Isolated pressurization system and bag configuration

Commercial, food, industrial, medical, pharmaceutical and beverage industries recognize the benefits of flexible film bags. Storing/dispensing fluids from flexible film bags is an accepted practice in many scientific fields.

Examples include mammalian cell cultures, viscous fluids, edible compositions, toxic or infectious substances, and reactive substances. These liquids, flowable substances, can be manipulated directly from flexible film bags.

Bag technology is rapidly developing specialized films to safely package flowable solutions such as solvents and acids.

Dispensing a flowable substance enclosed first in a flexible film bag that is surrounded or otherwise supported by a frame or a rigid container of some kind, has advantages over just dispensing or transferring a flowable substance directly from the container. Using flexible film bags for dispensing flowable substances greatly reduces the time needed to clean, rinse, and sterilize the containment vessel. Unused portions can be quickly contained and or sealed and removed for later use.

The evaporation or spoilage concerns are considerably lower for substances first in a bag rather than resealing an opened container.

A flexible film bag after depletion, can leave a support vessel relatively residue free. Another advantage is the dispensing volume of a flexible film bag is subsequently reduced as substance is removed from the bag. Regardless of how much fluid is dispensed or added to the bag during a typical application cycle, the variable volume inside the bag does not allow ambient atmosphere to enter or exit. A depleted bag will have almost zero volume at the end of this cycle. Depleted bags can be refilled or discarded, and can be recyclable items. Removing a bag after depletion provides a reusable outer container that can be quickly returned to service. It is efficient for workers to safely manage any residue at the fitment portion of the bag. Fitments are typically tubes/conduits sealed to these bags, and are less complicated to service. On-off valves “down stream” from the containment vessel, in emergencies can greatly reduce maintenance confusion. When manipulating sensitive or toxic substances, an enclosed depleted bag can be quickly separated, closed and/or replaced with another bag without the need to clean or service the line or the containment vessel.

From a manufacturing standpoint, flexible film bags can have relatively thin wall construction. “Burst strength” of seam welds can be reducible as well. A thin flexible film bag positioned within a rigid support container becomes stronger than just the film itself. Utilizing a support container would typically, be constructed to be able to contain the flowable substance and be rated for strength anyway without a bag liner.

The implementation of thinner flexible film materials for bag walls unfortunately will have some setback consequences, when applying conventional pumping methods. One such problem is twisting and/or collapse of the bag walls limiting complete dispense of the fluid. However, cost saving incentives will drive manufacturers toward, the use of thinner walled dispensing bags in general. This may require alternative dispensing methods. Flexible film bag use will continue demonstrating their advantages. Bags are desirable for having reduced disposal volume, reduced shipping/handling weight, and less storage space needed for folded/flattened bags. Another feature, sterilizing, is less problematic. Typically, the process to sterilize a bag is concentrated through a small fitment passageway and is easy to seal the inner portion of the bag. Reusable support vessels may not require sterilizing and can be rearranged, stacked, and stored more efficiently.

Examples of a flexible film bag application as utilized in the shipping/transportation fields, are the intermediate bulk containers (IBC's) frequently used to ship, store, transfer, and otherwise manipulate liquids and/or viscous substance materials. IBC's typically hold more than a 55-gallon drum but less than a bulk drum (500 gallon). IBC's are generally of the “bag in box” design including an inlet/outlet port construction where a primary container in the form of a flexible collapsible inner bag contains the material and a rigid box or frame-like structure forms a secondary container to house the flexible bag. When transporting palletized containers of this type, the large volume containers are loaded many times from a truck or another large freight-type compartment, such as a freight ship, to conveyors and are picked up and set down by forklifts. The outer walls of the enclosed bag after inspection have been subjected to continuous and abrasive movement of the bag against the walls of the rigid container. Such abrasion can result in bag damage, leakage, and resultant loss of contents and contamination of surrounding areas.

Advancements in flexible film technology have anticipated and addressed in part IBC fluid storage and handling, with the advent of multiwall barrier films, improved lamination techniques, advanced seam construction, lubrication of bag surfaces, etc. This has contributed to the increased application possibilities of flexible film bags within the bulk fluid industries

The beverage and food industry also recognizes the benefits of flexible film packaging. Flexible film bags are generally, integrated in a “closed system,” that anticipates dispensing of a flowable substance in a reasonably sanitary manner. Cleaning processes are typically reduced by replacing a collapsed bag with a filled bag without the need to clean/sterilize/refill the line or containment vessels. Some “down-stream” problems still afflict the system though. A mechanism is required to pump or expel the beverage, a nozzle or interface is used between the beverage and the external environment, and a device to control the flow rate of the beverage is typically employed. Periodically these systems need to be flushed and cleaned; requiring parts disassembly of the pumping mechanism.

Flexible film bag use in the medical/pharmaceutical industries is another example. Processes routinely manipulate liquids using flexible film bags and often require an “agitation free” flow system when transferring mammalian, microbial cell cultures, biological materials, liquid medications, and/or infectious agents. Gravity flow systems can limit the agitation of delicate fluids however. Reverse suction at the end of a dispense cycle is a reoccurring problem, often requiring additional monitoring. Within these systems environmental containment, worker safety, and flow line control are paramount. Generally, these systems rely on precision transfer devices routinely requiring maintenance and inspection. Disposal and/or transferring these substances depend on sterile, aseptic conditions throughout all stages.

To expel or dispense a liquid from a bag generally depends on conventional mechanical devices such as the diaphragm pump, a peristaltic pump, a direct gas pump, or by using gravity to cause the substance to flow out of the storage container.

A diaphragm pump uses a movable diaphragm to directly push the liquid out of the storage container. A disadvantage of this type of prior art pump is that the liquid, being pumped comes in direct contact with internal parts of the diaphragm pump. Such contact increases the risk of bacterial contamination and makes the system difficult to clean and sanitize.

A peristaltic pump, on the other hand, comprises a rotating apparatus which periodically squeezes a substance through a flexible tube. One disadvantage with using a peristaltic pump is when changing to a different liquid the pump and tubes need to be evacuated and sterilized before the next operation. Another disadvantage of the peristaltic pump is the rotating drive can wear to the point of allowing environmental air or other particle contaminations to enter into or escape the system.

A direct gas pump dispenses a flowable substance with compressed gas, typically used for carbonated beverages such as beer in a keg. In this system, a compressed gas is introduced into the liquid container, the pressure of which expels the liquid. A major drawback with this method however, when applied to edible, organic, or sensitive fluids such as cell cultures, is that direct contact with these fluids can contaminate or cause spoilage and/or environmental contamination.

In a gravity flow system, the weight of the liquid provides the force to expel the substance. One disadvantage of the gravity flow system, however, is that the flow rate of the dispensed liquid is dependent on the head pressure (egress/ingress port) of the fluid inside the container. As the liquid empties, the head pressure decreases, which results in a reduction of flow rate. A second disadvantage of the gravity flow system is that substances that are more viscous will flow at unacceptably slow flow rates.

Utilizing pumps and/or direct gas infusion, or gravity to dispense liquids from flexible film bags is generally problematic. Flow control is uneven in most cases and limited by the above disadvantages associated with these systems.

An alternative dispensing system is needed that can better manage dispensing a flowable substance from a flexible film bag: an isolated pressurization system that does not pump the substance or alter the composition of the substance at any stage of the flow cycle. Isolated pressure to dispense a flowable substance from a bag should not be subjected to alternating suction or infusion of gases as with conventional prior art pumping or gravity systems. The risk of leakage or spillage of the primary fluid is considerably, lowered by eliminating the use of conventional in-line pump mechanisms.

As an alternative system capable of manipulating flowable substances enclosed in flexible film bags without relying on inline pump mechanisms or gravity, an alternative solution should:

An isolated pressurization system can dispense a flow able substance from a flexible film bag, without the use of conventional in-line pumping devices, or gravity-flow manipulation. The system is similar to squeezing a tube of toothpaste as a comparison. Specifically, an isolated pressurization system that substantially surrounds the flexible film bag containing a flowable substance, and can gently or forcefully expel the contents. The system assembly to dispense a fluid from a flexible film or “primary bag” () consists of an enclosable first bag () configured inside a second enclosable bag (). A surface wall portion of each bag is joined at an annular seam () location. A bag-in-bag assembly patented in U.S. Pat. No. 7,896,199 KACZMAREK held by applicant, is improved on, by adding a lumen tube () sandwiched between surface portions of the first and second bag walls at the seam location. The lumen tube () traverses a segment of the annular seam (), and welds with the walls in a liquid-proof manner. The material within the annular seam () may be a weakened area () that is sliced, perforated, or otherwise removed. The system bags may be enclosed at least two possible ways. The inner bag () edge portions are seamed, together in a liquid-proof manner to substantiality enclose the first bag (), and the outer bag () edge portions subsequently are seamed together in the same manner enclosing the second bag (). A second way is when the annular seam () is opened prior to enclosing the bags, they may be adjacent each other and edge seamed separately. Appling this method of assembly, one of the bags folds into the other through the annular seam ().

After assembly, the system portion is positioned in a pressure-rated vessel () having an opening. The annular seam () is subsequently secured at the mouth of the vessel. A primary bag () passes through the annular seam () and is positioned within the vessel () ready for filling and dispensing. The primary bag () enters the inner-most bag (). The bag () having at least a first liner, isolates the primary bag () from the pressurizing means. A bracer element (), positioned in the opening of the vessel, reduces the area of the vessel () opening to approximate the diameter of a primary bag conduit (). The lumen tube () exiting the vessel () connects with a pressurizing means (not shown). The pressurizing means is introduced through the lumen tube () to increase the volume between the first and second bag(s) (), (). A retaining means () and cap () secures the bracer element () atop a primary bag () and interlocks with the vessel (). Additional embodiments and components of the present invention can be further appreciated from the detailed description given herein and the accompanying drawings which are given by way of illustration only and thus are not limitative of the present invention.

Refers to a seam/seal area of a first region of one or more inside and/or outside flexible film surface(s) to a second region of one or more inside and/or outside flexible film surface(s) region wherein the seam/seal is a liquid proof, impervious to gas, weld or bonded area connecting the films, formed by gluing, compression fitting, and/or heating the regions to at least their respective seal initiation temperatures. Heating/welding can be performed by any suitable means such as using a heated bar, hot air, direct flame, infrared radiation, radio frequency radiation, ultrasonic sealing, or the like.

A welded or not welded surrounding ring like configuration includes straight and/or curved inside perimeter area, a welded seam surrounds portions of un-bonded film surfaces that enclose volume between surfaces, and the surfaces are either weakened, sliced, punctured, perforated, or otherwise removed before or after bonding and before use whereas, the surrounding outer perimeter may be larger than the inside perimeter, and the seam may include outer perimeter extension segments about the seam.

an isolated pressurizing system components and bag configuration, can dispense a flow able substance contained in a flexible film bag consists of:

A first flexible film sheet composed of at least one or more sheets and may include one or more layers or liners configured as an enclosable first primary bag. Primary bagconfigured to contain a volume of flowable substance to be dispensed. A primary bagmay include metallic layers and/or conductive elements between and/or part of liner surfaces. The layers/liners may derive, from a group of thermoplastics or polymers that remain flexible after the polymerization reaction when forming the layers. A primary baghas at least a first egress/ingress means such as conduitconfigured as a passageway to at least a first inner most area and volume. A primary bagmay include a first flangethat connects in a liquid proof manner to the bag and a first conduit. Conduitand flangemay derive, from a group of thermoplastics or polymers that remain flexible after the polymerization reaction when forming these components. Flangeand conduitmay include metallic elements. At least one or more combinations of layer edge seams of bagsubsequently are seam/sealed together in a liquid proof manner enclosing at least a portion of first primary bag.

It is contemplated where a corrosive flow-able substance is to be contained and dispensed, a primary bagmay have one or more inner flexible metal liner/layer surfaces, configured as an enclose able primary bag. Conduit, and flangemay be a one or more component assembly, and may include interlocking threads, or welded or compression fitting these components together. Flangeand conduit, compose a fitment assembly and may include a flow controllable device or other flow controllable means approximate flangeand in-line with conduit. A gas escape hosewhen present may include a one-way valve, removable plug or “pinch off” type or other comparable closing or otherwise flow controlling means. Flange, may include raised surface portions and may include a gas escape hose. hosemay be configured, as an access conduit for probes, wires, or otherwise sensor elements to the volume of a primary bag. Hosemay be transparent and serve as a fill indicator.

The isolated pressurization system cross sectional viewis in part a bag within bag within bag configuration assembly. A first flexible film sheet, layer or linercomposed of one or more sheets and one or more liners and may derive from a group of thermoplastics and/or polymers that remain flexible after the polymerization reaction when forming the liners. Liner(s)may be impervious to gas/liquid infusion have outside and inside surface area and may include metallic layers and/or conductive elements between and/or part of layer surfaces. At least a first linerportion edge regions are seam/sealed together to form an enclosable first bag, capable of containing a flowable substance. Bagmay include additional liners that may or may not have all edge portions seamed. Portions of lumen tubes, wires cables, may be affixed to portions of surfaces and/or edge seams. Embodiments may include lumen tubes, wires, cables transverse a segment of edge seams and enter between enclosed surfaces of combinations of liner(s)and/or liner(s).

A first liner/layeras an enclosed first bag configured to substantially surround a primary bag. Layers or linersconfigured as an enclosable first bag, should have sufficient internal surface area at least equal to or greater than the outer surface area of a primary bagfilled to maximum volume. Increased internal bagarea may be required for internal seam allotments additional conduitsand flangeclearance plus any lumen tube segmentsA, reclosable tubes, space frame components, cables containing wires(), heating and/or cooling elements, permeation sensors, vibration devicesetc. positioned therein or between combinations of layer(s). In some embodiments more than one flangemay be present and include divider(s)or separation means, and may have raised structural elements between surfaces of layer(s), and the outside surface of primary bag. In some embodiments sensor elements, and or conductive wires, may be inserted through a reseal able tube, in which case the internal area of bagshould be increased proportionally. Liner(s)isolates compression gases/liquids, reaction substances or other pressurizing means from contact with the primary bagouter most surface. The liner(s)may include stretchable layers. In some embodiments portions of liner(s)separate components between layers and/or from the primary bag. Liner(s)may include compression fabric, insulation and/or other spacing components, as well as tubes, cables, wires, and may include reactive substances between layers. In some embodiments, sensor elements, conductive wires, heating or cooling elements, and/or vibration devices, may be affixed to and/or between layers of primary bagand/or liner(s).

At least a first one or more flexible film sheets including at least one or more liners where the edge regions of at least one first liner sheet is subsequently seam/sealed together at approximate the liner(s) edge portions form an enclosable second bag. The enclosable portion(s) of layermay have lumen tubes wires, cables, connected at and/or passing through seam segments. Embodiments include lumen tubes, wires, cables may transverse a segment of edge seams and enter between enclosed surfaces of combinations of liner(s)and/or liner(s). Bagmay have one or more sheets that enclose a volume and area capable of containing a gas/liquid, reactive substances, or other pressurizing means. Bagmay have more than one layer or liners impervious to gases/liquid infusion. Bagmay have metallic layers and/or metallic elements between and/or part of layer surfaces and derive from a group of thermoplastics and/or polymers that remain flexible after the polymerization reaction when forming the layers. Layer(s)have outside and inside surfaces and may have one or more seams approximate edge portions configured to enclose a first volume. At least a first linerconfigured as an enclosed second bag should have an inside area sufficient to contain the combined area of a maximum volume primary bag(s)that may include system components and including liner(s)configurations, including sufficient area for seam segments and including any combinations of components positioned therein.

A preferred embodiment consists of Liner(s)portions configured as a first enclosable second bag that surrounds Liner(s)configured as a first enclosable first bag. Either bags may include system components wires, lumen tubes, fitments, bags, configured therein. At least a first surface portion of a first linerjoins to at least a first surface portion of a second linerand including a first lumen tube sandwiched between a first surface portion of bagand a first surface portion of bag. An annular seambonds a surface portion of bagto a segment of lumen tube portion and to a surface portion of bagin a liquid-proof manner. The lumen tube transverse a segment region of the annular seamsuch that an end portion of lumen tubeprotrudes from an inside perimeter segment of the annular seam. The opposite end portion of lumen tubeA protrudes from an outside perimeter segment of annular seam. It is understood, that the material within the annular seammay remain unbroken prior to system configuration, and/or some layer surface portions may be cut, separated, or otherwise removed, prior to system operation. Edge portions of a first enclosable first bagare seamed as an enclosable/enclosed first bag. Edge portions of a first enclosable second bagare seamed as a first enclosed/enclosable second bag.

Another embodiment bag configuration assembly is possible and consists of liner(s)portions configured as a first enclosable bag. Liner(s)portions configured as a first enclosable second bag. The bags are adjacent each other prior to joining. Either bags may include system components wires, cables, lumen tubes, fitments, bags, configured therein. At least a first surface portion of a first linerjoins to at least a first surface portion of a second linerand including a first lumen tube sandwiched between a first surface portion of bagand a first surface portion of bag. An annular seambonds a surface portion of bagto a segment of lumen tube portion and to a surface portion of bagin a liquid-proof manner. The lumen tube wires, cables, transverse a segment region of the annular seam, such that an end portion of lumen tubeand wires, cables, protrudes from an inside perimeter segment of the annular seam. The opposite end portion of lumen tubeA and any wires, cables protrudes from an outside perimeter segment of annular seam. The film material within the inside perimeter of seammay be a weakened area that is cut, sliced, or otherwise removed before the bags are enclosed. Edge portions of a first enclosable first bagare seamed to substancely enclose first bag. Edge portions of a first enclosable second bagare seamed to substantially enclose a second bag. Subsequently one of the bags may be rolled into the other through the annular seamproviding a bag-in-bag assembly.

Seammay not bond all liners of either linersand/or linerswith this first seam. A (second) seammay be configured around the outside perimeter edge of a first seamand may bond combinations of linersand/or linersnot bonded by a first seam. The seam(s)may include one or more lumen tubesend portions within the inside perimeter area of annular seamand one or more lumen tubesA end portions protrude from the outside perimeter portions of an annular seam. The lumen(s) are sandwiched and welded between combinations of layersand combinations of layers. The lumen tubes traverse an inside perimeter portion and an outside perimeter portion of a segment of seam. Where more than two sheets are bonded by an annular seamone or more lumen tubes, wires, cables may pass unbroken through a segment of inside perimeter aperture to an opposing segment inside perimeter of same or second aperture to exit/enter between different layer sheet surfaces. Lumen tubes, surface portions of wires, cables should be of materials bondable with the seams and flexible film sheets in a liquid proof manner and may be pressure rated and derive from a group of thermoplastics and/or polymers that remain flexible after the polymerization reaction when forming.

When more than one layer is configured as an enclosed/enclosable layer, openings or weep holes may be present in selected regions of layers that configure layer. Gases liquids, reactive substances entering a first layermay partly surround and enter that layer before entering a second layer and could continue to additional layers.

Seammay bond, wires, cables, metallic elements seamed in the same manner as lumen tube(s). In some assemblies weld filler may be utilized (call-out), in part or all of seam. The inside perimeter of the annular seamregion is sized to allow one or more primary bag(s)and any associated components to enter or exit damage free to an inner most surrounding portion of liner(s).

Lumen tube portionA, may have a space frame componentconfigured at an end portion and positioned approximate between surface portions of Liner(s)and surface portions of Liner(s).

Space frame componenthaving holes about the frame may be a stand alone component or otherwise may be affixed to a lumen tube end portion and may include a ‘ball in basket” or equivalent type one way flow component or may have flexible film configured as a “collapsible” lumen segment. The segment functions as a one way valve. The space frame componentprovides space for gasses or reactive substances to expand. In some embodiments, componentmay be an enclosed pouchincluding more than one layers, attached to a lumen tube portionA.

Other embodiments include a pouchmay have weakened areas, semi.-flexible structure within the pouch allowing gases, liquids, reactive substances to expand in a controllable manner. Pouchmay be positioned between combinations of surface liner(s)and/or surface liner(s). The isolated pressurization system with or without primary bag(s)inside, is positioned and secured within a pressure-rated containment vessel. Insertion of the bags by folding, rolling or crunching and/or added lubricant, is possible and should provide a damage free removable instillation.

Vesselhaving an opening, a neck portion commutating with a volume and internal area. The neck portion may have internal or external threads interlocking with matching internal or external threads of an open top retaining cover means. It is contemplated other attaching/locking means are possible, including but not limited to internal or external aliment regions, pins, tabs, tape, springs, clips, grooves, screws slots or the like. The open top retaining cover meansconnects at a neck portion and prevents the bracer elementand positioning sleevefrom being forced out of the vessel.

Positioning sleevefits inside the neck portion of vessel, and positions and secures seamapproximate the internal open portion of vessel. Sleevemay consist of one or more part components and may be semi rigid, flexible, and/or split or segmented along a length to allow a lower positioning sleeve flangeto pass through the neck of vessel. Sleevemay be of flexible material and flangemay be seamed, glued, welded to seam. Openings() may be provided and located approximate a wall of sleeveand lower flangeallows lumen tubesreseal able tube, cables containing wires, conductive wires, or combinations thereof to exit the opening of the neck. Upper positioning flangemay fit over a top edge portion of vessel neck. In some cases sleevemay have flangeremovably attached at a portion of seam. In other embodiments a portion of sleeveis secured to the inside neck by means of tape, glue, or other removable or non-removable fastening means. A primary bag(s)may be inserted or removed through sleeveor pre-packaged inside bag.

Referring to, andbracer elementpositions primary bag egress/ingress conduitapproximate inside center of neck bore, and may be part of, or removable with sleeve.

The bracer elementwhen positioned in the neck acts as a securing plug or brace between a retaining cover meansand primary bag fitment flange. Bracer elementmay be cylindrical, cubical, spherical, triangular, or other shape configuration, and may be constructed of wood, metal, plastic or other non-crushable material. Bracer elementprevents a flangeand/or conduitfrom being forced out of the neck of vesselwhen a pressuring force is applied between surfaces of bags/linersand surfaces of bags/liners.

illustrative view of bracer element as a frame structure having space for wires, cables, external probes, and access to primary bagand flangeand conduit. Other embodiments a portion of flangeof primary bagmay have a conductive areaaccessible through bracer element.

illustrates an aseptic closure assembly including an open top retaining cover meansthat threads to neck of vesseland a removable crown capthat may be separate able, rotatable, twist in, snap in, or other releasable means and may include gaskets, o-rings, sealant, and/or utilize compression or form type fittings, or other suitable means effectively limiting infusion of dust, gases, liquids or other external contamination.

Open top retaining cover meanssecures flangeto the top edge portion of the neck of vessel. Open top retaining cover meansalso secures bracer elementto an outer surface portion of primary bag(s)and/or flange.

Illustrative view of variable diameter retaining sleeve. Sleevesegmented upper flange, lower flangeand openings. Sleevemay be thin flexible one-or more piece distortable insert component. Other embodiments, sleevemay be adhesives, tape, straps, clips, bands, pins or other suitable removable retaining means, that secure and position seamto the inside neck and internal volume of vessel.

Illustrative view lumen tube passing through retaining sleeve and bottom flange positioning annular. Other embodiments sleevemay be joined with annular seamand split along its cylinder length and upper flangeis segmented for easer insertion through the neck of vessel. Fastening meanssuch as glue or tape, or a removable or permanent adhesive can attach the sleeveto the neck.

View of enclosed annular seam with lumen tube portion coiled between film layers. Inside perimeter weakened film layermay consist of combinations of layersand/or layersand enclose a length of lumen tube, wires cables, within annular seam. It is contemplated a sterilization process may be applied to components within filmlayers before, during, or after seamis formed. Film portionsmay be perforated allowing communication between selected liners within seam. A sterilizing means may be introduced through a lumen tubeto surfaces of bagand surfaces of bagprior to system operation.

Spool type bracer element. A two or more piece bracer assembly. Upper bracer centering ring elementmay have continuous, segmented, or separated portions. Lower bracer ring centering elementmay have continuous, segmented or separated lower bracing portions. A two or more piece bracer element assembly may be collapsible, distortable, compressible and may include conductive elements that make or break a circuit limiting excessive injected pressure. An embodiment may include a “pinch off” segment between upper, lower portions of a tapered duct. The compression of ductdiameter could stop or alter the flow through a primary bag conduit.