MXPA97007403A - A protective sealant barrier for a jeri - Google Patents

Abstract

The present invention relates to a syringe having a protective sealing barrier, comprising: a barrel having one proximal and distal ends and defining therein containing compartment with an amount of medicament contained therein; a luer tip in fluid communication With the barrel compartment, the luer tip extends from the distal end of the barrel and has a terminal end, a collar circumferentially formed around the luer tip, the collar having a terminal end substantially coplanar with the terminal end of the luer tip; and a sealing membrane removably secured in full surface contact substantially with the terminal ends of the luer tip and collar, the membrane acts as a fluid barrier and retains the medicament contained in the barrel compartment of the syringe.

Description

TJ A BARRIERA SEALANT PROTECTIVE FOR TJNA SYRINGE Field of the Invention The invention relates to a protective sealing barrier for a syringe, and more particularly, to a protective sealing barrier for a syringe that can be configured for sterility maintenance or to prevent leakage, or both, and that can be released by an end user before using the syringe. BACKGROUND As is known in the art, syringes are medical delivery devices usable for administering a medicament to a patient. The syringes can be shipped empty in a sterile state and filled by an end user, for example, from a bottle or other source of medication at the time when the administration of the drug is desired. Alternatively, the syringes may be of the pre-filled form, wherein an established dose of medicament may be pre-filled into the syringe by a pharmaceutical manufacturer for distribution to the end user. In any case, the syringes typically include a barrel portion adapted to retain the medicament. The barrels are usually made of plastic or glass materials. The distal end of the barrel is normally configured to couple with a conventional piercing element, such as a pointed needle-cannula made of steel or similar material or a blunt-tipped cannula formed of plastic, to deliver the medicament contained in the barrel. In some syringes, the piercing element is attached to the syringe as an integral part of the distal end of the barrel of the syringe. An example of such a syringe is the HYPAK pre-filled syringe manufactured by Becton Dickinson Pharmaceutical Systems of Le Pont de Claix, France. In other syringes, the piercing element is attached to the syringe when the use of the syringe is desired. There are a number of basic types of such syringes. An example of such a syringe is the luer tip syringe. In a luer tip syringe, the hub of a piercing element is connected to a luer tip associated with the syringe. Another type of such syringes is the luer lock syringe. In a luer lock syringe, the luer tip is surrounded by a threaded collar. The socket of the piercing element is inserted on the luer tip and threadedly attached to the collar. In any of the aforementioned syringes, a plunger rod is inserted through the open distal end of the barrel of the syringe and, through its coupling with an elastomeric or rubber-like sealing element tightly sealed to the fluid within the syringe. Inside the barrel, a user can apply manual force to the plunger to deliver the medication through the piercing element. Whether it is the syringe of the type that will be filled by the final user, or whether the syringe of the pre-filled type to be filled by the pharmaceutical manufacturer, there is a need to maintain the sterility of the syringe until the moment it is used to deliver a medication.

When the syringe is of the pre-filled type, it is also important to maintain the sterility of any medication stored in the barrel until such time as the medication is desired to be used. It is also necessary in the pre-filled syringes to provide a fluid seal such that the medicament does not escape from the barrel of the syringe. For example, when the syringe has a fixed needle, such as the HYPAK registered pre-filled syringe, a rubber guard for the needle is inserted over the piercing element. The needle guard seals the passage of fluid to the medication contained in the barrel of the syringe while at the same time protecting the medication against contamination. Another approach of the prior art to provide a fluid seal and to maintain the sterility of a syringe is illustrated in Figure 1. Here, a luer bolt syringe 10 is shown, and includes a barrel 16 characterized by a proximal end 14 and a distal end 12. A luer collar 18 is formed adjacent the distal end of the barrel of the syringe. The luer collar 18 is characterized by a plurality of internal threads 20. As is true in luer bolt syringes, a luer tip 22 extends conventionally beyond the distal end of the luer collar 18, and is arranged for fluid communication with interior portions of the barrel of the syringe. Each of the syringes is typically provided with a lid 24 for the luer bolt tip, made of plastic, to seal the luer tip 22. Internal portions of the lid 24 of the bolt luer tip are configured to receive a luer tip 22 and for coupling with the outer surface of the luer tip 22. The lid 24 of the luer bolt tip includes one or more threads 26 configured to engage with the internal threads 20 associated with the luer collar. While it is generally sufficient to provide a fluid seal and maintain the sterility of various components of the syringe, including the luer tip and the inside of the barrel of the syringe, certain improvements to the aforementioned approach can be made. Generally, external means of evidence of violation are necessary, since the lid of the bolt luer tip is threadedly engaged with the luer collar, and relying only on the threaded structure, it is difficult to detect if the cap of the tip has been threadedly uncoupled. of the luer necklace. Also, due to the frictional forces between the plastic parts, and depending on how tightly the cap of the luer bolt tip is applied to the collar, it can be difficult to remove the luer bolt head cap from the luer collar. In addition, although the lid of the luer lock tip is a relatively small unit, it would be beneficial to further minimize the amount of waste that has to be discarded after the syringe is used. SUMMARY OF THE INVENTION These and other matters are addressed by the protective sealing barrier for a syringe according to the present invention. Depending on the functions required, the protective sealing barrier may be configured to maintain sterility, for maintenance against dripping, or both. The syringe, which can be made of plastic or glass, includes a luer tip and a collar that surrounds the luer tip. In a preferred embodiment, the terminal ends of the tip and the luer collar are substantially co-planar. The collar can be threaded, if desired. In a preferred embodiment, the protective sealing barrier is configured as a relatively flat membrane on the terminal ends of both the tip and the luer collar, in full surface contact substantially with the terminal ends. The membrane can be peelable from the terminal ends of the tip and the luer collar when it is desired to insert a conventional needle hub in order to deliver the medication from the syringe. The material selected for the membrane can be chosen with the purpose of providing sterility maintenance or to safeguard against leaks, or both. For example, the membrane may be formed from a single material, or from a combination of materials arranged in desired configurations, to provide either sterility maintenance or leak maintenance, or both. The material selected for the membrane can be chosen such that it is suitable for various sterilization processes by irradiation or by heat. For example, the membrane may be formed from a single material, or from a combination of materials arranged in desired configurations, which exhibit good heat resistance and which are able to withstand the changes in heat and pressure generated during the process of sterilization. Similarly, where it is desirable to employ gas sterilization techniques, the single material or the combination of materials arranged in desired configurations can be chosen to exhibit hydrophobic properties while at the same time being porous to the gas. The membrane can be stocked in standard sizes to fit any of the various sizes of manufactured syringes. The membrane provides a seal against dripping or for maintenance of sterility, or both, for the passage of internal fluid from the syringe as well as for the external portions of the luer tip and the internal portions of the luer collar, which will be urged into contact with the needle hub of a piercing element. The membrane is easily discarded and provides evidence of precise violation for the syringe in a manner that is easily operated by an end user. In an alternate embodiment, the syringe may be configured as a luer lock syringe, wherein the distal end of the luer tip extends past the distal end of the luer collar. Rather than assume a planar configuration, the membrane may be formed or otherwise configured to accommodate the protruding portion of the luer tip. The membrane is configured to make full surface contact substantially with the terminal ends of the luer tip and the luer collar. BRIEF DESCRIPTION OF THE DRAWINGS The invention will now be described in greater detail by reference to the accompanying drawings, in which: Figure 1 represents, in perspective view, a prior art manner for effecting a fluid seal and a fluid barrier; sterility in a luer lock syringe; Figure 2 represents, in cross-sectional view, an embodiment of a protective sealing barrier for a syringe according to the present invention; Figure 3 represents a top view of the protective sealing barrier illustrated in Fig.2; Figure 4 is a cross-sectional view of an alternative embodiment of a protective sealing barrier for a syringe according to the present invention; Figure 5 depicts an alternate embodiment of a protective sealing barrier for a luer bolt syringe; Figure 6 is a top view of the protective sealant barrier of Fig. 5; Figure 7 depicts a further alternate embodiment of a protective sealant barrier according to the present invention; Figure 8 depicts a further alternate embodiment of a protective sealant barrier according to the present invention. Detailed Description of the Invention A convention used throughout this description is that the term "distal" refers to the furthest address of a practitioner, while the term "proximal" refers to the address closest to a practitioner. It will be understood by the skilled artisan that the protective sealant barrier according to the present invention can be employed with syringes for the purpose of being filled by an end user, for example, from a source of medication such as a vial. The protective sealing barrier can also be used for syringes of the pre-filled type, which are normally filled with an amount of medicament by a pharmaceutical manufacturer before being shipped to an end user. Depending on the functions required, the protective sealant barrier may be configured for sterility maintenance, to provide a leak barrier, or both. For example, where the syringe is empty until its use is desired, then the barrier needs to be configured only to maintain sterility. However, when the syringe is of the pre-filled type and is to be filled with an amount of medicament before shipment to an end user, then the barrier is preferably configured as a leak-proof barrier, if not provided. external means for maintaining sterility, to also act as a sterility barrier. Also, solely to facilitate reading and explain the principles of the present invention, the terms "tip luer" or "luer lock" tip are frequently recited in this application. As the skilled artisan will appreciate, the terms "tip luer" or "luer lock" tip each designates a frustum-conical shape fluid tip which is formed or otherwise dimensioned to an appropriate standard such as standards specified by the International Organization of Standards (ISO). It will be understood by the skilled artisan, however, that the benefits and advantages provided by the protective sealant barrier in accordance with the present invention are not strictly limited to fluid tips configured to the ISO "luer tip" or luer lock tip. " Rather, the protective sealant barrier according to the present invention is broadly applicable to any fluid tip configured to a non-ISO standard dimension. It will be understood by the skilled artisan, then, that the patent claims attached hereto have the purpose of encompassing fluid tips sized or otherwise formed outside of the ISO standards for "luer tips" or "luer bolt" tips. Turning now to the drawings, in which similar numerals denote similar components, Figs. 2-4 represent a form of a syringe 30 which can enjoy the benefits of the protective sealant barrier of the present invention. The syringe 30 includes a barrel 32 having a proximal end 34 and a distal end 36. A flange 38 may be provided around the proximal end to improve digital manipulation of the syringe by the user. The plunger rod 40 is inserted in the proximal end 34, and engages with a sealing element 42 held within the barrel 32. The syringe 30 may be of the type intended to be filled by the end user before use, or may be of the pre-filled type, which is supplied to a pharmaceutical manufacturer to enable the pharmaceutical manufacturer to process the syringe in such a way that it contains a drug load 44 within the barrel of the syringe before distribution to the end user. As has been pointed out, a general interest in syringes is the ability to maintain the sterility of the syringe, and particularly the various fluid passages contained within the syringe, until a desired time is desired. Where the syringe is pre-filled with a load of medicament 44, it is also necessary to safeguard the sterility of the medicament until such time as the syringe is attempted to be used. Also, when the syringe is pre-filled with a medicine 44, another interest is to ensure that the medicine 44 does not drip out of the barrel 32. Therefore, the syringe 30 according to the present invention includes a protective sealant barrier which may be configured to maintain sterility or maintenance against leaks, or both, to mention the difficulties encountered in the aforementioned prior art approaches. In general, the syringe 30 includes a fluid passage structure 50 for coupling the piercing element hub, such as the hub of a needle cannula (not shown) to the syringe to deliver a medicated load 44 either pre-filled by a pharmaceutical manufacturer or filled by an end user to the barrel of the syringe. The fluid passage structure 50 includes a collar 51 provided around the distal end 36 of the syringe. If desired, the inner portions of the collar 51 may include one or more threads 53 configured to engage with complementary threads (not shown) associated with the hub of a piercing element used to deliver the medicament 44 from the barrel 32. The collar 51 includes a terminal end 52. A luer tip 54 is provided within the interior of the collar 51. The luer tip 54 includes a proximal end 55 disposed in fluid communication with the barrel 42. In a preferred embodiment, the luer tip 54 also includes a terminal end. 56 which is co-planar substantially with the terminal end 52 associated with the collar 51. Unlike conventional luer lock syringes known in the art, wherein the luer tip extends from the luer collar (see Fig. 1) , here, the luer tip 54 and the collar 51 include terminal ends that are preferably substantially co-planar, ie, the luer tip does not extend beyond the distal end of the collar . The syringe 30 includes a protective sealing barrier that covers the fluid passage structure 50. Here, the protective sealing barrier can be configured as a membrane 60 arranged in substantially full contact with the terminal ends 52, 56 of the collar and the luer tip, respectively. In a preferred embodiment, the membrane 60 is configured with a relatively flat structure, including a planar portion 62 configured to completely cover the terminal end 52 of the collar 51 and the terminal end 56 of the luer tip 54. The membrane 60 is designed to be Removable from syringe 30 when it is desired to use the syringe. In this sense, the membrane 60 may be attached to the terminal ends of the collar and the luer tip in various forms. For example, the membrane 60 can be supplied separately from the collar 51 and the luer tip 54 and adhered thereto via adhesives, welding, heat-sealing or the like. Practically speaking, the membrane 60 can also be formed with the luer tip, for example, via a co-injection process, with a construction that facilitates the removal of the membrane from the collar and the luer tip. For example, molding tools can be implemented to form at least the portion of the membrane 60 that is attached to the luer tip 54. The remainder of the membrane 60 can be formed separately and attached to the collar 51 and the luer tip 54. To help the user remove the membrane 60 from the syringe, a pull-tab 64 is provided adjacent the planar portion 62. Simply, a user can remove the membrane 60 from the fluid structure 50 by pulling the pull tab 64. Figure 4 illustrates an alternate configuration of a protective sealant barrier according to the present invention. Here, the membrane 70 includes a planar portion 72 and a pull tab 74. The pull tab 74 is stuck in an intermediate placement 75 of one end 74 of the pull tab to some area of the pre-filled syringe 30 to prevent the inadvertent detachment of membrane 70 until desired. Here, the pull tab 74 is glued to the outer surface of the collar 51, for example, by means of adhesives, welding, co-injection or the like. If desired, the terminal ends 52 and 56 may be scraped, contoured, formed or otherwise configured in a manner to improve adhesion of the membrane 60 (70) to the terminal ends. Terminal ends 52 and 56 may also be subjected to certain surface process treatments, such as corona or plasma treatments, for the same purpose. The co-planar configuration of the terminal ends 52 and 56 contribute to allow the membrane to make entire surface contact substantially between them. This allows the membrane 60 (70) to act as a good fluid barrier while at the same time maintaining the sterility of the fluid structure 50, including any medicament 44 that may be contained within the barrel of the syringe. Figures 5 and 6 represent an alternative embodiment of a protective sealant barrier according to the present invention, suitable for application to a luer bolt syringe. As previously explained, in a luer lock syringe, a luer tip 154 conventionally extends past the distal end of a luer collar 151. Hence, the terminal end 156 of the luer tip 154 extends beyond the terminal end. 152 of the luer collar 151. The protective sealing barrier according to the present invention may have a membrane 160 configured for sealing contact with the terminal ends of the luer tip 154 and the luer collar 151, thus configured. Particularly, the membrane 160 includes a planar portion 162 configured to entirely cover the terminal end 152 of the luer collar 151. The membrane 160 also has a protrusion as a tent 163 to accommodate the protruding portion of the luer tip 154. The protuberance as a tent campaign 163 can be preformed into the structure of the planar portion 162. Alternatively, the tent protrusion 163 may be created during the application of the membrane to the syringe. In any case, the protrusion as a tent is configured to make full surface contact substantially with the terminal end 156 of the luer tip 154. As configured herein, the protrusion as tent 163 has a cup-like shape. , such that the tent-like protrusion does not contact the outer portions of the luer tip 154, separated from the terminal end 156. However, referring to Fig. 7, it will be appreciated by the skilled artisan that if so desired, the protrusion as tent 263 can be realized as the structure that is created by simply stretching the membrane 260 between the terminal end 256 of the luer tip and the terminal end 252 of the collar and sticking the membrane thereto. If desired also, the tent tent boss may also be configured to make surface contact with outer portions of the luer tip. The characteristics of the membrane according to this embodiment, such as the ability to configure the membrane for various sterilization procedures, have been previously explained. Figure 8 depicts a 360 embodiment of a protective sealant barrier according to the present invention, which employs a multi-layer configuration. As before, the syringe includes a fluid structure 350 having a luer tip 354 and a collar 351. Preferably, the terminal ends 356, 352 of the respective luer tip and collar are substantially co-planar. The protective sealant barrier 360 is composed of a multi-layer configuration, including a bottom layer 370 which, as shown, is directly in full surface contact with the terminal ends 356, 352 of the luer tip and collar, respectively, and a top layer 380 attached to the bottom layer 370. A pull tab 385 is provided in the top layer 380. If desired, the bottom layer 370 needs to cover only the terminal end 356 of the luer tip, with the upper layer 380 serving to cover the terminal end 352 of the collar. When it is desired to use the syringe, the top layer 380 is removable by a final user to expose the bottom layer 370. In a preferred form, the bottom layer 370 is employed for sterility maintenance, ie, the bottom layer is configured as a sterility barrier around the luer tip 354 and the barrel 351. The top layer 380 does not need to be preservative-of-sterility, and in fact, the outer surface 381 of the top layer does not need to be sterile. A user does not need to remove the bottom layer 370 from the syringe in order to use the syringe. Simply, a user can pierce the bottom layer 370 at the terminal end 356 of the luer tip before connecting a piercing element to the syringe. Alternatively, the bottom layer 370 may have a pressure sensitive break point 375 disposed directly on the terminal end 356 of the luer tip 354. The pressure sensitive break point 375 may, for example, involve a weakened section the bottom layer 370. When a user engages the hub of a piercing element (not shown) around the luer tip 354 and exerts fluid pressure, either by aspirating medication into the syringe or expelling the medicament contained within the syringe (not shown), the pressure sensitive break point 375 will open, allowing the fluid to flow through the terminal end 356 and the luer tip 354. It will be appreciated that by the construction of FIG. 8, the bottom layer 370 can provide a barrier-of-sterility, while the upper layer 380 may be configured as a barrier against leakage. It will be appreciated by the skilled artisan that instead of removing the syringe membrane in order to gain access to the luer tip, the preceding protective sealing barriers described in FIGS. 2-7 can be pierced in the area of the luer tip, as described in Fig. 8 herein. Alternatively, the foregoing protective sealing barriers described in Figs. 2-7 may incorporate the features of the pressure sensitive breaking point described in Fig. 8 herein to gain access to the luer tip. It will be understood by the skilled artisan that the configuration of the protective sealant barrier presented here provides many benefits over conventional products in the prior art, such as a luer 24 tip cap. For example, the membrane may be formed of materials suitable for facilitating the processing of the syringe 30 according to the material selected for the syringe, a processing of the syringe 30 by a pharmaceutical company (particularly taking into consideration the medicine 44 which is intended to be contained therein), or the like. They can also be selected according to the required function-maintenance of sterility or maintenance against leakage, or both-of the protective sealant barrier. For example, where it is desirable that the protective sealant barrier according to the present invention act as a sterility barrier, the material selected for the membrane must be adequate to protect against the intrusion of bacterial contaminants., particles or other contaminants that could affect the sterility of the syringe 30, the fluid structure 50 or any medicament 44 contained within the barrel. For example, various composite or plastic films, metal foils, treated or coated papers or TYVEK materials may be employed. Where it is desirable to configure the protective sealing barrier as a barrier against leakage, it is preferable that the material selected for the membrane have hydrophobic properties, so that the fluid does not pass from the luer tip 54. Coo before, various composite or plastic films , metal sheets, treated or coated papers or TYVEK materials can be used for this purpose. Where the syringe is of the pre-filled type, it is not necessary that the protective sealing barrier also have sterility maintenance characteristics in it and by itself; because the syringe 30 can be kept sterile, for example, by external packing, such as bubble pack, formed around the syringe 30. However, when the syringe is of the pre-filled type, in order to avoid the need for external sterility barriers, such as a bubble pack, it is preferable that the protective sealant barrier be formed of a material having sterility maintenance characteristics as well as maintenance characteristics against leakage, ie, the material must be capable of blocking against bacteriological contaminants, particles or other contaminants, even having hydrophobic properties. For example, various composite or plastic films, metal foils, treated or coated papers or TYVEK materials may be used for this purpose. Where it is desirable to process the syringe 30 by an irradiation process or a heat sterilization process, the membrane can be selected from a material that exhibits good heat resistance or that is otherwise able to withstand changes in heat and pressure generated during the sterilization procedure. For example, several composite or plastic films, metal sheets or TYVEK materials are suitable for this purpose. If it is desired to sterilize the syringe 30 by various gas sterilization techniques, such as gas sterilization techniques of ethylene oxide, the skilled artisan will appreciate that the membrane may be formed of a material exhibiting hydrophobic properties while at the same time being porous to gas. For example, a TYVEK material may be employed. It will be understood that the membrane made of the preceding forms need not be formed of a simple material. For example, a combination of materials combined in a simple formulation, or a combination of materials arranged or otherwise constructed to achieve the desired properties is also possible. For example, the membrane may be constructed in a configuration of layers of different materials to achieve the desired properties. Unlike the luer tip cover 24 of the prior art, which couples with internal portions of the fluid passage structure, such as in the threads 18 (53) associated with a luer collar and the external portions of the luer tip 22 ( 54), the protective sealing barrier contacts only the terminal ends of the collar and the luer tip. Therefore, the protective sealing barrier avoids the difficulties associated with luer bolt-on end caps while providing good fluid sealing properties and maintaining sterility of the syringe. Unlike the luer bolt tip covers 24, which are formed of rigid materials such as thermoplastics, the protective sealing barrier is relatively flexible, allowing it to be easily shaped to the dimensions, shapes or tolerances associated with the terminal ends 52, 54 of the male luer tip and the female luer collar. Thus, the protective sealing barrier of the present invention eliminates to a large extent many of the problems with plastic tolerances or plastic creep that could be associated with plastic parts. Coupled with the co-planar configuration of the luer tip with luer collar, which allows substantially full surface contact between the membrane and the terminal ends of the collar and the luer tip, the protective sealing barrier of the present invention allows good safeguarding of sterility of the fluid passage and the medication, or both. Additionally, the protective sealant barrier provides a convenient planar surface that allows a pharmaceutical manufacturer to print pertinent information concerning the medicament 44 contained within the syringe. The protective sealant barrier can be stocked in a variety of standard sizes that accommodate a wide range of sizes of pre-filled syringes. Because the pre-filled sealant barrier is relatively flat, the space required to pack the entire pre-filled syringe is reduced, requiring less space for inventory and, generally, allowing more pre-filled syringes to be packaged in a container of a given size. It also reduces the amount of waste that must be discarded after the syringe is used. Also, the protective sealing barrier provides a good indication of violation for the syringe 30. For example, when a luer lock tip cap 24 is used, in the absence of external means of evidence of violation, it would be difficult for an end user to determine if syringe 30 has been violated, because a rapist would simply have to re-screw the tip cap into place in the syringe. The protective sealant barrier of the present invention provides a good indication of evidence of violation without the need to employ external means of evidence of violation; if an end user were to detect any detachment of the peelable membrane from one (or both) terminal ends 52, 54 of the collar or luer tip, the end user would have visual means to determine whether the sterility of the syringe has been compromised.

Other permutations of the protective sealant barrier according to the present invention are also possible. For example, rigid disks can be applied, or co-injected with these, to the terminal ends of the luer tip and the collar, instead of a membrane. The rigid discs would only cover the terminal end of the luer tip, if desired, as long as the outer packing or other means for providing sterility of the inner portions of the collar are provided. The disc would serve to maintain the sterility of the medicament contained within the syringe and provide a fluid barrier at the same time, in the manner previously described. It will be appreciated and understood by those skilled in the art that further and subsequent revisions of the invention may be conceived without departing from the spirit and scope of the appended claims, the invention not being limited to the specific embodiments shown.

Claims (20)

1. CLAIMS 1. A syringe having a protective sealing barrier, comprising: a barrel having proximal and distal ends and defining therein a compartment for retaining a quantity of medicament; a luer tip in fluid communication with the barrel compartment, the luer tip extending from the distal end of the barrel and having a terminal end; a collar circumferentially formed around the luer tip, the collar having an end end coplanar substantially with the terminal end of the luer tip; and a sealing membrane removably secured in surface contact substantially complete with the terminal ends of the luer tip and the collar. The syringe of claim 1, wherein the protective sealing barrier is configured to safeguard the sterility of the syringe. 3. The syringe of claim 1, wherein the protective sealing barrier is configured as a barrier to leak testing. 4. The syringe of claim 1, wherein the protective sealing barrier is configured as a leak-proof sterility maintenance barrier. 5. The syringe of claim 3, further containing a quantity of medicament in said compartment. 6. The syringe of claim 4, further containing an amount of medicament in said compartment. 7. The syringe of claim 1, wherein said sealing membrane comprises a planar portion and a pull tab portion, said planar portion configured for full surface contact substantially with the terminal ends of the luer tip and the collar, the tongue portion of shot attached to the planar portion and dimensioned to allow a user to pull the planar portion of the terminal ends. The syringe of claim 1, wherein said sealing membrane is formed of a material suitable for radiation sterilization. The syringe of claim 1, wherein said sealing membrane is formed of a material suitable for gas sterilization. 10. The syringe of claim 1, wherein said sealing membrane is formed of a material suitable for heat sterilization. The syringe of claim 1, wherein said sealing membrane comprises a heat sensitive adhesive to secure the sealing membrane to the terminal ends of the luer tip and the collar. 12. The syringe of claim 1, wherein said sealing membrane comprises a pressure sensitive adhesive to secure the sealing membrane to the terminal ends of the luer tip and the collar. 13. The syringe of claim 1, wherein the syringe is formed of a material selected from the group comprising glass and plastics. 4. A syringe having a protective sealing barrier, comprising: a barrel having proximal and distal ends and defining therein a compartment for retaining a quantity of medicament; a luer tip in fluid communication with the barrel compartment, the luer tip extending from the distal end of the barrel and having a terminal end; a collar circumferentially formed around the luer tip, the collar having a terminal end substantially coplanar with the terminal end of the luer tip; and a sealing membrane disposed over the terminal ends of the luer tip and collar, the sealing membrane having a first layer in substantially complete surface contact with the luer tip and the collar, a breaking point defined in the first layer in the region of the luer tip. 15. The protective sealant barrier of claim 14, wherein the sealing membrane further comprises a second layer disposed in said first layer. 16. The protective sealant barrier of claim 14, wherein said first layer is configured as a sterility barrier. 17. The protective sealant barrier of claim 15, wherein said first layer is configured as a sterility barrier. 18. The protective sealant barrier of claim 14, wherein said first layer is configured as a leak-proof barrier. 19. The protective sealant barrier of claim 15, wherein said second layer is configured as a leak-proof barrier. 20. A luer bolt syringe having a protective sealing barrier, comprising: a barrel having proximal and distal ends and defining a compartment for retaining a quantity of medicament; a luer tip in fluid communication with the barrel compartment, the luer tip extending from the distal end of the barrel and having a terminal end; a luer collar circumferentially formed around the luer tip, the collar having a terminal end projecting beyond the terminal end of the luer tip; and a sealing membrane disposed on the terminal ends of the luer tip and the collar in full surface contact substantially with the terminal ends of the luer tip and the luer collar.