Method of packaging freeze dried vaccines in syringes and plug for implementing the method

• US 5,184,450 A
• Filed: 02/18/1992
• Issued: 02/09/1993
• Est. Priority Date: 02/15/1991
• Status: Expired due to Term

• Current Assignee: Pasteur Merieux Serums et Vaccins SA (Sanofi )
• Original Assignee: Pasteur Merieux Serums et Vaccins SA (Sanofi )
• Inventors: Galy, Michel G. H., Gomez, Alain
• Primary Examiner(s): Coan, James F.
• Application Number:
  US07/836,615
• Time in Patent Office: 357 Days
• Field of Search: 53/440, 53/489, 53/485, 53/474, 53/127, 53/237, 53/284.6, 53/319, 53/287, 604/191, 604/226, 604/228
• US Class Current: 53/440
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/31596 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: B65B 29/10 Packaging two or more different substances isolated from one another in the package but capable of being mixed without opening the package, e.g. forming packages containing a resin and hardener isolated by a frangible partition

Abstract

In a method of packaging freeze dried vaccine in a bypass syringe sterilized syringes are disposed in rows in an aseptic dispensing machine. Doses of a solution or suspension to be freeze dried are introduced into the syringes. A temporary plug is inserted in the same machine into the mouth of the syringe body in a position allowing communication between the interior of the syringe body and the exterior. The syringes are introduced into a freeze drying machine. The vaccine is freeze dried. At the end of the freeze drying cycle the temporary plug is depressed in a controlled atmosphere in the freeze drying machine into a hermetic sealing position. The syringes are transferred into an aseptic dispensing machine. The temporary plug is removed. An intermediate piston-plug is fitted. The dose of solvent is introduced and an end piston-plug is fitted.

Claims

1. Method of packaging freeze dried vaccine in a bypass syringe in which sterilized syringes are disposed in rows in an aseptic dispensing machine, doses of a solution or suspension to be freeze dried are introduced into said syringes, a temporary plug is inserted in the same machine into the mouth of said syringe body in a position allowing communication between the interior of said syringe body and the exterior, said syringes are introduced into a freeze drying machine, the vaccine is freeze dried, at the end of the freeze drying cycle said temporary plug is depressed in a controlled atmosphere in said freeze drying machine into a hermetic sealing position, said syringes are transferred into an aseptic dispensing machine, said temporary plug is removed, an intermediate piston-plug is fitted, the dose of solvent is introduced and an end terminal piston-plug is fitted.

2. Method according to claim 1 wherein said temporary plug is depressed in a controlled atmosphere in said freeze drying machine by moving a plate of said freeze drying machine.

3. Method according to claim 1 wherein said temporary plug is extracted in a laminar flow aseptic dispensing machine by means of forked fingers.

4. Method according to claim 1 wherein said temporary plugs are recycled.

5. Temporary plug for implementing a method of packaging freeze dried vaccine in a bypass syringe in which sterilized syringes are disposed in rows in an aseptic dispensing machine, doses of a solution or suspension to be freeze dried are introduced into said syringes, a temporary plug is inserted in the same machine into the mouth of said syringe body in a position allowing communication between the interior of said syringe body and the exterior, said syringes are introduced into a freeze drying machine, the vaccine is freeze dried, at the end of the freeze drying cycle said temporary plug is depressed in a controlled atmosphere in said freeze drying machine into a hermetic sealing position, said syringes are transferred into an aseptic dispensing machine, said temporary plug is removed, an intermediate piston-plug is fitted, the dose of solvent is introduced and an end terminal piston-plug is fitted, said temporary plug comprising a first part adapted to enter at least partially into said syringe body and said passages enabling communication between the interior of said syringe and the exterior environment, a second part adapted to be inserted into said syringe body in a second insertion position of said temporary plug to seal hermetically said syringe body, and a third part adapted to project to the outside in any position of said temporary plug to enable grasping of said temporary plug to remove it from said syringe body.

6. Plug according to claim 5 further comprising on said first part a plurality of ribs between which are passages for vapour and gas.

7. Plug according to claim 6 wherein said first part has a small shoulder whereby said temporary plug may be positioned initially in said syringe body.

8. Plug according to claim 5 wherein said second part has a peripheral rib or lip.

9. Plug according to claim 5 wherein said third part has a peripheral groove enabling it to be grasped by an extractor tool.