EP-4736911-A1 - METHOD FOR MANUFACTURING A PREFILLED SYRINGE TO REDUCE GLIDING FORCE THEREIN

Abstract

Provided herein is a method for manufacturing a prefilled syringe. The method includes providing a prefilled syringe including a syringe barrel defining a chamber containing a fluid therein and a stopper axially sealing the fluid in the chamber, with the stopper including one or more ribs forming a sealing surface with the syringe barrel. The method also includes performing a terminal steaming process on the prefilled syringe, with the terminal steaming process including a first steaming cycle that exposes the syringe to steam at a set temperature and a set pressure and a second steaming cycle that exposes the syringe to steam at the set temperature and the set pressure. Performing of the terminal steaming process reduces a diameter of at least one rib of the one or more ribs, to reduce a contact pressure between the stopper and the syringe barrel.

Inventors

• RIVE, Adrien
• MILLERET, Anne
• VOIRIN, Coralie
• PERRIN, Eloïse
• RODRIGUEZ SAN JUAN, NESTOR

Assignees

• Becton Dickinson France
• Becton, Dickinson and Company

Dates

Publication Date

20260506

Application Date

20241029

Claims (16)

1. A method for manufacturing a prefilled syringe, the method comprising: providing a prefilled syringe comprising: a syringe barrel having a barrel proximal end and a barrel distal end and defining a chamber containing a fluid therein; and a stopper axially sealing the fluid in the chamber and movable within the chamber of the syringe barrel, the stopper including a main body and one or more ribs extending from an outer surface of the main body and around an outer circumference of the main body, the one or more ribs forming a sealing surface with the syringe barrel; and performing a terminal steaming process on the prefilled syringe, wherein performing the terminal steaming process comprises performing one or more steaming cycles to expose the syringe to steam at a set temperature and a set pressure; wherein performing of the terminal steaming process reduces a diameter of at least one rib of the one or more ribs, to reduce a contact pressure between the stopper and the syringe barrel.
2. The method of claim 1, wherein performing the one or more steaming cycles comprises performing a single steaming cycle.
3. The method of claim 1, wherein performing the one or more steaming cycles comprises: performing a first steam sterilization cycle to expose the syringe to steam at a set temperature and a set pressure; and performing a second steam sterilization cycle to expose the syringe to steam at the set temperature and the set pressure.
4. The method of any of claims 1-3, wherein in performing the one or more steaming cycles, the syringe is exposed to steam at a temperature of 90-200° C .
5. The method of any of claims 1-4, wherein in performing the one or more steaming cycles, the syringe is exposed to steam at a pressure of at least 2 bars and preferably 3 bars or more.
6. The method of any of claims 1-5, the one or more steaming cycles each have a duration of 10 minutes or more, preferably 20 minutes or more, more preferably 30 minutes or more, and most preferably 35 minutes or more.
7. The method of any of claims 1-6, wherein performing the one or more steaming cycles comprises performing a cooling with ventilation.
8. The method of claim 6, wherein the cooling with ventilation is performed at a temperature of 50° C and at a pressure of 3 bars.
9. The method of any of claims 1-8, wherein in performing the terminal steaming process, the diameter of the at least one rib is reduced by at least 0.1 mm, and preferably 0.1 to 0.15 mm.
10. The method of any of claims 1-9, wherein the gliding force required to advance the stopper within the syringe barrel is reduced by30-60%, and preferably 40-45%, after performing of the terminal steaming, as compared to no terminal steaming being performed.
11. The method of any of claims 1-10, wherein performing of the terminal steaming process compression sets an elastomeric material of the stopper, to reduce the diameter of the at least one rib.
12. A syringe comprising a syringe barrel and a stopper positioned therein, wherein the stopper is prepared for sliding engagement with the syringe barrel by the method of claim 1.
13. The syringe of claim 12, wherein the stopper comprises at least one rib, and wherein performing of the terminal steaming process reduces the diameter of the at least one rib.
14. The syringe of claim 12 or claim 13, wherein the syringe barrel comprises one of a siliconized glass barrel, a non-siliconized glass barrel, or a plastic barrel with or without a silicone coating.
15. The syringe of any of claims 12-14, wherein the stopper comprises a coated stopper or an uncoated stopper.
16. The syringe of claim 15, wherein the stopper is formed of butyl rubber, styrene butadiene rubber, poly isoprene rubber, liquid silicone rubber, or a thermoplastic elastomer, and wherein when the stopper comprises a coated stopper, the coating comprising silicone oil, PTFE, ETFE, polyethylene, parylene, or liquid silicone rubber.

Description

BACKGROUND OF THE INVENTION Field of the Invention The present disclosure relates generally to prefilled syringes and, more particularly, to a system and method for manufacturing prefilled syringes to reduce the gliding forces associated therewith. Description of Related Art Medical injection devices, such as syringes, are used in a variety of environments for administering liquids (e.g., medications or drugs) to a patient. Many syringes are provided as prefilled syringes, which provide the convenience of rapidly delivering the liquid therein to a patient without the need to first aspirate the medication from another container and meter its volume. For dispensing fluids, the prefilled syringe will typically include a syringe barrel with a plunger assembly inserted through an open proximal end of the barrel and an opening at the opposite distal end adapted to receive a needle therein by which a fluid is injected into the patient. The plunger assembly typically includes an elongated plunger rod extending out of the barrel, and a plunger head or stopper disposed at the distal end of the plunger rod. The stopper is typically made of an elastomeric material (preferably rubber, but possibly a thermoplastic elastomer) and is adapted to ensure the container closure integrity (CCI) of a syringe when the stopper is inserted into the syringe. Existing stopper designs include a stopper body having a tail portion disposed at its proximal end adapted for attachment to the distal end of the plunger rod, and a head portion disposed at its distal end adapted to interfit with the barrel of the syringe. The tail portion of the stopper may include a cavity formed therein configured to receive a distal head of the plunger rod, so as to engage the plunger rod with the stopper. Each of the cavity and the plunger head may be configured to provide engagement therebetween to secure the plunger rod to the stopper. The head portion of the stopper may include one or a plurality of annular, outwardly protruding ribs formed on an external cylindrical wall thereof, with the rib(s) applying a contact pressure against an inner surface of the syringe barrel to form a seal therewith that ensures the CCI of the syringe. A single rib or a series of two or three ribs may be spaced apart longitudinally along the stopper main body. It is recognized that ensuring of the CCI of the syringe is vital during both transport/storage of the syringe and use of the syringe, with it being desired to maintain an adequate contact pressure between the stopper and the syringe barrel to ensure the CCI. However, while a higher contact pressure is desirable for ensuring of the CCI of the syringe, such high contact pressure increases the friction between the stopper and inner surface of the syringe barrel and makes it more difficult to move the stopper through the syringe barrel during use of the syringe, making the syringe less user friendly. That is, a high contact pressure between the stopper and the syringe barrel increases the activation and gliding forces required to initiate movement of the plunger assembly relative to the syringe barrel and to further advance the plunger assembly distally into the syringe barrel during use. Accordingly, a need exists in the art for a prefilled syringe and method of manufacture thereof that provides sufficient contact pressure between the stopper and the syringe barrel, but that provides lower gliding forces during use of the prefilled syringe. SUMMARY OF THE INVENTION Provided herein is a method for manufacturing a prefilled syringe. The method includes providing a prefilled syringe comprising a syringe barrel having a barrel proximal end and a barrel distal end and defining a chamber containing a fluid therein, and a stopper axially sealing the fluid in the chamber and movable within the chamber of the syringe barrel, the stopper including a main body and one or more ribs extending from an outer surface of the main body and around an outer circumference of the main body, the one or more ribs forming a sealing surface with the syringe barrel. The method also includes performing a terminal steaming process on the prefilled syringe, wherein performing the terminal steaming process further comprises performing one or more steaming cycles to expose the syringe to steam at the set temperature and the set pressure. Performing of the terminal steaming process reduces a diameter of at least one rib of the one or more ribs, to reduce a contact pressure between the stopper and the syringe barrel. In certain configurations, performing the one or more steaming cycles comprises performing a single steaming cycle. In certain configurations, performing the one or more steaming cycles comprises performing a first steaming cycle to expose the syringe to steam at a set temperature and a set pressure and performing a second steaming cycle to expose the syringe to steam at the set temperature and the set pressure. In certain configurations, in