Patent Description:
Many pharmaceutical and bioprocessing processes utilize storage containers for storing fluid associated with the pharmaceutical or biological media. In certain instances, the container can include a bag having at least one flexible portion - such as a flexible sidewall.

Many pharmaceutical and biological media containers require venting. In certain instances, venting can prevent buildup of internal pressure, release of unwanted chemicals and byproducts, enhanced air circulation, or a combination thereof. <CIT> is concerned with a disposable flexible filtering pouch, in particular for use in an apparatus for collecting and filtering blood under sterile conditions.

The pharmaceutical and bioprocessing industries continue to demand better containers and associated technologies to permit more efficient storage and operation of pharmaceutical and biological containing fluids.

Embodiments are illustrated by way of example and are not intended to be limited in the accompanying figures.

The following description in combination with the figures is provided to assist in understanding the teachings disclosed herein. The following discussion will focus on specific implementations and embodiments of the teachings.

In accordance with the invention, a system for storing pharmaceuticals or biological media is defined in claim <NUM> and comprises a bag having a flexible sidewall defining an opening. A vent is coupled with the flexible sidewall at the opening and defines a vent passageway between an internal volume of the bag and an external environment. The vent is further coupled with the bag at a location spaced apart from and above the opening. In a particular embodiment, the vent can be coupled with the bag directly above the opening such that a line extending between the opening and location of coupling between the vent and bag is vertical, or generally vertical.

The system further includes a filter coupled with the bag. More particularly, the filter can be coupled with the bag at the location spaced apart from and above the opening. The filter is disposed between the bag and an end of the vent. In such a manner, the filter can act as a spacer such that the vent doesn't contact the bag at the location spaced apart from and above the opening in the flexible sidewall.

In an embodiment, a portion of the filter can be disposed on a first side of the bag and a second portion of the filter can be disposed on a second side of the bag opposite the first side. For example, in a particular embodiment, the filter can include a disk-like shape with projections emerging from opposing major surfaces of the disk-like shape. The filter can be installed relative to the bag such that at least a portion of a first projection on the first side of the disk-like shape is disposed on the first side of the bag and at least a portion of a second projection on the second side of the disk-like shape is disposed on a second side of the bag. In a particular embodiment, the first and second projections can correspond with a fluid pathway extending through the filter. Moreover, at least one of the first and second projections can include an engagement feature, such as a barb, adapted to form an interference fit with the bag, the vent, or a combination thereof.

In an embodiment, the location above and spaced apart from the opening in the flexible sidewall can correspond with a handle portion of the bag. More particularly, the location above and spaced apart from the opening can correspond with a portion of the bag having a single sidewall (e.g., not a portion of the bag defining an internal volume adapted to receive the pharmaceutical or biological media).

A lumen extending through the filter (e.g., through the first projection, the second projection, the disk-like shaped body, or a combination thereof) can be in fluid communication with the vent pathway. In a particular instance, vented fluid, including liquid or gaseous fluid, can move between the internal volume of the bag and the external environment through the vent passageway and through the lumen.

In an embodiment, the vented fluid can move through the bag (e.g., through the flexible sidewall or through the handle portion) prior to contacting the external environment. For example, in a particular embodiment, the lumen can extend through the bag. By way of example, one of the projections on the filter can extend through the bag such that a filter input is on a first side of the bag and a filter output is on a second side of the bag opposite the first side.

In an embodiment, the lumen can be adapted to lie along a generally horizontal plane when the system is in use (e.g., when the bag contains a pharmaceutical or biological media). In a more particular embodiment, the lumen can be perpendicular with a surface of the bag.

In certain instances, the filter can be coupled with the bag prior to coupling the vent to the filter. In other instances, the filter can be coupled with the vent prior to coupling the filter to the bag.

In accordance with the invention, a method of making a system for storing pharmaceuticals or biological media is defined in claim <NUM> and includes coupling a vent to an opening in a flexible sidewall of a bag. The method further includes installing a filter on the bag at a vertical elevation spaced apart from and above the opening. The method further includes attaching a free end of the vent to the filter, such that the filter is disposed between the bag and an end of the vent. In certain instances, installing the filter on the bag can occur prior to attaching the free end of the vent to the filter. In other instances, attaching the free end of the vent to the filter can occur prior to installing the filter on the bag.

In certain embodiments, coupling the vent to the opening is performed by welding the vent or an intermediary element to the bag, such as to the flexible sidewall of the bag.

In an embodiment, installing the filter is performed such that fluid flow through the filter occurs in a direction generally transverse to a major surface of the bag. More particularly, installation of the filter can occur such that fluid flow through the filter occurs in a direction generally transverse to the major surface of the bag when the bag is empty and supported or at least partially filled with pharmaceutical or biological media.

In an embodiment, the method can further include forming a lumen in the bag prior to installing the filter. By way of a non-limiting example, forming the lumen can include forming an opening in the bag having a diameter less than a diameter of a portion of the filter to be received in the lumen. After forming the lumen, the filter can be installed relative to the bag at the lumen. More particularly, the filter, or a portion thereof, can be inserted into the lumen. In an embodiment, the filter can form an interference fit with the lumen.

In an embodiment, the method can further include bending the vent or a portion thereof prior to attaching the free end of the vent to the filter. More particularly, the method can include bending the vent upward from the opening in the bag. In certain instances, attaching the free end of the vent to the filter can create an approximately <NUM> degree bend in the vent, as viewed between the opening and the filter.

A method of making a system for storing pharmaceuticals or biological media can include moving a free end of a vent extending from a flexible sidewall of a bag to a location above a non-free end of the vent. The method can further include coupling the free end of the vent to the bag.

In an embodiment, the method can further include coupling a filter to the bag. More particularly, coupling the filter to the bag can include coupling a barb portion of the filter with a lumen in the bag. In an embodiment, coupling the filter to the bag can be performed such that the barb passes from a first side of the bag to a second side of the bag opposite the first side.

In certain instances, biasing the free end of the vent is performed such that the non-free end of the vent is disposed at a vertical elevation below the free end of the vent.

In a particular instance, systems and methods described herein can be adapted for use with pharmaceuticals and biological media. In an embodiment, the systems and methods described herein can be used to maintain integrity of the filter during operation. More specifically, embodiments described herein can prevent filter wetting which can occur when fluid stored in the bag contacts the filter. In particular, embodiments described herein can reduce or prevent capillary action of fluid within the vent passageway that might cause wetting of the filter. Such wetting can lead to damaged fluid (particularly for sensitive pharmaceuticals), a damaged filter, or a combination thereof.

<FIG> includes a side view of a system <NUM> in accordance with an embodiment. The system <NUM> can generally include a bag <NUM> having a flexible sidewall <NUM> coupled with a handle portion <NUM>. In an embodiment, the flexible sidewall <NUM> can include two or more sheets of material coupled together. For example, by way of a non-limiting embodiment, the flexible sidewall <NUM> can include a first piece of material welded to a second piece of material. More particularly, the first and second pieces can be welded adjacent to the at least some of the edges thereof. In certain embodiments the bag <NUM> can include a collapsible bag.

In the illustrated embodiment, the handle portion <NUM> is disposed at a different vertical elevation as compared to the flexible sidewall <NUM>. More particularly, the handle portion <NUM> is disposed at a vertical elevation above the flexible sidewall <NUM>. In another embodiment, the handle portion <NUM> can be integral with the flexible sidewall <NUM>. The handle portion <NUM> can include a handle <NUM> adapted to permit user grasp of the system <NUM>. In certain embodiments, the handle <NUM> can be centered relative to the bag <NUM> as viewed when the bag <NUM> is empty and flattened on its side. In an embodiment, the handle portion <NUM> can include one or more engagement elements <NUM> adapted to permit engagement of the system <NUM> with an equipment (not illustrated), such as a rack, for filling, storing, transporting, or otherwise operating on fluid to be contained within the system <NUM>.

In an embodiment, the handle portion <NUM> can be formed from portions of the flexible sidewall <NUM> extending vertically upward from the flexible sidewall <NUM>. That is, the handle portion <NUM> can be integral with the flexible sidewall <NUM> of the bag <NUM> - or more particularly an upper portion of the flexible sidewall <NUM>.

In another embodiment, the handle portion <NUM> can be formed from a discrete component coupled to the flexible sidewall <NUM>. In a particular embodiment, the handle portion <NUM> can have a material composition different than the flexible sidewall <NUM>. In another particular embodiment, the handle portion <NUM> can have a material composition the same as the flexible sidewall <NUM>.

In an embodiment, the handle portion <NUM> can extend from only part of the flexible sidewall <NUM>. That is, in an embodiment, the handle portion <NUM> can extend around less than <NUM>% of the circumference of the bag <NUM>. For example, in a particular embodiment, the handle portion <NUM> can extend around approximately <NUM>% of the circumference of the bag <NUM>. In certain instances the bag <NUM> can be formed from two pieces of material welded together and the handle portion <NUM> can be formed from only one of the two pieces. In another embodiment, the handle portion <NUM> can extend around the entire circumference of the bag <NUM>. In yet a further embodiment, the handle portion <NUM> can extend around at least <NUM>% of the circumference of the bag <NUM>, at least <NUM>% of the circumference of the bag <NUM>, at least <NUM>% of the circumference of the bag <NUM>, or at least <NUM>% of the circumference of the bag <NUM>.

In an embodiment, the bag <NUM> can define a main opening <NUM> to permit filling of an internal volume of the bag <NUM>. The main opening <NUM> can be disposed, for example, along an upper section of the bag <NUM>, such as adjacent to or within the handle portion <NUM>. The main opening <NUM> can be selectively closable to selectively prevent unwanted fluid ingress or egress into and from an internal volume of the bag <NUM>. When not in use, the main opening <NUM> typically remains closed to maintain sterility of the internal volume.

The system <NUM> can include one or more fluid ports <NUM> adapted to permit, for example, sampling, transport, draining, or removal of fluid from the bag <NUM>. In a particular embodiment, at least one of the one or more fluid ports <NUM> can be disposed along a lower section of the bag <NUM>, such as for example, along a lower edge of the bag <NUM>. In an embodiment, the system <NUM> can include at least one fluid port <NUM>, at least two fluid ports <NUM>, at least three fluid ports <NUM>, at least four fluid ports <NUM>, or at least five fluid ports <NUM>. In another embodiment, the system <NUM> can include no greater than twenty fluid ports <NUM>, no greater than fifteen fluid ports <NUM>, or no greater than ten fluid ports <NUM>. In the illustrated embodiment, the fluid ports <NUM> have a same shape and size. In other embodiments, the fluid ports <NUM> can have different shapes, sizes, lumen diameters, operational capacities, or any combination thereof relative to one another. The one or more fluid ports <NUM> can be coupled with fluid lines adapted to permit transport of fluid from the bag <NUM> to an equipment or other fluid destination.

In an embodiment, the bag <NUM> can include an opening <NUM> in the flexible sidewall <NUM>. The opening <NUM> can extend through the flexible sidewall <NUM> and be in fluid communication with the internal volume of the bag <NUM>.

In an embodiment, the opening <NUM> is disposed above a fill-line of the bag. As used herein, the "fill-line" can refer to a prescribed capacity, or a maximum operational capacity, of the bag <NUM> as defined by the height of the internal volume. Elements disposed above the fill-line can stay dry while elements below the fill-line can contact the fluid. While the fill-line can refer to a maximum fill-line of the bag, the fill-line can also be relative to the volume of fluid within the bag <NUM>. Thus, in an embodiment, the fill-line can correspond with the relative fluid level in the bag <NUM> at any given moment. Elements above the relative fill-line remain dry while elements below the relative fill line come into contact with the fluid.

A vent <NUM> can be coupled with the flexible sidewall <NUM> of the bag <NUM>. In an embodiment, the vent <NUM> can be coupled with the flexible sidewall <NUM> at or adjacent to the opening <NUM>. In an embodiment, the vent <NUM> can be coupled to the flexible sidewall <NUM> through an intermediate element <NUM>. The intermediate element <NUM> can include a flanged portion <NUM> adapted to couple with the flexible sidewall <NUM> and a passageway <NUM> extending from the flanged portion <NUM>. In an embodiment, the intermediate element <NUM> can be permanently coupled with the flexible sidewall, such as welded to the flexible sidewall <NUM>. More particularly, in an embodiment, the flanged portion <NUM> of the intermediate element <NUM> can be ultrasonically welded to the flexible sidewall <NUM>. In certain instances, the flanged portion <NUM> can be removably coupled to the flexible sidewall <NUM>.

The vent <NUM> can include a tube defining a vent passageway (not illustrated). The vent passageway can extend between the internal volume of the bag <NUM> and the external environment. In an embodiment the vent <NUM> can be formed from or include a flexible material.

In an embodiment, the vent passageway can be in fluid communication with the passageway <NUM> of the intermediate element <NUM>. In a particular instance, the vent <NUM> can be engaged with the passageway <NUM> via an interference fit. In another particular instance, the vent <NUM> can be welded to the passageway <NUM>. In yet a further embodiment, the vent <NUM> can be coupled with the flanged portion <NUM> of the intermediate element <NUM>. By way of example, the vent <NUM> can be welded, adhered, or mechanically secured to the intermediate element <NUM>. One or more mechanical features, such as clamps (not illustrated), bands, ratchets, or other readily known securing devices can be used to secure the vent <NUM> to the intermediate element <NUM>.

Referring to <FIG>, in an embodiment, the vent <NUM> can include a fluid restrictor <NUM> adapted to permit selective restriction of fluid flow through the vent passageway. In an embodiment, the fluid restrictor <NUM> can include a hose clamp, a valve, a toggle, another fluid restricting device, or a combination thereof. In a certain instance, the fluid restrictor <NUM> can be manually operated, such as by hand. In another instance, the fluid restrictor <NUM> can be operated by a logic device, such as a microprocessor. As illustrated, and in accordance with certain embodiments, the fluid restrictor <NUM> can be disposed at a central, or generally central, location along the vent <NUM>. In an embodiment, fluid flow through at least a portion of the fluid restrictor <NUM> can occur along a plane generally tangent with the flexible sidewall <NUM> at the location of the fluid restrictor <NUM> when the bag <NUM> contains fluid. Alternatively, fluid flow through at least a portion of the fluid restrictor <NUM> can occur along a plane generally tangent with the flexible sidewall <NUM> at the location of the fluid restrictor <NUM> when the bag <NUM> is empty and flattened on its side. As used herein, "empty and flattened on its side" can refer to the orientation generally illustrated in <FIG>, where the bag <NUM> lies flat.

In certain instances, the vent passageway can lie along a line having a generally curved profile. In a particular embodiment, the vent passageway can lie along, or generally along, an arc forming an approximately <NUM> degree bend in the vent <NUM>.

In an embodiment, the vent <NUM> can be coupled with the bag <NUM> at a location <NUM> spaced apart from and above the opening <NUM>. In a particular embodiment, the location <NUM> can be directly above the opening <NUM>. Thus, for example, a line intersecting the opening <NUM> and the location <NUM> can be disposed along a Y-axis (vertical) when the bag <NUM> is upright (<FIG>).

In another embodiment, the location <NUM> can be laterally offset from the opening <NUM>. In such a manner, a line between the location <NUM> and the opening <NUM> can have an X-component and a Y-component. In certain embodiments, the X-component of the line can be greater than the Y-component of the line. For example, the X-component can be at least <NUM> times greater than the Y-component, at least <NUM> times greater than the Y-component, at least <NUM> times greater than the Y-component, at least <NUM> times greater than the Y-component, or at least <NUM> times greater than the Y-component. In other embodiments, the Y-component of the line can be greater than the X-component of the line. For example, the Y-component can be at least <NUM> times greater than the X-component, at least <NUM> times greater than the X-component, at least <NUM> times greater than the X-component, at least <NUM> times greater than the X-component, or at least <NUM> times greater than the X-component.

In an embodiment, the Y-component of the line, as measured between the opening <NUM> and the location <NUM>, can be at least <NUM>, at last <NUM>, at least <NUM>, at least <NUM>, or at least <NUM>. In another embodiment, the Y-component of the line, as measured between the opening <NUM> and the location <NUM>, can be no greater than <NUM>, no greater than <NUM>, no greater than <NUM>, or no greater than <NUM>.

In an embodiment, the line between the opening <NUM> and location <NUM> an be angularly offset from a Y-axis by at least <NUM>°, at least <NUM>°, at least <NUM>°, at least <NUM>°, at least <NUM>°, at least <NUM>°, at least <NUM>°, at least <NUM>°, at least <NUM>°, at least <NUM>°, or at least <NUM>°. In another embodiment, the line can be angularly offset from the Y-axis by no greater than <NUM>°, no greater than <NUM>°, no greater than <NUM>°, no greater than <NUM>°, no greater than <NUM>°, or no greater than <NUM>°.

In an embodiment, the location <NUM> is disposed adjacent to the handle portion <NUM> of the bag <NUM>. In a more particular embodiment, the location <NUM> is disposed adjacent to the handle <NUM>. In an embodiment, the location <NUM> is disposed within the handle portion <NUM> of the bag <NUM>. Thus, for example, the vent <NUM> can extend between locations along the flexible sidewall <NUM> and the handle portion <NUM>.

In certain instances, the location <NUM> is adapted to be disposed above the fill-line of the bag <NUM>. More particularly, the location <NUM> can be disposed above the fill-line of the bag <NUM>, as measured when the bag <NUM> is full of fluid. In certain instances, the opening <NUM> can be disposed above the fill-line.

Referring to <FIG>, the system <NUM> can include a filter <NUM> coupled with the bag <NUM>. In a more particular embodiment, the filter <NUM> can be coupled with the bag <NUM> at or adjacent to the location <NUM>.

In an embodiment, the filter <NUM> can extend through the bag <NUM> at the location <NUM>. In a more particular embodiment, the filter <NUM> can define a lumen <NUM> extending through the bag <NUM>. In yet a more particular embodiment, the lumen <NUM> can define a central axis extending perpendicular, or generally perpendicular with a major surface <NUM> of the bag <NUM> when the bag is empty and flattened on its side.

The filter <NUM> can be coupled with the vent <NUM>. In an embodiment, the filter <NUM> can be disposed at an end <NUM> of the vent <NUM>. The end <NUM> of the vent <NUM> can be opposite the end coupled with the bag <NUM> at or adjacent to the opening <NUM>.

In certain instances, the filter <NUM> can be disposed between the bag <NUM> and the end <NUM> of the vent <NUM>. That is, for example, the end <NUM> of the vent <NUM> can be spaced apart from the bag <NUM> by the filter <NUM>.

In the illustrated embodiment, a first portion <NUM> of the filter <NUM> is disposed on a first side <NUM> of the bag <NUM> and a second portion <NUM> of the filter <NUM> is disposed on a second side <NUM> of the bag <NUM>. In a particular embodiment, the first side <NUM> and second side <NUM> of the bag <NUM> can be opposite sides of the bag <NUM>. In another particular embodiment, the first side <NUM> and second side <NUM> of the bag <NUM> can define exterior surfaces of the bag <NUM>, interior surfaces of the bag <NUM>, or a combination thereof.

<FIG> includes a simplified cross-sectional view of the filter <NUM> coupled with the bag <NUM> at the location <NUM>. In an embodiment, the filter <NUM> is coupled to the bag <NUM> by an interference fit. In a particular embodiment, the filter <NUM> can include a barb <NUM> coupled with the bag <NUM>. As illustrated, the barb <NUM> can include an undulating or non-straight profile on the second portion <NUM> such that the second portion <NUM> engages with the bag <NUM> at the location <NUM>. The use of a barb may not be necessary where a frictional interference fit is sufficient to maintain engagement between the bag <NUM> and the filter <NUM>.

The end <NUM> of the vent <NUM> can be coupled with the filter <NUM>. In an embodiment, the vent <NUM> and filter <NUM> can be coupled together by an interference fit. In another embodiment, the vent <NUM> and filter <NUM> can be coupled together by a fastener, such as a threaded fastener. In yet another embodiment, the vent <NUM> and filter <NUM> can be welded together. In a further embodiment, the vent <NUM> and filter <NUM> can be adhered together by an adhesive or compound.

In an embodiment, the opening <NUM> is on the first side <NUM> of the bag <NUM> (<FIG>) and an end of the fluid flow path through the vent passageway and lumen <NUM> is on the second side <NUM> of the bag <NUM>. In such a manner, fluid flow between the internal volume of the bag <NUM> and the external environment can pass through the bag <NUM> at the location <NUM>.

As illustrated in <FIG>, the filter <NUM> can include a single-piece body. In another embodiment, the filter <NUM> can include a multi-piece construction.

In an embodiment, the filter <NUM> can include a disk shape defining a major surface <NUM>. In an embodiment the major surface <NUM> of the disk shape can be disposed adjacent a surface of the bag <NUM>. In certain instances, the filter <NUM> can be inserted into the bag <NUM> at the location <NUM> and biased toward the bag <NUM> until the major surface <NUM> of the filter <NUM> contacts the bag <NUM>.

The filter <NUM> can include a single use filter. In another embodiment, the filter <NUM> can be reusable. In an embodiment, the filter <NUM> can include a media or particulate for filtering. In another embodiment, the filter <NUM> can include a porous structure such as a block or structure of material having perforations or micro-perforations. In a further embodiment, the filter <NUM> can include a mesh, a screen, or a woven or non-woven medium. In yet another embodiment, the filter can include a combination of filter elements.

In accordance with embodiments described herein, a method of making a system for storing pharmaceuticals or biological media can include coupling the vent <NUM> to the opening <NUM> in the flexible sidewall <NUM> of the bag <NUM>. In a particular embodiment, coupling the vent <NUM> to the opening <NUM> is performed by welding. The method can further include installing the filter <NUM> on the bag <NUM> at a vertical elevation spaced apart from and above the opening <NUM>. In an embodiment, installing the filter <NUM> is performed such that the fluid flow through the filter <NUM> occurs in a direction generally transverse to a major surface of the bag <NUM>. In another embodiment, installing the filter is performed by inserting at least a portion of the filter <NUM> into the bag, such as for example, at a lumen formed in the bag prior to installing the filter <NUM>. In certain instances, forming the lumen includes forming an opening in the bag <NUM> with a diameter less than the diameter of the portion of the filter <NUM> adapted to be received in the lumen. The method can additionally include attaching a free end <NUM> of the vent <NUM> to the filter <NUM>. In certain instances, the method can further include bending the vent <NUM> prior to attaching the free end <NUM> of the vent <NUM> to the filter <NUM>.

Claim 1:
A system (<NUM>) for storing pharmaceuticals or biological media comprising:
a bag (<NUM>) including a flexible sidewall (<NUM>) defining an opening (<NUM>); and
a vent (<NUM>) coupled with the flexible sidewall (<NUM>) at the opening (<NUM>) and defining a vent passageway between an internal volume of the bag (<NUM>) and an external environment,
wherein the vent (<NUM>) is further coupled with the bag (<NUM>) at a location (<NUM>) spaced apart from and above the opening (<NUM>),
the system (<NUM>) further comprising a filter (<NUM>) coupled with the bag (<NUM>), characterised in that the filter (<NUM>) is disposed between the bag (<NUM>) and an end of the vent (<NUM>).