EP2502669B1 - Machine for the preparation of pharmaceutical products - Google Patents

Machine for the preparation of pharmaceutical products Download PDF

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Publication number
EP2502669B1
EP2502669B1 EP12161126.3A EP12161126A EP2502669B1 EP 2502669 B1 EP2502669 B1 EP 2502669B1 EP 12161126 A EP12161126 A EP 12161126A EP 2502669 B1 EP2502669 B1 EP 2502669B1
Authority
EP
European Patent Office
Prior art keywords
containers
machine according
station
transfer
rectilinear guide
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP12161126.3A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP2502669A1 (en
Inventor
Paolo Giribona
Walter Bianco
Michele Minisini
Garcia Gaspar De Viedma Santoro
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Health Robotics SRL
Original Assignee
Health Robotics SRL
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Health Robotics SRL filed Critical Health Robotics SRL
Publication of EP2502669A1 publication Critical patent/EP2502669A1/en
Application granted granted Critical
Publication of EP2502669B1 publication Critical patent/EP2502669B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • G—PHYSICS
    • G07—CHECKING-DEVICES
    • G07F—COIN-FREED OR LIKE APPARATUS
    • G07F11/00—Coin-freed apparatus for dispensing, or the like, discrete articles
    • G07F11/02—Coin-freed apparatus for dispensing, or the like, discrete articles from non-movable magazines
    • G07F11/04—Coin-freed apparatus for dispensing, or the like, discrete articles from non-movable magazines in which magazines the articles are stored one vertically above the other
    • G07F11/16—Delivery means
    • G07F11/165—Delivery means using xyz-picker or multi-dimensional article picking arrangements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/002—Compounding apparatus specially for enteral or parenteral nutritive solutions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/80—Mixing plants; Combinations of mixers
    • B01F33/84—Mixing plants with mixing receptacles receiving material dispensed from several component receptacles, e.g. paint tins
    • B01F33/841—Mixing plants with mixing receptacles receiving material dispensed from several component receptacles, e.g. paint tins with component receptacles fixed in a circular configuration on a horizontal table, e.g. the table being able to be indexed about a vertical axis
    • G—PHYSICS
    • G07—CHECKING-DEVICES
    • G07F—COIN-FREED OR LIKE APPARATUS
    • G07F11/00—Coin-freed apparatus for dispensing, or the like, discrete articles
    • G07F11/02—Coin-freed apparatus for dispensing, or the like, discrete articles from non-movable magazines
    • G07F11/04—Coin-freed apparatus for dispensing, or the like, discrete articles from non-movable magazines in which magazines the articles are stored one vertically above the other
    • G07F11/16—Delivery means
    • G07F11/165—Delivery means using xyz-picker or multi-dimensional article picking arrangements
    • G07F11/1657—Delivery means using xyz-picker or multi-dimensional article picking arrangements the picking arrangements using suction
    • G—PHYSICS
    • G07—CHECKING-DEVICES
    • G07F—COIN-FREED OR LIKE APPARATUS
    • G07F17/00—Coin-freed apparatus for hiring articles; Coin-freed facilities or services
    • G07F17/0092—Coin-freed apparatus for hiring articles; Coin-freed facilities or services for assembling and dispensing of pharmaceutical articles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
    • B01F2101/22—Mixing of ingredients for pharmaceutical or medical compositions

Definitions

  • the present invention relates to a machine for the preparation of pharmaceutical products.
  • a machine in the pharmaceutical product preparation field comprising a store for a plurality of containers, e.g. infusion bags, bottles and syringes; a dosing station for the preparation of a pharmaceutical product obtained by mixing, by means of a syringe, at least one pharmaceutical substance contained in a bottle and at least one diluent contained in an infusion bag; a weighing station of the bottles and/or infusion bags; and a robotized arm for gripping and transporting the containers.
  • a store for a plurality of containers e.g. infusion bags, bottles and syringes
  • a dosing station for the preparation of a pharmaceutical product obtained by mixing, by means of a syringe, at least one pharmaceutical substance contained in a bottle and at least one diluent contained in an infusion bag
  • a weighing station of the bottles and/or infusion bags e.g. weighing station of the bottles and/or infusion bags
  • a robotized arm for gripping and transport
  • Store, dosing station, weighing station and robotized arm are accommodated within a sterile containment chamber delimited by a protective casing provided with an access opening adapted to allow an operator to load and/or unload the various types of containers into/from the store itself.
  • the robotized gripping and transporting arm is normally used to transfer various types of containers between the store, the weighing station and the dosing station
  • the known machines of the above-described type for the preparation of pharmaceutical products have relatively long production cycles and relatively low productivity.
  • numeral 1 indicates as a whole a machine for the preparation of pharmaceutical products, comprising a box-like containment frame 2 having a substantially parallelepiped shape and defining an inner chamber 3, which is kept under substantially sterile conditions by a pneumatic device of known type, shaped so as to feed a flow of sterile air through chamber 3 and prevent the introduction of air from the external environment into chamber 3.
  • Chamber 3 accommodates a store 4 therein for storing syringes 5; a store 6 for storing bottles 7; an annular store 8 for storing infusion bags 9; and a robotized device 10 for gripping and transporting syringes 5 and/or 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 cylinder 12, a closing cap 14 mounted to protect the needle (not shown) from possible contaminations, and a piston 15, which is slidingly engaged in cylinder 12, and is provided with an end head 16 perpendicular to axis 11.
  • Each bag 9 is provided with an adapter member 17 of known type, which comprises two shaped jaws 18 movable between a clamping position and a releasing position of an upper edge of bag 9, and has a drawing pin 19 protruding upwards from one of the jaws 18 ( figure 5 ).
  • device 10 is mounted within store 8, comprises a plurality of articulated arms 20 hinged to one another, and is provided with a gripping claw 21, which is mounted to the free end of the arms 20, and is defined by two jaws 22 movable between a clamping position and a releasing position of a syringe 5 or a bottle 7.
  • each store 4, 6 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 with the pulleys (not shown) of the other conveyor 23, and are mounted so as to intermittently rotate about respective horizontal rotation axis 24 parallel to one another and transversal to direction A.
  • Each store 4, 6 further comprises a plurality of transport cradles 25, which extend between the conveyors 23, are coupled to the conveyors 23 to oscillate, with respect to conveyors 23, about respective horizontal fulcrum axes 26 parallel to one another and to axes 24, and which are uniformly distributed along the conveyors 23 themselves.
  • each cradle 25 of store 4 (hereinafter indicated by numeral 25a) has a substantially V-shaped transversal section, is arranged with a longitudinal axis 27a thereof parallel to axes 24, 26, is provided with a first slot 28 adapted to receive the flange 13 of a syringe 5 to ensure the correct longitudinal positioning of syringe 5 into cradle 25a, and furthermore has a second slot 29 adapted to be engaged by the jaws 22 to allow device 10 to collect the syringe 5 from the cradle 25a itself.
  • each cradle 25 of 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, which is obtained close to the lower end of cradle 25b, allows to correctly place a bottle 7 with its concavity facing downwards, and allows the jaws 22 to collect the bottle 7 itself.
  • each store 4 6 extends through a loading station obtained through frame 2 to allow the operator to load the syringes 5 or bottles 7 into the respective cradles 25a, 25b, and through a single collecting station, where the syringes 5 or bottles 7 are collected from the respective cradles 25a, 25b by means of device 10, the device 10 is relatively simple and cost-effective. Furthermore, the loading and unloading of syringes 5 and bottles 7 into, and respectively from, the corresponding cradles 25a, 25b does not require machine 1 to be stopped.
  • store 8 comprises a star-like wheel 31 having an annular shape, which extends about the device 10, is mounted to rotate intermittently, with respect to frame 2 and under the bias of an actuating device (known and not shown), about a substantially vertical rotation axis 32, and has a plurality of pockets 33, which are obtained along a peripheral edge of wheel 31, are open radially outwards and are each adapted to receive and hold a respective infusion bag 9.
  • the pockets 33 are fed by wheel 31 about axis 32 and along a circular path P extending through a loading and unloading station 34 of the bags 9 into, and respectively from, store 8, a weighing station 35 of bags 9, and a dosing station 36 for injecting a given amount of pharmaceutical product into the bags 9 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 perform rectilinear movements along guide 38 in direction 39, and a gripping fork 41 slidingly coupled to 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 corresponding adapter member 17.
  • 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 perform rectilinear movements along guide 38 in direction 39, and a gripping fork 41 slidingly coupled to 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 corresponding adapter member 17.
  • Device 37 of station 34 cooperates with a guide 42, which is parallel to the corresponding guide 38, is radially aligned with pocket 33 arranged each time in the station 34 to be slidingly engaged by the member 17 of a respective bag 9, and extends between store 8 and an opening 43 obtained through frame 2 to allow an operator to load the bags 9 on the guide 42 and to collect the bags 9 from the guide 42 itself.
  • the device 37 of station 35 cooperates with a weighing device 44 comprising a movable supporting member 45, which is coupled in a known manner to a fixed part of the device 44 to vertically move under the weight of the bags 9, is fork-shaped, and defines a guide 46 radially aligned with the pocket 33 arranged each time in station 35 to be slidingly engaged by the member 17 of a corresponding bag 9.
  • the device 37 of station 36 cooperates with a guide (not shown), which is parallel to the corresponding direction 39, is radially aligned with the pocket 33 arranged each time in station 36 to be slidingly engaged by the member 17 of a corresponding bag 9, and is adapted to stop the bag 9 itself underneath a syringe 5, which is transferred from device 10 between store 4 and a gripping and actuating assembly 47 of the syringe 5 itself.
  • a guide (not shown), which is parallel to the corresponding direction 39, is radially aligned with the pocket 33 arranged each time in station 36 to be slidingly engaged by the member 17 of a corresponding bag 9, and is adapted to stop the bag 9 itself underneath a syringe 5, which is transferred from device 10 between store 4 and a gripping and actuating assembly 47 of the syringe 5 itself.
  • 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 cylinder 12 and a gripping device 51 of piston 15.
  • Device 50 comprises two claws 52, which are aligned to each other in a direction 53, the orientation 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 in order to move, with respect to the block 48 itself, transversally to direction 53, and are normally kept in a clamping position of the cylinder 12 by respective springs 55 interposed between block 48 and jaws 54, and loaded so as to allow the axial movement of syringe 5 through the claws 52.
  • Device 50 further comprises an intermediate claw 56, which extends between the claws 52, and comprises, in turn, two jaws 57 slidingly coupled to the block 48 in order to move with respect to block 48 and under the bias of an actuating device (known and not shown), transversally to direction 53 between a clamping position and a releasing position of the cylinder 12 of a syringe 5.
  • an actuating device known and not shown
  • the jaws 57 are shaped so as to allow one of the jaws 57 to be inserted into the other jaw 57 and also to clamp syringes 5 of relatively small diameter.
  • Device 51 comprises two jaws 58, which are slidingly coupled to the block 48 in order to move with respect to block 48 and under the bias of an actuating device (known and not shown), transversally to direction 53 between a clamping position and a releasing position of the head 16 of a syringe 5, and are further slidingly coupled to block 48 in order to perform rectilinear movements in direction 53 itself with respect to block 48 and under the bias of an actuating device (known and not shown).
  • Each jaw 58 has a plurality of grooves 59 (two grooves 59, in this case) reciprocally overlapping in direction 53 to allow device 51 to receive and hold the heads 16 of syringes 5 of different size.
  • assembly 47 will now be described starting from when jaws 57 and jaws 58 are arranged in their releasing positions, and syringe 5 is inserted by means of the device 10 into the jaws 54 against the bias of the springs 55.
  • the jaws 58 are firstly closed over head 16 and then lowered in direction 53 so as to move the syringe 5 through the claws 52, arrange the flange 13 in contact with the upper claw 52 and, possibly, push piston 15 fully into cylinder 12.
  • the above-described operating sequence allows to correctly place syringe 5 in direction 53 while ensuring a correct, constant positioning of all syringe 5 regardless of the size thereof, of the initial position of pistons 15 along the corresponding cylinders 12, and of the initial axial, angular positions of syringes 5 within the claws 52.
  • jaws 57 are moved to their clamping position of syringe 5 within assembly 47, and the jaws 58 are moved to their clamping position of head 16 to control the movement of piston 15 during the steps of aspirating and injecting the pharmaceutical.
  • machine 1 further comprises a mixer device 60 for mixing together a lyophilized or powder pharmaceutical and a diluent contained in a bottle 7.
  • Device 60 comprises a rotating plate 61, which is mounted to alternatively rotate about a substantially horizontal rotation axis 62, and is provided with a pair of jaws 63 coupled in a known manner to plate 61 in order to move, with respect to plate 61, transversally to axis 62, between a clamping position and a releasing position of a bottle 7.
  • Each jaw 63 is shaped so as to have, in this case, a pair of seats 64, which cooperate with the corresponding seats 64 of the other jaw 63 to allow the jaws 63 to hold bottles 7 of different size.
  • path P further extends through a collecting station 65 of a given amount of liquid from bags 9.
  • the liquid of bag 9 is necessarily collected when the overall weight of pharmaceutical and diluent contained in bag 9 once the pharmaceutical has been injected needs to be equal to a given value lower than the weight of the sole diluent first contained in bag 9.
  • Station 65 has an aspiration assembly 66 comprising a gripping device 67 adapted to receive and hold an extraction needle 68, which is connected to a hydraulic aspiration circuit 69, is transferred by device 10 into device 67 once it has been separated from a protective cap thereof (known and not shown), and is moved by device 67 in direction A between a raised resting position, in which needle 68 is arranged outside bag 9, and a lowered operating position, in which needle 68 protrudes within bag 9 over the diluent contained in the bag 9 itself.
  • an aspiration assembly 66 comprising a gripping device 67 adapted to receive and hold an extraction needle 68, which is connected to a hydraulic aspiration circuit 69, is transferred by device 10 into device 67 once it has been separated from a protective cap thereof (known and not shown), and is moved by device 67 in direction A between a raised resting position, in which needle 68 is arranged outside bag 9, and a lowered operating position, in which needle 68 protrudes within bag 9 over the
  • Circuit 69 comprises an extraction pump 70, in this case a peristaltic pump, having an inlet hydraulically connected to needle 68 by means of a first pipe 71, and an outlet hydraulically connected to a collection reservoir 72 of the diluent collected from bags 9 by means of a second pipe 73.
  • extraction pump 70 in this case a peristaltic pump, having an inlet hydraulically connected to needle 68 by means of a first pipe 71, and an outlet hydraulically connected to a collection reservoir 72 of the diluent collected from bags 9 by means of a second pipe 73.
  • pipe 71 is provided with a flow sensor 74, a capacitance sensor in this case, which allows to discriminate between the passage of air and of liquid along pipe 71, and thus correctly calculate the volume of liquid aspirated from the bags 9 by means of pump 70.
  • the volume of liquid aspirated from the bags 9 is calculated only starting from when sensor 74 detects the passage of liquid along pipe 71.
  • machine 1 further comprises a feeding device 75 to feed a diluent into a bottle 7 containing a lyophilized or powder pharmaceutical.
  • device 75 comprises two feeding assemblies 76, each of which comprises, in turn, a feeding reservoir 77 (e.g. a bag 9) for the diluent; a feeding needle 78 coupled to frame 2 and hydraulically connected to reservoir 77 by means of a pipe 79; and a pumping device defined, in this case, by a syringe 80, which is connected to an intermediate point of pipe 79, and is actuated in a known manner to aspirate a predetermined amount of diluent from reservoir 77 and to feed the diluent itself into bottle 7.
  • a feeding reservoir 77 e.g. a bag 9
  • a feeding needle 78 coupled to frame 2 and hydraulically connected to reservoir 77 by means of a pipe 79
  • a pumping device defined, in this case, by a syringe 80, which is connected to an intermediate point of pipe 79, and is actuated in a known manner to aspirate a predetermined amount of diluent from reservoir 77 and
  • connection between pipe 79 and syringe 80 divides pipe 79 into two segments 79a, 79b, which are arranged in sequence and in the order between reservoir 77 and needle 78, and which are provided with respective check valves 81a, 81b, valve 81a of which avoids the flow back of diluent into segment 79a when diluent is fed to needle 78, and valve 81b avoids the flow back of the diluent from segment 79b when the diluent is aspirated from reservoir 77.
  • Device 75 further comprises a collection tank 82, which extends underneath the needles 78, is coupled in a known manner to frame 2 in order to move with respect to the frame 2, in direction A between a lowered resting position ( figure 13b ) and a raised operating position ( figure 13a ), and is hydraulically connected to a collection manifold 83 of the diluent.
  • Tank 82 further has a pair of tubes 84, each of which protrudes upwards from a bottom wall of tank 82, is substantially coaxial to the corresponding needle 78, and accommodates therein a protective cap 85 of the needle 78 itself arranged in the tube 84 with the concavity facing upwards.
  • tank 82 In use, tank 82 is moved, along with the caps 85 of the needles 78, to its lowered resting position to allow two bottles 7 to be inserted underneath the needles 78 and the diluent to be fed into the bottles 7 themselves.
  • the needles When the needles are extracted from the corresponding bottles 7, they may have residues of the lyophilized or powder pharmaceutical contained in the bottles 7 themselves, and at the end of each injection operating cycle of the feeding device 75, the tank 82 is moved to its raised operating position so as to fit the caps 85 on the corresponding needles 78, and the syringes 80 are actuated to allow needles 78 to be washed with the diluent contained in the reservoirs 77.
  • 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 frame 2 underneath store 8, and comprising, in this case, two collection containers 87, one of which (hereinafter indicated by numeral 87a) communicates with chamber 3 by means of a pair of chutes 88, while the other (hereinafter indicated by numeral 87b) communicates with chamber 3 by means of one chute only 89.
  • a collection container 87 one of which (hereinafter indicated by numeral 87a) communicates with chamber 3 by means of a pair of chutes 88, while the other (hereinafter indicated by numeral 87b) communicates with chamber 3 by means of one chute only 89.
  • the various processing waste is selectively fed by device 10 to the various chutes 88, 89 and, therefore, to the various containers 87a, 87b, thus allowing to separate the processing waste.
  • machine 1 The operation of machine 1 is easily inferred from the above description and no further explanations are required.

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  • General Physics & Mathematics (AREA)
  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Nutrition Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Specific Conveyance Elements (AREA)
EP12161126.3A 2011-03-23 2012-03-23 Machine for the preparation of pharmaceutical products Active EP2502669B1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IT000143A ITBO20110143A1 (it) 2011-03-23 2011-03-23 Macchina per la preparazione di prodotti farmaceutici

Publications (2)

Publication Number Publication Date
EP2502669A1 EP2502669A1 (en) 2012-09-26
EP2502669B1 true EP2502669B1 (en) 2014-01-01

Family

ID=43976870

Family Applications (1)

Application Number Title Priority Date Filing Date
EP12161126.3A Active EP2502669B1 (en) 2011-03-23 2012-03-23 Machine for the preparation of pharmaceutical products

Country Status (2)

Country Link
EP (1) EP2502669B1 (it)
IT (1) ITBO20110143A1 (it)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB707572A (en) * 1951-05-23 1954-04-21 Frederick William Clegg Method of and means for sampling articles dealt with in succession by apparatus repetitively performing an operation thereon
US7228198B2 (en) * 2002-08-09 2007-06-05 Mckesson Automation Systems, Inc. Prescription filling apparatus implementing a pick and place method
US20050133729A1 (en) * 2003-12-23 2005-06-23 Archie Woodworth Apparatus and method for fabricating a reconstitution assembly
US7163035B2 (en) * 2004-05-13 2007-01-16 Forhealth Technologies, Inc. Automated use of a vision system to detect foreign matter in reconstituted drugs before transfer to a syringe
EP2054145B1 (en) * 2006-07-26 2010-10-20 Health Robotics S.r.l. Device for the preparation of pharmaceutical products
ATE532709T1 (de) * 2008-12-09 2011-11-15 Sybermat Vorrichtung und verfahren zur verpackung von spritzen in nestern

Also Published As

Publication number Publication date
ITBO20110143A1 (it) 2012-09-24
EP2502669A1 (en) 2012-09-26

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