Method of producing prefilled sterile plastic syringes

• US 4,718,463 A
• Filed: 12/08/1986
• Issued: 01/12/1988
• Est. Priority Date: 12/20/1985
• Status: Expired due to Term

• Current Assignee: Mallinckrodt Medical Inc. (Mallinckrodt plc)
• Original Assignee: Mallinckrodt Incorporated (Mallinckrodt plc)
• Inventors: Johnson, Richard G., Jurgens, Raymond W. Jr., Nadler, Leroy R.
• Primary Examiner(s): Bell, Jr., Houston S.
• Application Number:
  US06/938,828
• Time in Patent Office: 400 Days
• Field of Search: 141/1-12, 141/85-92, 141/325, 141/326, 141/327, 141/18-29, 134/22.1, 134/169 R, 422/25-28
• US Class Current: 141/11
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• 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

There is disclosed a process for producing sterilized prefilled plastic syringes avoiding plastic deformation and distortion. The plastic barrels are subjected to repeated water jet washing steps to remove contaminants and depyrogenate the barrels. Tip seals and pistons are subjected to removal of debris and pyrogens and destruction of microbial contaminants. After the tip is assembled on the nozzle of the barrel, the barrel is filled with contrast media through its open end, after which the piston is assembled in the open end to seal the syringe and its contents. The assembled and sealed syringe is then subjected to autoclaving to sterilize the syringe and its contents, without deformation of the plastic syringe or a loss of integrity to the closed media/syringe system.

Claims

1. A method of producing a prefilled, sterile plastic syringe having a molded plastic barrel with an open end and a nozzle at the opposite end, a tip seal closing the nozzle, and a piston slidable in the barrel and sealing the open end of the barrel to retain a liquid therein;

the method comprising the steps of;

removing debris and other contaminants from the tip seal and piston;

destroying microbial contaminants on the tip seal and piston;

washing the barrel with a sequence of a multiplicity of jets of water to remove debris and pyrogens from the barrel;

applying a lubricant to the tip seal, piston and barrel;

assembling the tip seal on the nozzle of the barrel;

filling the barrel through its open end with a desired quantity of liquid material;

assembling the piston in the open end of the barrel after the filling thereof to complete the enclosure and sealing of the syringe and its contents; and

autoclaving the assembled and sealed syringe to sterilize the plastic syringe and its contents, while maintaining a pressure on the outside surfaces of the syringe at least equal to the pressure of the syringe contents during autoclaving.

2. A method as claimed in claim 1 wherein the filling of the barrel includes filing the barrel with a liquid contrast media.

3. A method as claimed in claim 1 wherein the autoclaving of the assembled and sealed syringe is performed by heating the assembled and sealed syringe to a temperature in the range of 120°

to 125°

C. to reach an F_o of approximately 20.