RU2815573C2 - System for lyophilization, resuspending and drug delivery and related methods - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to a modular syringe assembly. The modular syringe assembly includes a tubular syringe barrel having a proximal end and a distal end, a plunger, and a cap assembly. Moreover, the tubular cylinder of the syringe forms a longitudinal axis. Moreover, the piston is designed to slide inside the tubular cylinder of the syringe. The cap assembly includes a plug portion and a luer lock. A part of the plug is configured to be received at the distal end of the tubular syringe cylinder. A part of the plug forms a ventilation hole. The cap assembly may slide within the syringe tubular barrel along a longitudinal axis between a sealed position in which the vent hole is covered by the syringe tubular barrel to prevent ventilation between the cap assembly and the syringe tubular barrel, and a vent position in which the vent hole defines a vent between the cap assembly and the syringe tubular barrel.

EFFECT: method of lyophilizing a drug and resuspending the lyophilized drug using a modular syringe assembly.

26 cl, 20 dwg

Description

CROSS-REFERENCES TO RELATED APPLICATIONS

This application claims benefit from U.S. Provisional Patent Application No. 62/791,182, filed January 11, 2019, the contents of which are incorporated herein by reference in their entirety.

FIELD OF APPLICATION OF THE INVENTION

The present invention relates to a modular system for mixing two or more substances, such as liquids or powders. More specifically, the present invention relates to a modular system that can be used for lyophilization, resuspension and delivery of a drug, and corresponding methods of using it.

PREREQUISITES FOR CREATION OF THE INVENTION

Lyophilized drugs are known in the art. Typically, a lyophilized drug is presented in a bottle. To resuspend a drug, a healthcare provider typically performs a multi-step process that includes attaching a needle to a syringe; drawing the diluent from the bottle into the syringe using a needle; and injecting the diluent from the syringe into a vial containing the lyophilized drug, thereby resuspending the drug. To deliver a drug after reconstitution, the healthcare provider typically removes the resuspended drug from the vial using a syringe with an attached needle and then administers the drug into an IV bag or patient. This process provides many opportunities for the clinician to inadvertently stick himself or others with a needle. There is a need in the art for systems and methods for lyophilization, resuspension and drug delivery that overcome these and other disadvantages of the prior art.

BRIEF DESCRIPTION OF THE INVENTION

In accordance with one embodiment of the invention, the modular syringe assembly may include a tubular syringe barrel having a proximal end and a distal end, the tubular syringe barrel defining a longitudinal axis; a piston configured to slide inside the tubular barrel of the syringe; and a cap assembly including a stopper portion and a luer lock, wherein the stopper portion is configured to be received at a distal end of a tubular barrel of the syringe, wherein the stopper portion defines a vent hole. The cap assembly may slide within the syringe tubular barrel along a longitudinal axis between a sealed position in which the vent hole is covered by the syringe tubular barrel to prevent ventilation between the cap assembly and the syringe tubular barrel, and a vent position in which the vent hole defines a vent between the cap assembly and the syringe tubular barrel. syringe.

According to another embodiment, a method of lyophilizing a drug may include providing a modular syringe assembly containing a drug, wherein the modular syringe assembly includes a tubular syringe barrel, a plunger configured to slide within the tubular syringe barrel, and a cap assembly configured movable along the tubular barrel of the syringe between a sealed position and a vented position; lyophilizing the drug with the cap assembly in a vented position, wherein steam is vented through the cap assembly; and moving the cap assembly from the vent position to the seal position.

According to yet another embodiment, a method of resuspending a lyophilized drug may include providing a modular syringe assembly containing the lyophilized drug, wherein the modular syringe assembly includes a tubular syringe barrel, a piston slidable within the tubular syringe barrel, and a cap assembly including a luer lock. tip; connection of the piston rod to the piston; connecting the luer lock to the diluent source; and retracting the plunger rod to draw the diluent into the tubular barrel of the syringe.

BRIEF DESCRIPTION OF GRAPHIC MATERIALS

In FIG. 1 is a side view of an embodiment of a modular syringe assembly;

in FIG. 2 is a perspective view of the modular syringe assembly of FIG. 1;

in FIG. 3 is an exploded view of the syringe modular assembly of FIG. 1;

in FIG. 4 is a side view of a portion of the cap assembly of the modular syringe assembly of FIG. 1;

in FIG. 5 is a bottom view of a portion of the cap assembly of the modular syringe assembly of FIG. 4;

In FIG. 6 is a side cross-sectional view of the syringe modular assembly of FIG. 1, shown with the cap assembly in the vented position;

In FIG. 7 is a side cross-sectional view of the syringe modular assembly of FIG. 1, shown with the cap assembly in the sealed position;

in FIG. 8 is an exploded view of an alternative embodiment of the modular syringe assembly of FIG. 1;

in FIG. 9 is an exploded view of an alternative embodiment of the modular syringe assembly of FIG. 1;

In FIG. 10 is a perspective view of the modular syringe assembly of FIG. 1 in combination with a compression device;

in FIG. 11 is a side cross-sectional view of the compression device of FIG. 10;

In FIG. 12 is a perspective view of the modular syringe assembly of FIG. 1, with a piston rod connected to it;

In FIG. 13 is a flowchart of an embodiment of the drug lyophilization method;

In FIG. 14 is a side view of the syringe modular assembly of FIG. 12 connected to an intravenous injection bag;

In FIG. 15 is a side view of the syringe modular assembly of FIG. 12, connected to the bottle via a bottle adapter;

In FIG. 16 is a side view of the syringe modular assembly of FIG. 12, connected to a needle inserted into the bottle;

In FIG. 17 is a perspective view of the modular syringe assembly of FIG. 12, connected to the needle;

In FIG. 18 A, 18 B and 18 C show perspective, side and lateral cross-sectional views of an embodiment of the piston;

In FIG. 19 A, 19 B and 19 C show perspective, side and lateral cross-sectional views of another embodiment of the piston; And

In FIG. 20A, 20B and 20C show perspective, side and lateral cross-sectional views of yet another embodiment of the piston.

DETAILED DESCRIPTION

All publications, including, without limitation, patents and patent applications cited herein, are incorporated herein by reference as if fully set forth herein.

As used in this specification and in the claims, the singular forms include references to plural entities unless the context otherwise clearly indicates.

This application relates to a modular syringe assembly that can be used to mix two or more substances, such as liquids or powders. In a specific embodiment, the modular syringe assembly can be used with a lyophilized drug product. The modular syringe assembly can be converted from a variety of different configurations, which may allow the modular syringe assembly to be used during lyophilization, resuspension, and/or drug delivery. The use of a modular syringe assembly in some or all of the above steps can reduce or eliminate the risk of needle sticks associated with traditional processing of lyophilized drugs (which often use a needle to move the drug between different containers).

As shown in FIG. 1-3, an embodiment of a modular syringe assembly 100 is shown. in FIG. 1 is a side view of a modular syringe assembly 100; in FIG. 2 is a perspective view of a modular syringe assembly 100; in FIG. 3 is an exploded view of a modular syringe assembly 100; The modular syringe assembly 100 may include a tubular syringe barrel 102. The tubular syringe barrel 102 may define a longitudinal axis A shown in FIG. 3. The tubular syringe barrel 102 may define a hollow interior for receiving medication and may include a proximal end 104 and a distal end 106, both of which are open. A raised lip 108 may be provided at the proximal end 104. The raised edge 108 may facilitate attachment of the handle to the tubular barrel 102 of the syringe. A raised lip 110 may be provided at the distal end 106. The tubular syringe barrel 102 may be made of glass, plastic, or other suitable durable materials known in the art. For example, but not limited to, the tubular syringe barrel 102 may be made of borosilicate glass, polypropylene, Crystal Zenith, Makrolon RX, or polycarbonate.

As shown in FIG. 3, the modular syringe assembly 100 may include a plunger 112 slidable within a tubular syringe barrel 102. In the embodiment shown in FIG. 3, the piston 112 includes a rigid piston base 114 with a rubber piston tip 116 coupled thereto, however, in alternative embodiments, the rigid piston base 114 may be absent and the piston 112 may be constructed entirely of a plastic material, such as rubber. The piston 112 may slide internally and form a seal with the interior of the tubular barrel 102 of the syringe. As shown in FIG. 6 and 7, embodiments of the piston 112 may include a connection 118 for connection to a removable piston rod (not shown). For example, connection 118 may include internal threads or a quarter turn cam configured to receive a male mating member on the piston rod, or vice versa. In accordance with embodiments and without limitation, the rigid piston base 114 may be formed from polypropylene, Crystal Zenith, Makrolon RX, or polycarbonate. In accordance with embodiments (and without limitation), the piston tip 116 may be made of bromobutyl rubber.

Referring to FIG. 1-5, the modular syringe assembly 100 may further include a cap assembly 120 that is attached to the distal end 106 of the tubular syringe barrel 102. Referring to FIG. 4 and 5, the cap assembly 120 may include a proximal end 122 and a distal end 124. The plug portion 122 and the luer lock 124 may be co-molded parts, or in an alternative embodiment may be separate parts joined together, e.g. by means of fastening. The plug portion 122 may have an outer diameter that allows it to slide within the distal end 106 of the syringe tubular barrel 102 to form a seal with the syringe tubular barrel 102. As shown in FIG. 4, a portion of the plug 122 may include ribs 126 or other surface features that form a seal with the tubular barrel of the syringe 102 while providing a sliding surface for engagement therewith. As best shown in FIG. 4 and 5, a portion of the plug 122 may define a vent hole 128.

Referring to FIG. 6 and 7, the syringe modular assembly is shown in longitudinal section. The cap assembly 120 is configured to slide relative to the tubular syringe barrel 102 along the longitudinal axis A (FIG. 3) between the vent position shown in FIG. 6, and the sealed position shown in FIG. 7. In the ventilated position shown in FIG. 6, the cap assembly 120 rises above the distal end 106 of the tubular syringe barrel 102. In this position, the vent hole 128 defines a vent passage between the plug portion 122 and the barrel of the tubular syringe 102, allowing steam to escape from the tubular barrel of the syringe 102 into the environment. In the sealed position shown in FIG. 7, vent 128 is covered by the syringe tubular barrel 102, thereby blocking the flow of air between the syringe tubular barrel 102 and the cap assembly 120 (and preventing air from escaping between the interior of the syringe tubular barrel 102 and the environment). If the cap assembly 120 is in a sealed position and the plunger 112 is in the syringe tubular barrel 102, the space between the cap assembly 120 and the plunger 112 is sealed. The drug, such as a lyophilized drug, may be placed within the barrel of the tubular syringe 102 in the sealed space between the cap assembly 120 and the plunger 112, as described in more detail below. An example of a lyophilized drug may include infliximab.

As shown in FIG. 4, a portion of the plug 122 includes a distal end 130 and a proximal end 132 opposite the distal end 130. The distal end 130 may form a flange 134, for example, projecting radially from the portion of the plug 122. In accordance with embodiments, the vent hole 128 may be located at a distance from distal end 130 and may intersect with proximal end 132. As best shown in FIG. 3, an O-ring 136, such as a gasket, may be placed around the plug portion 122. If the cap assembly 120 is in the sealed position shown in FIG. 7, an O-ring 136 may be sandwiched between the flange 134 and the distal end 106 of the tubular barrel of the syringe 102, as shown in FIG. 7. If the cap assembly 120 is in the open position as shown in FIG. 6, the cap assembly 120 may be raised such that the flange 134 is spaced from the O-ring 136 and/or the O-ring 136 is spaced from the distal end 106 of the tubular barrel of the syringe 102. In embodiments without the O-ring 136 the flange 134 in the sealed position may be spaced from the distal end 106 of the tubular barrel 102 of the syringe, and the flange 134 in the sealed position may contact the distal end 106 of the tubular barrel of the syringe 102. With respect to FIG. 3 and 7, a ferrule 138 may be placed over the flange 134 to hold the cap assembly 120 in a sealed position. A raised lip 110 on the distal end 106 of the tubular syringe barrel 102 may assist in retaining the ferrule 138.

Referring to FIG. 1-3, cap assembly 120 may further include a luer lock 124. In embodiments, the luer lock 124 may be co-molded with a portion of the plug 122 (see FIG. 6), however other embodiments are possible. For example, the luer lock 124 and the plug portion 122 may be a molded plastic portion, but other embodiments are possible and will be described below. In accordance with embodiments and without limitation, the luer lock 124 and/or the plug portion 122 may be formed from polypropylene, Crystal Zenith, Makrolon RX, or polycarbonate.

As shown in FIG. 1-3, a cap OVS 142 (eg, from Vetter Pharma, Ravensburg, Germany) may be mounted on the luer lock 124. The OVS cap 142 may snap onto the luer lock 124. The OVS cap 142 may include a main cap 144 and a threaded portion 146 connected by a tamper evident frangible seal 148 (see FIG. 1). During use, the user may break the tamper evident seal 148, allowing the primary cap 144 to be removed and thereby exposing the luer lock 124 and threaded portion 146 of the OVS cap 142. As will be described in more detail below, another component may be associated with the luer lock. a tip 124 and a threaded portion 146 for dispensing the contents of the syringe module assembly 100. For example, you can use the EZ-Fill® Integrated Tip Cap from Ompi, Stevanato Group, Newton, PA, USA.

In FIG. 8 is an exploded view of an alternative embodiment of a modular syringe assembly 100. The embodiment shown in FIG. 8 is similar to the embodiment shown in FIG. 1-7, except for differences described below. According to the embodiment shown in FIG. 8, an O-ring 136 may be mounted radially between the plug portion 122 and the inner wall of the distal end 106 of the tubular barrel of the syringe 102 to form a seal therebetween. In this embodiment, the O-ring 136 may also include a flange 150 positioned between the distal end 106 of the tubular barrel of the syringe 102 and the flange 134 on the locking portion 122 if the cap assembly 120 is in a sealed position. In addition, the vent hole 128 may be located in the seal ring 136. Accordingly, the seal ring 136 may move up and down with respect to the distal end 106 of the tubular barrel of the syringe 102 to adjust whether the cap assembly is in a sealed or vented position. According to the embodiment shown in FIG. 8, the plug portion 122 may be a relatively rigid plastic member, and the O-ring 136 may be a relatively flexible rubber or plastic member that facilitates a seal between the plug portion 122 and the tubular barrel of the syringe 102.

In FIG. 9 is an exploded view of yet another alternative embodiment of a modular syringe assembly. The embodiment shown in FIG. 9 is similar to the embodiment shown in FIG. 1-7, except for differences described below. In the embodiment shown in FIG. 9, the O-ring can be omitted. Additionally or alternatively, the plug portion 122, flange 134, and luer lock 124 may be molded together from a rubber material. As shown, vent 128 may be co-molded into a portion of plug 122. In accordance with embodiments and without limitation, a portion of plug 122, flange 134, and/or luer lock 124 may be co-molded: plug and bromobutyl rubber flange, luer lock made of polypropylene, Crystal zenith, Makrolon RX or polycarbonate.

In FIG. 10 is a perspective view of the modular syringe assembly 100 of FIG. 1 in combination with compression device 160. In FIG. 11 is a side cross-sectional view of the compression device 160 shown in FIG. 10; The compression device 160 may be used to apply pressure to the cap assembly 120 and press it into the distal end 106 of the syringe tubular barrel 102, for example, to move the cap assembly 120 from a vent position to a sealed position. Pressure may be applied to the compression device 160 by a surface of the device, such as, for example, a lyophilization shelf or other movable surface. The compression device 160 may be geometrically shaped to match the shape of the cap assembly 120 to eliminate pressure on the cap OVS 142, reducing the likelihood of damage to the cap OVS 142 or portions of the cap assembly 120 when the cap assembly 120 is brought into a sealed position.

As shown in FIG. 11, for example, the compression device 160 may include a first cavity 162 and a second cavity 164 separated by a contact surface 166. The first cavity 162 may define an internal diameter allowing the first cavity 162 to extend over the cap assembly 120 and the distal end 106 of the tubular barrel of the syringe 102. B in accordance with embodiments, the internal diameter of the first cavity 162 may also provide clearance for passage of steam from the vent channel 128 between the compression device 160 and the syringe module assembly 100. The second cavity 164 may define an internal diameter that allows it to extend over the cap OVS 142. The contact surface 166 may have a predominantly transverse surface resting on the top surface of the cap assembly 120 and applying pressure from the compression tool 160 to the cap assembly 120. In accordance with In one embodiment, the internal diameter of the second cavity 164 may be smaller than the internal diameter of the first cavity 162. In practice, the compression device 160 may apply pressure to the flange 134 through the contact surface 166 of the cap assembly 120, moving the cap assembly 120 into the distal end 106 of the tubular syringe barrel 102, for example, by moving the cap assembly 120 from a vented position to a sealed position. The second cavity 164 in the compression tool 160 may serve as a softener for the OVS cap 142, thereby reducing or eliminating contact between the compression tool 160 and the OVS cap 142. This may help reduce or eliminate the possibility of damage to the OVS cap 142 and/or luer lock. tip 124 when moving cap 120 to the sealed position. Although the contact surface 166 is shown in FIG. 11 as being substantially perpendicular to the axis of the first cavity 162 and the axis of the second cavity 164, other configurations are possible as long as the contact surface 166 can transmit sufficient force to the cap assembly 120 to press it into the distal end 106 of the tubular barrel of the syringe 102.

FIG. 12 is a perspective view of the modular syringe assembly 100 of FIG. 1 with a piston rod 168, for example, removably connected to the piston 112.

In FIG. 13 is a flowchart of an embodiment of a method for lyophilizing a drug. The method may be implemented using embodiments of the modular syringe assembly 100 described herein. At step 200, the plunger 112 may be inserted into the tubular barrel of the syringe 102, such as the proximal end 104. The location of the plunger 112 within the tubular barrel of the syringe 102 may be varied to accommodate different volumes of drug to be lyophilized. For larger volumes, the piston 112 may be positioned toward the proximal end 104, while for smaller volumes, the piston 112 may be separated from the proximal end 104 in an upward direction.

Then, at step 202, the tubular barrel of the syringe 102 can be filled with a lyophilizable drug, for example, using standard laboratory equipment. An example of a drug that can be lyophilized during the process is infliximab. According to an embodiment, the proximal end 104 of the tubular syringe barrel 102 may rest on a cooling shelf of the lyophilization line during the filling step.

At step 204, the cap assembly 120 is inserted into the distal end 106 of the tubular syringe barrel 102 and placed in a vented position. In accordance with various embodiments, step 200 may be performed before or after step 204, provided that the plunger 112 or cap assembly 120 is applied to the tubular barrel of the syringe 102 before adding the drug. Once the drug is contained in the tubular barrel of the syringe, it can be lyophilized using traditional lyophilization equipment. In an embodiment, the lyophilization process may take less than about 72 hours. When the cap assembly 120 is in the vented position, steam released during the lyophilization process can escape through the open vent 128 in the cap assembly 120.

At step 206, the cap 120 is moved from the vented position to the sealed position. For example, the cap assembly 120 may be pressed into the distal end 106 of the tubular barrel of the syringe 102 until the flange 134 comes into contact with the distal end 106 of the tubular barrel 102 of the syringe. In alternative embodiments that include an O-ring 136, the cap 120 may be depressed until the O-ring 136 is clamped between the flange 134 and the distal end 106 of the syringe tubular barrel 102. In either case, when the cap assembly 120 is moved into a sealed position, the syringe tubular barrel 102 seals the vent hole 128, such as preventing air from passing between the interior of the syringe tubular barrel 102 and the environment through the vent hole 128. An induction foil seal may be applied to the proximal end 104 to further seal this end of the tubular barrel 102 of the syringe.

Step 206 may be performed by applying force to the cap assembly 120, holding the syringe tubular barrel 102 in place, thereby displacing the cap assembly 120 into the distal end 106 of the syringe tubular barrel 102. This can be achieved, for example, by pressing on the cap assembly 120. In embodiments, this can be achieved by applying force to the cap assembly 120 using a standard freeze-drying shelf, but alternatively other surfaces or structures may be used. In accordance with embodiments, force may be transmitted from the lyophilization shelf to the cap assembly 120 through a compression device 160 located between the lyophilization shelf and the cap assembly 120.

At step 208, the syringe modular assembly may be removed from the lyophilization shelf and a ferrule 138 secured over the cap assembly 120 to seal the syringe modular assembly 100 and the lyophilized drug contained therein. This can be done using conventional equipment.

Although the above-described method has been described above in connection with a single syringe module assembly 100, the same method can be implemented to simultaneously batch process multiple syringe module assemblies and the drugs contained therein.

As shown in FIG. 13, at step 210, the piston rod 168 may be coupled to the piston 112 to facilitate resuspension and/or delivery of the lyophilized drug. For example, piston rod 168 may be coupled to piston 112 by providing a threaded connection, cam lock, or other connection between piston rod 168 and piston 112.

Embodiments of the present invention also include methods for resuspending and/or delivering a lyophilized drug. To resuspend the drug, the main cap 144 may be separated from the OVS cap 142 by a frangible seal 148 to expose the luer lock 124 of the cap assembly 120. The threaded portion 146 of the OVS cap 142 may remain secured to the luer lock 124 and may be used to attach a diluent source such as like a water bottle, to the luer lock 124. The piston rod 168 can then be retracted to draw diluent into the tubular syringe barrel 102 to resuspend the thus lyophilized drug. The diluent source may be detached from the luer lock, for example, by unwinding from the threaded portion 146. In accordance with embodiments and without limitation, the diluent may include water for injection (WFI), saline, or a liquid specifically formulated for the drug product. In accordance with embodiments and without limitation, the diluent source may be a glass or plastic vial, bottle, or pouch.

Once resuspended, the drug may be delivered via the syringe modular assembly 100, for example, by compressing the plunger rod 168. As shown in FIG. 14-17, the luer lock may be attached without limitation to an IV bag 300 (FIG. 14), a vial adapter 302 attached to a vial 304 (FIG. 15), a needle 306 inserted into a vial 308 (FIG. 16), or needle 310 (FIG. 17). Although not shown, in other embodiments, one or more modular syringe assemblies 100 may be placed in an automatic syringe pump or a dedicated device, such as a syringe device for dispensing a resuspended drug. The devices can subsequently be used to administer the resuspended drug to a patient using techniques known in the art.

In FIG. 18A-C, 19A-C and 20A-C show alternative embodiments of the piston 112 that may connect directly to the piston rod, for example, without requiring the rigid base of the piston 114 depicted in FIG. 3. In the embodiment shown in FIG. 18 A-C, the piston 212 includes a cavity-shaped sleeve 218 including threads configured to engage corresponding threads on the distal end of the piston rod. In the embodiment shown in FIG. 19 A-C, the piston 312 includes a sleeve 318 in the form of a cavity containing a plurality of ribs adapted to engage corresponding ribs at the distal end of the piston rod. The piston 412 shown in FIG. 20 A-C also includes a coupling 418 in the form of a ribbed cavity containing a rib for engagement with ribs at the distal end of the piston rod. Connection 318 to FIG. 19 A-C includes a substantially flat top for receiving a piston rod having a corresponding flat top. Connection 418 to FIG. 20 A-C includes a substantially domed top for receiving a piston rod having a corresponding domed top.

The rubber pistons 212, 312, 412 may also include a plurality of ribs 212A, 312A, 412A, respectively, configured to form a seal between the piston and the tubular barrel 102 of the syringe. In accordance with embodiments and without limitation, pistons 212, 312, 412 may be formed from bromobutyl rubber.

In accordance with alternative embodiments, various components of the modular syringe assembly 100 may be colored, tinted, and/or plain to protect light-sensitive drug products. In accordance with yet another alternative embodiment, the modular syringe assembly 100 can be used to mix two liquids, or powders, or drug-coated microspheres, or liquid. In powder and microsphere embodiments, the device can be filled with powder and microspheres, adding liquid later, just like a lyophilized drug, although alternative sequences are possible depending on existing processing lines. In other alternative embodiments, two modular syringe assemblies 100 may be connected end to end using a male adapter and used to transfer liquid from one to the other, as is the case with prefilled syringes.

Claims (43)

1. Modular syringe assembly containing: a tubular syringe barrel having a proximal end and a distal end, the tubular syringe barrel defining a longitudinal axis; a piston configured to slide inside the tubular barrel of the syringe; And a cap assembly including a plug portion and a luer lock, the plug portion being configured to be received at a distal end of a tubular barrel of the syringe, the plug portion defining a vent hole; wherein the cap assembly is configured to slide within the syringe tubular barrel along a longitudinal axis between a sealed position in which the vent hole is closed by the syringe tubular barrel to prevent ventilation between the cap assembly and the syringe tubular barrel, and a vent position in which the vent hole defines a vent passage between the assembly cap and barrel of a tubular syringe. 2. The modular syringe assembly of claim 1, wherein the plug portion further includes a distal end defining a flange and a proximal end opposite the distal end, wherein a vent hole intersects the proximal end of the plug portion. 3. The modular syringe assembly of claim 1, wherein the flange is in contact with the distal end of the syringe tubular barrel if the cap assembly is in a sealed position, and the flange is spaced from the distal end of the syringe tubular barrel if the cap assembly is in a vented position. 4. The modular syringe assembly of claim 1, wherein the cap assembly includes an O-ring that is installed between the plug portion and the distal end of the tubular barrel of the syringe. 5. Modular syringe assembly according to claim 4, in which the ventilation hole is located in the o-ring. 6. The modular syringe assembly according to claim 1, in which the ventilation hole is molded into parts in the form of a plug. 7. The modular syringe assembly according to claim 1, further comprising an OVS cap placed on a luer lock. 8. The modular syringe assembly of claim 1, wherein the piston includes a coupling for detachable connection to the piston rod. 9. The modular syringe assembly of claim 8, further comprising a piston rod connected to the piston through a removably coupled connection. 10. The modular syringe assembly according to claim 1, additionally containing a lyophilized drug placed inside the tubular barrel of the syringe. 11. The modular syringe assembly of claim 10, wherein the lyophilized drug product contains infliximab. 12. The modular syringe assembly of claim 1, further comprising a ferrule ring configured to be applied to the cap assembly when in a sealed position to hold the cap assembly in a sealed position. 13. A method of lyophilization of a medicinal product, including: providing a modular syringe assembly containing a medicinal product, the modular syringe assembly including a tubular syringe barrel, a piston slidable within the tubular syringe barrel, and a cap assembly configured to move along the tubular syringe barrel between a sealed position and a vented position; lyophilizing the drug with the cap assembly in a vented position, wherein steam is vented through the cap assembly; And moving the cap assembly from the vent position to the seal position. 14. The method according to claim 13, additionally including: inserting a piston into the proximal end of the tubular barrel of the syringe; filling the tubular cylinder of a syringe with a medicinal product; And inserting the cap assembly into the distal end of the tubular barrel of the syringe with the cap assembly in the venting position. 15. The method of claim 13, wherein moving the cap assembly from the vent position to the seal position includes pressing the cap assembly into the distal end of the tubular barrel of the syringe. 16. The method of claim 15, wherein application of the cap assembly to the distal end of the tubular barrel of the syringe seals a vent hole located in the cap assembly. 17. The method of claim 13, wherein moving the cap assembly from the vent position to the sealed position comprises applying a force to the cap assembly using a lyophilization shelf. 18. The method of claim 17, wherein applying force to the cap assembly by the lyophilization shelf includes applying force to a compression device located between the lyophilization shelf and the cap assembly. 19. The method of claim 13, further comprising applying a ferrule to the cap assembly while it is in a sealed position. 20. The method of claim 13, further comprising attaching the piston rod to the piston. 21. The method according to claim 13, in which the medicinal product contains infliximab. 22. A method for resuspending a lyophilized drug, including: providing a modular syringe assembly according to claim 1, wherein the tubular barrel of the syringe contains a lyophilized drug; connection of the piston rod to the piston; connecting the luer lock to the diluent source; And retracting the piston rod to draw the diluent into the tubular barrel of the syringe. 23. The method according to claim 22, additionally including the delivery of a resuspended medicinal product by: disconnecting the diluent source from the luer lock; And pressing the plunger to force the lyophilized drug through the luer lock. 24. The method of claim 23, wherein delivery of the resuspended medicinal product further includes the following: attaching at least one of a needle, vial, vial adapter, or IV bag to a luer lock. 25. The method of claim 22, further comprising removing the primary portion of the OVS cover to expose the luer lock. 26. The method according to claim 22, wherein the lyophilized medicinal product contains infliximab.