WO2016196632A1

WO2016196632A1 - Package fitment comprising dual port

Info

Publication number: WO2016196632A1
Application number: PCT/US2016/035265
Authority: WO
Inventors: William P. Roberts
Original assignee: Cryovac, Inc.
Priority date: 2015-06-02
Filing date: 2016-06-01
Publication date: 2016-12-08

Abstract

The presently disclosed subject matter is directed to a dual port assembly for a container, such as an IV bag, wherein each port can function as an access port or an administration port. The port assembly includes a housing, a gasket, and a cover that cooperate to enable dispensing of a product housed within a container.

Description

PACKAGE FITMENT COMPRISING DUAL PORT

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of and priority from U.S. Provisional Application No. 62/169,576 filed June 2, 2015. FIELD OF THE INVENTION

The presently disclosed subject matter relates generally to fitments useful in a wide variety of containers, including (but not limited to) medical IV bags. The presently disclosed subject matter further relates to methods of making and using the disclosed fitments. BACKGROUND

One of the most widely used methods of medical therapy is the intravenous (IV) infusion of liquid medicaments and/or nutrients into the bloodstream of a patient. A familiar apparatus that is used in many IV infusion applications is a container (such as an IV bag or bottle) that houses the liquid to be infused into the patient.

When the IV container is a bag or bottle, a rigid IV spike is pushed into the access port of the container to establish a pathway for fluid communication through which the liquid can flow out of the container. To complete the path for fluid communication from the IV container to the patient, a sharp needle is connected to the IV line to puncture the patient. Alternatively, when it is desired to inject a pharmaceutical or other material into the IV container, the material is typically injected through the insertion of a hypodermic needle directly into an administration port to flow into the container interior.

Prior art fitments include several designs that are inserted into flexible tubes that extend from an IV bag. A more recent trend is towards fitments that do not require tubing and can be directly sealed into bags, commonly referred to as "hard ports" because they are free from flexible tubing. Hard ports are available in single- port and dual-port designs and comprise multiple pieces that are assembled together, with at least one elastomeric septum component to afford a site for spike/needle puncture. Hard ports are typically economical and are growing in use, particularly with non-PVC IV bags that are readily sealed to the ports using heat sealing technology. However, prior art hard ports require excessive plastic. In addition, a pair of ports (dual port) for injection and spiking must be assembled from more than three pieces of material. These and other factors can lead to high production costs and/or material waste.

Hard ports perform up to four sealing functions. The first function is to enable sealing between the port and the IV bag. For this function, current dual port designs typically employ a ribbed section with two channels to connect to the bag interior. The ribbed sections are a source of distortion in the films to which they are sealed, since the flat films are forced to stretch and adopt a three-dimensional contour. Too much distortion can cause damage to films and lead to weaker seals or other defects, such as wrinkles or channel leaks in surrounding seals. There is a need for reduced distortion of films by reducing the size of the ribbed section.

The second sealing function is to prevent the escape of fluid from the interior of the IV bag. This seal is typically not present initially because the port is used during manufacture as a device to add liquid into a bag. The seal is a result of a capping process performed after filling. Many ports rely on heat sealing for this step, which gives reliable seals but is operationally more difficult than snap-fit capping. Thus, a need exists for a reliable seal produced by a snap-fit mechanism.

The third sealing function is a sterility barrier that protects the spiking and injection surfaces against microbial contamination from the time of initial sterilization to the time of use. At the time of use, a cover is removed to expose the sterile surface. Existing devices for achieving the sterile surface rely on a snap-off or tear- off plastic cover. The method of removing the cover can be ergonomically

challenging, and the exposed sterile surface can be too small. Therefore, it would be advantageous to have an easily removed cap that exposes a suitably large sterile surface below.

The fourth sealing function is the re-sealing of a rubber septum at the injection site when the injection needle has been withdrawn. This serves to prevent fluid (e.g., medication) from escaping the injection site. The septum that performs this function is typically a separate part. As set forth above, there exists a need to reduce the number of parts used to assemble the port.

The presently disclosed subject matter addresses some or all of the

shortcomings noted in the prior art, and discloses a fitment comprising a dual port that allows handling of fewer parts and less plastic material, with avoidance of heat sealing operations, and/or improves the reliability of the seals.

SUMMARY

In some embodiments, the presently disclosed subject matter is directed to a port assembly comprising at least two ports, wherein the assembly comprises a housing comprising a base, at least two reservoirs, a hollow channel connecting the base and each reservoir, and a bridge that connects the at least two reservoirs. The assembly further comprises a gasket comprising a bridge that connects at least two sealing sections positioned within the reservoirs, each of the least one sealing sections comprising a penetration section that is continuous with a sealing flange that forms a liquid seal against an interior of a reservoir of the housing. The assembly also comprises a cover comprising a bridge that connects at least two removable sections, each of the at least two removable sections positioned over a sealing section of the gasket to form a sterile seal. In some embodiments, each of the at least two ports is selected from the group consisting of access ports and administration ports.

In some embodiments, the presently disclosed subject matter is directed to a method of making a container comprising a port assembly. The method comprises obtaining the disclosed port assembly, obtaining a flexible front container sheet and a flexible rear container sheet, positioning the base of the port assembly between the front and rear container sheets, and sealing the front and rear sheets together to form a perimeter seal and to seal the base to the front and rear sheets to form a container comprising a port assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a perspective view of a port assembly in accordance with some embodiments of the presently disclosed subject matter;

Figure 2 is a partial cut away view of a port assembly housing in accordance with some embodiments of the presently disclosed subject matter;

Figure 3A is a perspective view of one embodiment of a gasket in accordance with some embodiments of the presently disclosed subject matter;

Figure 3B is a cut away view of one embodiment of a gasket within a port assembly; Figure 3C is a cut away view of one embodiment of a gasket within the port assembly after removal of a section of the cover, in accordance with the presently disclosed subject matter;

Figure 4A is a perspective view of a cover in accordance with some

embodiments of the presently disclosed subject matter;

Figure 4B is a cut away view of one embodiment of a cover;

Figure 4C is a cut away view of a cover within the port assembly in

accordance with some embodiments of the presently disclosed subject matter;

Figure 4D is a cut away view of a cover in an open position within the port assembly in accordance with certain embodiments of the invention;

Figure 5 is a perspective view of one method of assembling the disclosed port assembly; and

Figure 6 is a perspective view of an IV bag having a port assembly of the invention. DETAILED DESCRIPTION

I. General Considerations

The presently disclosed subject matter is directed to a dual port assembly for a container, such as an IV bag. Particularly, Figure 1 illustrates one embodiment of assembly 5 comprising first and second port sections 10, 15 that can each function as an access port and/or an administration port. The port assembly includes a dual channel housing 20 that accommodates dual-headed gasket 25 and cap 30, as set forth in more detail herein below. The port sections are connected at the top and bottom by bridge 35 and base 40, respectively. These connections provide a strengthening feature to the port design. Bridge 35 also facilitates snap-fit assembly processes, and serves to reduce the total number of parts to be assembled.

The disclosed port assembly can enable a user to access a solution housed within a container, but can also enable the injection of material into the container interior. For example, in some embodiments, it may be desirable to inject a medicament into a medical solution, and then administer the resultant product intravenously into a patient. The presently disclosed port assembly is constructed to enable such use so that contamination of the housed solution is prevented and the resultant product does not leak out of the access and/or administration ports. II. Definitions

While the following terms are believed to be well understood by one of ordinary skill in the art, the following definitions are set forth to facilitate explanation of the presently disclosed subject matter.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which the presently disclosed subject matter belongs.

Following long standing patent law convention, the terms "a", "an", and "the" refer to "one or more" when used in the subject application, including the claims. Thus, for example, reference to "a port" includes a plurality of such ports, and so forth.

Unless indicated otherwise, all numbers expressing quantities of components, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term "about." Accordingly, unless indicated to the contrary, the numerical parameters set forth in the instant specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by the presently disclosed subject matter.

As used herein, the term "about", when referring to a value or to an amount of mass, weight, time, volume, concentration, percentage, and the like can encompass variations of, and in some embodiments, ±20%, in some embodiments ±10%, in some embodiments ±5%, in some embodiments ±1 %, in some embodiments ±0.5%, and in some embodiments ±0.1 %, from the specified amount, as such variations are appropriated in the disclosed films and methods.

The term "additive port" as used herein refers to a resealable port that provides for single or repeated injection of a liquid substance.

The term "container" as used herein refers to any of the wide variety of vessels (such as bags or pouches and the like) that contain one or more ports.

The term "port" as used herein refers to a structure for providing fluid communication between two elements.

Although the majority of the above definitions are substantially as understood by those of skill in the art, one or more of the above definitions can be defined hereinabove in a manner differing from the meaning as ordinarily understood by those of skill in the art, due to the particular description herein of the presently disclosed subject matter.

III. The Disclosed Fitment

III.A. Generally

As set forth in Figure 1 , the presently disclosed port assembly comprises first and second port sections 10, 15 that can each function as an access port or an administration port. The port assembly further comprises housing 20, gasket 25, and cover 30, as set forth in more detail below. As shown in Figure 6, the disclosed assembly 5 can be sealed in between first and second walls of an IV bag 6 via a perimeter seal 7. Thus, the disclosed fitment can be adapted to communicate with the interior of a container to allow the contents to be dispensed and/or to insert a product (such as a medicament) into the container interior.

III. B- Housing 20

As set forth above, port assembly 5 comprises housing 20. As illustrated in Figure 2a, housing 20 comprises base 40 that enables the fitment to be secured to a container, such as a flexible bag. For example, as shown in Figure 6 and according to certain embodiments of the invention, base 40 can be secured between two sheets of a flexible IV bag 6 and sealed in place via a bag perimeter seal 7. The sealing can be effected by heat sealing, ultrasonic welding, RF sealing, and the like, as would be apparent to those of ordinary skill in the packaging art. In some embodiments as shown in Figure 2, for example, base 40 can include parallel faces and tapered ends. However, the shape of base 40 is not limited and can include square, rectangular, circular, trapezoidal, and the like configurations. Base 40 can optionally comprise one or more ribs 45 that function to reduce the amount of plastic used, concentrate seal pressure and surface heating, and maintain an even distribution of seal pressure to promote reliable sealing.

Housing 20 further includes channels 60 and reservoirs 55 positioned at the distal ends of the channels. Channels 60 extend the length of the port assembly and cooperate with base 40 to allow communication between the port and the container interior. As can be seen in Figures 1 and 2, channels 60 can in some embodiments taper in thickness as they reach base 40, allowing the thickness of the base to be minimized to reduce plastic use and minimize the distortion from planarity that is imposed on the sheets to which it is sealed. As a result, thinning, wrinkling, and distortion of the sheets are minimized and reliable sealing is promoted. Further, in some embodiments, the length of the channel can be long enough to be grasped easily with the fingers of a user, (such as a medical practitioner) to inject a substance into an access port or to spike an administration port. Channels 60 are hollow to allow the movement of fluid between the container interior and reservoirs 55 and to accommodate injection needles and drainage spikes.

In some embodiments, as detailed further herein, reservoirs 55 are sized and shaped to house gasket 25 and cover 30. A reservoir wall near each channel may form interior seal surface 65 that functions to mate with a seal rim of gasket 25. The interior of reservoir 55 further includes collar 70, including snap-latch apertures 75 for support and positioning of cover 30, as described in more detail below.

In some embodiments, the reservoirs are connected to each other by housing bridge 35, which stabilizes the fitment and allows for easier assembly of the port (i.e., proper positioning of the gasket, base, and cover). The bridge provides a non- sealing area of the port that can be modified with snap-latch apertures 75 without impinging on a seal surface. Furthermore, the bridge can provide for safe and easy grasping or hanging of the container in use or for transportation or storage purposes.

In some embodiments, housing 20 comprises one or more snap-latch apertures 75 that allow for reliable assembly of gasket 25 and/or cover 30 to housing 20. More generally, the housing can comprise one or more slots, snaps, hooks, buttons, and the like to provide for reliable assembly of the gasket and cover onto housing 20. Alternatively, the gasket and/or cover can in some embodiments be permanently affixed to housing 20, e.g., by ultrasonic welding.

In some embodiments, housing 20 can be constructed from a molded thermoplastic material that has the appropriate properties of flexibility, durability, autoclavability, and inertness. Such materials can include (but are not limited to) any of the wide variety of rigid or semi-rigid plastics known and used in the art, such as polycarbonate, polypropylene, polyethylene, polystyrene, PVC, ABS, polyester, polyamide, and the like). For example, in some embodiments, the housing can be constructed from random copolymers of propylene and ethylene comprising about 1 - 6 weight percent ethylene, using injection molding.

I II . Gasket 25 As set forth above, port assembly 5 comprises gasket 25, as shown in Figures 3A-3C. Particularly, gasket 25 comprises two punctureable sections 88, each forming a closure over a thermoplastic sealing rim 85. Each punctureable section comprises either a thermoplastic separation membrane 86, an elastomeric septum 80, or both. Where both are present, the septum 80 is positioned over the

separation membrane 86. Each punctureable section 88 and sealing rim 85 is connected to the other by gasket bridge 92, as shown in Figure 3A.

At least one elastomeric septum 80 can include target ring 90 to assist the user in piercing the septum in the correct location with a syringe needle, IV spike, etc. The target ring may be aligned to a thermoplastic inner tube 101 that connects to the top of a sealing rim 85 and serves to guide an injection needle to the center of the channel 60 in the housing 20. In some embodiments, the septum can also include one or more raised portions 100 that function to contact the cover 30 and form a seal against contamination prior to use.

Each punctureable section 88 provides an area for injection of a substance through the port into the container and/or insertion of a spike for draining of fluid from the container. Because the septum is elastomeric, it functions to provide a seal after a punctureable section has been pierced.

As illustrated in the figures, gasket 25 includes gasket bridge 92 that nests within housing bridge 35 to help a user properly assemble the port assembly (i.e., properly align the gasket with the housing and/or cover). In some embodiments, the gasket can include one or more snap-latch features 93 that associate with apertures 75 on housing 20. However, in some embodiments, gasket 25 and housing 20 lack corresponding snap latches and are permanently attached to each other, e.g., by ultrasonic welding.

Gasket sealing rims 85 can therefore be placed within the interior of reservoirs 55 of the housing. Once fully inserted, snap latches 93 engage with apertures 75 in the housing, and sealing rims 85 form a compression seal against seal surfaces 65. In this way, the gasket is properly positioned and centered for use, and a secure seal is established to prevent the contents of the container from escaping prior to use, as shown in Figure 3C.

As set forth above, gasket 25 can be constructed by co-injection molding to combine a thermoplastic and an elastomer, which in some embodiments can be a thermoplastic elastomer (TPE). Suitable thermoplastic materials can include any material that adheres sufficiently to the TPE. For example, in some embodiments, the thermoplastic material can be a random copolymer of propylene and ethylene, comprising about 1 -6 weight percent ethylene. Examples of suitable TPE materials include autoclave-compatible varieties of Santoprene™ (available from Exxon, Houston, Texas, United States of America), Versaflex® (available from PolyOne, Avon Lake, Ohio, United States of America), and the like.

III. D. Cover 30

As set forth above, port assembly 5 comprises cover 30 that spans the surface of each septum 80 and protects the punctureable section 88 until ready for use. When the port is sterilized, cover 30 ensures a sterile surface for injection and/or spiking. Thus, the cover operates as a sterile barrier to shield the interior face of septum 80 and/or separation membrane 86 from microbial contamination after initial sterilization that is performed in connection with manufacture and filling of the container, e.g., by autoclave (steam) sterilization of the filled container.

As illustrated in Figures 4A and 4B, in some embodiments, cover 30

comprises two removable sections 121 on opposite sides of cover bridge 115 and positioned over each punctureable section 88. Each removable section comprises one or more releasable latches 122 holding the removable section in place within the housing collar 70 up until the time of use, and a gripping member 110 such as a tab that allows the removable section to be gripped by a user's fingers and removed, causing release of the releasable latches 122. The cover can include two separation zones 120 positioned between each removable section 121 and the cover bridge 115

As illustrated in Figure 4B, cover 30 interacts with septum 80 of gasket 25 to maintain the sterility of the fitment. Particularly, the cover comprises cover inner wall 105 that is shaped to align with septum outer wall 71 to form a sterile seal. The cover 30 held within housing 20 by releasable latches 122 for the removable sections, and permanent latches 123 for the cover bridge and the corresponding apertures 75.

As illustrated in Figure 4C, cover bridge 115 is shaped to cooperate with gasket bridge 92 and housing bridge 35. For example, in some embodiments, the cover bridge and gasket bridge are fit together and then are positioned within the interior of housing bridge 35. In some embodiments, cover 30 can include one or more snap-latch features 76 that can be used to adjoin it with gasket bridge 92. The cover can therefore be securely connected to the gasket.

As illustrated in Figure 4D, a portion of separation zone 120 may serve as a hinge while the removable section 121 is moved up and down, breaking completely only if the removable section is twisted after opening. In some embodiments, the cover bridge 115 comprises a raised center 116 that mates with latching

features 117 on the tops of the removable sections when they are in a fully opened position, but not removed. This provides a means to hold the removable sections so that the punctureable section underneath is fully accessible for use. After use, the removable section can then be restored to its original position for disposal. The releasable latches 122 may be designed so that they become permanently misshapen on first opening. This leads to a much lower force for re-opening of the removable section, which serves as a means for tamper evidence. The retention of the removable section on the port assembly during use may be desirable as it avoids the creation of a small plastic scrap piece that may be misplaced, and also serves to re-cover the used port to avoid contact with any liquid that escaped to the outer surface of the punctureable section.

Cover 30 can be constructed from any of a wide variety of thermoplastic materials, such as those used for making housing 20, such as by injection molding.

IV. Methods of Making the Disclosed Fitment

As illustrated in Figure 5, port assembly 5 can be constructed by providing housing 20, gasket 25, and cover 30, and in some embodiments assembling all three together by snap-fitting. In some embodiments, cover 30 and gasket 25 are pre- assembled and then inserted into housing 20. The gasket 25 and/or cover 30 may include one or more alignment aids and/or latches to facilitate the connection and ensure correct orientation of the cover 30 to the housing 20. As the parts are assembled, corresponding sealing surfaces are mated and snap-latches and apertures are engaged, for example, as described herein.

In some embodiments, the cover and gasket may be pre-assembled together, then this subassembly can be assembled to the housing after the housing has been sealed into the container and used as a filling tube for adding liquid to the container. Alternatively, the port can be completely assembled before incorporation into the container. In these latter embodiments, a vertical form-fill-seal process can be used for making a flexible IV bag, which serves to introduce the contents into the IV bag before all of the perimeter seals have been made, eliminating the need to fill through the housing.

After assembly, port assembly 5 can be sterilized within a container and/or as a separate unit.

V. Methods of Using the Disclosed Port

The presently disclosed subject matter provides an improved port assembly for use with a container. The port assembly provides access for injecting a substance (such as a medicament) into the container interior. The disclosed assembly also provides access for a user to withdraw the contents of a container (such as through an IV line). Any of a wide variety of containers can be used with the disclosed port assembly, including (but not limited to) containers for housing solutions in the medical industry that are maintained and extracted under sterile conditions. Thus, for example, in some embodiments, the disclosed port assembly can be sealed between 2 layers of an IV bag film, about the perimeter seal.

Typically, the container is sterilized after the fitment has been inserted into the container and the container filled. For example, in some embodiments, the filled container can be steam sterilized at 121 °C for about 30 minutes.

When a user desires to use the disclosed assembly, removable sections 121 must be removed or placed in an open position to expose punctureable sections 88. In some embodiments, removable sections 121 can be removed by prying upward and disengaging at separation zone 120, for example. However, the disclosed cover is not limited and the punctureable sections 88 can be exposed using any method known and used in the art.

After the removal or repositioning of removal sections 121 , punctureable sections 88 are then available for use. In embodiments wherein port 10 or 15 is an access port, a needle extending from a syringe or other like device is introduced into the septum 80 and, optionally, guided by the target ring 90 and/or inner tube 101 through the septum 80 and into channel 60 of housing 20. During penetration of the gasket by the needle, the resiliency of the septum causes the parted region to be firmly and sealingly engaged against the sidewall of the needle to maintain a seal against the needle and to maintain the sealed integrity of the channel into which the needle has been advanced. After delivery of the medicine or drug, the needle is retracted from the channel and gasket, and this operation is followed by self-closure of the puncture of the gasket, thereby maintaining the integrity of the gasket.

In embodiments wherein port 10 or 15 is an administration port, a standard IV spike can be inserted into the surface of the septum 80 and/or separation membrane 86 and into channel 60. As is well known in the art, the spike and associated materials are dimensioned so that once inserted, channel 60 is open into the interior compartment of the container. Conventionally, the spike is retained in the channel so that the container can be inverted to dispense the contents of the container.

The port assembly 5 can be designed so that both port sections 10, 15 are interchangeable, and both can serve as either an injection site or a spiking site. Alternatively, port assembly 5 can be designed to differentiate port sections 10, 15, designating one for injection only and the other for spiking only. In these

embodiments, gasket 25 can be designed to have different features within each port section. For example, on the spiking side, the inner tube 101 may be omitted and the septum may not extend completely to the center, leaving an exposed section of the underlying separation membrane, while retaining the outer portion of the septum to form the sterile seal with the cover and to provide a seal along the sides of an inserted spike.

VI. Advantages of the Presently Disclosed Subject Matter

In some embodiments, the presently disclosed subject matter provides a double port design constructed from only 3 parts that can be assembled only by snap-fit operations while producing reliable seals. The disclosed design also uses considerably less material (plastic) compared to prior art double port designs. As a result, the disclosed subject matter ensures a cost savings compared to prior art ports.

In addition, the disclosed port provides a design for each part that can be readily injection molded and does not require a rubber curing step, thereby ensuring high throughput molding and avoiding risk of contamination by catalyst residue and crosslinking by-products that are associated with cured rubbers. Further, the presently disclosed subject matter affords a unique co-injection molded gasket design that introduces a rubber septum element, but provides an optional means for isolation of the rubber from the contents of the container and does not rely on the rubber to provide the primary liquid package seal. Rather, it employs a reliable rim-flange seal to prevent leakage.

Further, the assembly is well suited for complete pre-assembly before package incorporation, as would be needed for a vertical form-fill-seal process, while remaining well suited to partial assembly of gasket and cover, sealing the housing into an empty package, filling through the housing, then adding the cover-gasket pre- assembly.

These features afford greater simplification of the disclosed assembly, reliability of liquid seals, and adaptability of the port to be used for filling or as a fully pre-assembled port.

The presently disclosed subject matter defines a design that includes a very compact base for sealing into the container, thereby minimizing distortion of films and promoting reliable seals. Furthermore, the presently disclosed subject matter affords a sterile surface for needle or spike insertion that is sufficiently large so as to minimize risk of inadvertently contacting any surrounding non-sterile surfaces.

Some embodiments of the presently disclosed subject matter afford an optional means for using the port that does not entail breaking off any parts, and also for re-covering penetration surfaces to guard against contact with liquid residues

Claims

claimed is:

A port assembly comprising at least two ports, wherein the assembly comprises:

a. a housing comprising a base, at least two reservoirs, a hollow channel connecting the base and each reservoir, and a bridge that connects the at least two reservoirs;

b. a gasket comprising a bridge that connects at least two sealing

sections positioned within the reservoirs, each of the at least two sections including a penetration section that is continuous with a sealing flange that forms a liquid seal against an interior of a reservoir in the housing, at least one of said penetration sections comprising a resealable septum; and

c. a cover comprising a bridge that connects at least two removable

sections, each of the at least two removable sections positioned over a sealing section of the gasket to form a sterile seal;

wherein each of the at least two ports is selected from the group consisting of access ports and administration ports.

The assembly of claim 1 , wherein the base of the housing comprises at least one rib.

The assembly of claim 1 , wherein each of the at least two reservoirs and the bridge of the housing are sized and shaped to house the gasket in only one orientation.

The assembly of claim 1 , wherein each of the at least two reservoirs comprise at least one collar that are sized and shaped to house the at least two removable sections of the cover.

The assembly of claim 1 , wherein the housing, gasket and cover comprise one or more mated latch features to hold the assembly together.

The assembly of claim 1 wherein the resealable septum form a sterile seat against the cover.

7. The assembly of claim 1 , wherein the gasket provides an independent fluid seal against the housing reservoirs.

8. The assembly of claim 1 , wherein the gasket is constructed from a

thermoplastic elastomeric material and a plastic material using co-injection molding.

9. The assembly of claim 1 , wherein the cover comprises at least one

gripping member.

10. The assembly of claim 1 , wherein the cover comprises at least one

separation zone.

1 1 . The assembly of claim 10, wherein the separation zone forms a hinge.

12. The assembly of claim 1 , wherein the cover, the gasket and the housing are snap-fit together.

13. The assembly of claim 1 , wherein the cover and the housing are

constructed from one or more injection molded plastic materials.

14. A container comprising the port assembly of claim 1 .

15. The container of claim 14, wherein the container is a medical intravenous fluid bag.

16. The container of claim 14, wherein the base is secured within a seal of the container.

17. A method of making a container comprising a port assembly, the method comprising:

a. obtaining the port assembly of claim 1 ;

b. obtaining a flexible front container sheet and a flexible rear container sheet;

c. positioning the base of the port assembly between the front and rear container sheets; and d. sealing the front and rear sheets together to form a perimeter seal and to seal the base to the front and rear sheets to form a container comprising a port assembly.

18. The method of claim 17, wherein the base comprises at least one rib.

19. The method of claim 17, wherein the container is a medical fluid bag.

20. The method of claim 17, wherein the container and the assembly are free of PVC.