Process and apparatus used in producing prefilled, sterile delivery devices

• US 5,373,684 A
• Filed: 12/14/1992
• Issued: 12/20/1994
• Est. Priority Date: 12/14/1992
• Status: Expired due to Term

• Current Assignee: Mallinckrodt Medical Inc. (Mallinckrodt plc)
• Original Assignee: Mallinckrodt Medical Inc. (Mallinckrodt plc)
• Inventors: Vacca, Rita D.
• Primary Examiner(s): Sipos, John
• Assistant Examiner(s): Moon, Daniel
• Application Number:
  US07/988,265
• Time in Patent Office: 736 Days
• Field of Search: 53/425, 53/426, 53/440, 53/471, 53/467, 141/18, 141/25, 141/92, 206/365, 220/661, 222/388, 604/218, 604/236, 604/238
• US Class Current: 53/425
• CPC Class Codes: A61M 2005/3104 Caps for syringes without needle
• CPC Class Codes: A61M 2005/3123 having air entrapping or venting means, e.g. purging channels in pistons
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/31515 Connection of piston with piston rod
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like

Abstract

A process and apparatus used in manufacturing prefilled, sterile delivery devices such as syringe assemblies. The process includes sealing a syringe container portion at both ends and filling the same through a port provided in the container portion between the two ends. After filling, the port is closed and sealed and the syringe assembly is sterilized to provide a sterile delivery device with sterile contents. A suitable syringe container portion for producing prefilled, sterile delivery devices is also disclosed.

Claims

1. A method of producing a prefilled, sterile delivery device having a container portion with a sealed tip end and an opposite open end, and a piston positioned within said open end and slidable in sealing engagement with the container portion to retain a fluid therein;

the method comprising the steps of;

forming a container portion with a sealed tip at one end, an open opposite end adapted to receive a piston, and a port disposed between the sealed tip end and the open opposite end through which the container portion can be filled with a desired quantity of fluid material;

removing debris and other contaminants from the piston;

removing debris from the container portion;

assembling the piston in the open end of the container portion so that the piston is disposed at a position between the port and the open end of the container portion;

filling the container portion through the port with the desired quantity of fluid material while the piston remains in said position within the container portion;

closing and sealing said port after said filling step to provide a sealed container portion with the fluid material sealed therein between the piston and the sealed tip of the container portion; and

sterilizing the assembled and sealed delivery device to provide a sterile delivery device with sterile fluid contents.

2. A method as claimed in claim 1, wherein the step of forming a container portion with a sealed tip end comprises attaching a tip seal separate from the container portion to said one end of the container portion.

3. A method as claimed in claim 1, wherein the filling step comprises filling the container portion with a medical fluid.

4. A method as claimed in claim 1, wherein the sterilizing step comprises autoclaving the assembled and sealed delivery apparatus.

5. A method as claimed in claim 1, wherein the step of forming a container portion comprises forming a molded plastic barrel.

6. A method as claimed in claim 5, wherein the sterilizing step comprises autoclaving the assembled and sealed delivery apparatus.

7. A method as claimed in claim 6, wherein the autoclaving step is performed by heating the assembled and sealed delivery apparatus to a temperature in the range of 120°

to 125°

C.

8. A method as claimed in claim 6, wherein the autoclaving step is performed while maintaining a pressure on the outside of the container portion which is at least equal to the pressure of the contents of the container portion during the autoclaving.

9. A method as claimed in claim 6, wherein the step of forming a container portion with a sealed tip end comprises attaching a tip seal separate from the container portion to said one end of the container portion.

10. A method of producing a prefilled sterile delivery device having sterile contents, the method comprising steps of:

a) forming a container having a sealed nozzle end, an open opposite end, and a filling port disposed in the container between said sealed nozzle end and said open opposite end;

b) positioning a piston into the open opposite end of said container so as to be located in a position between the filling port and the open opposite end, wherein the piston seals said open opposite end and is slidable therein, the container defining a sealed storage volume between said sealed nozzle end and said piston;

c) inspecting the position of said piston in said open opposite end of the container to insure that the piston will properly seal medical fluid contained in said storage volume;

d) filling the container through said filling port with medical fluid while the piston remains in said position in the open opposite end of the container until said storage volume contains a desired amount of the fluid;

e) closing and sealing said filling port to sealingly enclose the medical fluid within said storage volume between the piston and the sealed tip of the container portion; and

f) sterilizing the filled, sealed container to provide a prefilled sterile delivery device containing sterile medical fluid therein.

11. A method according to claim 10, wherein the filled, sealed container is sterilized by autoclaving.

12. A method according to claim 10, wherein the sealed nozzle end of said container is formed by attaching a tip seal separate from the container to the nozzle end of said container.