Pre-filled plastic syringes and containers and method of terminal sterilization thereof

• US 5,256,154 A
• Filed: 01/31/1992
• Issued: 10/26/1993
• Est. Priority Date: 01/31/1992
• Status: Expired due to Fees

• Current Assignee: Nycomed A/S (Takeda Pharmaceutical Company Limited)
• Original Assignee: Sterling Winthrop, Inc. (GlaxoSmithKline PLC)
• Inventors: Pack, Thomas M., Armbruster, Randy E., Liebert, Richard T., Brown, Neil H.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US07/829,106
• Time in Patent Office: 634 Days
• Field of Search: 604/199, 604/110, 604/218, 604/221, 604/222, 604/236, 604/238, 604/232
• US Class Current: 604/199
• CPC Class Codes: A61L 2/06 Hot gas
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61M 2005/3121 via the proximal end of a syringe, i.e. syringe end opposite to needle cannula mounting end
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 5/178 Syringes
• CPC Class Codes: A61M 5/28 Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
• CPC Class Codes: A61M 5/3145 Filters incorporated in syringes
• CPC Class Codes: A61M 5/315 Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
• CPC Class Codes: A61M 5/31505 Integral with the syringe barrel, i.e. connected to the barrel so as to make up a single complete piece or unit

Abstract

Disclosed is a pre-filled plastic syringe containing a liquid product for terminal sterilization comprising: a syringe barrel equipped with a one-way valve and a slidable plunger to equalize pressure differentials; a filter engaging the one way valve to prevent backward migration of viruses and bacteria; an end cap covering the open end of the barrel to maintain sterility; and an end cap restraining device to prevent plunger blow-out.

Claims

1. A pre-filled plastic syringe for autoclaving a sterilizable material contained therein comprising:

a barrel having a distal end terminating in a nozzle and a proximal end;

a one-way valve removably mounted onto said nozzle;

a slidable plunger in the barrel located in the proximity of the proximal end thereof;

an end cap removably connected to the proximal end of the barrel; and

an end cap restraining device removably mounted to the proximal end of the barrel over the end cap.

2. The pre-filled plastic syringe of claim 1 wherein:

said proximal end of the barrel comprises a flange; and

said end cap having a base with a flange thereon to removably engage the flange of the barrel to maintain sterility during the sliding movement of the plunger.

3. The pre-filled plastic syringe of claim 2 wherein said end cap further comprises a compressible bulb integral with the base of the end cap and extending into the barrel toward the slidable plunger and adapted to be compressed by the slidable plunger when pressure increases inside the barrel during autoclaving.

4. A pre-filled plastic syringe for autoclaving a sterilizable material contained therein comprising:

a barrel having a distal end terminating in a nozzle and a proximal end having a flange;

a one-way valve removably mounted onto said nozzle for the release of pressure generated in the syringe during autoclaving;

a slidable plunger in the barrel located in the proximity of the proximal end thereof to retain said sterilizable material and to slide toward the proximal end or distal end of the barrel in response to pressure differentials inside the barrel and the autocalve chamber;

an end cap having a base with a flange and a compressible bulb thereon sealingly connected to said flange on the proximal end of said barrel to maintain sterility during the sliding movement of the plunger, said compressible bulb integral with the base of the end cap and extending into the barrel toward the slidable plunger and adapted to be compressed by the slidable plunger when pressure increases inside the barrel during autoclaving; and

an end cap restraining device having hook-shaped means to engage the flange on the proximal end of the barrel to prevent expulsion of the plunger.

5. The pre-filled plastic syringe of claim 4 wherein said end cap comprises:

a semi-rigid base having a flange to engage the flange at the proximal end of the barrel in a mating relationship and hermetically seal said proximal end of the barrel; and

a compressible bulb portion of a highly elastomeric material extending into said barrel that compresses or expands in response to the pressure of the plunger exerted on said bulb portion.

6. A method of terminally sterilizing a material in a syringe for chemical/pharmaceutical use, said syringe comprising:

a barrel having a distal end terminating in a nozzle and proximal end having a flange;

a one-way valve removably mounted onto said nozzle for the release of pressure generated in the syringe during autoclaving;

a slidable plunger in the barrel located in the proximity of the proximal end thereof to retain said sterilizable material and to slide toward the proximal end or distal end of the barrel in response to pressure differentials inside the barrel and the autoclave chamber;

an end cap having a base with a flange and a compressible bulb thereon sealingly connected to said flange on the proximal end of said barrel to maintain sterility during the sliding movement of the plunger; and

an end cap restraining device having hook-shaped means to engage the flange on the proximal end of the barrel to prevent expulsion of the plunger, said method comprising the steps of;

mounting the one-way valve onto the nozzle of the barrel;

positioning the barrel with its proximal end up;

filling the barrel with the liquid material to be sterilized;

inserting the plunger into the barrel;

closing the proximal end of the barrel by engaging the flange of the end cap with the flange of the barrel;

securing retention of the end cap in the barrel by closing the proximal end thereof with the end cap restraining device; and

autoclaving the pre-filled assembled syringe to sterilize the liquid material therein.

7. The method of claim 6 wherein said end cap comprises:

a semi-rigid base having a flange to engage said flange at the proximal end of the barrel in a mating relationship and hermetically sealing said barrel; and

a compressible bulb portion of a highly elastomeric material extending into said barrel that compresses or expands in response to the pressure of the plunger exerted on said bulb portion.