EP1094012A2

EP1094012A2 - Plastic closure for vials and other medical containers

Info

Publication number: EP1094012A2
Application number: EP00121655A
Authority: EP
Inventors: Hubert Jansen; Jean-Claude Thibault
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 1999-10-20
Filing date: 2000-10-04
Publication date: 2001-04-25
Anticipated expiration: 2020-10-04
Also published as: EP1094012B1; AU774241B2; ES2275466T3; JP2001171717A; ATE348052T1; DE60032307T2; AU6655500A; DE60032307D1; EP1094012A3

Abstract

The plastic closure of this invention is particularly, but not exclusively adapted for sealing pharmaceutical substances within prefilled cartridges and other medical containers or as a collar for retaining a fluid transferset on a medical container. The plastic closure of this invention includes a generally tubular portion which surrounds the rim of the container and a free end portion which is permanently radially deformed or crimped toward the neck of the container. The plastic closure of this invention is formed of a polymer, preferably a polymeric alloy or melt blend, which is sufficiently malleable to permit radial deformation, yet sufficiently rigid to retain its shape following deformation and sufficiently resistant to creep to maintain the seal between the plastic closure and the container following deformation.

Description

FIELD OF THE INVENTION

This invention relates to an improved plastic closure such as a cap or collar for closing or sealing containers such as vials containing a medicament which eliminates the problems associated with a malleable metal cap or collar such as aluminum. The plastic closure of this invention may be used as a cap to seal a conventional vial having an elastomeric stopper or as a collar for retaining a fluid transferset separate from or integral with the collar.

BACKGROUND OF THE INVENTION

It is conventional to store pharmaceutical such as drugs substances or vaccines in a sealed vial or other container for later use. Such substances may be in a dry or powdered form to increase shelf life and reduce inventory space. Such dry or powdered substances are generally stored in a sealed vial and later reconstituted in liquid form for administration to a patient by adding a diluent or solvent. Alternatively, the substance may be in liquid or even gaseous form.

A conventional vial for storing a pharmaceutical substance generally includes an open end, a radial rim portion surrounding the open end and a reduced diameter neck portion adjacent the rim portion. The vial is conventionally sealed with an elastomeric stopper which generally includes a tubular portion inserted into the neck of the vial and a planar rim portion which overlies the vial rim. The stopper is normally secured to the vial with a thin malleable metal cap, such as aluminum. The aluminum cap includes a tubular portion which surrounds the rim portions of the stopper and vial, an inwardly projecting annular portion which overlies the rim portion of the stopper and a distal end portion which is crimped or deformed radially into the vial neck beneath the vial rim portion. Because aluminum is malleable, the collar accommodates the buildup of tolerances of the dimensions of the stopper and vial rim. The dimensions and tolerances of standard vials and stoppers are set by the International Standards Organization (ISO).

The radial portion of the aluminum cap which overlies the stopper rim portion may be closed, in which case the aluminum cap is removed by "peeling" the aluminum cap from the vial. A pre-slit tab located in the middle area is provided which overlies the vial rim, permitting the cap to be torn from the top and peeled from the vial prior to use. This closed embodiment of an aluminum cap has several disadvantages. First, the tearing of the metal cap creates sharp edges which may cut or damage sterile gloves and cut the person administering the drug, thereby exposing both the healthcare worker and the patient to disease and contamination of the drug. Second, the tearing of the aluminum cap generates metal particles which may also contaminate the drug. The dangers associated with the tearing of an aluminum cap has been solved in part by adding a "flip-off" plastic cap. In one such embodiment, the aluminum collar includes a central opening and a shallow plastic cup-shaped cap is received over the aluminum collar having a central projecting riveting portion which is received and secured in the central opening of the aluminum collar. The plastic cap is then removed by forcing the flip-off cap away from the aluminum collar, which tears an annular serrated portion surrounding the central opening and exposes an opening in the collar for receipt of a hypodermic needle or the like. This embodiment reduces but does not eliminate the possibility of tearing the sterile gloves of the healthcare worker. More importantly, however, aluminum dust is still created which may contaminate the medicament. It is also important to note that metallic dust is also created simply by forming and affixing the aluminum collar to the vial because aluminum dust is created in forming the aluminum collar, crimping of the collar and removal of the flip-off plastic cap. Aluminum collars have also been used to secure a fluid transferset on vials. Transfersets may be utilized, for example, to transfer fluid from a syringe to a vial, such as to reconstitute a dry or powdered substance in a vial by adding a diluent or solvent. The reconstituted substance may then be withdrawn from the vial by the syringe. The inner surface of the transferset may be part of the fluid path and the aluminum collar or ring may bring aluminum particles in the sterile room where the substance is added to the vial or into the fluid path contaminating the substance. There have been attempts to reduce this problem by applying a coating to the aluminum cap or collar. Finally, the prior art also includes snap-on cup-shaped plastic caps or collars having a radially inwardly projecting end portion which is snapped over the rim portion of the vial. Snap-on plastic collars, however, do not assure adequate sealing of the vial or fully accommodate the tolerances of standard vials and stoppers as required.

The need therefore remains for a closure for vials and other medical containers which may be utilized with conventional containers, such as pharmaceutical vials or cartridges, which assures sealing of the container and which achieves a good level of cleanliness, without metal particles or dust which may contaminate the contents, and which does not expose the healthcare worker to sharp metal edges. The plastic closure of this invention solves these problems and permits the use of the plastic closure of this invention for attaching and sealing containers as described below.

SUMMARY OF THE INVENTION

The plastic closure for sealing a cartridge or other medical container of this invention eliminates the problems associated with a malleable metal or aluminum cap or collar, but accommodates the buildup of tolerances of the rim portion of the container and the elastomeric stopper, when used. The plastic closure of this invention is relatively inexpensive to manufacture and use. The plastic closure of this invention may be utilized as a cap to seal a conventional pharmaceutical cartridge. As used herein, the term closure is generic to either a cap or collar.

The plastic closure for sealing a container of this invention may be utilized with any number of conventional cartridges having an open end and a reduced diameter neck portion adjacent the open end. The plastic closure of this invention includes a generally tubular portion and a portion which is deformed radially or crimped toward the reduced diameter portion of the container to retain the closure on the container and as a cap to seal the open end of the container. The plastic closure of this invention may also be used as a cap or collar with a conventional vial and elastomeric stopper. In the preferred embodiment, the plastic closure of this invention is formed of a polymer which is sufficiently malleable to permit radial deformation, yet sufficiently rigid to retain its shape following deformation and sufficiently resistant to creep to maintain the seal between the plastic cap and the container following radial deformation.

The preferred embodiment of the plastic closure of this invention is formed of a composite polymer including a polymer alloy or melt blend which includes a relatively tough soft malleable co-polymer and a relatively rigid polymer. In the most preferred embodiment of the plastic closure of this invention, the composite polymer is a polymer alloy of a relatively soft malleable co-polymer and a relatively rigid polymer. The preferred relatively rigid polymer is a polyamide or a polycarbonate and the preferred relatively soft co-polymer may be selected from polyesters or polyolefins. The resultant polymer alloy or composite preferably has an elongation at yield between 5% and 10% and an elongation at break greater than 100% with a flectural modulus of greater than 1900 MPa.

Where the container or cartridge includes a radial rim portion adjacent the open end, the plastic closure of this invention includes a generally cylindrical tubular portion preferably having an internal diameter generally equal to or slightly greater than the external diameter of the rim portion of the container adapted to be received over the rim portion of the container having a free distal end adapted to be deformed radially inwardly or crimped beneath the rim portion of the container and sealed relation. The plastic cap or collar of this invention may also include a radially inwardly projecting proximate portion which overlies the rim portion of the container and/or the stopper. This radial portion may be closed or more preferably includes a central opening which may be closed with a flip-off or peel-off type plastic closure or seal. In the preferred embodiment, the peel-off seal includes a looped end portion which is welded or glued in place to provide an indication of tampering and a free end which may be gripped to remove the seal.

The method of this invention includes forming a plastic closure having a generally cylindrical tubular portion having an internal diameter generally equal to or slightly greater than an outside diameter of the rim portion of the container and an integral radial rim portion, disposing the closure over the rim of the container with the radial rim portion overlying the rim portion of the vial and the tubular portion surrounding the container rim, and then radially permanently deforming or crimping the free end of the tubular portion of the collar toward the neck portion of the container, beneath the rim portion, permanently securing the closure on the container and sealing the container open end. In the most preferred embodiment of the method of this invention, the plastic closure of this invention is formed by injection molding the plastic closure from a polymeric alloy or a composite having a relatively soft malleable polymer or co-polymer and a relatively rigid polymer, wherein a polymeric alloy or composite is formed during the injection molding. Where a resilient or polymeric ring is utilized to prevent rotation of the closure on the container, the ring may be co-injected with the polymer forming the closure or an annular groove may be formed in the tubular portion of the closure, adjacent the free end. The method then includes inserting the annular resilient ring in the groove prior to radial permanent deformation of the free end of the closure as described, such that the resilient ring is biased against the rim portion of the container. A thermoplastic elastomer may also be co-injected with the polymer forming the closure to form a coating or film on the inside surface of the closure which is integrally bonded to the polymer of the cap.

The plastic closure of this invention may be utilized with a cartridge or other medical container having a conventional elastomeric stopper or as a collar in combination with a transferset having a sealing member as disclosed in the prior art or more preferably the collar portion may be formed integral with components of the transferset. Where the plastic closure of this invention is used to seal a container having an elastomeric stopper, the proximate radial lip of the closure is received over and preferably biased against the resilient radial lip of the stopper during radial deformation or crimping of the free of the tubular portion of the closure beneath the rim of the container. The plastic closure of this invention thus eliminates the problems associated with malleable metal collars or caps, such as aluminum, and is relatively inexpensive, and simple to manufacture, particularly when compared with aluminum caps having a protective coating. The plastic closure of this invention assures an excellent seal of the container and can be injection molded in a clean environment or washed, if necessary. Finally, the plastic closure of this invention accommodates the tolerances of the vial and particularly the buildup of tolerance variations in the combination of a conventional vial and elastomeric stopper. Other advantages and meritorious features of the present invention will be more fully understood from the following description of the preferred embodiments, the appended claims and the drawings, a brief description of which follows.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a side cross-sectional view of one preferred embodiment of the plastic closure of this invention secured to and sealing a conventional vial having an elastomeric stopper;

Figure 2 is an exploded side cross-sectional view of the open end of a conventional vial, elastomeric stopper and the plastic closure shown in Figure 1 prior to radial deformation of the free end of the closure;

Figure 3 is a side partially cross-sectioned view of the assembly shown in Figure 1 illustrating radial deformation or crimping of the closure;

Figure 4 is a cross sectional view of a plastic closure of this invention assembled on a cartridge used in an injector device;

Figure 5 is a close up view of selected portions of Figure 4;

Figure 6 is a cross-sectional view of a another example cartridge having the plastic collar of this invention;

Figure 7 is a close up view of selected portions of Figure 6;

Figure 8 is a cross-sectional view of another example cartridge having closure designed according to this invention;

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Figures 1 to 3 illustrate one preferred embodiment of a pharmaceutical substance container, stopper and cap assembly 20 of this invention. As set forth above, the closure of this invention may be utilized to seal various containers and is particularly useful for sealing containers for holding pharmaceuticals such as the conventional vial 22 illustrated in Figures 1 to 3 and the cartridges shown in Figures 4 through 8. The vial includes an open end 24, an annular radially extending rim portion 26 and a neck portion 28 adjacent the rim portion. The neck portion 28 of the vial has a reduced diameter when compared to the rim portion 26 and the container portion 30. The internal surface 31 of the vial adjacent the open end 24 is generally cylindrical. Medicament vials of this type are generally formed of glass or a sterilizable plastic. The open end 24 of the vial is typically closed with an elastomeric stopper 32 having a tubular body portion 34 which is received in the open end 24 of the vial and a planar rim portion 36 which overlies the rim portion 26 of the vial as shown in Figure 1. The stopper is generally formed of a resilient elastomeric material such as synthetic or natural rubber. The central portion 38 of the planar rim portion 36 may be pierced with a hypodermic needle, for example, to either withdraw fluid from the vial or add a solvent or diluent to the vial where the substance in the vial is in dry or powder form. The tubular portion 34 of the stopper has an external diameter generally greater than the internal diameter of the internal cylindrical surface 31 of the vial to provide a tight or interference fit.

One preferred embodiment of the closure 40 is shown in Figure 1 attached to a vial 22 and stopper 32 assembly, prior to assembly in Figure 2 and during assembly in Figure 3. This embodiment of the collar 40 includes a tubular portion 42 which surrounds the rim portion 26 of the vial and the planar rim portion 36 of the stopper. Where the external surface of the rim portion 26 of the vial is cylindrical, the tubular portion 42 of the collar will generally also be cylindrical. As shown in Figure 1, the free end 44 of the tubular portion 42 is deformed inwardly or crimped beneath the adjacent surface of the rim portion 26 of the vial, permanently securing the collar 40 on the vial and sealing the vial. This embodiment of the collar 40 also includes an integral radial proximate portion 46 which overlies the

rim portions

26 and 36 of the vial and stopper, respectively. The radial portion 46 is preferably integral with the tubular portion 42 of the collar. This embodiment of the collar 40 also includes a central opening 48 which overlies the central portion 38 of the stopper, preferably coaxially aligned with the central portion of the stopper. As described below, however, the central opening 48 may be eliminated in certain applications of this invention. As used herein, the terms proximate and distal are used solely for ease of description, wherein the term proximate refers to elements or portions of elements closest to the rim portion 36 of the stopper and distal refers to elements or portions of elements more remote from the rim portion of the stopper. Further, the terms cap and collar are sometimes used herein interchangeably.

The illustrated collar 40 includes a shallow cup-shaped cap 50. In the disclosed embodiment, the cap 50 includes a tubular portion 52 which surrounds the proximate portion of the tubular portion 42 of the collar, an integral central radial bridging portion 54 and a plurality of U-shaped tabs which, in the disclosed embodiment, are integral with the central bridging portion 54. The U-shaped tabs 56 are received through the central opening 48 of the collar and snap in place to securely retain the cap 50 on the collar 40. As shown in Figure 2, the cap 50 may be preassembled on the collar 40 prior to assembly of the collar on the vial. The tabs 56 may also be separate members or the central portion of the cap 50 including the tabs 56 may be a separate member,

The collar 40 is then assembled on the vial 22 as shown in Figure 2. In a typical application, the tubular portion 34 of the stopper is first inserted into the opening 24 of the vial 22 generally after the vial is filled. As set forth above, the plastic collar 40 of this invention may be used with various containers including conventional medicament vials as shown. Thus, in a typical application, the vial 22 will first be filled with a medicament. The tubular portion 42 of the collar 40 is then received over the rim portion 36 of the stopper and the rim portion 26 of the vial as shown in Figure 3. The free end 44 (shown before deformation in phantom in Figure 3) is then deformed radially beneath the radial rim 26 of the vial by a suitable tool, such as the crimping tool 58 shown in Figure 3. The disclosed embodiment of the crimping tool includes a conical rim 60 which deforms or crimps the free end 44 of the collar beneath the rim 26 of the vial. In a typical application, the tool 58 is rotated around the rim 26 of the collar 40, deforming or crimping the free end 44 as shown in Figures 1 and 3. In certain applications, it may be desirable to heat either the free end 44 of the collar or the tool 58 to facilitate crimping. The sealed vial may now be stored for later use.

When the vial is ready for use, the cap 50 may be removed simply by forcing one side of the cap 50 upwardly away from the collar 40, removing the cap 50 from the collar 40 and exposing the central opening 48 of the collar and the central portion 38 of the stopper. The central portion 38 of the stopper may then be pierced with a conventional hypodermic needle, for example, providing access to the container portion 30 of the vial. Where the material of the cap 50 is selected to provide resiliency, such as polyethylene or polypropylene, the tabs 56 will bend under thumb pressure, permitting easy removal of the closure 50. Alternatively, where the material of the cap is relatively rigid, at least some of the tabs 56 will break also permitting removal of the cap. It should also be noted that the radial portion 46 of the collar is preferably compressed against the resilient rim portion 32 of the elastomeric stopper during radial deformation of the free end 44 of the collar to assure a secure seal of the vial following installation. The tabs 56 are thus compressed into the radial rim 32 of the stopper as shown in Figure 1.

The polymer selected for the plastic closure of this invention can best be described by its required physical properties. The polymer must be sufficiently malleable to permit radial deformation or crimping, yet sufficiently rigid to retain its shape following deformation. The polymer must also be sufficiently resistant to creep to maintain the seal between the plastic cap and the container following radial deformation. It has been found that a polymer having an elongation at yield between 5% and 10% and an elongation at break greater than 100%, combined with a flexural modulus of greater than 1,900 MPa has superior performance. Where the plastic closure of this invention is utilized for sealing vials containing a medicament, the polymer should also be sterilizable and, in certain applications such as the plastic collar for a vial transferset described below, the polymer is preferably relatively clear and maintains its clarity under the stress of deformation or crimping. It has been found that certain polymer alloys or composite polymers including melt blends or alloys and co-polymers having polymers of different malleability and rigidity are preferred in many applications. That is, the plastic closure of this invention is preferably formed of a polymer alloy, composite polymer or co-polymer including a relatively rigid polymer and a tough relatively soft malleable co-polymer. The most preferred polymer is a polymer alloy or melt blend including a polyamide or polycarbonate as the rigid polymer providing the strength and resistance to creep desired for this application. The relatively soft malleable co-polymer may be selected from various polymers including polyesters and polyolefins; however, a polymer alloy including a polycarbonate or polyamide and a polyester has been found particularly suitable for this application.

As will be understood, various polymeric melt blends, alloys, composites and co-polymers are being developed on a rapidly increasing basis and therefore the plastic collar of this invention is not limited to a specific polymer, provided the polymer has the desired physical properties described above. Suitable polymers for the plastic collar of this invention include EASTAR® MB polymers, which are melt blend and alloy polymers and EASTAR® thermoplastic polymers, which are neat polymers sold by Eastman Chemical Company of Kingsport, Tennessee and Eastman Chemical AG of Zug, Switzerland under the trade names "DA003, DN003" and "DN004". These materials are polymer melt blends, alloys and co-polymers of polycarbonate or polyamide and polyester. As used herein, the terms melt blends and alloys refer to polymeric compositions having two or more polymers of different physical properties or characteristics, such as the EASTAR® polymers of Eastman Chemical Company described above which include a polycarbonate or polyamide and a polyester. The polymer selected for the plastic collar of this invention may also include fillers and other constituents which would be more accurately described as a composite. Although the base polymers may still be a polymeric melt blend or alloy. As used herein, the term composite is used in its broadest sense to include alloys or melt blends, composites and co-polymers. As will be understood, the manufacturer or supplier of the raw material will normally blend the polymers based upon the specifications of the customer. The polymers may be co-injected to form a polymeric melt blend, alloy or composite or formed by any other suitable processes. It is anticipated, however, that other polymers having the described physical characteristics may also be utilized in the plastic collar or cap of this invention. In certain applications, it may also be desirable to coat at least the interior surface 43 of the collar shown in Figure 2 with a thermoplastic elastomer, or the entire collar may have a thin layer of a thermoplastic elastomer. The thermoplastic elastomer coating may be applied as a film or by co-injection with the polymer forming the collar 40. The collar 40 and the closure 50 may be formed by conventional injection molding processes.

Although figures 1-3 include an illustration of a generic vial or container for a pharmaceutical substance, this invention is particularly useful for closing off or sealing cartridges that are prefilled with pharmaceutical substances. Such cartridges are well-known and typically are used with injector devices where the cartridge is inserted into the appropriate portion of the injector device by a medical professional prior to administering an injection. The cartridges typically are prefilled with the desired pharmaceutical substance. A variety of cartridge designs are utilized to accommodate substances in different forms.

Figures 4 and 5 illustrate one example cartridge that includes a plastic closure 140 designed according to this invention. In this example, the cartridge 122 is utilized within an injector device that is schematically illustrated at 180. The cartridge 122 includes an open end 124 that is closed off by an elastomeric stopper member 132 in cooperation with the plastic closure 140. At the opposite end of the cartridge 122, a stopper member 170 operates to maintain a substance within the interior 131 of the cartridge 122. The stopper member 170 also cooperates with the injector mechanisms schematically illustrated at 160 of the injector 180 in a conventional manner.

As best seen in Figure 5, the elastomeric stopper member 132 extends across the opening 124 and includes a portion 136 that rests against the rim portion 126 of the cartridge 122. A central portion 138 of the stopper member 132 extends across the opening 124 and is piercable by a hypodermic needle device, for example, so that a pharmaceutical substance within the cartridge 122 can be injected in a desired manner.

The cap 140 has a portion 144 that is crimped or radially deformed inwardly toward the reduced neck portion 128 of the cartridge 122. The radial portion 146 of the cap 140 effectively maintains the stopper member 132 in place against the end of the shoulder portion 126 of the cartridge 122.

Figures 6 and 7 illustrate another example embodiment where a plastic closure designed according to this invention is provided on the end of a cartridge 222. In this example, the cartridge 222 includes two

stopper members

270 and 272. A first substance 276 is maintained between the

stoppers

270 and 272 when the cartridge 222 is prefilled by a pharmaceutical supplier, for example. A second substance 278 is maintained between the stopper 272 and the stopper member 232 at the open end of the cartridge 222. A bypass passage 274 is provided so that when an injector mechanism is used and a stopper member 270 is moved toward the end of the cartridge 222 including the stopper member 232, the stopper member 272 proceeds in the same direction and the substance or fluid 276 is permitted to flow through the bypass 274 to mix with the substance 278. Those skilled in the art will recognize that this type of cartridge is a especially useful for prefilling cartridges with pharmaceutical substances that are maintained in a dry, powdered or lyophilized form. The substance 276 is typically used for reconstituting the substance 278 prior to injecting that substance into a patient.

As best seen in Figure 7, the cap 240 includes the tubular collar portion 242 and the radially crimped or deformed portion 244 that both at least partially engage the shoulder portion 226 at the end of the cartridge 222. The stopper member 232 in this embodiment includes a central portion 238 and an additional flange portion near the end 236 for engaging the end of the cartridge 222. Otherwise, the operation of the example of Figures 6 and 7 is the same as described above.

Figure 8 illustrates another embodiment where a plastic cap 340 designed according to this invention is used to close off the end of a cartridge 322. In this example, the cartridge 322 includes a stopper member 338 at the open end 324 and a stopper or plunger member 370 at the opposite end. There are two

distinct chambers

380 and 382 between the plunger member 370 and the stopper member 338. A chamber separating portion 384 operates to maintain substances within the

chambers

380 and 382 separate from each other until a desired sequence of injection or a desired mixing operation needs to be completed. The operation of a multi-chamber cartridge such as that illustrated in Figure 8 is known in the art. The inclusion of a plastic cap 340 designed according to this invention provides additional advantages compared to the use of conventional aluminum caps as described above.

Although several example cartridges for maintaining pharmaceutical substances have been illustrated, this invention is not limited to those examples. Any number of cartridge styles or configurations that have a reduced diameter neck portion near the open end, which will accommodate a plastic cap or closure designed according to this invention, can be used as will be appreciated by those skilled in the art who have the benefit of this disclosure.

As will be understood, various modifications may be made to the disclosed example plastic closures of this invention within the purview of the appended claims. Therefore, the scope of legal protection given to this invention can only be determined by studying the following claims.

Claims

A plastic closure for sealing a container having an open end and a reduced diameter portion adjacent said open end, said plastic closure having a generally tubular portion and a portion which is permanently deformed radially toward said reduced diameter portion of said container, said plastic closure formed of a polymer which is sufficiently malleable to permit radial deformation, yet sufficiently rigid to retain its shape following deformation and sufficiently resistant to creep to remain in a desired position on said container following radial deformation.
The plastic closure for sealing a container as defined in Claim 1, wherein said polymer is relatively clear and maintains its clarity under the stress of deformation.
The plastic closure for sealing a container as defined in Claims 1 or 2, wherein said plastic closure is formed of a composite polymer including a relatively soft malleable polymer and a relatively rigid polymer.
The plastic closure for sealing a container as defined in Claim 3, wherein said closure is formed of a polymeric alloy comprising a soft malleable copolymer and said relatively rigid polymer.
The plastic closure for sealing a container as defined in Claims 3 or 4, wherein said relatively rigid polymer is a polycarbonate or polyamide.
The plastic closure for sealing a container as defined in Claims 3 or 4, wherein said relatively soft polymer is a polyester or polyolefin.
The plastic closure for sealing a container as defined in Claim 1, wherein said polymer has an elongation at yield between 5% and 10% and an elongation at brake greater than 100% with a flexural modulus of greater than 1,800 MPa.
The plastic closure for sealing a container as defined in Claim 1, wherein said container includes a radial rim adjacent said open end, said plastic closure having a tubular portion surrounding said container rim and an integral radial rim portion received over said rim of said container and said tubular portion having a free end deformed radially inwardly beneath said rim of said container, and said cylindrical tubular portion of said closure including an annular resilient ring retained on an internal surface adjacent said free end preventing rotation of said closure on said container.
The plastic closure for sealing a container as defined in Claim 1, wherein said container includes a radial rim adjacent said open end and an elastomeric stopper extending across said open end of said container and overlying said rim portion of said container, said closure having a tubular portion surrounding said rim portion of said container having a free distal end deformed radially inwardly and engaging said rim portion of said container and an integral proximate radial portion overlying said rim portion of said stopper.
The plastic closure for sealing a container as defined in Claim 9, wherein said proximate radial portion of said closure includes a central opening overlying a central portion of said stopper and said closure including a cup-shaped cap having a tubular portion overlying a proximate portion of said closure and a radial portion overlying said central opening of said closure and said cap secured to said closure by retainer elements received within said central opening of said closure.
The plastic closure for sealing a container as defined in Claim 10, wherein said retainer elements are spaced U-shaped tabs integral with said cap received through said central opening of said closure each having a free end engaging a portion of said closure adjacent said central opening.
The plastic closure for sealing a container as defined in Claim 1, wherein said container is a cartridge adapted to contain a pharmaceutical substance.
The plastic closure for sealing a container as defined in Claim 12, wherein said cartridge has at least two chambers.
The plastic closure of Claim 12, wherein said cartridge includes more than one stopper member that selectively move multiple substances within said cartridge.
The plastic closure for sealing a container as defined in Claim 1, wherein said plastic closure includes an elastomeric coating on an internal surface of a free end of said tubular portion and said elastomeric coating integrally bonded to said internal surface.
A sealed cartridge assembly comprising a cartridge having an open end, a radial rim portion surrounding said open end and a reduced diameter neck portion adjacent said rim portion, a seal member extending across said open end, and a plastic collar having a tubular portion surrounding said rim portion of said cartridge having a free end permanently deformed radially inwardly toward said neck portion retaining said collar said cartridge, said plastic collar formed of a polymer that is sufficiently malleable to permit radial deformation, yet sufficiently rigid to retain its shape following deformation and sufficiently resistant to creep to maintain said seal member between said collar and said cartridge following deformation.
The cartridge assembly of Claim 16, wherein the cartridge has a plurality of chambers.
The assembly of Claim 17, including a plurality of stopper members that move within the cartridge to selectively separate or mix different substances maintained in the plurality of chambers, respectively.
The assembly of Claim 17, including a bypass that permits selective movement of substance from one of the plurality of chambers to another one of the plurality of chambers.
The assembly of Claim 16, wherein the seal member comprises an elastomeric stopper.