Method and device for filling a disposable injector
The invention relates to a method and a device for the sterile filling of a disposable injector with a defined dose of an injection solution, wherein the disposable injector comprises a cylinder/piston unit with a cylinder and with a piston that can be pulled back manually. The defined dose of the injection solution is stored in an interior of a container of a needle syringe held in a bored stopper. The cylinder interior is connected to the container interior in a gas-tight and liquid-tight manner through the bored stopper. The cylinder/piston unit is filled by pulling back the piston or by pressing the needle syringe piston. With the present invention, a method and a device for filling a disposable injector are developed in which, without intermediate weighing or risk of inaccurate readings, the disposable injector can be filled with a defined dose of an injection solution from a syringe with a fused-in needle.
1. A method for the sterile filling of a needleless disposable injector ( 4 ) with a defined dose of an injection solution ( 1 ) from a needle syringe ( 150 ) including a glass cylinder ( 151 ) having a fused-in needle ( 152 ), the glass cylinder ( 151 ) having a head ( 156 ) oriented in the direction of the fused-in needle ( 152 ), the disposable injector ( 4 ) comprises a cylinder/piston unit ( 100 ) with a cylinder ( 101 ) and with a single piston ( 111 ), the cylinder ( 101 ) having a cylinder interior ( 110 ), the cylinder ( 101 ) having a cylinder floor having a nozzle-like bore ( 106 ) ending in a recess ( 107 ), a closure cap ( 120 ) is removably affixed to a lower portion of the cylinder/piston unit ( 100 ), the closure cap ( 120 ) having a plate-like foot ( 129 ), the plate-like foot ( 129 ) having an integral adapter opening ( 127 ), said method comprising the steps of:
the defined dose of the injection solution ( 1 ) is initially stored in the interior ( 157 ) of a container ( 151 ) of the needle syringe ( 150 ) and the fused-in needle ( 152 ) is inserted and held in a bored stopper ( 131 ) having a bore ( 132 ) therethrough as least as long as the fused-in needle ( 152 ) prior to the fused-in needle ( 152 ) insertion, the bore ( 132 ) having a cross-section corresponding to a cross-section of the fused-in needle ( 152 ), the bored stopper ( 131 ) includes a receiving hollow ( 133 ) for receiving and holding the head ( 156 ) of the glass cylinder ( 151 ) in a gas-tight and liquid-tight and sterile manner, the bored stopper ( 131 ) prior to the sterile filling of the needleless injector ( 4 ) closes in a sterile manner the integral adapter opening ( 127 ) and simultaneously closes the recess ( 107 ) of the cylinder ( 101 ) in a sterile, gas-tight and liquid-tight manner,
the cylinder interior ( 110 ) for the sterile filling is connected to the container interior ( 157 ) in a gas-tight and liquid-tight manner through the bored stopper ( 131 ) via the fused-in needle ( 152 ), and
the cylinder/piston unit ( 100 ) is filled by pulling back the piston ( 111 ) or by pressing a needle syringe piston ( 153 ) moveable within the interior ( 157 ) of the container ( 151 ).
2. A device for the sterile filling of a needleless disposable injector ( 4 ) with a defined dose of an injection solution ( 1 ) from a needle syringe ( 150 ) including a glass cylinder ( 151 ) having a fused-in needle ( 152 ), the disposable injector ( 4 ) comprising a cylinder/piston unit ( 100 ) with a cylinder ( 101 ) and with a single movable piston ( 111 ), the cylinder ( 101 ) having a cylinder interior ( 110 ), said device comprising:
the defined dose of the injection solution ( 1 ) is stored in an interior ( 157 ) of a container ( 151 ) of the needle syringe ( 150 ), the fused-in needle ( 152 ) held in a bored stopper ( 131 ) having a bore ( 132 ) therethrough as least as long as the fused-in needle ( 152 ) prior to the fused-in needle ( 152 ) insertion, the bore ( 132 ) having a cross-section corresponding to a cross-section of the fused-in needle ( 152 ),
the bored stopper ( 131 ) comprises a receiving hollow ( 133 ),
the glass cylinder ( 151 ) having a head ( 156 ) oriented in the direction of the fused-in needle ( 152 ), and
the cylinder interior ( 110 ) is operably connectable during the sterile filling of the needleless disposable injector ( 4 ) to the container interior ( 157 ) via the fused-in needle ( 152 ), the head ( 156 ) of the glass cylinder ( 151 ) for the sterile filling of the needless disposable injector ( 4 ) is in insertable relationship within the receiving hollow ( 133 ) of the bored stopper ( 131 ) in a gas-tight and liquid-tight and sterile manner.
3. The device as claimed in claim 2 , wherein a removable pump rod ( 140 ) is secured on the piston ( 111 ).
4. The device as claimed in claim 2 , wherein the bored stopper ( 131 ) is made from a synthetic thermoplastic.
5. The device as claimed in claim 2 , wherein the needle syringe ( 150 ) comprises a movable piston ( 153 ) moveable within the interior ( 157 ) of the container ( 151 ).
6. The device as claimed in claim 5 , wherein the needle syringe ( 150 ) further comprises a piston rod ( 154 ) operably connected to the moveable piston ( 153 ).
7. The device as claimed in claim 2 , wherein the head ( 156 ) has a spherical cap shape.
8. The device as claimed in claim 7 , wherein the hollow ( 133 ) of the bored stopper ( 131 ) has a concave shape for receiving the head ( 156 ).
9. The method of claim 1 further comprising the steps of:
after the sterile filling of the needleless disposable injector ( 4 ) with a defined dose of an injection solution ( 1 ) removing the bored stopper ( 131 ) and replacing it with a sterile closure stopper ( 128 ) for closing off of the recess ( 107 ) in a sterile, gas-tight and liquid-tight manner for interim storage of the needless disposable injector ( 4 ).
10. The device as clamed in claim 2 , further comprising a sterile closure stopper ( 128 ) for interim storage of the needless disposable injector ( 4 ) after sterile filling thereof.