Bags and bag fitments containing rigid fluoropolymer spike ports

Abstract

The fitment for the bag includes an integrally formed spike port, the spike port including an aperture, a puncture barrier film, and an internal gasket. The fitment can be a fluoropolymer. The puncture barrier can be a fluoropolymer film. The internal gasket is positioned within the aperture and provides an additional puncture barrier for the spike port. The fitment can be incorporated into the bag by joining two sheets, such as fluoropolymer sheets, together and bonding the fitment to the periphery of the sheets. The bag can be used in processes involving exposure to or retention at cryogenic temperatures.

Description

[Technical Field]

[0001] The present disclosure relates to a bag including a fluoropolymer fitment that includes a spike port. [Background technology]

[0002] The medical bag can include a spike port welded directly to the sheet used to form the bag to provide for fluid transfer from the bag. Cell and gene therapy bags typically use conventional medical bags and corresponding fluid transfer methods, for example, for administration in a clinical setting. Summary of the Invention

[0003] The present disclosure relates to a bag including a fluoropolymer fitment that includes a spike port.

[0004] By incorporating a spike port integrally with the fitment for the bag and joining a sheet to the fitment to form the bag, a bag can be provided that includes a spike port for fluid transfer, while also providing a bag that is suitable for applications that involve exposure to or retention at cryogenic temperatures, for example, during processing of the contents of the bag.

[0005] In one embodiment, a fitment for a bag includes a fitment body including first and second sidewalls, each extending between opposing ends, the fitment body comprising a fluoropolymer material and a spike port. The spike port includes a spike port body. The spike port body is integrally formed with the fitment body, the spike port body including an aperture configured to receive a spike. The spike port further includes a first puncture barrier comprising a fluoropolymer film and an internal gasket disposed within the spike port body. The internal gasket is configured to provide a second puncture barrier.

[0006] In one embodiment, the internal gasket comprises silicone, a thermoplastic elastomer, a fluoropolymer, ethyl vinyl acetate, or a combination thereof.

[0007] In one embodiment, the diameter of the aperture ranges from 0.18 inches (about 4.5 mm) to 0.22 inches (about 5.6 mm).

[0008] In one embodiment, the fitment further includes an additional port integrally formed with the fitment body.

[0009] In one embodiment, the first puncture barrier is joined to the end of the spike port body by welding, the first puncture barrier covering the aperture.

[0010] In one embodiment, the first puncture barrier is disposed within the aperture.

[0011] In one embodiment, the inner surface of the spike port body includes an annular protrusion and the outer surface of the internal gasket includes an annular groove.

[0012] In one embodiment, the aperture has a first diameter in a first portion of the spike port body and a second diameter in a second portion of the spike port body that is smaller than the first diameter, and the internal gasket has an outer diameter that is smaller than the first diameter and larger than the second diameter.

[0013] In one embodiment, the inner surface of the spike port body includes one or more first engagement features and the internal gasket includes one or more second engagement features configured to engage with said first engagement features.

[0014] In one embodiment, the bag further includes a first fluoropolymer sheet and a second fluoropolymer sheet. A first portion of the periphery of the first fluoropolymer sheet is welded to a first portion of the periphery of the second fluoropolymer sheet, a second portion of the periphery of the first fluoropolymer sheet is welded to the fitment, and a second portion of the periphery of the second fluoropolymer sheet is welded to the fitment. The first portion of the periphery of the first fluoropolymer sheet and the second portion of the periphery of the first fluoropolymer sheet are the entire periphery of the first fluoropolymer sheet. The first portion of the periphery of the second fluoropolymer sheet and the second portion of the periphery of the second fluoropolymer sheet are the entire periphery of the second fluoropolymer sheet.

[0015] In one embodiment, a method includes providing a fitment, the fitment including a fitment body including first and second sidewalls, each extending between opposite ends, the first and second sidewalls defining a central opening, the fitment body including a fluoropolymer material, and a spike port body integrally formed with the fitment body, the spike port body including an aperture configured to receive a spike, the fitment including a fluoropolymer. The method further includes installing an internal gasket within the spike port body and welding a fluoropolymer film to the fitment to provide a puncture barrier.

[0016] In one embodiment, the method further includes providing a first fluoropolymer sheet, providing a second fluoropolymer sheet, welding a first portion of the periphery of the first fluoropolymer sheet to a first portion of the periphery of the second fluoropolymer sheet, and welding a second portion of the periphery of the first fluoropolymer sheet and a second portion of the second fluoropolymer sheet to the fitment, wherein the first portion of the periphery of the first fluoropolymer sheet and the second portion of the periphery of the first fluoropolymer sheet are the entire periphery of the first fluoropolymer sheet, and the first portion of the periphery of the second fluoropolymer sheet and the second portion of the periphery of the second fluoropolymer sheet are the entire periphery of the second fluoropolymer sheet.

[0017] In one embodiment, the internal gasket comprises silicone or ethyl vinyl acetate.

[0018] In one embodiment, the diameter of the aperture ranges from 0.18 inches to 0.22 inches.

[0019] In one embodiment, a fluoropolymer film is bonded to the end of the spike port body to cover the aperture.

[0020] In one embodiment, the fluoropolymer film is disposed within the spike port body.

[0021] In one embodiment, the inner surface of the spike port body includes an annular protrusion and the outer surface of the internal gasket includes an annular groove, and installing the internal gasket includes positioning the internal gasket so that the annular protrusion is received in the annular groove.

[0022] In one embodiment, the aperture has a first diameter in a first portion of the spike port body and a second diameter in a second portion of the spike port body that is smaller than the first diameter, the internal gasket has an outer diameter that is smaller than the first diameter and larger than the second diameter, and installing the internal gasket includes inserting the internal gasket from the first portion of the spike port body into the aperture.

[0023] In one embodiment, the inner surface of the spike port body includes one or more first engagement features, the internal gasket includes one or more second engagement features configured to engage with the first engagement features, and installing the internal gasket includes engaging the one or more first engagement features with the one or more second engagement features.

[0024] In one embodiment, a method of performing a process includes providing a bag according to an embodiment herein, adding a process fluid to the bag, bringing the bag to a temperature of -80°C or less, and inserting a spike into an aperture of the spike port. [Brief explanation of the drawings]

[0025] [Figure 1] FIG. 1 is a perspective view of a fitment according to one embodiment. [Figure 2] FIG. 1 is a cross-sectional view of a fitment according to one embodiment. [Figure 3A] FIG. 1 is a cross-sectional view of a spike port according to one embodiment. [Figure 3B] FIG. 1 is a cross-sectional view of a spike port according to one embodiment. [Figure 3C] FIG. 1 is a cross-sectional view of a spike port according to one embodiment. [Figure 3D] FIG. 1 is a cross-sectional view of a spike port according to one embodiment. [Figure 4] 1 illustrates a bag according to one embodiment. [Figure 5] 1 illustrates a method of manufacturing a bag according to one embodiment. [Figure 6]10A-10C illustrate a method of use of a bag according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0026] The present disclosure relates to a bag including a fluoropolymer fitment that includes a spike port.

[0027] 1 shows a perspective view of a fitment according to one embodiment. Fitment 100 includes a fitment body 102 having a first side wall 104 and a second side wall 106. First side wall 104 and second side wall 106 each meet at opposing end points 108. A spike port 110 is integrally formed with fitment body 102. Spike port 110 includes a spike port body 112, an end 114, an aperture 116, and a puncture barrier film 118. An internal gasket (not shown) can be included within spike port body 114.

[0028] Fitment 100 is a fitment configured to be attached to a flexible sheet, such as a fluoropolymer sheet, to form a bag containing fitment 100. Fitment 100 is configured to provide one or more ports that allow communication between the interior space of such a bag and the exterior of the bag. Fitment 100 can be a single, integral piece with all features integrally formed, or it can be assembled from multiple pieces secured together using, for example, one or more welds. Fitment 100 can comprise any suitable material, such as a fluoropolymer. In one embodiment, fitment 100 is formed entirely from a fluoropolymer. In an embodiment, the fluoropolymer can include one or more of an ethylene tetrafluoroethylene (ETFE) polymer, a polychlorotrifluoroethylene (PCTFE) polymer, a polyvinyl fluoride (PVF) polymer, a polyvinylidene fluoride (PVDF) polymer, or the like. In one embodiment, the fluoropolymer is ETFE.

[0029] The fitment 100 includes a first sidewall 104 and a second sidewall 106. The first sidewall 104 and the second sidewall 106 meet at opposing endpoints 108. One or both of the first sidewall 104 and the second sidewall 106 can be curved. In one embodiment, one or both of the first sidewall 104 and the second sidewall 106 can include one or more recesses. In one embodiment, one or both of the first sidewall 104 and the second sidewall 106 can include protrusions. The first sidewall 104 and the second sidewall 106 can provide the fitment 100 with a “boat” shape. The first sidewall 104 and the second sidewall 106 each provide an exterior surface configured to allow attachment of a sheet, such as a fluoropolymer sheet, so that the fitment 100 can be contained in a bag. The first sidewall 104 and the second sidewall 106 can be contoured such that the first sidewall 104 and the second sidewall 106 provide an attachment surface that allows for continuous attachment of a sheet or film, allowing a smooth transition from attachment of the sheets to each other to attachment of the sheets to the first sidewall 104 or the second sidewall 106. In one embodiment, the first sidewall 104 and the second sidewall 106 can define a central opening configured to communicate with the interior space of the bag formed by attaching the sheet or film to the fitment 100. The sidewalls 104, 106 can be shaped according to the disclosure of U.S. Patent Application No. 16 / 257,921, the entirety of which is incorporated herein by reference.

[0030] A spike port 110 is provided in the fitment 100. The spike port is configured to receive a spike such that the spike can be positioned to communicate with the interior space of a bag containing the fitment 100. The spike port 110 includes a spike port body 112 extending from the fitment 100 to an end 114. The end 114 is positioned such that the end 114 is provided on the exterior of a bag formed using the fitment 100 when the bag is formed. The spike port body 112 can be formed integrally with other components of the fitment 100, such as the first and second side walls 104, 106. The spike port body includes an aperture 116 that extends from the end 114 through the spike port body 112 such that the aperture 116 can provide communication between the interior space of the bag formed using the fitment 100 and the spike port body. In one embodiment, aperture 116 can connect to a central opening defined by fitment 100, for example, between first sidewall 104 and second sidewall 106. In one embodiment, aperture 116 extends entirely through fitment 100. Aperture 116 is sized so that any suitable spike can be inserted into spike port 110 so that fluid can be added to or removed from a bag formed using fitment 100. Aperture 116 can be sized for use with one or more different types of spikes. In one embodiment, aperture 116 is sized to be independent of manufacturer variations or sizing of spikes within a specified range. In one embodiment, aperture 116 has an inner diameter ranging from 0.18 inches to 0.22 inches. An internal gasket (not shown) can be provided within spike port body 112, aperture 116, for example, as described below and shown in FIGS. 2 and 3A-3C.

[0031] The puncture barrier film 118 can be provided to close the aperture 116 prior to insertion of the spike. The puncture barrier film 118 can be provided over the opening of the aperture 116 at the end 114 or can be provided within the aperture 116. The puncture barrier film 118 can be a polymer film of any suitable polymer. In one embodiment, the puncture barrier film 118 is a fluoropolymer film. In one embodiment, the puncture barrier film 118 is a film of the same fluoropolymer as the fluoropolymer contained in the spike port body 112. In one embodiment, the puncture barrier film 118 is a film of the fluoropolymer used in the fluoropolymer sheet used to form the bag containing the fitment 100. The puncture barrier film 118 is joined to the spike port body 112 by any suitable method, for example, welding, such as heat welding.

[0032] FIG. 2 shows a cross-sectional view of a fitment according to one embodiment. Fitment 200 includes a sidewall 202. Sidewall 202 partially defines a central opening 204. A spike port 206 is joined to sidewall 202. Spike port 206 includes a spike port body 208 having an aperture 210 formed therein. Aperture 210 includes a first end 212 and a second end 214. First end 212 of aperture 210 is connected to central opening 204. Second end 214 of aperture 210 is disposed at the end of spike port body 208. An internal gasket 216 is disposed within aperture 210. A puncture barrier film 218 can be disposed at or near second end 214 of aperture 210. One or more additional ports 220, for example, ports 220 having hose return connections 222, may optionally be included in fitment 200.

[0033] Fitment 200 is a fitment to which polymer sheets can be joined to form a bag. Fitment 200 provides an attachment area to which polymer sheets can be joined and provides one or more ports, such as spike port 206 and optional additional port 220, to allow communication between the interior and exterior of the bag. Fitment 200 can be a single, integral piece with all features integrally formed, or it can be assembled from multiple pieces secured together using, for example, one or more welds. Fitment 200 can comprise any suitable material, such as a fluoropolymer. In one embodiment, fitment 200 is formed entirely from a fluoropolymer. In an embodiment, the fluoropolymer can include one or more of an ethylene tetrafluoroethylene (ETFE) polymer, a polychlorotrifluoroethylene (PCTFE) polymer, a polyvinyl fluoride (PVF) polymer, a polyvinylidene fluoride (PVDF) polymer, or the like. In one embodiment, the fluoropolymer is ETFE.

[0034] 2, sidewall 202 is visible. Sidewall 202 can be a sidewall that partially defines a portion of fitment 200 to which a polymer sheet can be attached to form a bag. In one embodiment, sidewall 202 is one of first sidewall 104 or second sidewall 106, as described above and shown in FIG. 1. In fitment 200, sidewall 202 partially defines central opening 204. Central opening 204 is located on the side of fitment 200 that faces the interior of the bag when a polymer sheet is attached to fitment 200 to form a bag.

[0035] Spike port 206 extends from fitment 200. Spike port 206 is a port configured to receive a spike so that fluid can be added to or removed from a bag containing fitment 200. Spike port 206 includes a spike port body 208. Spike port body 208 defines an aperture 210. Aperture 210 is configured to receive a spike so that the spike can be positioned to communicate with the interior space of the bag containing fitment 200. Spike port body 208 can be formed integrally with another portion of fitment 200, such as sidewall 202. Aperture 210 extends through spike port body 208 from a first end 212 to a second end 214. First end 212 is positioned such that first end 212 is located on the outside of a bag formed by joining a polymer sheet to fitment 200. Second end 214 is configured to communicate with the interior space of the bag formed by the attachment of the polymer sheet to fitment 200. In the embodiment shown in FIG. 2, second end 214 communicates with central opening 204. In alternative embodiments, second end 214 can be on the opposite side of fitment 210 from first end 212. In one embodiment, aperture 210 is sized to be independent of manufacturer variations or sizing of spikes within a specified range. In one embodiment, aperture 216 has an inner diameter in the range of 0.18 inches to 0.22 inches.

[0036] An internal gasket 216 is provided within the aperture 210 of the spike port 206. The internal gasket is configured to provide a puncture barrier before a spike is inserted into the aperture 210 and to retain the spike after it has been inserted into or through the internal gasket 216. The puncture barrier provided by the internal gasket 216 may be in addition to a dedicated puncture barrier, such as the puncture barrier film 118 described above and shown in FIG. 1 or the puncture barrier film 218 provided in FIG. 2. The internal gasket 216 may be a separate piece from the spike port body 208. The internal gasket 216 may be retained within the aperture 210 by any suitable connection, for example, a mechanical connection, such as a press fit, engagement of one or more engagement features, contact with one or more shoulders formed in the spike port body 208, combinations thereof, etc. The internal gasket 216 can be formed from any one or more suitable materials, with non-limiting examples of suitable materials including silicone, ethyl vinyl acetate (EVA) polymer, thermoplastic elastomer, fluoropolymer, neoprene, and the like. The material of the internal gasket 216 can have any suitable hardness. In one embodiment, the material of the internal gasket 216 has a Shore A durometer of up to 90. In one embodiment, the material of the internal gasket 216 has a Shore A durometer of 50 to 90. In one embodiment, the material of the internal gasket 216 has a Shore A durometer of 50 to 70. In one embodiment, the material of the internal gasket 216 has a Shore A durometer of approximately 70. The material of the internal gasket 216 can have any suitable glass transition temperature selected depending on the conditions to which the internal gasket 216 will be subjected. In one embodiment, the glass transition temperature of the material of the internal gasket 216 can be −30° C. or lower. In one embodiment, the glass transition temperature of the material of the inner gasket 216 may be less than or equal to −125° C. In one embodiment, the glass transition temperature of the material of the inner gasket 216 may be less than or equal to −170° C.

[0037] A puncture barrier film 218 can be provided to close the aperture 210 prior to insertion of the spike. The puncture barrier film 218 can be provided over the first end 212 of the aperture 210 or can be provided within the aperture 210. The puncture barrier film 218 can be a polymer film of any suitable polymer. In one embodiment, the puncture barrier film 218 is a fluoropolymer film. The puncture barrier film 218 is joined to the spike port body 208 by any suitable method, for example, welding, such as heat welding.

[0038] Optional port 220 may be another port provided in fitment 200 to allow communication between the interior of a bag formed using fitment 200 and the exterior of the bag. Port 220 may be any suitable port for providing such communication. In one embodiment, port 220 may be a spike port similar to or identical to spike port 208. In one embodiment, port 220 may be a port that includes another connection mechanism, such as, for example, hose return 222 shown in FIG. 2 . In one embodiment, port 220 may be in communication with central opening 204. In one embodiment, port 220 may extend through fitment 200. In an embodiment, two or more of optional ports 220 may be included. In one embodiment, optional additional port 220 may include hose return connection 222. Hose barb connection 222 may include one or more protrusions extending outward from port 220, such as the conical protrusions shown in FIG. 2, so that a hose can be extended over hose barb connection 222 and held in place on port 220 to facilitate transfer of fluid to or from a bag containing fitment 200 when the hose is connected. In embodiments, other suitable attachments may be provided on port 220, such as quick connect-disconnect systems, luer connection mechanisms, formed tubing, etc. Examples of such attachments include, by way of non-limiting example, sterile connectors, such as those according to U.S. Provisional Patent Applications Nos. 63 / 255,581 and 63 / 297,148, which are incorporated herein by reference in their entireties. In embodiments including more than one of optional additional ports 222, the connectors provided on each port 220 may all be the same type of connector, or may be different types of connectors.

[0039] FIG. 3A shows a cross-sectional view of a spike port according to one embodiment. The spike port 300 includes a spike port body 302 having an inner surface 304. An annular protrusion 306 extends from the inner surface 304. An internal gasket 308 includes an outer surface 310. An annular groove 312 is formed in the outer surface 310 of the gasket 308. In one embodiment, one or both of the annular protrusion 306 and the annular groove 312 are continuous around the inner surface 304 or the outer surface 310, respectively. In one embodiment, one or both of the annular protrusion 306 and the annular groove 312 include one or more discontinuities relative to the circumference of the inner surface 304 or the outer surface 310, respectively. The internal gasket 308 can be installed within the spike port 300 by inserting the internal gasket 308 into the space defined by the inner surface 304 until the annular protrusion 306 is received in the annular groove 312. The internal gasket 308 may be configured such that the outer surface 310 forms a press fit with the inner surface 304 of the spike port body 302. A puncture barrier film 314 may be provided at or near the end of the spike port body 302.

[0040] FIG. 3B shows a cross-sectional view of a spike port according to one embodiment. The spike port 320 includes a spike port body 322 having a first section 324 with a first inner diameter and a second section 326 with a second inner diameter. The first inner diameter is larger than the second inner diameter. The first and second inner diameters can each be sized so that a spike can be received through an internal gasket 334 and provide fluid communication through the spike port 320, including the internal gasket 334. A shoulder 328 can be provided where the spike port body 322 transitions from the first section 324 to the second section 326. The first section 324 with the first inner diameter can extend to an end 330 that includes a puncture barrier film 332. The second section 326 can connect to a central opening of a fitment containing the spike port 320, such as the central opening 110 described above and shown in FIG. 1 . An internal gasket 334 can be included in the spike port 320. The internal gasket 334 can be sized so that it can be inserted into the spike port body 322 at the first section 324 and retained on the shoulder 328. For example, the internal gasket 334 can have an outer diameter that is equal to or less than the first inner diameter and greater than the second inner diameter. The internal gasket 334 can be installed in the spike port 320 by inserting the internal gasket 334 into the first section 324 until it contacts the shoulder 328, thus seating the internal gasket 334. The puncture barrier film 332 can be bonded to the spike port 320 at or near the end 330 after the internal gasket 334 is inserted and seated against the shoulder 328. A retainer 336 can be provided to hold the internal gasket 334 in place.

[0041] 3C shows a cross-sectional view of a spike port according to one embodiment. The spike port 340 includes a spike port body 342 having a first section 344 having a first inner diameter and a second section 346 having a second inner diameter. The first and second inner diameters can each be sized such that a spike can be received through an internal gasket 350 and the spike can provide fluid communication through the spike port 340, including the internal gasket 350. One or both of the first section 344, the second section 346, or a transition region between the first section 344 and the second section 346 can include one or more spike port body engagement features 348 on the inner surface of the spike port body. The internal gasket 350 can have an outer diameter equal to or less than the first inner diameter and greater than the second inner diameter. The internal gasket 350 can include one or more internal gasket engagement features 352 configured to engage with the spike port body engagement features 348. The internal gasket engagement feature 352 and the spike port body engagement feature 348 can be any suitable corresponding pair of engagement features, for example, corresponding tabs, protrusions, detents, etc., and corresponding recesses, grooves, etc. The internal gasket engagement feature can be configured to secure the internal gasket 350 in place when the internal gasket 350 is positioned within the spike port body 342. In one embodiment, the internal gasket engagement feature 352 and the spike port body engagement feature 348 are configured such that their engagement resists rotation of the internal gasket 350 relative to the spike port body 342. In one embodiment, the internal gasket engagement feature 352 and the spike port body engagement feature 348 are configured such that their engagement resists translational movement of the internal gasket within the first section 344 of the spike port body 342, preventing the internal gasket from sliding within or escaping from the spike port body 342.The internal gasket 350 can be installed in the spike port 340 by inserting the internal gasket into the spike port body first section 344, compressing the internal gasket 350, and optionally rotating the internal gasket 350 so that the internal gasket engagement feature 352 and the spike port body engagement feature 348 engage with one another. A puncture barrier film 354 can be provided at the end of the spike port 340. A retainer 356 can be provided to hold the internal gasket 350 in place.

[0042] FIG. 3D shows a cross-sectional view of a spike port according to one embodiment. The spike port 360 includes a spike port body 362 defining an aperture 364. An internal gasket 366 is disposed within the aperture 364 and is integrally formed with the spike port body 362. In the embodiment shown in FIG. 3D, the internal gasket 366 can be made of the same material as the spike port body 362. The internal gasket 366 can completely block the aperture 364 until it is penetrated by a spike inserted into the spike port 360. The internal gasket 366 can be formed, for example, by molding the spike port body 362 to include the internal gasket 366. Optionally, when the internal gasket 366 is integrally formed with the spike port body 362, the internal gasket 366 can further function as a puncture barrier film and can optionally include or omit a separate puncture barrier film, such as puncture barrier films 314, 332 or 354 described above and shown in Figures 3A-3C.

[0043] FIG. 4 shows an exploded view of a bag according to one embodiment. Bag 400 includes a fitment 402 including a spike port 404. Fitment 402 can be any fitment described herein. Fitment 402 further includes a first side wall 422 and a second side wall 424. Fitment 402 can include or be constructed entirely of a fluoropolymer material. Bag 400 further includes a first sheet 406 having a first perimeter 408. First sheet perimeter 408 includes a first portion 410 and a second portion 412. Bag 400 also includes a second sheet 414 having a second sheet perimeter 416. Second sheet perimeter 416 includes a first portion 418 and a second portion 420. The first sheet perimeter 408 and the second sheet perimeter 416 are outer regions of the first and second sheets 406, 412, respectively. One or both of the first sheet 406 and the second sheet 414 can include or be entirely composed of a fluoropolymer material. The fluoropolymer material used for the first sheet 406 and the second sheet 414 can be the same fluoropolymer material used in the fitment 402. The bag 400 can be formed by joining the first sheet perimeter 408 to the second sheet perimeter 416 at their respective first portions 410, 418. Forming the bag 400 further includes joining the second portion 412 of the first sheet perimeter 408 to the first sidewall 422 of the fitment 402 and joining the second portion 420 of the second perimeter 416 to the second sidewall 424 of the fitment 402. The entire first sheet perimeter 408 and the entire second sheet perimeter 416 are joined to either the other sheet perimeter 408, 416 or the fitment 402 to separate the interior of the bag from the external environment. The joining of the first sheet perimeter 408 to the second sheet perimeter 416 and / or the fitment 402 can be by any suitable means of joining materials, such as welding, e.g., heat welding. In one embodiment, the weld can have a weld width ranging from about 1 / 8 inch (about 3.2 millimeters (mm)) to about 1 / 2 inch (about 12.7 mm).The use of a larger weld width can provide robustness to the weld during bag cooling and warming. The bond at the peripheral edges 408, 416 can be spaced from the edges of the first and second sheets 406, 414, yet still within their outer regions, as appropriate for forming the bag. In one embodiment, the weld joining the first sheet 406 and the second sheet 414 can have the same weld width as the weld joining the first sheet 406 to the fitment 402 and / or the weld joining the second sheet 414 to the fitment 402. In one embodiment, the weld joining the first sheet 406 and the second sheet 414 can have a different weld thickness than the weld joining the first sheet 406 to the fitment 402 and / or the weld joining the second sheet 414 to the fitment 402.

[0044] 5 illustrates a method of manufacturing a bag according to one embodiment. Method 500 includes providing a fitment body 502, installing an internal gasket within the fitment body 504, and attaching a puncture barrier 506. Method 500 can further include providing first and second sheets 508, joining the first sheet to the second sheet 510, and joining the first and second sheets to the fitment 512.

[0045] At 502, a fitment body is provided. The fitment body includes a spike port. In one embodiment, the spike port can be attached to the fitment body by welding. In one embodiment, the spike port can be integrally formed with the fitment body. The fitment body can be any fitment body including a spike port as described herein, such as fitment 100 shown in FIG. 1 and described above, fitment 200 shown in FIG. 2 and described above, or a fitment including one of spike ports 300, 320, 340 shown in FIGS. 3A-3C and described above. The fitment body provided at 502 can be formed of a fluoropolymer material.

[0046] At 504, an internal gasket is installed within the fitment body. The internal gasket can be configured to be installed within the fitment body, for example, by having an outer diameter equal to or smaller than the inner diameter of at least a portion of a spike port included in the fitment body. In one embodiment, installing the internal gasket at 504 includes inserting the internal gasket into the spike port. The internal gasket can be inserted into a position that forms a press fit with the inner surface of the spike port. The internal gasket can be inserted to a depth that contacts a shoulder formed where the inner diameter of the spike port transitions from the first inner diameter to the second inner diameter. The internal gasket can be inserted such that corresponding engagement features on the internal gasket and the inner surface of the spike port can engage with each other, for example, to retain the internal gasket and / or prevent rotation of the internal gasket relative to the spike port.

[0047] At 506, a puncture barrier is attached. The puncture barrier can be, for example, a fluoropolymer film. The puncture barrier can be attached at 506 to close an aperture in the spike port. The puncture barrier can be attached at the end of the spike port, within the aperture, or any other suitable location that can close the aperture through the spike port of the fitment. In one embodiment, the puncture barrier is attached to the end of the spike port. The puncture barrier can be attached via any suitable attachment means that provides a seal. In one embodiment, the puncture barrier is attached by welding, such as heat welding and ultrasonic welding, or any other suitable welding. In one embodiment, the puncture barrier is attached by heat welding.

[0048] First and second sheets can be provided at 508 to form a bag including a fitment with a spike port, an internal gasket, and a puncture barrier. The first and second sheets can be sheets of any suitable material, such as, for example, a film of a fluoropolymer material. In one embodiment, the first and second sheets can include a fluoropolymer material that is also included in the fitment body. In one embodiment, the first and second sheets include ethylene tetrafluoroethylene (ETFE). The first and second sheets can be of a size and shape appropriate to form the bag.

[0049] The first and second sheets can be joined together at 510. The first and second sheets are joined at or near their outermost edges along a portion of their peripheries. The sheets can be joined by welding, such as by heat welding. The weld can be continuous along a portion of the peripheries of the first and second sheets. In one embodiment, the weld can have a weld width ranging from about 1 / 8 inch (about 3.2 millimeters (mm)) to about 1 / 2 inch (about 12.7 mm).

[0050] At 512, the first sheet and the second sheet can be joined to the fitment. A portion of the peripheral edge of the first sheet that is not joined or will not be joined to the second sheet is attached to a first side wall of the fitment. A portion of the peripheral edge of the second sheet that is not joined or will not be joined to the first sheet is attached to a second side wall of the fitment. Attachment of the first sheet and the second sheet to the fitment can be by any suitable method of joining the sheets and the fitment. In one embodiment, the first and second sheets are joined to the fitment at 512 by welding, such as by heat welding. In one embodiment, the weld can have a weld width ranging from about 1 / 8 inch (about 3.2 millimeters (mm)) to about 1 / 2 inch (about 12.7 mm). Attachment of the first sheet and the second sheet to the fitment can be by a continuous attachment that corresponds to the joining of the first sheet and the second sheet to each other. Sequential attachment can reduce or eliminate weaknesses in the attachment of the sheets and fitment to one another. While method 500 is shown in FIG. 5 as the first and second sheets being joined to one another at 510 and then connected to the fitment at 512, it is understood that the order of these steps can be changed. In one embodiment, the first sheet and / or the second sheet can be joined to the fitment at 512 and then the first and second sheets can be joined to one another at 510. In one embodiment, the first and second sheets can be joined to one another at 510 during a period that overlaps with the time the first and second sheets are joined to the fitment at 512. Once the sheets are attached to one another at 510 and to the fitment at 512, only the fitment can be in communication with the interior space of the resulting bag, for example, via a spike port.

[0051] FIG. 6 illustrates a method of using a bag according to one embodiment. Method 600 includes providing a bag 602, filling the bag with a process fluid 604, cryogenically cooling the bag and process fluid 606, and inserting a spike into a spike port 608. The bag provided in 602 can be any bag provided herein that includes a fitment that includes a spike port. In 604, the bag can be filled with a process fluid. The process fluid can be any suitable process fluid, such as a biological reaction mixture containing cells, cell culture medium, gene therapy material, and / or any other suitable contents for a process fluid. The bag and process fluid can be exposed to or cryogenically cooled in 606, for example, by bringing the bag and process fluid to dry ice temperatures, liquid nitrogen temperatures, or the like. In one embodiment, the bag can be cryogenically cooled in a refrigeration system (e.g., a blast chiller, a low-temperature freezer, etc.). In one embodiment, the bag is exposed to a temperature of −50° C. or below. In one embodiment, the bag is exposed to a temperature of −80° C. or below. In one embodiment, the bag is exposed to a temperature of −150° C. or less. In one embodiment, the bag is exposed to a temperature of −190° C. or less. Following the cryogenic temperature exposure in 606, a spike can be inserted into the bag at 608. The spike is inserted through a spike port included in the bag's fitment provided in 602. In one embodiment, the bag and process fluid can be thawed after the cryogenic temperature exposure in 606 and prior to the insertion of the spike at 608. Insertion of the spike can be used to extract process fluid from the bag, for example, to transfer the process fluid to another container, to administer the process fluid to a subject, or for any other suitable extraction of the process fluid from the bag.

[0052] Aspects: It is understood that any of embodiments 1-10 and 21 can be combined with any of embodiments 11-19 or embodiment 20. It is understood that any of embodiments 11-19 can be combined with embodiment 20.

[0053] Aspect 1. A fitment for a bag, comprising: a fitment body including first and second sidewalls, each of the first and second sidewalls extending between opposite ends, the fitment body comprising a fluoropolymer material; A spike port, a spike port body, the spike port body being integrally formed with a fitment body, the spike port body including an aperture configured to receive a spike; a first puncture barrier comprising a fluoropolymer film; and an internal gasket disposed within the spike port body, the internal gasket configured to provide a second puncture barrier; a spike port and Equipped with a bag for fitment.

[0054] Embodiment 2. The fitment of claim 1, wherein the internal gasket comprises silicone, a thermoplastic elastomer, a fluoropolymer, ethyl vinyl acetate, or a combination thereof.

[0055] Embodiment 3. The fitment of embodiment 1 or 2, wherein the diameter of the aperture is in the range of 0.18 inches (approximately 4.5 mm) to 0.22 inches (approximately 5.6 mm).

[0056] Embodiment 4. A fitment according to any one of embodiments 1 to 3, further comprising an additional port integrally formed with the fitment body.

[0057] Embodiment 5. A fitment according to any of embodiments 1-4, wherein the first puncture barrier is joined to the end of the spike port body by welding, the first puncture barrier covering the aperture.

[0058] Embodiment 6. The fitment of any of embodiments 1-5, wherein a first puncture barrier is disposed within the aperture.

[0059] Embodiment 7. A fitment according to any one of embodiments 1 to 6, wherein the inner surface of the spike port body includes an annular protrusion and the outer surface of the internal gasket includes an annular groove.

[0060] Embodiment 8. A fitment according to any of embodiments 1-7, wherein the aperture has a first diameter in a first portion of the spike port body and a second diameter in a second portion of the spike port body that is smaller than the first diameter, and the internal gasket has an outer diameter that is smaller than the first diameter and larger than the second diameter.

[0061] Aspect 9. The fitment of Aspect 8, wherein the inner surface of the spike port body includes one or more first engagement features, and the internal gasket includes one or more second engagement features configured to engage with the first engagement features.

[0062] Embodiment 10. A bag comprising the fitment of any one of embodiments 1-9, a first fluoropolymer sheet, and a second fluoropolymer sheet, a first portion of the peripheral edge of the first fluoropolymer sheet is welded to a first portion of the peripheral edge of the second fluoropolymer sheet; a second portion of the peripheral edge of the first fluoropolymer sheet is welded to the fitment; a second portion of the peripheral edge of the second fluoropolymer sheet is welded to the fitment; the first portion of the periphery of the first fluoropolymer sheet and the second portion of the periphery of the first fluoropolymer sheet are the entire periphery of the first fluoropolymer sheet; and the first portion of the periphery of the second fluoropolymer sheet and the second portion of the periphery of the second fluoropolymer sheet are the entire periphery of the second fluoropolymer sheet; bag.

[0063] Embodiment 11. Provide a fitment, the fitment comprising: a fitment body including first and second sidewalls, each of the first and second sidewalls extending between opposite ends, the first and second sidewalls defining a central opening, the fitment body comprising a fluoropolymer material; and a spike port body integrally formed with the fitment body, the spike port body including an aperture configured to receive a spike, the fitment comprising a fluoropolymer; placing an internal gasket within the spike port body; welding a fluoropolymer film to the fitment to provide a puncture barrier; A method comprising:

[0064] Embodiment 12. Providing a first fluoropolymer sheet; providing a second fluoropolymer sheet; welding a first portion of a peripheral edge of the first fluoropolymer sheet to a first portion of a peripheral edge of the second fluoropolymer sheet; welding a second portion of the peripheral edge of the first fluoropolymer sheet and a second portion of the second fluoropolymer sheet to the fitment; further comprising the first portion of the periphery of the first fluoropolymer sheet and the second portion of the periphery of the first fluoropolymer sheet are the entire periphery of the first fluoropolymer sheet; and the first portion of the periphery of the second fluoropolymer sheet and the second portion of the periphery of the second fluoropolymer sheet are the entire periphery of the second fluoropolymer sheet; 12. The method of embodiment 11.

[0065] Embodiment 13. The method of any one of embodiments 11-12, wherein the internal gasket comprises silicone, a thermoplastic elastomer, a fluoropolymer, ethyl vinyl acetate, or a combination thereof.

[0066] Embodiment 14. The method of any one of embodiments 11 to 13, wherein the diameter of the aperture is in the range of 0.18 inches (about 4.5 mm) to 0.22 inches (about 5.6 mm).

[0067] Embodiment 15. The method of any of embodiments 11-14, wherein a fluoropolymer film is bonded to the end of the spike port body to cover the aperture.

[0068] Embodiment 16. The method of any one of embodiments 11-15, wherein the fluoropolymer film is disposed within the spike port body.

[0069] Embodiment 17. The method of any of embodiments 11-16, wherein the inner surface of the spike port body includes an annular protrusion and the outer surface of the internal gasket includes an annular groove, and installing the internal gasket includes positioning the internal gasket so that the annular protrusion is received in the annular groove.

[0070] Embodiment 18. The method of any of embodiments 11-17, wherein the aperture has a first diameter in a first portion of the spike port body and a second diameter in a second portion of the spike port body that is smaller than the first diameter, and the internal gasket has an outer diameter that is smaller than the first diameter and larger than the second diameter, and wherein installing the internal gasket comprises inserting the internal gasket from the first portion of the spike port body into the aperture.

[0071] Aspect 19. The method of aspect 18, wherein the inner surface of the spike port body includes one or more first engagement mechanisms, and the internal gasket includes one or more second engagement mechanisms configured to engage with the first engagement mechanisms, and installing the internal gasket includes engaging the one or more first engagement mechanisms with the one or more second engagement mechanisms.

[0072] Aspect 20. Providing a bag according to aspect 10; adding a process fluid to the bag; The bag must be kept at a temperature of -80°C or below. Inserting a spike into the aperture of the spike port A method for carrying out the process, including:

[0073] Embodiment 21. A fitment according to any one of embodiments 1 to 9, wherein the spike port is independent of the configuration of the spike.

[0074] The examples disclosed in this application should be considered in all respects as illustrative and not restrictive. The scope of the present invention is indicated by the appended claims, rather than the foregoing description, and all changes that come within the meaning and range of equivalence of the claims are intended to be embraced therein.

Claims

1. A fitment for a bag, comprising: a fitment body including first and second side walls, each of the first and second side walls extending between opposite ends, the fitment body comprising a fluoropolymer material; A spike port, a spike port body, the spike port body being integrally formed with a fitment body, the spike port body including an aperture configured to receive a spike; a first puncture barrier comprising a fluoropolymer film; and an internal gasket disposed within the spike port body, the internal gasket configured to provide a second puncture barrier; a spike port and Equipped with a bag for fitment.

2. 10. The fitment of claim 1, wherein the internal gasket comprises silicone, a thermoplastic elastomer, a fluoropolymer, ethyl vinyl acetate, or a combination thereof.

3. 10. The fitment of claim 1, wherein the diameter of the aperture ranges from 0.18 inches to 0.22 inches.

4. The fitment of claim 1 , further comprising an additional port integrally formed with the fitment body.

5. 2. The fitment of claim 1, wherein the first puncture barrier is joined to the end of the spike port body by welding, the first puncture barrier covering the aperture.

6. The fitment of claim 1 , wherein the first puncture barrier is disposed within the aperture.

7. 10. The fitment of claim 1, wherein the inner surface of the spike port body includes an annular protrusion and the outer surface of the internal gasket includes an annular groove.

8. 2. The fitment of claim 1, wherein the aperture has a first diameter in a first portion of the spike port body and a second diameter in a second portion of the spike port body that is smaller than the first diameter, and the internal gasket has an outer diameter that is smaller than the first diameter and larger than the second diameter.

9. 9. The fitment of claim 8, wherein the inner surface of the spike port body includes one or more first engagement features, and the internal gasket includes one or more second engagement features configured to engage with the first engagement features.

10. A bag comprising the fitment of claim 1, a first fluoropolymer sheet, and a second fluoropolymer sheet, a first portion of the peripheral edge of the first fluoropolymer sheet is welded to a first portion of the peripheral edge of the second fluoropolymer sheet; a second portion of the peripheral edge of the first fluoropolymer sheet is welded to the fitment; a second portion of the peripheral edge of the second fluoropolymer sheet is welded to the fitment; the first portion of the peripheral edge of the first fluoropolymer sheet and the second portion of the peripheral edge of the first fluoropolymer sheet are the entire peripheral edge of the first fluoropolymer sheet; and the first portion of the peripheral edge of the second fluoropolymer sheet and the second portion of the peripheral edge of the second fluoropolymer sheet are the entire peripheral edge of the second fluoropolymer sheet; bag.

11. a fitment body including first and second sidewalls, each of the first and second sidewalls extending between opposite ends, the first and second sidewalls defining a central opening, the fitment body comprising a fluoropolymer material; and a spike port body integrally formed with the fitment body, the spike port body including an aperture configured to receive a spike, the fitment comprising a fluoropolymer; placing an internal gasket within the spike port body; welding a fluoropolymer film to the fitment to provide a puncture barrier; A method comprising:

12. providing a first fluoropolymer sheet; providing a second fluoropolymer sheet; welding a first portion of a peripheral edge of the first fluoropolymer sheet to a first portion of the peripheral edge of the second fluoropolymer sheet; welding a second portion of the peripheral edge of the first fluoropolymer sheet and a second portion of the second fluoropolymer sheet to the fitment; further comprising the first portion of the peripheral edge of the first fluoropolymer sheet and the second portion of the peripheral edge of the first fluoropolymer sheet are the entire peripheral edge of the first fluoropolymer sheet; and the first portion of the peripheral edge of the second fluoropolymer sheet and the second portion of the peripheral edge of the second fluoropolymer sheet are the entire peripheral edge of the second fluoropolymer sheet; The method of claim 11.

13. The method of claim 11 , wherein the internal gasket comprises a silicone, a thermoplastic elastomer, a fluoropolymer, ethyl vinyl acetate, or a combination thereof.

14. The method of claim 11, wherein the diameter of the aperture ranges from 0.18 inches to 0.22 inches.

15. The method of claim 11 , wherein the fluoropolymer film is bonded to an end of the spike port body to cover the aperture.

16. The method of claim 11 , wherein the fluoropolymer film is disposed within the spike port body.

17. 12. The method of claim 11, wherein the inner surface of the spike port body includes an annular protrusion and the outer surface of the internal gasket includes an annular groove, and installing the internal gasket includes positioning the internal gasket so that the annular protrusion is received in the annular groove.

18. 12. The method of claim 11, wherein the aperture has a first diameter in a first portion of the spike port body and a second diameter in a second portion of the spike port body that is smaller than the first diameter, and the internal gasket has an outer diameter that is smaller than the first diameter and larger than the second diameter, and wherein installing the internal gasket comprises inserting the internal gasket from the first portion of the spike port body into the aperture.

19. 20. The method of claim 18, wherein the inner surface of the spike port body includes one or more first engagement features, and the internal gasket includes one or more second engagement features configured to engage with the first engagement features, and installing the internal gasket includes engaging the one or more first engagement features with the one or more second engagement features.

20. Providing a bag according to claim 10; adding a process fluid to the bag; bringing the bag to a temperature of −80° C. or less; inserting the spike into the aperture of the spike port; A method for carrying out the process, including:

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