Method for assembling and filling containers for a needleless injection device

Abstract

A method and device are for assembling and filling containers for a needleless injection device. Each container includes a tube, an upper stopper, a lower stopper and a nozzle. The containers being arranged so that, once assembled and filled with a sterile pharmaceutical formulation to be injected, the containers are subsequently introduced into an auto-injection actuator. An aseptic carousel filling method includes supplying tubes; supplying lower stoppers; placing lower stoppers, forming a tube which is closed off at the bottom. The tube is filled with a sterile formulation, forming a tube which is closed off at the bottom and filled. Upper stoppers close off the tube, forming a closed-off and filled tube. The closed-off and filled tube are placed in a nozzle to form an assembled and filled container for a needleless injection device. The assembled and filled container are then collected for an injection device.

1 . Method for assembling and filling containers for needle-free injection devices, each container comprising:
 a tube comprising a tubular wall defining an upper orifice and a lower orifice, an upper flange extending peripherally from the tubular wall around the upper orifice outwardly and optionally a lower flange extending peripherally from the tubular wall around the lower orifice, an upper cap arranged to be housed in said upper orifice and a lower cap arranged to be housed in said lower orifice,   a nozzle arranged to house said tube,   
       said containers being arranged so that, once assembled and filled with a sterile formulation for pharmaceutical use to be injected, said containers can subsequently be introduced into a self-injection actuator, 
       the aseptic filling method comprising the steps of:
 (i) supplying at least one tube of a series of tubes, 
 (ii) supplying a series of lower caps, 
 (iii) placing the lower caps, during which at least one lower cap is introduced at least partially into said lower orifice of a tube of said series of tubes to form at least one lower-sealed tube sealed by said lower cap, 
 (iv) filling said at least one lower-sealed tube by discharging said sterile formulation to be injected into said at least one lower-sealed tube to form at least one lower-sealed and filled tube, 
 (v) supplying a series of upper caps, 
 (vi) sealing the upper orifice of said lower-sealed and filled tube by introducing at least partially at least one cap of said series of upper caps into the upper orifice of said at least one lower-sealed and filled tube to form at least one sealed and filled tube, 
 (vii) supplying a series of nozzles, 
 (viii) placing said at least one sealed and filled tube into at least one nozzle of said series of nozzles, to form at least one assembled and filled container for needle-free injection devices, and 
 (ix) collecting said at least one assembled and filled container for injection devices, 
 
       said steps (iii), (iv), (vi) being carried out consecutively by at least one movement of said at least one tube along a movement trajectory passing through a lower capping area and/or a filling area and an upper capping area, said movement of said at least one tube being carried out by rotating, at least one rotating carousel comprising a plate provided with a series of housings each provided with at least one through orifice and an upper wall, said at least one supplied tube being arranged in a housing, said rotation of said carousel being arranged to move said at least one tube along said movement trajectory. 
     
     
         2 . Method according to  claim 1 , wherein said supply of a series of tubes is carried out according to the steps of:
 a) Supplying a conveyor using tubs each comprising a nest in which tubes are arranged through orifices in the nest,   b) Picking up the nest provided with these tubes with a first robotic arm, during which the upper flanges of the tubes rest on an upper surface of the nest, and placing the nest on a surface of a centring table after which the lower flanges of the tubes rest on said surface and a portion of the tubular wall of the tubes is exposed protruding through the nest orifices,   c) Picking up at least one tube by gripping with a clamp positioned on a second robotic arm, moving the tube by moving the robotic arm and placing said tube in a housing of said carousel.   
     
     
         3 . Method according to  claim 1 , wherein each of the areas selected from the supplying area, the lower capping area, the filling area the upper capping area and the collecting area, is occupied by a housing of said series of housings of the carousel, so that rotating the carousel allows the housings of the series of housings to move from one area to another. 
     
     
         4 . Method according to  claim 3 , wherein the number of housings of the series of housings is equal to or greater than 2 corresponding to the minimum number of areas. 
     
     
         5 . Method according to  claim 3 , wherein the number of housings of the series of housings is greater than 5 and wherein a housing of said series of housings is positioned between two areas selected from the supplying area, the lower capping area, the filling area, the upper capping area and the collecting area, provided with or without a tube. 
     
     
         6 . Method according to  claim 1 , wherein each sealed and filled tube positioned in the collecting area is collected with a third robotic arm provided with gripping means, and is conveyed by the third robotic arm into a tray comprising a series of positions occupied by nozzles at the predetermined position of said tube on the nozzle to which said tube is assembled to form an assembled and filled container for needle-free injection devices. 
     
     
         7 . Method according to  claim 6 , wherein the tray comprising assembled and filled containers for needle-free injection devices is placed into a tub by moving means, by comprising a fourth robotic arm or a conveyor. 
     
     
         8 . Method according to  claim 2 , wherein each sealed and filled tube is then positioned in a nozzle placement area where a nozzle is connected to said sealed and filled tube by supplying a nozzle with a nozzle provided with a head moving from the bottom upwards and the head of which, provided with the nozzle in the bottom position, moves vertically upwards to place the nozzle when the head is in the top position and form said assembled and filled container for needle-free injection devices and returns to the bottom position without the nozzle, said nozzle being positioned under the carousel. 
     
     
         9 . Method according to  claim 1 , wherein the lower capping is carried out in the lower capping area by supplying a lower cap using a first piston provided with a piston head moving from the bottom upwards and the piston head of which, provided with the cap in the bottom position, moves vertically upwards into the lower orifice of said housing of the tube to place the lower cap therein when the head is in the top position and form said lower-sealed tube, and returns to the bottom position without said lower cap, said first piston being positioned under the carousel. 
     
     
         10 . Method according to  claim 1 , wherein the filling of said at least one lower-sealed tube is carried out by discharging said sterile formulation to be injected into said at least one lower-sealed tube using a filling needle arranged to discharge a predetermined amount at a flow rate such that the predetermined amount is discharged during a residence time T which is shorter than or equal to the residence time of the lower-sealed tube in the filling area, to form said at least one lower-sealed and filled tube, said filling needle being positioned above the carousel. 
     
     
         11 . Method according to  claim 10 , wherein said filling needle is slidable and has a top resting position and a bottom filling position. 
     
     
         12 . Method according to  claim 1 , wherein the upper capping is carried out in the upper capping area by supplying an upper cap using a second piston provided with a piston head moving from the top downwards and the piston head of which, provided with the upper cap in the top position, moves vertically downwards into the upper orifice of said lower-sealed and filled tube to place the upper cap therein when the head is in the bottom position and form said sealed and filled tube, and returns to the top position without said upper cap, said second piston being positioned above the carousel. 
     
     
         13 . Method according to  claim 1 , wherein the steps are carried out consecutively by continuously moving the plate of said carousel. 
     
     
         14 . Method according to  claim 1 , wherein the steps are carried out consecutively by discontinuously moving the plate of said carousel. 
     
     
         15 . Method for assembling and filling containers for needle-free injection devices, each container comprising:
 a tube comprising a tubular wall defining an upper orifice and a lower orifice, an upper flange extending peripherally from the tubular wall around the upper orifice outwardly and a lower flange extending peripherally from the tubular wall around the lower orifice, an upper cap arranged to be housed in said upper orifice and a lower cap arranged to be housed in said lower orifice, a nozzle arranged to house said tube, said containers being arranged so that, once assembled and filled with a sterile formulation to be injected, said containers can be introduced into a self-injection actuator,   
       said device being comprising:
 a rotating carousel comprising a plate provided with a series of housings each provided with at least one through orifice, 
 means for rotating said plate arranged to rotate the plate around an axis of rotation, 
 a supply for a series of tubes arranged to supply at least one tube of said series of tubes in at least one housing of said carousel, 
 a supply for a series of lower caps, located under said plate and arranged to supply a lower cap at least partially into the lower orifice of a tube of said series of tubes to form at least one lower-sealed tube sealed by said lower cap, 
 filling means for said at least one lower-sealed tube, located above said plate and arranged to discharge said sterile formulation to be injected into said at least one lower-sealed tube to form at least one lower-sealed and filled tube, 
 a supply fora series of upper caps located above said plate and arranged to seal the upper orifice of said lower-sealed and filled tube by introducing at least partially at least one cap of said series of upper caps into the upper orifice of said at least one lower-sealed and filled tube to form at least one sealed and filled tube, a supply for at least one nozzle arranged to supply a nozzle to be connected to said at least one sealed and filled tube, and 
 collecting means for said at least one assembled and filled container for injection devices. 
 
     
     
         16 . Device according to  claim 15 , wherein said supply for a series of upper caps is located in an upper capping area and comprises a vibrating bowl arranged to contain a series of upper caps and position the upper caps in an insertion position, a second piston provided with a piston head arranged to move from the top downwards and introduce said at least one upper cap into the upper orifice of said at least one tube of said series of tubes, and a conveyor connected to said vibrating bowl and to said second piston, said conveyor being arranged to supply said at least one upper cap in the insertion position to said piston head of said second piston. 
     
     
         17 . Device according to  claim 15 , wherein said supply for a series of lower caps is located in a lower capping area and comprises a vibrating bowl arranged to contain a series of lower caps and position the lower caps in an insertion position, a first piston provided with a piston head arranged to move from the bottom upwards and introduce said at least one lower cap into the lower orifice of said at least one tube of said series of tubes and a conveyor connected to said vibrating bowl and to said first piston, said conveyor being arranged to supply said at least one lower cap in the insertion position to said piston head of said first piston. 
     
     
         18 . Device according to  claim 15 , wherein the filling means for said at least one lower-sealed tube comprises a sterile injectable solution tank and a filling needle connected to said sterile injectable solution tank by a supply duct, said needle being arranged to discharge a predetermined amount at a flow rate such that the predetermined amount is discharged during a residence time T which is shorter than or equal to the residence time of the lower-sealed tube in the filling area, said filling needle being positioned above the plate of the carousel. 
     
     
         19 . Device according to  claim 15 , wherein the supply for a series of tubes arranged to supply at least one tube of said series of tubes in at least one housing of said carousel comprises:
 a conveyor of tubs each comprising a nest in which the tubes are arranged through the nest orifices, said conveyor being arranged to supply said tubs to a nest supplying area,   a first robotic arm arranged to pick up a nest provided with the tubes and place the nest on a centring table comprising an upper surface, the lower flanges of the tubes resting on said surface and a portion of the tubular wall of the tubes being exposed protruding through the nest orifices when the nest is placed on said centring table,   a second robotic arm arranged to pick up at least one tube by gripping the exposed protruding tubes.   
     
     
         20 . Device according to  claim 18 , wherein said filling needle is slidable and has a top resting position and a bottom filling position. 
     
     
         21 . Device according to  claim 16 , wherein said supply for at least one nozzle arranged to supply a nozzle to be connected to said at least one sealed and filled tube comprises a third robotic arm provided with a clamp, arranged to pick up each sealed and filled tube positioned in the collecting area and convey the sealed and filled tube into a tub comprising a series of positions occupied by nozzles at the predetermined position of said tube on the nozzle to be assembled to form an assembled and filled container for needle-free injection devices. 
     
     
         22 . Device according to  claim 15 , wherein said supply for at least one nozzle arranged to supply a nozzle to be connected to said at least one sealed and filled tube comprises a supply for at least one nozzle by a nozzle provided with a head moving from the bottom upwards and the head of which, provided with the nozzle in the bottom position moves vertically upwards to place the nozzle when the head is in the top position and form said assembled and filled container for needle-free injection devices in a nozzle placement area of the carousel and returns to the bottom position without the nozzle, said nozzle being positioned under the carousel, and wherein said collecting means comprise a third robotic arm provided with a clamp, arranged to pick up an assembled and filled container and convey the assembled and filled container into a tray.