AU2010246344A1 - Method and machine for the preparation of pharmaceutical products - Google Patents

Abstract

The preparation of pharmaceutical products is 5 carried out in a machine provided with at least one store (4, 6) for storing syringes (5) and/or bottles (7), a dosing station (36) for transferring at least one pharmaceutical between a syringe (5) and a bottle (7), two containers (87a, 87b) for collecting the processing 10 waste, and a gripping and transporting device (10) for transferring the syringes (5) and/or bottles (7) between the store (4, 6) and the dosing station (36) and for selectively feeding the processing waste into the two containers (87a, 87b). Main figure: 15

Description

AUSTRALIA Patents Act COMPLETE SPECIFICATION (ORIGINAL) Class Int. Class Application Number: Lodged: Complete Specification Lodged: Accepted: Published: Priority Related Art: Name of Applicant: Health Robotics S.r.l. Actual Inventor(s): Paolo Giribona, Walter Bianco, Michele Minisini, Garcia Gaspar De Viedma Santoro Address for Service and Correspondence: PHILLIPS ORMONDE FITZPATRICK Patent and Trade Mark Attorneys 367 Collins Street Melbourne 3000 AUSTRALIA Invention Title: METHOD AND MACHINE FOR THE PREPARATION OF PHARMACEUTICAL PRODUCTS Our Ref : 901035 POF Code: 1545/505962 The following statement is a full description of this invention, including the best method of performing it known to applicant(s): 2 METHOD AND MACHINE FOR THE PREPARATION OF PHARMACEUTICAL PRODUCTS This application claims priority from US 5 Application No. 12/870,878 filed on 30 August 2010, the contents of which are to be taken as incorporated herein by this reference. DESCRIPTION 10 The present invention relates to a machine for the preparation of pharmaceutical products. A machine is known in the pharmaceutical product preparation field comprising a store for storing syringes; a store for storing bottles; a store for 15 storing infusion bags; a dosing station for the preparation of a pharmaceutical product obtained by mixing at least one pharmaceutical substance contained in a bottle and at least one diluent contained in an infusion bag with one another; a robotized gripping and 20 transporting arm for transferring the syringes and/or bottles and/or infusion bags between the dosing station and the respective stores; a feeding device for feeding a diluent into a bottle containing a lyophilized or powdered pharmaceutical; a picking device of a 25 predetermined amount of diluent from the infusion bags; and a station for collecting the processing waste of the 3 machine. Generally, the collection station is provided with a container, in which the processing waste, e.g. syringes, bottles, bottle seals, needles and needle 5 protection caps, is stored without being separated. Since the processing waste of the known machines for the preparation of pharmaceutical products is not separated, the disposal of the processing waste is made according to the methods required for disposing the most 10 dangerous processing waste and is thus relatively complex and costly. It is an object of the present invention to provide a machine for the preparation of pharmaceutical products which is free from the above-described drawbacks and 15 which is simple and cost-effective to be implemented. According to the present invention, there is provided a machine for the preparation of pharmaceutical products as disclosed in claims from 1 to 3. The present invention further relates to a method 20 for the preparation of pharmaceutical products. According to the present invention, there is provided a method for the preparation of pharmaceutical products as disclosed in claim 4. The present invention will now be described with 25 reference to the accompanying drawings, which illustrate a non-limitative embodiment thereof, in which: 4 figure 1 is a diagrammatic perspective view, with parts removed for clarity, of a preferred embodiment of the machine according to the present invention; figure 2 is a diagrammatic perspective view, with 5 parts removed for clarity, of a first detail of the machine in figure 1; figure 3 is a diagrammatic perspective view, with parts removed for clarity, of a detail in figure 2; figure 4 is a diagrammatic perspective view, with 10 parts removed for clarity, of a second detail of the machine in figure 1; figure 5 is a diagrammatic perspective view, with parts removed for clarity, of a third detail of the machine in figure 1; 15 figure 6 is a diagrammatic perspective view, with parts removed for clarity, of a detail in figure 5; figure 7a is a diagrammatic perspective view, with parts removed for clarity, of a fourth detail of the machine in figure 1; 20 figure 7b is a perspective view of a detail in figure 7a; figure 8 is a schematic perspective view, with parts enlarged and parts removed for clarity, of a fifth detail of the machine in figure 1; 25 figure 9 is a diagrammatic front view, with parts removed for clarity, of the detail in figure 8; 5 figure 10 is a diagrammatic perspective view, with parts removed for clarity, of a sixth detail of the machine in figure 1; figure 11 is a diagrammatic perspective view, with 5 parts removed for clarity, of a seventh detail of the machine in figure 1; figure 12 diagrammatically shows the operating principle of the detail in figure 11; figure 13 is a diagrammatic perspective view, with 10 parts removed for clarity, of an eighth detail of the system in figure 1 shown in two different operating positions; figure 14 diagrammat'idally shows the operating principle of the detail in figure 13; and 15 figure 15 is a diagrammatic perspective view, with parts removed for clarity, of a ninth detail of the machine in figure 1. With reference to figure 1, numeral 1 indicates as a whole a machine for the preparation of pharmaceutical 20 products comprising a substantially parallelepiped containment box-like frame 2-defining an inner chamber 3, which is maintained in substantially sterile conditions by a pneumatic device of known type, shaped so as to feed a flow of sterile air through the chamber 25 3 and prevent the introduction of air from the external environment into the chamber 3.

The chamber 3 accommodates therein a store 4 for storing syringes 5; a store 6 for storing bottles 7; an annular store 8 for storing infusion bags 9; and a robotized gripping and transporting device 10 of the 5 syringes 5 and/or of the bottles 7. Each syringe 5 (figure 3) has a longitudinal axis 11, and comprises a cylinder 12 provided with an end flange 13 orthogonal to axis 11, a needle (not shown) coupled to the cylinder 12, a closing cap 14 mounted to 10 protect the needle (not shown) from possible contaminations, and a piston 15, which is slidingly engaged in the cylinder 12, and is provided with an end head 16 perpendicular to axis 11. Each bag 9 is provide'dWith an adapter member 17 of 15 known type, which comprises two shaped jaws 18, mobile between a clamping position and a releasing position of an upper edge of the bag 9, and has a drawing pin 19 protruding upwards from one of the jaws 18 (figure 5). As shown in figures 1, 3, and 4, the device 10 is 20 mounted within the store 8, comprises a plurality of jointed arms 20 hinged to one another, and provided with a gripping arm 21, which is' mounted on the free end of the arms 20, and is defined by two jaws 22 mobile between a clamping position and a releasing position of 25 a syringe 5 or a bottle 7. With reference to fiejere 2, each store 4, 6 7 comprises two reciprocally parallel belt conveyors 23, each of which extends in a substantially vertical direction A, faces the other conveyor 23, and is looped about a pair of pulleys (not shown), which are coaxial 5 with the pulleys (not shown) of the other conveyor 23, and are mounted so as to intermittently rotate about respective rotation axis 24 parallel to one another and transversal to direction A. Each store 4, 6 further comprises a plurality of 10 transport cradles 25, which extend between the conveyors 23, are coupled to the conveyors 23 to oscillate, with respect to conveyors 23, 'about respective axes 26 with fulcrum parallel to one another and to axes 24, and which are uniformly distributed along the conveyors 23 15 themselves. As shown in figure 3, each cradle 25 of the store 4 (hereinafter indicated by numeral 25a) has a substantially V-shaped transversal section, is arranged with an axis 27a thereof parallel to axes 24, 26, is 20 provided with a first slot 28 adapted to receive the flange 13 of a syringe 5 to guarantee the correct longitudinal positioning of the syringe 5 in the cradle 25a, and further has a second slot 29 adapted to be engaged by the jaws 22 to allow the device 10 to pick 25 the syringe 5 from the cradle 25a itself. With reference to figure 4, each cradle 25 of the 8 store 6 (hereinafter indicated by numeral 25b) has a substantially V-shaped transversal section, is arranged with a longitudinal axis thereof 27b inclined with respect to axis 24, 26, and is provided with a slot 30, 5 which is obtained near the lower end of the cradle 25b, allows to correctly position a bottle 7 with its concavity facing downwards, and allows the jaws 22 to pick the bottle 7 itself. Each store 4, 6 extends through a loading station 10 obtained through the frame 2 to allow the operator to load the syringes 5 or bottles 7 into the respective cradles 25a, 25b, and through a single picking station, where the syringes 5 or the' bottles 7 are picked from the respective cradles 25a, 25b by the device 10, and 15 for this reason the device 10 is relatively simple and cost-effective. Furthermore, the loading and unloading of the syringes 5 and of the bottles 7 in, and respectively from, the respective cradles 25a, 25b does not require the machine 1 to be stopped at all. 20 As shown in figures 5 and 6, the store 8 comprises an annular, star-shaped wheel 31, which extends about the device 10, is mounted to rotate intermittently, with respect to the frame 2 and under the bias of an actuating device (known and not shown), about a 25 substantially vertical rotation axis 32, and has a plurality of pockets 33, 'which are obtained along a 9 peripheral edge of the wheel 31, open radially outwards and are each adapted to receive and withhold a respective infusion bag 9. The pockets 33 are fed by the wheel 31 about axis 5 32 and along a circular path P extending through a loading and unloading station 34 of the bags 8 into, and respectively from, the store 8, a weighing station 35 of the bags 9, and a dosing station 36 for injecting a predetermined amount of pharmaceutical into the bags 9 10 themselves. Each station 34, 35, 36 is provided with a linear transfer device 37 comprising a rectilinear guide 38 parallel to a horizontal direction 39 transversal to axis 32, a slide 40 slidingly coupled to the guide 38 to 15 perform rectilinear movements along the guide 38 in direction 39, and a gripping fork 41 slidingly coupled to a slide 40 to move, with respect to the slide 40 and transversally to direction 39, between a coupling position and a releasing position of the pin 19 of a 20 respective adapter member 17 The device 37 from station 34 cooperates with a guide 42, which is parallel to the respective guide 38, is radially aligned with the pocket 33 arranged each time in station 34 to be slidingly engaged by the member 25 17 of a respective pocket 9, and extends between the store 8 and an opening 43 obtained through the frame 2 10 to allow an operator to load the bags 9 on the guide 42 and to pick the bags 9 from the guide 42 itself. With reference to figures 7a and 7b, device 37 of station 35 cooperates with a weighing device 44 5 comprising a supporting mobile member 45, which is coupled in known manner to a fixed part of the device 44 to move vertically under the weight of the bags 9, is fork-shaped and defines a guide 46 radially aligned with the pocket 33 arranged on eadh time in station 35 to be 10 slidingly engaged by the member 17 of a respective bag 9. The device 37 of station 36 cooperates with a guide (not shown), which is parallel to the respective guide 38, is radially aligned with the pocket 33 arranged each 15 time in station 36 to be slidingly engaged by the member 17 of a respective bag 9, and is adapted to stop the bag 9 itself underneath a syringe 5, which is transferred from the device 10 between' the store 4 and a gripping and actuating assembly 47 of the syringe 5 itself. 20 As shown in figures 8 and 9, the assembly 47 comprises a supporting block 48, which is mounted to rotate about a horizontal rotation axis 49 transversal to axis 32, and supports a gripping device 50 of the cylinder 12 and a gripping device 51 of the piston 15. 25 The device 50 comprises two grippers 52, which are reciprocally aligned in a direction 53, the orientation 11 of which depends on the position of the block 48 about axis 49, and each comprise two respective jaws 54, which are slidingly coupled to the block 48 to move, with respect to the block 48 itself, transversally to 5 direction 53, and are normally maintained in a clamping position of the cylinder 12 by respective springs 55 arranged between the block 48 and the jaws 54 and loaded so as to allow the axial movement of the syringe 5 through the grippers 52. 10 The device 50 further comprises an intermediate gripper 56, which extends between the grippers 52, and comprises, in turn, two jaws 57 slidingly coupled to the block 48 to move with respect to the block 48 and under the bias of an actuating device (known and not shown), 15 transversally to direction 53 between a clamping position and a releasing position of the cylinder 12 of a syringe 5. With regards to the above, it is worth noting that the jaws 57 are shaped so as to allow one of the jaws 57 20 to be inserted inside the other jaw 57 and also to clamp syringes 5 of relatively small diameter. The device 51 comprises two jaws 58, which are slidingly coupled to the block 48 to move with respect to the block 48 and under the bias of an actuating 25 device (known and not shown), transversally to direction 53 between a clamping position and a releasing position 12 of the head 16 of a syringe 5, and are further slidingly coupled to the block 48 to perform rectilinear movements in direction 53 itself with respect to the block 48 and under the bias of an actuating device (known and not 5 shown) . Each jaw 58 has a plurality of grooves 59 (two grooves 59, in the case in point) superimposed on one another in direction 53 to allow the device 51 to receive and withhold the heads 16 of syringes 5 of different size. 10 The operation of the assembly 47 will now be described starting from an instant in which the jaws 57 and the jaws 58 are arranged in their releasing positions and the syringe 5 is inserted by the device 10 within the jaws 54 against the bias of the springs 55. 15 Once the syringe 5 is inserted within the grippers 52, the jaws 58 are firstly closed over the head 16 and then lowered in direction 53 so as to move the syringe 5 through the grippers 52, arrange the flange 13 in contact with the upper jaw 52 and, possibly, push the 20 piston 15 fully into the cylinder 12. The operating sequence shown above allows to correctly position the syringe 5 in direction 53 and guarantees a correct, constant positioning of all syringe 5 regardless of the -sitze thereof, of the initial 25 position of the -istons -15 along the respective cylinders 12, and of the axial, initial angular 13 positions of the syringes 5 in the grippers 52. Finally, the jaws 57 are moved from the clamping position thereof of the syringe 5 within the assembly 47, and the jaws 58 are moved to the clamping position 5 thereof of the head 16 for controlling the movement of the piston 15 during the steps of aspirating and injecting of the pharmaceutical. With reference to figure 10, the machine 1 further comprises a mixer device 60 for mixing a lyophilized or 10 powder pharmaceutical and .a diluent contained in a bottle 7 to one another. The device 60 comprises a rotating plate 61, which is mounted to alternatively rotate about a substantially horizontal rotation axis 62',-Iand is provided with a pair 15 of jaws 63 coupled in known manner to the plate 61 to move, with respect to the plate 61, transversally to the axis 62, between a clamping position and a releasing position of a bottle 7. Each jaw 63 is shaped so as to display, in the case in point, a pair of seats 64, which 20 cooperate with corresponding seats 64 of the other jaw 63 to allow the jaws 63 to withhold bottles 7 of different size. As shown in figures 11 and 12, the path P further extends through a picking station 65 of a predetermined 25 amount of liquid from the bags 9. The picking of the liquid of bag 9 is necessary when the total weight of 14 the pharmaceutical and of the diluent contained in the bag 9 after having injected the pharmaceutical needs to be equal to a determined value lower than the weight of the diluent initially contained in the bag 9 itself 5 alone. The station 65 has an aspiration assembly 66 comprising a gripping device 67 adapted to receive and withhold an extraction needle 68, which is connected to a hydraulic aspiration circuit 69, is transferred by the 10 device 10 in the device 67 after having been separated from a protective cap thereof (known and not shown), and is moved by the device 67 in direction A between a raised resting position, in which the needle 68 is arranged outside the bag 9, and a lowered operating 15 position, in which the needle 68 protrudes within the bag 9 over the diluent contained in the bag 9 itself. The circuit 69 comprises an extraction pump 70, a peristaltic pump in the case in point, having an inlet hydraulically connected to the needle 68 by means of a 20 first pipe 71, and an outlet hydraulically connected to a collection reservoir 72 of the diluent picked from the bags 9 by means of a second pipe 73. The bags 9 contain a determined amount of air, and for this reason the pipe 71 is provided with a flow 25 sensor 74, a capacitance sehsor in the case in point, which allows to discriminate between the passage of air 15 and of liquid along the pipe 71, and thus correctly calculate the volume of liquid aspirated from the bags 9 by means of the pump 70. In other words, the volume of liquid aspirated from the bags 9 is calculated only 5 starting from the instant in which the sensor 74 detects the passage of liquid along the pipe 71. With reference to figures 13 and 14, the machine 1 further comprises a feeding device 75 for feeding a diluent into a bottle 7 containing a lyophilized or 10 powder pharmaceutical. The device 75 comprises feeding assemblies 76, two in the case in point., each of which comprises, in turn, a feeding reservoir 77 (e.g. a bag 9) for the diluent; a feeding needle 78 coupled to the frame 2 and 15 hydraulically connected to the reservoir 77 by means of a pipe 79; and a pumping device defined, in the case in point, by a syringe 80, which is connected to an intermediate point of the :ipe 79, and is actuated in known manner to aspirate a predetermined amount of 20 diluent from the reservoir 77 and to feed the diluent itself into the bottle 7. The connection between the pipe 79 and the syringe 80 divides the pipe 79 into two segments 79a, 79b, which are arranged in sequence and in this order between the 25 reservoir 77 and the needle 78, and which are provided with respective check valves 81a, 81b, of which valve 16 Bla avoids the flow back of diluent into segment 79a when diluent is fed to the needle 78, and valve 81b avoids the flow back of diluent from segment 79b when the diluent is aspirated from the reservoir 77. 5 The device 75 further comprises a collection reservoir 82, which extends underneath the needles 78, is coupled in known manner to the frame 2 to move with respect to the frame 2, in direction A between a lowered resting position (figure 13b) and an operating raised 10 position (figure 13a), and is hydraulically connected to a collection manifold 83 of the diluent. The reservoir 82 further displays a pair of tubes 84, each of which protrudes upwards from a bottom wall of the reservoir 82, is substantially coaxial to the respective needle 15 78, and accommodates therein a protective cap 85 of the needle 78 itself arranged in the tube 84 with the concavity facing upwards. In use, the reservoir 82 is moved, with the caps 85 of the needles 78, to its lowered resting position to 20 allow inserting two bottles"7 underneath the needles 78 and feeding the diluent into the bottles 7 themselves. When they are extracted from the respective bottles 7 the bottles may have residues of the lyophilized or powder pharmaceutical, and for this reason at the end of 25 each injection operating cycle of the feeding device 75, the reservoir 82 is moved into its raised operating 17 position so as to fit the caps 85 on the respective needles 78, and the syringes 80 are actuated to allow to wash the needles 78 with the diluent contained in the reservoirs 72. 5 The diluent fed through the needles 78 flows firstly into the respective caps 85 and thus into the reservoir 82 and into the manifold 83. With this regard, it is worth noting that: the amount of diluent used to wash the needles 78 10 also allows to wash the caps 85; the caps 85 are, like the needles 78, initially sterile and may therefore be used to wash the respective needles 78 at the end of each programmed injection operating cycles in a working session of the machine 1; 15 and the conclusion of the working session of the machine 1 requires only the -replacement of needles 78 and of the respective caps':85 and does not require the sterilization of the reservoir 82. 20 As shown in figure 15, the machine 1 is further provided with a collection device 86 of the processing waste (e.g. syringes 5, bottle 7, needles 78, and caps 85) accommodated within the frame 2 underneath the store 8, and comprising, in the case in point, two collection 25 containers 87, of which one (hereinafter indicated by numeral 87a) communicates with the chamber 3 by means of 18 a pair of slides 88 and the other (hereinafter indicated by numeral 87b) communicates with the chamber 3 itself by means of one chute only 89. In use, the various processing waste is selectively 5 fed by the device 10 to the various chutes 88, 89 and, thus, to the various containers 87a, 87b, thus allowing to separate the processing waste. The operation of the machine 1 is easily inferred from the description above and no further explanations 10 are required.

Claims (4)

1.- A machine for the preparation of pharmaceutical products comprising at least one store (4, 6) for storing syringes (5) and/or bottles (7); a dosing 5 station (36) for transferring at least one pharmaceutical between a syringe (5) and a bottle (7); a gripping and transporting device (10) for transferring the syringes (5) and/or the bottles (7) between the store (4, 6) and the dosing station (36); and a 10 collection station (86) provided with a first container (87a) for processing waste of the machine; and characterized in that the collection station (86) is further provided with at least a second container (87b) for the processing waste; the gripping and transporting 15 device (10) being adapted to selectively feed the processing waste into said first and second container (87a, 87b).

2.- A machine according to claim 1, wherein, for each container (87a, 87b), the collection station (86) 20 further comprises at least one respective chute (88, 89) for the processing waste into the container (87a, 87b) itself.

3.- A machine according to claim 1 or 2 and further comprising control means of the gripping and 25 transporting device (10) ' for selectively feeding the processing waste into said' first and second container 20 (87a, 87b)

4.- A method for preparing pharmaceutical products in a machine comprising at least one store (4, 6) for storing syringes (5) and/or bottles (7); a dosing 5 station (36) for transferring at least one pharmaceutical between a syringe (5) and a bottle (7); a gripping and transporting device (10) for transferring the syringes (5) and/or the bottles (7) between the store (4, 6) and the dosing station (36); and a 10 collection station (86) provided with two containers (87a, 87b) for processing waste of the machine; the method being characterized in that it comprises the step of: selectively feeding the processing waste into said 15 containers (87a, 87b) by means of said gripping and transporting device, (10) .