Patent Publication Number: US-8992853-B2

Title: Devices, systems and methods for localized sterilization

Description:
RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Patent Application No. 61/538,124, filed Sep. 22, 2011, to U.S. Provisional Patent Application No. 61/564,898, filed Nov. 30, 2011, and to U.S. Provisional Patent Application No. 61/650,625, filed May 23, 2012, the disclosures of which are incorporated by reference herein in their entireties. 
    
    
     FIELD OF THE INVENTION 
     This invention relates to devices, systems and methods for sterilization of components at and near point-of-use connection points, particularly in bioprocessing and biomanufacturing applications. 
     BACKGROUND 
     Today&#39;s market demand for new drugs, combined with the difficult economic climate, is challenging bioprocessors to review their manufacturing systems and seek ways to make them more flexible, reliable and cost effective. Increasingly, biomanufacturers are turning to single-use aseptic processing systems to meet or beat aggressive product introduction timeframes while controlling cost. 
     In the pharmaceutical fluid drug processing and manufacturing industry, there is a need for aseptic sterile conditions in the direct fluid product transfer path to minimize bacteria contamination, which results in contamination of the product batches at various stages of production. With the costs to manufacture a single drug approaching $1 billion and time-to-market ranging from 8 to 12 years, bioprocess manufacturers need to minimize all bio-burden contamination risk points in their process. By introducing a localized non-encumbering sterilization process at each process connection with optional sterilant level verification, the contamination risk concerns of bioprocess manufacturers would be addressed. 
     It is known to use localized steam sterilization, and steam sterilization is approved by the FDA. However, the use of steam suffers from several drawbacks. First, steam production has recurring costs. Also, there are thermal safety issues regarding the handling of steam by floor personnel. Moreover, concerns arise over the collection, recycling, or reprocessing of steam condensate after sterilization. 
     Ozone sterilization of medical and pharmaceutical devices has also been approved by the FDA. It is currently used on large scale batch sterilization of components used in sterile processing. However, small localized connector or small device “point-of-use” (POU) ozone sterilization is not known to be in use. 
     SUMMARY 
     Some embodiments of the invention are directed to a portable gas transfer device for point-of-use sterilization at a sterilization site. The device includes: a housing; a pressurized gas canister held by the housing; a first passageway in fluid communication with the pressurized gas canister and configured to supply pressurized pre-sterilization gas from the pressurized gas canister to the site; a gas discharge canister held by the housing; and a second passageway in fluid communication with the gas discharge canister and configured to supply post-sterilization gas from the site to the gas discharge canister. 
     In some embodiments, the device includes a sensor disposed in the second passageway upstream of the gas discharge canister, the sensor configured to detect a characteristic of the post-sterilization gas. The device may include at least one controller configured to receive a detection signal from the sensor and determine whether the site has been adequately sterilized based on the received detection signal. The controller may be configured to determine whether the site has been sterilized to a Sterility Assurance Level (SAL) of 10 −6 . The device may include at least one indicator on the housing to provide visual feedback that the site has been adequately sterilized based on a determination that the site has been adequately sterilized. The device may include a memory for storing data related to the received detection signal and/or the determination of whether the site has been adequately sterilized. 
     The pressurized pre-sterilization gas may be ozone. The detected characteristic may be an ozone level in the post-sterilization gas and the controller may be configured to determine whether the site has been adequately sterilized based on the ozone level over a period of time. The gas discharge canister may be a gas discharge catalyst canister including a catalyst material held therein, with the catalyst material configured to convert waste ozone in the post-sterilization gas to oxygen. The catalyst material may comprise manganese dioxide/copper oxide, activated charcoal or a molecular sieve. The device may include a vent on the housing for the expulsion of oxygen from the gas discharge catalyst canister. 
     In some embodiments, the device includes a gas fill port valve on the housing, with the gas fill port valve configured to receive pressurized gas from a recharging station to refill the pressurized gas canister. In some embodiments, the device includes an electrical interface on the housing, with the electrical interface configured to connect with an electrical connection to: recharge a battery pack of the portable gas transfer device; and/or transfer data to a database, including sterilization validation data. 
     Other embodiments of the invention are directed to a gas dispersion device. The device includes a housing and a gas flow member held in the housing. The housing defines a fluid flow path along an axis. The fluid flow path has first and second opposite ends. Each of the first and second ends is configured to operatively connect with at least one flow component. The gas flow member has an upper portion and a lower portion. The gas flow member includes a supply gas passageway extending from a gas supply port at the upper portion to first and second gas dispersion openings at the bottom portion. The gas flow member further includes first and second return gas passageways, with each return gas passageway extending from a return gas opening at the bottom portion to a return discharge port at the upper portion. The gas flow member is positionable in a sterilization position with the gas flow member lower portion disposed in the fluid flow path. In the sterilization position, the gas dispersion openings are configured to disperse pressurized pre-sterilization gas received from the gas supply port to sterilize flow components operatively connected with the first and second ends of the fluid flow path. In the sterilization position, the return gas discharge ports are configured to discharge post-sterilization gas received from the return gas openings. The gas dispersion device may be single-use disposable. 
     In some embodiments, the fluid flow path comprises a chamber and a pair of conduits extending away from the chamber, with each conduit including a flange at a distal end thereof, with the flanges defining the first and second ends of the fluid flow path. In some embodiments, at least one flow component is operatively connected with each of the first and second ends of the fluid flow path. The at least one flow component is at least one of a connector, a fitting, a flow passageway, a sensor and a transmitter. In some embodiments, in the sterilization position, the dispersion openings are configured to disperse gas received from the gas supply port around and/or past the flow components to achieve a Sterile Assurance Level (SAL) of 10 −6  for the flow components. In some embodiments, in the sterilization position, the first and second gas dispersion openings are generally aligned with the axis. 
     The gas flow member may be movable between the sterilization position and a product flow position. In the product flow position, the lower portion of the gas flow member may be withdrawn out of the fluid flow path. In the product flow position, the fluid flow path may be configured to receive bioprocessing fluid flow therethrough. The lower portion of the gas flow member may include a seal configured to seal the fluid flow path. The device may include a locking mechanism to lock the device in product flow position. 
     In some embodiments, the device includes a shear key held in the housing and at least one shear cutter access port on the housing. The at least one shear cutter access port is configured to receive a shear cutter therethrough to cut the shear key. When the shear key is cut, the gas flow member moves from the sterilization position to the product flow position. 
     Other embodiments of the invention are directed to a system for sterilizing a process connection or joint. The system includes a gas dispersion device positioned in the process connection or joint and a portable gas transfer device. The gas dispersion device includes a housing defining a fluid flow path and a gas flow member held in the housing. The gas flow member has an upper portion and a lower portion disposed in the fluid flow path. The gas flow member includes a supply gas passageway extending from a gas supply port at the upper portion to at least one gas dispersion opening at the lower portion, and the gas flow member further includes at least one return gas passageway extending from a gas return opening at the lower portion to a gas discharge port at the upper portion. The portable gas transfer device includes: a supply gas canister containing pressurized gas; a gas discharge canister; and a gas transport member in fluid communication with the supply gas canister and the gas discharge canister, with the gas transport member held in a guided opening configured to receive the upper portion of the gas dispersion device. When the upper portion of the gas flow member is received in the guided opening, the portable gas transfer device is configured to: supply pre-sterilization pressurized gas from the supply gas canister to the at least one gas dispersion opening such that gas is dispersed in the fluid flow path to sterilize the process connection or joint; and receive post-sterilization gas in the gas discharge canister from the at least one gas return opening. 
     In some embodiments, when the upper portion of the gas flow member is received in the guided opening, the gas flow member and the gas transport member mate such that the supply gas passageway of the gas flow member is aligned with a supply passageway of the gas transport member and the at least one return gas passageway of the gas flow member is aligned with at least one discharge gas passageway of the gas transport member. 
     The portable gas transfer device may include: a gas sensor disposed in a passageway between the gas transport member and the gas discharge canister, with the sensor configured to detect a characteristic of the post-sterilization gas; and a controller configured to monitor the detected characteristic and validate that the process connection or joint has been sterilized based on detected characteristic. The portable gas transfer device may be configured to halt the supply of pre-sterilization gas to the gas dispersion device after validation that the process connection or joint has been sterilized. The portable gas transfer device may include an indicator to provide visual feedback after validation that the process connection or joint has been sterilized. 
     Other embodiments of the invention are directed to a sterilization gas supply and refilling system for portable gas transfer devices. The system includes a portable gas transfer device, a portable gas transfer device docking station and a gas supply manifold. The portable gas transfer device includes: a housing; a pressurized gas canister held by the housing, with the pressurized gas canister configured to supply pressurized pre-sterilization gas to a sterilization site; a gas discharge canister held by the housing, with the gas discharge canister configured to receive post-sterilization gas from the sterilization site; and a gas fill valve on the housing. The docking station includes a docking area configured to receive the portable gas transfer device, with the docking area including a gas supply connection for attachment with the portable gas transfer device fill valve. The gas supply manifold is configured to supply pressurized gas through the gas supply connection to the portable gas transfer device pressurized gas canister, thereby refilling the pressurized gas canister. The system may include a plurality of portable gas transfer devices and a plurality of docking areas, with each docking area configured to receive one of the gas transfer devices. 
     In some embodiments, the portable gas transfer device includes an electrical interface on the housing, and the docking area includes an electrical connection configured to: charge a battery pack of the portable gas transfer device; and receive data from memory of the portable gas transfer device, wherein the data includes sterilization validation data from at least one past sterilization event. 
     In some embodiments, the system includes a gas supply unit configured to supply pressurized gas to the gas supply manifold. The gas supply unit may include an ozone generation unit configured to generate ozone from an oxygen supply and/or a secondary gas supply. The system may include a gas catalytic converter in fluid communication with the gas supply manifold and the docking area, with the gas catalytic converter configured to: receive ozone gas that has been held in the portable gas transfer device and/or the gas supply manifold past a time limit; convert the received ozone gas to oxygen; and discharge the oxygen to atmosphere. 
     Other embodiments of the invention are directed to a method for sterilizing a bioprocessing connection or joint. The method includes: supplying pressurized ozone gas from a portable gas transfer device to the connection or joint; dispersing the pressurized ozone gas at the connection or joint; receiving at the portable gas transfer device post-sterilization gas supplied from the connection or joint; detecting the level of ozone in the received post-sterilization gas; and determining whether the connection or joint has been adequately sterilized based on the detected level of ozone. 
     In some embodiments, the method includes: positioning a gas dispersion device at the connection or joint; dispersing the pressurized ozone gas at the connection or joint using the gas dispersion device; and receiving at the portable gas transfer device post-sterilization gas supplied from the gas dispersion device. The gas dispersion device may include: a housing defining a fluid flow path; and a gas flow member held in the housing, the gas flow member having an upper portion and a lower portion, the gas flow member comprising a supply gas passageway extending from the top portion to first and second gas dispersion openings at the lower portion, the gas flow member further comprising first and second return gas passageways extending from the bottom portion to the top portion. The gas flow member may be movable between a sterilization position wherein the gas flow member lower portion is disposed in the fluid flow path and a product flow position wherein the lower portion is withdrawn from the fluid flow path. The method may include positioning the gas dispersion device at the connection or joint with the gas flow member in the sterilization position. The method may include: determining that the connection or joint has been adequately sterilized based on the detected level of ozone in the received post-sterilization gas; then moving the gas flow member to the product flow position; locking the gas flow member in the product flow position; and flowing bioprocessing fluid and/or material through the fluid flow path. 
     In some embodiments, the method includes: determining that the connection or joint has been adequately sterilized based on the detected level of ozone in the received post-sterilization gas; and halting the supply of pressurized ozone gas from a portable gas transfer device to the connection or joint. In some embodiments, the method includes determining whether a Sterility Assurance Level (SAL) of 10 −6  has been achieved. In some embodiments, the method includes converting the received post-sterilization gas to oxygen at the portable gas transfer device. 
     Other embodiments of the invention are directed to a system including a sealable local environment and an ozone source operably coupled to the sealable local environment. The sealable local environment is configured to receive two or more fluid path members and to sealingly contain the two or more fluid path members. The sealable local environment is further configured to be manipulated to interconnect the two or more fluid path members within the sealable local environment while the sealable local environment remains sealed. The two or more fluid path members sealingly contained within the sealable local environment may be exposed to ozone to sterilize the two or more fluid path members prior to interconnecting the two or more fluid path members. In some embodiments, the sealable local environment includes a membrane configured to receive the ozone source, and the ozone source includes a syringe configured to inject ozone past the membrane. The sealable local environment may include a rigid structure configured to contain the two or more fluid path members, and the rigid structure may include an assembly chamber including one or more manipulators enabling the two or more fluid path members to be interconnected from outside the assembly chamber. 
     Other embodiments of the invention are directed to a system for point-of-use sterilization, including: a pressurized gas source; and a gas dispersion device. The gas dispersion device includes a housing defining a chamber; first and second flow conduits in fluid communication with the chamber, with each conduit extending away from the chamber, and with each conduit including a distal end portion configured to operatively connect with at least one fluid flow component; and a gas flow member held at least partially in the housing, with the gas flow member having a gas inlet port configured to operatively connect with the pressurized gas source and first and second dispersion openings in fluid communication with the gas inlet port. When the pressurized gas source is operatively connected with the gas inlet port, the dispersion openings are configured to disperse gas received from the pressurized gas source throughout the chamber and through the conduits to sterilize fluid flow components connected thereto. 
     In some embodiments, the pressurized gas source is a portable gas transfer device. In some embodiments, the pressurized gas source is or includes a syringe. 
     In some embodiments, the gas flow member includes a butterfly valve element. The butterfly valve element includes main faces and is adapted for rotational movement in the chamber between a closed position and an open position. The butterfly valve includes an inlet for introduction of gas, with the inlet communicating with a central gas dispersion opening extending transversely through a medial portion of the valve element for outward dispersion of gas at both main faces of the valve element. The butterfly valve element includes gas return ports at opposite marginal portions on opposite main faces of the butterfly valve element communicating with gas discharge ports at an end portion of the valve element. 
     In some embodiments, the gas flow member is movable between a sterilization position wherein the gas dispersion openings are disposed in the chamber and a product flow position, wherein the gas flow member is retracted from the chamber and/or rotated within the chamber to reach the product flow position. 
     It is noted that any one or more aspects or features described with respect to one embodiment may be incorporated in a different embodiment although not specifically described relative thereto. That is, all embodiments and/or features of any embodiment can be combined in any way and/or combination. Applicant reserves the right to change any originally filed claim or file any new claim accordingly, including the right to be able to amend any originally filed claim to depend from and/or incorporate any feature of any other claim although not originally claimed in that manner. These and other objects and/or aspects of the present invention are explained in detail in the specification set forth below. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         FIG. 1  is a top perspective view of a gas dispersion device according to some embodiments. 
         FIG. 2  is a partially transparent top perspective view of the device of  FIG. 1 . 
         FIG. 3  is a partially transparent bottom perspective view of the device of  FIG. 1 . 
         FIG. 4  a partially transparent end view of the device of  FIG. 1 . 
         FIG. 5  is a cross-sectional side view of the device of  FIG. 1 . 
         FIG. 6  is a cross-sectional end view of the device of  FIG. 1 . 
         FIG. 7  is a cross-sectional side view of the device of  FIG. 1  in a post-sterilization or product flow position. 
         FIG. 8  is a cross-sectional end view of the device of  FIG. 1  in a post-sterilization or product flow position. 
         FIG. 9  is a schematic view illustrating various exemplary sensor/transmitter mounting configurations to point-of-use connection points and employing the device of  FIG. 1 . 
         FIG. 10  is an enlarged schematic view illustrating one of the exemplary sensor/transmitter mounting configurations of  FIG. 9 . 
         FIG. 11  is an enlarged schematic view illustrating one of the exemplary sensor/transmitter mounting configurations of  FIG. 9 . 
         FIG. 12  is a top perspective view of a portable gas transfer device according to some embodiments. 
         FIG. 13  is an enlarged bottom perspective view of the portable gas transfer device of  FIG. 12 . 
         FIG. 14  is an enlarged bottom perspective view of the portable gas transfer device of  FIG. 12 . 
         FIG. 15  is an enlarged bottom perspective view of the portable gas transfer device of  FIG. 12 . 
         FIG. 16  is a cross-sectional front view of a portion of the portable gas transfer device of  FIG. 12 . 
         FIG. 17  is top perspective view of a fixed housing member of the portable gas transfer device of  FIG. 12 . 
         FIG. 18  is a side perspective view of the member of  FIG. 17 . 
         FIG. 19  is bottom perspective view of a movable gas transfer member of the portable gas transfer device of  FIG. 12 . 
         FIG. 20  is a transparent perspective view of the member of  FIG. 19 . 
         FIG. 21  is a top perspective view of the member of  FIG. 19 . 
         FIG. 22  is an enlarged partially transparent view illustrating interior components of the portable gas transfer device of  FIG. 12 . 
         FIG. 23  is an enlarged partially transparent view illustrating portions of gas flow passageways of the portable gas transfer device of  FIG. 12 . 
         FIG. 24  is an enlarged partially transparent view illustrating portions of gas flow passageways of the portable gas transfer device of  FIG. 12 . 
         FIG. 25  is an enlarged partially transparent view illustrating portions of gas flow passageways of the portable gas transfer device of  FIG. 12 . 
         FIG. 26  is a partial perspective view of the portable gas transfer device of  FIG. 12 . 
         FIG. 27  is an enlarged partially transparent view illustrating interior components of the portable gas transfer device of  FIG. 12 . 
         FIG. 28  is a partial perspective view of the portable gas transfer device of  FIG. 12  positioned over the gas dispersion device of  FIG. 1 . 
         FIG. 29  is an end view of the portable gas transfer device of  FIG. 12  coupled to the gas dispersion device of  FIG. 1 . 
         FIG. 30  is a partial top perspective view of the portable gas transfer device of  FIG. 12 . 
         FIG. 31  is schematic illustrating a sterilization gas supply/refilling system for use with the portable gas transfer device of  FIG. 12 . 
         FIG. 32  is a front view of a sterilization apparatus according to some embodiments. 
         FIG. 33  is a perspective view of a sealable local environment of the apparatus of  FIG. 32 . 
         FIG. 34  is a cross-sectional front view of the sealable local environment of  FIG. 33 . 
         FIG. 35  is an enlarged perspective view of the sealable local environment of  FIG. 33  showing a membrane configured to receive a pressurized gas source. 
         FIG. 36  is an enlarged perspective view of the sealable local environment of  FIG. 35  showing the pressurized gas source inserted into or past the membrane. 
         FIG. 37  is an enlarged perspective view of an injection member of the pressurized gas source of  FIG. 35 . 
         FIG. 38  is a top perspective view of a sterilization apparatus according to other embodiments. 
         FIG. 39  is a flow diagram of a method of sterilizing an open portion of a fluid path according to some embodiments. 
         FIG. 40  is a flow diagram of a method of sterilizing two or more fluid path connectors according to some embodiments. 
         FIG. 41  is a schematic perspective view of a gas dispersion device according to other embodiments. 
         FIG. 42  is a front elevation view of a valve element of the gas dispersion device of  FIG. 41 . 
         FIG. 43  is a top perspective view the gas dispersion device of  FIG. 41 . 
         FIG. 44  is a transparent side view of a gas dispersion device according to other embodiments. 
         FIG. 45  is a transparent end view of the gas dispersion device of  FIG. 44 . 
         FIG. 46  is an enlarged perspective view of the gas dispersion device of  FIG. 44 . 
     
    
    
     DETAILED DESCRIPTION 
     The present invention now will be described more fully with reference to the accompanying drawings, in which embodiments of the invention are shown. However, this invention should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. In the drawings, like numbers refer to like elements throughout. Thicknesses and dimensions of some components may be exaggerated for clarity. 
     As used herein, the term “comprising” or “comprises” is open-ended, and includes one or more stated features, integers, elements, steps, components or functions but does not preclude the presence or addition of one or more other features, integers, elements, steps, components, functions or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. 
     As used herein, the common abbreviation “e.g.,” which derives from the Latin phrase “exempli gratia,” may be used to introduce or specify a general example or examples of a previously mentioned item, and is not intended to be limiting of such item. If used herein, the common abbreviation “i.e.,” which derives from the Latin phrase “id est,” may be used to specify a particular item from a more general recitation. 
     The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a,” “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. 
     Well-known functions or constructions may not be described in detail for brevity and/or clarity. 
     Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein. 
     In addition, spatially relative terms, such as “under,” “below,” “lower,” “over,” “upper,” “downward,” “upward,” “inward, “outward” and the like, may be used herein for ease of description to describe one element or feature&#39;s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. 
     It will be understood that when an element is referred to as being “attached,” “coupled” or “connected” to another element, it can be directly attached, coupled or connected to the other element or intervening elements may also be present. In contrast, when an element is referred to as being “directly attached,” directly coupled” or “directly connected” to another element, there are no intervening elements present. 
     It is noted that any one or more aspects or features described with respect to one embodiment may be incorporated in a different embodiment although not specifically described relative thereto. That is, all embodiments and/or features of any embodiment can be combined in any way and/or combination. Applicant reserves the right to change any originally filed claim or file any new claim accordingly, including the right to be able to amend any originally filed claim to depend from and/or incorporate any feature of any other claim although not originally claimed in that manner. These and other objects and/or aspects of the present invention are explained in detail in the specification set forth below. 
     As used herein, the terms “flow component” and “fluid flow component” mean a component that is attachable or operatively attachable to a gas dispersion device and/or to another fluid flow component that is in fluid communication with the gas dispersion device. Alternatively, the fluid flow component may be integrated with the gas dispersion device. The flow component has one or more interior surfaces that are to be exposed to product fluid, such as bioprocessing fluid. The interior surface(s) may include hidden and/or occluded areas. The gas dispersion device is configured to disperse gas around, into and/or through the fluid flow component such that the interior surfaces including the hidden/occluded areas are sterilized to a predetermined level (e.g., a Sterility Assurance Level of 10 −6 ). Exemplary fluid flow components include, but are not limited to: connectors, fittings, fluid flow members such as tubes, sensors, transmitters and valves. The sterilization gas dispersed from the gas dispersion device may flow past or through the flow component (e.g., in the case of certain fittings and fluid flow members) or may flow adjacent or around the flow component (e.g., in the case of certain sensors and transmitters). 
     The gas dispersion devices of the present invention effectively sterilize the fluid flow members, which may be located at or near process connections or joints. The gas dispersion devices may be disposed at these connections or joints to effectively sterilize the connection/joint and/or any nearby or attached fluid flow component. It will be understood that any of the fluid flow components described above (e.g., connectors, fittings, sensors, transmitters, etc.) may be disposed at or near (or integrated with) a “process connection or joint” as the term is used herein. 
     A gas dispersion interconnect device  10  according to some embodiments is illustrated in  FIGS. 1-8 . The gas dispersion device  10  includes a housing  12 . At least a portion of the housing  12  defines an internal cavity or chamber  14 . The housing  12  includes an upper portion  16  and a lower portion  18 . As illustrated, the chamber  14  is defined in the lower portion  18  of the housing  12  ( FIG. 5 ). 
     First and second flow conduits  20  are in fluid communication with and extend outwardly away from the chamber  14 . As illustrated in  FIG. 5 , the first and second conduits  20  are diametrically opposed and extend away from the chamber along an axis A 1 . The chamber  14  and the conduits  20  may be collectively referred to as a fluid flow path  15  ( FIGS. 7 and 8 ). A distal end portion of each conduit  20  includes a flange  22  configured to connect or operatively connect to a fluid flow component (for example, via a sanitary clamp). As will be described in detail below, the gas dispersion device  10  is configured to disperse pressurized gas to sterilize the fluid flow components connected thereto. 
     The gas dispersion device  10  includes an elongated gas flow member  24 . The gas flow member  24  has an upper portion  26  and a lower portion  28 . The gas flow member upper portion  26  includes a gas supply/inlet port or opening  30  and the gas flow member lower portion  28  includes first and second gas dispersion openings  32 . A gas inflow or supply passageway  34  extends between the inlet port  30  and the gas dispersion openings  32 . 
     The gas flow member  24  includes first and second gas return passageways  36  ( FIG. 2 ). Each gas return passageway  36  extends between a gas return opening or port  38  at the gas flow member lower portion  28  ( FIGS. 3 and 4 ) and a gas discharge opening or port  40  at the gas flow member upper portion  26  ( FIG. 1 ). 
     The gas flow member  24  is positionable in a sterilization position, as illustrated in  FIGS. 1-6 . In the sterilization position, the gas flow member lower portion  28  is disposed in the chamber  14  or the fluid flow path  15 . In this regard, the gas dispersion openings  32  are positioned and configured to effectively and rapidly disperse pressurized gas received from the gas inlet port  30  through the conduits  20  and adjacent and/or past fluid flow components attached to the flanges  22 . In some embodiments, the gas dispersion openings  32  are generally or substantially aligned with the axis A 1  in the sterilization position ( FIGS. 2 and 4 ). It will be understood that, in use, the device  10  may be positioned such that the axis A 1  is defined as a longitudinal (horizontal) axis, a latitudinal (vertical) axis or any angle or axis therebetween. 
     In the sterilization position, the gas return openings or ports  38  are also disposed in the chamber  14  or the fluid flow path  15 . As illustrated, the gas return openings  38  may be offset from the axis A 1  ( FIG. 4 ). 
     The gas dispersion device  10  may be temporarily locked in the sterilization position via a locking mechanism. As shown in  FIG. 6 , an opening  41  extends inwardly from an outer surface of the gas flow member  24 , and a pin  42  is received in the opening  41  to retain the gas flow member  24  in the sterilization position. The pin  42  is part of a “shear key assembly” described in more detail below. 
     Also as shown in  FIG. 6 , the gas dispersion device  10  includes a main actuator spring  44 . In the sterilization position, the spring  44  is held within a main actuator spring containment body  46 ; the spring containment body  46  is disposed within the housing  12 . A flat washer  48  is positioned above the spring  44  and a retaining ring  50  is positioned above the washer  48 . At least one of the washer  48  and the retaining ring  50  is attached to the outer surface of the gas flow member  24 . In the sterilization position, the spring  44  is compressed and held in place by the washer  48  and the retaining ring  50 . 
     Still referring to  FIG. 6 , a first annular seal  52  is provided in a groove  54  of the spring containment body  46 . The seal  52  inhibits the passage of pre- and post-sterilization gas as well as bioprocessing fluid/material that flows through the fluid flow path after sterilization has taken place. 
     Again, in the sterilization position, the gas dispersion device  10  is configured to rapidly disperse gas from the gas dispersion openings  32 . The gas is dispersed throughout the chamber  14 , through the conduits  20 , and adjacent and/or past flow components attached to the flanges  22 , thereby efficiently sterilizing these components. The gas is received from a pressurized gas source through the gas supply port  30  and flows through the gas inflow passageway  34  before being dispersed from the gas dispersion openings  32 . As will be described in more detail below, the pressurized gas source may be received on a collar  55  ( FIG. 1 ) at the top portion of the housing  12 . 
     In some embodiments, the housing  12  is a one-piece housing. In some embodiments, the housing upper portion  16  and the housing lower portion  18  are discrete components. This may accommodate the placement of the spring containment body  46  within the housing  12 . As illustrated in  FIG. 5 , the housing lower portion  18  may include at least one locating guide pin  58  and the spring containment body  46  may include at least one opening  60  sized and configured to receive the at least one guide pin  58 . There may be a plurality of guide pins  58  and openings  60  or the guide pin  58  may be an annular or semi-annular protrusion and the opening  60  may be a corresponding annular or semi-annular groove. The housing upper and lower portions  16 ,  18  may be welded (e.g., ultrasonically welded) at joint  56 . In some embodiments, most or all of the components of the gas dispersion device  10  are formed of an inert polymer. In some embodiments, the spring  44 , the washer  48  and/or the retaining ring  50  are formed of a metallic material such as stainless steel. 
     The gas dispersion device  10  is movable between the sterilization position, described above, and a post-sterilization or product flow position, as illustrated in  FIGS. 7 and 8 . In the product flow position, the gas flow member lower portion  28  is withdrawn from the chamber  14  after flow components attached to the flanges  22  have been adequately sterilized. With the gas flow member  24  withdrawn from the chamber  14 , the chamber  14  and the conduits  20  define an open flow path  15  (e.g., along the axis A 1 ). The open flow path provides a low resistance path for product, such as bioprocessing fluid/material, to flow, including along or past flow components attached to the flanges  22  that were sterilized when the gas dispersion device  10  was in the sterilization position. 
     As illustrated in  FIG. 8 , the movement from the sterilization position to the product flow position is initiated by cutting a shear key  58 ; the process for cutting the shear key  58  will be described in more detail below. According to some embodiments, the shear key  58  comprises a brittle ceramic or polymeric material that crumbles, shatters or otherwise fractures when cut. In some embodiments, the shear key is made of brittle polystyrene. After the shear key  58  is cut, previously compressed spring  60  expands and retaining pin  42  retracts away from the gas flow member  24  and clear of the opening  41  therein. At this point, previously compressed spring  44  expands and forces the washer  48  and the retaining ring  50  upward, and in turn forces the gas flow member  24  upward. 
     The gas dispersion device  10  may include a locking mechanism to lock the gas dispersion device  10  or the gas flow member  24  in the product flow position. In the illustrated embodiment, first and second post-sterilization locking cams  62  are disposed in the housing upper portion  16 . A spring  64  biases each cam  62  inwardly toward the gas flow member  24 . Each cam  62  has a side surface  66  that tapers inwardly from bottom to top. Each cam  62  also has a flat or substantially flat top surface  68 . As noted above, the spring  44  forces the washer  48  and/or the retaining ring  50  upwardly after the pin  42  becomes disengaged with the opening  41  in the gas flow member  24 . As the washer  48  travels upwardly, the washer  48  engages the cam side surface  66  and compresses the spring  64  such that the washer  48  can extend upwardly past the top portion of the cam side surface  66 . After the washer  48  has cleared the top portion of the cam side surface  66 , the spring  64  urges the cam  62  inwardly such that the washer  48  may rest on the cam top surface  68 . The gas dispersion device  10  or the gas flow member  24  is now locked in place in the post-sterilization or product flow position. 
     The gas flow member lower portion  28  includes a second seal  70 . The second seal  70  may take the form of an annular seal or o-ring positioned below the gas dispersion openings  32 . For example, as shown in  FIG. 8 , the gas flow member lower portion  28  may include a seat  72  on which the second seal  70  may be positioned, with the seal positioned below the gas dispersion openings  32  and the return gas flow ports  38 . 
     As illustrated in  FIGS. 7 and 8 , in the product flow position, the second seal  70  is brought into contact with a lower portion of the spring containment body  46 . In this regard, a “double seal” is provided with the first and second seals  52 ,  70  to inhibit upward flow of bioprocessing or product fluid/material that flows through the fluid flow pathway  15 . 
     Referring back to  FIG. 6 , in the sterilization position, the gas flow member  24  (or the upper portion  26  thereof) extends a first distance d 1  from a top portion of the threaded collar  55 . As shown in  FIG. 8 , in the post-sterilization or product flow position, the gas flow member  24  (or the upper portion  26  thereof) extends a second distance d 2  from a top portion of the threaded collar  55 , with the second distance d 2  being greater than the first distance d 1 . In some embodiments, the second distance d 2  is less than about 1 inch greater than the first distance d 1 . In some embodiments, the second distance d 2  is between about 0.5 and about 0.75 inches greater than the first distance d 1 . The difference between the distances d 2  and d 1  represents the amount of upward travel of the gas flow member  24  between the sterilization position and the product flow position. 
     Referring again to  FIG. 3 , a bottom portion of the gas dispersion device  10  may include a well  84  (i.e., below the chamber  14 ). The well  84  may be used to accommodate a sensor/transmitter to be attached or integrated to the gas dispersion device  10 . The well  84  may be of varying size depending on the size or type of sensor/transmitter to be accommodated. Where used, a through-hole  86  provides fluid communication for a probe or the like of the sensor/transmitter. The through-hole  86  may also be of varying size depending on the application. 
     The gas interconnect dispersion device  10  may be employed to efficiently disperse low-temperature gases/vapors for localized sterilization of fluid flow components at point-of-use connection sites. As described above, the fluid flow components (including connectors, fittings, fluid flow paths such as tubing and the like, sensors and/or transmitters) may be connected or operatively connected to the conduits  20  or the flanges  22  of the gas dispersion device  10 . 
     Current technology employs “pre-sterilized” flow components such as connectors, fittings, fluid flow paths, sensors/transmitters and the like. However, during the process of connecting such flow components to a drug manufacturing or processing system, the sterile connectors, fittings and sensors/transmitters are often exposed to an ambient non-sterile atmosphere that has the potential to cause microbial contamination. The gas dispersion interconnect device  10  helps ensure that after a “pre-sterilized” aseptic flow component is exposed to an ambient non-sterile atmosphere, any residual microbial contamination can be reduced to the necessary level. 
     Low-temperature gas/vapor sterilants include: ozone gas, ethylene oxide (EO or EtO), vaporized hydrogen peroxide (VHP or HPV), hydrogen peroxide gas plasma, vaporized formaldehyde, gaseous chlorine dioxide and vaporized peracetic acid. 
     Pressurized ozone gas may be advantageously used because it is an efficient FDA-approved sterilant, because it leaves no residual surface coatings, because it is safe and inexpensive to produce, because of its low pressure handling characteristics and/or because it is easily reverted back to oxygen using a chemical catalyst. While the discussion herein largely focuses on the use of ozone gas as the sterilant, it will be appreciated that other low-temperature gases/vapors, such as those listed above, may be employed. 
     As pressurized ozone gas dispersed by the gas dispersion device  10  migrates through joints or process connections joined by the dispersion device  10  and/or flow components operatively connected to the gas dispersion device  10 , it sterilizes all internal surfaces, including occluded or hidden areas of the flow components where bacteria or microbial populations can grow, to achieve a Sterility Assurance Level (SAL) of 10 −6  as mandated by the FDA. That is, the gas dispersion device  10  can effectively sterilize connected or operatively connected connectors, fittings, fluid flow paths, sensors and/or transmitters including occluded portions thereof to a SAL of 10 −6 . The gas dispersion device  10  may effectively disperse the gas to sterilize further downstream areas, including downstream occluded areas, as well. 
     The gas dispersion interconnect device  10  is typically “single-use” and can be used to sterilize connection points in the fluid product transfer path in drug processing and manufacturing systems, for example. In addition, the gas interconnect device  10  can be used to sterilize single-use and reusable aseptic disposable sensors/transmitters, as described below. 
     Sensors/transmitters can be integrated with and mounted to the gas dispersion device  10 . Thus, the present invention contemplates the integration and mounting of various types of single-use or reusable sensors and transmitters into a drug manufacturing system, and their subsequent sterilization using ozone gas at the point-of-use (POU) connection point. The types of sensors and transmitters that may be sterilized include, but are not limited to: pressure sensors and transmitters, flow rate sensors and transmitters, temperature sensors and transmitters, CO 2  sensors and transmitters, O 2  sensors and transmitters, pH sensors and transmitters, conductivity sensors and transmitters and redox and O.R.P. sensors and transmitters. By exposing the sensor mounting at aseptic connection points to a calculated concentration of ozone gas, the majority of the microbial population is killed to achieve a SAL of 10 −6 . 
     According to some embodiments, a sensor/transmitter mounting and fitting assembly includes a single-use or reusable sensor/transmitter, a single-use mounting fitting and an ozone gas dispersion sterilization device, such as the device  10  described above. Two or more of the sensor/transmitter mounting and fitting assemblies may be integrated to form an integrated, single-use assembly. 
     Exemplary embodiments of such assemblies are shown in  FIGS. 9-11 . Three exemplary configurations are illustrated together in  FIG. 9 . As best shown in  FIGS. 9 and 10 , a first configuration  300  includes the gas dispersion sterilization device  10 , a mounting fitting  302  and a long probe sensor/transmitter  304 . The fitting  302  is T-shaped and includes a first run portion  302   a  extending between first and second ends and a second run portion  302   b  extending outwardly from the first run portion  302   a.    
     The first end of the first run  302   a  is operatively connected to one of the conduits  20  (or one of flanges  22 ) the gas dispersion device  10  via a sanitary clamp  306 . The opposite end of the first run  302   a  is operatively connected to the sensor/transmitter  304  via another sanitary clamp  306 . The length of the first run  302   a  can be selected to accommodate the length of the long probe sensor  304 . In some embodiments, the length of the first run  302   a  is selected to accommodate sensor probes having lengths of 9-10 inches or greater. 
     The second run  302   b  of the fitting  302  is operatively connected to a vessel V (such as a bioreactor) via another sanitary clamp  306 . This connection point is adjacent an isolation valve associated with the bioreactor or product vessel V. The isolation valve is movable between open and closed positions. 
     With the isolation valve in the closed position, a pressurized ozone gas source, such as a syringe or a hand-held or portable ozone gas supply canister (described in detail below), is provided. The portable ozone gas supply canister is configured to connect with the gas flow member top portion  26  of the gas dispersion device  10  and supply pressurized ozone through the gas inlet port  30  ( FIG. 1 ), thereby effectively and rapidly dispersing the ozone gas through the dispersion openings, as described above. All internal cavities and components including the sensor/transmitter  304 , mounting fitting  302  and other attached components are exposed to the ozone gas and sterilized to the requisite SAL of 10 −6 . As will be described below, excessive amounts of “post-sterilization” ozone gas will be passed through the gas outlet ports  40  of the gas dispersion device  10  and through a catalytic filter associated with the portable ozone canister to convert the waste ozone gas to oxygen before it reenters the atmosphere. Also as described below, the “post-sterilization” gas may be monitored and analyzed before or during the conversion process to ensure that the required log 6 reduction of microbial species has occurred; the portable ozone gas supply canister includes the catalytic device and a measuring and/or monitoring device to measure and/or indicate that an SAL of 10 −6  has been achieved with respect to components connected or operatively connected to the gas dispersion device  10 . 
     Referring to  FIG. 9 , a second exemplary configuration  310  is shown. An in-line sensor/transmitter  312  and a mounting fitting  314  are operatively connected to one of the conduits or flanges  20 ,  22  of the gas dispersion device  10  via a sanitary clamp  306 . The other one of the conduits or flanges  20 ,  22  of the gas dispersion device  10  is operatively connected to the vessel V. Thus, an in-line sensor/transmitter mounting assembly is formed. In the manner described above, an isolation valve associated with the vessel V is closed, and a portable ozone gas supply canister is attached to the gas dispersion device  10 . All internal cavities including the sensor/transmitter  312 , mounting fitting  314  and other attached components are exposed to the ozone gas and sterilized to the requisite SAL of 10 −6 . 
     A third exemplary configuration  320  is shown in  FIGS. 9 and 11 . Here, the gas dispersion device  10  is configured to receive the sensor/transmitter  322  via the well  84 , thereby forming a direct sensor/transmitter mounting configuration. One of the flanges  22  of the gas dispersion device  10  is operatively connected to the vessel V via a fitting  324  and a sanitary clamp  306 . Again, an isolation valve associated with the vessel V is closed, and a portable ozone gas supply canister is attached to the gas dispersion device. All internal cavities including the sensor/transmitter  322  and the fitting  324  and other attached or nearby components are exposed to the ozone gas and sterilized to the requisite SAL of 10 −6 . 
     In the third configuration  320 , a sanitary clamp  306  connects the other one of the flanges  22  of the gas dispersion device  10  with a flow blocking member  326 . It is contemplated that the gas dispersion device  10  may alternatively be formed or manufactured with a closed conduit, or with no conduit at this location (e.g., the gas dispersion device  10  includes only one conduit  20 ). Further, it is noted that, in place of the flow blocking member  326 , a fluid flow path such as a fitting or a tube could be connected to the flange  22  via the sanitary clamp  306 . The fluid flow path may be connected to another container or vessel, for example. In this configuration, the gas dispersion device  10  would be configured to further sterilize this additional fluid flow path running to the other container or vessel. 
     For all of the above-described configurations, all or some of the gas dispersion device, the sensor/transmitter and any associated mounting fittings or flow components may be integrated so as to form a single-use disposable assembly that may be integrated to the bioprocessing system. The above described sterilization/product flow processes may take place, after which point the entire integrated assembly is removed and the vessel is cleaned around the isolation valve area. It is noted that the vessel may also be single-use disposable and, in some embodiments, may also be integrated with the assembly. 
     As discussed above, the gas dispersion device  10  is configured to receive pressurized gas through the gas supply port  30  from a pressurized gas supply source. Various pressurized gas sources, such as a syringe or the like, are contemplated as described below. One such source is included in the portable gas canister assembly or portable gas transfer device  100  shown in  FIGS. 12-27 . The device  100  includes a housing  101  having an upper portion  102  and a lower portion  104 . A carry handle  106  may be provided between the housing upper and lower portions  102 ,  104 . The device  100  includes a gas supply canister  108  and a gas discharge canister or gas discharge catalyst canister  110 . As illustrated, the gas supply canister  108  and the gas discharge catalyst canister  110  may each extend between the housing upper and lower portions  102 ,  104 . One or more support columns  112  may also extend between the housing upper and lower portions  102 ,  104  to provide strength. According to some embodiments, the canisters  108 ,  110  are metallic. According to some embodiments, the gas supply canister  108  is nickel plated aluminum. According to some embodiments, the gas discharge catalyst canister  110  is stainless steel. According to some embodiments, the gas supply canister  108  has an internal volume of about 0.5 liters. According to some embodiments, the gas supply canister is configured to hold ozone at a pressure of about 100 psig. 
     Disposed on the housing upper portion  102  are a plurality of status indicator lights  114 , a display  116  and an operator interface  118 . Also disposed on the housing upper portion  102  is a gas discharge vent  120 . The vent  120  is in fluid communication with the gas discharge catalyst canister  110 . The functionality of these components will be described below. 
     Attached to the housing lower portion  104  is a mounting nut  122 . Referring to  FIG. 13 , the mounting nut  122  includes an opening  124  sized and configured to receive therethrough the gas flow member  24  of the gas dispersion device  10 . The mounting nut opening  124  is also sized and configured to receive and engage the collar  55  of the gas dispersion device  10 . The interior of the mounting nut opening  124  may be threaded such that the mounting nut  122  threadingly engages the collar  55 . 
     A guide bar  126  is provided on each side surface of the housing  101  (only one guide bar  126  is visible in  FIG. 13 ). The guide bars  126  may be received in guide tracks of a recharging station, which is described in greater detail below. Gas refill supply valve  128  (e.g., a check valve) and electrical interface  130  are also disposed on the housing  101 . These components are connected to the recharging station. 
     An alignment key  132  is located on the housing lower portion  104 . The alignment key  132  is aligned with and received within a locating guide  80  of the gas dispersion device  10  ( FIG. 1 ). The alignment key  132  is shown in greater detail in  FIG. 14 . The alignment key  132  includes first and second shear cutter ports  134 . First and second shear cutters  136  are located within the alignment key  132  with each shear cutter  136  aligned with a respective shear cutter port  134 . When the alignment key  132  is matingly received in the locating guide  80 , the shear cutter ports  134  are in alignment with shear cutter access ports  82  of the gas dispersion device  10  ( FIG. 1 ). 
     As illustrated in  FIGS. 15 and 16 , above the mounting nut opening  124  is a guided opening  138 . The guided opening  138  is sized and configured to receive the gas flow member  24  of the gas dispersion device  10 . The guided opening  138  has a similar shape or profile to that of the gas flow member  24  such that the gas flow member  24  can be matingly received in the guided opening  138 . The guided opening  138  may have a polygonal and/or an oblong shape or profile to inhibit rotation of components therein, including the gas flow member  24  of the gas dispersion device  10 . 
     A fixed housing portion  140  is illustrated in  FIG. 16 . The fixed housing portion  140  may be part of the housing  101  or attached thereto. At or near the bottom of the fixed housing portion  140  is an annular groove  142  that is configured to receive a retaining ring  144  therein. A top portion of the mounting nut  122  rests on the retaining ring  144 . 
     The fixed housing portion  140  defines the guided opening  138 . Referring to  FIGS. 17 and 18 , the fixed housing portion  140  includes a relatively larger upper bore  146  with a sill  148  defined at the top of the guided opening  138 . 
     A gas flow or transfer member  150  is movable within the fixed housing member  140 . As shown in  FIGS. 19-21 , the movable gas flow member  150  includes a lower stem portion  152  and an upper head portion  154 . The lower stem portion  152  is shaped and configured to fit within the guided opening  138  of the fixed housing portion  140 . The upper head portion  154  is shaped and configured to fit within the upper bore  146  of the fixed housing portion  140 . The head portion  154  sits on the sill  148  with the gas flow member  150  in a “seated” position. As will be explained in more detail below, when the gas dispersion device  10  and the gas transfer device  100  are initially coupled, the gas flow member  150  is in the seated position when the gas dispersion device  10  is in the sterilization position. Also, the gas flow member  150  moves upward into a “raised” position when the gas dispersion device  10  moves to the post-sterilization or product flow position. 
     One gas supply passageway  156  and first and second gas return or discharge passageways  158  extend through the gas flow or transfer member  150 . A counterbore forms a ledge or sill  156 L,  158 L in each passageway  156 ,  158  near a bottom surface  160  of the stem portion  152  ( FIG. 19 ). As illustrated in  FIGS. 15 and 16 , a stainless steel tube or fitting  166  is inserted into the passageway  156  such that one end of the tube  166  abuts the ledge  156 L and the other end of the tube  166  extends outwardly from the lower surface  160  of the stem portion  152 . Similarly, a stainless steel tube or fitting  168  is inserted into each passageway  158  such that one end of the tube  168  abuts the ledge  158 L and the other end of the tube  168  extends outwardly from the lower surface  160 . 
     A face seal  169  is adhered or otherwise attached to the lower surface  160  of the gas flow member  150 . The face seal  169  has generally the same shape or profile as the guided opening  138  and the gas flow member stem portion  152 . The face seal  169  includes apertures that are aligned with the gas flow member passageways  156 ,  158 . When attached, the stainless steel tubes  166 ,  168  extend downwardly past the face seal  169 . 
     As shown in  FIGS. 20 and 21 , each of the passageways  156 ,  158  extends upwardly through the stem portion  152 , then makes a pair of 90 degree turns in the head portion  154 . This configuration allows for the passageways to be spaced apart a greater radial distance such that tubes connected thereto may wrap around a compression spring, as described below. An opening  162  may be formed from one of the 90 degree runs of the passageway  156  and openings  164  may be formed from one of the 90 degree runs of the passageways  158 . The openings  162 ,  164  may be filled with plugs  167  ( FIG. 22 ). 
     An opening  166  is formed from the other of the 90 degree runs of the passageway  156  and openings  168  are formed from the other of the 90 degree runs of the passageways  158 . The openings  166 ,  168  are located in alcoves  170 . The alcoves  170  provide tooling space for the attachment of fittings  172 , such as barbed fittings, to the openings  166 ,  168  ( FIG. 22 ). 
     Turning to  FIG. 22 , a flexible tube  174  is attached to the fitting  172  attached to the opening  166 . A flexible tube  176  is attached to the fitting  172  attached to each opening  168 . The flexible tubes  176  receive return or discharge gas that flows upwardly through the passageways  158  of the gas transfer member  150 . The flexible tube  174  ultimately supplies pressurized gas to the passageway  156  of the gas transfer member  150  such that the pressurized gas may flow downwardly therethrough. 
     The tubes  174 ,  176  extend upwardly and wrap around a compression spring  178 . The tubes  174 ,  176  may be wrapped around the spring  178  in a helical configuration, for example. Again, the gas transfer member  150  is configured to move upward from its seated position; for example, the gas transfer member  150  may move upward after a “successful sterilization event” has been performed by the gas dispersion device  10  and detected or validated by the gas transfer device  100 . In  FIG. 22 , the gas transfer member  150  is shown in its “seated” or down position. The compression spring  178  is received in a central valley  171  of the gas flow member head  154  ( FIG. 21 ) and helps urge the gas transfer member  150  in the seated position. Further, the gas flow member head  154  includes an opening  180  sized and configured to receive a pin  182 . The pin  182  is extendable and retractable, for example by a solenoid valve  184 . The solenoid valve  184  may be received in an opening  185  of the fixed housing member  140  ( FIG. 18 ). In  FIG. 22 , the pin  182  is shown in its extended position, engaging the opening  180 , thereby further urging the gas flow member to remain the down or seated position. 
       FIG. 23  illustrates a portion of the gas transfer device  100  above the compression spring  178 . As illustrated, the tubes  174 ,  176  terminate near a top portion of the spring  178 , at which point they connect with gas flow passageways (via barbed connectors, for example). Pressurized gas is supplied from the gas supply canister  108 , as shown by the arrows indicated SG. The pressurized supply gas travels along passageway  190  to a first port of a solenoid valve and then travels along a different passageway  192  from a second port of the solenoid valve. The solenoid valve is described in further detail below. The gas that travels through passageway  192  enters the supply tube  174  and travels downwardly to the gas transfer member  150 , where the supply gas enters the supply gas passageway  156 . 
     The return or discharge gas flowing upwardly through the tubes  176  is routed to a common return gas passageway  194  and travels in a path shown by the arrows RG. Face seals  196 ,  198  may be provided to seal the supply gas and return gas passageways, respectively. 
       FIG. 24  shows the path of the pressurized supply gas SG in greater detail. A solenoid valve  200  is provided. Supply gas passageway  190  is attached to a first port  202  of the solenoid valve  200  and supply gas passageway  192  is attached to a second port  204  of the solenoid valve. The solenoid valve  202  is “normally off” or “normally closed” such that supply gas typically will not flow into or through the passageway  192 . The valve  202  may be energized or otherwise receive a signal to open when supply gas is needed (i.e., when sterilization is to begin at the gas dispersion device  10 ). At this point, the supply gas will flow into and through the passageway  192 , through the tube  174  and downwardly through the passageway  156  of the gas flow or transfer member  150 . 
       FIG. 25  shows the path of the discharge or return gas RG in greater detail. The return gas passageway  194  ultimately branches into two segments. A first segment  206  directs a portion of the discharge or return gas RG to a gas level monitor sensor  210 . The gas level monitor sensor  210  is configured to monitor characteristics of the return gas such that a determination can be made as to whether a successful sterilization has taken place. For example, if ozone is used as the pressurized gas, the sensor  210  may monitor the amount of oxygen or ozone in the return gas such that a concentration over time (e.g., ppm ozone/time) can be used to determine or validate whether sterilization is complete. Also shown in  FIG. 25  are printed circuit boards  212 . A lesser or greater number of circuit boards may be provided in various embodiments. The printed circuit board(s)  212  may include or be associated with at least one controller. The printed circuit board(s) and/or the controller may control certain operations such as supplying power to the solenoid valves, monitoring the sensors, validating sterilization events and other operations that are described herein. 
     A second segment  208  directs a portion of the return gas RG to the gas discharge catalyst canister  110 . Referring to  FIG. 26 , return gas is supplied to a gas diffuser tube  214  located in the gas discharge catalyst canister  110 . The gas diffuser tube  214  includes a plurality of apertures  216  on an outer surface thereof such that return gas is diffused in the area surrounding the diffuser tube  214 . A suitable catalyst material  218  is positioned around the gas diffuser tube  214  to convert the return gas to oxygen, which is then released through the gas vent  120  ( FIG. 12 ). For example, if ozone is used as the sterilization gas, manganese dioxide/copper oxide, activated charcoal or a molecular sieve may be supplied around the gas diffuser tube  214  such that waste ozone is converted to oxygen. 
     A shear cutter assembly  220  is illustrated in  FIG. 27 . The shear cutter assembly  220  is positioned inside the housing  101 . The assembly includes first and second spur gears  222 ,  224  having a 2:1 gear reduction. The first gear  222  is driven by a DC motor  226  and a planetary gear reducer  228  (these components are hidden from view by respective casings or housings). An eccentric cam  230  having an extended portion  232  is driven by gear  224  via a cam shaft  234 . A cam follower  236  engages the cam  230 . Attached to the cam follower  236  are the shear cutters  136  (see  FIG. 14 ). A spring  238  surrounds at least a portion of each shear cutter  136 ; the springs  238  are also attached to the cam follower  236 . The springs  238  are biased such that the cam follower  236  is urged toward the cam  230 . 
     The motor  226  drives the gear  222 , which in turn drives the gear  224 , which in turn rotates the cam shaft  234  and the eccentric cam  230 . As the eccentric cam  230  rotates, the springs  238  compress and the cam follower  236  and the shear cutters  136  are pushed away from the cam shaft  234 . Eventually, when the cam extended portion  232  engages the cam follower  236 , the shear cutters  136  fully extend from the shear cutter ports  134  ( FIG. 14 ). As noted above, the alignment key  132  of the canister assembly  100  may be matingly received in the locating guide  80  of the gas dispersion device  10  such that the shear cutter ports  134  are aligned with shear cutter access ports  82  of the gas dispersion device  10  ( FIG. 1 ). As such, with the shear cutters  136  extended, the shear key  58  of the gas dispersion device  10  is cut, allowing the gas dispersion device  10  (or the gas flow member  24  thereof) to move from the sterilization position to the product flow position, as discussed further below. 
     Connection of the gas dispersion device  10  and the gas transfer device  100  and the ensuing operation of the combined system will now be described in greater detail. As shown in  FIG. 28 , the gas transfer device  100  is positioned over the gas dispersion device  10 ; specifically, the mounting nut  122  is centered over the collar  55  and the gas flow member upper portion  26 . As shown in  FIG. 29 , the alignment key  132  of the transfer device  100  is matingly received in the locating guide  80  of the gas dispersion device  10 . The mounting nut  122  is then rotated to threadingly engage the collar  55  of the gas dispersion device. Although not illustrated in  FIGS. 28 and 29 , flow components (e.g., connectors, fittings, sensors, tubes, etc.) will typically be operatively connected to the flanges  22  of the gas dispersion device  10  for subsequent sterilization before the gas transfer device  100  is introduced. 
     The gas transfer device  100  is connected with the gas dispersion device  10  in the sterilization position. This is apparent from  FIG. 29 , wherein the gas dispersion and gas return ports  32 ,  38  are visible through the conduit  20 . As such, the gas flow member  24  is in its lowered position when the gas canister assembly  100  is coupled to the gas dispersion device  10 . 
     Referring to  FIGS. 1 ,  2 ,  15  and  16 , the gas flow member upper portion  26  of the gas dispersion device  10  is received in the guided opening  138  of the gas transfer device  100 . The top surface of the gas flow member upper portion  26  contacts the face seal  169 . The tube  166  is received in the gas supply passageway  34  through the gas supply port  30  and the tubes  168  are received in the gas return passageways  36  through the return discharge gas ports  40 . The ends of the tubes  166 ,  168  may be seated on a ledge in respective passageways  34 ,  36  similar to the opposite ends of the tubes  166 ,  168  seated on the ledges  156 L,  158 L in the passageways  156 ,  158  ( FIG. 19 ). The insertion of the tubes  166 ,  168  into the passageways along with the face seal  169  help to ensure a sealed connection between the gas dispersion device  10  and the gas transfer device  100 . 
     In this position, the gas supply passageway  34  of the gas dispersion device  10  is in fluid communication with the gas supply canister  108  and the gas return passageways  36  of the gas dispersion device  10  are in fluid communication with the gas discharge catalyst canister  110 , with the exception of any flow blocking mechanisms disposed therebetween (e.g., the solenoid valve  200  shown in  FIG. 24 ). 
     With the portable gas transfer device  100  coupled to the gas dispersion device  10  as described above, an operator may use the display  116 , the operator interface  118  and/or the indicator lights  114  to initiate and monitor a sterilization process. As shown in  FIG. 30 , the display  116  may display data including, but not limited to, a date and time stamp  250 , an identification of the gas supply canister assembly  252 , a connection or joint identification  254  and an operator identification  256 . 
     The date and time  250  may be dynamically updated by at least one onboard controller of the gas transfer device  100 . The gas canister assembly identification  252  may also be provided by the onboard controller. These data may be automatically displayed on the display  116  without any user input. In some embodiments, these data are displayed before the gas transfer device  100  is connected to the gas dispersion device  10  as well as after the gas transfer device  100  is connected to the gas dispersion device  10 . 
     The connection or joint identification  254  identifies the connection or joint in the bioprocessing system that is to be sterilized. Specifically; this is the connection or joint at which a particular gas dispersion device  10  is attached (e.g., a specific connection or joint in a bioprocessing system). The connection or joint identification  254  may be displayed on the display  116  without any user input and/or before the gas canister assembly  100  is connected with the gas dispersion device  10 . In this regard, the connection or joint identification  254  may direct the operator to the proper connection or joint to be sterilized. In some other embodiments, the operator may use the operator interface  118  to input the connection or joint identification, which may be marked on or near the connection or joint or on a map, for example. The operator may depress the arrow keys  260  to scroll between various displays or lists, one of which may include a list of possible connections or joints. The operator may depress the “enter” key  262  when the correct connection or joint identification is found or highlighted. Other configurations for the operator interface  118  are contemplated. As just one example, the display  116  may be a touch-sensitive display to supplement or replace the operator interface  118 . 
     The operator identification  256  generally must be input by the operator. The operator may use the operator interface  118  to enter a password or other identifying information. Once the operator has been identified, the gas transfer device  100  may “unlock” to allow the sterilization process to begin. 
     The operator may press the “start” button  264  to begin the sterilization process. The indicators  114  provide visual feedback to the operator throughout the process. The indicators  114  may be differently colored LEDs or the like to provide the visual feedback. For example, the indicator  114   a  may be an amber LED that indicates that sterilization is in progress, the indicator  114   b  may be a green LED that indicates that a successful sterilization has taken place and the indicator  114   c  may be a red LED that indicates an unsuccessful sterilization or that a sterilization “fault” has occurred. 
     At the beginning of the sterilization process, power or a signal is supplied to the solenoid valve  200  ( FIG. 24 ). The solenoid valve  200  turns on or opens, allowing the pressurized supply gas SG to exit the port  204  and flow along the passageway  192 . The supply gas SG flows in the tube  174  downwardly and around the spring  178  ( FIG. 22 ). The supply gas SG enters the movable gas transfer member  150  at port  166  ( FIG. 21 ) and flows downwardly through the passageway  156  of the gas transfer member  150  ( FIGS. 19 and 20 ). The supply gas SG enters the gas dispersion device  10  through the gas supply port  30  of the gas flow member  24  ( FIG. 1 ). The supply gas flows downwardly, then outwardly through the gas flow member supply gas passageway  34 , at which point the supply gas is rapidly dispersed via the gas dispersion openings  32  ( FIG. 5 ). The dispersed supply gas flows through the conduits  20  and past or adjacent flow components operatively attached to the flanges  22 , as described in detail above. 
     “Post-sterilization” or return gas is received in the gas return openings  38  ( FIGS. 3 and 4 ) and flows upwardly through the gas flow member return gas passageways  36  ( FIG. 2 ). The return gas flows upwardly through the movable gas flow member passageways  158  ( FIGS. 19-21 ). The return gas then enters the tubes  176  and flows therethrough upwardly and around the spring  178  ( FIG. 22 ). As shown in  FIG. 23 , the return gas RG flows through a pair of short passageways which converge into the single return gas passageway  194 . As shown in  FIG. 25 , the return gas RG flows through the passageway  194  toward the gas discharge catalyst canister  110  and the gas level monitor sensor  210 . Segments  206  and  208  branch from the passageway  194 . A portion of the return gas RG is directed through the segment  208  into the gas discharge catalyst canister  110 , where it is converted into a safe and/or stable discharge gas, which is then discharged through the vent  120 , as described above. 
     A portion of the return gas RG is direction through the segment  208  to contact the gas level monitor sensor  210 . The sensor  210  continuously detects a characteristic, such as a level of a substance, of the return gas RG. The signal detected by the sensor  210  is provided to a controller, which continuously monitors the detected characteristic. For example, if the pressurized sterilization gas is ozone, the sensor  210  detects the level of ozone present in the return gas. The controller determines the level of ozone over time (e.g., ppm of ozone over time). A threshold value of level of ozone over time is known to correlate to a predetermined required sterilization level, such as a SAL of 10 −6 . When this threshold value is reached, the controller determines that a “good sterilization” has taken place. A good sterilization indicates that all components in fluid communication with the gas dispersion device  10  have been adequately sterilized. 
     After it has been determined or validated that a “good sterilization” has taken place, the sterilization process ends. The controller sends a signal to the solenoid  184  and the pin  182  is retracted from the opening  180  in the head portion  154  of the movable gas flow member  150  ( FIG. 22 ). At this point, the movable gas flow member  150  remains in position; the weight of the spring  178  continues to urge the movable gas flow member  150  downward such that the head portion  154  remains seated on the sill  148  of the fixed housing member  140  ( FIG. 17 ). 
     Referring to  FIG. 27 , the controller then sends a signal to turn on the motor  226 . The motor  226  drives the gear  222 , which in turn drives the gear  224 . The motor turns the gear  222  one full revolution, which corresponds to one half revolution of the gear  224  due to the 2:1 reduction. The rotation of the gear  224  results in a corresponding rotation of the cam shaft  234  and eccentric cam  230 . The extended portion  232  of the cam  230  fully engages the cam follower  236  after 180 degrees of rotation. As a result, the cam follower  236  and the shear cutters  136  attached thereto are pushed against the force of the spring  238  such that the shear cutters  136  extend out of the shear cutter ports  134  of the alignment key  132  ( FIG. 14 ) and into the shear cutter access ports  82  of the gas dispersion device  10  ( FIG. 1 ). 
     The shear cutters  136  cut the shear key  58  of the gas dispersion device  10  such that the pin  42  retracts from the opening  41  in the gas flow member  24  and the gas flow member  24  moves to the product flow position due to the force of the spring  44  ( FIGS. 6 and 8 ). As illustrated in  FIG. 7 , the gas dispersion device  10  or the gas flow member  24  is locked in the product flow position by the locking cams  62 . The gas dispersion device  10  is typically single-use disposable; accordingly, this locking action will advantageously hinder or prevent the gas dispersion device  10  from being reused for sterilization purposes. 
     Although not illustrated in  FIG. 16 , as discussed above, the gas dispersion device gas flow member  24  engages the gas canister assembly movable gas flow member  150  at the face seal  169 . The tube  166  extends into the gas dispersion device gas supply port  30  and the tubes  168  extend into the gas return openings  40  ( FIG. 1 ). When the gas dispersion device gas flow member  24  moves upward into the product flow position, the movable gas flow member  150  moves upward a corresponding distance. In some embodiments, the upward travel is less than about 1 inch. In some embodiments, the upward travel is between about 0.5 and about 0.75 inches. 
     As described above, at least one of the indicators  114  ( FIG. 30 ) may provide visual feedback to the operator that the sterilization process is complete and/or that a successful or “good” sterilization event has been validated. After the sterilization process, the operator may loosen the mounting nut  122  and disconnect the gas transfer device  100  from the gas dispersion device  10 . 
     A sterilization gas supply/refilling system  300  according to some embodiments is illustrated in  FIG. 31 . The system  300  includes a portable gas transfer device docking station  302 . The docking station has a plurality of docking areas, with each area configured to receive one of a plurality of portable gas transfer devices  100   1 ,  100   2 ,  100   3 ,  100   4 . Although not illustrated, each docking area may include guide tracks to receive the portable gas transfer device guide bars  126  shown in  FIG. 13 . This configuration provides audible and/or tactile feedback that the portable gas transfer device has been properly seated in the docking area. Each docking area includes a gas supply connection for the gas refill supply valve  128  and an electrical connection for the electrical interface  130 . 
     The portable gas transfer devices  100   1 ,  100   2 ,  100   3 ,  100   4  are refilled through the valve  128  with pressurized sterilization gas supplied from the gas supply manifold  304 . Various transmitters may be integrated into the gas supply manifold  304 , including a pressure transmitter (PT)  306 , a relative humidity transmitter (RHT)  308 , and/or a gas concentration monitor transmitter (GCMT)  310 . Other sensors or transmitters may be incorporated as needed. Signals from the transmitters are fed to an electrical control interface system  314 . 
     In some embodiments, the gas supply manifold  304  is supplied with an existing sterilization gas supply. Alternatively, a sterilization gas generation and/or supply system  320  may be provided to supply gas to the gas supply manifold  304 . In the illustrated embodiment, the system  320  generates ozone gas from a separate oxygen supply. The system  320  pressurizes and supplies the gas to the manifold  304 . Pressure levels (e.g., 90-100 psig) are controlled by a pressure regulator (PR). 
     In some embodiments, a relative humidity (RH) generating system  322  is provided. The effectiveness of certain sterilization gases in achieving a (log 6) pathogen kill rate is enhanced by increased RH levels. The RH system  322  may supply clean moisture (at a controlled RH) to sterilization gas steam, for example. 
     Certain sterilization gases (such as ozone) have relatively short “half-life” gas concentration reduction due to pressurization. As such, a gas catalytic converter system  312  may be provided; any portable gas transfer devices  100  that have been docked past the allowable “half-life” time limit may be discharged to the gas catalytic converter system  312 . The gas catalytic converter system  312  converts harmful or toxic sterilization gases to a safe discharge gas. In the case of ozone (O 3 ), it is converted to (O 2 ) by the catalytic converter. The discharged portable gas transfer devices may then be refilled from the gas supply manifold system  304 . Furthermore, unused sterilization gas from the gas supply manifold  304  may be directed to the gas catalytic converter system  312 . These actions may all be controlled automatically from the electrical control interface system  314 . 
     As noted above, the docking station  302  also includes an electrical connection for the electrical interface  130  of each portable gas transfer device  100 . Each portable gas transfer device  100  includes at least one battery pack to provide power to various components (e.g., the display, the controller, etc.). The electrical connection at the docking station recharges the battery pack. In addition, the electrical connection transfers electronic validation data from the portable gas transfer devices to a central data base  318  via a data transfer interface  316 . 
     Specifically, the data transfer interface  316  controls the transfer of electronic sterilization validation protocol data from the portable gas transfer devices to the main central data base  318 . Each time a portable gas transfer device  100  sterilizes a single-use aseptic connection or joint in a bioprocess system, an electronic signature of the portable gas transfer device ID, the single-use connection ID, the operator ID (all described above in connection with the display  116 ), as well as the gas concentration per time (e.g., ppm of ozone/time) is stored on an EPROM in the portable gas transfer device controller. Other data such as relative humidity may also be included as each bio-process system warrants. 
     As indicated above, the electrical control interface  314  is the overall system control hub. It controls each subsystem function, sensor/transmitter monitoring, and data transfer to the central database computer. It is noted that, when the gas transfer devices are docked in the docking areas, they are effectively “reset” for future use. This includes not only refilling the pressurized gas canister, but also sending a signal to the solenoid  184  such that the pin  182  engages the opening  180  of the gas transfer member  150  ( FIG. 22 ), for example. 
     A power supply/distribution system  324  system supplies the AC/DC power requirements of the overall system. 
     Pressurized gas, such as ozone, may be injected in a single-use connection site or joint in a number of ways. Examples include, but are not limited to: a gas syringe injection; a single-use valve system (e.g., the gas dispersion interconnect device  10  described above); a rotating gas dispersing tube; and a gas dispersing spray ball. 
     A sterilization apparatus  400  according to some embodiments is illustrated in  FIG. 32 . Generally, the sterilization apparatus  400  includes two portions: a sealable local environment  410  and a pressurized gas (e.g., ozone) source  420 , the form and function of each of which are described in detail with reference to  FIGS. 32-40 . An aseptic connection point (not shown in  FIG. 32 ), such as an open portion of a fluid path or two or more fluid flow components or connectors, may be received within the sealable local environment  410 . Although the aseptic connection point may have been pre-sterilized, for purposes of this description, it is assumed that an ambient environment  430  may not be sufficiently sterile. Accordingly, to effect an aseptic connection, the aseptic connection point is received within the sealable local environment  410  which is then sealed against the ambient environment  430 . 
     After the sealable local environment  410  is sealed, the ozone source  420  is used to introduce a supply of ozone (not shown in  FIG. 32 ) into the sealable local environment  410 . Exposure to the supply of ozone, for example at a predetermined concentration and for a predetermined duration, enables the sealable local environment  410  and the aseptic connection point therein to reach a predetermined sterilization level. As a result, an aseptic connection may be made within an ambient environment  430  that may not be sterile. The ozone source  420  may include a pneumatic injection device, such as a syringe, adapted to penetrate a membrane described with reference to  FIG. 35  to introduce the supply of ozone into the interior of the sealable local environment  410 . Alternatively, the ozone source  420  may include another type of pump or may include an ozone generator, such as a water electrolysis ozone generator. Alternatively, the ozone source  420  may take the form of the portable gas transfer device  100  described above or a similar device. 
       FIG. 33  is a perspective view of a sealable local environment  410  of the sterilization apparatus  400  of  FIG. 32  in which the sealable local environment  410  includes a rigid structure. As further described with reference to  FIG. 38 , the sealable local environment may alternatively comprise a flexible body. The sealable local environment  410 , shown in a closed position, may be configured to receive the aseptic connection point (not shown in  FIG. 33 ) which, for sake of example, may include a pair of more fluid path connectors or fluid flow components (referred to below as “connectors”). As previously described, the connectors may be pre-sterilized but may need to be coupled in a non-sterile ambient environment  430  ( FIG. 32 ). To allow the connectors to be aseptically coupled within the non-sterile ambient environment  430 , each of the connectors may be received in chambers  440  and  450  of the sealable local environment  410 . The chambers  440  and  450  may include openings  442  and  452 , respectively, to enable connection lines (not shown in  FIG. 33 ) to extend from the sealable local environment  410  to fluid lines or fluid sources (also not shown in  FIG. 33 ) to which the connectors are coupled. 
     Once the connectors are in place in the sealable local environment  410 , the sealable local environment may be sealed by securing a closure device  460 . The closure device  460  may be in the form of a screw-driven closure that may be closed and secured by turning a knob  462 . Once the connectors have been sterilized within the sealable local environment  410 , as further described below, the sealable local environment  410  may be manipulated to enable the connectors enclosed therein to be coupled together while the sterile, sealable local environment  410  remains sealed. The sealable local environment  410  may include a manipulator  470 , such as a screw-driven manipulator, that enables the chambers  440  and  450  of the sealable local environment to be drawn together without unsealing the sealable local environment  410 . In some embodiments, an actuator  472 , such as a knob, may be turned to drive the chambers  440  and  450  together so as to forcibly interconnect the connectors within the sterile, sealable local environment  410 . Once the connectors have been interconnected, the closure device  460  may be released and the joined connectors (or other secured connection point) may be removed from the sealable local environment  410 . The connection point may then be exposed to a potentially non-sterile environment without exposing the fluid path to contamination. 
       FIG. 34  is an internal cross-sectional view of the sealable local environment  410  of  FIG. 33 . As previously described with reference to  FIG. 33 , the sealable local environment  410  includes chambers  440  and  450  to receive parts of the connection point, such as a pair of fluid path connectors or fluid flow components (not shown in  FIG. 34 ). The chambers  440  and  450  may include end portions  444  and  454 , respectively, to forcibly engage portions of the fluid path connectors. By forcibly engaging ends of the fluid path connectors, when the actuator  472  is manipulated to drive the chambers  440  and  450  together, the fluid path connectors will be forcibly interconnected at a central point  480  of the sealable local environment  410 . It is noted that, before the actuator  472  is manipulated to interconnect the fluid path connectors, the fluid path connectors or other connection point may not be joined together at the central point  480 . As described with reference to  FIG. 35 , the supply of ozone or other gas is introduced near the central point  480  to facilitate sterilization of interior portions of the fluid path connectors or other connection point before the connection point is closed. 
     As previously described with reference to  FIG. 33 , once the aseptic connection has been made within the sealable local environment  410 , the sealable local environment  410  may be unsealed and the aseptically sealed fluid path connectors or other connection point may be removed and exposed to the ambient environment without risk of contamination of the fluid path. 
       FIG. 35  is a perspective view of the sterilization apparatus  400  of  FIG. 32  showing a membrane  500  in the sealable local environment  410  configured to receive a supply of ozone (not shown) from the ozone source  420 . As previously described with reference to  FIG. 34 , according to some embodiments, the membrane  500  is near the central point  480  ( FIG. 34 ) of the sealable local environment  410  so that the supply of ozone may reach interior portions of the fluid path connectors or other connection point to sterilize interior portions of the connection point that may engage the fluid within. 
     In some embodiments, the membrane  500  may define a small opening sized to closely engage sides of a needle or other injection member  422  of the ozone source  420 . Having the membrane  500  and the injection member  422  closely match in size may prevent leakage at the membrane  500 . The membrane  500  may be comprised of a penetrable material to enable the injection member  422  to penetrate the membrane  500  while the membrane sealingly engages sides of the injection member  422 . As previously described with reference to  FIG. 32 , the ozone source may include a pneumatic device, such as a syringe or other pump. Alternatively, the ozone source may include an ozone generator that is securable to the membrane  500  or a similar port formed in the sealable local environment  410  to receive the supply of ozone. An exemplary “ozone generator” is the portable gas transfer device  100  described above. 
       FIG. 36  is another perspective view of the sterilization apparatus  400  of  FIG. 32  showing the ozone source  420  upon insertion into the membrane  500 . As previously described, the injection member  422  may penetrate and puncture the membrane  500 , facilitating a tight seal between the membrane  500  and the injection member  422 . In some embodiments, the tight seal between the membrane  500  and the injection member  422  prevents microbial contamination of the interior of the sealable local environment  410  while containing the supply of ozone within the interior of the sealable local environment  410 . 
       FIG. 37  is a cutaway view of the ozone source  420  showing details of the injection member  422  according to some embodiments. In some embodiments, the sealable local environment  410  permits the injection member  420  to be inserted into the sealable local environment  410  to a depth sufficient to enable one or more orifices  424  of the injection member  422  to enter into the sealable local environment  410 . The supply of ozone (not shown) is presented into the sealable local environment  410  through the orifices  424 . 
     In some embodiments, after sterilization, the supply of ozone may be captured from the sealable local environment  410  prior to unsealing the sealable local environment. The captured ozone may thus be stored or disposed of as desired. For example, the captured supply of ozone may be passed through a catalytic converter to convert the ozone to oxygen, and then released. 
       FIG. 38  is a top perspective view of a sterilization apparatus according to other embodiments in which a sealable local environment  510  comprises a flexible body. The sealable local environment  510  may be in the nature of a glove box that includes flexible openings in a more rigid shell to receive a user&#39;s hands  520 . Alternatively, the sealable local environment  510  overall may include a flexible body allowing the user&#39;s hands  520  to manipulate the sealable local environment  510  to enable connection of fluid path connectors or fluid flow components or some other connection point within a sterile sealable local environment  510 . The sealable local environment  510  may include one or more membranes or other orifices  530  to receive an ozone source (not shown in  FIG. 38 ). The sealable local environment  510  also may include one or more outlets  540  to enable fluid lines coupled to the fluid path connectors or other connection point to extend outwardly through sides of the sealable local environment  510 . 
       FIG. 39  is a flow diagram of a method  600  of sterilizing an open portion of a fluid path according to some embodiments. At block  602 , an open portion of a fluid path is received in a sealable local environment. As previously described with reference to  FIG. 34 , for example, the open portion of the fluid path may include fluid path connectors to be interconnected in a potentially non-sterile environment. The sealable local environment  410  may be opened and the fluid path connectors may be inserted within the sealable local environment  410 . At block  604 , the sealable local environment is sealed. As described with reference to  FIG. 33 , the sealable local environment  410  may be sealed through the use of a closure device  460 . At block  606 , a supply of ozone is received into the sealable local environment, where the portion of the fluid path is exposed to the ozone. As described with reference to  FIGS. 34-37 , for example, an ozone source, such as a syringe or other pneumatic device or an ozone generator may be coupled to the sealable local environment  410  and a supply of ozone thus may be introduced into the sealable local environment  410 . As also previously described, by introducing the supply of ozone into the sealable local environment before the fluid path connectors are interconnected, the fluid path is exposed to and sterilized by the ozone. 
       FIG. 40  is a flow diagram of a method  700  of sterilizing an open portion of a fluid path according to some embodiments. At block  702 , two or more fluid path connectors are received in a sealable local environment, where the two or more fluid path connectors are configured to be used in an aseptic fluid environment, and where the two of more fluid path connectors are received in the sealable local environment prior to interconnecting the two or more fluid path connectors. As previously described with reference to  FIG. 34 , the two or more fluid path connectors may need to be interconnected in a potentially non-sterile environment. The sealable local environment  410  may be opened and the fluid path connectors may be inserted within the sealable local environment  410 . At block  704 , the sealable local environment is sealed. As described with reference to  FIG. 33 , the sealable local environment  410  may be sealed through the use of a closure device  460 . 
     At block  706 , a supply of ozone is received into the sealable local environment, where the supply of ozone is supplied at a combination of a concentration and for a duration configured to cause the sealable local environment to reach a predetermined sterilization level. As described with reference to  FIGS. 34-37 , for example, an ozone source, such as a syringe or other pneumatic device or an ozone generator may be coupled to the sealable local environment  410  and a supply of ozone thus may be introduced into the sealable local environment  410 . As also previously described, by introducing the supply of ozone into the sealable local environment before the fluid path connectors are interconnected, the fluid path is exposed to and sterilized by the ozone. The concentration of ozone may be calculated based on the duration for which the fluid path connectors are to be exposed or based on the ozone source selected. At block  708 , after the predetermined sterilization level is reached, the two or more fluid path connectors are interconnected within the sealable local environment. As described with reference to  FIGS. 33 and 34 , in a rigid sealable local environment  410 , a manipulator or actuator  472  may be used to forcibly interconnect the fluid path connectors within the sealable local environment. As described with reference to  FIG. 38 , when the sealable local environment includes a flexible body, a user may manipulate the flexible body to interconnect the fluid path connectors. 
     Although the component  420  is described herein as an ozone source, it is contemplated that the component  420  could be a source of other pressurized gas/vapor, including low-temperature gas/vapor sterilants such as, but not limited to: ethylene oxide (EO or EtO), vaporized hydrogen peroxide (VHP or HPV), hydrogen peroxide gas plasma, vaporized formaldehyde, gaseous chlorine dioxide and vaporized peracetic acid. 
     It is noted that the ozone source  420  (or other pressurized gas/vapor source) could be used in connection with the gas dispersion device  10  described above or a similar device. For example, referring to  FIG. 1 , the ozone source  420  could be inserted into the gas supply port  30 . A membrane similar to the membrane  500  could be positioned at or near the gas supply port  30 , and the membrane could receive the ozone source injection member  422  therethrough. Thus, the gas dispersion device  10  may be used with other pressurized gas/vapor sources, such as a syringe. The gas dispersion device  10  may provide advantages as the internal portions of the interconnected process connection or joint, or fluid flow components attached to the gas dispersion device  10 , need not be disconnected and exposed to an ambient and potentially non-sterile atmosphere after sterilization and before a fluid, such as bioprocessing fluid, flows therethrough. 
     A gas interconnect dispersion device  800  according to some other embodiments is illustrated in  FIGS. 41-43 . The gas dispersion device  800  is similar to the gas dispersion device  10 ; however, the gas dispersion device  800  includes a rotatable gas flow member rather than a retractable gas flow member. Other differences between the gas dispersion devices  10  and  800  will be apparent from the description below. 
     The gas dispersion interconnect device  800  shown in  FIG. 41  includes a cylindrical valve body  802  defining a valve cavity  804  therein, in which is disposed a butterfly valve element  806  (e.g., a rotatable gas flow member). The interconnect device  800  includes a first inlet/discharge port assembly  840  including inlet/discharge conduit  842 , and connection flange  846  having central opening  848  therein communicating with the interior bore of conduit  842 . The bore in conduit  842  communicates with the interior volume of the valve cavity  804 . 
     In like manner, the interconnect device  800  includes a second inlet/discharge port assembly  850 , comprising inlet/discharge conduit  852  coupled to connection flange  856  having an inlet/discharge opening that communicates with the bore of conduit  852 . The bore in conduit  852  communicates with the interior volume of valve cavity  804 . 
     The butterfly valve element  806  includes a cylindrical collar  816  having an open bore  818  therein communicating with an interior passage (not shown) in the main body portion  810  of the valve element. The main body portion as shown has a top surface  814  containing gas discharge ports at its lateral portions, by which previously used sterilization gas (e.g., ozone gas) can be discharged from the valve in the direction indicated by arrows B. 
     Depending downwardly from the main body portion  810  is a lower collar member  820 , which may be journaled or otherwise secured in the valve assembly, being coaxial with the upper collar member  816 , whereby the valve in operation can be bi-directionally rotated in the directions indicated by the bi-directional arrow A. 
     The butterfly valve  806  is shaped so that it has a cross-sectional profile that is taperingly convergent from the central axis defined by collar members  816  and  820 , to the lateral edges  812  of the valve element. The main body  810  of the valve element thus may have a flattened or flap-like character. 
     The main body  810  of the butterfly valve  806  has a central opening extending transversely through the main body  810  (transverse to the central axis of the valve element, as defined by the center line of the valve element extending longitudinally through the main body  810  and upper collar  816  and lower collar  820 ) and outwardly from the respective faces of the valve element. The transverse dispersion opening  822  communicates by an interior passage (not shown in  FIG. 41 ) with the bore  818  of upper collar  816 , so that ozone gas introduced into the bore  818 , in the direction indicated by arrow C, flows through the upper collar  816  and the internal passage of main body  810  and is discharged at both faces of valve element from the transverse opening  822  into the valve cavity  804 , so that the dispersed sterilant fluid is thereafter distributed throughout the valve cavity  804  and passages in conduits  842  and  852 . 
     Such gas introduction can be carried out so that the gas dispersion interconnect device  800  that is coupled with flow circuitry elements at each of the flanges  846  and  856 , e.g., to tubing, piping, conduits, or other flow passage structure or fluid flow components achieves a sterile connection. 
     The main body  810  of the valve element  806  is also provided with lateral gas return ports  826  and  830  on one face of the main body (on the front face of the valve element in the view shown in  FIG. 41 ), with lateral gas return ports  834  and  836  on the opposite face and opposite marginal portion of the valve element  806  (i.e., the right-hand marginal portion on the back face of the valve element in the view shown in  FIG. 41 ). 
     The front face gas return ports  826  and  830  in the view shown communicate with the return gas discharge port at the top face  814  at the left-hand portion thereof, and the return gas ports  834  and  836  communicate with the return gas discharge port at the right-hand portion of the top surface  814  of the valve element  806 . 
     In this manner, each of the front and rear main faces of the butterfly valve element  806  present gas return discharge port openings communicating with interior passages in the main body  810 , so that gas following contact with interior surfaces of the valve chamber and associated flow circuitry structure enters the gas return port openings, flows through the interior passage structure of the valve element and is discharged from the valve at the gas discharge ports on the top surface  814  of the valve element, flowing in the direction indicated by arrows B in  FIG. 41 . 
     The valve element  806  may be rotatable as shown by the arrow A between a sterilization position and a product flow position. In the sterilization position, the dispersion opening  822  may be aligned or generally aligned with the bores of the conduits  842 ,  852 . In the product flow position, the valve element  806  may be rotated (e.g., by 90 degrees or about 90 degrees) so as to provide additional fluid flow space in the valve cavity  804 . 
       FIG. 42  is a front elevation view of the valve element  806 . As illustrated, the dispersion opening  822  extends through the body of the valve element. The dispersion opening  822  is configured to rapidly disperse “pre-sterilization” pressurized gas received from the upper collar bore  818  in the direction C ( FIG. 41 ). Also shown are gas return openings or ports  826 ,  830 . The gas return openings  826 ,  830  are configured to receive “post-sterilization” gas, which is then directed upward in the direction B ( FIG. 41 ). Gas return openings  834 ,  836  ( FIG. 41 ) are disposed on the opposite side of the valve element  806  and are not visible in  FIG. 42 . 
     As shown in  FIGS. 41 and 43 , at least a portion of the valve element  806  may be contained in the valve cavity  804  by a lid  870 . The lid  870  may include openings or ports  872  that may be aligned with the gas discharge openings at the valve element top surface  814 . The upper collar  816  may extend upwardly past the lid  870 . 
     The gas dispersion device  800  may be configured to receive a device similar to the portable gas transfer device  100  described above which may supply pressurized gas to the gas dispersion device  800  and/or may receive discharged post-sterilization gas from the gas dispersion device  800 . Further, the ozone source  420  of  FIG. 32  (or other pressurized gas/vapor source) could be used in connection with the gas dispersion device  800  or a similar gas dispersion device. For example, referring to  FIG. 41 , the ozone source  420  could be inserted into the upper collar bore  818 . A membrane similar to the membrane  500  ( FIG. 35 ) could be positioned at or near the upper collar bore  818 , and the membrane could receive the ozone source injection member  422  therethrough. Thus, the gas dispersion device  800  may be used with other pressurized gas/vapor sources, such as a syringe. 
     A gas interconnect dispersion device  900  according to some other embodiments is illustrated in  FIGS. 44-46 . The device includes a housing  910 , with the housing defining an internal cavity or chamber  912 . A top portion  914  includes a gas inlet port  916  and a pair of gas outlet ports  918 . Two flow conduits  920  are in fluid communication with the chamber  912 , with each of the conduits  920  extending away from the chamber  912  at different sides of the housing  910 . The housing may be generally cylindrical in shape, and the conduits  920  may be diametrically opposed. 
     A rotatable gas flow tube assembly  930  ( FIG. 46 ) is at least partially disposed within the chamber  912 . The rotatable tube assembly  930  includes a pair of dispersion openings  932  in fluid communication with the gas inlet port  916 . The dispersion openings  932  are configured to effectively and rapidly disperse pressurized “pre-sterilization” gas received from the gas inlet port  916  throughout the chamber  912  and through the conduits  920 . The rotatable tube assembly  930  is rotatable between a sterilization position and a product flow position, as described in more detail below. 
     The device  900  also includes a pair of return tubes  934  ( FIG. 45 ) at least partially disposed within the chamber  912 . Each return tube  934  is in fluid communication with a respective gas outlet port  918 . The tubes  934  are configured to receive “post-sterilization” gas; as described above, “post-sterilization” gas means gas that has already been dispersed and sterilized various components and/or has sterilized various components to a Sterile Assurance Level (SAL) of 10 −6 . The ends or tips of the tubes  934  disposed in the chamber  912  may be beveled, as best seen in  FIG. 45 . 
     Like the devices  10  and  800  described above, the device  900  is connectable or operatively connectable to various components, such as connectors, fittings, flow passageways and sensors/transmitters (e.g., fluid flow components), via the conduits  920 . Specifically, a distal end portion of each conduit  920  is configured to connect or operatively connect with at least one fluid flow component. As illustrated, the distal end portion of each conduit  920  includes a flange  940  to accommodate connection with such components, such as by a sanitary clamp. When the device  900  is connected to fluid flow components, the rotatable tube dispersion openings  932  are configured to disperse gas received from the gas inlet port  916  through or past the conduits  920  and adjacent or past the fluid flow components to sterilize these components (e.g., to achieve a SAL of 10 −6  for these components). 
     In some embodiments, at least a portion of the housing  910 , the conduits  920  and the flanges  940  form a monolithic structure. The rotatable tube assembly  930  may include a T-shaped member that defines the dispersion openings  932 . The rotatable tube assembly  930  may be at least partially enclosed within the chamber  912  by a lid  950 . Extending from or through the lid  950  is a collar  952  that defines the gas inlet port  916 . The lid  950  may also include through-holes that align with the gas outlet ports  918 . As illustrated, the rotatable tube assembly  930  and/or the lid  950  include one or more o-rings or other seals to effectuate a seal between the various components and to hinder the passage of pre- or post-sterilization gas or other fluid (e.g., bioprocessing fluid). 
     In some embodiments, the lid  950  is ultrasonically sealed or welded to the housing  910 . Again, the rotatable tube assembly  930  is free to rotate from a sterilization position to a product flow position (a rotation of approximately 90 degrees). 
       FIG. 45  illustrates the gas dispersion interconnect device  900  wherein the rotatable tube assembly  930  is in the sterilization position. It can be seen that the dispersion opening  932  is aligned with and substantially centered with the bore of the conduit  920  to provide effective dispersion and sterilization. 
     After components connected or operatively connected to the gas dispersion device  900  have been adequately sterilized (i.e., to an SAL of 10 −6 ), the rotatable tube assembly  930  may be rotated 90 degrees or about 90 degrees to a product flow position and bioprocessing fluid may pass through the conduits  920  and/or the chamber  912  of the gas dispersion device. Bioprocessing fluid passes through the sterilized path and past the sterilized flow components so that it can be measured and/or transferred with little to no contamination. In the product flow position, the dispersion openings  932  may be sealed by sidewalls of the housing  910  or chamber  912 . 
     The gas dispersion device  900  may be configured to receive a device similar to the portable gas transfer device  100  described above which may supply pressurized gas to the gas dispersion device  900  and/or may receive post-sterilization gas from the gas dispersion device  900 . Further, the ozone source  420  of  FIG. 32  (or other pressurized gas/vapor source) could be used in connection with the gas dispersion device  900  or a similar gas dispersion device. For example, referring to  FIG. 45 , the ozone source  420  could be inserted into the gas inlet port  916 . A membrane similar to the membrane  500  ( FIG. 35 ) could be positioned at or near the gas inlet port  916 , and the membrane could receive the ozone source injection member  422  therethrough. Thus, the gas dispersion device  900  may be used with other pressurized gas/vapor sources, such as a syringe. 
     It will be understood that various components or features of the gas dispersion interconnect devices  10 ,  800  and  900  may be combined. By way of example, the rotatable tube assembly  930  of the device  900  may also be retractable. By way of further example, the extendable/retractable gas flow member  24  of the gas dispersion device  10  may also be rotatable. 
     Many alterations and modifications may be made by those having ordinary skill in the art, given the benefit of present disclosure, without departing from the spirit and scope of the invention. Therefore, it must be understood that the illustrated embodiments have been set forth only for the purposes of example, and that it should not be taken as limiting the invention as defined by the following claims. The following claims, therefore, are to be read to include not only the combination of elements which are literally set forth but all equivalent elements for performing substantially the same function in substantially the same way to obtain substantially the same result. The claims are thus to be understood to include what is specifically illustrated and described above, what is conceptually equivalent, and also what incorporates the essential idea of the invention.