System for filling and assembling pharmaceutical delivery devices
The present invention provides for an assembly for filling and capping a barrel of a pre-filled syringe. The assembly includes a syringe body having a neck end, a rimmed end, and a side wall extending between the neck end and rimmed end. The body has an outer surface and an inner surface. The assembly includes a piston having an upper surface, a lower surface, and a side surface extending between the upper and lower surfaces. The inner surface of the body and the side surface of the piston is in contact to form a liquid impermeable seal. The assembly further includes a stabilization member that at least partially surrounds and contacts the outer surface of the body. The stabilization member is positioned proximate the rimmed end of the body to provide additional mass thereto in an amount sufficient to permit the assembly to be conveyed freestanding in a longitudinally upright position on the stabilization member through an apparatus for filling and capping pharmaceutical vials. Methods for producing a pre-filled syringe barrel are also provided.
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This application is a continuation-in-part of co-pending patent application Ser. No. 09/993,299, filed on Nov. 23, 2001.
FIELD OF THE INVENTIONThis invention relates to the production of prefilled syringes for use in medical or veterinary treatment.
BACKGROUND OF THE INVENTIONPrefilled disposable syringes have gained wide acceptance as a preferred dosage form for administration of medicaments, primarily for reasons of safety and convenience. Most importantly, prefilled syringes minimize handling of a medicament prior to administration, thereby reducing the chance of dosage errors or contamination of the medicament.
Many different types of prefilled disposable syringes have been developed. Most known prefilled syringes include an elongate syringe “cartridge” or “barrel” comprising a cylindrical glass or plastic container into which the medicament or a component thereof is prefilled. In some types of prefilled syringes, the barrel forms the body of a syringe, having a mouth which permits attachment to an injection needle, and a movable bottom comprising an elastomeric piston which is acted upon by a plunger to administer the medicament.
One common problem with prefilled disposable syringes is that a dedicated filling and capping line is usually required to fill the medicament into the syringe barrel. This problem has previously been addressed by the invention described in European Patent No. 298,585, which describes a system for producing prefilled syringe barrels on ordinary equipment for filling and capping pharmaceutical vials. That patent describes a system whereby the syringe barrel is made shorter and wider than a conventional barrel, so that it has the shape of a standard pharmaceutical vial, and is then filled and capped on standard machinery for filling and capping vials, through which the barrels are conveyed while standing on their bases. Since the pharmaceutical vial is a standardized container which is widely used in the pharmaceutical industry, most pharmaceutical companies have existing vial filling equipment. The equipment need only be modified by the addition of a station for insertion of the rubber piston into the body of the barrel. Therefore, the invention described in that prior patent eliminates the need for specialized filling equipment, thereby reducing cost.
Despite the improvements described in the applicant's above-mentioned European patent, the further disadvantage exists that the relatively squat vial-shaped barrels cannot be used in all types of delivery systems. Some delivery systems, such as syringe pumps and two component systems, may require the use of conventional, elongate barrels which cannot be filled on standard vial-filling equipment. Therefore, it would be advantageous to provide a system which allows the preparation of conventional, elongate prefilled syringe barrels on standard equipment for filling and capping pharmaceutical vials.
SUMMARY OF THE INVENTIONThe one aspect, the present invention provides for an assembly for filling and capping a barrel of a pre-filled syringe comprising:
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- a) a syringe body having a neck end, a rimmed end, and a side wall extending between the neck end and rimmed end, the body having an outer surface and an inner surface;
- b) a piston having an upper surface, a lower surface, and a side surface extending between the upper and lower surfaces, the inner surface of the body and the side surface of the piston in contact to form a liquid impermeable seal; and
- c) a stabilization member that at least partially surrounds and contacts the outer surface of the body, the stabilization member is positioned proximate the rimmed end of the body to provide additional mass thereto in an amount sufficient to permit the assembly to be conveyed freestanding in a longitudinally upright position on the stabilization member through an apparatus for filling and capping pharmaceutical vials.
In a further aspect, the stabilization member comprises a sleeve, the sleeve has a top end and a base end, and the rimmed end of the body is positioned within the sleeve proximate the base end of the sleeve.
In still a further aspect, the base end of the sleeve has a radially projecting flange.
In yet a further aspect, the flange has a substantially flat outwardly facing wall that is substantially vertical when the assembly is standing longitudinally upright.
In still a further aspect, the stabilization member further comprises a stabilization cap having a hollow portion with an upper end and a lower end, the lower end having a finger flange that extends radially outwardly therefrom, the hollow portion is sized to closely fit within the body, and the finger flange is sized to fit within the base end of the sleeve.
In yet a further aspect, the piston comprises a material that is impermeable to liquid and sufficiently permeable to a sterilizing gas to permit sterilization of the seal between the inner surface of the body and the side surface of the piston upon exposure to a sterilizing gas.
In still a further aspect, the piston comprises neoprene.
In yet a further aspect, the piston comprises a material that is substantially resistant to the effects of at least one standard cycle of gamma radiation.
In still a further aspect, the piston comprises bromo-butyl rubber.
In yet a further aspect, the syringe body comprises cerium oxide in an amount sufficient to prevent discoloration of the body upon exposure to at least one standard cycle of gamma radiation.
In still a further aspect, the syringe body comprises about 1 wt % cerium oxide based on the total weight of the syringe body.
In a second aspect, the present invention provides a method for producing a barrel for a pre-filled syringe, comprising:
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- a) providing a syringe body having a neck end, a rimmed end, and a side wall extending between the neck end and rimmed end, the body having an outer surface and an inner surface;
- b) providing a piston having an upper surface, a lower surface, and a side surface extending between the upper and lower surfaces;
- c) providing a stabilization member; and
- d) forming an assembly comprising the syringe body, the piston, and the stabilization member such that: (i) the inner surface of the body contacts at least a portion of the side surface of the piston to form a liquid impermeable seal; (ii) the stabilization member at least partially surrounds and contacts the outer surface of the body; and (iii) the stabilization member is positioned proximate the rimmed end of the body to provide additional mass thereto in an amount sufficient to permit the assembly to be conveyed freestanding in a longitudinally upright position on the stabilization member through an apparatus for filling and capping pharmaceutical vials.
In a further aspect, the syringe body provided in step (a) is pre-sterilized, the piston provided in step (b) is pre-sterilized, and the stabilization member provided in step (c) is pre-sterilized and steps (a)-(d) are performed in an aseptic environment.
In still a further aspect, the method further comprises, subsequent to step (d), the step of (e) overwrapping the assembly with an overwrap material in an aseptic environment to maintain sterility.
In yet a further aspect, the method further comprises, subsequent to step (e), the steps of:
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- f) removing the overwrap;
- g) filling the body with at least one pharmaceutical component through the neck end using the apparatus for filling and capping pharmaceutical vials; and
- h) capping the neck end of the body using the apparatus for filling and capping pharmaceutical vials.
In still a further aspect, the at least one pharmaceutical component is in the form of a solid when filled into the body.
In yet a further aspect, the at least one pharmaceutical component is in the form of a liquid when filled into the body.
In still a further aspect, the method further comprises, subsequent to step (g) and prior to step (h), the step of lyophilizing the at least one pharmaceutical.
In yet a further aspect, the method further comprises, prior to step (b), the step of selecting a material for the piston that is impermeable to liquid but sufficiently permeable to a sterilizing gas to permit sterilization of the seal between the inner surface and the body and the side surface of the piston upon exposure to a sterilizing gas.
In still a further aspect, the method further comprises, subsequent to step (d), the step of (e) overwrapping the assembly with an overwrap material.
In yet a further aspect, the method further comprises, subsequent to step (e), the step of (f) sterilizing the barrel with a sterilizing gas.
In still a further aspect, the method further comprises, prior to step (b), the step of selecting a material for the piston that is sufficiently resistant to at least one cycle of gamma radiation.
In yet a further aspect, the method further comprises, prior to step (a), the step of selecting a material for the syringe body material that comprises cerium oxide in an amount sufficient to prevent discoloration of the body upon exposure to at least one cycle of gamma radiation.
In still a further aspect, the method further comprises, subsequent to step (d), the step of (e) overwrapping the assembly with an overwrap material.
In yet a further aspect, the method further comprises, subsequent to step (e), the step of (f) sterilizing the barrel with at least one cycle of gamma radiation.
In a third aspect, the present invention provides a method for producing a pre-filled syringe barrel, comprising:
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- a) providing a sterile assembly comprising a syringe body having a neck end, a rimmed end, a side wall extending between the neck end and the rimmed end, an outer surface and an inner surface, a piston having an upper surface, a lower surface, and a side surface extending between the upper and lower surfaces and a stabilization member, the sterile assembly formed such that: (i) the inner surface of the body contacts at least a portion of the side surface of the piston to form a liquid impermeable seal; (ii) the stabilization member is at least partially surrounds and contacts the outer surface of the body; and (iii) the stabilization member is positioned proximate the rimmed end of the body to provide additional mass thereto in an amount sufficient to permit the assembly to be conveyed freestanding in a longitudinally upright position on the stabilization member through an apparatus for filling and capping pharmaceutical vials;
- b) filling the body with at least one pharmaceutical component through the neck end using the apparatus for filling and capping pharmaceutical vials; and
- c) capping the neck end of the body using the apparatus for filling and capping pharmaceutical vials.
In a further aspect, the method further comprises, prior to step (b), the step of maintaining the assembly in an aseptic environment until it is ready to be filled through the neck end of the body with the at least one pharmaceutical component.
In still a further aspect, steps (b) and (c) are performed in an aseptic environment.
BRIEF DESCRIPTION OF THE DRAWINGSThe invention will now be described, by way of example only, by reference to the accompanying drawings in which:
A first preferred embodiment of the invention will now be discussed below in the context of a syringe barrel which is intended for use in a delivery device for a two component medicament. Such a delivery device is described in U.S. Pat. No. 6,149,623, issued on Nov. 21, 2000 which is incorporated herein by reference in its entirety.
The barrel 10 comprises a body 12 preferably made of glass and having a generally cylindrical side wall 14 with an inner surface 16 and an outer surface 18. At one end, the body 12 has a relatively narrow neck 20 with a neck flange 21 surrounding an open mouth 22, and at the other end the body 12 has an open rimmed end 24. Although the lower end of the body 12 is referred to herein as the “rimmed end”, it is to be appreciated that the body 12 may or may not have a perceptible inwardly or outwardly extending rim or flange at its lower edge.
The body 12 illustrated in
Barrel 10 further comprises a generally cylindrical elastomeric piston 26 having an upper surface 28 which forms the bottom wall of the barrel 10 in its assembled state, and an opposed lower surface 30 with an internally threaded bore (not shown). Piston 26 also has a side surface 32 connecting the upper and lower surfaces 28 and 30, the side surface 32 being adapted to form a hermetic seal with the inner surface 16 of body 12, and preferably being provided with one or more ribs 34 to improve the seal with the body 12. Piston 26 is preferably made from an elastomeric material such as rubber.
The open mouth 22 of body 12 is sealed in a conventional manner by an elastomeric closure 36 with an overlying metal cap 38 crimped over the neck flange 21.
Barrel 10 is also provided with an activation cap 40 at its rimmed end 24, the cap 40 performing a number of functions which are described below. As best seen in
Preferably, the sleeve 42 has an inwardly projecting portion 48 extending radially inwardly from the inner wall of the sleeve 42. The inwardly projecting portion 48 shown in
The activation cap 40 further comprises piston support means 50 including a piston support surface 52 on which the piston 26 is supported such that its upper surface 28 is spaced from the rimmed end 24 of the body 12 (shown in
In the preferred embodiment of
In order to permit engagement of piston 26 by a plunger, the piston support surface 52 is annular with a central aperture 64, and engages an outer edge of the lower surface 30 of the piston 26. In the embodiment illustrated in FIGS. 1 to 3, the piston is preferably provided with a threaded bore (not shown) open to its lower surface 30 which is adapted for connection to the threaded end of a plunger.
As discussed above, the system of the invention is adapted to improve the stability of conventional, elongate syringe barrels, thereby permitting them to be conveyed standing upright through standard equipment for filling and capping pharmaceutical vials. This object is partly attained by provision of the sleeve 42, which may lower the centre of gravity of the barrel 10 somewhat, thereby improving its stability. Stability can be further enhanced by increasing the thickness of the sleeve 42 throughout part or all of its height. For example, as shown in
Shingling can be prevented as shown in the preferred embodiment of
The first step of the method, illustrated in
In the second step illustrated in
The next step in the method, schematically illustrated in
After sterilization, a force is applied to the second assembly 72 to cause relative movement of the body 12 toward the base end 44 of the sleeve 42, thereby causing insertion of the piston 26 into the body 12 such that the side surface 32 of the piston 26 forms a hermetic seal with the inner surface 16 of the body 12 and seals the rimmed end 24. Preferably, the body 12 is pushed downward into sleeve 42 in the direction shown by the arrow in
With the piston 26 fully inserted in the body 12 as shown in
The mouth 22 of the body 12 is then sealed in a conventional manner by application of an elastomeric closure 36 as shown in
The next step in the method is illustrated in
As mentioned above, the barrel 10 of the first preferred embodiment comprises an activation cap 40 and is therefore specifically directed to delivery devices for two component pharmaceuticals. In the example described above, a liquid medicament, or a liquid component of a medicament, is contained in the barrel 10. However, the first preferred embodiment is also adaptable to the situation where the barrel 10 contains a solid medicament or a solid component of a medicament, which is to be combined with a liquid, such as a diluent, prior to administration.
A first preferred method for filling barrel 10 with a solid medicament is illustrated in
A second preferred method for filling barrel 10 with a solid medicament is illustrated in
As mentioned above, the barrel 10 according to the first preferred embodiment is capable of use in a two component delivery device, such as preferred delivery device 78 shown in
The pre-assembly further comprises a rear needle 93 and a forward needle 94 housed in a luer lock assembly 96 which is secured to both the vial coupling 86 and the syringe socket 90. When the delivery device 78 is assembled as in
Where the barrel 10 contains a liquid medicament or a component thereof, the vial 82 of pre-assembly 80 may comprise either a solid or liquid. Where the vial 82 contains a solid, the medicament is formed by pushing the liquid contents of barrel 10 into the vial 82, mixing the solid and liquid ingredients, followed by aspirating the medicament suspension or solution into the barrel 10 prior to removal of the vial coupling 86.
A second preferred embodiment of the present invention is now described below with reference to
Barrel 110 comprises a body 112 preferably made of glass and having a generally cylindrical side wall 114 with an inner surface 116 and an outer surface 118. At one end, the body 112 has a relatively narrow neck 120 with a neck flange 121 surrounding an open mouth 122, and at the other end the body 112 has an open rimmed end 124. Preferably, the rimmed end 124 is provided with an inwardly extending projection 125 which has a function to be described below. The dimensions of body 112 are similar to those of body 12 described above, although it will be appreciated that the dimensions of body 112 can be varied as discussed above in the context of the first preferred embodiment.
Barrel 110 further comprises a generally cylindrical elastomeric piston 126 having an upper surface 128 which forms the bottom wall of barrel 110 in its assembled state, and an opposed lower surface 130. Piston 126 also has a side surface 132 connecting the upper and lower surfaces 128 and 130, the side surface 132 being adapted to form a hermetic seal with the inner surface 116 of body 112, and preferably being provided with one or more ribs 134 to improve the seal with the body 112. Piston 126 is preferably made from an elastomeric material such as rubber. The lower surface of piston 126 comprises an extension 139 for attachment to a plunger as described in greater detail in above-mentioned European Patent No. 298,585.
The open mouth 122 of body 112 is sealed in a conventional manner by an elastomeric closure 136 with an overlying metal cap 138 crimped over the neck flange 121.
The barrel 110 further comprises a stabilization cap 140 which has a number of functions. Firstly, stabilization cap 140 functions as a piston support means, having a cylindrical portion 142 with an upper end 144 and a lower end 146, the upper end having a piston support surface 148. The outer diameter of the cylindrical portion 142 is such that the cylindrical portion 142 can be received inside the body 112. The stabilization cap 140 also has a radially projecting flange 150 at its lower end which functions as a finger flange during use of the syringe. Furthermore, the cylindrical portion 142 of cap 140 has a radially inwardly recessed band 152 which is adapted to form a snap fit with the inwardly projecting portion 125 of the body side wall 114, thereby preventing removal of piston 126 from the body.
The next step comprises placement of a cylindrical sleeve 154 over the piston 126 and cap 140 as illustrated in
As shown in
After combining the piston 126, stabilization cap 140 and sleeve 154 to form a first assembly 160 as shown in
Preferably, the inner surface of the sleeve 154 is provided with a detent 164 which prevents premature insertion of the piston 126 into the body 112, as discussed in detail with reference to the first preferred embodiment.
The next step of the method, illustrated in
The steps followed for filling, capping and terminal sterilization of the sealed body 112 are shown in
After removal of the sleeve 154, the barrel 110 can be combined with a needle (not shown) and a plunger (not shown) to form a prefilled disposable syringe, as described in above-mentioned U.S. Pat. No. 5,137,511.
In the variant shown in
In order to assemble syringe barrels 168, the pistons 126 are first inserted into the support assemblies 172 as shown in
After insertion of the pistons 126, the trays 170 and the barrels 168 are conveyed through equipment adapted for filling syringe barrels packaged in trays. After filling, the barrels 168 are sealed and capped as described above, preferably while standing on the trays 170. The filled and capped barrels 168 may then be removed from trays 170 prior to shipment, with the trays being reused. Alternatively, the tray 170 and barrels 168 may be shipped as a unit to their final destination.
To produce a prefilled syringe barrel 192, the piston 26 is first inserted into the stabilization means as shown in
The inclusion of the upper sleeve may increase the stability of the barrels as they travel through a filling line, since the upper collar 260 and the flange 66 are preferably of the same diameter. Thus, if adjacent barrels traveling through the filling line contact one another, they will do so at the flange 66 near the base of the barrel, and also at the collars 260. This will increase the stability of the barrels as they travel through the filling line.
It will be appreciated that the activation caps, stabilization caps, sleeves and handling trays described above will preferably be made from materials which are substantially unaffected by the conditions employed during sterilization. As sterilization is usually performed at elevated temperature, it is preferred that these components be made of heat-resistant materials. It is preferred that these components be formed from plastics, more preferably heat-resistant plastics.
Furthermore, it may be preferred in some embodiments of the present invention to utilize syringe bodies and pistons which are siliconized. Siliconization is preferably performed during manufacture of the syringe body and the piston.
In one aspect, the present invention provides an assembly for filling and capping a barrel 10 of a pre-filled syringe. The assembly generally has a syringe body 12, a piston 26, and a stabilization member. The stabilization member is positioned proximate the rimmed end of the body to provide additional mass thereto in an amount sufficient to permit the barrel 10 to be conveyed freestanding in a longitudinally upright position on the stabilization member through an apparatus for filling and capping pharmaceutical vials. In essence, the stabilization member acts to lower the center of gravity of the barrel 10 while the barrel 10 is in a longitudinally upright position (see
The following description is a variant on the method steps for assembling and filling a barrel with at least one pharmaceutical component in accordance with either the first or the second preferred embodiments of the invention. For convenience, the method variant will be described having reference to
The syringe body 12, piston 26, and sleeve 42 can be pre-sterilized in any method known in the art. The pre-sterilized syringe body 12, the pre-sterilized piston 26, and the pre-sterilized sleeve 42 can be assembled in an aseptic environment to form the assembly shown in
The following description is a variant on the method steps for assembling and filling a barrel with at least one pharmaceutical component in accordance with either the first or the second preferred embodiments of the invention. For convenience, the method variant will be described having reference to
The syringe body 12, piston 26, and sleeve 42 can be assembled in a relatively clean room to form the assembly shown in
The following description is a variant on the method steps for assembling and filling a barrel with at least one pharmaceutical component in accordance with either the first or the second preferred embodiments of the invention. For convenience, the method variant will be described having reference to
The syringe body 12, piston 26, and sleeve 42 can be assembled in a relatively clean room to form the assembly shown in
Although the invention has been described with reference to certain preferred embodiments, it is not limited thereto. Rather, the invention includes all embodiments which may fall within the scope of the following claims.
Claims
1. An assembly for filling and capping a barrel of a pre-filled syringe, the assembly comprising:
- a) a syringe body having a neck end, a rimmed end, and a side wall extending between the neck end and rimmed end, the body having an outer surface and an inner surface;
- b) a piston having an upper surface, a lower surface, and a side surface extending between the upper and lower surfaces, the inner surface of the body and the side surface of the piston in contact to form a liquid impermeable seal; and
- c) a stabilization member that at least partially surrounds and contacts the outer surface of the body, the stabilization member is positioned proximate the rimmed end of the body to provide additional mass thereto in an amount sufficient to permit the assembly to be conveyed freestanding in a longitudinally upright position on the stabilization member through an apparatus for filling and capping pharmaceutical vials.
2. An assembly according to claim 1, wherein the stabilization member comprises a sleeve, the sleeve has a top end and a base end, and the rimmed end of the body is positioned within the sleeve proximate the base end of the sleeve.
3. An assembly according to claim 2, wherein the base end of the sleeve has a radially projecting flange.
4. An assembly according to claim 3, wherein the flange has a substantially flat outwardly facing wall that is substantially vertical when the assembly is standing longitudinally upright.
5. An assembly according to claim 2, wherein the stabilization member further comprises a stabilization cap having a hollow portion with an upper end and a lower end, the lower end having a finger flange that extends radially outwardly therefrom, the hollow portion is sized to closely fit within the body, and the finger flange is sized to fit within the base end of the sleeve.
6. An assembly according to claim 1, wherein the piston comprises a material that is impermeable to liquid and sufficiently permeable to a sterilizing gas to permit sterilization of the seal between the inner surface of the body and the side surface of the piston upon exposure to a sterilizing gas.
7. An assembly according to claim 1, wherein the piston comprises neoprene.
8. An assembly according to claim 1, wherein the piston comprises a material that is substantially resistant to the effects of at least one standard cycle of gamma radiation.
9. An assembly according to claim 1, wherein the piston comprises bromo-butyl rubber.
10. An assembly according to claim 9, wherein the syringe body comprises cerium oxide in an amount sufficient to prevent discoloration of the body upon exposure to at least one standard cycle of gamma radiation.
11. An assembly according to claim 9, wherein the syringe body comprises about 1 wt % cerium oxide based on the total weight of the syringe body.
12. A method for producing a barrel for a pre-filled syringe, comprising:
- a) providing a syringe body having a neck end, a rimmed end, and a side wall extending between the neck end and rimmed end, the body having an outer surface and an inner surface;
- b) providing a piston having an upper surface, a lower surface, and a side surface extending between the upper and lower surfaces;
- c) providing a stabilization member; and
- d) forming an assembly comprising the syringe body, the piston, and the stabilization member such that: (i) the inner surface of the body contacts at least a portion of the side surface of the piston to form a liquid impermeable seal; (ii) the stabilization member at least partially surrounds and contacts the outer surface of the body; and (iii) the stabilization member is positioned proximate the rimmed end of the body to provide additional mass thereto in an amount sufficient to permit the assembly to be conveyed freestanding in a longitudinally upright position on the stabilization member through an apparatus for filling and capping pharmaceutical vials.
13. A method according to claim 12, wherein the syringe body provided in step (a) is pre-sterilized, the piston provided in step (b) is pre-sterilized, and the stabilization member provided in step (c) is pre-sterilized and steps (a)-(d) are performed in an aseptic environment.
14. A method according to claim 13, further comprising, subsequent to step (d), the step of (e) overwrapping the assembly with an overwrap material in an aseptic environment to maintain sterility.
15. A method according to claim 14, further comprising, subsequent to step (e), the steps of:
- f) removing the overwrap;
- g) filling the body with at least one pharmaceutical component through the neck end using the apparatus for filling and capping pharmaceutical vials; and
- h) capping the neck end of the body using the apparatus for filling and capping pharmaceutical vials.
16. A method according to claim 15, wherein the at least one pharmaceutical component is in the form of a solid when filled into the body.
17. A method according to claim 15, wherein the at least one pharmaceutical component is in the form of a liquid when filled into the body.
18. A method according to claim 17, further comprising, subsequent to step (g) and prior to step (h), the step of lyophilizing the at least one pharmaceutical.
19. A method according to claim 12, further comprising, prior to step (b), the step of selecting a material for the piston that is impermeable to liquid but sufficiently permeable to a sterilizing gas to permit sterilization of the seal between the inner surface and the body and the side surface of the piston upon exposure to a sterilizing gas.
20. A method according to claim 19, further comprising, subsequent to step (d), the step of (e) overwrapping the assembly with an overwrap material.
21. A method according to claim 20, further comprising, subsequent to step (e), the step of (f) sterilizing the barrel with a sterilizing gas.
22. A method according to claim 21, further comprising, subsequent to step (f), the steps of:
- g) removing the overwrap;
- h) filling the body with at least one pharmaceutical component through the neck end using the apparatus for filling and capping pharmaceutical vials; and
- i) capping the neck end of the body using the apparatus for filling and capping pharmaceutical vials.
23. A method according to claim 22, wherein the at least one pharmaceutical component is in the form of a solid when filled into the body.
24. A method according to claim 22, wherein the at least one pharmaceutical component is in the form of a liquid when filled into the body.
25. A method according to claim 24, further comprising, subsequent to step (h) and prior to step (i), the step of lyophilizing the at least one pharmaceutical.
26. A method according to claim 12, further comprising, prior to step (b), the step of selecting a material for the piston that is sufficiently resistant to at least one cycle of gamma radiation.
27. A method according to claim 26, further comprising, prior to step (a), the step of selecting a material for the syringe body material that comprises cerium oxide in an amount sufficient to prevent discoloration of the body upon exposure to at least one cycle of gamma radiation.
28. A method according to claim 27, further comprising, subsequent to step (d), the step of (e) overwrapping the assembly with an overwrap material.
29. A method according to claim 28, further comprising, subsequent to step (e), the step of (f) sterilizing the barrel with at least one cycle of gamma radiation.
30. A method according to claim 29, further comprising, subsequent to both steps (f) the steps of:
- g) removing the overwrap;
- h) filling the body with at least one pharmaceutical component through the neck end using the apparatus for filling and capping pharmaceutical vials; and
- i) capping the neck end of the body using the apparatus for filling and capping pharmaceutical vials.
31. A method according to claim 30, wherein the at least one pharmaceutical component is in the form of a solid when filled into the body.
32. A method according to claim 30, wherein the at least one pharmaceutical component is in the form of a liquid when filled into the body.
33. A method according to claim 32, further comprising, subsequent to step (h) and prior to step (i), the step of lyophilizing the at least one pharmaceutical.
34. A method for producing a pre-filled syringe barrel, comprising:
- a) providing a sterile assembly comprising a syringe body having a neck end, a rimmed end, a side wall extending between the neck end and the rimmed end, an outer surface and an inner surface, a piston having an upper surface, a lower surface, and a side surface extending between the upper and lower surfaces and a stabilization member, the sterile assembly formed such that: (i) the inner surface of the body contacts at least a portion of the side surface of the piston to form a liquid impermeable seal; (ii) the stabilization member is at least partially surrounds and contacts the outer surface of the body; and (iii) the stabilization member is positioned proximate the rimmed end of the body to provide additional mass thereto in an amount sufficient to permit the assembly to be conveyed freestanding in a longitudinally upright position on the stabilization member through an apparatus for filling and capping pharmaceutical vials;
- b) filling the body with at least one pharmaceutical component through the neck end using the apparatus for filling and capping pharmaceutical vials; and
- c) capping the neck end of the body using the apparatus for filling and capping pharmaceutical vials.
35. A method according to claim 34, further comprising, prior to step (b), the step of maintaining the assembly in an aseptic environment until it is ready to be filled through the neck end of the body with the at least one pharmaceutical component.
36. A method according to claim 35, wherein steps (b) and (c) are performed in an aseptic environment.
37. A method according to claim 36, wherein the at least one pharmaceutical component is in the form of a solid when filled into the body.
38. A method according to claim 36, wherein the at least one pharmaceutical component is in the form of a liquid when filled into the body.
39. A method according to claim 38, further comprising, subsequent to step (b) and prior to step (c), the step of lyophilizing the at least one pharmaceutical.
Type: Application
Filed: Sep 25, 2004
Publication Date: May 26, 2005
Applicant: Duoject Medical Systems (Bromont)
Inventor: David Reynolds (Bromont)
Application Number: 10/951,039