Method and apparatus to insert stoppers into prefilled syringes

• US 20060168916A1
• Filed: 11/05/2004
• Published: 08/03/2006
• Est. Priority Date: 11/05/2004
• Status: Abandoned Application

• Current Assignee: Basho Technologies Incorporated
• Original Assignee: Basho Technologies Incorporated
• Inventors: Rink, Markus, Stroeter, Bernd, Griebel, Robert Andree Emil, Manz, Stefan, Bausch, Ernst Wilhelm
• Application Number:
  US10/982,373
• Publication Number:
  US 20060168916A1
• Time in Patent Office: Days
• US Class Current: 53/489
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 7/2821 applying plugs or threadless stoppers for bottles or jars B67B1/04

Abstract

An apparatus and method for inserting a stopper into a medical syringe minimizing the amount of entrapped air between the stopper and the contained liquid. The apparatus in a first embodiment utilizes a vacuum to assist inserting the stopper within the syringe. In a second embodiment a vacuum is used to transport the stopper and cause the insertion into the syringe. This method eliminates a mechanical device that transports the stopper to the syringe.

Claims

1. An apparatus for inserting stoppers into prefilled syringes comprising:

(a) a stopper tube movement within a base;

(b) a stopper tube attached to the stopper tube movement;

(c) at least one radial vacuum port in the stopper tube, said ports connecting to a vacuum means;

(d) a sealing element attached to the circumference of the stopper tube;

(e) a stopper ram movement within the base, mounted adjacent to the stopper tube movement;

(f) a stopper ram affixed to the stopper ram movement, aligned within the stopper tube; and

(g) stoppers temporarily affixed to the stopper ram movement, wherein sequential timed motion of the stopper tube movement and the stopper ram movement, with vacuum application, inserts the stoppers into the syringe above a prefilled liquid.

2. The apparatus of claim 1 wherein the apparatus comprises two or more of the following elements:

stopper tubes, stoppers, sealing elements, stopper rams, and syringes;

thereby able to insert stoppers into multiple syringes simultaneously.

3. The apparatus of claim 1 wherein the vacuum application to insert the stoppers is between 0.01 and 4 seconds duration and to an absolute pressure of 0.01 to 300 millibars.

4. A method for inserting stoppers into prefilled syringes in an apparatus comprising a stopper tube having a vacuum means port and a sealing element, a stopper tube movement affixed to the stopper tube, a stopper ram, and a stopper ram movement affixed to the stopper ram, the method comprising the steps of:

(a) inserting the stopper into the stopper tube above the vacuum means port by lowering the stopper ram movement, stopper tube movement and attached stopper;

(b) lowering the stopper tube movement and the stopper ram movement until the sealing element seals against the syringe thereby creating a vacuum chamber including the syringe and stopper tube;

(c) evacuating the chamber to a vacuum;

(d) lowering the stopper ram and stopper below the vacuum means port and out of the stopper tube into the syringe;

(e) venting to atmospheric pressure, the stopper tube and space above the stopper thereby forcing the stopper to a position close to a prefilled liquid; and

then

(f) raising the stopper ram and stopper tube up to the home position immediately prior to step (a).

5. The method of claim 4 wherein the chamber is evacuated for a period between 0.01 and 4 seconds to an absolute pressure of 0.01 to 300 millibars.

6. The method of claim 4 wherein the apparatus comprises two or more of the following elements:

stopper tubes, stoppers, sealing elements, stopper rams, and syringes;

thereby able to insert stoppers into multiple syringes simultaneously.

7. An apparatus for inserting stoppers into prefilled syringes using a vacuum, the apparatus comprising:

(a) a stopper tube movement within a base;

(b) a stopper tube attached to the stopper tube movement;

(c) at least one radial vacuum port in the stopper tube, said ports connecting to vacuum means;

(d) a sealing element attached to the circumferences of the stopper tube;

(e) stopper transport device having a first end attached to the top of the stopper tube; and

(f) means for feeding stoppers into a second end of the stopper transport device, wherein sequential operation of the stopper tube movement and application of vacuum and atmospheric pressure inserts the stoppers into the syringes.

8. The apparatus of claim 7 wherein the apparatus comprises two or more of the following elements:

stopper tubes, stoppers, sealing elements, syringes, and stopper transport devices, thereby able to insert stoppers into multiple syringes simultaneously.

9. The apparatus of claim 7 wherein the vacuum application is to an absolute pressure of between 0.01 and 800 millibars.

10. A method for inserting stoppers into prefilled syringes in an apparatus comprising a stopper tube having a vacuum means port and a sealing element, a mechanical arm affixed to the stopper tube, and a stopper transport device affixed to the top of the stopper tube, the method comprising the steps of:

(a) lowering the mechanical arm and stopper tube until the sealing element seals at the top of the syringe;

(b) feeding a stopper into an open end of the stopper transport device;

(c) activating a vacuum in the stopper tube, syringe and transport device thereby transporting the stopper to the top of the stopper tube;

(d) activating a higher vacuum in the stopper tube and syringe thereby inserting the stopper into the syringe above a prefilled liquid; and

then

(e) raising the mechanical arm and stopper tube up to the home position immediately prior to step (a).

11. The method of claim 10 wherein the apparatus comprises two or more of the following elements:

stopper tubes, stoppers, sealing elements, syringes, and stopper transport devices, thereby able to insert stoppers into multiple syringes simultaneously.

12. The method of claim 10 wherein a step is added after step (d) to increase the pressure in the stopper tube transport device thereby forcing the stopper further into the syringe.

13. The method of claim 10 wherein the actuating vacuum of step (c) is between 10 and 800 millibars.

14. The method of claim 10 wherein the actuating higher vacuum of step (d) is between 0.01 and 300 millibars.