to adhere to a surface during a decontamination cycle of a decontamination process.

Description

[0001] BIOLOGICAL INDICATOR PACKAGE HAVING IMPROVED USABILITY FEATURES

[0002] Field of Invention

[0003] This application relates generally to a biological indicator package, and more particularly to a biological indicator package having improved usability features.

[0004] Background

[0005] Biological indicator packages, in one form, include an envelope pouch and a biological indicator (or Bl) contained in the pouch. The biological indicator includes a biological carrier and viable organisms in the form of bacterial spores loaded onto the carrier. The bacterial spores are used to assess whether necessary conditions are satisfied to kill a specified number of microorganisms for a given bio decontamination process, for example, a sterilization process. The Bl is exposed to the bio decontamination process and then incubated under defined growth conditions to determine whether any spores survived the process. If no spores survive, the test is considered to have passed and the bio decontamination process is considered to have been successful. If growth is detected, the test is considered to have failed and the bio decontamination process is considered to have been unsuccessful.

[0006] Current biological indicator packages have various shortcomings, drawbacks, and disadvantages. For example, some current biological indicator packages need to use a separate piece of tape to stick the biological indicator package to a surface inside the bio decontamination unit, particularly if the biological indicator package cannot be hung from a surface in the unit. Also, current biological indicator packages require a separate tool such as a forceps to transfer the biological indicator from the biological indicator package to, for example, a growth media for incubation. Further, some current biological indicator packages that include vapor permeable pouches are not equipped with a chemical indicator (or Cl) to verify that a decontamination process has been completed, in which case a separate chemical indicator must be utilized. Still further, current biological indicator packages require information to be written down by hand, increasing the possibility of human documentation error in critical data collection. Any one or more of the foregoing can increase the time for a user to carry out a bio decontamination process.

[0007] Accordingly, there remains a need for further contributions in this area of technology.

[0008] Summary of Invention

[0009] The application relates to biological indicator packages that employ components that improve the usability of the biological indicator.

[0010] According to one aspect of the invention, a biological indicator package includes an intermediate support member having a first side and a second side; a pouch protruding from the first side of the intermediate support member, the pouch being vapor permeable; a biological indicator contained in the pouch, the biological indicator including an organism carrier and a spore loaded onto the organism carrier; a tab protruding from the second side of the intermediate support member, the tab including a tab front layer and a tab back layer, wherein at least one of the tab front layer and the tab back layer has a tab adhesive layer configured to adhere the tab front layer to the tab back layer, wherein the tab adhesive layer is further configured to enable peeling apart of the tab front layer away from the tab back layer to expose the tab adhesive layer, wherein the tab adhesive layer, once exposed, is configured to adhere to a surface during a decontamination cycle of a decontamination process.

[0011] Embodiments of the invention may include one or more of the following additional features separately or in combination.

[0012] The first side and the second side may be opposite sides of the intermediate support member.

[0013] In a state where the tab front layer is adhered to the tab back layer by the tab adhesive layer, the tab front layer may overhang the tab back layer to define a handle for a user to peel the tab front layer away from the tab back layer, the handle not including the tab adhesive layer. The tab front layer and the tab back layer may have respectively a tab front adhesive layer and a tab back adhesive layer, wherein the tab front adhesive layer and the tab back adhesive layer form the tab adhesive layer.

[0014] In a state where the tab front layer is peeled away from the tab back layer, the tab front layer having the tab front adhesive layer, and the tab back layer having the tab back adhesive layer, together form an angularly adjustable clamshell adhesive support.

[0015] In a state where the surface is flat and the tab front adhesive layer and the tab back adhesive layer are adhered to the surface, the pouch and the tab front layer and the tab back layer form substantially an inverted T-shape configuration, the pouch forming the base of the T-shape configuration, and the tab front layer and the tab back layer forming the transverse portion of the T-shape configuration.

[0016] The tab front layer may have the tab adhesive layer and the tab back layer may not have the tab adhesive layer, wherein in a state where the tab front layer is peeled away from the tab back layer, the tab front layer having the tab adhesive layer forms an adhesive support, and the tab back layer not having the tab adhesive layer forms a non-adhesive support.

[0017] In a state where the surface is flat and the tab adhesive layer of the tab front layer is adhered to the surface, the pouch and the tab front layer and the tab back layer form substantially an inverted T-shape configuration, the pouch forming the base of the T-shape configuration, and the tab front layer and the tab back layer forming the transverse portion of the T-shape configuration.

[0018] The pouch may include a pouch front layer and a pouch back layer, wherein at least one of the pouch front layer and the pouch back layer has a semipermanent seal that semi permanently seals the pouch front layer to the pouch back layer, and wherein the semipermanent seal is configured to enable peeling apart of the pouch front layer away from the pouch back layer to expose the biological indicator.

[0019] In a state where the pouch front layer is semi permanently sealed to the pouch back layer by the semipermanent seal, the pouch front layer may overhang the pouch back layer to define a handle for a user to peel the pouch front layer away from the pouch back layer, the handle not including the semipermanent seal.

[0020] The pouch and the tab may be connected by the intermediate support member.

[0021] The intermediate support member may include an intermediate support member front layer and an intermediate support member back layer, and the intermediate support member front layer may be sealed to the intermediate support member back layer by a permanent seal.

[0022] In a state where the pouch front layer is semi permanently sealed to the pouch back layer by the semipermanent seal, the biological indicator may be circumscribed in part by the permanent seal and in part by the semipermanent seal.

[0023] The pouch may include a pouch front layer and a pouch back layer, wherein the intermediate support member includes an intermediate support member front layer and an intermediate support member back layer, wherein a Tyvek sheet front layer forms the pouch front layer, the intermediate support member front layer and the tab front layer, wherein a Tyvek sheet back layer forms the pouch back layer, the intermediate support member back layer and the tab back layer, wherein the intermediate support member front layer and the intermediate support member back layer are connected together by a permanent seal.

[0024] The biological indicator may further include one or more chemical indicators configured to indicate whether a decontamination cycle occurred in the vicinity of the biological indicator package.

[0025] The one or more chemical indicators may be located on the tab.

[0026] According to another aspect of the invention, a biological indicator package includes an intermediate support member having a first side and a second side; a pouch protruding from the first side of the intermediate support member, the pouch being vapor permeable; a biological indicator and a removal tool contained in the pouch, the biological indicator including an organism carrier and a spore loaded onto the organism carrier, the removal tool being removably attached to the biological indicator; a tab protruding from the second side of the intermediate support member, the tab including a tab adhesive layer configured to adhere to a surface during a decontamination cycle of a decontamination process.

[0027] Embodiments of the invention may include one or more of the following additional features separately or in combination.

[0028] The first side and the second side may be opposite sides of the intermediate support member.

[0029] The tab may include a tab front layer and a tab back layer, wherein at least one of the tab front layer and the tab back layer has the tab adhesive layer, wherein the tab adhesive layer is configured to adhere the tab front layer to the tab back layer, wherein the tab adhesive layer is further configured to enable peeling apart of the tab front layer away from the tab back layer to expose the tab adhesive layer, wherein the tab adhesive layer, once exposed, is configured to adhere to a surface during a decontamination cycle of a decontamination process.

[0030] In a state where the tab front layer is adhered to the tab back layer by the tab adhesive layer, the tab front layer may overhang the tab back layer to define a handle for a user to peel the tab front layer away from the tab back layer, the handle not including the tab adhesive layer.

[0031] The tab front layer and the tab back layer may have respectively a tab front adhesive layer and a tab back adhesive layer, wherein the tab front adhesive layer and the tab back adhesive layer form the tab adhesive layer.

[0032] In a state where the tab front layer is peeled away from the tab back layer, the tab front layer may have the tab front adhesive layer, and the tab back layer may have the tab back adhesive layer, together form an angularly adjustable clamshell adhesive support.

[0033] In a state where the surface is flat and the tab front adhesive layer and the tab back adhesive layer are adhered to the surface, the pouch and the tab front layer and the tab back layer form substantially an inverted T-shape configuration, the pouch forming the base of the T-shape configuration, and the tab front layer and the tab back layer forming the transverse portion of the T-shape configuration.

[0034] The tab front layer may have the tab adhesive layer and the tab back layer may not have the tab adhesive layer, wherein in a state where the tab front layer is peeled away from the tab back layer, the tab front layer having the tab adhesive layer forms an adhesive support, and the tab back layer not having the tab adhesive layer forms a non-adhesive support.

[0035] In a state where the surface is flat and the tab adhesive layer of the tab front layer is adhered to the surface, the pouch and the tab front layer and the tab back layer form substantially an inverted T-shape configuration, the pouch forming the base of the T-shape configuration, and the tab front layer and the tab back layer forming the transverse portion of the T-shape configuration.

[0036] The pouch may include a pouch front layer and a pouch back layer, wherein at least one of the pouch front layer and the pouch back layer has a semipermanent seal that semi permanently seals the pouch front layer to the pouch back layer, and wherein the semipermanent seal is configured to enable peeling apart of the pouch front layer away from the pouch back layer to expose at least the removal tool.

[0037] In a state where the pouch front layer is semi permanently sealed to the pouch back layer by the semipermanent seal, the pouch front layer may overhang the pouch back layer to define a handle for a user to peel the pouch front layer away from the pouch back layer, the handle not including the semipermanent seal.

[0038] The biological indicator and the removal tool may be oriented in the pouch such that the removal tool is closer to the handle than the biological indicator.

[0039] The pouch and the tab may be connected by the intermediate support member.

[0040] The intermediate support member may include an intermediate support member front layer and an intermediate support member back layer, and the intermediate support member front layer may be sealed to the intermediate support member back layer by a permanent seal.

[0041] In a state where the pouch front layer is semi permanently sealed to the pouch back layer by the semipermanent seal, the biological indicator and the removal tool may be circumscribed in part by the intermediate support member and in part by the semipermanent seal.

[0042] The pouch may include a pouch front layer and a pouch back layer, wherein the intermediate support member includes an intermediate support member front layer and an intermediate support member back layer, wherein a Tyvek sheet front layer forms the pouch front layer, the intermediate support member front layer and the tab front layer, wherein a Tyvek sheet back layer forms the pouch back layer, the intermediate support member back layer and the tab back layer, wherein the intermediate support member front layer and the intermediate support member back layer are connected together by a permanent seal.

[0043] The biological indicator package may further include a chemical indicator configured to indicate whether a decontamination cycle occurred in the vicinity of the biological indicator package.

[0044] The chemical indicator may be located on the tab.

[0045] According to another aspect of the invention, a biological indicator package includes an intermediate support member having a first side and a second side; a pouch protruding from the first side of the intermediate support member, the pouch being vapor permeable; a biological indicator contained in the pouch, the biological indicator including an organism carrier and a spore loaded onto the organism carrier; a tab protruding from the second side of the intermediate support member, the tab having a front surface portion and a back surface portion opposite that of the front surface portion, the back surface portion having a tab adhesive layer configured to adhere to a surface during a decontamination cycle of a decontamination process; wherein the tab adhesive layer is configured to releasably adhere to a release liner or to a front surface portion of a tab of an adjacently stacked biological indicator package.

[0046] Embodiments of the invention may include one or more of the following additional features separately or in combination.

[0047] The first side and the second side may be opposite sides of the intermediate support member.

[0048] The biological indicator package may further include a release liner, wherein the tab adhesive layer is configured to releasably adhere to the release liner.

[0049] The pouch may include a pouch front layer and a pouch back layer, wherein the intermediate support member includes an intermediate support member front layer and an intermediate support member back layer, wherein a Tyvek sheet front layer forms the pouch front layer and the intermediate support member front layer, wherein a Tyvek sheet back layer forms the pouch back layer and the intermediate support member back layer, wherein the intermediate support member front layer and the intermediate support member back layer are connected together by a permanent seal.

[0050] The Tyvek sheet back layer may also form the tab.

[0051] A stack of biological indicator packages may include a lower biological indicator package according to any foregoing aspect and embodiments thereof; and an upper biological indicator package according any foregoing aspect and embodiments thereof, wherein the tab adhesive layer of the back surface portion of the tab of the upper biological indicator package is configured to releasably adhere to the front surface portion of the tab of the lower biological indicator package.

[0052] The front surface portion of the tab of the lower biological indicator package may be configured as a release liner surface.

[0053] The stack of biological indicator packages may further include a release liner, wherein the back surface portion of the tab of the lower biological indicator package is configured to releasably adhere to the release liner.

[0054] The pouch may include a pouch front layer and a pouch back layer, wherein the intermediate support member includes an intermediate support member front layer and an intermediate support member back layer, wherein a Tyvek sheet front layer forms the pouch front layer and the intermediate support member front layer, wherein a Tyvek sheet back layer forms the pouch back layer and the intermediate support member back layer, wherein the intermediate support member front layer and the intermediate support member back layer are connected together by a permanent seal.

[0055] The Tyvek sheet back layer may also form the tab.

[0056] The biological indicator package may further comprise a chemical indicator configured to indicate whether a decontamination cycle occurred in the vicinity of the biological indicator package.

[0057] The chemical indicator may be located on the tab.

[0058] According to another aspect of the invention, a plurality of biological indicator packages includes a first biological indicator package including a first pouch and a first biological indicator contained in the first pouch, the first pouch being vapor permeable, the first biological indicator including a first organism carrier and a first spore loaded onto the first organism carrier, the first biological indicator package having a first left side and a first right side opposite the first left side; a second biological indicator package including a second pouch and a second biological indicator contained in the second pouch, the second pouch being vapor permeable, the second biological indicator including a second organism carrier and a second spore loaded onto the second organism carrier, the second biological indicator package having a second left side and a second right side opposite the second left side; wherein the second left side of the second biological indicator package is separably connected side by side to the first right side of the first biological indicator package by a perforated connection; wherein the perforated connection is configured to enable separation of the first biological indicator package from the second biological indicator package by tearing the perforated connection.

[0059] Embodiments of the invention may include one or more of the following additional features separately or in combination.

[0060] The first pouch may include a first pouch front layer and a first pouch back layer, wherein at least one of the first pouch front layer and the first pouch back layer has a first semipermanent seal that semi permanently seals the first pouch front layer to the first pouch back layer, and wherein the first semipermanent seal is configured to enable peeling apart of the first pouch front layer away from the first pouch back layer to expose the first biological indicator; and, wherein the second pouch includes a second pouch front layer and a second pouch back layer, wherein at least one of the second pouch front layer and the second pouch back layer has a second semipermanent seal that semi permanently seals the second pouch front layer to the second pouch back layer, and wherein the second semipermanent seal is configured to enable peeling apart of the second pouch front layer away from the second pouch back layer to expose the second biological indicator.

[0061] The first pouch front layer and first pouch back layer may be formed by a first single layer folded upon itself such that a first fold in the first single layer connects the first pouch front layer and the first pouch back layer; and, the second pouch front layer and second pouch back layer may be formed by a second single layer folded upon itself such that a second fold in the second single layer connects the second pouch front layer and the second pouch back layer.

[0062] In a state where the first pouch front layer is semi permanently sealed to the first pouch back layer by the first semipermanent seal, the first pouch front layer may overhang the first pouch back layer to define a first handle for a user to peel the first pouch front layer away from the first pouch back layer, the first handle not including the first semipermanent seal; and, in a state where the second pouch front layer is semi permanently sealed to the second pouch back layer by the second semipermanent seal, the second pouch front layer may overhang the second pouch back layer to define a second handle for a user to peel the second pouch front layer away from the second pouch back layer, the second handle not including the second semipermanent seal.

[0063] In a state where the first pouch front layer is semi permanently sealed to the first pouch back layer by the first semipermanent seal, the first biological indicator may be circumscribed in part by the first semipermanent seal and in part by the first fold; and, in a state where the second pouch front layer is semi permanently sealed to the second pouch back layer by the second semipermanent seal, the second biological indicator may be circumscribed in part by the second semipermanent seal and in part by the second fold.

[0064] A first Tyvek sheet front layer may form the first pouch front layer and a first Tyvek sheet back layer may form the first pouch back layer; and, a second Tyvek sheet front layer may form the second pouch front layer and a second Tyvek sheet back layer may form the second pouch back layer.

[0065] One or more of a distal end of the first pouch front layer of the first biological indicator package and a distal end of the first pouch back layer of the first biological indicator package may be configured to connect to a surface during a decontamination cycle of a decontamination process; and one or more of a distal end of the second pouch front layer of the second biological indicator package and a distal end of the second pouch back layer of the second biological indicator package may be configured to connect to a surface during a decontamination cycle of a decontamination process.

[0066] The distal end of the first pouch front layer and the distal end of the first pouch back layer may include respective orifices that are concentrically aligned and configured to enable hanging of the biological indicator package on a projection; and the distal end of the second pouch front layer and the distal end of the second pouch back layer may include respective orifices that are concentrically aligned and configured to enable hanging of the biological indicator package on a projection.

[0067] The first biological indicator package may include a first chemical indicator on a first surface of the first biological indicator package, the first chemical indicator being configured to indicate whether a decontamination cycle occurred in the vicinity of the first biological indicator package; and the second biological indicator package may include a second chemical indicator on a second surface of the second biological indicator package, the second chemical indicator being configured to indicate whether a decontamination cycle occurred in the vicinity of the second biological indicator package.

[0068] According to another aspect of the invention, a biological indicator package includes a pouch that is vapor permeable; a biological indicator contained in the pouch, the biological indicator including an organism carrier and a spore loaded onto the organism carrier; a chemical indicator on a surface of the biological indicator package, the chemical indicator being configured to indicate whether a decontamination cycle occurred in the vicinity of the biological indicator package.

[0069] Embodiments of the invention may include one or more of the following additional features separately or in combination.

[0070] In top plan view the biological indicator package may have a first external surface area and a second external surface area that is adjacent to the first external surface area, wherein the surface of the biological indicator package on which the chemical indicator is located is the second external surface area of the biological indicator package, and the biological indicator is contained in the pouch in the first external surface area of the biological indicator package.

[0071] In top plan view the biological indicator package may include an orifice spaced from the pouch and the chemical indicator, the orifice being configured to enable hanging of the biological indicator package on a projection.

[0072] The pouch may include a pouch front layer and a pouch back layer, wherein at least one of the pouch front layer and the pouch back layer has a semipermanent seal that semi permanently seals the pouch front layer to the pouch back layer, and wherein the semipermanent seal is configured to enable peeling apart of the pouch front layer away from the pouch back layer to expose the biological indicator.

[0073] The pouch front layer and pouch back layer may be formed by a single layer folded upon itself such that a fold in the single layer connects the pouch front layer and the pouch back layer.

[0074] A Tyvek sheet front layer may form the pouch front layer and a Tyvek sheet back layer may form the pouch back layer.

[0075] The chemical indicator may be formed on the Tyvek sheet front layer.

[0076] The biological indicator package may further include an intermediate support member having a first side and a second side, the pouch protruding from the first side of the intermediate support member, and a tab protruding from the second side of the intermediate support member, the tab being configured to connect to a surface during a decontamination cycle of a decontamination process.

[0077] The first side and the second side may be opposite sides of the intermediate support member.

[0078] The pouch may protrude from the first side of the intermediate support member to provide in top plan view a first external surface area that is adjacent to the intermediate support member, and the tab may protrude from the second side of the intermediate support member to provide in top plan view a second external surface area that is adjacent to the intermediate support member, wherein the surface of the biological indicator package on which the chemical indicator is located is the second external surface area of the tab, and the biological indicator is contained in the pouch in the first external surface area of the pouch.

[0079] The tab may be configured to connect to a surface by an adhesive on the tab.

[0080] In top plan view the biological indicator package may include an orifice spaced from the pouch and the chemical indicator, the orifice being configured to enable hanging of the biological indicator package on a projection.

[0081] The pouch may include a pouch front layer and a pouch back layer, wherein the intermediate support member includes an intermediate support member front layer and an intermediate support member back layer.

[0082] At least one of the pouch front layer and the pouch back layer may have a semipermanent seal that semi permanently seals the pouch front layer to the pouch back layer, and the semipermanent seal may be configured to enable peeling apart of the pouch front layer away from the pouch back layer to expose the biological indicator.

[0083] The tab may include a tab front layer and a tab back layer, wherein a Tyvek sheet front layer forms the pouch front layer, the intermediate support member front layer and the tab front layer, wherein a Tyvek sheet back layer forms the pouch back layer, the intermediate support member back layer and the tab back layer, wherein the intermediate support member front layer and the intermediate support member back layer are connected together by a permanent seal.

[0084] The chemical indicator may be formed on the tab front layer of the Tyvek sheet front layer.

[0085] A Tyvek sheet front layer may form the pouch front layer and the intermediate support member front layer, and a Tyvek sheet back layer may form the pouch back layer, the intermediate support member back layer and the tab.

[0086] The chemical indicator may be formed on the tab of the Tyvek sheet back layer. According to another aspect of the invention, a biological indicator package includes a pouch that is vapor permeable; a biological indicator contained in the pouch, the biological indicator including an organism carrier and a spore loaded onto the organism carrier; a release liner in a surface of the biological indicator package; and, a peel and stick label on the release liner, the peel and stick label including a label face on a first side thereof and a label adhesive on a second side thereof that is opposite the first side, the peel and stick label being releasably adhered to the release liner by the label adhesive; wherein the peel and stick label and the release liner are configured to enable peeling apart of the peel and stick label away from the release liner to expose the label adhesive, wherein the label adhesive, once exposed, is configured to adhere to a surface.

[0087] Embodiments of the invention may include one or more of the following additional features separately or in combination.

[0088] In top plan view the biological indicator package may have a first external surface area and a second external surface area that is adjacent to the first external surface area, wherein the release liner on which the peel and stick label is located is in the second external surface area of the biological indicator package, and the biological indicator is contained in the pouch in the first external surface area of the biological indicator package.

[0089] In top plan view the biological indicator package may include an orifice spaced from the pouch and the release liner on which the peel and stick label is located, the orifice being configured to enable hanging of the biological indicator package on a projection.

[0090] The pouch may include a pouch front layer and a pouch back layer, wherein at least one of the pouch front layer and the pouch back layer has a semipermanent seal that semi permanently seals the pouch front layer to the pouch back layer, and wherein the semipermanent seal is configured to enable peeling apart of the pouch front layer away from the pouch back layer to expose the biological indicator.

[0091] The pouch front layer and the pouch back layer may be formed by a single layer folded upon itself such that a fold in the single layer connects the pouch front layer and the pouch back layer.

[0092] A Tyvek sheet front layer may form the pouch front layer and a Tyvek sheet back layer may form the pouch back layer.

[0093] The release label on which the peel and stick label is located may be formed on the Tyvek sheet front layer.

[0094] The biological indicator package may further include an intermediate support member having a first side and a second side, the pouch protruding from the first side of the intermediate support member, and a tab protruding from the second side of the intermediate support member, the tab being configured to connect to a surface during a decontamination cycle of a decontamination process.

[0095] The first side and the second side may be opposite sides of the intermediate support member.

[0096] The pouch may protrude from the first side of the intermediate support member to provide in top plan view a first external surface area that is adjacent to the intermediate support member, and the tab may protrude from the second side of the intermediate support member to provide in top plan view a second external surface area that is adjacent to the intermediate support member, wherein the surface of the biological indicator package in which the release liner is located is the second external surface area of the tab, and the biological indicator is contained in the pouch in the first external surface area of the pouch.

[0097] The tab may be configured to connect to a surface by an adhesive on the tab.

[0098] In top plan view the biological indicator package may include an orifice spaced from the pouch and the release liner on which the peel and stick label is located, the orifice being configured to enable hanging of the biological indicator package on a projection.

[0099] The pouch may include a pouch front layer and a pouch back layer, and the intermediate support member may include an intermediate support member front layer and an intermediate support member back layer.

[0100] At least one of the pouch front layer and the pouch back layer may have a semipermanent seal that semi permanently seals the pouch front layer to the pouch back layer, and wherein the semipermanent seal is configured to enable peeling apart of the pouch front layer away from the pouch back layer to expose the biological indicator.

[0101] The tab may include a tab front layer and a tab back layer, wherein a Tyvek sheet front layer forms the pouch front layer, the intermediate support member front layer and the tab front layer, wherein a Tyvek sheet back layer forms the pouch back layer, the intermediate support member back layer and the tab back layer, wherein the intermediate support member front layer and the intermediate support member back layer are connected together by a permanent seal.

[0102] The release liner on which the peel and stick label is located may be formed on the tab front layer of the Tyvek sheet front layer.

[0103] A Tyvek sheet front layer may form the pouch front layer and the intermediate support member front layer, and a Tyvek sheet back layer may form the pouch back layer, the intermediate support member back layer and the tab.

[0104] The release liner on which the peel and stick label is located may be formed on the tab of the Tyvek sheet back layer.

[0105] The biological indicator package may further include a chemical indicator on a surface of the biological indicator package, the chemical indicator being configured to indicate whether a decontamination cycle occurred in the vicinity of the biological indicator package, wherein the surface of the biological indicator package on which the chemical indicator is located is the second external surface area of the biological indicator package.

[0106] In top plan view the chemical indicator may be separate from the release liner on which the peel and stick label is located.

[0107] The following description and the annexed drawings set forth certain illustrative embodiments of the invention. These embodiments are indicative, however, of but a few of the various ways in which the principles of the invention may be employed. Other objects, advantages and novel features according to aspects of the invention will become apparent from the following detailed description when considered in conjunction with the drawings.

[0108] Brief Description of the Drawings

[0109] The annexed drawings, which are not necessarily to scale, show various aspects of the invention.

[0110] Fig. 1 A is a bottom isometric view of a biological indicator package in accordance with an embodiment of the invention.

[0111] Fig. 1 B is a bottom isometric view of the Fig. 1 A biological indicator package, showing a pouch opened and a biological indicator removed.

[0112] Fig. 1 C is a bottom plan view of the Fig. 1 A biological indicator package.

[0113] Fig. 1 D is a side elevation cross section view of the Fig. 1 A biological indicator package as viewed from the plane 1 D-1 D in Fig. 1 C.

[0114] Fig. 1 E is an exploded view of the Fig. 1 D side elevation cross section view.

[0115] Fig. 1 F is a plan view as viewed from the plane 1 F-1 F in Fig. 1 E.

[0116] Fig. 1 G is a plan view as viewed from the plane 1 G-1 G in Fig. 1 E.

[0117] Fig. 1 H is a side elevation cross section view as viewed from the plane 1 D- 1 D in Fig. 1 C except with a tab front layer peeled away from a tab back layer, and oriented such that a pouch, the tab front layer and the tab back layer form an inverted T-shape configuration.

[0118] Fig. 2A is a bottom isometric view of a biological indicator package in accordance with another embodiment of the invention.

[0119] Fig. 2B is a bottom isometric view of the Fig. 2A biological indicator package, showing a pouch opened and a biological indicator and a removal tool removed.

[0120] Fig. 20 is a bottom plan view of the Fig. 2A biological indicator package.

[0121] Fig. 2D is a side elevation cross section view of the Fig. 2A biological indicator package as viewed from the plane 2D-2D in Fig. 2C.

[0122] Fig. 2E is an exploded view of the Fig. 2D side elevation cross section view.

[0123] Fig. 2F is a plan view as viewed from the plane 2F-2F in Fig. 2E.

[0124] Fig. 2G is a plan view as viewed from the plane 2G-2G in Fig. 2E.

[0125] Fig. 2H is a side elevation cross section view as viewed from the plane 2D- 2D in Fig. 2C except with a tab front layer peeled away from a tab back layer, and oriented such that a pouch, the tab front layer and the tab back layer form an inverted T-shape configuration.

[0126] Fig. 3A is an exploded top isometric view of an upper biological indicator package, a lower biological indicator package, and a release liner, in accordance with another embodiment of the invention.

[0127] Fig. 3B is a top isometric view of the Fig. 3A biological indicator package, applicable to either the upper biological indicator package or the lower biological indicator package, showing a pouch opened and a biological indicator removed.

[0128] Fig. 3C is a bottom plan view of the Fig. 3A biological indicator package, applicable to either the upper biological indicator package or the lower biological indicator package.

[0129] Fig. 3D is a side elevation cross section view of the Fig. 3A biological indicator package as viewed from the plane 3D-3D in Fig. 3C, applicable to either the upper biological indicator package or the lower biological indicator package.

[0130] Fig. 3E is an exploded view of the Fig. 3D side elevation cross section view.

[0131] Fig. 3F is a plan view as viewed from the plane 3F-3F in Fig. 3E.

[0132] Fig. 3G is a plan view as viewed from the plane 3G-3G in Fig. 3E.

[0133] Fig. 3H is a plan view as viewed from the plane 3H-3H in Fig. 3E.

[0134] Fig. 31 is a plan view as viewed from the plane 31-31 in Fig. 3E.

[0135] Fig. 4A is a top plan view of a first biological indicator package separably connected side by side to a second biological indicator package by a perforated connection, in accordance with another embodiment of the invention.

[0136] Fig. 4B is a top isometric view of the first biological indicator package of the Fig. 4A side by side connected first and second biological indicator packages, showing a pouch opened and a biological indicator removed.

[0137] Fig. 4C is a bottom plan view of the first biological indicator package of the Fig. 4A side by side connected first and second biological indicator packages.

[0138] Fig. 4D is a side elevation cross section view of the Fig. 4A biological indicator package as viewed from the plane 4D-4D in Fig. 4C. Fig. 4E is an exploded view of the Fig. 4D side elevation cross section view.

[0139] Fig. 4F is a plan view as viewed from the plane 4F-4F in Fig. 4E.

[0140] Fig. 4G is a plan view as viewed from the plane 4G-4G in Fig. 4E.

[0141] Fig. 5A is a top plan view of a biological indicator package in accordance with another embodiment of the invention, showing a chemical indicator in a top surface of either of the biological indicator packages shown in Fig. 4A.

[0142] Fig. 5B is a top plan view of a biological indicator package in accordance with another embodiment of the invention, showing a chemical indicator in a top surface of the biological indicator package shown in Fig. 1 A.

[0143] Fig. 50 is a top plan view of a biological indicator package in accordance with another embodiment of the invention, showing a chemical indicator in a top surface of the biological indicator package shown in Fig. 2A.

[0144] Fig. 5D is a top plan view of a biological indicator package in accordance with another embodiment of the invention, showing a peel and stick label in a top surface of the biological indicator package shown in Fig. 3A.

[0145] Fig. 6A is a top plan view of a biological indicator package in accordance with another embodiment of the invention, showing a peel and stick label in a top surface of either of the biological indicator packages shown in Fig. 4A.

[0146] Fig. 6B is a top isometric view of the Fig. 6A biological indicator package, showing the peel and stick label removed from a release liner of the biological indicator package.

[0147] Fig. 60 is a top plan view of a biological indicator package in accordance with another embodiment of the invention, showing a peel and stick label in a top surface of the biological indicator package shown in Fig. 1 A.

[0148] Fig. 6D is a top isometric view of the Fig. 6C biological indicator package, showing the peel and stick label removed from a release liner of the biological indicator package.

[0149] Fig. 6E is a top plan view of a biological indicator package in accordance with another embodiment of the invention, showing a peel and stick label in a top surface of the biological indicator package shown in Fig. 2A. Fig. 6F is a top isometric view of the Fig. 6E biological indicator package, showing the peel and stick label removed from a release liner of the biological indicator package.

[0150] Fig. 6G is a top plan view of a biological indicator package in accordance with another embodiment of the invention, showing a peel and stick label in a top surface of the biological indicator package shown in Fig. 3A.

[0151] Fig. 6H is a top isometric view of the Fig. 6G biological indicator package, showing the peel and stick label removed from a release liner of the biological indicator package.

[0152] Detailed Description

[0153] While the present invention can take many different forms, for the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications of the described embodiments, and any further applications of the principles of the invention as described herein, are contemplated as would normally occur to one skilled in the art to which the invention relates.

[0154] Figs. 1 A-1 H show a biological indicator package 100 in accordance with an embodiment of the invention. The biological indicator package 100 includes an intermediate support member 110 having a first side 112 and a second side 114, a pouch 120 protruding from the first side 112 of the intermediate support member 110, a biological indicator 126 contained in the pouch 120, and a tab 130 protruding from the second side 114 of the intermediate support member 110. The pouch 120 is vapor permeable, for example, vapor permeable to hydrogen peroxide vapor produced during a decontamination cycle of a bio decontamination unit. The biological indicator 126 includes an organism carrier 140 also known in the art as a coupon, coupon carrier, indicator coupon, among others. The organism carrier 140 may be made of stainless steel. A spore 142 is loaded onto the organism carrier 140. By way of example, the organism carrier 140 may be inoculated with an E6 (6- log) population of Geobacillus stearothermophilus spores 142.

[0155] The tab 130 includes a tab front layer 152 and a tab back layer 154. At least one of the tab front layer 152 and the tab back layer 154 has a tab adhesive layer 160 configured to adhere the tab front layer 152 to the tab back layer 154. The tab adhesive layer 160 is further configured to enable peeling apart of the tab front layer 152 away from the tab back layer 154 to expose the tab adhesive layer 160. The tab adhesive layer 160 may be provided for example by a removable adhesive. The tab adhesive layer 160, once exposed, is configured to adhere to a surface during a decontamination cycle of a decontamination process.

[0156] As will be described in greater detail below, several advantages may be realized by the biological indicator package 100 in accordance with the invention. For example, the tab adhesive layer 160 avoids the need to use a separate piece of tape to stick the biological indicator package 100 to a surface. Moreover, the tab front layer 152 and the tab back layer 154 remain part of the biological indicator package 100 even after they are peeled apart and adhered to a surface. Thus, the ability to adhere the biological indicator package 100 to a surface is incorporated into the biological indicator package 100 itself. This eliminates the need for a user to obtain and / or handle a separate piece of tape and prevents a user from placing a piece of tape in such a manner to interfere with the spore 142 on the organism carrier 140. The foregoing and other advantages will become apparent in the description that follows.

[0157] Turning now to Figs. 1 A-1 B, the first side 112 and the second side 114 of the intermediate support member 110 are opposite sides of the intermediate support member 1 10, and the intermediate support member 110 is rectangular in shape. Other embodiments are contemplated. For example, the first side 112 and the second side 1 14 may be at right angles relative to one another, or at other angles relative to one another. The intermediate support member 110 may be other than rectangular in shape, for example, triangular.

[0158] As shown in Fig. 1 C, in a state where the tab front layer 152 is adhered to the tab back layer 154 by the tab adhesive layer 160, the tab front layer 152 overhangs the tab back layer 154 to define a handle 168 for a user to peel the tab front layer 152 away from the tab back layer 154, the handle 168 not including the tab adhesive layer 160.

[0159] In the illustrated embodiment, the tab front layer 152 and the tab back layer 154 have respectively a tab front adhesive layer 162 and a tab back adhesive layer 164, and the tab front adhesive layer 162 and the tab back adhesive layer 164 form the afore mentioned tab adhesive layer 160. The tab front layer 152 and the tab back layer 154 are flexible to enable more easily the peeling apart of the tab front layer 152 and the tab back layer 154. As shown in Figs. 1 A-1 B, in a state where the tab front layer 152 is peeled away from the tab back layer 154, the tab front layer 152 having the tab front adhesive layer 162, and the tab back layer 154 having the tab back adhesive layer 164, together form an angularly adjustable clamshell adhesive support. As shown in Fig. 1 H, in a state where the surface onto which the biological indicator package 100 is to be adhered is flat, and the tab front adhesive layer 162 and the tab back adhesive layer 164 are adhered to such surface, the pouch 120 and the tab front layer 152 and the tab back layer 154 form substantially an inverted T-shape configuration, the pouch 120 forming the base of the T-shape configuration, and the tab front layer 152 and the tab back layer 154 forming the transverse portion of the T-shape configuration.

[0160] In an alternate embodiment, the tab front layer 152 has the tab front adhesive layer 162 and the tab back layer 154 does not have the tab back adhesive layer 164; that is, the tab back adhesive layer 164 is omitted. In such alternate embodiment, in a state where the tab front layer 152 is peeled away from the tab back layer 154, the tab front layer 152 having the tab front adhesive layer 154 forms an adhesive support, and the tab back layer 154 not having the tab back adhesive layer 164 forms a non-adhesive support. In this regard, the tab back layer 154 may function as a passive support, or “kickstand” support for the biological indicator package 100. With reference again to Fig. H, in such alternate embodiment as well, in a state where the surface onto which the biological indicator package 100 is to be adhered is flat, and the tab front adhesive layer 162 of the tab front layer 152 is adhered to the surface, the pouch 120 and the tab front layer 152 and the tab back layer 162 form substantially an inverted T-shape configuration, the pouch 120 forming the base of the T-shape configuration, and the tab front layer 152 and the tab back layer 162 forming the transverse portion of the T-shape configuration.

[0161] In another alternate embodiment, the tab front layer 152 does not have the tab front adhesive layer 162 and the tab back layer 154 has the tab back adhesive layer 164; that is, the tab front adhesive layer 162 is omitted. In such alternate embodiment, in a state where the tab front layer 152 is peeled away from the tab back layer 154, the tab back layer 154 having the tab back adhesive layer 164 forms an adhesive support, and the tab front layer 152 not having the tab front adhesive layer 154 forms a non-adhesive support. In this regard, the tab front layer 152 may function as a passive support, or “kickstand” support for the biological indicator package 100. With reference again to Fig. H, in such alternate embodiment as well, in a state where the surface onto which the biological indicator package 100 is to be adhered is flat, and the tab back adhesive layer 164 of the tab back layer 154 is adhered to the surface, the pouch 120 and the tab front layer 152 and the tab back layer 162 form substantially an inverted T-shape configuration, the pouch 120 forming the base of the T-shape configuration, and the tab front layer 152 and the tab back layer 162 forming the transverse portion of the T-shape configuration.

[0162] Referring now to Figs. 1 A-1 D, the pouch 120 includes a pouch front layer 172 and a pouch back layer 174. At least one of the pouch front layer 172 and the pouch back layer 174 has a semipermanent seal 180 that semi permanently seals the pouch front layer 172 to the pouch back layer 174. The semipermanent seal 180 is configured to enable peeling apart of the pouch front layer 172 away from the pouch back layer 174 to expose the biological indicator 126. The semipermanent seal 180 may be provided for example by a semipermanent adhesive that is designed to hold surfaces together semi-permanently, allowing for separation by peeling apart. As shown in Fig. 1A, in a state where the pouch front layer 172 is semi permanently sealed to the pouch back layer 174 by the semipermanent seal 180, the pouch front layer 172 overhangs the pouch back layer 174 to define a handle 188 for a user to peel the pouch front layer 172 away from the pouch back layer 174, the handle 188 not including the semipermanent seal 180.

[0163] The pouch front layer 172 and the pouch back layer 174 are configured such that once the pouch front layer 172 is peeled away from the pouch back layer 174 so that an end of the biological indicator 126 extends outward beyond the peeled apart portions of the pouch front layer 172 and the pouch back layer 174, the biological indicator 126 can easily slide out by tilting the biological indicator package 100 with the pouch 120 in the downward direction. In other words, so long as the pouch front layer 172 and the pouch back layer 174 are peeled away from each other such that in top plan view an end of the biological indicator 126 protrudes beyond the peeled away portions, shown at line L-L in Figs. 1 B and 1 F, the remaining non-peeled away portions of the pouch front layer 172 and the pouch back layer 174 will allow the remainder of the biological indicator 126 to slide out of the pouch 120.

[0164] In the illustrated embodiment, the pouch 120 and the tab 130 are connected by the intermediate support member 1 10. Also, the intermediate support member 110 includes an intermediate support member front layer 192 and an intermediate support member back layer 194. As shown for example in Figs. 1 D and 1 H, the intermediate support member front layer 192 is sealed to the intermediate support member back layer 194 by a permanent seal 198. The permanent seal 198 is configured such that the intermediate support member front layer 192 cannot be removed from the intermediate support member back layer 194 without causing damage. The permanent seal 198 may be provided for example by an adhesive or by application of heat. With reference to Figs. 1 B, 1 D, and 1 F, in a state where the pouch front layer 172 is semi permanently sealed to the pouch back layer 174 by the semipermanent seal 180, the biological indicator 126 is circumscribed in part by the intermediate support member 1 10 and in part by the semipermanent seal 180.

[0165] As shown in Figs. 1 D-1 E, a Tyvek sheet front layer TF may form the pouch front layer 172, the intermediate support member front layer 192 and the tab front layer 152, and a Tyvek sheet back layer TB may form the pouch back layer 174, the intermediate support member back layer 194 and the tab back layer 154.

[0166] As will be described in greater detail below, the biological indicator package 100 may include one or more chemical indicators configured to indicate whether a decontamination cycle occurred in the vicinity of the biological indicator package 100. By way of example, the one or more chemical indicators may be located on the tab 130 rather than the pouch 120 to avoid during application of the chemical indicator potential interference with the biological indicator 126, particularly the spore 142 thereof.

[0167] Figs. 2A-2H show a biological indicator package 200 in accordance with another embodiment of the invention. The Figs. 2A-2H biological indicator package 200 is in many respects similar to the above-described biological indicator package 100, and consequently the same reference numerals are used to denote structures corresponding to similar structures in the biological indicator package 100. In addition, the foregoing description of the biological indicator package 100 is equally applicable to the Figs. 2A-2H biological indicator package 200 except as noted below. Moreover, it will be appreciated upon reading and understanding the specification that aspects of the biological indicator packages 100, 200 may be substituted for one another or used in conjunction with one another where applicable.

[0168] Turning then to Figs. 2A-2H, the biological indicator package 200 includes the intermediate support member 1 10 having the first side 112 and the second side 114, the pouch 120 protruding from the first side 1 12 of the intermediate support member 1 10, the biological indicator 126 and a removal tool 228 contained in the pouch 120, and the tab 130 protruding from the second side 1 14 of the intermediate support member 1 10. The pouch 120 is vapor permeable, for example, vapor permeable to hydrogen peroxide vapor produced during a decontamination cycle of a bio decontamination cycle of a bio decontamination unit. The biological indicator 126 includes the organism carrier 140 also known in the art as a coupon, coupon carrier, indicator coupon, among others. The organism carrier 140 may be made of stainless steel. The spore 142 is loaded onto the organism carrier 140. By way of example, the organism carrier 140 may be inoculated with an E6 (6-log) population of Geobacillus stearothermophilus spores 142.

[0169] The tab 130 includes the tab adhesive layer 160, which is configured to adhere to a surface during a decontamination cycle of a decontamination process.

[0170] As will be described in greater detail below, several advantages may be realized by the biological indicator package 200 in accordance with the invention. For example, after a decontamination process is completed, the removal tool 228 provided with the biological indicator 126 in the pouch 120 enables a user to transfer the biological indicator 126 from the biological indicator package 200 to, for example, a growth media for incubation. Thus, the biological indicator package 200 does not require a separate tool such as a forceps to transfer the biological indicator 126. Also, the tab adhesive layer 160 avoids the need to use a separate piece of tape to stick the biological indicator package 200 to a surface. Moreover, the tab 130 remains part of the biological indicator package 200 even after adhered to a surface. Thus, the ability to adhere the biological indicator package 200 to a surface is incorporated into the biological indicator package 200 itself. This eliminates the need for a user to obtain and / or handle a separate piece of tape and prevents a user from placing a piece of tape in such a manner to interfere with the spore 142 on the organism carrier 140. The foregoing and other advantages will become apparent in the description that follows.

[0171] Referring then to Figs. 2A-2D, the pouch 120 includes a pouch front layer 172 and a pouch back layer 174. At least one of the pouch front layer 172 and the pouch back layer 174 has a semipermanent seal 180 that semi permanently seals the pouch front layer 172 to the pouch back layer 174. The semipermanent seal 180 is configured to enable peeling apart of the pouch front layer away 172 from the pouch back layer 174 to expose at least the removal tool 228. The semipermanent seal 180 may be provided for example by a semipermanent adhesive that is designed to hold surfaces together semi-permanently, allowing for separation by peeling apart. As shown in Fig. 2A, in a state where the pouch front layer 172 is semi permanently sealed to the pouch back layer 174 by the semipermanent seal 180, the pouch front layer 172 overhangs the pouch back layer 174 to define a handle 288 for a user to peel the pouch front layer 172 away from the pouch back layer 174, the handle 288 not including the semipermanent seal 180.

[0172] As shown in Figs. 2A and 2C, the biological indicator 126 and the removal tool 228 are oriented in the pouch 120 such that the removal tool 228 is closer to the handle 288 than the biological indicator 126. In the illustrated embodiment, the removal tool 228 has a clamp end and a grip end at opposite ends. The clamp end clamps to the biological indicator 126 as shown. The grip end, when compressed, releases the clamp force from the biological indicator 16. As will be appreciated, the removal tool 228 can take on any configuration that facilitates removal of the biological indicator 126 from the pouch 120 followed by release of the biological indicator 126. For example, the removal tool 228 may be in the form of a transfer stick having a J-hook end and a grip end at opposite ends, wherein the J-hook end hooks to an opening in the biological indicator 126 and the grip end enables pulling of the biological indicator 126 followed by release of the biological indicator 126 by rotating the transfer stick such that the J-hook end unhooks from the opening in the biological indicator 126.

[0173] The pouch front layer 172 and the pouch back layer 174 are configured such that once the pouch front layer 172 is peeled away from the pouch back layer 174 so that the grip end of the removal tool 228 extends outward beyond the peeled apart portions of the pouch front layer 172 and the pouch back layer 174, the removal tool 228 can easily slide the biological indicator 126 out by the user pulling on the grip end and thus the removal tool 228 and the biological indicator 126 held thereby. Once removed, the user need merely compress the grip end to release the biological indicator 126. In other words, so long as the pouch front layer 172 and the pouch back layer 174 are peeled away from each other such that in top plan view the grip end of the removal tool 228 protrudes beyond the peeled away portions, shown at line M-M in Figs. 2B and 2F, the remaining non-peeled away portions of the pouch front layer 172 and the pouch back layer 174 will allow the remainder of the removal tool 228 as well as the biological indicator 126 to slide out of the pouch 120.

[0174] In the illustrated embodiment, the pouch 120 and the tab 130 are connected by the intermediate support member 1 10. Also, the intermediate support member 110 includes an intermediate support member front layer 192 and an intermediate support member back layer 194. As shown for example in Figs. 2D and 2H, the intermediate support member front layer 192 is sealed to the intermediate support member back layer 194 by the permanent seal 198. The permanent seal 198 is configured such that the intermediate support member front layer 192 cannot be removed from the intermediate support member back layer 194 without causing damage. The permanent seal 198 may be provided for example by an adhesive or by application of heat. With reference to Figs. 2B, 2D, and 2F, in a state where the pouch front layer 172 is semi permanently sealed to the pouch back layer 174 by the semipermanent seal 180, the biological indicator 126 and the removal tool 228 are circumscribed in part by the intermediate support member 110 and in part by the semipermanent seal 180.

[0175] As shown in Figs. 2D-2E, a Tyvek sheet front layer TF may form the pouch front layer 172, the intermediate support member front layer 192 and the tab front layer 152, and a Tyvek sheet back layer TB may form the pouch back layer 174, the intermediate support member back layer 194 and the tab back layer 154.

[0176] As will be described in greater detail below, the biological indicator package 200 may include a chemical indicator configured to indicate whether a decontamination cycle occurred in the vicinity of the biological indicator package 200. By way of example, the chemical indicator may be located on the tab 130 rather than the pouch 120 to avoid during application of the chemical indicator potential interference with the biological indicator 126, particularly the spore 142 thereof.

[0177] Figs. 3A-3I show a biological indicator package 300 in accordance with another embodiment of the invention. The Figs. 3A-3I biological indicator package 300 is in many respects similar to the above-described biological indicator packages 100, 200 and consequently the same reference numerals are used to denote structures corresponding to similar structures in the biological indicator packages 100, 200. In addition, the foregoing descriptions of the biological indicator packages 100, 200 are equally applicable to the Figs. 3A-3I biological indicator package 300 except as noted below. Moreover, it will be appreciated upon reading and understanding the specification that aspects of the biological indicator packages 100, 200, 300 may be substituted for one another or used in conjunction with one another where applicable.

[0178] Turning then to Figs. 3A-3I, the biological indicator package 300 includes the intermediate support member 110 having the first side 112 and the second side 114, the pouch 120 protruding from the first side 1 12 of the intermediate support member 1 10, the biological indicator 126 contained in the pouch 120, and a tab 330 protruding from the second side 1 14 of the intermediate support member 1 10. The pouch 120 is vapor permeable, for example, vapor permeable to hydrogen peroxide vapor during a decontamination cycle of a bio decontamination unit. The biological indicator 126 includes the organism carrier 140 also known in the art as a coupon, coupon carrier, indicator coupon, among others. The organism carrier 140 may be made of stainless steel. The spore 142 is loaded onto the organism carrier 140. By way of example, the organism carrier 140 may be inoculated with an E6 (6-log) population of Geobacillus stearothermophilus spores 142.

[0179] The tab 330 has a front surface portion 352 and a back surface portion 354 opposite that of the front surface portion 352. The back surface portion 354 has a tab adhesive layer 360 configured to adhere to a surface during a decontamination cycle of a decontamination process. The tab adhesive layer 360 also is configured to releasably adhere to a release liner 356 or to a front surface portion 352 of a tab 330 of an adjacently stacked biological indicator package 300. In some embodiments, the biological indicator package 300 may further include the release liner 356 as part of the biological indicator package 300, the tab adhesive layer 360 being releasably adhered to the release liner 356. In some embodiments, the biological indicator package 300 may not include the release liner 356 as part of the biological indicator package 300, that is, the release liner 356 may be omitted.

[0180] As will be described in greater detail below, several advantages may be realized by the biological indicator package 300 in accordance with the invention. For example, multiple biological indicator packages 300 can be stacked as shown in Fig. 3A, where an upper biological indicator package 300A adheres to the top of a lower biological indicator package 300B, and the lower biological indicator package 300B adheres to the top of the release liner 356. In the Fig. 3A embodiment, a user merely need peel the upper biological indicator package 300A away from the lower biological indicator package 300B and adhere the upper biological indicator package 300A to a surface in the decontamination unit. The lower biological indicator package 300B can be used for another decontamination process, at which time the user merely need peel the lower biological indicator package 300B away from the release liner 356 and adhere the lower biological indicator package 300B to a surface in the decontamination unit. Fig. 3A shows two stacked biological indicator packages 300A, 300B. It will be appreciated that the biological indicator packages 300 can be stacked greater than two for example three, four, or more if desired, with the only limitation being a gradual compounded tilting effect owing to the height of the pouch 120 being thicker in the stack direction than the height of the tab 330 (see Fig. 3D), causing a slight tilt when stacked that gradually increases the greater the number of biological indicator packages 300 that are stacked.

[0181] Also, the tab adhesive layer 360 avoids the need to use a separate piece of tape to stick the biological indicator package 300 to a surface. Moreover, the tab 330 remains part of the biological indicator package 300 even after adhered to a surface. Thus, the ability to adhere the biological indicator package 300 to a surface is incorporated into the biological indicator package 300 itself. This reduces time for a user to obtain and / or handle a separate piece of tape and prevents a user from placing a piece of tape in such a manner to interfere with the spore 142 on the organism carrier 140. The foregoing and other advantages will become apparent in the description that follows. Referring then to Figs. 3A-3D and 3H-3I, the pouch 120 includes a pouch front layer 172 and a pouch back layer 174. At least one of the pouch front layer 172 and the pouch back layer 174 has a semipermanent seal 180 that semi permanently seals the pouch front layer 172 to the pouch back layer 174. The semipermanent seal 180 is configured to enable peeling apart of the pouch front layer away 172 from the pouch back layer 174 to expose the biological indicator 126. The semipermanent seal 180 may be provided for example by a semipermanent adhesive that is designed to hold surfaces together semipermanently, allowing for separation by peeling apart. As shown in Fig. 3G, in a state where the pouch front layer 172 is semi permanently sealed to the pouch back layer 174 by the semipermanent seal 180, the pouch front layer 172 overhangs the pouch back layer 174 to define a handle 188 for a user to peel the pouch front layer 172 away from the pouch back layer 174, the handle 188 not including the semipermanent seal 180.

[0182] In the illustrated embodiment, the pouch 120 and the tab 130 are connected by the intermediate support member 1 10. Also, the intermediate support member 110 includes an intermediate support member front layer 192 and an intermediate support member back layer 194. As shown for example in Fig. 3D, the intermediate support member front layer 192 is sealed to the intermediate support member back layer 194 by the permanent seal 198. The permanent seal 198 is configured such that the intermediate support member front layer 192 cannot be removed from the intermediate support member back layer 194 without causing damage. The permanent seal 198 may be provided for example by an adhesive or by application of heat. With reference to Figs. 3B, 3D, 3G, and 3I, in a state where the pouch front layer 172 is semi permanently sealed to the pouch back layer 174 by the semipermanent seal 180, the biological indicator 126 is circumscribed in part by the intermediate support member 110 and in part by the semipermanent seal 180.

[0183] As shown in Figs. 3D-3E a Tyvek sheet front layer TF may form the pouch front layer 172 and the intermediate support member front layer 192, and a Tyvek sheet back layer TB may form the pouch back layer 174 and the intermediate support member back layer 194.

[0184] With reference again to Figs. 3A-3B, a stack of biological indicator packages 300 may include the lower biological indicator package 300B and the upper biological indicator package 300A. The tab adhesive layer 360 of the back surface portion 354 of the tab 330 (see Figs. 3B and 3G) of the upper biological indicator package 300A may be configured to releasably adhere to the front surface portion 352 of the tab 330 (see Figs. 3B and 3H) of the lower biological indicator package 300B. In an embodiment, the front surface portion 352 of the tab 330 of the lower biological indicator package 300B is configured as a release liner surface, or at least to have a release liner characteristic, to facilitate peeling away the tab adhesive layer 360 of the back surface portion 354 of the tab 330 of the upper biological indicator package 300A from the front surface portion 352 of the tab 330 of the lower biological indicator package 300B. The stack of biological indicator packages 300 may further include the release liner 356, and the back surface portion 354 of the tab 330 (see Figs. 3B and 3G) of the lower biological indicator package 300B may be configured to releasably adhere to the release liner 356 (see Figs. 3B and 3F).

[0185] For each biological indicator package 300A, 300B of the stack of biological indicator packages 300 shown in Fig. 3A, as shown in Figs. 3D-3E a Tyvek sheet front layer TF may form the pouch front layer 172 and the intermediate support member front layer 192, and a Tyvek sheet back layer TB may form the pouch back layer 174 and the intermediate support member back layer 194. 3j. In the illustrated embodiment, the Tyvek sheet back layer TB also forms the tab 330.

[0186] As will be described in greater detail below, the biological indicator package 300 may include a chemical indicator configured to indicate whether a decontamination cycle occurred in the vicinity of the biological indicator package 300. By way of example, the chemical indicator may be located on the tab 330 rather than the pouch 120 to avoid during application of the chemical indicator potential interference with the biological indicator 126, particularly the spore 142 thereof. Figs. 4A-4G show a plurality of biological indicator packages 400 in accordance with another embodiment of the invention. The Figs. 4A-4G plurality of biological indicator packages 400 includes biological indicator packages 400A, 400B that in many respects are similar to the above-described biological indicator packages 100, 200, 300 and consequently the same reference numerals are used to denote structures corresponding to similar structures in the biological indicator packages 100, 200, 300. Structures denoted with reference numerals that are further indexed with the letters A or B indicate which of the plurality of biological indicator packages 400A, 400B the structures are a part of. In addition, the foregoing descriptions of the biological indicator packages 100, 200, 300 are equally applicable to the biological indicator packages 400A, 400B of the Figs. 4A-4G plurality of biological indicator packages 400 except as noted below. Moreover, it will be appreciated upon reading and understanding the specification that aspects of the biological indicator packages 100, 200, 300, 400 may be substituted for one another or used in conjunction with one another where applicable.

[0187] Turning then to Figs. 4A-4G, the plurality of biological indicator packages 400 includes a first biological indicator package 400A and a second biological indicator package 400B. The first biological indicator package 400A includes a first pouch 120A and a first biological indicator 126A contained in the first pouch 120A. The first pouch 120A is vapor permeable, for example vapor permeable to hydrogen peroxide vapor produced during a decontamination cycle of a bio decontamination unit. The first biological indicator 126A includes a first organism carrier 140A also known in the art as a coupon, coupon carrier, indicator coupon, among others. The first organism carrier 140A may be made of stainless steel. A first spore 142A is loaded onto the first organism carrier 140A. By way of example, the first organism carrier 140A may be inoculated with an E6 (6-log) population of Geobacillus stearothermophilus spores 142A. The first biological indicator package 400A has a first left side 402A and a first right side 404A opposite the first left side 402A. The second biological indicator package 400B includes a second pouch 120B and a second biological indicator 126B contained in the second pouch 120B. The second pouch 120B is vapor permeable, for example vapor permeable to hydrogen peroxide vapor produced during a decontamination cycle of a bio decontamination unit. In the same manner as the first biological indicator 126A, the second biological indicator 126B includes a second organism carrier also known in the art as a coupon, coupon carrier, indicator coupon, among others. The second organism carrier may be made of stainless steel. A second spore is loaded onto the second organism carrier. By way of example, the second organism carrier may be inoculated with an E6 (6-log) population of Geobacillus stearothermophilus spores. The second biological indicator package 400B has a second left side 402B and a second right side 404B opposite the second left side 402B. As shown in Fig. 4A, the second left side 402B of the second biological indicator package 400B is separably connected side by side to the first right side 404A of the first biological indicator package 400A by a perforated connection 406. The perforated connection 406 is configured to enable separation of the first biological indicator package 400A from the second biological indicator package 400B by tearing the perforated connection 406.

[0188] As will be described in greater detail below, several advantages may be realized by the plurality of biological indicator packages 400A, 400B in accordance with the invention. For example, the perforated connection 406 that connects the plurality of biological indicator packages 400A, 400B enables the plurality of biological indicator packages 400A, 400B to be packed and shipped as a set. The connected plurality of biological indicator packages 400A, 400B provide a larger footprint than a single biological indicator package, allowing greater surface area with which to grasp by a user, thereby simplifying handling of the biological indicator packages 400A, 400B. In the illustrated embodiment, first and second biological indicator packages 400A, 400B are connected by the perforated connection 406. It will be appreciated that a larger number of biological indicator packages 400 may be connected side by side greater than two, for example three, four, or more if desired. For example, in an embodiment where there are three side by side connected plurality of biological indicator packages 400, that is first, second and third biological indicator packages, the left side of the second biological indicator package is separably connected by a perforated connection to the right side of the first biological indicator package, and the right side of the second biological indicator package is separably connected by a perforated connection to the left side of the third biological indicator package. The foregoing and other advantages will become apparent in the description that follows.

[0189] As shown in Figs. 4B-4G, the first pouch 120A includes the first pouch front layer 172A and the first pouch back layer 174A. At least one of the first pouch front layer 172A and the first pouch back layer 174A has a first semipermanent seal 180A that semi permanently seals the first pouch front layer 172A to the first pouch back layer 174A. The first semipermanent seal 180A is configured to enable peeling apart of the first pouch front layer 172A away from the first pouch back layer 174A to expose the first biological indicator 126A. The first semipermanent seal 180A may be provided for example by a semipermanent adhesive that is designed to hold surfaces together semi-permanently, allowing for separation by peeling apart. In the same manner, the second pouch includes a second pouch front layer and a second pouch back layer. At least one of the second pouch front layer and the second pouch back layer has a second semipermanent seal that semi permanently seals the second pouch front layer to the second pouch back layer. The second semipermanent seal is configured to enable peeling apart of the second pouch front layer away from the second pouch back layer to expose the second biological indicator 126B. The second semipermanent seal may be provided for example by a semipermanent adhesive that is designed to hold surfaces together semipermanently, allowing for separation by peeling apart.

[0190] The first pouch front layer 172A and the first pouch back layer 174A are configured such that once the first pouch front layer 172A is peeled away from the first pouch back layer 174A so that an end of the first biological indicator 126A extends outward beyond the peeled apart portions of the first pouch front layer 172A and the first pouch back layer 174A, the first biological indicator 126A can easily slide out by tilting the first biological indicator package 400A with the first pouch 120A in the downward direction. In other words, so long as the first pouch front layer 172A and the first pouch back layer 174A are peeled away from each other such that in top plan view an end of the first biological indicator 126A protrudes beyond the peeled away portions, shown at line L-L in Fig. 4F, the remaining non-peeled away portions of the first pouch front layer 172A and the first pouch back layer 174A will allow the remainder of the first biological indicator 126A to slide out of the first pouch 120A. In the same manner, the second pouch front layer and the second pouch back layer are configured such that once the second pouch front layer is peeled away from the second pouch back layer so that an end of the second biological indicator 126B extends outward beyond the peeled apart portions of the second pouch front layer and the second pouch back layer, the second biological indicator 126B can easily slide out by tilting the second biological indicator package 400B with the second pouch 120B in the downward direction.

[0191] With continued reference to Figs. 4D-4E, the first pouch front layer 172A and the first pouch back layer 174A are formed by a first single layer folded upon itself such that a first fold 476 in the first single layer connects the first pouch front layer 172A and the first pouch back layer 174A. In the same manner, the second pouch front layer and the second pouch back layer are formed by a second single layer folded upon itself such that a second fold in the second single layer connects the second pouch front layer and the second pouch back layer.

[0192] As shown in Figs. 4A-4D, in a state where the first pouch front layer 172A is semi permanently sealed to the first pouch back layer 174A by the first semipermanent seal 180A, the first pouch front layer 172A overhangs the first pouch back layer 174A to define a first handle 188A for a user to peel the first pouch front layer 172A away from the first pouch back layer 174A, the first handle 188A not including the first semipermanent seal 180A. In the same manner, in a state where the second pouch front layer is semi permanently sealed to the second pouch back layer by the second semipermanent seal, the second pouch front layer overhangs the second pouch back layer to define a second handle for a user to peel the second pouch front layer away from the second pouch back layer, the second handle not including the second semipermanent seal.

[0193] With reference to Figs. 4C, 4D, and 4F, in a state where the first pouch front layer 172A is semi permanently sealed to the first pouch back layer 174A by the first semipermanent seal 180A, the first biological indicator 126A is circumscribed in part by the first semipermanent seal 180A and in part by the first fold 476. In the same manner, in a state where the second pouch front layer is semi permanently sealed to the second pouch back layer by the second semipermanent seal, the second biological indicator 126B is circumscribed in part by the second semipermanent seal and in part by the second fold.

[0194] As shown in Figs. 4D-4E, a first Tyvek sheet front layer TFA may form the first pouch front layer 172A and a first Tyvek sheet back layer TBA may form the first pouch back layer 174A. In the same manner, a second Tyvek sheet front layer forms the second pouch front layer and a second Tyvek sheet back layer forms the second pouch back layer.

[0195] With continued reference to Figs. 4D-4E, one or more of a distal end 496 of the first pouch front layer 172A of the first biological indicator package 400A and a distal end 498 of the first pouch back layer 174A of the first biological indicator package 400A may be configured to connect to a surface during a decontamination cycle of a decontamination process. In the illustrated embodiment, the distal end 496 of the first pouch front layer 172A and the distal end 498 of the first pouch back layer 498 include respective orifices that are concentrically aligned and configured to enable hanging of the biological indicator package 400A on a projection. In the same manner, one or more of a distal end of the second pouch front layer of the second biological indicator package 400B and a distal end of the second pouch back layer of the second biological indicator package 400B may be configured to connect to a surface during a decontamination cycle of a decontamination process. The distal end of the second pouch front layer and the distal end of the second pouch back layer include respective orifices that are concentrically aligned and configured to enable hanging of the biological indicator package 400B on a projection. As will be described in greater detail below, the first biological indicator package 400A may include a first chemical indicator on a first surface of the first biological indicator package 400A, the first chemical indicator being configured to indicate whether a decontamination cycle occurred in the vicinity of the first biological indicator package 400A. In the same manner, the second biological indicator package 400B may include a second chemical indicator on a second surface of the second biological indicator package 400B, the second chemical indicator being configured to indicate whether a decontamination cycle occurred in the vicinity of the second biological indicator package 400B.

[0196] Figs. 5A-5D show biological indicator packages 500 (500A, 500B, 500C, 500D) in accordance with another embodiment of the invention. The Figs. 5A-5D biological indicator packages 500 are in many respects similar to the abovedescribed biological indicator packages 100, 200, 300, 400 and consequently the same reference numerals are used to denote structures corresponding to similar structures in the biological indicator packages 100, 200, 300, 400. In addition, the foregoing descriptions of the biological indicator packages 100, 200, 300, 400 are equally applicable to the Figs. 5A-5D biological indicator packages 500 except as noted below. Moreover, it will be appreciated upon reading and understanding the specification that aspects of the biological indicator packages 100, 200, 300, 400, 500 may be substituted for one another or used in conjunction with one another where applicable.

[0197] Referring initially to Figs. 5A-5D generally, each of the biological indicator packages 500 (500A, 500B, 5000, 500D) includes a pouch 120, a biological indicator 126 contained in the pouch 120, and a chemical indicator 532 on a surface of the biological indicator package 500. The pouch 120 is vapor permeable, for example, vapor permeable to hydrogen peroxide vapor produced during a decontamination cycle of a bio decontamination unit. The biological indicator 126 can take any suitable form, for example, as described with respect to the earlier described biological indicator packages. With reference to Fig. 1 B, the biological indicators 126 of the biological indicator packages 500 each include the organism carrier 140, also known in the art as a coupon, coupon carrier, indicator coupon, among others. The organism carrier 140 may be made of stainless steel. A spore 142 is loaded onto the organism carrier 140. By way of example, the organism carrier 140 may be inoculated with an E6 (6-log) population of Geobacillus stearothermophilus spores 142.

[0198] The chemical indicator 532 is configured to indicate whether a decontamination cycle occurred in the vicinity of the biological indicator package 500. In the illustrated embodiment, the chemical indicator 532 has a relatively large and relatively dark colored circle, an arrow, and a relatively small and relatively lighter colored circle. The chemical indicator 532 is configured to undergo a change in color, for example as by the relatively small and relatively lighter colored circle becoming relatively dark in color, after the chemical indicator 532 has been exposed to a sufficient quantity of sterilant in a bio decontamination unit for a sufficient period of time to indicate that the decontamination process has been completed and, accordingly, a decontamination cycle has occurred in the vicinity of the biological indicator package 500.

[0199] As will be described in greater detail below, several advantages may be realized by the biological indicator package 500 (500A, 500B, 500C, 500D) in accordance with the invention. For example, as the biological indicator package 500 is equipped with the chemical indicator 532 to verify that a decontamination process has been completed, thereby eliminating the need for a user to obtain and / or handle a separate chemical indicator. The biological indicator package 500 is a self- contained package that includes both the biological indicator 126 and the chemical indicator 532. Thus, the end user can easily determine via the chemical indicator 532 if there is a vaporized hydrogen peroxide (VHP) (H2O2) present in the space where the biological indicator 126 is used. The foregoing and other advantages will become apparent in the description that follows.

[0200] Fig. 5A is a top plan view of the biological indicator package 500A, which is made up of the biological indicator package 400A (or 400B) shown in Figs. 4A-4G and a chemical indicator 532 in a top surface thereof. In top plan view, the biological indicator package 500A has a first external surface area 534 and a second external surface area 536 that is adjacent to the first external surface area 534. The surface of the biological indicator package 500A on which the chemical indicator 532 is located is the second external surface area 536 of the biological indicator package 500A. Also, the biological indicator 126A contained in the pouch 120A is located in the first external surface area 534 of the biological indicator package 500A. In top plan view, the biological indicator package 500A includes an orifice 548 spaced from the pouch 1 0A and the chemical indicator 532, the orifice 548 being configured to enable hanging of the biological indicator package 500A on a projection.

[0201] The pouch 120A of the biological indicator package 500, in the same manner as the pouch 120A of the Figs. 4A-4G biological indicator package 400A, includes a pouch front layer and a pouch back layer. At least one of the pouch front layer and the pouch back layer has a semipermanent seal that semi permanently seals the pouch front layer to the pouch back layer. The semipermanent seal is configured to enable peeling apart of the pouch front layer away from the pouch back layer to expose the biological indicator 126A. The pouch front layer and pouch back layer are formed by a single layer folded upon itself such that a fold in the single layer connects the pouch front layer and the pouch back layer. In the same manner as the pouch 120A of the Figs. 4A-4G biological indicator package 400A, a Tyvek sheet front layer forms the pouch front layer and a Tyvek sheet back layer forms the pouch back layer. The chemical indicator 532 is formed on the Tyvek sheet front layer.

[0202] Fig. 5B is a top plan view of a biological indicator package 500B, which is made up of the biological indicator package 100 shown in Figs. 1A-1 1 and a chemical indicator 532 in a top surface thereof. Fig. 50 is a top plan view of a biological indicator package 500C, which is made up of the biological indicator package 200 shown in Figs. 2A-2H and a chemical indicator 532 in a top surface thereof. Fig. 5D is a top plan view of a biological indicator package 500D, which is made up of the biological indicator package 300 shown in Figs. 3A-3I and a chemical indicator 532 in a top surface thereof.

[0203] Each of the biological indicator packages 500B, 500C, 500D includes, in the same manner as the above described biological indicator packages 100, 200, 300, an intermediate support member 110 having a first side 112 and a second side 114. The pouch 120 protrudes from the first side 1 12 of the intermediate support member 112. A tab 130 protrudes from the second side 1 14 of the intermediate support member 1 10, the tab 130 being configured to connect to a surface during a decontamination cycle of a decontamination process. The first side 112 and the second side 1 14 are opposite sides of the intermediate support member 110. The pouch 120 protrudes from the first side 1 12 of the intermediate support member 110 to provide in top plan view a first external surface area 534 that is adjacent to the intermediate support member 110. The tab 130 protrudes from the second side 1 14 of the intermediate support member 110 to provide in top plan view a second external surface area 536 that is adjacent to the intermediate support member 1 10. The surface of the biological indicator package 500B, 500C, 500D on which the chemical indicator 532 is located is the second external surface area 536 of the tab 130. Also, the biological indicator 126 is contained in the pouch 120 in the first external surface area 534 of the pouch 120.

[0204] The tab 130 of each of the biological indicator packages 500B, 500C, 500D is configured to connect to a surface by an adhesive on the tab 130 in the same manner as the afore described biological indicator packages 100, 200, 300. In top plan view, each of the biological indicator packages 500B, 500C, 500D includes an orifice 548 spaced from the pouch 120 and the chemical indicator 532, the orifice 548 being configured to enable hanging of the biological indicator package 500 on a projection.

[0205] The pouch 120 of each of the biological indicator packages 500B, 500C, 500D, in the same manner as the afore described biological indicator packages 100, 200, 300, includes a pouch front layer and a pouch back layer. Also, the intermediate support member 110 includes an intermediate support member front layer and an intermediate support member back layer. The intermediate support member front layer and the intermediate support member back layer are connected together by a permanent seal. At least one of the pouch front layer and the pouch back layer has a semipermanent seal that semi permanently seals the pouch front layer to the pouch back layer. The semipermanent seal is configured to enable peeling apart of the pouch front layer away from the pouch back layer to expose the biological indicator 126. For the biological indicator packages 500B, 500C, in the same manner as the afore described biological indicator packages 100, 200, a Tyvek sheet front layer forms the pouch front layer, the intermediate support member front layer and a tab front layer, and a Tyvek sheet back layer forms the pouch back layer, the intermediate support member back layer and a tab back layer. Also, in the same manner as the afore described biological indicator package 300, a Tyvek sheet front layer forms the pouch front layer and the intermediate support member front layer, and a Tyvek sheet back layer forms the pouch back layer, the intermediate support member back layer and the tab 330.

[0206] For the biological indicator packages 500B, 500C, the chemical indicator 532 is formed on the tab front layer of the Tyvek sheet front layer. For the biological indicator package 500D, the chemical indicator 532 is formed on the tab of the Tyvek sheet back layer.

[0207] Figs. 6A-6H show biological indicator packages 600 (600A, 600B, 600C, 600D) in accordance with another embodiment of the invention. The Figs. 6A-6H biological indicator packages 600 are in many respects similar to the abovedescribed biological indicator packages 100, 200, 300, 400, 500 and consequently the same reference numerals are used to denote structures corresponding to similar structures in the biological indicator packages 100, 200, 300, 400, 500. In addition, the foregoing descriptions of the biological indicator packages 100, 200, 300, 400, 500 are equally applicable to the Figs. 6A-6H biological indicator packages 600 except as noted below. Moreover, it will be appreciated upon reading and understanding the specification that aspects of the biological indicator packages 100, 200, 300, 400, 500, 600 may be substituted for one another or used in conjunction with one another where applicable. Referring initially to Figs. 6A-6H generally, each of the biological indicator packages 600 (600A, 600B, 600C, 600D) includes a pouch 120, a biological indicator 126 contained in the pouch 120, a release liner 682 in a surface of the biological indicator package 600, and a peel and stick label 684 on the release liner 682. The pouch 120 is vapor permeable, for example, vapor permeable to hydrogen peroxide vapor produced during a decontamination cycle of a bio decontamination unit. The biological indicator 126 can take any suitable form, for example, as described with respect to the earlier described biological indicator packages. With reference to Fig. 1 B, the biological indicators 126 of the biological indicator packages 600 each include the organism carrier 140, also known in the art as a coupon, coupon carrier, indicator coupon, among others. The organism carrier 140 may be made of stainless steel. A spore 142 is loaded onto the organism carrier 140. By way of example, the organism carrier 140 may be inoculated with an E6 (6- log) population of Geobacillus stearothermophilus spores 142.

[0208] The peel and stick label 684 includes a label face 686 on a first side thereof and a label adhesive 690 on a second side thereof that is opposite the first side. The peel and stick label 684 is releasably adhered to the release liner 682 by the label adhesive 690. The peel and stick label 684 and the release liner 682 are configured to enable peeling apart of the peel and stick label 684 away from the release liner 682 to expose the label adhesive 690. The label adhesive 690, once exposed, is configured to adhere to a surface, for example, a media vial or documentation.

[0209] As will be described in greater detail below, several advantages may be realized by the biological indicator package 600 (600A, 600B, 600C, 600D) in accordance with the invention. For example, the peel and stick label 684 shows traceability from the biological indicator 126 to an associated product, for example, a media vial or documentation. The peel and stick label 684 eliminates the need for a user to write the label information down by hand and avoids the possibility of human documentation error in critical data collection. The foregoing and other advantages will become apparent in the description that follows. Fig. 6A is a top plan view, and Fig. 6B is a top isometric view, of the biological indicator package 600A, which is made up of the biological indicator package 400A (or 400B) shown in Figs. 4A-4G, a release liner 682 in a top surface thereof, and a peel and stick label 684 on the release liner 682. In top plan view, the biological indicator package 600A has a first external surface area 534 and a second external surface area 536 that is adjacent to the first external surface area 534. The surface of the biological indicator package 600A in which the release liner 682 on which the peel and stick label 684 is located is the second external surface area 536 of the biological indicator package 600A. Also, the biological indicator 126A contained in the pouch 120A is located in the first external surface area 534 of the biological indicator package 600A. In top plan view, the biological indicator package 600A includes an orifice 548 spaced from the pouch 120A and the release liner 682 on which the peel and stick label 684 is located, the orifice 548 being configured to enable hanging of the biological indicator package 600A on a projection.

[0210] The pouch 120A of the biological indicator package 600, in the same manner as the pouch 120A of the Figs. 4A-4G biological indicator package 400A, includes a pouch front layer and a pouch back layer. At least one of the pouch front layer and the pouch back layer has a semipermanent seal that semi permanently seals the pouch front layer to the pouch back layer. The semipermanent seal is configured to enable peeling apart of the pouch front layer away from the pouch back layer to expose the biological indicator 126A. The pouch front layer and pouch back layer are formed by a single layer folded upon itself such that a fold in the single layer connects the pouch front layer and the pouch back layer. In the same manner as the pouch 120A of the Figs. 4A-4G biological indicator package 400A, a Tyvek sheet front layer forms the pouch front layer and a Tyvek sheet back layer forms the pouch back layer. The release liner 682 on which the peel and stick label is located is formed on the Tyvek sheet front layer.

[0211] Fig. 60 is a top plan view, and Fig. 6D is a top isometric view, of the biological indicator package 600B, which is made up of the biological indicator package 100 shown in Figs. 1 A-1 1, a release liner 682 in a top surface thereof, and a peel and stick label 684 on the release liner 682. Fig. 6E is a top plan view, and Fig. 6F is a top isometric view, of the biological indicator package 600C, which is made up of the biological indicator package 200 shown in Figs. 2A-2H, a release liner 682 in a top surface thereof, and a peel and stick label 684 on the release liner 682. Fig. 6G is a top plan view, and Fig. 6H is a top isometric view, of the biological indicator package 600D, which is made up of the biological indicator package 300 shown in Figs. 3A-3I, a release liner 682 in a top surface thereof, and a peel and stick label 684 on the release liner 682.

[0212] Each of the biological indicator packages 600B, 600C, 600D includes, in the same manner as the above described biological indicator packages 100, 200, 300, an intermediate support member 110 having a first side 112 and a second side 114. The pouch 120 protrudes from the first side 1 12 of the intermediate support member 112. A tab 130 protrudes from the second side 1 14 of the intermediate support member 1 10, the tab 130 being configured to connect to a surface during a decontamination cycle of a decontamination process. The first side 112 and the second side 1 14 are opposite sides of the intermediate support member 110. The pouch 120 protrudes from the first side 1 12 of the intermediate support member 110 to provide in top plan view a first external surface area 534 that is adjacent to the intermediate support member 110. The tab 130 protrudes from the second side 1 14 of the intermediate support member 110 to provide in top plan view a second external surface area 536 that is adjacent to the intermediate support member 1 10. The surface of the biological indicator package 600B, 600C, 600D in which the release liner 682 on which the peel and stick label 684 is located is the second external surface area 536 of the tab 130. Also, the biological indicator 126 is contained in the pouch 120 in the first external surface area 534 of the pouch 120.

[0213] The tab 130 of each of the biological indicator packages 600B, 600C, 600D is configured to connect to a surface by an adhesive on the tab 130 in the same manner as the afore described biological indicator packages 100, 200, 300. In top plan view, each of the biological indicator packages 600B, 600C, 600D includes an orifice 548 spaced from the pouch 120 and the release liner 682 on which the peel and stick label 684 is located, the orifice 548 being configured to enable hanging of the biological indicator package 600 on a projection.

[0214] The pouch 120 of each of the biological indicator packages 600B, 600C, 600D, in the same manner as the afore described biological indicator packages 100, 200, 300, includes a pouch front layer and a pouch back layer. Also, the intermediate support member 110 includes an intermediate support member front layer and an intermediate support member back layer. The intermediate support member front layer and the intermediate support member back layer are connected together by a permanent seal. At least one of the pouch front layer and the pouch back layer has a semipermanent seal that semi permanently seals the pouch front layer to the pouch back layer. The semipermanent seal is configured to enable peeling apart of the pouch front layer away from the pouch back layer to expose the biological indicator 126. For the biological indicator packages 600B, 600C, in the same manner as the afore described biological indicator packages 100, 200, a Tyvek sheet front layer forms the pouch front layer, the intermediate support member front layer and a tab front layer, and a Tyvek sheet back layer forms the pouch back layer, the intermediate support member back layer and a tab back layer. Also, in the same manner as the afore described biological indicator package 300, a Tyvek sheet front layer forms the pouch front layer and the intermediate support member front layer, and a Tyvek sheet back layer forms the pouch back layer, the intermediate support member back layer and the tab 330.

[0215] For the biological indicator packages 600B, 600C, the release liner 682 on which the peel and stick label 684 is located is formed on the tab front layer of the Tyvek sheet front layer. For the biological indicator package 600D, the release liner 682 on which the peel and stick label 684 is located is formed on the tab of the Tyvek sheet back layer.

[0216] As with the Figs. 5A-5D biological indicator packages 500, the biological indicator package 600 may further include a chemical indicator 532 on a surface of the biological indicator package 600. The chemical indicator 532 may be configured to indicate whether a decontamination cycle occurred in the vicinity of the biological indicator package 600. The surface of the biological indicator package 600 on which the chemical indicator 532 is located is the second external surface area 536 of the biological indicator package 600.

[0217] As shown in Figs. 6A-6H, in top plan view, the chemical indicator 532 is separate from the release liner 682 on which the peel and stick label 684 is located.

[0218] Although the invention has been shown and described with respect to a certain embodiment or embodiments, it is obvious that equivalent alterations and modifications will occur to others skilled in the art upon the reading and understanding of this specification and the annexed drawings. In particular regard to the various functions performed by the above described elements (components, assemblies, devices, compositions, etc.), the terms (including a reference to a “means”) used to describe such elements are intended to correspond, unless otherwise indicated, to any element which performs the specified function of the described element (i.e., that is functionally equivalent), even though not structurally equivalent to the disclosed structure which performs the function in the herein illustrated exemplary embodiment or embodiments of the invention. In addition, while a particular feature of the invention may have been described above with respect to only one or more of several illustrated embodiments, such feature may be combined with one or more other features of the other embodiments, as may be desired and advantageous for any given or particular application.

Claims

Claims1. A biological indicator package, comprising: an intermediate support member having a first side and a second side; a pouch protruding from the first side of the intermediate support member, the pouch being vapor permeable; a biological indicator contained in the pouch, the biological indicator including an organism carrier and a spore loaded onto the organism carrier; a tab protruding from the second side of the intermediate support member, the tab including a tab front layer and a tab back layer, wherein at least one of the tab front layer and the tab back layer has a tab adhesive layer configured to adhere the tab front layer to the tab back layer, wherein the tab adhesive layer is further configured to enable peeling apart of the tab front layer away from the tab back layer to expose the tab adhesive layer, wherein the tab adhesive layer, once exposed, is configured to adhere to a surface during a decontamination cycle of a decontamination process.

2. The biological indicator package of claim 1 , wherein the first side and the second side are opposite sides of the intermediate support member.

3. The biological indicator package of any of claims 1 -2, wherein, in a state where the tab front layer is adhered to the tab back layer by the tab adhesive layer, the tab front layer overhangs the tab back layer to define a handle for a user to peel the tab front layer away from the tab back layer, the handle not including the tab adhesive layer.

4. The biological indicator package of any of claims 1 -3, wherein the tab front layer and the tab back layer have respectively a tab front adhesive layer and a tab back adhesive layer, wherein the tab front adhesive layer and the tab back adhesive layer form the tab adhesive layer.

5. The biological indicator package of claim 4, wherein, in a state where the tab front layer is peeled away from the tab back layer, the tab front layer having the tab front adhesive layer, and the tab back layer having the tab back adhesive layer, together form an angularly adjustable clamshell adhesive support.

6. The biological indicator package of any of claims 4-5, wherein in a state where the surface is flat and the tab front adhesive layer and the tab back adhesive layer are adhered to the surface, the pouch and the tab front layer and the tab back layer form substantially an inverted T-shape configuration, the pouch forming the base of the T-shape configuration, and the tab front layer and the tab back layer forming the transverse portion of the T-shape configuration.

7. The biological indicator package of any of claims 1 -3, wherein the tab front layer has the tab adhesive layer and the tab back layer does not have the tab adhesive layer, wherein in a state where the tab front layer is peeled away from the tab back layer, the tab front layer having the tab adhesive layer forms an adhesive support, and the tab back layer not having the tab adhesive layer forms a nonadhesive support.

8. The biological indicator package of claim 7, wherein in a state where the surface is flat and the tab adhesive layer of the tab front layer is adhered to the surface, the pouch and the tab front layer and the tab back layer form substantially an inverted T-shape configuration, the pouch forming the base of the T-shape configuration, and the tab front layer and the tab back layer forming the transverse portion of the T-shape configuration.

9. The biological indicator package of any of claims 1 -8, wherein the pouch includes a pouch front layer and a pouch back layer, wherein at least one of the pouch front layer and the pouch back layer has a semipermanent seal that semi permanently seals the pouch front layer to the pouch back layer, and wherein thesemipermanent seal is configured to enable peeling apart of the pouch front layer away from the pouch back layer to expose the biological indicator.

10. The biological indicator package of claim 9, wherein, in a state where the pouch front layer is semi permanently sealed to the pouch back layer by the semipermanent seal, the pouch front layer overhangs the pouch back layer to define a handle for a user to peel the pouch front layer away from the pouch back layer, the handle not including the semipermanent seal.11 . The biological indicator package of any of claims 9-10, wherein the pouch and the tab are connected by the intermediate support member.

12. The biological indicator package of any of claims 9-1 1 , wherein the intermediate support member includes an intermediate support member front layer and an intermediate support member back layer, and the intermediate support member front layer is sealed to the intermediate support member back layer by a permanent seal.

13. The biological indicator package of any of claims 9-12, wherein, in a state where the pouch front layer is semi permanently sealed to the pouch back layer by the semipermanent seal, the biological indicator is circumscribed in part by the permanent seal and in part by the semipermanent seal.

14. The biological indicator package of any of claims 1 -13, wherein the pouch includes a pouch front layer and a pouch back layer, wherein the intermediate support member includes an intermediate support member front layer and an intermediate support member back layer, wherein a Tyvek sheet front layer forms the pouch front layer, the intermediate support member front layer and the tab front layer, wherein a Tyvek sheet back layer forms the pouch back layer, the intermediate support member back layer and the tab back layer, wherein theintermediate support member front layer and the intermediate support member back layer are connected together by a permanent seal.

15. The biological indicator package of any of claims 1 -14, further comprising one or more chemical indicators configured to indicate whether a decontamination cycle occurred in the vicinity of the biological indicator package.

16. The biological indicator package of claim 15, wherein the one or more chemical indicators is located on the tab.

17. A biological indicator package, comprising: an intermediate support member having a first side and a second side; a pouch protruding from the first side of the intermediate support member, the pouch being vapor permeable; a biological indicator and a removal tool contained in the pouch, the biological indicator including an organism carrier and a spore loaded onto the organism carrier, the removal tool being removably attached to the biological indicator; a tab protruding from the second side of the intermediate support member, the tab including a tab adhesive layer configured to adhere to a surface during a decontamination cycle of a decontamination process.

18. The biological indicator package of claim 17, wherein the first side and the second side are opposite sides of the intermediate support member.

19. The biological indicator package of any of claims 17-18, wherein the tab includes a tab front layer and a tab back layer, wherein at least one of the tab front layer and the tab back layer has the tab adhesive layer, wherein the tab adhesive layer is configured to adhere the tab front layer to the tab back layer, wherein the tab adhesive layer is further configured to enable peeling apart of the tab front layeraway from the tab back layer to expose the tab adhesive layer, wherein the tab adhesive layer, once exposed, is configured to adhere to a surface during a decontamination cycle of a decontamination process.

20. The biological indicator package of claim 19, wherein, in a state where the tab front layer is adhered to the tab back layer by the tab adhesive layer, the tab front layer overhangs the tab back layer to define a handle for a user to peel the tab front layer away from the tab back layer, the handle not including the tab adhesive layer.21 . The biological indicator package of any of claims 19-20, wherein the tab front layer and the tab back layer have respectively a tab front adhesive layer and a tab back adhesive layer, wherein the tab front adhesive layer and the tab back adhesive layer form the tab adhesive layer.

22. The biological indicator package of claim 21 , wherein, in a state where the tab front layer is peeled away from the tab back layer, the tab front layer having the tab front adhesive layer, and the tab back layer having the tab back adhesive layer, together form an angularly adjustable clamshell adhesive support.

23. The biological indicator package of any of claims 21 -22, wherein in a state where the surface is flat and the tab front adhesive layer and the tab back adhesive layer are adhered to the surface, the pouch and the tab front layer and the tab back layer form substantially an inverted T-shape configuration, the pouch forming the base of the T-shape configuration, and the tab front layer and the tab back layer forming the transverse portion of the T-shape configuration.

24. The biological indicator package of any of claims 19-20, wherein the tab front layer has the tab adhesive layer and the tab back layer does not have the tab adhesive layer, wherein in a state where the tab front layer is peeled away from thetab back layer, the tab front layer having the tab adhesive layer forms an adhesive support, and the tab back layer not having the tab adhesive layer forms a nonadhesive support.

25. The biological indicator package of claim 24, wherein in a state where the surface is flat and the tab adhesive layer of the tab front layer is adhered to the surface, the pouch and the tab front layer and the tab back layer form substantially an inverted T-shape configuration, the pouch forming the base of the T-shape configuration, and the tab front layer and the tab back layer forming the transverse portion of the T-shape configuration.

26. The biological indicator package of any of claims 19-25, wherein the pouch includes a pouch front layer and a pouch back layer, wherein at least one of the pouch front layer and the pouch back layer has a semipermanent seal that semi permanently seals the pouch front layer to the pouch back layer, and wherein the semipermanent seal is configured to enable peeling apart of the pouch front layer away from the pouch back layer to expose at least the removal tool.

27. The biological indicator package of claim 26, wherein, in a state where the pouch front layer is semi permanently sealed to the pouch back layer by the semipermanent seal, the pouch front layer overhangs the pouch back layer to define a handle for a user to peel the pouch front layer away from the pouch back layer, the handle not including the semipermanent seal.

28. The biological indicator package of claim 27, wherein the biological indicator and the removal tool are oriented in the pouch such that the removal tool is closer to the handle than the biological indicator.

29. The biological indicator package of any of claims 27-28, wherein the pouch and the tab are connected by the intermediate support member.

30. The biological indicator package of any of claims 27-29, wherein the intermediate support member includes an intermediate support member front layer and an intermediate support member back layer, and the intermediate support member front layer is sealed to the intermediate support member back layer by a permanent seal.31 . The biological indicator package of any of claims 27-30, wherein, in a state where the pouch front layer is semi permanently sealed to the pouch back layer by the semipermanent seal, the biological indicator and the removal tool are circumscribed in part by the intermediate support member and in part by the semipermanent seal.

32. The biological indicator package of any of claims 19-31 , wherein the pouch includes a pouch front layer and a pouch back layer, wherein the intermediate support member includes an intermediate support member front layer and an intermediate support member back layer, wherein a Tyvek sheet front layer forms the pouch front layer, the intermediate support member front layer and the tab front layer, wherein a Tyvek sheet back layer forms the pouch back layer, the intermediate support member back layer and the tab back layer, wherein the intermediate support member front layer and the intermediate support member back layer are connected together by a permanent seal.

33. The biological indicator package of any of claims 17-32, further comprising a chemical indicator configured to indicate whether a decontamination cycle occurred in the vicinity of the biological indicator package.

34. The biological indicator package of claim 33, wherein the chemical indicator is located on the tab.

35. A biological indicator package, comprising: an intermediate support member having a first side and a second side; a pouch protruding from the first side of the intermediate support member, the pouch being vapor permeable; a biological indicator contained in the pouch, the biological indicator including an organism carrier and a spore loaded onto the organism carrier; a tab protruding from the second side of the intermediate support member, the tab having a front surface portion and a back surface portion opposite that of the front surface portion, the back surface portion having a tab adhesive layer configured to adhere to a surface during a decontamination cycle of a decontamination process; wherein the tab adhesive layer is configured to releasably adhere to a release liner or to a front surface portion of a tab of an adjacently stacked biological indicator package.

36. The biological indicator package of claim 35, wherein the first side and the second side are opposite sides of the intermediate support member.

37. The biological indicator package of any of claims 35-36, further comprising a release liner, wherein the tab adhesive layer is configured to releasably adhere to the release liner.

38. The biological indicator package of any of claims 35-37, wherein the pouch includes a pouch front layer and a pouch back layer, wherein the intermediate support member includes an intermediate support member front layer and an intermediate support member back layer, wherein a Tyvek sheet front layer forms the pouch front layer and the intermediate support member front layer, wherein a Tyvek sheet back layer forms the pouch back layer and the intermediate support member back layer, wherein the intermediate support member front layer and the intermediate support member back layer are connected together by apermanent seal.

39. The biological indicator package of claim 38, wherein the Tyvek sheet back layer also forms the tab.

40. A stack of biological indicator packages, comprising: a lower biological indicator package according to any of claims 35-36; and, an upper biological indicator package according to any of claims 35-36, wherein the tab adhesive layer of the back surface portion of the tab of the upper biological indicator package is configured to releasably adhere to the front surface portion of the tab of the lower biological indicator package.41 . The stack of biological indicator packages of claim 40, wherein the front surface portion of the tab of the lower biological indicator package is configured as a release liner surface.

42. The stack of biological indicator packages of any of claims 40-41 , further comprising a release liner, wherein the back surface portion of the tab of the lower biological indicator package is configured to releasably adhere to the release liner.

43. The stack of biological indicator packages of any of claims 40-42, wherein the pouch includes a pouch front layer and a pouch back layer, wherein the intermediate support member includes an intermediate support member front layer and an intermediate support member back layer, wherein a Tyvek sheet front layer forms the pouch front layer and the intermediate support member front layer, wherein a Tyvek sheet back layer forms the pouch back layer and the intermediate support member back layer, wherein the intermediate support member front layer and the intermediate support member back layer are connected together by a permanent seal.

44. The biological indicator package of claim 43, wherein the Tyvek sheet back layer also forms the tab.

45. The biological indicator package of any of claims 35-44, further comprising a chemical indicator configured to indicate whether a decontamination cycle occurred in the vicinity of the biological indicator package.

46. The biological indicator package of claim 45, wherein the chemical indicator is located on the tab.

47. A plurality of biological indicator packages, comprising: a first biological indicator package including a first pouch and a first biological indicator contained in the first pouch, the first pouch being vapor permeable, the first biological indicator including a first organism carrier and a first spore loaded onto the first organism carrier, the first biological indicator package having a first left side and a first right side opposite the first left side; a second biological indicator package including a second pouch and a second biological indicator contained in the second pouch, the second pouch being vapor permeable, the second biological indicator including a second organism carrier and a second spore loaded onto the second organism carrier, the second biological indicator package having a second left side and a second right side opposite the second left side; wherein the second left side of the second biological indicator package is separably connected side by side to the first right side of the first biological indicator package by a perforated connection; wherein the perforated connection is configured to enable separation of the first biological indicator package from the second biological indicator package by tearing the perforated connection.

48. The biological indicator package of claim 47, wherein the first pouch includes a first pouch front layer and a first pouchback layer, wherein at least one of the first pouch front layer and the first pouch back layer has a first semipermanent seal that semi permanently seals the first pouch front layer to the first pouch back layer, and wherein the first semipermanent seal is configured to enable peeling apart of the first pouch front layer away from the first pouch back layer to expose the first biological indicator; and, wherein the second pouch includes a second pouch front layer and a second pouch back layer, wherein at least one of the second pouch front layer and the second pouch back layer has a second semipermanent seal that semi permanently seals the second pouch front layer to the second pouch back layer, and wherein the second semipermanent seal is configured to enable peeling apart of the second pouch front layer away from the second pouch back layer to expose the second biological indicator.

49. The biological indicator package of claim 48, wherein the first pouch front layer and first pouch back layer are formed by a first single layer folded upon itself such that a first fold in the first single layer connects the first pouch front layer and the first pouch back layer; and, wherein the second pouch front layer and second pouch back layer are formed by a second single layer folded upon itself such that a second fold in the second single layer connects the second pouch front layer and the second pouch back layer.

50. The biological indicator package of any of claims 48-49, wherein, in a state where the first pouch front layer is semi permanently sealed to the first pouch back layer by the first semipermanent seal, the first pouch front layer overhangs the first pouch back layer to define a first handle for a user to peel the first pouch front layer away from the first pouch back layer, the first handle not including the first semipermanent seal; and, wherein, in a state where the second pouch front layer is semi permanently sealed to the second pouch back layer by the second semipermanent seal, thesecond pouch front layer overhangs the second pouch back layer to define a second handle for a user to peel the second pouch front layer away from the second pouch back layer, the second handle not including the second semipermanent seal.51 . The biological indicator package of any of claims 48-50, wherein, in a state where the first pouch front layer is semi permanently sealed to the first pouch back layer by the first semipermanent seal, the first biological indicator is circumscribed in part by the first semipermanent seal and in part by the first fold; and, wherein, in a state where the second pouch front layer is semi permanently sealed to the second pouch back layer by the second semipermanent seal, the second biological indicator is circumscribed in part by the second semipermanent seal and in part by the second fold.

52. The biological indicator package of any of claims 48-51 , wherein a first Tyvek sheet front layer forms the first pouch front layer and a first Tyvek sheet back layer forms the first pouch back layer; and, wherein a second Tyvek sheet front layer forms the second pouch front layer and a second Tyvek sheet back layer forms the second pouch back layer.

53. The plurality of biological indicator packages of any of claims 47-52, wherein one or more of a distal end of the first pouch front layer of the first biological indicator package and a distal end of the first pouch back layer of the first biological indicator package is configured to connect to a surface during a decontamination cycle of a decontamination process; wherein one or more of a distal end of the second pouch front layer of the second biological indicator package and a distal end of the second pouch back layer of the second biological indicator package is configured to connect to a surface during a decontamination cycle of a decontamination process.

54. The plurality of biological indicator packages of claim 53, wherein the distal end of the first pouch front layer and the distal end of the first pouch back layer include respective orifices that are concentrically aligned and configured to enable hanging of the biological indicator package on a projection; wherein the distal end of the second pouch front layer and the distal end of the second pouch back layer include respective orifices that are concentrically aligned and configured to enable hanging of the biological indicator package on a projection.

55. The plurality of biological indicator packages of any of claims 47-54, wherein the first biological indicator package includes a first chemical indicator on a first surface of the first biological indicator package, the first chemical indicator being configured to indicate whether a decontamination cycle occurred in the vicinity of the first biological indicator package; wherein the second biological indicator package includes a second chemical indicator on a second surface of the second biological indicator package, the second chemical indicator being configured to indicate whether a decontamination cycle occurred in the vicinity of the second biological indicator package.

56. A biological indicator package, comprising: a pouch that is vapor permeable; a biological indicator contained in the pouch, the biological indicator including an organism carrier and a spore loaded onto the organism carrier; a chemical indicator on a surface of the biological indicator package, the chemical indicator being configured to indicate whether a decontamination cycle occurred in the vicinity of the biological indicator package.

57. The biological indicator package of claim 56, wherein in top plan view the biological indicator package has a first external surface area and a second external surface area that is adjacent to the first external surface area, wherein the surfaceof the biological indicator package on which the chemical indicator is located is the second external surface area of the biological indicator package, and the biological indicator is contained in the pouch in the first external surface area of the biological indicator package.

58. The biological indicator package of any of claims 56-57, wherein in top plan view the biological indicator package includes an orifice spaced from the pouch and the chemical indicator, the orifice being configured to enable hanging of the biological indicator package on a projection.

59. The biological indicator package of any of claims 56-58, wherein the pouch includes a pouch front layer and a pouch back layer, wherein at least one of the pouch front layer and the pouch back layer has a semipermanent seal that semi permanently seals the pouch front layer to the pouch back layer, and wherein the semipermanent seal is configured to enable peeling apart of the pouch front layer away from the pouch back layer to expose the biological indicator.

60. The biological indicator package of claim 59, wherein the pouch front layer and pouch back layer are formed by a single layer folded upon itself such that a fold in the single layer connects the pouch front layer and the pouch back layer.61 . The biological indicator package of any of claims 59-60, wherein a Tyvek sheet front layer forms the pouch front layer and a Tyvek sheet back layer forms the pouch back layer.

62. The biological indicator package of claim 61 , wherein the chemical indicator is formed on the Tyvek sheet front layer.

63. The biological indicator package of claim 56, further comprising an intermediate support member having a first side and a second side, the pouchprotruding from the first side of the intermediate support member, and a tab protruding from the second side of the intermediate support member, the tab being configured to connect to a surface during a decontamination cycle of a decontamination process.

64. The biological indicator package of claim 63, wherein the first side and the second side are opposite sides of the intermediate support member.

65. The biological indicator package of any of claims 63-64, wherein the pouch protrudes from the first side of the intermediate support member to provide in top plan view a first external surface area that is adjacent to the intermediate support member, and the tab protrudes from the second side of the intermediate support member to provide in top plan view a second external surface area that is adjacent to the intermediate support member, wherein the surface of the biological indicator package on which the chemical indicator is located is the second external surface area of the tab, and the biological indicator is contained in the pouch in the first external surface area of the pouch.

66. The biological indicator package of any of claims 63-65, wherein the tab is configured to connect to a surface by an adhesive on the tab.

67. The biological indicator package of any of claims 63-66, wherein in top plan view the biological indicator package includes an orifice spaced from the pouch and the chemical indicator, the orifice being configured to enable hanging of the biological indicator package on a projection.

68. The biological indicator package of any of claims 64-67, wherein the pouch includes a pouch front layer and a pouch back layer, wherein the intermediate support member includes an intermediate support member front layer and an intermediate support member back layer.

69. The biological indicator package of claim 68, wherein at least one of the pouch front layer and the pouch back layer has a semipermanent seal that semi permanently seals the pouch front layer to the pouch back layer, and wherein the semipermanent seal is configured to enable peeling apart of the pouch front layer away from the pouch back layer to expose the biological indicator.

70. The biological indicator package of any of claims 68-69, wherein the tab includes a tab front layer and a tab back layer, wherein a Tyvek sheet front layer forms the pouch front layer, the intermediate support member front layer and the tab front layer, wherein a Tyvek sheet back layer forms the pouch back layer, the intermediate support member back layer and the tab back layer, wherein the intermediate support member front layer and the intermediate support member back layer are connected together by a permanent seal.71 . The biological indicator package of claim 70, wherein the chemical indicator is formed on the tab front layer of the Tyvek sheet front layer.

72. The biological indicator package of any of claims 68-69, wherein a Tyvek sheet front layer forms the pouch front layer and the intermediate support member front layer, and a Tyvek sheet back layer forms the pouch back layer, the intermediate support member back layer and the tab.

73. The biological indicator package of claim 72, wherein the chemical indicator is formed on the tab of the Tyvek sheet back layer.

74. A biological indicator package, comprising: a pouch that is vapor permeable; a biological indicator contained in the pouch, the biological indicator including an organism carrier and a spore loaded onto the organism carrier; a release liner in a surface of the biological indicator package; and,a peel and stick label on the release liner, the peel and stick label including a label face on a first side thereof and a label adhesive on a second side thereof that is opposite the first side, the peel and stick label being releasably adhered to the release liner by the label adhesive; wherein the peel and stick label and the release liner are configured to enable peeling apart of the peel and stick label away from the release liner to expose the label adhesive, wherein the label adhesive, once exposed, is configured to adhere to a surface.

75. The biological indicator package of claim 74, wherein in top plan view the biological indicator package has a first external surface area and a second external surface area that is adjacent to the first external surface area, wherein the release liner on which the peel and stick label is located is in the second external surface area of the biological indicator package, and the biological indicator is contained in the pouch in the first external surface area of the biological indicator package.

76. The biological indicator package of any of claims 74-75, wherein in top plan view the biological indicator package includes an orifice spaced from the pouch and the release liner on which the peel and stick label is located, the orifice being configured to enable hanging of the biological indicator package on a projection.

77. The biological indicator package of any of claims 74-76, wherein the pouch includes a pouch front layer and a pouch back layer, wherein at least one of the pouch front layer and the pouch back layer has a semipermanent seal that semi permanently seals the pouch front layer to the pouch back layer, and wherein the semipermanent seal is configured to enable peeling apart of the pouch front layer away from the pouch back layer to expose the biological indicator.

78. The biological indicator package of claim 77, wherein the pouch front layer and pouch back layer are formed by a single layer folded upon itself such thata fold in the single layer connects the pouch front layer and the pouch back layer.

79. The biological indicator package of any of claims 77-78, wherein a Tyvek sheet front layer forms the pouch front layer and a Tyvek sheet back layer forms the pouch back layer.

80. The biological indicator package of claim 79, wherein the release label on which the peel and stick label is located is formed on the Tyvek sheet front layer.81 . The biological indicator package of claim 74, further comprising an intermediate support member having a first side and a second side, the pouch protruding from the first side of the intermediate support member, and a tab protruding from the second side of the intermediate support member, the tab being configured to connect to a surface during a decontamination cycle of a decontamination process.

82. The biological indicator package of claim 81 , wherein the first side and the second side are opposite sides of the intermediate support member.

83. The biological indicator package of any of claims 81 -82, wherein the pouch protrudes from the first side of the intermediate support member to provide in top plan view a first external surface area that is adjacent to the intermediate support member, and the tab protrudes from the second side of the intermediate support member to provide in top plan view a second external surface area that is adjacent to the intermediate support member, wherein the surface of the biological indicator package in which the release liner is located is the second external surface area of the tab, and the biological indicator is contained in the pouch in the first external surface area of the pouch.

84. The biological indicator package of any of claims 81 -83, wherein the tabis configured to connect to a surface by an adhesive on the tab.

85. The biological indicator package of any of claims 81 -84, wherein in top plan view the biological indicator package includes an orifice spaced from the pouch and the release liner on which the peel and stick label is located, the orifice being configured to enable hanging of the biological indicator package on a projection.

86. The biological indicator package of any of claims 82-85, wherein the pouch includes a pouch front layer and a pouch back layer, wherein the intermediate support member includes an intermediate support member front layer and an intermediate support member back layer.

87. The biological indicator package of claim 86, wherein at least one of the pouch front layer and the pouch back layer has a semipermanent seal that semi permanently seals the pouch front layer to the pouch back layer, and wherein the semipermanent seal is configured to enable peeling apart of the pouch front layer away from the pouch back layer to expose the biological indicator.

88. The biological indicator package of any of claims 86-87, wherein the tab includes a tab front layer and a tab back layer, wherein a Tyvek sheet front layer forms the pouch front layer, the intermediate support member front layer and the tab front layer, wherein a Tyvek sheet back layer forms the pouch back layer, the intermediate support member back layer and the tab back layer, wherein the intermediate support member front layer and the intermediate support member back layer are connected together by a permanent seal.

89. The biological indicator package of claim 88, wherein the release liner on which the peel and stick label is located is formed on the tab front layer of the Tyvek sheet front layer.

90. The biological indicator package of any of claims 86-87, wherein a Tyvek sheet front layer forms the pouch front layer and the intermediate support member front layer, and a Tyvek sheet back layer forms the pouch back layer, the intermediate support member back layer and the tab.91 . The biological indicator package of claim 90, wherein the release liner on which the peel and stick label is located is formed on the tab of the Tyvek sheet back layer.

92. The biological indicator package of any of claims 75 or 83, further comprising a chemical indicator on a surface of the biological indicator package, the chemical indicator being configured to indicate whether a decontamination cycle occurred in the vicinity of the biological indicator package, wherein the surface of the biological indicator package on which the chemical indicator is located is the second external surface area of the biological indicator package.

93. The biological indicator package of claim 92, wherein in top plan view the chemical indicator is separate from the release liner on which the peel and stick label is located.

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