Method and apparatus for preparing syringes containing a lyophile medicine

• US 4,729,208 A
• Filed: 06/25/1987
• Issued: 03/08/1988
• Est. Priority Date: 12/08/1983
• Status: Expired due to Fees

• Current Assignee: Pasteur Mérieux Sérums & Vaccins
• Original Assignee: Institut Merieux (CIE Merieux Alliance SAS)
• Inventors: Genet, Alain, Galy, Michel
• Primary Examiner(s): Spruill, Robert L.
• Assistant Examiner(s): Weihrouch, Steven P.
• Application Number:
  US07/065,652
• Time in Patent Office: 257 Days
• Field of Search: 34/5, 53/154, 53/167, 53/202, 53/428, 53/432, 53/433, 53/111 R, 53/510, 53/511, 53/127, 53/319, 53/322, 53/324, 53/328
• US Class Current: 53/432
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: A61M 5/008 Racks for supporting syringes or needles A61M5/001 takes precedence

Abstract

A series of syringe bodies with their lower ends closed is filled with a solution of medicine to a predetermined level in the bodies. The syringe bodies are placed in a lyophilizer with the bodies arranged in a predetermined pattern. A plurality of plungers for the syringe bodies is arranged in a corresponding pattern and above the syringe bodies. After the medicine in the syringe bodies is lyophilized in the lyophilizer, a reduced pressure is created in the lyophilizer and the plungers are simultaneously moved into the syringe bodies to a predetermined level above the lyophilized medicine. The pressure within the lyophilizer is then increased to atmospheric and the assembled syringes are removed. Apparatus for implementing the process can include a lower rack having openings for retaining the syringe bodies in the predetermined pattern, and an upper rack seatable on the lower rack for retaining the piston portions of plungers in facing relation to, aligned with, and above the openings of the syringe bodies. A mechanism within the lyophilizer can be used to simultaneously push the plungers downwardly into the lyophile medicine-containing syringe bodies.

Claims

1. Process for simultaneously preparing a series of auto-injectable syringes containing a lyophile medicine, the syringes being of the type having a tubular body with an open upper end, and a lower end adapted to receive an injection needle, and an elongated plunger having a piston at its lower end which is insertable through the open upper end and frictionally slidable in the tubular body, said method comprising the steps of:

sealing the lower ends of a number of tubular syringe bodies with a removable seal;

positioning the syringe bodies vertically on a first flat horizontal rack so that the tubular bodies pass through holes of the first rack, and are held in the rack with their upper ends at the same level;

filling a predetermined quantity of a solution of the medicine into each tubular body through the open upper end of the body;

placing the same number of plungers in a second rack by introducing the piston ends of the plungers into holes of the second rack of a size to retain the pistons by friction;

positioning the second rack retaining the plungers on the first rack holding the syringe bodies to form an assembly in which the holes of the second rack are coaxially aligned with the holes of the first rack and the piston ends of the plungers face toward and are axially aligned with but spaced above the upper ends of the syringe bodies so the upper ends of the syringe bodies are open;

placing the assembly in a lyophilizer apparatus;

performing lyophilization on the medicine in the syringes within the lyophilizer apparatus;

then establishing a pressure lower than atmospheric pressure in the lyophilizer apparatus;

then simultaneously forcing the plungers downwardly into the syringe bodies to move the pistons to a predetermined position in the bodies, above the lyophile medicine;

then increasing the pressure in the lyophilizer to atmospheric pressure; and

then removing the medicine-containing syringes from the lyophilizer, and from the racks, without removing the plungers from the pistons;

said second rack comprising a plurality of disengageable cross-members being held in an operative position against each other by a removable clamp, said cross-members having vertical side wall along the length thereof with said vertical side walls having at spaced intervals half-holes formed therein whereby, when two of said cross-members are placed in juxtaposition, said half-holes, respectively, thereof, will face each other to define said holes of said second rack, said process further including the step of, after lyophilization, removing said medicine-containing syringes by sequentially removing said cross-members one-by-one.

2. Process according to claim 1, wherein the plungers are forced downwardly by a pressing plate in the lyophilizer apparatus.

3. Apparatus for simultaneously preparing a series of auto-injectable syringes containing a lyophile medicine, the syringes being of the type having a tubular body with an open upper end, and a lower end adapted to receive an injection needle, and an elongated plunger having a piston at its lower end which is insertable through the open upper end of and frictionally slidable in the tubular body, said apparatus comprising:

a first flat rack having rows of identical holes for receiving therein the tubular bodies of the syringes and for holding the tubular bodies generally vertically, with their upper ends at the same level;

means to hold the said first rack within a lyophilizer horizontally at a predetermined distance from a horizontal support.

a second flat rack with holes formed to correspond to each hole of the first rack when the two racks are superimposed, said holes of said second rack being of a dimension to frictionally retain a piston therein, with its plunger extending upwardly therefrom;

means for supporting the second rack within a lyophilizer at a fixed predetermined distance above the first rack with the holes of the second rack aligned with the holes of the first rack, so that said pistons enter and are forced downwardly into the tubular syringe bodies simultaneously, in response to simultaneously applying a downward force to upper ends of the plungers;

said second rack comprising a number of dismountable cross-members each having two vertical side walls and with half-holes formed in said vertical side walls and with said cross-members being mountable along side each other to extend substantially in a single plane whereby said half-holes define said holes of said second rack.

4. Apparatus according to claim 3, wherein each hole of the first rack is of a size slightly larger than the tubular syringe bodies to receive the bodies with slight play.

5. Apparatus according to claim 3, wherein the second rack is thick enough in the region of the holes for the sides of the holes to guide the pistons, during the beginning of the downward movement of the plungers, and until the pistons engage in the upper ends of the tubular syring bodies.