Bag fitment with internal spike port

Abstract

A fitment for forming a bag may be provided with an internal spike port opening configured to receive a spike. The fitment further includes one or more mechanisms to prevent the spike from contacting the bag when the spike is received in the spike port. The bag may be formed by attaching one or more sheets to the fitment. The bag may be interfaced with a spike by inserting it into the internal spike port opening through an optional first puncture barrier and then inserting it through a second puncture barrier disposed within the internal spike port opening. The internal spike port opening may be provided on the surface of the fitment so as not to extend beyond the outer edge of the fitment.

Description

Technical Field

[0001] The present disclosure is directed to a fitment having an internal spike port for use in forming a bag, and a bag formed using such a fitment.

Background Art

[0002] Medical bags can include a port welded directly to the sheet used to form the bag for fluid transfer from the bag. Bags for cell and gene therapy generally use conventional medical bags and corresponding fluid transfer methods, for example, for administration at the clinical site.

Summary of the Invention

[0003] The present disclosure is directed to a fitment having an internal spike port for use in forming a bag, and a bag formed using such a fitment.

[0004] By providing a spike port inside the fitment, a spike port can be provided to facilitate fluid transfer to and from the bag. When provided internally, the spike port can further provide improved resistance to damage, leakage, and other such problems when the bag is frozen and then thawed. Further, the spike port can be configured such that the length of the bag is not increased and no rigid protrusion is required to provide the spike port, thereby making the bag easier to handle and use with storage and / or transport equipment without further modification. A feature can be provided on the fitment to prevent the spike from contacting and damaging the sheet used to form the bag.

[0005] In one embodiment, the fitment for the bag includes a fitment body comprising a first side wall and a second side wall, each of which extends between its endpoints. The fitment body comprises a biocompatible material. The fitment body comprises a spike port opening and one or more guide mechanisms, the guide mechanisms configured to separate the spike inserted into the spike port opening from the bag sheet attached to one or both of the first and second side walls.

[0006] In one embodiment, one or more guide mechanisms include guide projections extending from the fitment body, and the spike port opening extends through the guide projections.

[0007] In one embodiment, one or more guide mechanisms include a plurality of wings extending from a first side wall and / or a second side wall.

[0008] In one embodiment, the fitment further includes a plurality of additional ports integrally formed with the fitment body. In one embodiment, the spike port opening is located between two of the plurality of additional ports.

[0009] In one embodiment, the spike port opening includes a barrier film. In one embodiment, the barrier film is formed integrally with the fitment body. In one embodiment, the fitment further includes a barrier film located at the end of the spike port opening.

[0010] In one embodiment, the fitment further includes an internal gasket disposed within the spike port opening. In one embodiment, the fitment further includes a barrier film located at the end of the spike port opening.

[0011] In one embodiment, the bag includes a fitment. The fitment includes a fitment body including a first side wall and a second side wall. Each of the first and second side walls extends between its two endpoints. The fitment body includes a biocompatible material. The fitment body includes a spike port opening and one or more guide mechanisms, the guide mechanisms configured to separate a spike inserted into the spike port opening from a bag sheet attached to one or both of the first and second side walls. The bag further includes one or more polymer sheets, the one or more polymer sheets being bonded to the first and second side walls. The one or more polymer sheets are sealed to form a bag. The one or more guide mechanisms extend into the internal space defined by the fitment and the one or more polymer sheets. The one or more guide mechanisms are configured to separate a spike inserted into the spike port opening from the one or more polymer sheets.

[0012] In one embodiment, one or more guide mechanisms include guide projections extending from the fitment body, and the spike port opening extends through the guide projections.

[0013] In one embodiment, one or more guide mechanisms include a plurality of wings extending from a first side wall and / or a second side wall.

[0014] In one embodiment, the spike port opening includes a barrier membrane formed integrally with the fitment.

[0015] In one embodiment, the bag further includes an internal gasket disposed within the spike port opening.

[0016] In one embodiment, a method for inserting a spike into a bag includes guiding the spike into a spike port opening provided on a fitment contained within the bag, and passing the spike through a puncture barrier provided within the spike port opening, wherein, once the spike is inserted into the bag, one or more guide mechanisms are provided between the spike and one or more sheets forming the bag.

[0017] In one embodiment, one or more guide mechanisms include guide projections extending from the fitment body, and the spike port opening extends through the guide projections.

[0018] In one embodiment, one or more guide mechanisms include a plurality of wings extending from a first side wall and / or a second side wall of the fitment.

[0019] In one embodiment, the method further includes passing the spike through a second puncture barrier provided on the fitment. In one embodiment, the spike passes through the second puncture barrier when it enters the spike port opening. [Brief explanation of the drawing]

[0020] [Figure 1] This is a diagram showing a fitment according to one embodiment. [Figure 2] This is a cross-sectional view of a fitment according to one embodiment. [Figure 3] This is a cross-sectional view of a fitment according to one embodiment. [Figure 4] This figure shows a bag according to one embodiment. [Figure 5] This is a diagram showing a fitment according to one embodiment. [Figure 6] This is a cross-sectional view of a fitment according to one embodiment. [Figure 7] This is a cross-sectional view of a fitment according to one embodiment. [Figure 8] This figure shows a bag according to one embodiment. [Figure 9] A flowchart of a method of interfacing with a bag.

Best Mode for Carrying Out the Invention

[0021] The present disclosure is directed to a fitting having an internal spike port for use in forming a bag, and a bag formed using such a fitting.

[0022] As used herein, a “biocompatible” material refers to a material that is capable of contacting a buffer material such as a buffer used in drug products, proteins, blood products, and / or vaccine production, and has no adverse effect on the drug products, proteins, blood products, and / or buffer material. Non-limiting examples of biocompatible materials include fluoropolymers, polyolefins such as polyethylene, ethyl vinyl acetate (EVA) polymers, etc. The biocompatible material can include a laminated material, such as laminated polyethylene.

[0023] As used herein, a “spike” refers to a spike interface for accessing the contents of a bag. The spike can be any suitable spike for accessing the contents of the bag. The spike can be a connection to another device, such as a tube, luer connector, hose barb, another connector at the end of the tube opposite the spike, such as a removable cap, and / or any other suitable mechanism such as a valve, filter, etc., and can be part of a bag interface device. The spike can have a circular cross-sectional shape. The spike can have an outer diameter in the range of 0.1 inches to 0.5 inches (2.5 millimeters (mm) to 12.7 mm). In an embodiment, the size of the spike selected for use with a bag can be a size suitable for the fitting used with the bag.

[0024] As used herein, “spike port opening” is an opening configured to receive a spike so that the spike may be inserted into a bag through the spike port opening and used to provide fluid communication. The spike port opening has an inner diameter larger than the outer diameter of the spike to be used in the spike port opening.

[0025] Figure 1 shows a fitment according to one embodiment. The fitment 100 includes a fitment body 102 having a first side wall 104 and a second side wall 106. The fitment body 102 further includes a spike port opening 108 and one or more additional ports 110 provided on the hose barb connection portion 112. The fitment 100 further includes a guide projection 114.

[0026] The fitment 100 is a fitment used to form a bag. One or more sheets can be attached to the fitment 100 to define the bag, and these sheets are sealed to the fitment 100 and around the outer perimeter of the bag outside the fitment 100 to define the internal space. A bag formed using a fitment such as the fitment 100 is described below and shown in Figure 4.

[0027] The fitment body 102 is a body configured to form a fitment for a bag. The fitment body 102 may be formed from any suitable biocompatible material, such as a fluoropolymer, polyolefin, or EVA. In one embodiment, the fitment body 102 is formed from a fluoropolymer. In an embodiment, the fluoropolymer may include one or more of the following: ethylene tetrafluoroethylene (ETFE) polymer, polychlorotrifluoroethylene (PCTFE) polymer, polyvinyl fluoride (PVF) polymer, polyvinylidene fluoride (PVDF) polymer, etc. In one embodiment, the fluoropolymer is ETFE. The fitment body 102 may be made from a material selected so as to be able to be welded to a material used for a sheet to form a bag containing the fitment 100. In an embodiment, the fitment body 102 includes the same material as that used for a sheet to form a bag containing the fitment 100. The fitment body 102 includes a first side wall 104 and a second side wall 106. The first side wall 104 and the second side wall 106 each extend from a first endpoint to a second endpoint. The first side wall 104 and the second side wall 106 may be shaped to define a central region of a fitment body 102, which may be provided with one or more fittings including a spike port opening 108 and optionally one or more additional ports 110. The first side wall 104 and the second side wall 106 may be configured to provide a continuous surface to which a sheet can be welded to form a bag containing the fitment 100. The extension, curvature, and geometry of the first side wall 104 and the second side wall 106, as well as examples of sheet welding to the first side wall 104 and the second side wall 106, are further described in U.S. Patent Application No. 15 / 705,878, which is incorporated herein by reference in its entirety.

[0028] The spike port opening 108 is an opening through the fitment 100 configured to receive spikes. The spike port opening 108 extends from the portion of the fitment 100 that is on the outside of the bag formed using the fitment 100 to the portion of the fitment 100 that is on the inside of the bag formed using the fitment 100. The spike port opening 108 is sized to accommodate (one or more) spikes such that the spike port opening 108 has an internal size capable of accommodating one or more spikes selected for use with the bag formed using the fitment 100. For example, the spike port opening 108 may have an internal diameter larger than the outer diameter of the largest spike selected for use with the bag formed using the fitment 100. In one embodiment, the spike port opening 108 is provided in a portion of the fitment body 102 that does not extend beyond the edges of the first and second side walls 106 on the outside of the bag formed using the fitment 100.

[0029] The additional port 110 may optionally be included in the fitment 100 for, for example, filling, unfilling, and / or venting bags formed using the fitment 100 during processes such as vaccine manufacturing. The hose barb connector 112 may be provided on projections through which the optional additional port 110 passes. The hose barb connector 112 is provided on the sides of the first side wall 104 and the second side wall 106 such that the hose barb connector 112 is on the outside of the bag formed including the fitment 100.

[0030] The guide projection 114 extends from the fitment body 102 such that the guide projection 114 extends into the internal space of the bag formed using the fitment 100. The guide projection 114 is an example of a guide mechanism configured to prevent contact between the spike inserted into the bag through the spike port opening 108 and the sheet attached to the fitment 100 to form the bag. Thus, the guide mechanism allows for the insertion of the spike without the risk of puncturing or otherwise damaging the bag formed using the fitment 100. The spike port opening 108 passes through the guide projection 114. The guide projection 114 is configured to extend the spike port opening 108 so that the spike terminates within the spike port opening 108, and thus the spike cannot come into contact with the sheet used to form the bag together with the fitment 100. In one embodiment, the guide projection 114 is generally conical or frustoconical in shape. In one embodiment, the guide projection 114 is generally cylindrical in shape. In one embodiment, the ends of the guide projections 114 are rounded or otherwise smoothed to prevent damage to the bag sheet formed using the fitment 100.

[0031] Figure 2 shows a cross-sectional view of a fitment according to one embodiment. The fitment 200 includes a fitment body 202, a spike port opening 204, and a barrier film 206. The fitment 200 may further include one or more additional ports 208 provided on the hose barb connection portion 210. The fitment 200 further includes guide projections 212. The fitment 200 further includes a barrier film 214.

[0032] The spike port opening 204 is an opening formed through the fitment body 202. A barrier membrane 206 is provided within the spike port opening and forms a puncture barrier, sealing the bag formed by the fitment 200 before penetration by the spike. The barrier membrane 206 may be formed integrally with the fitment body 202. The barrier membrane 206 provides a puncture barrier within the spike port opening 204. The barrier membrane 206 can prevent the spike from flowing out of the bag through the spike port opening 204 intact. The barrier membrane 206 is configured to puncture when the spike is inserted with sufficient force. In one embodiment, the puncture force of the barrier membrane 206 may be 20 N or less. In one embodiment, the puncture force of the barrier membrane 206 is in the range of 5 N to 15 N. The barrier membrane 206 may be configured to provide a retaining force for the inserted spike. The retaining force can be any suitable retaining force capable of holding the spike to resist the action of gravity on the spike and to resist accidental contact with the spike, bag, or any parts attached to the spike. In one embodiment, the barrier film 206 has a thickness in the range of 0.003 inches to 0.010 inches (7.6 to 25.4 μm). The thickness of the barrier film may be modified based on the material used for the fitment body 202, desired properties of the puncture barrier 206 such as the required puncture force, and manufacturing constraints relating to the integral formation of the barrier film 206.

[0033] Optional additional ports 208 may be provided in the fitment body 202. The optional additional ports 208 may include one or more of the following: a filling port, a discharge port, a ventilation port, or any other suitable port for accessing the contents of the bag. The optional additional ports 208 may be provided on projections extending from the fitment 200 such that the projections extend outward from the bag when the bag is formed by attaching a sheet to the fitment 200. The projections including the optional additional ports 208 may further optionally include an interface mechanism, such as the hose barb 210 shown in Figure 2.

[0034] The guide projection 212 is an extension of the fitment body 202 that surrounds the spike port opening 204. The guide projection 212 extends from the fitment body 202 so that it extends into the internal space of the bag formed by attaching the sheet to the fitment 200. The guide projection 212 surrounds the spike port opening 204. The guide projection 212 extends beyond the insertable length of the spike to be used with the spike port opening 204, so that when the spike is fully inserted into the spike port opening 204, the end of the spike remains inside the spike port opening 204 along the length of the guide projection 212. Thus, the guide projection 212 allows the spike port opening 204 to be mounted on the fitment 200 without extending outward from the bag, while preventing the spike from contacting and potentially damaging the sheet used to form the bag containing the fitment 200.

[0035] In one embodiment, the fitment 200 may further include an optional barrier film provided on or within the spike port opening 204, such as the barrier film 314 described below and shown in Figure 3.

[0036] Figure 3 shows a cross-sectional view of a fitment according to one embodiment. The fitment 300 includes a fitment body 302, a spike port opening 304, and an internal gasket 306. The fitment may further include one or more additional ports 308 provided on the hose barb connection portion 310. The fitment 300 further includes a guide projection 312.

[0037] The spike port opening 304 is an opening formed through the fitment body 302. An internal gasket 306 may be disposed within the spike port opening 304. The internal gasket 306 is configured to provide a puncture barrier before the insertion of a spike into the spike port opening 304, and to hold the spike once it is inserted into or through the internal gasket 306. The puncture barrier provided by the internal gasket 306 may be in addition to another puncture barrier, such as the barrier film 214 described above and shown in Figure 2. The internal gasket 306 may be a separate piece from the fitment body 302. The internal gasket 306 may be held within the spike port opening 304 by any preferred connection, such as a mechanical connection, e.g., press-fit, engagement of one or more engagement mechanisms, contact with one or more shoulders formed within the spike port body 208, or a combination thereof. In one embodiment, the puncture force of the internal gasket 306 may be 20 N or less. In one embodiment, the puncture force of the internal gasket 306 is in the range of 5N to 15N. The internal gasket 306 may be formed from any one or more suitable materials, non-limiting examples of suitable materials include silicone, ethyl vinyl acetate (EVA) polymer, thermoplastic elastomer, fluoropolymer, neoprene, and the like. The material of the internal gasket 306 may have any suitable hardness. In one embodiment, the material of the internal gasket 306 has a Shore A durometer of up to 90. In one embodiment, the material of the internal gasket 306 has a Shore A durometer of 50 to 90. In one embodiment, the material of the internal gasket 306 has a Shore A durometer of 50 to 70. In one embodiment, the material of the internal gasket 306 has a Shore A durometer of about 70. The material of the internal gasket 306 may have any suitable glass transition temperature selected based on the conditions that the internal gasket 306 will be subjected to. In one embodiment, the glass transition temperature of the material of the internal gasket 306 may be -30°C or lower. In another embodiment, the glass transition temperature of the material of the internal gasket 306 may be -125°C or lower.In one embodiment, the glass transition temperature of the material of the internal gasket 306 may be -170°C or lower.

[0038] Optional additional ports 308 may be provided in the fitment body 302. The optional additional ports 308 may include one or more of the following: a filling port, a discharge port, a sample port, a ventilation port, or any other suitable port for accessing the contents of the bag. The optional additional ports 308 may be provided on projections extending from the fitment 300 such that the projections extend outward from the bag when the bag is formed by attaching a sheet to the fitment 300. The projections including the optional additional ports 308 may further optionally include an interface mechanism, such as the hose barb 310 shown in Figure 3.

[0039] The guide projection 312 is an extension of the fitment body 302 that surrounds the spike port opening 304. The guide projection 312 extends from the fitment body 302 so that it extends into the internal space of the bag formed by attaching the sheet to the fitment 300. The guide projection 312 surrounds the spike port opening 304. The guide projection 312 extends beyond the insertable length of the spike to be used with the spike port opening 304, so that when the spike is fully inserted into the spike port opening 304, the end of the spike remains inside the spike port opening 304 along the length of the guide projection 312. Thus, the guide projection 312 allows the spike port opening 304 to be mounted on the fitment 300 without extending outward from the bag, while preventing the spike from contacting and potentially damaging the sheet used to form the bag containing the fitment 300.

[0040] An optional barrier film 314 may be provided on the outer side of the bag over the spike port opening 304. The barrier film 314 provides a second puncture barrier in addition to the barrier membrane 306. In one embodiment, the barrier film 314 is a film of a biocompatible material. In one embodiment, the barrier film 314 is a film formed from the same material as the fitment 300 and / or the sheet used to form the bag using the fitment 300. The barrier film 314 may be attached to the fitment body 302 by any preferred connection, such as welding or bonding. In one embodiment, the barrier film 314 is attached to the fitment body 302 by welding, such as ultrasonic welding. The barrier film 314 may be configured to have a puncture force similar to that of the internal gasket 306 or barrier membrane 206 described above and shown in Figure 2. In an embodiment, the barrier film 314 may have a puncture force of 20 N or less. The barrier film 314 may be configured to provide a retaining force for the inserted spike. The retaining force can be any suitable retaining force capable of holding the spike in order to resist the action of gravity on the spike and to resist accidental contact with the spike, bag, or any part attached to the spike. In one embodiment, the retaining force provided by the spike port opening 204 or 304, the barrier membrane 206 or internal gasket 306, and optionally further included barrier film 314 may be greater than the puncture force. In one embodiment, the retaining force provided by the spike port opening 204 or 304, the barrier membrane 206 or internal gasket 306, and optionally further included barrier film 314 may be greater than 20 N.

[0041] Figure 4 shows a bag according to one embodiment. The bag 400 includes a fitment 402 and one or more sheets 404. The fitment 402 includes a spike port opening (not shown), and further includes a first side wall 406, a second side wall (not shown), one or more additional ports 408 provided on the hose barb connection portion 410, and a guide projection 412.

[0042] Bag 400 is a bag configured to contain materials such as liquids. Non-limiting examples of materials that can be stored in the bag include drug products, proteins, blood products, and / or buffering materials. Bag 400 may be configured to be sterilizable, for example, by gamma irradiation. An example of such irradiation is described in U.S. Patent Application No. 15 / 705,878, which is incorporated herein by reference in its entirety. Bag 400 may be further configured for use at low temperatures, such as dry ice temperature or liquid nitrogen temperature. In one embodiment, Bag 400 may be exposed to temperatures below -50°C. In one embodiment, Bag 400 may be exposed to temperatures below -80°C. In one embodiment, Bag 400 may be exposed to temperatures below -150°C. In one embodiment, Bag 400 may be exposed to temperatures below -190°C.

[0043] The fitment 402 is a fitment to which a sheet 404 can be attached to form a bag 400. The fitment 402 may further provide a spike port opening and one or more additional ports 408 to allow communication with the internal space of the bag 400. The fitment 402 may be formed from any suitable biocompatible material, such as a fluoropolymer, polyolefin, or EVA. The fitment 402 may be made from a material selected so as to be able to be welded to the material used for the sheet to form the bag 400.

[0044] Sheet 404 is one or more polymer sheets that are sealed to and / or to each other in the fitment 402 to define an internal space and form the bag 400. Sheet 404 may be formed from any suitable biocompatible material, such as fluoropolymers, polyolefins, or EVA. In one embodiment, sheet 404 is formed from a fluoropolymer film. In some embodiments, the fluoropolymer film includes ethylene tetrafluoroethylene (ETFE) polymer, polychlorotrifluoroethylene (PCTFE) polymer, polyvinyl fluoride (PVF) polymer, polyvinylidene fluoride (PVDF) polymer, or a combination thereof. In another embodiment, the fluoropolymer film includes ethylene tetrafluoroethylene (ETFE) polymer, polyvinyl fluoride (PVF) polymer, polyvinylidene fluoride (PVDF) polymer, or a combination thereof. Sheet 404 may include a material selected for compatibility with the material of the fitment 402, so that the sheets can be attached to the fitment 402 by welding, such as ultrasonic welding.

[0045] The first sidewall 406 and the second sidewall are provided on the fitment, each extending from a first endpoint to a second endpoint. The second sidewall may be, for example, the second sidewall 106 described above. The first sidewall 406 and the second sidewall may be shaped to define a central region of the fitment 402, which may be provided with one or more fittings including a spike port opening and optionally one or more additional ports 408. The first sidewall 406 and the second sidewall may be configured to provide a continuous surface to which a sheet 404 can be attached to form a bag 400. The extension, curvature, and geometry of the first sidewall 406 and the second sidewall, as well as examples of welding a sheet such as the sheet 404 to the first sidewall and the second sidewall, are further described in U.S. Patent Application No. 15 / 705,878, which is incorporated herein by reference in its entirety.

[0046] Optionally, additional ports 408 may be provided in the fitment 402. The optional additional ports 408 may include one or more of the following: a filling port, a discharge port, a ventilation port, or any other suitable port for accessing the contents of the bag. The optional additional ports 408 may be provided on projections extending from the fitment 400 such that the projections extend outward from the bag when the bag is formed by attaching a sheet to the fitment 400. The projections including the optional additional ports 408 may further optionally include an interface mechanism, such as the hose barb 410 shown in Figure 4.

[0047] The guide projection 412 is an extension of the fitment 402 surrounding the spike port opening. The guide projection 412 extends from the fitment 402 so that the guide projection 412 extends into the internal space of the bag 400. The guide projection 412 surrounds the spike port opening. The guide projection 412 extends beyond the insertable length of the spike to be used with the spike port opening, so that when the spike is fully inserted, the end of the spike remains in the spike port opening along the length of the guide projection 412. Thus, the guide projection 412 allows the spike port opening to be positioned on the fitment 400 without extending outward from the bag, while preventing the spike from contacting and potentially damaging the sheet 404 used to form the bag 400.

[0048] Figure 5 shows a fitment according to one embodiment. The fitment 500 includes a fitment body 502 having a first side wall 504 and a second side wall 506. The fitment body 502 further includes a spike port opening 508 and one or more additional ports 510 provided on the hose barb connection portion 512. The fitment 500 further includes wings 514.

[0049] The fitment 500 is a fitment used to form a bag. One or more sheets can be attached to the fitment 500 to define the bag, and these sheets are sealed to the fitment 500 and around the outer perimeter of the bag outside the fitment 500 to define the internal space. A bag formed using a fitment such as the fitment 500 is described below and shown in Figure 4.

[0050] The fitment body 502 is a body configured to form a fitment for a bag. The fitment body 502 may be formed from any suitable biocompatible material, such as a fluoropolymer, polyolefin, or EVA. In one embodiment, the fitment body 502 is formed from a fluoropolymer. In this embodiment, the fluoropolymer may include one or more of the following: ethylene tetrafluoroethylene (ETFE) polymer, polychlorotrifluoroethylene (PCTFE) polymer, polyvinyl fluoride (PVF) polymer, polyvinylidene fluoride (PVDF) polymer, etc. In this embodiment, the fluoropolymer is ETFE. The fitment body 502 may be made from a material selected to be able to be welded to a material used for a sheet to form a bag containing the fitment 500. In this embodiment, the fitment body 502 includes the same material used for a sheet to form a bag containing the fitment 500. The fitment body 502 includes a first side wall 504 and a second side wall 506. The first side wall 504 and the second side wall 506 each extend from a first endpoint to a second endpoint. The first side wall 504 and the second side wall 506 may be shaped to define a central region of a fitment body 502, which may be provided with one or more fittings including a spike port opening 508 and optionally one or more additional ports 510. The first side wall 504 and the second side wall 506 may be configured to provide a continuous surface to which a sheet can be welded to form a bag containing the fitment 500. The extension, curvature, and geometry of the first side wall 504 and the second side wall 506, as well as examples of sheet welding to the first side wall 504 and the second side wall 506, are further described in U.S. Patent Application No. 15 / 705,878, which is incorporated herein by reference in its entirety.

[0051] The spike port opening 508 is an opening through the fitment 500 configured to receive spikes. The spike port opening 508 extends from the portion of the fitment 500 that is on the outside of the bag formed using the fitment 500 to the portion of the fitment 500 that is on the inside of the bag formed using the fitment 500. The spike port opening 508 is sized to accommodate (one or more) spikes such that the spike port opening 508 has an internal size capable of accommodating one or more spikes selected for use with the bag formed using the fitment 500. For example, the spike port opening 508 may have an internal diameter larger than the outer diameter of the largest spike selected for use with the bag formed using the fitment 500. In one embodiment, the spike port opening 508 is provided in a portion of the fitment body 502 that does not extend beyond the edges of the first and second side walls 506 on the outside of the bag formed using the fitment 500.

[0052] The additional ports 510 may optionally be included in the fitment 500 for, for example, filling, unfilling, and / or venting bags formed using the fitment 500 during processes such as vaccine manufacturing. The hose barb connectors 512 may be provided on projections through which the optional additional ports 510 pass. The hose barb connectors 512 are provided on the sides of the first side wall 504 and the second side wall 506 such that the hose barb connectors 512 are on the outside of the bag formed including the fitment 500.

[0053] The wing 514 is provided as a guide mechanism included in the fitment 500 to prevent contact between the spike and the sheet of the bag formed using the fitment 500. The wing 514 is a projection of the fitment body 502 of the fitment 500. In one embodiment, the wing 514 extends from one or both of the first side wall 504 and the second side wall 506, which are configured to extend into the internal space of the bag formed using the fitment 500. The wing 514 may be shaped and sized to prevent contact between the spike inserted into the spike port opening 508 and the sheet used to form the bag containing the fitment 500. The wing 514 may be configured to extend into the internal space by a length greater than the potential extension of the spike into the internal space when fully inserted into the spike port opening 508. In the embodiment shown in Figure 5, the wing 514 is provided extending from each of the first side wall 504 and the second side wall 506. In embodiments, a wing 514 may be provided to prevent contact between the spikes and one of the sheets forming the bag, including the fitment 500. In such embodiments, the spike port opening 508 may be positioned and / or angled to reduce the likelihood of the spikes contacting the unprotected sheets of the bag. In one embodiment, the spike port opening 508 may have one or more indexing mechanisms configured to ensure the orientation of the spikes. In embodiments, the wing 514 may include smoothing at potential contact points with the sheets used with the fitment 500 to form the bag, such as beveling, rounding, or chamfering.

[0054] Figure 6 shows a cross-sectional view of a fitment according to one embodiment. The fitment 600 includes a fitment body 602, a spike port opening 604, and a barrier film 606. The fitment 600 may further include one or more additional ports 608 provided on the hose barb connection portion 610. The fitment 600 further includes one or more wings 612. The fitment 600 further includes a barrier film 614.

[0055] The spike port opening 604 is an opening formed through the fitment body 602. The barrier membrane 606 is provided within the spike port opening and forms a puncture barrier, sealing the bag formed by the fitment 600 before penetration by the spike. The barrier membrane 606 may be formed integrally with the fitment body 602. The barrier membrane 606 provides a puncture barrier within the spike port opening 604. The barrier membrane 606 can prevent the spike from flowing out of the bag through the spike port opening 604 intact. The barrier membrane 606 is configured to puncture when the spike is inserted with sufficient force. In one embodiment, the puncture force of the barrier membrane 606 may be 20 N or less. In one embodiment, the puncture force of the barrier membrane 606 may be in the range of 5 N to 15 N. In one embodiment, the barrier membrane 606 has a thickness in the range of 0.003 inches to 0.010 inches (7.6 to 25.4 μm). The thickness of the barrier film can be modified based on the material used for the fitment body 602, desired properties of the puncture barrier 606 such as the required puncture force, and manufacturing constraints related to the integral formation of the barrier film 606.

[0056] Optional additional ports 608 may be provided in the fitment body 602. The optional additional ports 608 may include one or more of the following: a filling port, a discharge port, a ventilation port, or any other suitable port for accessing the contents of the bag. The optional additional ports 608 may be provided on projections extending from the fitment 600 such that the projections extend outward from the bag when the bag is formed by attaching a sheet to the fitment 600. The projections including the optional additional ports 608 may further optionally include an interface mechanism, such as the hose barb 610 shown in Figure 6.

[0057] The wing 612 is configured to extend into the internal space of the bag formed using the fitment 600. The wing 612 may be shaped and sized to prevent contact between the spike inserted into the spike port opening 604 and the sheet used to form the bag, including the fitment 600. The wing 612 may be configured to extend into the internal space by a length greater than the potential extension of the spike into the internal space when fully inserted into the spike port opening 604.

[0058] An optional barrier film 614 may be provided on the outer side of the bag over the spike port opening 604. The barrier film 614 provides a second puncture barrier in addition to the barrier membrane 606. In one embodiment, the barrier film 614 is a film of a biocompatible material. In one embodiment, the barrier film 614 is a film formed from the same material as the fitment 600 and / or the sheet used to form the bag using the fitment 600. The barrier film 614 may be attached to the fitment body 602 by any preferred connection, such as welding or bonding. In one embodiment, the barrier film 614 is attached to the fitment body 602 by welding, such as ultrasonic welding. The barrier film 614 may be configured to have a puncture force similar to that of the barrier membrane 606 or internal gasket 706 described above and shown in Figure 7. In an embodiment, the barrier film 614 may have a puncture force of 20 N or less. The barrier film 614 may be configured to provide a retaining force for the inserted spike. The retaining force can be any suitable retaining force capable of holding the spike in order to resist the action of gravity on the spike and to resist accidental contact with the spike, bag, or any part attached to the spike. In one embodiment, the retaining force provided by the spike port opening 604 or 704, the barrier membrane 606 or internal gasket 706, and optionally further included barrier film 714 may be greater than the puncture force. In one embodiment, the retaining force provided by the spike port opening 604 or 704, the barrier membrane 606 or internal gasket 706, and optionally further included barrier film 714 may be greater than 20 N.

[0059] Figure 7 shows a cross-sectional view of a fitment according to one embodiment. The fitment 700 includes a fitment body 702, a spike port opening 704, and an internal gasket 706. The fitment may further include one or more additional ports 708 provided on the hose barb connection portion 710. The fitment 700 further includes one or more wings 712.

[0060] The spike port opening 704 is an opening formed through the fitment body 702. An internal gasket 706 may be disposed within the spike port opening 704. The internal gasket 706 is configured to provide a puncture barrier before the insertion of a spike into the spike port opening 704, and to hold the spike once it is inserted into or through the internal gasket 706. The puncture barrier provided by the internal gasket 706 may be in addition to another puncture barrier, such as the barrier film 614 described above and shown in Figure 6. The internal gasket 706 may be a separate piece from the fitment body 702. The internal gasket 706 may be held within the spike port opening 704 by any preferred connection, such as a mechanical connection, e.g., press-fit, engagement of one or more engagement mechanisms, contact with one or more shoulders formed within the spike port opening 704, or a combination thereof. In one embodiment, the puncture force of the internal gasket 706 may be 20 N or less. In one embodiment, the puncture force of the internal gasket 706 is in the range of 5N to 15N. The internal gasket 706 may be formed from any one or more suitable materials, non-limiting examples of suitable materials include silicone, ethyl vinyl acetate (EVA) polymer, thermoplastic elastomer, fluoropolymer, neoprene, and the like. The material of the internal gasket 706 may have any suitable hardness. In one embodiment, the material of the internal gasket 706 has a Shore A durometer of up to 90. In one embodiment, the material of the internal gasket 706 has a Shore A durometer of 50 to 90. In one embodiment, the material of the internal gasket 706 has a Shore A durometer of 50 to 70. In one embodiment, the material of the internal gasket 706 has a Shore A durometer of about 70. The material of the internal gasket 706 may have any suitable glass transition temperature selected based on the conditions that the internal gasket 706 will be subjected to. In one embodiment, the glass transition temperature of the material of the internal gasket 706 may be -70°C or lower. In another embodiment, the glass transition temperature of the material of the internal gasket 706 may be -125°C or lower.In one embodiment, the glass transition temperature of the material of the internal gasket 706 may be -170°C or lower.

[0061] Optional additional ports 708 may be provided in the fitment body 702. The optional additional ports 708 may include one or more of the following: a filling port, a discharge port, a ventilation port, or any other suitable port for accessing the contents of the bag. The optional additional ports 708 may be provided on projections extending from the fitment 700 such that the projections extend outward from the bag when the bag is formed by attaching a sheet to the fitment 700. The projections including the optional additional ports 708 may further optionally include an interface mechanism, such as the hose barb 710 shown in Figure 7.

[0062] The wing 712 is configured to extend into the internal space of the bag formed using the fitment 700. The wing 712 may be shaped and sized to prevent contact between the spike inserted into the spike port opening 704 and the sheet used to form the bag, including the fitment 700. The wing 712 may be configured to extend into the internal space by a length greater than the potential extension of the spike into the internal space when fully inserted into the spike port opening 704.

[0063] In one embodiment, the fitment 700 may further include an optional barrier film provided on or within the spike port opening 704, such as the barrier film 214 or barrier film 614 described above and shown in Figures 2 and 6, respectively.

[0064] Figure 8 shows a bag according to one embodiment. The bag 800 includes a fitment 802 and one or more sheets 804. The fitment 802 includes a spike port opening (not shown), and the fitment 802 further includes a first side wall 806, a second side wall (not shown), one or more additional ports 808 provided on a hose barb connection 810, and one or more wings 812.

[0065] Bag 800 is a bag configured to contain materials such as liquids. Non-limiting examples of materials that can be stored in the bag include drug products, proteins, blood products, and / or buffering materials. Bag 800 may be configured to be sterilizable, for example, by gamma irradiation. An example of such irradiation is described in U.S. Patent Application No. 15 / 705,878, which is incorporated herein by reference in whole. Bag 800 may be further configured for use at low temperatures, such as dry ice temperature or liquid nitrogen temperature. In one embodiment, Bag 800 may be exposed to temperatures below -50°C. In one embodiment, Bag 800 may be exposed to temperatures below -80°C. In one embodiment, Bag 800 may be exposed to temperatures below -150°C. In one embodiment, Bag 800 may be exposed to temperatures below -190°C.

[0066] The fitment 802 is a fitment to which a sheet 804 can be attached to form a bag 800. The fitment 802 may further provide a spike port opening and one or more additional ports 808 to allow communication with the internal space of the bag 800. The fitment 802 may be formed from any suitable biocompatible material, such as a fluoropolymer, polyolefin, or EVA. The fitment 802 may be made from a material selected so as to be able to be welded to the material used for the sheet to form the bag 800.

[0067] Sheet 804 is one or more polymer sheets that are sealed to and / or to each other in the fitment 802 to define an internal space and form the bag 800. Sheet 804 may be formed from any suitable biocompatible material, such as fluoropolymers, polyolefins, or EVA. In one embodiment, sheet 804 is formed from a fluoropolymer film. In some embodiments, the fluoropolymer film includes ethylene tetrafluoroethylene (ETFE) polymer, polychlorotrifluoroethylene (PCTFE) polymer, polyvinyl fluoride (PVF) polymer, polyvinylidene fluoride (PVDF) polymer, or a combination thereof. In another embodiment, the fluoropolymer film includes ethylene tetrafluoroethylene (ETFE) polymer, polyvinyl fluoride (PVF) polymer, polyvinylidene fluoride (PVDF) polymer, or a combination thereof. Sheet 804 may include a material selected for compatibility with the material of the fitment 802, so that the sheets can be attached to the fitment 802 by welding, such as ultrasonic welding.

[0068] The first sidewall 806 and the second sidewall are provided on the fitment, each extending from a first endpoint to a second endpoint. The second sidewall may be, for example, the second sidewall 106 described above. The first sidewall 806 and the second sidewall may be shaped to define a central region of the fitment 802, which may be provided with one or more fittings including a spike port opening and optionally one or more additional ports 808. The first sidewall 806 and the second sidewall may be configured to provide a continuous surface to which a sheet 804 can be attached to form a bag 800. The extension, curvature, and geometry of the first sidewall 806 and the second sidewall, as well as examples of welding a sheet such as the sheet 804 to the first and second sidewalls, are further described in U.S. Patent Application No. 15 / 705,878, which is incorporated herein by reference in its entirety.

[0069] Optionally, additional ports 808 may be provided in the fitment 802. The optional additional ports 808 may include one or more of the following: a filling port, a discharge port, a sampling port, a ventilation port, or any other suitable port for accessing the contents of the bag. The optional additional ports 808 may be provided on projections extending from the fitment 800 such that the projections extend outward from the bag when the bag is formed by attaching a sheet to the fitment 800. The projections including the optional additional ports 808 may further optionally include an interface mechanism, such as the hose barb 810 shown in Figure 8.

[0070] The wing 812 is provided as a guide mechanism included in the fitment 502 to prevent contact between the spike and the sheet 504 when the spike is inserted into the bag 500. The wing 812 is a projection from one or both of the first side wall 806 and the second side wall. The wing 812 is configured to extend into the internal space of the bag 800. The wing 812 may be shaped and sized to prevent contact between the spike and the sheet 804 when the spike is inserted into the spike port opening. The wing 812 may be configured to extend into the internal space of the bag 800 by a length greater than the potential extension of the spike into the internal space when the spike is fully inserted into the spike port opening.

[0071] Figure 9 is a flowchart of a method for interfacing with the bag. Method 900 includes, in 902, guiding the spike into a spike port opening provided on the fitment of the bag, and, in 904, passing the spike through a puncture barrier provided in the spike port opening.

[0072] In 902, the spike is guided through the spike port opening of the fitment. The spike port opening may be any spike port opening provided herein, for example. The spike may be any suitable spike for interface with the bag, for example, any suitable medical spike sized to accommodate the spike port opening. In one embodiment, when the spike is guided through the spike port opening in 902, the spike may penetrate a barrier film such as the barrier film 214 or 614 described above and optional barrier films shown in Figures 2 and 6, respectively.

[0073] In 904, the spike is allowed to pass through a puncture barrier positioned within the spike port opening. The puncture barrier may be integrated with the fitment, such as the barrier membrane 206 or 606 described above and shown in Figures 2 and 6, respectively, or it may be separate from the fitment, such as the internal gasket 306 or 706 described above and shown in Figures 3 and 7, respectively. Penetration of the puncture barrier by the spike can allow the spike to access the contents of the bag. In one embodiment, in 904, following passage through the puncture barrier, the spike may penetrate a barrier film, such as the optional barrier film 214 or 614 described above and shown in Figures 2 and 6, respectively.

[0074] After the spike has passed through the puncture barrier in 904, the spike may be separated from the sheet forming the bag by guide projections such as 114, 212, 312, or 412 as described above and shown in Figures 1 to 4, respectively, wings such as 514, 612, 712, or 812 as described above and shown in Figures 5 to 8, respectively, or any other suitable guiding mechanism to prevent contact between the spike and the sheet of the bag.

[0075] Pattern:

[0076] It should be understood that any of embodiments 1 to 10 can be combined with any of embodiments 11 to 15 or 16 to 20.

[0077] Embodiment 1. A fitment for a bag, The fitting body comprises a first side wall and a second side wall, each of which extends between its two endpoints, and the fitting body contains a biocompatible material. The fitment body includes the spike port opening. A fitment comprising one or more guide mechanisms, wherein the guide mechanisms are configured to separate a spike inserted into a spike port opening from a back sheet attached to one or both of a first and second side wall.

[0078] Embodiment 2. The fitment according to Embodiment 1, wherein one or more guide mechanisms include guide projections extending from the fitment body, and a spike port opening extends through the guide projections.

[0079] Embodiment 3. The fitment according to Embodiment 1 or 2, wherein one or more guide mechanisms include a plurality of wings extending from a first side wall and / or a second side wall.

[0080] Embodiment 4. The fitment according to any one of Embodiments 1 to 3, further comprising a plurality of additional ports integrally formed with the fitment body.

[0081] Embodiment 5. The fitment according to Embodiment 4, wherein the spike port opening is located between two of a plurality of additional ports.

[0082] Embodiment 6. The fitment according to any one of Embodiments 1 to 5, wherein the spike port opening includes a barrier membrane.

[0083] Embodiment 7. The fitment according to Embodiment 6, wherein the barrier film is formed integrally with the fitment body.

[0084] Embodiment 8. The fitment according to Embodiment 7, further comprising a barrier film located at the end of the spike port opening.

[0085] Embodiment 9. The fitment according to any one of Embodiments 1 to 8, further comprising an internal gasket disposed within the spike port opening.

[0086] Embodiment 10. The fitment according to Embodiment 9, further comprising a barrier film located at the end of the spike port opening.

[0087] Appearance 11. A bag, A fitment comprising a fitment body including a first side wall and a second side wall, wherein each of the first and second side walls extends between its two endpoints, the fitment body comprises a fluoropolymer material, and the fitment body comprises a spike port opening and one or more guide mechanisms, One or more polymer sheets, wherein one or more polymer sheets are bonded to a first side wall and a second side wall, and one or more polymer sheets are sealed to form a bag, and Equipped with, A bag in which one or more guide mechanisms extend into an internal space defined by a fitment and one or more polymer sheets, and one or more guide mechanisms are configured to separate a spike inserted into a spike port opening from one or more polymer sheets.

[0088] Embodiment 12. The bag according to Embodiment 11, wherein one or more guide mechanisms include guide projections extending from the fitment body, and a spike port opening extends through the guide projections.

[0089] Embodiment 13. The bag according to Embodiment 11 or 12, wherein one or more guide mechanisms include a plurality of wings extending from a first side wall and / or a second side wall.

[0090] Embodiment 14. The bag according to any one of Embodiments 11 to 13, wherein the spike port opening includes a barrier membrane formed integrally with the fitment.

[0091] Embodiment 15. The bag according to any one of Embodiments 11 to 14, further comprising an internal gasket disposed in the spike port opening.

[0092] Embodiment 16. A method for inserting a spike into a bag, comprising guiding the spike into a spike port opening provided on a fitment contained within the bag, and passing the spike through a puncture barrier provided within the spike port opening, wherein, once the spike is inserted into the bag, one or more guide mechanisms are provided between the spike and one or more sheets forming the bag.

[0093] Embodiment 17. The method according to Embodiment 16, wherein one or more guide mechanisms include guide projections extending from the fitment body, and a spike port opening extends through the guide projections.

[0094] Embodiment 18. The method according to Embodiment 16 or 17, wherein one or more guide mechanisms include a plurality of wings extending from a first side wall and / or a second side wall of the fitment.

[0095] Embodiment 19. The method according to any one of embodiments 16 to 18, further comprising passing a spike through a second puncture barrier provided on a fitment.

[0096] Embodiment 20. The method according to Embodiment 19, wherein the spike is allowed to pass through a second puncture barrier when the spike enters the spike port opening.

[0097] The examples disclosed in this application should be considered in all respects as illustrative and not restrictive. The scope of the invention is indicated not by the foregoing description but by the appended claims, and all modifications occurring within the meaning and equivalent scope of the claims are incorporated herein.

Claims

1. It is a fitment for the bag, The fitting body comprises a first side wall and a second side wall, each of the first and second side walls extending between its two ends, and the fitting body comprises a biocompatible material. The fitting body includes a spike port opening, A fitment in which the fitment body includes one or more guide mechanisms, the guide mechanisms configured to separate the spike inserted into the spike port opening from the bag sheet attached to one or both of the first and second side walls.

2. The fitment according to claim 1, wherein the one or more guide mechanisms include guide projections extending from the fitment body, and the spike port opening extends through the guide projections.

3. The fitment according to claim 1, wherein the one or more guide mechanisms include a plurality of wings extending from the first side wall and / or the second side wall.

4. The fitment according to claim 1, further comprising a plurality of additional ports integrally formed with the fitment body.

5. The fitment according to claim 4, wherein the spike port opening is located between two of the plurality of additional ports.

6. The fitment according to claim 1, wherein the spike port opening includes a barrier membrane.

7. The fitment according to claim 6, wherein the barrier film is formed integrally with the fitment body.

8. The fitment according to claim 7, further comprising a barrier film located at the end of the spike port opening.

9. The fitment according to claim 1, further comprising an internal gasket disposed in the spike port opening.

10. The fitment according to claim 9, further comprising a barrier film located at the end of the spike port opening.

11. It is a bag, A fitment comprising a fitment body including a first side wall and a second side wall, wherein each of the first and second side walls extends between its two endpoints, the fitment body comprises a fluoropolymer material, and the fitment body comprises a spike port opening and one or more guide mechanisms, One or more polymer sheets, wherein the one or more polymer sheets are bonded to the first side wall and the second side wall, and the one or more polymer sheets are sealed to form the bag, and Equipped with, A bag in which one or more guide mechanisms extend into an internal space defined by the fitment and the one or more polymer sheets, and the one or more guide mechanisms are configured to separate the spikes inserted into the spike port opening from the one or more polymer sheets.

12. The bag according to claim 11, wherein the one or more guide mechanisms include guide projections extending from the fitment body, and the spike port opening extends through the guide projections.

13. The bag according to claim 11, wherein the one or more guide mechanisms include a plurality of wings extending from the first side wall and / or the second side wall.

14. The bag according to claim 11, wherein the spike port opening includes a barrier membrane formed integrally with the fitment.

15. The bag according to claim 11, further comprising an internal gasket disposed in the spike port opening.

16. A method for inserting a spike into a bag, comprising guiding the spike into a spike port opening provided on a fitment contained within the bag, and passing the spike through a puncture barrier provided within the spike port opening, wherein, once the spike is inserted into the bag, one or more guide mechanisms are provided between the spike and one or more sheets forming the bag.

17. The method according to claim 16, wherein the one or more guide mechanisms include guide projections extending from the fitment body, and the spike port opening extends through the guide projections.

18. The method according to claim 16, wherein the one or more guide mechanisms include a plurality of wings extending from the first side wall and / or second side wall of the fitment.

19. The method according to claim 16, further comprising passing the spike through a second puncture barrier provided on the fitment.

20. The method according to claim 19, wherein when the spike enters the spike port opening, the spike is allowed to pass through the second puncture barrier.

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