JPH11152161A - Locking ring connector assembly for vial - Google Patents

Abstract

PROBLEM TO BE SOLVED: To reduce a number of protective walls against microorganisms required for protecting a sterile state of a system by including a cap, a collar and a locking ring and allowing a vial access device to be exposed by breaking the cap receiving the access device from the collar at a weakened part for separation. SOLUTION: The connector assembly 30 for a vial whose opening end is closed by a plug 22 has a cap 32, a collar 42 and a locking ring 60. The collar 42 has a joint 39 with a vial and is equipped with a sealing rib 40 at a distal end 44 adjacent to the joint 39. The locking ring 60 serves to fix the collar 42 to a rim of the vial at a second position, wherein a swell 70 is made to protrude from the inside adjacent to the distal end 64, and a locking face 72 toward the distal end is provided on the swell 70. The cap 32 receives a vial access device 80, and it can be removed from the collar 42 by breaking at a weakened part 100 to have the access device 80 exposed.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

FIELD OF THE INVENTION The present invention relates to a connector assembly for a vial, and more particularly, to minimizing the number of components of the connector assembly and reducing the number of microorganisms required to maintain the sterility of the system. The present invention relates to a ring connector assembly for locking a vial that reduces the number of barriers.

[0002]

BACKGROUND OF THE INVENTION It is generally known in the art to reduce inventory locations and / or extend the shelf life of certain drugs, and to convert these drugs to a dry or powdered state. That has its advantages. These dry or powdered drugs are usually stored in closed containers such as vials. These agents are also returned (reduced) to a liquid state with a suitable diluent or solvent. Vials, typically made of glass or plastic material, include an elastomeric stopper that seals the open end of the vial. The stopper includes a flat surface resting on the top end of the vial, in addition to the portion inserted into the vial neck relative to the vial rim. The flat surface is usually securely attached to the vial rim with an aluminum crimp cap.

[0003] Due to the adaptive nature of aluminum,
The crimp cap is easily adapted to any different dimensions or tolerances that exist between the stopper and the vial. The crimp cap results in an even distribution of the sealing force between the stopper and the vial.

It is generally known in the art, however, that vials / stoppers / aluminum crimp caps protect the sterility of the drug contained within the vial under defined conditions for a suitable long storage period. It recognized. The size and dimensions of the various vials and closure elements are
It may be shaped to a predetermined standard such as the SO standard.

One method of returning (reducing) the drug contained in a vial is to introduce a solvent or diluent from a syringe by piercing a stopper that seals the vial. Due to various considerations, as the convenience for health workers is left to the reducing drug, the technology allows for safety and provides a standard seal for effective reduction of the drug contained in the vial. We know how to turn a small vial into a suitable system. In these systems, the fluid transfer assembly is typically connected to the neck of the vial. The fluid transfer assembly includes a structure for connecting the vial to a source of diluent, such as a diluent contained in a bottle, bag, or syringe. The transfer assembly is then arranged to allow fluid flow from the source of diluent into the vial, thereby reducing the drug.

In some forms, the system includes a rubber vial that is inserted into a vial neck without the need for a flat surface to rest against the vial rim. Such that it is advantageously removed for a fluid transfer assembly having This plug remains in the neck until such time as drug reduction is desired. When the transfer assembly is deployed, the stopper is biased toward the inside of the vial, opening the neck, thereby allowing fluid to flow through the transfer assembly and into the vial body. An example of such a way is M
ONOVIAL (registered trademark) [Becton Diki
nson Pharmaceutical System
of Le Pont de Claix, Franc
e., a drug dispensing device, as demonstrated by U.S. Pat. No. 5,358,501]. When forming reduction systems that exhibit superior properties to form excellent drugs, these systems are characterized and formed, particularly in terms of convenience in use, maintaining the sterile state of the drug contained in the vial, The vial is relatively large in size, typically 12
("Ml") or more.

[0007] Thus, some pharmaceutical companies want to have a way to reduce in vials of a size smaller than the size that the above-mentioned systems usually form.

[0008] Then, in response to the foregoing, one logical means surrounding the dilemma is the use of vials already used by pharmaceutical companies, such as ISO standard vials / stoppers / aluminum crimp cap elements. The goal is to change the features associated with the elements as accurately as possible and to provide a reduction system surrounding these elements for use by health workers. The prior art has considered several attempts in that regard. For example, a PCT patent application (WO97 / 10156, Biod
ome, SA of Issoire Cedex, F
The aluminum crimp cap, which is typically used to seal the flat surface of a standard stopper to the vial rim, as demonstrated by the lance, provides a rubber piercing fluid transfer around the vial neck. Replaced by assembly.

[0009]

The rubber piercing fluid transfer assembly is placed by the end user when it is desired to reduce the drug contained in the vial.
The transfer assembly disclosed in this patent application is fairly rigid and features an outermost plastic locking ring. The locking ring theoretically secures the plastic transfer assembly against the flat surface of the stopper and thus seals this portion of the stopper against the vial rim. But, as pointed out, in fact, glass element (small bottle), rubber element (stopper)
There is a significant discrepancy between the dimensional tolerances of the plastic elements (fluid transfer assemblies) that form the system. The adaptive nature of aluminum crimp caps takes into account differences in tolerances. However, due to the rigid nature of the sealing ring in this manner, individual vials, stoppers, or transfer assemblies can be provided, and the sealing force achieved by the outer sealing ring on the stopper and vial is limited. Not enough, but not enough even. Thus, during manufacturing, shipping, or storage, the potential contamination of the drug subjected to environmental pressure to which the vial is exposed presents a problem.

[0010] Accordingly, there is a need for a safe and effective drug reduction system that can be attached to standard vial and closure devices in such a way that the fluid transfer assembly is efficiently replicated in the sealing force achievable by the aluminum crimp cap. It is said. In view of this, such a drug reduction system is disclosed.

[0011]

SUMMARY OF THE INVENTION The present invention addresses the above problems in a convenient and cost effective manner. The connector assembly according to the present invention is designed to use standard vials and stoppers so that it can be processed by pharmaceutical manufacturers in standard processing equipment. The connector assembly can explain in detail the reason for the dimensional or tolerance mismatch in the vial or stopper element, or the elements forming the connector assembly itself, to ensure good microbial defense properties. .

[0012] The connector assembly features a protective cap for covering the open end of the vial neck. The cap has an open proximal end, a closed distal end, and
A shield wall formed between the distal end and the open proximal end. The collar is provided adjacent the proximal opening of the cap. The collar may be molded with the cap or may be manufactured individually and then attached to the cap. The collar is characterized by a proximal end, a distal end, and sidewalls between the proximal and distal ends. One or more ribs are provided within the collar adjacent the distal end.

The ribs are also designed to form a tight seal against the stopper when the collar is positioned relative to the stopper. The interior of the collar is shaped to mate with a vial access device provided to pierce the stopper.

A locking ring is provided between the collar and the rim of the vial. The locking ring features a proximal end and a distal end, and an annular portion between the proximal and distal ends. An inwardly projecting ridge is provided adjacent the proximal end of the locking ring. In addition, a cooperative locking structure is provided between the collar and the locking ring to hold the locking ring in a respective locking position of the collar.

[0015] In one embodiment, the cooperative locking structure may be formed as a ratchet tooth provided between the side wall of the collar and the annular portion of the locking ring. Alternatively, the cooperative locking structure may be a cooperative screw. The locking ring also features a skirt disposed proximally of the ridge that serves to engage the shoulder of the vial disposed proximally of the rim.

The connector assembly is transported to the pharmacy so that the locking ring is held in each unlocked position of the collar. In a sterile environment in which the vial is filled with medicament and the stopper is placed against the rim, the connector assembly is mounted to the vial. The connector assembly includes an inwardly protruding ridge on the locking ring, from a first position where the locking ring is disposed about the rim and the cap remote from the plug, about an outer surface of the rim, and a lower surface of the rim. To a second position where it is pressed against. Also, by this action, the ribs provided inside the collar are pressed to seal against the stopper, forming a microbiological barrier that protects the sterile condition of the vial entry device contained by the connector assembly. I do. Then, during an aseptic environment, the locking ring
A distal end of the collar may be biased for each locking position of the collar. Therefore, the locking ridge on the ring should ensure that the collar is securely fastened to the vial.
It is urged against the lower surface of the rim.

If necessary, the cap and collar can be removed from the collar by a twisting action so that the user can engage the device for entry into the vial held by the connector assembly in a convenient manner. It can also be manufactured by means. In one form, the cap is different from the material forming the cap and collar, such as polypropylene or polyethylene. . . Like thermoplastic elastomers. . . It may be formed with a collar with a fragile connection formed of a material. The user can simply twist the cap to shear the weakened connection and remove the cap to expose the vial access device.

One way to achieve this structure is by co-injection molding. Overall, minimizing the number of elements forming the connector assembly will not only ensure the sterility of the access device to the vial, but also the biological barrier necessary to protect the drug contained within the vial. The number will be reduced concomitantly.

[0019]

DETAILED DESCRIPTION OF THE INVENTION The convention used throughout this application is that the term "proximal" means the distance close to the rim 14 of the vial 10, while the term "distal" means far from the rim of the vial. Means distance.

Referring to the drawings, wherein like numerals refer to like elements in the drawings, FIGS. 1 and 2 illustrate a first embodiment of a connector assembly for a vial 10 in accordance with the present invention.
Example 30 is shown. The vial 10 is characterized by a bottom wall 11, side portions 13, a neck 12, and an annular rim 14. The shoulder 21 is provided between the rim 14 and the side portion 13. The annular rim 14 is
8, a side surface portion 20, and a top surface 16. The stopper 22 is typically used to close the open end 17 leading to the vial. The plug 22 is characterized by a flat portion 24 covering the uppermost surface 16 of the rim and a plug portion 23 closing the inner surface 19 of the neck 12. The vial 10 is typically filled with the desired drug, such as a dried or lyophilized drug, and then stoppered 22 in a sterile room environment. For the purposes of the present invention, the dimensions and characteristics of the vial 10 and stopper 22 are consistent with various generally accepted standards, such as the ISO standards governing the vial and stopper used for drug use. You will notice good things.

As explained above, a disadvantage of that technique is that it ensures that a suitable sealing force is between the stopper 22 and the vial 10. A solution to this problem in a vial connector assembly that is easily processed by the pharmacy, and hopefully the drug is processed and directed into the vial, plugged in the vial, and completely processed in a sterile room environment. Including is also an advantage.

Then, using the above considerations, a first embodiment 30 of the connector assembly of the present invention is provided. The connector assembly 30 comprises three main elements: a cap 32, a collar 42, and a locking ring 6.
0.

The cap 32 is characterized by a closed distal end 34, an open proximal end 36, and a shielding wall 38 therebetween. The cap 32 is provided adjacent to the collar 42. The cap 32 and the collar 42 may be integrally formed or formed separately and joined together by mechanical means, welding, gluing, or the like. In a preferred configuration, the cap 32 and collar 42 are formed together and joined by a weakened portion 100 as described below.

The collar 42 is designed to fit into the vial rim 14. A collar 42 is disposed adjacent to the proximal opening 36 of the cap. The collar 42 includes a straight tubular portion 37 forming an interior 35. The interior 35 may be engaged or otherwise provided with a device 80 for entry into a vial, as described more fully below.
Has the function of surrounding The adjacent tubular section 37 is provided with a vial connection 39. The vial joint 39 in the collar includes a distal end 44, an open proximal end 46,
Also, the side surface 48 is shown. One or more sealing ribs 40 are provided on the adjacent distal end 44 of the vial joint 39. Ribs 40 may take any shape suitable for the sealing function, such as an annular, spire, square, or other geometric shape. As described below, the collar 42 includes the sealing rib 4.
0 is spaced from a flat surface 24 of the plug 22 (FIG. 3) and a second position (FIGS. 4 and 5) where the sealing rib 40 is in contact with and engaged with the flat surface. Are located. The locking ring 60 is disposed between the rim 14 and the collar 42. The locking ring 60 serves to secure the collar to the rim in the second position. The locking ring 60 includes a proximal end 64, a distal end 62, and an annular portion 66 therebetween. The annular portion 66 is preferably
The outer diameter F of the rim 14 (FIGS. 2 and 3) shows an inner diameter "G" that is at least equal to, but not less than, the following. The locking ring 60 includes an inwardly projecting ridge 70 adjacent the distal end 64. A locking surface 72 facing the distal end is provided on the ridge 70. The locking surface 72 is designed to fit on the underside of the rim. The locking surface 72 has an inner diameter “H” that is smaller than the outer diameter F of the rim 14 (FIGS. 2 and 3).

A cooperative locking structure is provided between the locking ring and the collar. Number 68 in color
This locking structure, indicated by b and 68a in the locking ring, may be constituted by various means. Referring to FIGS. 2 and 6A, locking structure 68 is shown.
a and 68b can form cooperative ratchet teeth around the circumference of the side surface 48 of the collar (68b) and the annulus 66 of the ring (68a), respectively. Alternatively, as shown in FIG. 6, the locking structure may be shaped like a cooperative screw provided between the collar 42 and the locking ring 60. Alternative structures can also be considered as locking structures. Independently, the locking structure 68b is preferably disposed adjacent the proximal end 46 of the collar and includes a locking structure 68a.
Is disposed adjacent the distal end 62 of the ring.

The connector assembly 30 typically surrounds the vial access device 80. The device 80 for entering the vial is configured to pierce the stopper 22 in order to use the drug contained in the vial 10. Without being limited to this range, generally, the device 80 for entering a vial is
It may feature a body 82 that is frictionally engaged with the inner surface 35 that is coupled to the tubular portion 37 of the collar. A distally facing drilling element 84 is attached to the body.

A connector end 86 which is threaded into the fluid in communication with the piercing element 84 is used to attach the vial access device to an external element such as a syringe, rigid bottle, flexible bottle, or the like. Is provided. Drilling element 84
However, it will be apparent to those skilled in the art that they may take various forms, such as sharp metal or plastic needles, spikes, or any pointed structure capable of piercing stopper 22. Similarly, the connector end 86 may be a spike (shown here), a needle, a luer connector or a rigid fluid bottle, luer lock or luer slip syringe that the end user would like to use with the connector assembly, flexible, It may be formed as any other preferred form for fitting to various external elements such as a fluid bag or the like. A protective shield 85 may more preferably be arranged around the connector end 86 when the connector end is formed like a needle.

The operation of the connector assembly is mainly described in FIG.
5 will be described.

In practice, a pharmaceutical customer fills the bottle 10 with the desired drug in a processed or otherwise manner, and then applies a stopper 22 to the neck of the vial. Both of these operations are performed in a sterile room environment. As shown in FIG. 3, the manufacturer making the components typically supplies the connector assembly to the pharmaceutical manufacturer in a pre-assembled, sterile condition and applies just the already sealed bottle. State.

As shown in FIG. 3, in the pre-assembled condition, the locking ring 60 is positioned on each collar 42 such that the cooperative locking structures 68a, 68b form an unlocked position. In other words, the proximal end 64 of the ring is adapted so that the distance "K" between the locking surface 72 of the ridge 70 and the distal end 44 of the collar is slightly less, if not less. Are displaced proximally from the proximal end 46 of the collar so as to be at least equal to the combined thicknesses "B" and "C", respectively. Locking structures 68a, 68b hold the ring in the collar. The vial entry device is enclosed inside cap 32 and collar 42. The pre-assembled connector assembly 30, ie, the open proximal end 64 of the ring, passes around the side of the rim 14 and is placed directly on the vial 10 in a sterile room.

FIG. 4 shows the arrangement of the connector assembly in its second position with respect to the vial 10. Here, the raised portion 70 is provided on the locking surface 7 facing the lower surface portion 18 of the rim.
2 along with the outer surface of the rim. It will again be understood that in this position, the distance "K" will be at least equal, if not slightly less, to the combined thicknesses "B" and "C" at the rim 14 and the plug flat, respectively. You.

At the same time, a rib 40 provided on the collar 42
Is brought into close proximity to the plug 22 such that the ribs are engaged in sealing contact with the flats 24. At this stage, the ring 60 may be continuously disposed in the unlocked position with respect to the collar 42.

Once the connector assembly has been biased to the second position, the connector assembly is "locked" to the vial. As shown in FIG. 5, the locking ring 60 is moved distally of each collar 42 until the locking position is reached (or, when viewed from the other side, the collar 42 is positioned relative to the locking ring 60). Moved to the end). As shown, the ridge locking surface 72
Project distally toward the lower surface 18 of the rim.
In the embodiment 30 disclosed in FIGS. 1 to 5, this operation is performed in a sterile room, for example, by using a suitable jig attached to a conventional small bottle sealing machine (stopping machine). . The jig exerts a distal force on the ring 60 and a proximal force on the collar 42 such that the locking surface 72 of the ridge is on the lower surface 18 of the rim and the rib 40 of the collar 42 is Flat surface 2
The ridge 70 and the collar end 44 are effectively "squeezed" with each other until they engage. A compressive force is provided between the flat surface of the stopper and the top surface 16 of the vial rim 14, as described above. Further, the sealing ribs 40 are urged so as to firmly engage the flat surface of the stopper. The effect is ... two microbiology, one between the sealing rib and the flat surface of the plug, and one between the flat surface of the plug and the top surface of the rim. A typical barrier is formed by the same means across the entire flat surface of the plug. The vial access device 80 is thus connected to the connector assembly 30.
Mounted by microbiological isolation within
2 is a vial 10 for isolating the drug contained in the vial.
Tightly closed. Locking structures 68a and 68b between the locking ring and the collar will hold the two in the locked position. Connector assembly 30
Is securely attached to the vial, and the filled vial is removed from the sterile room and delivered to the desired end user.

The squeezing function between the ridge 70 and the distal end of the collar 40 is achieved by using a cooperative locking structure, such as the ratchet teeth shown in FIG. 6A. "The effect is enhanced. That is, by using ratchet teeth as a cooperative locking structure, the connector assembly 30
More flexibly, it can compensate for any tolerances or dimensional changes in the rim or plug and more reliably ensure that a uniform sealing force is exerted across the face of the plug by its collar. Of course, this provides a favorable seal both between the stopper and the vial and between the collar and the stopper. Similar advantages may be achieved with the cooperative locking structure of the screw shown in FIG. 6B.

In order to use the small bottle, the cap 32
Has a collar 4 to expose the access device 80 to the vial.
2 removed. Various means are so shaped to remove the cap, but FIGS. 8A and 8B
The figure shows that the cap 32 and the collar 42 are co-injection molded, and the fragile portion 100 is provided therebetween. Vulnerable part 10
0 is a device for removing the cap from the collar and entering the vial 8
It allows the user to apply a torsional force on the cap 32 to expose the zero. Cap 32 and collar 4
2, a material having low shear resistance is used for the fragile portion 100, a material having higher shear resistance is used for the cap and the rest of the collar, and are formed together by a co-injection molding process. Is also good. For example, the fragile portion 100 exhibits low shear resistance and good bonding properties to the material selected for the remainder of the cap, and various varieties typically represented by polypropylene or polyethylene. Thermoplastic elastomer (“TPE
)).

As shown in FIG. 8A, the fragile portion 100
May be formed as a series of TPE pockets or "teeth" 110 cast into an interior 112 formed between the cap 32 and the collar 42. Each tooth 1
Between 10, there is an inclusion 116, and the inclusion 116 is
It is formed of a material having a higher shear resistance than the material forming the cap 32 and the remainder of the collar 42.

As a result, the fragile portion 100 allows the user to exert an appropriate twisting force "TF" on the cap for removal. At the same time, the presence of the intervening portion 116 will enhance the vulnerability to accidental removal of the cap due to, for example, collision during delivery, accidental opening by the end user, and the like. Alternatively, as shown in FIG.
It may be formed as a rigid portion 120 of E material.
In any event, by forming the cap 32 and the collar 42 as a single unit, a possible area (seam between the cap and the collar), which is added for microbiological contamination, is eliminated and the need arises. Resulting in a concomitant reduction in the number of microbiological barriers employed.

The cap 32 and the collar 42 are
It may be realized by being formed individually and joined by various means such as welding, gluing and the like. It protects the integrity of the connection between the cap and the collar, but provides a moderate twisting force TF, allowing the user to remove the cap. As before, the cap and collar can be formed of a suitable material such as polyethylene or polypropylene. Then, when using,
The cap 32 is removed from the collar 42, exposing the vial access device. The external element is attached to the connector end 86 and a proximal force is applied. Drilling element 84 is urged through stopper 22 and communicates with the interior of the vial. The main body 82 is slidably disposed on the inner surface 35 of the collar 42. Engagement between the body 82 and the inner surface 35 may include frictional engagement, screw engagement, a lot and follower arrangement,
This is done by mechanical engagement, such as other arrangements within the purview of those skilled in the art. If necessary, the body 82 is held against inadvertent movement from the inner surface 35 by providing a stop 88 adjacent the proximal end of the body 82 and stopped by a shoulder 89 inside the collar 42.

FIG. 7 shows a second embodiment 230 of the connector assembly according to the present invention.

In describing this embodiment, the same elements are:
Except for adding a "2" before the numerical designation of those elements, it is described with respect to the embodiment 30 of FIGS.
Therefore, the detailed description of these same elements need not be repeated for embodiment 230.

Here, the connector assembly 230 includes:
Raised portion 27 in which skirt portion 290 projects inward at the proximal end
0, except that it is provided on the locking ring 260 and is substantially as described above. Skirt 290
Indicates that the length "L" is at least equal to the distance "M" between the lower surface 218 of the rim and the shoulder 221 of the vial.

The purpose of the skirt 290 is to provide a means for automatically engaging the locking ring 260 with the collar 242 in the locked position while the connector assembly is placed in the vial.

That is, when the connector assembly 230 is disposed on the rim 214, the proximal end 291 of the skirt
Will eventually contact the vial shoulder 221. At that time, the skirt 290 is prevented from moving further toward the proximal end of each rim 214 by the force exerted distally by the shoulder 221 on the skirt 290. Continued proximal movement of the collar 242 and ring 260, therefore,
The inwardly protruding ridge 270 (due to the away-direction force exerted by the vial on the skirt) protrudes into the lower surface 218 of the rim, causing the ring 260
Is fixed so that the collar 242 does not move in the opposite direction. As before, a cooperative locking structure 268a, b provided between the locking ring and the collar holds the two in the locked position in each vial 210. As before, the connector assembly 230 is pre-assembled and supplied to the pharmacy with a vial access device 280 aseptically engaged within the cap 232 and collar 242. Also, as before, the vulnerable part (here again indicated by numeral 100)
May be coupled between the cap 232 and the collar 242.

The various components are made of standard materials of the art. For example, caps, collars, and rings may be injection molded from various thermoplastics (the structure of the fragile portion has already been described).

The vial entry device may be made from various medical plastics, medical stainless steel, combinations of these materials, and the like. Various rubbers or elastomers are selected for the stopper. The vial may be made of a glass or plastic material suitable to fit to contain the drug. If necessary, interfering means, such as heat-shrinkable plastic pieces, may be incorporated between the vial and the collar.

The form further added in the present invention is:
It will be recognized and understood by those skilled in the art that modifications may be made without departing from the spirit and scope of the appended claims and that the invention is not limited to the particularly shown embodiments. Would.

BRIEF DESCRIPTION OF THE DRAWINGS The present invention will be described in detail by the method referring to the accompanying drawings.

FIG. 1 is an exploded perspective view showing a first embodiment of a connector assembly according to the present invention.

FIG. 2 is a sectional view of FIG.

FIG. 3 is a cross-sectional view illustrating the arrangement of the connector assembly relative to the vial in a first position where the locking ring is disposed about the rim.

FIG. 4 is a cross-sectional view showing the arrangement of the connector assembly with respect to the vial at a second position where a locking ridge provided on the ring protrudes from the lower surface of the rim.

FIG. 5 is a cross-sectional view illustrating movement of a locking ring to each locking position of a collar.

FIG. 6A is a cross-sectional view illustrating a cooperative locking structure such as a ratchet tooth provided between a locking ring and a collar. (B) is a sectional view showing a cooperative locking structure such as a screw provided between the locking ring and the collar.

FIG. 7 is a sectional view of a second embodiment of the connector assembly according to the present invention.

FIGS. 8A and 8B illustrate two methods of removing a cap and forming a weakness between the cap and the collar to place the vial entrance into the device.

[Explanation of symbols]

 10 Small bottle 22 Plug 30 Connector assembly 32 Cap 42 Collar 60 Lock ring

Claims (9)

[Claims] A vial including a neck, an open end at a proximal end of the neck, and a rim having a side surface and a lower surface facing away from the open proximal end and surrounding the open end;
A plug having a flat surface covering the rim and closing the open end of the vial, comprising: a proximal end of the opening; a closed end; and a connection between the distal end and the proximal end of the opening. A protective cap including a shield wall formed therebetween and covering an open end of the vial; a proximal end, a distal end, and a proximal end provided adjacent to an open proximal end of the protective cap; Forming a sidewall between the distal end and the distal end, wherein the proximal end is spaced apart from the plug in a first position and the proximal end engages the flat surface of the stopper. A collar provided between the collar and the rim of the vial; a base end and a distal end; an annular portion between the base end and the distal end; A locking ring having an inwardly protruding ridge provided at an end portion, wherein the collar and the locking ring And a cooperative locking structure for holding the locking ring in a respective locking position of the collar, wherein after the collar is disposed in the second position, the locking ring comprises: The ridge engages a lower surface of the rim to attach the collar to the second position;
A connector assembly which is biased to a locked position. 2. The connector assembly according to claim 1, further comprising a vial access device having a piercing element for piercing said stopper. 3. The connector assembly according to claim 2, wherein the vial access device engages an inner portion of the collar. 4. A vial including a neck, an open end at a proximal end of the neck, and a rim having a side surface and a lower surface facing away from the open proximal end and surrounding the open end.
A plug having a flat surface covering the rim and closing the open end of the vial, comprising: a proximal end of the opening; a closed end; and a connection between the distal end and the proximal end of the opening. A protective cap including a shield wall formed therebetween and covering an open end of the vial; a proximal end, a distal end, and a proximal end provided adjacent to an open proximal end of the protective cap; A first location having a sidewall between the portion and the distal end, and one or more rib elements adjacent the distal end, wherein the proximal end is spaced from the plug; A collar movable between a second position engaging the flat surface of the stopper and a collar disposed between the collar and a rim of the vial; a proximal end and a distal end; An annular portion between the proximal end and the distal end, and an inwardly projecting ridge provided on the proximal end A locking ring, provided between the collar and the locking ring, and a cooperative locking structure for holding the locking ring at each locking position of the collar, wherein the collar is the second After being placed in the position, the locking ring engages the lower surface of the rim so that the ridge engages the collar in the second position.
A connector assembly which is biased to a locked position. 5. A body engagable within the collar, a piercing element for piercing the vial stopper, and a fluid in fluid communication with the piercing element for connection to an external element. 5. The connector assembly according to claim 4, further comprising a vial access device having a connection end. 6. The vial includes a shoulder, the locking ring includes a skirt disposed proximal to the ridge, and the collar is biased toward the second position. When the skirt engages the vial shoulder and urges the locking ring toward the locking position; and / or the cooperative locking structure comprises the collar and the locking One or more cooperating ratchet teeth provided between the ring and the cooperative locking structure is one or more screws provided between the collar and the locking ring. The connector assembly according to claim 1, wherein: 7. The cap is formed of a material selected from a group including polypropylene or polyethylene, and includes a weak portion formed of a thermoplastic elastomer between the cap and the collar. The connector assembly according to claim 1, 4 or 6, wherein 8. The connector assembly according to claim 2, wherein the connecting end of the vial entry device is selected from the group comprising a luer connector, a spike, or a needle. 9. The cap may be welded, glued, or
The connector assembly according to claim 1, wherein the collar is formed integrally with mechanical means.