CN120112320A

CN120112320A - Syringe nest for improved aseptic filling and stoppering

Info

Publication number: CN120112320A
Application number: CN202380075043.3A
Authority: CN
Inventors: A·希尔; B·菲茨帕特里克; M·纳吉
Original assignee: Silicon Dioxide Medical Product Co
Current assignee: Silicon Dioxide Medical Product Co
Priority date: 2022-09-29
Filing date: 2023-09-29
Publication date: 2025-06-06
Also published as: WO2024073636A1; EP4593909A1

Abstract

A syringe nest includes a substantially flat base and a plurality of syringe receptacles. Each receptacle includes a cylindrical wall defining an upper opening. The inner surface of the cylindrical wall has a diameter greater than the diameter of the main body portion but less than the diameter of the rear flange of the syringe barrel. One or more upwardly extending ribs are positioned around the upper opening of each receptacle and limit radial movement of the syringe barrel within the receptacle by contacting the rear flange. Centering the syringe barrel in the receptacle in this manner results in an improved process for preparing a prefilled syringe, and in particular, in improved filling and stoppering steps.

Description

Syringe nest for improved aseptic filling and stoppering

The present application claims priority from U.S. provisional patent application No. 63/411,381 filed on 9/29 of 2022, the entire contents of which are incorporated herein by reference.

Technical Field

Embodiments of the present disclosure relate to syringe nest (nest), particularly to syringe nest configured to hold a plurality of syringe barrels during preparation of a pre-filled syringe, particularly during filling and/or stoppering steps.

Disclosure of Invention

Prefilled syringes are becoming increasingly important in the pharmaceutical industry. To fill and seal or tamponade filled syringes, a syringe barrel having a main body portion, a front dispensing portion, and a rear flange is typically disposed in a tray, commonly referred to as a "syringe nest. The syringe nest is configured to hold a plurality of syringe barrels. For example, some syringe nest may be configured to hold 100 syringes, e.g., 10 syringe barrel receptacles per row of 10 rows.

The front dispensing portion of the syringe barrel, which most commonly includes a spike needle (STAKED NEEDLE) or Luer tip (Luer tip) configured to receive a needle attachment through a Luer connection, is sealed by a removable tip cap, such as a rigid needle shield in the case of a spike needle or a tip cap in the case of a Luer tip. Conventionally, the diameter of the tip cap may be similar to the diameter of the main body portion of the syringe barrel. The rear flange is generally (but not always) circular in cross-section, the rear flange having a diameter greater than the diameter of the main body portion of the syringe barrel.

The syringe nest includes a substantially planar base and a plurality of syringe receptacles, i.e., bores, defined in the base. Each of the receptacles includes a cylindrical wall defining an upper opening and a lower opening. The inner diameter of the cylindrical wall is greater than the diameter of the main body portion of the syringe barrel (and the diameter of the tip cap), but less than the diameter of the rear flange so that the syringe barrel can be inserted downwardly into the upper opening until the rear flange seats on the top surface of the cylindrical wall. Typically, the front dispensing portion sealed by the removable tip cap and the body portion of a quantity of syringe barrel extend out of the lower opening of the receptacle. Since the removable tip cap typically has a diameter similar to that of the main body portion of the syringe barrel, each receptacle may be configured such that the inner diameter of the cylindrical wall is only slightly larger than the diameter of the main body portion of the syringe barrel. Thus, radial movement, i.e. lateral movement, of the syringe barrel within the receptacle is limited.

The syringe barrels are typically filled by a sterile filling machine. During the aseptic filling process, the syringe nest containing a plurality of syringe barrels is aligned with a fixture comprising a plurality of filling needles (the number of filling needles corresponds to the number of syringe barrels held by the syringe nest, i.e. to the number of receptacles in the nest). The filling needle is then inserted into the lumen of the syringe barrel through the rear opening. A predetermined volume of injectable medical solution is deposited into the lumen and the filling needle is then removed.

After the syringe barrel is filled, the rear opening of the lumen is stoppered to seal the fluid-containing lumen before the filled syringe barrel exits the sterile environment. To this end, the syringe nest is aligned with a plunger nest (sometimes also referred to as a stopper nest). The plunger nest contains a plurality of plungers, i.e. stoppers (the number of plungers corresponds to the number of syringe barrels held by the syringe nest, i.e. to the number of receptacles in the syringe nest). The syringe nest and plunger nest are also aligned with a fixture comprising a plurality of plunger insertion rods, with the plunger nest positioned directly between the syringe nest and the plunger insertion rods. A vacuum is achieved in the sterile chamber to remove air that may prevent the plunger (i.e., stopper) from being installed. A plunger insertion rod (sometimes also referred to as a needle) is then deployed into contact with the plurality of plungers to push the plungers out of the plunger nest and into the lumen of the syringe barrel until a predetermined position along the axis of the syringe barrel is reached.

The filling and plugging process is typically fully automated, wherein movement of the parts is controlled by one or more central processing units.

Once the syringe barrel has been filled and stoppered, it may be referred to as a prefilled syringe. A syringe nest containing a plurality of prefilled syringes is typically inserted into the cassette. The cassette typically includes a shoulder upon which the substantially flat base of the syringe nest sits, thereby placing a plurality of pre-filled syringes within the interior space defined by the side walls of the cassette. The lid is then sealed to the cassette to enclose the syringe nest and prefilled syringe therein.

In embodiments of the present invention, it may be desirable to utilize tamper evident tip caps. In this way, the prefilled syringe will immediately indicate to the medical professional whether the tip cap has been previously removed.

However, the tamper evident tip cap may have a diameter that is significantly larger than the diameter of the main body portion of the syringe barrel. Since the syringe barrels are first inserted into the receptacles of the dispensing end of the syringe nest, the inner diameter of the cylindrical wall of each receptacle must be large enough to accommodate the increased diameter of the tip cap, i.e., the inner diameter of the cylindrical wall of each receptacle must be at least slightly larger than the diameter of the tip cap. The result is a gap between the body portion of the syringe barrel and the inner surface of the cylindrical wall, which allows the syringe barrel to move radially within the receptacle.

During filling of the syringe barrel, the filling needle must be aligned with the rear opening of the syringe barrel held by the syringe nest. Similarly, during subsequent stoppering of the syringe barrel, the plunger must be aligned with the rear opening of the syringe barrel held by the syringe nest. To prevent complications caused by misalignment, it has been determined that radial movement of the syringe barrel within the syringe nest should be reduced.

Embodiments of the present disclosure relate to a syringe nest comprising one or more ribs positioned about an upper opening of each receptacle, the one or more ribs configured to limit radial movement of a syringe barrel within the receptacle by contact between the one or more ribs and an outer surface of a rear flange of the syringe barrel.

Some embodiments of the present disclosure relate to a syringe nest comprising a substantially planar base and a plurality of receptacles, each of the receptacles sized and configured to receive a syringe barrel having a main body portion, a front dispensing portion, and a rear flange. Each receptacle includes a cylindrical wall defining an upper opening. The diameter of each receptacle measured from the inner surface of the cylindrical wall is greater than the diameter of the main body portion of the syringe barrel but less than the diameter of the rear flange of the syringe barrel that it is configured to receive. One or more upwardly extending ribs are positioned around the upper opening of each receptacle. The one or more ribs are configured to limit radial movement of the syringe barrel within the receptacle by contact between an inner surface of the one or more ribs and an outer surface of the syringe flange. By limiting radial movement, the one or more ribs are configured to substantially centrally retain each syringe barrel of the plurality of syringe barrels within the receptacle.

Embodiments of the present disclosure also relate to a syringe nest, such as the syringe nest described above, and a plurality of syringe barrels positioned within a plurality of receptacles. For example, some embodiments relate to (a) a syringe nest comprising a substantially planar base and a plurality of receptacles, and (b) a plurality of syringe barrels, each syringe barrel removably positioned within one of the plurality of receptacles. Each syringe barrel includes a main body portion, a front dispensing portion, and a rear flange. The diameter of each receptacle measured from the inner surface of the cylindrical wall is greater than the diameter of the main body portion of the syringe barrel but less than the diameter of the rear flange of the syringe barrel positioned therein. The syringe nest also includes one or more upwardly extending ribs positioned about the upper opening of each of the plurality of receptacles. The one or more ribs limit radial movement of a syringe barrel positioned within the receptacle by contact between an inner surface of the one or more ribs and an outer surface of the syringe flange. By restricting radial movement in this manner, one or more ribs substantially centrally retain each syringe barrel of the plurality of syringe barrels within the receptacle.

In some embodiments, the one or more ribs may be a single rib extending around the circumference of the upper opening of the receptacle. Alternatively, in some embodiments, the one or more ribs may include two or more ribs, each of the two or more ribs extending around a portion of the circumference of the upper opening of the receptacle.

In some embodiments, at least a portion of the cylindrical wall of each of the receptacles may extend upwardly from a substantially planar base. In such embodiments, one or more ribs may extend upwardly from the top surface of the cylindrical wall. Alternatively, in some embodiments, the upper opening of each of the receptacles may be substantially in the same plane as the upper surface of the substantially planar base. In such embodiments, one or more ribs may extend upwardly from the upper surface of the substantially planar base.

In some embodiments, the cylindrical wall of each receptacle may also define a lower opening.

In some embodiments, one or more ribs may have an inner surface configured to be positioned 1.5mm or less, alternatively 1.25mm or less, alternatively 1.0mm or less, alternatively 0.75mm or less, alternatively 0.50mm or less from an outer surface of a flange of a syringe barrel that the associated receptacle is configured to receive when the syringe barrel is centered within the receptacle. For some embodiments including multiple syringe barrels, one or more ribs may have an inner surface that is positioned 1.5mm or less, alternatively 1.25mm or less, alternatively 1.0mm or less, alternatively 0.75mm or less, alternatively 0.50mm or less from a flange of a syringe barrel positioned within an associated receptacle when the syringe barrel is centered within the receptacle.

In any embodiment, the one or more ribs may be positioned at a radial distance from the inner surface of the cylindrical wall (i.e., from the perimeter of the upper opening of the receptacle) selected to provide a desired limit to movement of the receptacle configured to receive or the syringe barrel received by the receptacle. In some embodiments, the inner surface of the one or more ribs may be positioned between about 0.50mm and about 2.0mm from the upper opening of the receptacle (i.e., the inner surface of the cylindrical wall), alternatively between about 0.75mm and about 1.75mm from the upper opening of the receptacle, alternatively between about 1.0mm and about 1.5mm from the upper opening of the receptacle.

In some embodiments, each of the one or more ribs may have a chamfered surface configured to guide the flange of the syringe barrel toward the upper opening of the receptacle during insertion of the syringe barrel into the receptacle.

In some embodiments, the diameter of the inner surface of the cylindrical wall may be at least 3mm greater than the diameter of the body portion of the syringe barrel received by the associated receptacle, alternatively at least 4mm greater than the diameter of the body portion of the syringe barrel, alternatively at least 5mm greater than the diameter of the body portion of the syringe barrel.

In some embodiments, the syringe barrel may include a peg needle and a removable needle shield. In some embodiments, the needle shield may be a tamper evident needle shield. In some embodiments, the needle shield may have a diameter that is greater than the diameter of the body portion of the syringe barrel and less than the diameter of the rear flange of the syringe barrel. Alternatively, in some embodiments, the syringe barrel may include a luer tip and a removable tip cap. In some embodiments, the tip cap may be a tamper evident tip cap. In some embodiments, the tip cap may have a diameter that is greater than the diameter of the body portion of the syringe barrel and less than the diameter of the rear flange of the syringe barrel.

In some embodiments, each syringe barrel of the plurality of syringe barrels may have a volume of 1mL or less, optionally less than 1mL, optionally 0.75mL or less, optionally less than 0.75mL, optionally 0.5mL or less, optionally the syringe barrel may have a volume of about 0.5 mL.

The syringe nest of any embodiment may be made of any desired material. In some embodiments, the syringe nest may be made of plastic. For example, the syringe nest may be made of polypropylene. In any embodiment, the syringe nest may also be injection molded.

The syringe nest of any embodiment may have a desired number of receptacles. In some embodiments, the syringe nest may have fifty to one hundred receptacles.

Embodiments of the present disclosure also relate to a set of nested syringe barrels that include (a) a syringe nest of any of the embodiments described herein and (b) a plurality of syringe barrels, each syringe barrel of the plurality of syringe barrels received within one of a plurality of receptacles of the syringe nest. Each of the syringe barrels may include a removable needle shield or removable tip cap sealing the dispensing opening, optionally tamper-evident removable needle shield or removable tip cap.

Embodiments of the present disclosure also relate to a set of nest-type prefilled syringes comprising (a) a syringe nest of any of the embodiments described herein and (b) a plurality of prefilled syringes, each of the plurality of prefilled syringes having a syringe barrel received within one of a plurality of receptacles of the syringe nest. Each prefilled syringe may comprise a removable needle shield or removable tip cap sealing the dispensing opening, optionally tamper-evident removable needle shield or removable tip cap, an injectable medical solution in the lumen of the syringe barrel, and a plunger sealing the rear opening of the lumen.

Embodiments of the present disclosure also relate to a package of pre-filled syringes comprising (a) a syringe nest of any of the embodiments described herein and (b) a plurality of pre-filled syringes, each of the plurality of pre-filled syringes having a syringe barrel received within one of a plurality of receptacles of the syringe nest, (c) a case comprising a shoulder on which the syringe nest seats such that the pre-filled syringes are positioned within an interior of the case defined by a case sidewall, and (d) a lid sealed to the case to enclose the pre-filled syringes. Each prefilled syringe may comprise a removable needle shield or removable tip cap sealing the dispensing opening, optionally tamper-evident removable needle shield or removable tip cap, an injectable medical solution in the lumen of the syringe barrel, and a plunger sealing the rear opening of the lumen. In some embodiments, the cover may be a flexible membrane.

Embodiments of the present disclosure also relate to a method of preparing a plurality of prefilled syringes, the method comprising a stoppering step in which a plurality of plungers are inserted into lumens of a plurality of syringe barrels. During the stoppering step, a plurality of syringe barrels are retained in the syringe nest of any of the embodiments described herein, and a plurality of plungers are retained in the plunger nest. The plunger nest is then aligned with the syringe nest and a fixture comprising a plurality of plunger insertion rods pushes the plurality of plungers out of the plunger nest and into the lumen of the syringe barrel a desired distance. The ribs of the syringe nest may ensure that each syringe barrel of the plurality of syringe barrels is substantially centered in the receptacle of the syringe nest during the step of stoppering.

Embodiments of the present disclosure also relate to a method of preparing a plurality of prefilled syringes, the method comprising a filling step, wherein a medical solution is injected into the lumens of a plurality of syringe barrels. During the filling step, a plurality of syringe barrels are retained in the syringe nest of any of the embodiments described herein. Then, a plurality of filling needles are inserted into the lumens of the syringe barrels, and an injectable medical solution is injected from the filling needles into the lumens of the plurality of syringe barrels. The ribs of the syringe nest may ensure that each syringe barrel of the plurality of syringe barrels is substantially centered in the receptacle of the syringe nest during the filling step.

Embodiments of the present disclosure also relate to a method of preparing a plurality of pre-filled syringes, the method comprising a stoppering step such as described above and a filling step such as described above. The ribs of the syringe nest may ensure that each syringe barrel of the plurality of syringe barrels is substantially centered in the receptacle of the syringe nest during both the step of plugging and the step of filling.

As used herein, substantially centered in the receptacle means that the syringe barrel is positioned within the receptacle such that a filling needle and/or plunger aligned with the center of the receptacle will enter the rear opening of the syringe barrel.

For the purposes of this disclosure, a syringe barrel is shown and described as having a rear flange that is circular in cross-section. However, it should be understood that the concepts described herein are equally applicable to syringe barrels having rear flanges that are not circular in cross-section.

While the present disclosure refers to tamper-evident tip caps as having a substantially larger diameter than the body portion of the syringe barrel to which they are attached, it should be appreciated that any tip cap, whether tamper-evident or not, may have a substantially larger diameter than the body portion of the syringe barrel in order to benefit from reducing radial movement of the syringe barrel within the nest using the embodiments of the syringe nest described herein.

Drawings

Fig. 1 is a perspective view of an embodiment of a syringe nest having a plurality of pre-filled syringes received therein and a cassette configured to hold the syringe nest.

Fig. 2 is a perspective cross-sectional view of a portion of a syringe nest according to embodiments disclosed herein.

Fig. 3 is a cross-sectional side elevation view of a bore (i.e., receptacle) of a syringe nest showing an exemplary syringe barrel received therein, according to embodiments disclosed herein.

Fig. 4 is a perspective view of a system for plugging a plurality of syringe barrels according to embodiments disclosed herein.

Fig. 5 is a cross-sectional side elevation view of a system for plugging a plurality of syringe barrels according to embodiments disclosed herein.

Fig. 6 is a top plan view of a syringe nest according to embodiments disclosed herein.

Fig. 7 is a cross-sectional side elevation view of a bore (i.e., receptacle) of a syringe nest according to embodiments disclosed herein.

Fig. 8 is a top plan view of an embodiment of a receptacle showing radial movement of a syringe barrel within the receptacle that may be permitted in the absence of one or more ribs as disclosed herein.

Fig. 9 is a perspective view of an embodiment of a 0.5mL syringe barrel with a tamper-evident tip cap.

Fig. 10 is a cross-sectional side elevation view of a bore (i.e., a receptacle) of a syringe nest, showing a gap between a body portion of a syringe barrel and an inner surface of a cylindrical wall of the receptacle when the syringe barrel is centered in the receptacle, according to embodiments disclosed herein.

Fig. 11 is a cross-sectional side elevation view of a portion of a bore (i.e., receptacle) of a syringe nest, showing the distance between the outer surface of a flange of a syringe barrel and the inner surface of one or more ribs when the syringe barrel is centered in the receptacle, according to embodiments disclosed herein.

Fig. 12 is a cross-sectional side elevation view of a portion of a system for plugging a plurality of syringe barrels according to embodiments disclosed herein, showing alignment of a bore of a plunger nest with a bore of a syringe nest prior to insertion of a plunger into a lumen of a syringe barrel according to embodiments disclosed herein.

Detailed Description

The present invention will now be described more fully with reference to the accompanying drawings, in which several embodiments are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are examples of the invention, which has the full scope indicated by the language of the claims. Like numbers refer to like or corresponding elements throughout. The following disclosure relates to all embodiments unless specifically limited to a certain embodiment.

Embodiments of the present disclosure relate to a syringe nest (alone or in combination with a plurality of syringe barrels or prefilled syringes contained therein) configured to limit radial movement of a syringe barrel received within a bore of the syringe nest. Examples of such syringe nest 10 are shown in fig. 2-3.

However, before describing the syringe nest 10, a brief description of the syringe barrel is required, examples of which are also shown in FIGS. 2-3. The syringe barrel 100 includes a main body portion 101, a front dispensing portion 102, and a rear flange 103. The cylindrical side wall of the syringe barrel 100 defines a central lumen 104 that is accessible through a rear opening 105 prior to stoppering. The front dispensing portion 102 is provided with a removable tip cap 120 prior to being placed into the syringe nest 10.

The removable tip cap 120 may take any of a variety of configurations, including, for example, a rigid needle shield (e.g., in the case of a syringe that is a stake needle syringe) or a tip cap (e.g., in the case of a syringe having a luer compatible tip). Additionally, in some embodiments, the removable tip cap 120 may include tamper evident features.

The body portion 101 of the syringe barrel has a first diameter, identified as D1 in fig. 3. The front dispensing portion 102 with attached tip cap 120 has a second diameter, identified as D2 in fig. 3. The rear flange 103 has a third diameter, identified as D3 in fig. 3. As shown in fig. 3, the diameter D3 of the rear flange is greater than the diameter D1 of the body portion, and the diameter D2 of the front dispensing portion with attached tip cap may be less than the diameter D3 of the rear flange, but significantly greater than the diameter D1 of the body portion (as it causes the radial movement problem described herein).

In some embodiments, the syringe barrel may include a small volume lumen. For example, in some embodiments, the syringe barrel may have a volume of 1mL or less, alternatively less than 1mL, alternatively 0.75mL or less, alternatively less than 0.75mL, alternatively 0.5mL or less, alternatively 1mL or 0.5mL, alternatively 0.5 mL. In some embodiments, the pre-filled syringe may have a fill volume of about 300 microliters (0.3 mL) of injectable solution. An example of a 0.5mL syringe barrel 100 having a relatively high diameter tamper evident tip cap 120 is shown in fig. 9.

In some embodiments, the syringe barrel 100 may have a body portion 101 diameter D1 of between about seven millimeters and about nine millimeters, alternatively between about seven millimeters and about eight millimeters. In some embodiments, the syringe barrel 100 may have a tip cap 120 diameter D2 of between about ten millimeters and about thirteen millimeters, alternatively between about eleven millimeters and about twelve millimeters. In some embodiments, the syringe barrel 100 may have a flange 103 diameter D3 of between about twelve millimeters and about fifteen millimeters, alternatively between about thirteen millimeters and about fourteen millimeters.

Returning to the syringe nest, embodiments of the syringe nest 10 disclosed herein may include a flat or substantially flat base 11 and a plurality of syringe receptacles 12, i.e., holes, defined in the base. Each syringe receiving section 12 includes a cylindrical wall 13 having an inner surface 14 spanning between and defining an upper opening 15 and a lower opening 17. Each syringe receptacle 12 is sized and configured to receive a syringe barrel 100.

For example, the cylindrical wall 13 has an inner surface 14 with a diameter identified as D4 in fig. 3 that is large enough to receive the body portion 101 of the syringe barrel and the front dispensing portion 102 of the syringe barrel with the tip cap 120 attached. As in the illustrated embodiment, where the diameter D2 of the front dispensing portion of the syringe barrel with attached tip cap is greater than the diameter D1 of the body portion of the syringe barrel, the result is a gap G between the body portion 101 of the syringe barrel and the inner surface 14 of the cylindrical wall 13.

However, the inner surface 14 of the cylindrical wall 13 has a diameter D4 that is smaller than the diameter D3 of the rear flange 103 of the syringe barrel. In this way, the rear flange 103 of the syringe barrel seats on the top surface 16 of the cylindrical wall, preventing the syringe barrel 100 from sliding completely through the receptacle 12. In the illustrated embodiment, the cylindrical wall 12 extends upwardly from the base 11 to the top surface 16. However, in other (not shown) embodiments, the cylindrical wall 12 may extend downwardly from the base 11 such that the top surface 16 of the cylindrical wall 12 is part of the upper surface of the base. In some embodiments, the syringe nest 10 can be configured to hold syringe barrels having a volume of 1mL or greater, such as syringe barrels having a volume between 1mL and 3 mL.

The syringe nest 10 also includes one or more ribs 20 positioned around the upper opening 15 of each receptacle 12 (e.g., positioned on the top surface 16 of the cylindrical wall 12). As shown in fig. 2-3, one or more ribs 20 extend upwardly from the top surface 16 of the cylindrical wall 12. The particular height of the rib or ribs 20 is important only because it is sufficient to provide abutting contact with the outer surface of the rear flange 103 of the syringe barrel 100, but not so high as to interfere with the processes that the syringe nest 10 will be subjected to, such as filling and plugging processes, sealing of the box housing the nest, and the like.

In the illustrated embodiment, the one or more ribs 20 are formed by a pair of ribs, each of which extends around slightly less than half of the circumference of the upper opening 15 of the receptacle 12, such that a small gap is formed between the first rib and the second rib. In other (not shown) embodiments, one or more of the ribs 20 may be a single rib extending around the entire circumference of the upper opening 15 of the receptacle 12. In still other (not shown) embodiments, one or more of the ribs 20 may include any number of ribs positioned at intervals around the circumference of the upper opening 15 of the receptacle 12, such as three ribs, four ribs, five ribs, six ribs, and the like.

The one or more ribs 20 are configured to limit radial movement of the syringe barrel 100 within the receptacle by providing abutting contact between the one or more ribs and the outer surface of the syringe barrel rear flange 103. By so doing, the one or more ribs 20 are configured to substantially centrally retain the syringe barrel 100 within the receptacle 12.

Advantageously, one or more ribs 20 may be positioned to provide an inner abutment contact surface having a diameter that is close to (but larger than) the diameter of the rear flange 103 of a particular type of syringe barrel 100 (e.g., a syringe barrel for which the syringe nest 10 is specifically designed).

In some embodiments, for example, one or more ribs 20 may be configured to be positioned 1.5mm or less from the outer surface of rear flange 103 when the syringe barrel is centered within receptacle 12 (meaning that the diameter of one or more ribs (as measured from one side of receptacle's upper opening 15 to the opposite side of receptacle's upper opening) may be within 3.0mm of rear flange diameter D3), alternatively, one or more ribs may be configured to be positioned 1.25mm or less from the outer surface of rear flange 103 when the syringe barrel is centered within receptacle 12 (meaning that the diameter of one or more ribs (as measured from the inner surface of a rib on one side of receptacle's upper opening to the inner surface of a rib on the opposite side of receptacle's upper opening) may be within 2.5mm of rear flange diameter D3), alternatively, one or more ribs may be configured to be positioned 1.25mm or less from the outer surface of rear flange 103 when the syringe barrel is centered within receptacle 12; alternatively one or more ribs (as measured from one side of receptacle's upper opening 3.5 mm to the opposite side of receptacle's upper opening) may be positioned 1.25mm or less from the outer surface of rear flange 103) may be positioned 1.5mm or less from the inner surface of a rib (as measured from the inner surface of a rib on the opposite side of receptacle's upper opening) 2.5mm to the inner surface of receptacle's upper opening) may be positioned about 2.5mm or less than the inner surface of a rib (as measured from the inner surface of a rib on one side of a receptacle's upper opening of a receptacle ' 3) may be positioned at the opposite side of one side of upper opening of a receptacle ' 3) 3 mm of upper opening of the receptacle) 3 may be measured from one or lower opening of the upper opening of the diameter of the upper flange may be measured from the inner flange of the inner flange may be 3 mm of the inner flange may be, the one or more ribs may be configured to be positioned 0.5mm or less from the outer surface of the rear flange 103 when the syringe barrel is centered within the receptacle 12 (meaning that the diameter of the one or more ribs (as measured from one side of the upper opening of the receptacle to the opposite side of the upper opening of the receptacle) may be within 1.0mm of the diameter D3 of the rear flange).

Thus, in these embodiments, the radial movement (i.e., lateral movement) of the syringe barrel may be limited to 1.5mm or less from the central location, alternatively to 1.25mm or less from the central location, alternatively to 1.0mm or less from the central location, alternatively to 0.75mm or less from the central location, alternatively to 0.50mm or less from the central location.

In some embodiments, depending on the surface area of the top surface 16 of the cylindrical wall supporting the rear flange 103 of the syringe barrel 100, the one or more ribs 20 may be positioned such that the inner surface of the one or more ribs is between about 0.50mm and about 2.0mm from the upper opening 15 of the receptacle 12, alternatively between about 0.75mm and about 1.75mm from the upper opening of the receptacle, alternatively between about 1.0mm and about 1.5mm from the upper opening of the receptacle.

In some embodiments, the difference between D4 and D1 may be at least 4mm, meaning that without the presence of one or more ribs 20 of the present disclosure, the syringe barrel 100 will be able to move radially 2mm or more in any direction from the central position, i.e., the gap G is at least 2mm. In some embodiments, the difference between D4 and D1 may be at least 5mm, meaning that without the presence of one or more ribs 20 of the present disclosure, the syringe barrel 100 will be able to move radially 2.5mm or more in any direction from the central position, i.e., the gap G is at least 2.5mm. For example, in some embodiments, the difference between D4 and D1 may be between about 4mm and about 7mm, meaning that the syringe barrel 100 may be capable of moving radially from the center position in any direction from about 2mm to about 3.5mm, i.e., the gap G is between about 2mm and about 3.5mm, without the presence of one or more ribs 20 of the present disclosure.

An example of syringe barrel movement that may occur without the rib 20 of the present disclosure is shown in fig. 8. As shown in fig. 8, the body portion 101 of the syringe barrel held within the receptacle 12 of the syringe nest may be movable in any radial direction from a central position (three examples of which are shown). Such radial movement of the syringe barrel 101 may cause a filling needle (which is intended to be aligned with the center of the receptacle) used during the filling process to contact a portion of the syringe barrel (e.g., the top surface of flange 103, the inner surface of the wall defining the lumen, etc.), which may result in improper filling and/or damage to the syringe barrel, the filling apparatus, or both. Similarly, the large radial movement of syringe barrel 101 may cause the plunger to contact a portion of the syringe barrel (e.g., the top surface of flange 103) during the stoppering process, which may have similar undesirable effects, such as failing to stopple a filled syringe barrel and/or damaging the syringe barrel, the stoppering device, or both. Less severe radial movement of the syringe barrel 101 within the receptacle 12 may result in the plunger being inserted into the lumen of the syringe barrel, but in a manner that does not achieve adequate sealing, and thus container seal integrity (CCI).

Where one or more ribs 20 are positioned to provide an inner surface proximate to the outer surface of the rear flange 103 of the syringe barrel 100 inserted into the receptacle 12, it may be desirable to provide the one or more ribs 20 with a chamfered or beveled surface 21 configured to guide the flange of the syringe barrel toward the upper opening 15 of the receptacle during insertion of the syringe barrel into the receptacle. An example of such a chamfer surface 21 is shown in fig. 2. By providing an angled transition between the upper and inner surfaces of each of the one or more ribs 20, if the syringe barrel 100 is not fully aligned with the receptacle 12 when inserted, the rear flange 103 of the syringe barrel will be in contact with the chamfered surface 21 and the syringe barrel will be guided into better alignment with the receptacle.

Embodiments of the syringe nest 10 of the present disclosure may be used to hold a plurality of syringe barrels 100 during a method of preparing a plurality of pre-filled syringes, including, for example, during a filling step, a stoppering step, or both. By reducing radial movement of the syringe barrels 100 within the receiving portion 12 of the syringe nest 10, i.e., by maintaining each syringe barrel substantially centered in the receiving portion, the ribs 20 help ensure proper alignment of the filling insert (also referred to as a filling needle) and more importantly the plunger 130 (in view of tight dimensional tolerances between the plunger and the inner wall of the syringe barrel 100 into which the plunger is inserted) with the plurality of syringe barrels during the filling and/or stoppering process.

Accordingly, embodiments of the present disclosure relate to a method of preparing a plurality of prefilled syringes. The method may include a filling step, a plugging step, or both, wherein a plurality of syringe barrels 100 are positioned within receptacles 12 of syringe nest 10 according to embodiments of the present disclosure. Each of the syringe barrels 100 may include a removable tip cap 120 having a diameter that is greater than the diameter of the body portion 101 of the syringe barrel. And the syringe nest 10 may include one or more ribs 20 surrounding the upper opening 15 of each receptacle 12 configured to keep each syringe barrel substantially stable, i.e., with limited movement in a radial direction, and centered within the receptacle.

In some embodiments, the method may include the step of inserting a plurality of plungers into the lumens of a plurality of syringe barrels, i.e., a stoppering step. Examples of systems that may be employed in the plugging step are shown, for example, in fig. 4-5. In this step, a plurality of syringe barrels 100 are held in receptacles 12 of embodiments of syringe nest 10 as disclosed herein, and a plurality of plungers 30 are held in plunger nest 300. The syringe nest 10 and plunger nest 300 are aligned such that each plunger 30 is positioned substantially directly above the rear opening 105 of the syringe barrel 100, as shown, for example, in fig. 5. One or more ribs 20 surrounding each receptacle 12 of the syringe nest 10 ensure that each syringe barrel of the plurality of syringe barrels 100 is substantially centered in the receptacle of the syringe nest and is thus positioned to receive a plunger 30. The fixture, including a plurality of plunger insertion rods 400, is then operated to push each plunger 30 out of the plunger nest 300 and into the lumen 104 of the syringe barrel 100 held within the syringe nest 10.

In some embodiments, the method may include the step of filling the lumens of the plurality of syringe barrels with an injectable medical solution. During this step, a plurality of syringe barrels 100 are held in the syringe nest 10 as disclosed herein. The syringe nest 10 is then aligned with a fixture comprising a plurality of filling needles positioned substantially directly above the rear opening 105 of each syringe barrel 100. The one or more ribs 20 surrounding each receptacle 12 of the syringe nest 10 ensure that each syringe barrel of the plurality of syringe barrels 100 is substantially centered in the receptacle of the syringe nest and is therefore properly positioned to receive a filling needle. A plurality of filling needles are then inserted through the rear opening 105 into the lumens 104 of the syringe barrels 100, and an injectable medical solution is injected from the filling needles into the lumens of the plurality of syringe barrels until a desired volume of solution is present in the lumens. The filling needle is then removed from the lumen 104 of the syringe barrel 100 and the syringe nest 10 may be transported to a stoppering station where the syringe barrel may be stoppered, for example as described herein.

Embodiments of the present disclosure also relate to packaging of pre-filled syringes, wherein the pre-filled syringes are positioned within the receptacles 12 of the syringe nest 10 according to embodiments of the present disclosure. An example of such a package is shown in fig. 1. The package may include a syringe nest 10 as described herein, a plurality of prefilled syringes, and a cassette 200 in which the syringe nest is held. The cassette 200 may include a shoulder on which the syringe nest 10 sits such that the syringe nest 10 and the syringes contained therein are positioned within the interior of the cassette as defined by the side walls of the cassette. Typically, the syringe may be suspended above the bottom wall of the cassette. The package may also include a removable cover, such as a flexible film sealed to the upper flange of the box. The cartridge may be constructed in accordance with ISO 11040-7.

In some embodiments, nest 10 may be made of plastic. For example, the nest 10 may be made of polypropylene. In some embodiments, nest 10 may be a single unitary piece. For example, in some embodiments, the nest 10 can be injection molded from a plastic material (e.g., polypropylene).

In some embodiments, nest 10 may include one hundred receptacles, for example ten receptacles per row.

Exemplary embodiments of the invention

1. A syringe nest comprising:

A substantially flat base, and

A plurality of syringe receptacles, each of the receptacles comprising a cylindrical wall defining an upper opening;

Wherein each of the receptacles is sized and configured to receive a syringe barrel having a main body portion, a front dispensing portion, and a rear flange;

wherein the inner surface of the cylindrical wall has a diameter greater than the diameter of the main body portion of the syringe barrel but less than the diameter of the rear flange, and

One or more of the ribs extending upwardly, the one or more upwardly extending ribs are positioned around the upper opening of each receptacle;

Wherein the one or more ribs are configured to limit radial movement of the syringe barrel within the receptacle by contact between the one or more ribs and an outer surface of the syringe flange.

2. A syringe nest comprising:

A substantially flat base, and

wherein the one or more ribs are configured to maintain each syringe barrel of the plurality of syringe barrels substantially centered within the receptacle.

3. The syringe nest of any preceding embodiment, further comprising a syringe barrel having a body portion positioned within each receptacle, a front dispensing portion, and a rear flange.

4. A syringe nest comprising:

A substantially flat base, and

A plurality of syringe barrels, each syringe barrel removably positioned within one of the plurality of receptacles, and each syringe barrel having a main body portion, a front dispensing portion, and a rear flange;

Wherein one or more ribs limit radial movement of the syringe barrel within the receptacle by contact between the one or more ribs and an outer surface of the syringe flange.

5. A syringe nest comprising:

A substantially flat base, and

Wherein one or more ribs maintain each syringe barrel of the plurality of syringe barrels substantially centered within the receptacle.

6. The syringe nest of any preceding embodiment, wherein the one or more ribs comprise a single rib extending around a circumference of the upper opening of the receptacle.

7. The syringe nest of any preceding embodiment, wherein the one or more ribs comprises two or more ribs, each rib of the two or more ribs extending around a portion of the circumference of the upper opening of the receptacle.

8. The syringe nest of any preceding embodiment, wherein at least a portion of the cylindrical wall of the receptacle extends upwardly from the base, and wherein the one or more ribs extend from a top surface of the cylindrical wall.

9. The syringe nest of any preceding embodiment, wherein the upper opening of the receptacle is substantially in the same plane as the upper surface of the base, and wherein the one or more ribs extend upwardly from the upper surface of the base.

10. The syringe nest of any preceding embodiment, wherein the cylindrical wall of each receptacle further defines a lower opening.

11. The syringe nest of any preceding embodiment, wherein the one or more ribs are configured to have an inner surface that is positioned 1.5mm or less, alternatively 1.25mm or less, alternatively 1.0mm or less, alternatively 0.75mm or less, alternatively 0.50mm or less from an outer surface of the flange when the syringe barrel is centered within the receptacle.

12. The syringe nest of any preceding embodiment, wherein the one or more ribs have an inner surface that is positioned 1.5mm or less, alternatively 1.25mm or less, alternatively 1.0mm or less, alternatively 0.75mm or less, alternatively 0.50mm or less from the flange when the syringe barrel is centered within the receptacle.

13. The syringe nest of any preceding embodiment, wherein the one or more ribs provide an inner surface positioned between about 0.50mm and about 2.0mm from an upper opening of the receptacle, alternatively between about 0.75mm and about 1.75mm from an upper opening of the receptacle, alternatively between about 1.0mm and about 1.5mm from an upper opening of the receptacle.

14. The syringe nest of any preceding embodiment, wherein the diameter of the inner surface of the cylindrical wall is at least 4mm greater than the diameter of the body portion of the syringe barrel, alternatively at least 5mm greater than the diameter of the body portion of the syringe barrel.

15. The syringe nest of any preceding embodiment, wherein each rib of the one or more ribs comprises a chamfered surface configured to guide a flange of a syringe barrel toward an upper opening of the receptacle during insertion of the syringe barrel into the receptacle.

16. The syringe nest of any preceding embodiment, wherein the syringe comprises a peg needle and a removable needle shield.

17. The syringe nest of any preceding embodiment, wherein the needle shield is tamper evident.

18. The syringe nest of any preceding embodiment, wherein the needle shield has a diameter that is greater than a diameter of a major portion of the syringe body and less than a diameter of the rear flange.

19. The syringe nest of any preceding embodiment, wherein the syringe comprises a luer tip and a removable tip cap.

20. The syringe nest of any preceding embodiment, wherein the tip cap is tamper evident.

21. The syringe nest of any preceding embodiment, wherein the tip cap has a diameter that is greater than a diameter of a major portion of the syringe body and less than a diameter of the rear flange.

22. The syringe nest of any preceding embodiment, wherein the nest is made of plastic, optionally wherein the nest is made of polypropylene, optionally wherein the nest is injection molded.

23. The syringe nest of any preceding embodiment, wherein the nest comprises fifty to one hundred receptacles.

24. The syringe nest of any preceding embodiment, wherein the syringe barrel has a volume of 1mL or less, optionally less than 1mL, optionally 0.75mL or less, optionally less than 0.75mL, optionally 0.5mL or less, optionally wherein the syringe barrel has a volume of 0.5 mL.

25. A set of nested syringe barrels, comprising:

the syringe nest according to any preceding embodiment, and

A plurality of syringe barrels, each syringe barrel of the plurality of syringe barrels received within one of the plurality of receptacles.

26. A set of nest-type injectors, comprising:

the syringe nest according to any preceding embodiment, and

A plurality of syringes, each syringe of the plurality of syringes having a syringe barrel received within one of the plurality of receptacles;

wherein each of the plurality of syringes further comprises

An injectable medical solution in the lumen of the syringe barrel,

A removable needle shield or removable tip cap sealing the dispensing opening, and

A plunger sealing the rear opening of the lumen.

27. A syringe package comprising:

the syringe nest according to any preceding embodiment, and

A cassette comprising a shoulder on which the syringe nest sits such that the syringe is positioned within an interior of the cassette defined by a cassette sidewall, and

A cap sealed to the cartridge to enclose the syringe therein;

wherein each syringe of the plurality of syringes comprises:

an injectable medical solution in the lumen of the syringe barrel,

A plunger sealing the rear opening of the lumen.

28. The syringe package of any preceding embodiment, wherein the cover is a flexible film.

29. A method of preparing a plurality of prefilled syringes, the method comprising the step of inserting a plurality of plungers into the lumens of a plurality of syringe barrels, wherein:

a plurality of syringe barrels are held in a syringe nest according to any of the preceding embodiments,

A plurality of plungers are held in plunger nest seats,

The plunger nest is aligned with the syringe nest, and

A fixture comprising a plurality of plunger insertion rods pushes the plurality of plungers out of the plunger nest and a desired distance into the lumen of the syringe barrel.

30. A method of preparing a plurality of prefilled syringes, the method comprising the step of filling a lumen of a plurality of syringe barrels with an injectable medical solution, wherein:

A plurality of filling needles are inserted into the lumen of the syringe barrel, and

An injectable medical solution is injected from the filling needle into the lumens of the plurality of syringe barrels.

31. The method of any preceding embodiment, wherein the one or more ribs ensure that each syringe barrel of the plurality of syringe barrels is substantially centered in the receptacle of the syringe nest.

32. A method of preparing a plurality of prefilled syringes, the method comprising:

(i) Filling lumens of a plurality of syringe barrels with an injectable medical solution, wherein:

Injecting an injectable medical solution from the filling needle into the lumens of the plurality of syringe barrels, and

(Ii) Inserting a plurality of plungers into the lumens of a plurality of syringe barrels, wherein:

The plurality of syringe barrels are held in the syringe nest,

A plurality of plungers are held in plunger nest seats,

The plunger nest is aligned with the nest, and

A fixture comprising a plurality of plunger insertion rods pushing the plurality of plungers out of the plunger nest and into a lumen of the syringe barrel;

wherein the one or more ribs ensure that each syringe barrel of the plurality of syringe barrels is substantially centered in the receptacle of the nest during both the filling and plunger insertion steps.

It can be seen that the described embodiments provide unique and novel syringe nest with a number of advantages over the syringe nest of the art. While certain specific structures embodying the present invention have been shown and described herein, it will be apparent to those skilled in the art that various modifications and rearrangements of the parts may be made without departing from the spirit and scope of the underlying inventive concept, and this is not limited to the particular forms shown and described herein, except as indicated by the scope of the appended claims.

Claims

1. A syringe nest comprising:

A substantially flat base, and

2. A syringe nest comprising:

A substantially flat base, and

3. The syringe nest of any preceding claim, wherein the one or more ribs are configured to retain each syringe barrel of the plurality of syringe barrels substantially centered within the receptacle.

4. The syringe nest of any preceding claim, wherein the one or more ribs comprise a single rib extending around a circumference of an upper opening of the receptacle.

5. The syringe nest of any preceding claim, wherein the one or more ribs comprise two or more ribs, each rib of the two or more ribs extending around a portion of a circumference of an upper opening of the receptacle.

6. The syringe nest of any preceding claim, wherein at least a portion of a cylindrical wall of the receptacle extends upwardly from the base, and wherein the one or more ribs extend from a top surface of the cylindrical wall.

7. The syringe nest of any preceding claim, wherein the upper opening of the receptacle is substantially in the same plane as the upper surface of the base, and wherein the one or more ribs extend upwardly from the upper surface of the base.

8. The syringe nest of any preceding claim, wherein the one or more ribs are configured to have an inner surface that is positioned 1.5mm or less, alternatively 1.25mm or less, alternatively 1.0mm or less, alternatively 0.75mm or less, alternatively 0.50mm or less from an outer surface of the flange when a syringe barrel is centered within the receptacle.

9. The syringe nest of any preceding claim, wherein the one or more ribs provide an inner surface positioned between about 0.50mm and about 2.0mm from an upper opening of the receptacle, alternatively between about 0.75mm and about 1.75mm from an upper opening of the receptacle, alternatively between about 1.0mm and about 1.5mm from an upper opening of the receptacle.

10. The syringe nest of any preceding claim, wherein the diameter of the inner surface of the cylindrical wall is at least 4mm greater than the diameter of the body portion of the syringe barrel, alternatively at least 5mm greater than the diameter of the body portion of the syringe barrel.

11. The syringe nest of any preceding claim, wherein each rib of the one or more ribs comprises a chamfered surface configured to guide a flange of a syringe barrel toward an upper opening of the receptacle during insertion of the syringe barrel into the receptacle.

12. The syringe nest of any preceding claim, wherein each syringe of a plurality of syringes comprises a peg needle and a removable needle shield, optionally a tamper evident removable needle shield, the needle shield having a diameter that is greater than a diameter of a body portion of the syringe and less than a diameter of a rear flange of the syringe.

13. The syringe nest of any preceding claim, wherein each syringe of a plurality of syringes comprises a luer tip and a removable tip cover, optionally a tamper-evident removable tip cover, the tip cover having a diameter that is greater than a diameter of a body portion of the syringe and less than a diameter of a rear flange of the syringe.

14. The syringe nest of any preceding claim, wherein each syringe barrel of the plurality of syringe barrels has a volume of 1mL or less, optionally less than 1mL, optionally 0.75mL or less, optionally less than 0.75mL, optionally 0.5mL or less, optionally wherein each syringe barrel of the plurality of syringe barrels has a volume of 0.5 mL.

15. A set of nest-type injectors, comprising:

an injector nest according to any preceding claim, and

wherein each of the plurality of syringes further comprises

An injectable medical solution in the lumen of the syringe barrel,

A plunger sealing the rear opening of the lumen.

16. A syringe package comprising:

an injector nest according to any preceding claim, and

A cap sealed to the cartridge to enclose the syringe therein;

wherein each syringe of the plurality of syringes comprises:

an injectable medical solution in the lumen of the syringe barrel,

A plunger sealing the rear opening of the lumen.

17. A method of preparing a plurality of prefilled syringes, the method comprising the step of inserting a plurality of plungers into the lumens of a plurality of syringe barrels, wherein:

A plurality of syringe barrels are held in a syringe nest according to any preceding claim,

A plurality of plungers are held in plunger nest seats,

The plunger nest is aligned with the syringe nest, and

18. A method of preparing a plurality of prefilled syringes, the method comprising the step of filling a lumen of a plurality of syringe barrels with an injectable medical solution, wherein:

19. A method of preparing a plurality of prefilled syringes, the method comprising:

The plurality of syringe barrels are held in the syringe nest,

A plurality of plungers are held in plunger nest seats,

The plunger nest is aligned with the nest, and

20. The method of any preceding claim, wherein the one or more ribs ensure that each syringe barrel of the plurality of syringe barrels is substantially centered in the receptacle of the syringe nest.