Patent Publication Number: US-2009230077-A1

Title: Molded container with raised nipple and method for use

Description:
TECHNICAL FIELD 
     The invention relates to the field of molded containers, particularly to a blow-fill-seal (BFS) vial containing an internal elastomeric stopper, where the elastomeric stopper has a raised nipple that projects beyond the outer shell of the vial. 
     BACKGROUND OF THE INVENTION 
     Small vials with elastomeric stoppers are traditionally used to contain small amounts of liquids, particularly liquid medications, or as storage and dispensing vessels for lyophilized medications that are reconstituted prior to use. Safe retention of the elastomeric stopper requires a foil over-cap, to prevent the expulsion of the stopper should pressure within the vial rise. Additionally, the elastomeric stoppers generally require siliconization as a lubricant to insert the stoppers in the vials during the manufacturing process, thus introducing a potentially additional chemical compound. Furthermore, glass vials are inherently liable to breakage. In the end, a stoppered glass vial requires at least three different structural compounds (glass, elastomers, and foil), and assembly requires numerous steps. 
     More recently, large advances have been made in molded plastic containers, often referred to as “blow-fill-seal” or “BFS” containers. As is well known in the art, resin is extruded and molded into a container, and the container is then filled and the resin container sealed, all is a series of automated steps, generally carried out in a continuous or near-continuous process in a sterile environment within the BFS molding machinery. The evolution of this method of packaging is also well known in the art. Initially, various methods were described for blow molding a hollow thermoplastic article; for example, as seen in U.S. Pat. Nos. 3,137,748 and 3,288,898. More complex process for manufacturing BFS containers are later seen in U.S. Pat. Nos. 3,464,085 and 3,597,793. A further evolutionary step, by way of example only is seen in U.S. Pat. No. 3,919,374; which enabled the addition of an elastomeric stopper to a BFS vial. More recently, methods have been taught, as in U.S. Pat. No. 4,707,966; for molding a flat bottomed thermoplastic container, filling the container from the top, and then, prior to sealing, effecting a secondary operation, such as positioning an insert such as an elastomeric stopper in the top opening of the container, and then partially or completely encapsulating the insert in such a way that the encapsulating portion of the material can easily be broken away to gain access. 
     The BFS manufacturing process traditionally includes sub-components such as a thermoplastic polymer storage and feeding system; an extruder with a parison head; a sterile air filling chamber; a specialized mandrel capable of filling the container, mold halves capable of opening and closing, and therein forming the container; and various downstream items of equipment, such as inspection and leak detection systems, labelers, and packaging machinery. 
     Aseptic processing equipment, such as tanks fitted with sterility filters, ensures that the BFS machinery is continuously provided with sterile product. Thermoplastic polymer granules are typically fed via a vacuum tubing system into a hopper in the blow-fill-seal extruder, where they are heated to form a melt, typically at about 215° C. The thermoplastic polymer melt is formed via a circular orifice into a plastic parison (hollow tube), which is held open by a stream of sterile filtered air. The lower part of the divided mold halves then close to seal the bottom of the open parison and the parison wall is blown and/or compressed by vacuum to the cooled mold walls to form the lower part of the BFS container. A filling mandrel fills a predetermined quantity of product into the container, and after withdrawal of the mandrel, the upper portion of the mold closes to form and seal the upper part of the BFS container. For BFS vials with encapsulated stoppers or other inserts, an intermediate step includes placement of the insert in the correct position prior to encapsulation as part of the BFS process. Since multiple cavities may be built within a single mold, the rate of production is substantially related to the number of cavities in each BFS mold. 
     Vials with encapsulated stoppers generally resemble the type of prior art construction as illustrated in  FIG. 1 . There are a number of problems with such a construction. Firstly, the relatively right angle shoulder where the encapsulated thermoplastic turns over the top of the stopper creates an area that is difficult to blow mold. Secondly, the need for a reproducible fracture area wherein the vial may be opened requires a weakened area for such a fracture area, which can be difficult to design into such packaging. Lastly, the designs, owing to the fact that the stopper is encapsulated within the thermoplastic shell, result in a stopper surface that lies below the level of the shell. Thus, when opened, the exposed surface of the stopper essentially lies in a hole, surround by a raised thermoplastic area, as seen in  FIG. 2 . This can make access to the stopper, such as for cleaning and disinfection difficult. As taught below, the instant invention overcomes these and many other shortcomings of contemporary BFS vial design. 
     SUMMARY OF INVENTION 
     In its most general configuration, the present invention advances the state of the art with a variety of new capabilities and overcomes many of the shortcomings of prior devices in new and novel ways. The present invention is a molded container having a raised nipple, formed according to the traditional blow-fill-seal (BFS) methods described above. The container comprises a cap portion, a body portion, and with an encapsulated stopper. 
     The body portion has a body portion wall having a wall shoulder portion with a distal aspect and a proximal aspect. The body portion has an adjoining cap portion such that the body portion wall meets a cap portion wall at an engineered separation site, designed to represent an area of weakness in the walls of the container. 
     The container has a stopper enclosed within the container shell that prevents the transfer of contents from the body portion to the cap portion. A portion of the stopper is enclosed within the body portion and a portion of the stopper is enclosed within the cap portion. The stopper has a stopper wall and a stopper shoulder with a central raised nipple having a nipple top surface with an injection site and a nipple sidewall. The engineered separation site is adjacent to the nipple sidewall such that when the cap portion is removed from the body portion at the engineered separation site, a portion of the nipple extends out of the body portion. 
     This projection of a part of the nipple beyond the body portion presents numerous advantages over the prior art. When the cap of a traditionally formed BFS a vial is removed, the surface of the stopper lies essentially in a hole formed by the surrounding BFS shell. Thus, to clean the surface, it is necessary to place a cleaning means into the hole, hoping that the means will reach and adequately clean the surface of the stopper. Additionally, the relatively small hole means that the operator has only a very small surface area to hit with the needle, or other removal means, used to puncture the stopper and access the container contents. 
     The instant invention allows all of the top surface of the nipple to be easily cleaned, if desired, and allows substantially all of the top surface of the nipple to be accessed by a needle, or other removal means, to puncture the stopper and access the container contents. 
     The body wall shoulder portion, adjacent to the cap portion, may be configured at a non-orthogonal angle from the longitudinal axis of the container. This also has numerous advantages over the prior art, including but not limited to the following. It can be difficult, when the body wall should of a BFS vial comprises an orthogonal angle, to insure sufficient plastic at the bend to form a sufficiently strong container. Additionally, such a right-angle bend imposes a geometry that makes design of a suitable breakage line between the body and the cap of a BFS vial more difficult. 
     In another embodiment, the wall shoulder portion further comprises at least one raised gusset, extending from the wall shoulder portion and having a lateral surface substantially parallel to the longitudinal axis of the container. Such gusset(s) not only tend to strengthen the BFS vial, but cooperate with a variety of connectors. 
     Extending the length of the lateral surface increases the surface area of interaction between the container and the interior surface of a needle-free container, and a larger surface area for interaction results in a more stable cooperation between the elements and a more positive centering of a needle-free connector. 
     To assist in the separation of the cap portion and the body portion, the cap portion may have a cap portion wall formed with a grip enhancing feature such as a flattened tab ( 332 ), see  FIGS. 13(   a ) and  13 ( b ). Various embodiments employing different geometries maybe useful in facilitating the opening of the container, which is often of a relatively small size. Such a flattened tab may have relatively short lateral expanse such that the easiest means of removing the cap portion from the body portion is to use two hands, one to grip the body portion and another to twist off the cap portion. While one-handed removal of the cap portion in such a design is not impossible, it may require a degree of hand strength not universally found among those desiring to use the container. 
     The hand strength required for one-handed opening may be decreased by increasing the moment arm of the tab, that is, the larger the tab relative to the container, the less force that must be applied at a distal point on the tab to effect a rupture at the engineered separation site. This allows easier removal of the cap portion from the body portion by torquing the cap portion. Such relative elongation of the tab simply increases the leverage available for opening the container at the engineered separation site. 
     Clean and accurate removal of the cap portion from the body portion may also be facilitated by refinements in the engineered separation site where the body portion wall meets the cap portion wall. In one embodiment of the instant invention, the engineered separation site comprises a line of discontinuity in shell thickness between the body portion wall and the cap portion wall. The discontinuity creates a natural fracture zone between the adjoining body portion and cap portion. In a further embodiment, the engineered separation site is formed by a progressive attenuation of the thickness of the wall shoulder portion tapering from a maximum thickness at the distal aspect of the wall shoulder portion to reach a minimum thickness at the proximal aspect of the wall shoulder portion ( 221 ), see  FIG. 7 . Variations, modifications, alternatives, and alterations of the various preferred embodiments may be used alone or in combination with one another, as will become more readily apparent to those with skill in the art with reference to the following detailed description of the preferred embodiments and the accompanying figures and drawings. 
     There is disclosed a container ( 10 ) with at least one diameter ( 12 ) and a longitudinal axis ( 14 ), comprising a container shell ( 50 ) comprising a body portion ( 200 ) with a body portion wall ( 220 ) having a wall shoulder portion ( 221 ) having a distal aspect ( 222 ) and a proximal aspect ( 223 ) and an adjoining cap portion ( 300 ) having a cap portion wall ( 320 ), wherein the body portion wall ( 220 ) meets the cap portion wall ( 320 ) at an engineered separation site ( 400 ); and a stopper ( 100 ) enclosed within the container shell ( 50 ) and preventing the transfer of contents from the body portion ( 200 ) to the cap portion ( 300 ), such that a portion of the stopper ( 100 ) is enclosed within the body portion ( 200 ) and a portion of the stopper( 100 ) is enclosed within the cap portion ( 300 ), wherein the stopper ( 100 ) has a stopper wall ( 120 ) and a stopper shoulder ( 123 ) with a central raised nipple ( 130 ) having a nipple top surface ( 134 ) with an injection site ( 135 ) bounded by a raised injection guide ( 136 ) and a nipple sidewall ( 132 ), and wherein the engineered separation site ( 400 ) is adjacent to the nipple sidewall ( 132 ) such that when the cap portion ( 300 ) is removed from the body portion ( 200 ) at the engineered separation site ( 400 ) a portion of the nipple ( 130 ) extends out of the body portion ( 200 ). Further, there is disclosed a container ( 10 ) with at least one diameter ( 12 ) and a longitudinal axis ( 14 ), comprising a container shell ( 50 ) comprising a body portion ( 200 ) with a body portion wall ( 220 ) having a wall shoulder portion ( 221 ) configured at a non-orthogonal angle from the longitudinal axis ( 14 ) of the container ( 10 ) having a distal aspect ( 222 ) and a proximal aspect ( 223 ) wherein the wall shoulder portion ( 221 ) further comprises at least one raised gusset ( 228 ) extending from the wall shoulder portion ( 221 ) and having a lateral surface ( 229 ) substantially parallel to the longitudinal axis ( 14 ) of the container ( 10 ) wherein the lateral surface ( 229 ) begins at the distal aspect ( 222 ) of the wall shoulder portion ( 221 ) and extends substantially parallel to the longitudinal axis ( 14 ) of the container at least 25% of the longitudinal distance from the distal aspect ( 222 ) to the injection site ( 135 ) measured along the longitudinal axis ( 14 ) of the container ( 10 ), and an adjoining cap portion ( 300 ) having a cap portion wall ( 320 ), wherein the body portion wall ( 220 ) meets the cap portion wall ( 320 ) at an engineered separation site ( 400 ) wherein the engineered separation site ( 400 ) comprises a line of discontinuity in shell thickness between the body portion wall ( 220 ) and the cap portion wall ( 320 ) formed by a progressive attenuation of the thickness of the wall shoulder portion ( 221 ) tapering from a maximum thickness at the distal aspect ( 222 ) of the wall shoulder portion ( 221 ) to reach a minimum thickness at the proximal aspect ( 223 ) of the wall shoulder portion ( 221 ) and a stopper ( 100 ) enclosed within the container shell ( 50 ) and preventing the transfer of contents from the body portion ( 200 ) to the cap portion ( 300 ), such that a portion of the stopper ( 100 ) is enclosed within the body portion ( 200 ) and a portion of the stopper ( 100 ) is enclosed within the cap portion ( 300 ), wherein the stopper ( 100 ) has a stopper wall ( 120 ) and a stopper shoulder ( 123 ) with a central raised nipple ( 130 )) having a nipple top surface ( 134 ) with an injection site ( 135 ) and a nipple sidewall ( 132 ), and wherein the engineered separation site ( 400 ) is adjacent to the nipple sidewall ( 132 ) such that when the cap portion ( 300 ) is removed from the body portion ( 200 ) at the engineered separation site ( 400 ) a portion of the nipple ( 130 ) extends out of the body portion ( 200 ). Further, there is disclosed a container ( 10 ) with at least one diameter ( 12 ) and a longitudinal axis ( 14 ), comprising a container shell ( 50 ) comprising a body portion ( 200 ) with a body portion wall ( 220 ) having a wall shoulder portion ( 221 ) configured at a non-orthogonal angle from the longitudinal axis ( 14 ) of the container ( 10 ) having a distal aspect ( 222 ) and a proximal aspect ( 223 ) wherein the wall shoulder portion ( 221 ) further comprises at least one raised gusset ( 228 ) extending from the wall shoulder portion ( 221 ) and having a lateral surface ( 229 ) substantially parallel to the longitudinal axis ( 14 ) of the container ( 10 ) wherein the lateral surface ( 229 ) begins at the distal aspect ( 222 ) of the wall shoulder portion ( 221 ) and extends substantially parallel to the longitudinal axis ( 14 ) of the container at least 25% of the longitudinal distance from the distal aspect ( 222 ) to the injection site ( 135 ) measured along the longitudinal axis ( 14 ) of the container ( 10 ), and an adjoining cap portion ( 300 ) having a cap portion wall ( 320 ) formed with a grip enhancing feature ( 330 ) the grip enhancing feature ( 330 ) is a flattened tab ( 332 ) formed such that a distance from a most distant point on the tab ( 332 ) from a center of the injection site ( 135 ) is at least 65% of the largest of the at least one diameter ( 12 ) of the container ( 10 ), wherein the body portion wall ( 220 ) meets the cap portion wall ( 320 ) at an engineered separation site ( 400 ) wherein the engineered separation site ( 400 ) comprises a line of discontinuity in shell thickness between the body portion wall ( 220 ) and the cap portion wall ( 320 ) formed by a progressive attenuation of the thickness of the wall shoulder portion ( 221 ) tapering from a maximum thickness at the distal aspect ( 222 ) of the wall shoulder portion ( 221 ) to reach a minimum thickness at the proximal aspect ( 223 ) of the wall shoulder portion ( 221 ); and a stopper ( 100 ) enclosed within the container shell ( 50 ) and preventing the transfer of contents from the body portion ( 200 ) to the cap portion ( 300 ), such that a portion of the stopper ( 100 ) is enclosed within the body portion ( 200 ) and a portion of the stopper ( 100 ) is enclosed within the cap portion ( 300 ), wherein the stopper ( 100 ) has a stopper wall ( 120 ) and a stopper shoulder ( 123 ) with a central raised nipple ( 130 )) having a nipple top surface ( 134 ) with an injection site ( 135 ) and a nipple sidewall ( 132 ), and wherein the engineered separation site ( 400 ) is adjacent to the nipple sidewall ( 132 ) such that when the cap portion ( 300 ) is removed from the body portion ( 200 ) at the engineered separation site ( 400 ) a portion of the nipple ( 130 ) extends out of the body portion ( 200 ). 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
       Without limiting the scope of the present invention as claimed below and referring now to the drawings and figures, all not to scale: 
         FIG. 1  is a cross section view of an embodiment of a prior art molded container; 
         FIG. 2  is a cross section view of a prior art molded container with a cap portion removed; 
         FIG. 3  is a side elevation view of an embodiment of the instant invention; 
         FIG. 4  is a cross section view of the cap portion and a part of a body portion of the present invention; 
         FIG. 5  is a cross section view of a part of the body portion of the embodiment of the instant invention of  FIG. 4 , with the cap portion removed; 
         FIG. 6  is a cross section view of a stopper of the instant invention; 
         FIG. 7  is a cross section view of the cap portion, the stopper, and a part of the body portion of another embodiment of the molded container of the instant invention; 
         FIG. 8  is a cross section view of a part of the body portion of the embodiment of  FIG. 5 , and a needle-free connector; 
         FIG. 9   a  is a cross section view showing potential misalignment between the body portion of the embodiment of  FIG. 5 , and a needle-free connector; 
         FIG. 9   b  is a top plan view of an embodiment of the instant invention, showing raised gussets extending from a wall shoulder portion; 
         FIG. 10  is a cross section view of a part of the body portion of the BFS vial and a needle-free connector; 
         FIG. 11  is a cross section view of a part of the body portion of the embodiment of the instant invention with the needle-free connector inserted; 
         FIG. 12   a  is a top plan view of a prior art needle-free connector suitable for use with the instant invention; 
         FIG. 12   b  is a side elevation view of a prior art needle-free connector suitable for use with the instant invention; 
         FIG. 12   c  is a bottom plan view of a prior art needle-free connector suitable for use with the instant invention; 
         FIG. 12   d  is a cross section view of a prior art needle-free connector suitable for use with the instant invention; 
         FIG. 13   a  is a top plan view of an embodiment of the instant invention; 
         FIG. 13   b  is a side elevation view of an embodiment of the instant invention; 
         FIG. 14   a  is a top plan view of an embodiment of the instant invention; and 
         FIG. 14   b  is a side elevation view of an embodiment of the instant invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
     The molded container ( 10 ), see  FIG. 4 , of the instant invention enables a significant advance in the state of the art. The detailed description set forth below in connection with the drawings is intended merely as a description of the presently preferred embodiments of the invention, and is not intended to represent the only form in which the present invention may be constructed or utilized. The description sets forth the designs, functions, means, and methods of implementing the invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and features may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention. 
     With reference generally now to  FIGS. 1 through 14 , the instant invention comprises a molded container ( 10 ) with at least one diameter ( 12 ), see  FIG. 7 , and a longitudinal axis ( 14 ), see  FIG. 4 . Such a container would be most commonly formed according to the traditional blow-fill-seal (BFS) methods described above. As seen in  FIG. 3 , and in detail in  FIG. 4 , on its largest level, the container ( 10 ) comprises a cap portion ( 300 ) and a body portion ( 200 ) with an encapsulated stopper ( 100 ). 
     As seen in  FIGS. 4 and 5 , the container has a container shell ( 50 ) comprising a body portion ( 200 ) with a body portion wall ( 220 ) having a wall shoulder portion ( 221 ) having a distal aspect ( 222 ) and a proximal aspect ( 223 ), best seen in  FIG. 5 . The terms “distal” and proximal” are intended to represent positions relatively farther and relatively nearer, respectively, from the longitudinal axis ( 14 ) of the container ( 10 ). The body portion ( 200 ) has an adjoining cap portion ( 300 ), seen in  FIG. 4 , having a cap portion wall ( 320 ), wherein the body portion wall ( 220 ) meets the cap portion wall ( 320 ) at an engineered separation site ( 400 ), seen in  FIG. 4 . The engineered separation site ( 400 ) is designed to represent an area of weakness in the walls ( 220 ,  320 ) of the container, such that a uniform and repeatable breakage area is created for the removal of the cap portion ( 300 ) from the body portion ( 200 ). 
     The container ( 10 ) has a stopper ( 100 ), well seen in  FIG. 5  and shown in detail removed from the container in  FIG. 6 , enclosed within the container shell ( 50 ), seen in  FIG. 4 , that prevents the transfer of contents from the body portion ( 200 ) to the cap portion ( 300 ). A portion of the stopper ( 100 ) is enclosed within the body portion ( 200 ) and a portion of the stopper ( 100 ) is enclosed within the cap portion ( 300 ), as seen in  FIG. 4 . The stopper ( 100 ) has a stopper wall ( 120 ) and a stopper shoulder ( 123 ), see  FIG. 6 , with a central raised nipple ( 130 ) having a nipple top surface ( 134 ) with an injection site ( 135 ) and a nipple sidewall ( 132 ), as seen in  FIG. 5 . The engineered separation site ( 400 ), see  FIG. 4 , is adjacent to the nipple sidewall ( 132 ) such that when the cap portion ( 300 ) is removed from the body portion ( 200 ) at the engineered separation site ( 400 ) a portion of the nipple ( 130 ) extends out of the body portion ( 200 ), as seen in  FIGS. 4 and 5 . 
     This projection of a part of the nipple ( 130 ) beyond the body portion ( 200 ) presents numerous advantages over the prior art. As discussed above, the traditionally encapsulated stopper within a BFS vial lies entirely within the shell of the BFS vial, as seen in  FIG. 1  (prior art). Thus, when the cap of such a vial is removed, the surface of the stopper lies essentially in a hole formed by the surrounding BFS shell, as seen in  FIG. 2  (prior art). Thus, to clean the surface, it is necessary to place a cleaning means into the hole, hoping that the means will reach and adequately clean the surface of the stopper at the bottom of the hole. Additionally, the relatively small hole means that the care giver has only a very small surface area to hit with the needle, or other removal means, used to puncture the stopper and access the container contents. 
     The instant invention, as seen in  FIG. 5 , allows all of the top surface ( 134 ) of the nipple ( 130 ) to be easily cleaned, if desired, and allows substantially all of the top surface ( 134 ) of the nipple ( 130 ) to be accessed by a needle, or other removal means, to puncture the stopper ( 100 ) and access the container ( 10 ) contents. Additionally, in some embodiments, the injection site ( 135 ) on the top surface ( 134 ) of the nipple ( 130 ) is bounded by a raised injection guide ( 136 ) to assist in correct placement of the needle or other removal means into the stopper ( 100 ). 
     The body wall shoulder portion ( 221 ), adjacent to the cap portion ( 300 ), may be configured at a non-orthogonal angle, seen in  FIG. 5 , from the longitudinal axis ( 14 ) of the container ( 10 ). This also has numerous advantages over the prior art. The traditional BFS vial, such as the prior art examples seen in  FIGS. 1 and 2 , have shoulders over the embedded stoppers that are configured approximately orthogonally to a longitudinal axis of the container, resulting in approximately a right-angle bend at the most lateral portion of the shoulder area. It can be difficult, given such an orthogonal angle, to insure sufficient plastic at the bend, to form a sufficiently strong container, using traditional BFS methods. Additionally, such a right-angle bend imposes a geometry that makes design of a suitable breakage line between the body and the cap of a BFS vial more difficult. Both of these problems are reduced with the instant invention, and in particular, the advantages towards the design of a suitable breakage line will be discussed in more detail below. 
     The instant invention may also be configured so that the body portion wall ( 220 ) has an ingress preventer ( 224 ), seen in  FIGS. 4 and 5 , wherein the ingress preventer ( 224 ) cooperates with a stopper ingress preventer ( 124 ) formed in the stopper wall ( 120 ). Such cooperation decreases the likelihood that the stopper ( 100 ) can be inadvertently forced into the container ( 10 ) by external pressure. In another embodiment, a wall retention surface ( 226 ) on the body portion wall ( 220 ) cooperates with a stopper retention surface ( 126 ) on the stopper wall ( 120 ). By way of example only, such cooperation may provide sufficient frictional fit so that the stopper ( 100 ) is less likely to be forced into, or expelled from, the container ( 10 ). In yet another embodiment, also seen in  FIG. 5 , the wall retention surface ( 226 ) further comprises at least one wall egress preventer ( 227 ), wherein the wall egress preventer ( 227 ) cooperates with a stopper egress preventer ( 127 ) on the stopper retention surface ( 126 ). Such cooperation reduces the chances of the stopper ( 100 ) being inadvertently expelled from the container ( 10 ) such as, by way of example only, might be caused by an over pressurization of the interior of the container ( 10 ). 
     In another embodiment, the wall shoulder portion ( 221 ) further comprises at least one raised gusset ( 228 ), seen in  FIGS. 9   b  and  10 , extending from the wall shoulder portion ( 221 ) and having a lateral surface ( 229 ) substantially parallel to the longitudinal axis ( 14 ) of the container ( 10 ). Such gusset(s) ( 228 ) not only tend to strengthen the BFS vial, but may cooperate with a variety of needle-free connectors, such as, by way of example only, the SMARTSITE® needle-free connector manufactured by Cardinal Health, Inc. of Dublin, Ohio, USA. 
     Extending the length of the lateral surface ( 229 ), see  FIG. 9   b,  increases the surface area of interaction between the lateral surface ( 229 ) and the interior surface of a needle-free container, as can be seen in  FIGS. 10 and 11 . A larger surface area for interaction results in a more stable cooperation between the elements and a more positive centering of a needle-free connector, as will be discussed immediately below in relationship to  FIGS. 8-11 . 
     The advantage of the at least one raised gusset design may be seen in  FIGS. 8-11 . In  FIG. 8 , a needle free connector ( 500 ), see  FIG. 12   a,  of the type, by way of example only, of the SMARTSITE® needle-free connector poised at the moment of puncture of the injection site ( 135 ), see  FIG. 8 , of the raised nipple ( 130 ). One skilled in the art can see, as would be confirmed by reference to  FIG. 9   a,  that it is relatively easy for an operator to place the needle-free connector ( 500 ) eccentrically on the container ( 10 ), potentially leading to an unstable connection and an improper puncturing of the injection surface ( 135 ). 
     Typical features of a needle-free connector ( 500 ) may be seen in  FIGS. 12   a - 12   d,  as well as in  FIGS. 8 ,  9   a,  and  10 - 11 . As seen in  FIGS. 10 and 12   a - d , some of the features of a typical needle-free connector include a connector male end fluid port ingress regulator ( 523 ), essentially shaped as a spike-like means for puncturing the stopper ( 100 ) at the injection site ( 135 ) and a connector male end fluid port interlock ( 524 ), essentially configured as resilient clips that allow the needle-free connector ( 500 ) to cooperate with various configurations of the body portion ( 200 ) of the container ( 10 ). 
     The effect of the raised gusset ( 228 ) design, particularly embodiments employing a lateral surface ( 229 ) substantially parallel to the longitudinal axis of the container ( 10 ), may be appreciated by one skilled in the art as illustrated in  FIG. 10 . As the needle-free connector approaches the top of the container ( 10 ), the raised gusset(s) ( 228 ), particularly the lateral edges ( 229 ), interacts with the clip-like sides of the needle-free connector. This tends to guide the needle-free connector to a proper central placement on the injection site ( 135 ). Additionally, as can be seen in  FIG. 11 , the raised gusset(s) ( 228 ) tend to fill the interior volume of the needle-free connector and to insure a closer and more stable fit with the body portion ( 200 ) of the container ( 10 ). The details of a typical needle-free container suitable for use with the instant invention are shown, by way of example only, in  FIGS. 12   a - d.    
     As seen in  FIGS. 13   a - b  and  14   a - b , to assist in the separation of the cap portion ( 300 ) and the body portion, the cap portion ( 300 ), see  FIG. 7 , may have a cap portion wall ( 320 ) formed with a grip enhancing feature ( 330 ). Such a grip enhancing feature ( 330 ) may be a flattened tab ( 332 ) having a lateral aspect ( 333 ). Various embodiments employing different geometries maybe useful in facilitating the opening of the container ( 10 ) which is often of a relatively small size. By way of example only, the grip enhancing features may be a flattened tab ( 332 ) attached to the cap portion ( 300 ), seen in  FIGS. 13   a - b  and  14   a - b . Such a flattened tab ( 332 ) may have relatively short lateral expanse such that the easiest means of removing the cap portion ( 300 ) from the body portion ( 200 ) is to use two hands, one to grip the body portion ( 200 ) and another to twist off the cap portion ( 300 ). Such a twisting motion is shown in  FIG. 13   b  by the two-headed arrow indicating rotation that is shown on the cap portion ( 300 ). While one-handed removal of the cap portion ( 300 ) in such a design is not impossible, it may require a degree of hand strength not universally found among those desiring to use the container ( 10 ). It may be desirable to facilitate one-handed removal of the cap portion by altering the geometry of the tab ( 332 ). 
     The hand strength required for one-handed opening may be decreased by increasing the moment arm of the tab ( 332 ) that is, the larger the tab ( 332 ) relative to the container ( 10 ), the less force that must be applied at a distal point on the tab ( 332 ) to effect a rupture at the engineered separation site ( 400 ). By way of example, a tab ( 332 ) is shown in  FIGS. 7 and 14   b  formed such that a distance from a most distant point on the tab ( 332 ), at the lateral aspect ( 333 ), from a center of the injection site ( 135 ) is at least 50% of the largest of the at least one diameter ( 12 ) of the container ( 10 ). A similar construction may be seen in  FIG. 14   b.  This allows easier removal of the cap portion ( 300 ) from the body portion ( 200 ) by simply torquing the cap portion ( 300 ), in the direction shown by the single headed arrow on the cap portion ( 300 ) seen in  FIG. 14   b.  In a further embodiment, the tab ( 332 ) is formed such that a distance from a most distant point on the tab ( 332 ), at the lateral aspect ( 333 ), from a center of the injection site ( 135 ) is at least 65% of the largest of the at least one diameter ( 12 ) of the container ( 10 ), as may be seen in  FIG. 7  and  FIG. 14   b.  Such relative elongation of the tab ( 332 ) simply increases the leverage available for opening the container ( 10 ) at the engineered separation site ( 400 ). 
     Clean and accurate removal of the cap portion ( 300 ) from the body portion ( 200 ) may also be facilitated by refinements in the engineered separation site ( 400 ) where the body portion wall ( 220 ) meets the cap portion wall ( 320 ). Such a site ( 400 ) could comprise, by way of example, a score line in the shell wall ( 52 ). In one embodiment of the instant invention, as seen in  FIGS. 4 and 5 , the engineered separation site ( 400 ) comprises a line of discontinuity in shell thickness between the body portion wall ( 220 ) and the cap portion wall ( 320 ). The discontinuity creates a natural fracture zone between the adjoining body portion ( 200 ) and cap portion ( 300 ). As seen in  FIG. 5 , in a further embodiment, the engineered separation site ( 400 ) is formed by a progressive attenuation of the thickness of the wall shoulder portion ( 221 ), see  FIG. 5 , tapering from a maximum thickness at the distal aspect ( 222 ) of the wall shoulder portion ( 221 ) to reach a minimum thickness at the proximal aspect ( 223 ) of the wall shoulder portion ( 221 ). 
     Numerous alterations, modifications, and variations of the preferred embodiments disclosed herein will be apparent to those skilled in the art and they are all anticipated and contemplated to be within the spirit and scope of the claimed invention. For example, although specific embodiments have been described in detail, those with skill in the art will understand that the preceding embodiments and variations can be modified to incorporate various types of substitute and or additional or alternative materials, relative arrangement of elements, and dimensional configurations. Accordingly, even though only few variations of the present invention are described herein, it is to be understood that the practice of such additional modifications and variations and the equivalents thereof, are within the spirit and scope of the invention as defined in the following claims. 
     INDUSTRIAL APPLICABILITY 
     The container with a raised nipple of the instant invention answers a long-felt need in the area of BFS containers having internally encapsulated stoppers. The design of the invention allows a portion of the raised nipple to extend beyond the body portion of the container, after opening, such that it may be easily accessed and cleaned. Additional modifications, including the provision of an improved engineered separation site at the point of opening, and raised gussets that may provide a secure connection with various needle-free connectors improves the safety and efficiency found in this art.