CZ20004375A3 - Pre-filled tank - Google Patents

Abstract

A prefilled plastic syringe (1) that includes a syringe body (1a) (1), a movable plug (3) that seals the syringe body (1 a) (1) to the end; a needle adapter (13) that is part of the syringe body (1a) and which is located at the other end than the movable plug (3) and the closure (9) that seals the syringe (1) at the end where the needle adapter ( 13). The injection fluid (10) is located within the body (1a) of the syringe (1) between the movable plug (3) and the closure (9), and the closure (9) is located in the needle adapter (13) and / or in the syringe body (1a) (1).

Description

Technical area

This invention relates to prefilled containers, cartridges and syringes. It relates in particular to a novel form of syringe which can be prefilled, fitted with a hypodermic needle and packaged as a ready-to-use product.

State of the art

The applicant has previously submitted various proposals for the manufacture of molded plastic syringes. Reference is made, for example, to the applicant's previous patent applications PCT/AU92/00007 and PCT/AU95/00723. In both of these previous cases, the pre-filled syringe was sealed at the needle end by a closure in the form of a stem detachable from the syringe. While the applicant's previous proposals were significant improvements over the pre-filled products available prior to these developments, the use of a stem to seal the syringe has led to certain difficulties. First, the stem protruding from the end of the syringe is susceptible to accidental impacts, both during manufacture and in use, and this can lead to contamination or inadvertent opening of the unit. Second, in a system such as that disclosed in PCT/AU95/00723, it is necessary to remove the stem from the needle adapter before inserting a hypodermic needle. This means that the needle must be attached separately just before use. This can be inconvenient and there is also the possibility of contamination during needle attachment.

Description of the invention

It is an object of the present invention to provide a prefilled syringe which is sealed in a manner which addresses at least to some extent the difficulties described with the above-mentioned units.

• · · · ·

In accordance with the present invention, there is provided a prefilled plastic syringe comprising:

a) syringe body;

b) a movable plug that seals the body at one end;

c) a needle adapter which is part of the syringe body and which is located at the other end than the movable stopper; and

d) a cap that seals the syringe at the end where the needle adapter is; where the injection fluid is located in the body between the movable stopper and the cap, and where the cap is located in the needle adapter and/or in the syringe body.

The needle adapter preferably comprises a hollow truncated cone, the interior of which communicates with the interior of the syringe body. Most preferably, the needle adapter is in the form of a truncated cone surrounded by a peripheral wall separated from the cone by a space. An example of such an adapter is a luer-type needle adapter. The luer adapter comprises a thread on the inner surface of the peripheral wall which is compatible with the thread of a hypodermic needle to be mounted on the needle adapter. Hypodermic needles used in conjunction with a luer-type needle adapter are connected to one end of a support which is conical, hollow, and dimensionally matches the central cone of the luer adapter. The lower portion of the needle support comprises a lip which is shaped to fit the inner surface of the peripheral wall so that rotation of the hypodermic needle relative to the needle adapter facilitates the insertion of the needle.

Most preferably, the syringe utilizes a luer-type needle adapter and the syringe is used in conjunction with a hypodermic needle mounted on a conical support as described above.

The closure may be a separate component located in the syringe body or in the needle adapter by means of, for example, friction fit or other suitable means. In such a case • · ······· 9 9 9 9 · • · · 9 · · ·

999· 9 ·9 ··· ·· 9

in case it is preferred to was closing made from such material and about such a thickness, so that could have been easy pierced. The deadline is but preferably part walls, which is the edge connected to to the inner surface bodies syringes, or to the inner

surface of the needle adapter, and which extends through the opening of the syringe body or through the needle adapter. Most preferably, the closure is located entirely within the needle adapter of the syringe. In an embodiment of the invention, where the needle adapter comprises a hollow conical cone communicating with the interior of the syringe body, it is preferred that the closure is an integral part of a wall that is connected to the inner surface of the cone and extends through its opening. In this embodiment of the invention, the wall portion may be located at any position along the inner wall of the needle adapter. Preferably, it is connected by an edge to the inner surface of the frustocone and located at least 2.0 mm and more preferably at least 4.0 mm from the open end of the frustocone so as to reduce the possibility of the wall portion breaking off from the inner wall during careless handling (i.e., damaging the seal formed by the wall portion).

In order to allow the syringe to be easily opened at the time when it is desired to expel the injection fluid, it is desirable that the closure can either be pierced by the back needle of a double-ended hypodermic needle (in this case positioned closed to the open end of the needle adapter), or alternatively can be separated or partially broken off from the inner surface of the truncated cone or syringe body with the aid of a suitable tool.

standard is the closure

In a particularly preferred embodiment of the invention, the syringe comprises a frusto-conical needle adapter and the cap is a wall portion that extends beyond the inner lumen of the cone and is connected by a rim to the inner surface of the cone.

Φ·· ·· ···

In this embodiment of the invention, it is desirable that the wall portion includes a weakened portion at or adjacent to its connection to the inner surface of the cone. The weakened portion thus forms a break line along which the closure can be separated (at least partially) from the inner surface of the cone. The thickness of the wall portion is preferably between 0.8 mm and 1.5 mm except for the weakened portion where the thickness is preferably between 0.05 and 0.2 mm. Although it is possible to utilize a weakened portion that occupies the entire circumference of the wall portion, this option is not preferred because the application of force to the wall portion in such an embodiment may result in the closure completely separating from the needle adapter. Although this may not adversely affect the operation of the syringe, it is considered undesirable for the closure to float freely in the injection fluid. For this reason, it is preferred that the weakened portion occupy a circumference of 330-350°C so that if the closure were to break away from the inner surface of the cone along the weakened portion, it would still remain attached to the inside of the needle adapter and would function as a hinge for the portion adjacent to the inner surface of the cone that is not weakened.

The seal represented by the wall portion can be broken off by applying force against the wall portion. For this purpose, a tool can be used, which can be a rod of smaller diameter than the inner diameter of the cone and which is of sufficient length to reach the wall portion. Such a tool preferably has a flat end to contact most of the surface of the closure. Once the closure is separated, a hypodermic needle can be attached to the needle adapter, whereby the syringe is ready for immediate use.

Alternatively and most preferably, where the closure is edge-attached to the needle adapter, the prefilled syringe also comprises a hollow closure passage, a hypodermic needle and a needle support having an internal cavity, said hypodermic needle being adapted to be attached to one end of the needle support and said • · • ·

5 • · · * · • ·· • • · · · • · · · ♦ * · · • · · · · · · » · • · · »· · ♦ · · • · • · · • · • · · the needle support is placed above, but not fully snapped to needle adapter, where the first end said closing the passage is located in the said internal cavity and the other end

a closure passage is located in said needle adapter, wherein the closure passage is in fluid communication with the hypodermic needle and is long enough that movement of the needle support toward the end of the syringe with the movable stopper causes the closure passage to break the seal provided by the stopper.

It is desirable that the length of the closure passage be large enough that full engagement of the needle support into the needle adapter provides sufficient movement of the needle support (and hence the closure passage) to allow the seal provided by the closure to be broken.

The cavity in the needle support preferably includes an end face having a centrally located opening. A hypodermic needle may be attached and secured at one end of the opening so that it projects from the cavity. The closure passage is preferably located in the cavity with a first end abutting an end face of the housing in the inner passage aligned with an opening in the end face of the needle support. The second end of the closure passage is preferably adjacent to or abutting a surface of the closure. In this manner, movement of the needle support toward the movable syringe stopper causes the end face to push against the first end of the closure passage, thereby exerting pressure on the closure. By fully moving the support toward the needle adapter, the closure passage moves sufficiently to break the connection at the edge of the closure passage with the needle adapter, thereby facilitating direct communication of fluid from the syringe body to the hypodermic needle through the open closure via the closure passage.

• · ········»»· ··«···· ··♦· 9 ·· ·«· ··

The closure passage may be integral with the needle support and may extend therethrough, but is preferably a separate component.

The closure passage preferably includes a central passage and a rib extending outwardly from the passage, so that contact between the closure passage and the inner surface of the needle adapter is minimized. This reduces friction between the surfaces. Alternatively, other closures may be used that do not include a passage in their construction, but simply allow fluid flow. An example of such an alternative closure may be a solid rod that has a smaller diameter than the smallest diameter of the passage in the needle adapter with a directed rib that is configured to contact the inner surface of the needle adapter.

Desirably, the prefilled syringe also includes a cap placed over the hypodermic needle. A tamper-evident strip may be provided around the lower portion of the cap so that prior removal of the cap may be recognized by the absence of the strip or by its breakage.

The embodiment of the invention utilizing a closure passage provides significant advantages in ease of use and prevention of contamination. In particular, it is possible to prepare all components for injection, assemble and fill the syringe in an aseptic environment. The filled and assembled syringe can also be hermetically sealed with a clean plastic material, such as cellophane, before transporting the product from the clean environment.

The pre-filled product may also be delivered to practitioners with the hypodermic needle in position above the needle adapter, but not fully inserted. During use, the hypodermic needle may be pushed or twisted towards the needle adapter even when • · • · · · φ · · φφφ • φ φ φ φ φ φφ

-y * ΦΦΦΦ ΦΦΦ φφφφ / Φ Φ Φ Φ Φ Φ Φ Φ •ΦΦΦ < Φ» ΦΦ» ΦΦ Φ hermetically sealed product seal. Full insertion of the hypodermic needle onto the needle adapter causes the seal formed by the cap to be broken, so that when the package is opened, removal of the hypodermic needle cover (if present) provides an open pre-filled syringe ready for use and prevents contamination that could be caused by the application of other components or products to the syringe after the package has been opened.

The prefilled plastic syringe of the invention is preferably made of a thermoplastic material, such as polypropylene. Other suitable materials include translucent and transparent plastics, such as PET, polyamides, or TPX. Other suitable materials are well known to those skilled in the art.

Examples of embodiments of the invention

Examples of the invention are now described with reference to particularly preferred embodiments of the invention, in which prefilled syringes are syringes assembled and packaged in a sterile environment and available for immediate use. The embodiments of the invention are shown in the following figures, in which:

Figure 1 is a schematic diagram illustrating a pre-filled syringe packaged in an outer packaging;

Figure 2 is a schematic diagram illustrating the pre-filled syringe shown in Figure 1 with the packaging removed and prior to opening the syringe;

Figure 3 is an end view of the prefilled syringe shown in Figure 2 from the plunger end;

Figure 4 is an enlarged schematic view of the needle adapter and cap of the pre-filled syringe shown in Figure 2 ;

Figure 5 is an enlarged view of the central cone of the needle adapter shown in Figure 4 and the attached cap;

Figure 6 is a schematic diagram illustrating the needle adapter end of the prefilled syringe shown in Figure 2 with a hypodermic needle and needle support positioned on the end of the syringe needle adapter, but prior to full insertion; Figure 7 is a schematic diagram illustrating the needle adapter and components of the hypodermic needle shown in Figure 6 after the hypodermic needle and needle support have been securely positioned on the syringe needle adapter;

Figure 8 is a schematic diagram illustrating the end of a prefilled syringe with a needle adapter and a passage through which injection fluid can flow after the closure is opened;

Figure 9 is a schematic diagram illustrating a closure passage;

Figure 10 is a cross-section of a removable tape used to secure the cover in position over the hypodermic needle prior to use;

Figure 11 is a schematic diagram illustrating an alternative embodiment of the invention utilizing a double-ended hypodermic needle;

Figure 12 is a schematic diagram representing the end of the prefilled syringe with the needle adapter shown in Figure 11;

Figure 13 is a schematic diagram representing the end of the truncated cone in the needle adapter shown in Figure 12;

and

Figure 14 is a schematic diagram representing a double-ended hypodermic needle with a support and a cover.

Figure 1 is a schematic diagram illustrating how a preferred form of the invention may be presented to physicians and other healthcare providers. The prefilled syringe JL is preferably manufactured by preparing all of the injection components in an aseptic environment, assembling and filling the syringe in an aseptic environment, and packaging the syringe in an outer packaging 17 .

The syringe JL, which is illustrated in Figure 2 without a protective cover, comprises a syringe body 1a and a piston rod 2 attached to a movable stopper 3. The movable stopper 3 seals the syringe body at one end - the other end of the syringe body is sealed by a cap 9 which is an integral part of the central truncated cone 13a of the needle adapter 13 at the other end of the syringe. The syringe body 1a is filled with an injection fluid 10 and this fluid is located in the syringe body 1a between the movable stopper 3^ ^and the cap 9.

A hypodermic needle 5 is secured to a needle support 1_. The needle support 1_ includes an internal cavity 7a (best shown in Figure 6) and is located at the end of a frustoconical 13a of the needle adapter 13. The hypodermic needle 5 is hollow and in fluid communication with the cavity 7a.

A hollow closure passage shown as a separate tube 21 (again best seen in Figure 6) is positioned between the needle support 11 and the closure 9 and the use of this tube in conjunction with the needle support 11 to separate the closure 9 is described below.

The hypodermic needle 15 is protected by a cover which is held in position by a circumferential band 4_, and which is shown in detail in Figure 10.

The needle adapter 13 also includes an outer peripheral wall 15.

Figure 3 illustrates the syringe from the end of the syringe plunger rod, showing the thumb pressure 12, finger support edges 16 and grip facilitating ribs 18. These features are given simply as an example of a particular form of the invention, it will be appreciated, however, that any plunger rod based mechanisms or movable φ · φ · φ ·· • · · φφφ • φ φ φ φ φ φ φφφφφ φ φ φφφφ φ φφφ φφφ •φφφ φ· φφφ φφ «·· stoppers as are known in the art are considered adequate for the purposes of the present invention.

Figure 4 illustrates the needle adapter end of the prefilled syringe shown in Figure 2. The needle adapter comprises a central truncated cone 13a and an outer peripheral wall 15. This is characteristic of a standard luer-type needle adapter and is therefore suitable for use in conjunction with a standard hypodermic and needle support of the type shown in Figure 2. The outer peripheral wall 15 includes a helical rib 20 which facilitates the engagement of the needle support 11 on the needle adapter 13 by means of a screw mechanism. The needle adapter 13 has an opening 22 between the outer peripheral wall 15 and the central truncated cone 13a.

The difference from a standard luer lock is the provision of the closure 9 in the form of an integral end wall portion located in a central frustocone 13a.

Although the closure 9 is integral with the central frustocone 13a, it is attached at the edge, as best seen in Figure 5. The portion of the closure 9 adjacent the inner surface of the frustocone 13a is the break line 8_, which represents a peripheral portion of reduced thickness, such that application of force against the closure 9 toward the end of a prefilled syringe with a movable stopper will cause the inner surface of the frustocone 13a to tear away along the break line _8 of reduced thickness. In the present embodiment, the syringe is made of polypropylene and the closure 9_ has a thickness of about 1.2 mm. The break line has a thickness of about 0.1 mm. The break line _8 preferably does not extend over the entire circumference of the closure 9, so that when a force is applied against the closure, at least some portion of the closure remains attached to the inner surface of the frustocone 13a, such that the closure 9 remains attached to a portion of the inner surface of the frustocone 13a. The diameter of the inner • ·

· ·» * · ♦ 9 9 ······ » passage of the central frustocone 13a is slightly larger on the syringe body side of the cap 9, so that the cap is adapted when it is separated and turned back by the tube 21.

The function of the syringe is shown in more detail in Figures 6, 7 and 8. Figure 6 shows the end of the syringe with the needle adapter with the cap 9 sealing the syringe. This is the way in which the product can be supplied to the end user. The needle support 1_ is placed over the central frustocone 13a, but the edge 7b of the needle support 1_ does not fit into the helical portion 20 of the outer peripheral wall 15 . The tube 21 is placed with the first end of the support against the end of the cavity 7a and the second end in support against the face of the cap 9. The tube 21 has a central channel 21a which is arranged so that the fluid directly communicates with the channel 5a in the hypodermic needle _5. The circumferential tamper-indicating strip £ holds the cover 6 in position.

Figure 7 shows the end of the prefilled syringe with needle adapter after separation of the closure portion 9_ from the inner surface of the central truncated cone 13a. This separation is preferably achieved by applying a force to the cover 6 or the peripheral band 4. in the direction of the end of the prefilled syringe with movable stopper. This force then rotates the needle support 1_ further onto the truncated cone 13a. To engage the threaded screw 20, it is preferred that the force be applied in conjunction with the rotation so as to screw the needle support 1_ into the central cone 13a and towards the end of the syringe with movable stopper. This movement of the support Ί_ causes a force which is applied to the tube 21 and subsequently to the closure 9_, causing it to tear away from the inner surface of the central frustocone 13a along the break line 8_. In the preferred embodiment of the invention shown in Figure 7, the break line 8_ does not extend over the entire circumference of the closure and thus functions as a hinge, as can be clearly seen in Figure 7. The tube 21 is preferably beveled at the end. This facilitates easy insertion • · * φ φ ·

φ φφ φφφ of the tube 21 into the frustocone 13a when the product is assembled, but it also means that the tube 21 is less likely to separate the closure 9_ from the frustocone 13a. The open closure 2 ^is maintained between the inner surface of the frustocone 13a and the outer surface of the tube 21 once the needle support 2 has been firmly fitted to the needle adapter 13.

Figure 8 shows the end of the pre-filled syringe 2 ^with a needle adapter, ready for use. The tamper-evident circumferential strip _4 is removed together with the cover 6 (unlike Figure 7). The injection fluid 10 can now be expelled from the syringe 2 ⁱⁿ the direction of the arrow shown in Figure 8 by moving the piston rod 2 towards the end of the syringe with the needle adapter. The injection fluid 10 moves in the direction of the arrow in Figure 8 through the channel 21a and thus through the hollow hypodermic needle 5.

Figure 9 shows a schematic view of the tube 21 and Figure 10 shows an enlarged cross-section of the circumferential tamper-indicating strip £. This strip comprises an internal rib 14 and an end edge 14a adapted to clamp around the edge 6a of the cover 6.

An alternative embodiment of the invention is shown in Figures 11 to 14. In this embodiment, the features described in the first embodiment are numbered in a similar manner. The primary difference between the embodiment of the invention shown in Figures 11 to 14 and the embodiment of the invention shown in Figures 1 to 10 relates to the position of the closure 2 ^and the use of a double-ended hypodermic needle.

Figure 11 shows a prefilled syringe 2' having a syringe body 1a, a piston rod 2 and a movable stopper 3. The needle adapter 13 comprises a central truncated cone 13a and an outer peripheral wall 15. The hypodermic needle 5 is attached to a needle support 7. In contrast to the embodiment shown in Figures 1 • 4 · • · · ··«· · · · • 99 9 9 9 9 9

0 · ···· · · 9 · · « · i J ······ · ··· · ·· ·«· · ·· · to 10, the hypodermic needle 5 extends beyond the needle support Ί_ and has a sharpened end 5b located in the cavity 7a. When the product is assembled and filled, the sharpened end 5b of the hypodermic needle 5 is located near, but not in contact with, the closure 9.

The needle adapter 13 and the central truncated cone 13a are shown in detail in Figures 12 and 13. In order to ensure proper piercing of the closure 9_ by the sharpened end 5b of the hypodermic needle 5> when the needle support Ί_ is fully attached to the needle adapter 13, it is important that the closure 9 is located near the end of the central cone 13a. Although it can be located at the very end of the central cone 13a, it is preferred that it be located a short distance from the cone, e.g. 0.5 mm from the end of the cone 13a.

It will be appreciated that in use, the insertion of the needle support 2 fully onto the needle adapter 13 will cause the sharpened end 5b of the hypodermic needle 2 to move towards and through the closure 9, thereby breaking the seal formed by the closure 9, so that the injection fluid 10 can be expelled from the syringe in a similar manner as described with respect to the first form of the invention.

Figure 14 is an enlarged presentation of the hypodermic needle 2' of the needle support 7 of the housing 6.

It is apparent from the foregoing that the preferred embodiments of the invention, as illustrated and described above, can be manufactured, assembled and packaged in an aseptic or cleanroom environment. This product can be transported and stored with minimal risk of contamination and the packaging can protect the syringe from any contamination and can only be removed when the syringe is ready for use. Since the syringe opening mechanism is activated by engaging the needle support 1_ onto the needle adapter 13, there is no exposure of the needle adapter or needle support to the environment and possible contamination prior to use. The consequent advantages in ease of use will be apparent to those skilled in the art.

Various modifications may be made to the embodiments described herein without departing from the spirit or scope of the present invention as defined in the following claims.

Claims (30)

PATENT CLAIMS Pre-filled plastic syringe containing: (a) the body of the syringe; b) a movable plug that seals the syringe body at one end; c) a needle adapter which is an integral part of the body located at the end of the syringe and which is remote from the movable plug; and d) a cap that seals the syringe with the needle adapter; wherein the injection fluid is disposed within the body by a movable stopper and closure, and wherein it is in the needle adapter and / or in the body of the syringe. The pre-filled plastic syringe that is disposed at the end of the syringe between the closure is the subject of claim 1, wherein the needle adapter comprises a hollow truncated cone whose interior communicates via fluid with the interior of the syringe body. The pre-filled plastic syringe of claims 1 or 2, wherein the needle adapter is in the form of a truncated cone surrounded by a peripheral wall separated from the cone. Pre-filled plastic syringe as claimed in any one of claims 1 to 3, wherein the closure is made of such a material and has a thickness such that it can be easily pierced. Pre-filled plastic syringe as claimed in any one of claims 1 to 4, wherein the closure is a separate component that is disposed within the body of the syringe or the needle adapter. Pre-filled plastic syringe as claimed in any one of claims 1 to 4, wherein the closure is a portion of a wall that is peripherally connected to the inner surface of the body 99 9 9 999999 9 9 9999 9 99 which extends beyond the opening of the syringe body or needle adapter. A pre-filled plastic syringe as claimed in any one of the preceding claims 1 to 3, wherein the closure is disposed entirely within the syringe needle adapter. The plastic pre-filled syringe of claim 7, wherein the needle adapter comprises a hollow truncated cone with an open end that communicates via fluid to the interior of the syringe body and the closure is an integral part of the wall that is attached to the inner surface of the truncated cone its opening. The plastic pre-filled syringe of claim 7, wherein a portion of the wall is positioned at any position along the entire length of the inner wall of the needle adapter. The plastic pre-filled syringe of claim 8, wherein the closure is a portion of a wall that is peripherally attached to the inner surface of a truncated cone body and is located at least 2.0 mm from its open end. The plastic pre-filled syringe of claim 10, wherein a portion of the wall is edge joined to the inner surface of the truncated cone and is located at least 4.0 mm from its open end. A plastic pre-filled syringe as claimed in any one of the preceding claims, wherein the needle adapter is a luer needle adapter. A plastic pre-filled syringe as claimed in any one of the preceding claims, and wherein the closure can be pierced by the rear needle of a double-sided hypodermic needle. A plastic pre-filled syringe as claimed in any one of the preceding claims, wherein the closure may be detached or partially detached from the inner surface of the needle adapter or syringe body using a suitable tool. A plastic pre-filled syringe as claimed in any one of claims 8 to 14, wherein the closure is part of a wall that extends over the inner channel of the truncated cone and is peripherally secured to its inner surface. The plastic pre-filled syringe of claim 15, wherein said wall portion comprises a peripheral weakened portion at the attachment point or a portion adjacent said attachment to the inner surface of the truncated cone. The plastic pre-filled syringe of claim 16, wherein said wall portion has a thickness of between 0.8 mm to 1.5 mm except for the weakened portion where it has a thickness of between 0.05 to 0.2 mm. The plastic pre-filled syringe of claim 17, wherein said weakened portion does not extend around the periphery of the entire wall portion. The plastic pre-filled syringe of claim 18, wherein the weakened portion has a circumferential range between 330 to 350 ° so that when the closure is broken off the inner surface of the needle adapter along the weakened portion, the closure remains affixed to the inner surface of the needle adapter and may function as a hinge for this portion adjacent to the inner portion of the needle adapter that is not weakened. The plastic pre-filled syringe of any one of the preceding claims, further comprising a hollow closure passage, a hypodermic needle and an internal cavity needle support, wherein said hypodermic needle is attached to one end of the needle support and said needle support is positioned above the needle. an adapter, wherein the first end of said closure passage is located in said inner cavity of the needle support and the second end Uzáv φ φ • • «« «φ φ φ φ φ φ · · • • • • φ φ φ φ φ φ φ φ φ * * * * * * * * * * * * * * * * * * * uzáv by means of a fluid with a hypodermic needle and is of such a length that the movement of the needle support toward the end of the movable stopper causes the closure passage to cancel the seal provided by the closure. The plastic pre-filled syringe of claim 20, wherein the length of the closure passage is such that full fit of the needle support into the needle adapter provides sufficient movement of the closure passage to disengage the seal provided by the closure. The plastic pre-filled syringe of claim 21, wherein the cavity in the needle support comprises an end face in which a bore is centrally located. The plastic pre-filled syringe of claim 22, wherein the hypodermic needle is secured and secured in the opening of the needle support and extends from the cavity. The plastic pre-filled syringe of claim 23, wherein the closure passage is disposed in a cavity with a first end adjacent the end face of the inner channel cavity in a configuration with an opening in the end face of the needle support. The plastic pre-filled syringe of claim 24, wherein one end of the closure passage adjoins or adjoins the surface of the closure. A plastic pre-filled syringe as claimed in claims 20 to 25, wherein said closure passage is an integral part of the syringe and extends from the needle support. A plastic pre-filled syringe as claimed in claim 26 wherein said closure passage is a separate component. • · A plastic pre-filled syringe as claimed in claims 20 to 27, wherein said closure passage comprises a central channel and a rib extending from said channel. The plastic pre-filled syringe of claims 20 to 28, further comprising a housing positioned above the hypodermic needle. A plastic pre-filled syringe as claimed in any preceding claim, wherein the filled and assembled syringe is hermetically sealed with a clean plastic container. A method of using a plastic pre-filled syringe as claimed in any one of claims 20 to 29, wherein said hypodermic needle is pushed or turned into the needle adapter while the hermetically sealed package is still closed. The method of claim 31, wherein moving the hypodermic needle into the needle adapter causes the closure passage to cancel the seal provided by the closure. A pre-filled plastic syringe as claimed in any one of the preceding claims and made of a thermoplastic material. 34. The pre-filled plastic syringe described herein with reference to what is shown in any of the figures. is subject