EP4501301B1 - Vorrichtung und verfahren zur herstellung von arzneimitteln - Google Patents

Vorrichtung und verfahren zur herstellung von arzneimitteln

Info

Publication number
EP4501301B1
EP4501301B1 EP24190105.7A EP24190105A EP4501301B1 EP 4501301 B1 EP4501301 B1 EP 4501301B1 EP 24190105 A EP24190105 A EP 24190105A EP 4501301 B1 EP4501301 B1 EP 4501301B1
Authority
EP
European Patent Office
Prior art keywords
syringe
warehouse
area
zone
drug
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
EP24190105.7A
Other languages
English (en)
French (fr)
Other versions
EP4501301A1 (de
EP4501301C0 (de
Inventor
Cristiano CAZZANIGA
Giorgio VANONI
Marco JANNACE
Alessandro MOSSA
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.)
Cia Automation And Robotics Srl
Sipar Srl
Original Assignee
Cia Automation And Robotics Srl
Sipar 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 Cia Automation And Robotics Srl, Sipar Srl filed Critical Cia Automation And Robotics Srl
Publication of EP4501301A1 publication Critical patent/EP4501301A1/de
Application granted granted Critical
Publication of EP4501301C0 publication Critical patent/EP4501301C0/de
Publication of EP4501301B1 publication Critical patent/EP4501301B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/22—Arrangements for transferring or mixing fluids, e.g. from vial to syringe with means for metering the amount of fluid
    • 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
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • 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

Definitions

  • the present invention relates to an apparatus and a method for preparing drugs.
  • the present invention relates to an automated type apparatus and the related method for preparing (or compounding) injectable pharmaceutical solutions in a safe and controlled environment and, more in particular (but not exclusively), for preparing chemotherapy drugs and/or any injectable type drug based on the specific needs of hospital facilities and the like (e.g., intravitreal syringes, monoclonal antibodies, state-of-the-art antibiotics, vaccine partitioning, and the like) .
  • injectable type drug e.g., intravitreal syringes, monoclonal antibodies, state-of-the-art antibiotics, vaccine partitioning, and the like.
  • the drugs are prepared manually in a sterile environment and, in particular, under a vertical laminar air flow hood so as to safeguard the safety of the operator, the sterility conditions of the preparations and, consequently, the quality thereof.
  • the traditional manual preparation method includes the establishment of possible sources of error and problems, with a consequent impact on the quality of the finished product.
  • a further drawback of manual preparation is the lack of ensured safety for the operator assigned to the preparation, who may be exposed to cytotoxic and mutagenic substances which can be very harmful to health.
  • a further drawback of the traditional preparation method is represented by an incomplete traceability of the production process.
  • a further drawback is the difficulty, if not impossibility, of carrying out checks on the correctness of drug dosages.
  • a further drawback is represented by the fact that the rules for a good preparation of drugs include the presence of two operators (one operator at each hood), of which one is responsible for the preparation and the other for checking the correctness of the process; therefore, the manual control which can be subject to errors and the need to employ at least two operators entails increases in cycle times as well as in the related costs.
  • a further and not negligible drawback is represented by the fact that a manual preparation is subject to contamination related precisely to the manual handling of the components necessary for the preparations.
  • Such apparatuses comprise a functional storage area or warehouse for receiving and storing the components necessary for a preparation and a work area in which a manipulator operates to pick up the components from the storage area and combine them to form the finished product.
  • Such types of automatic apparatus have a drawback linked to a non-optimal level of automation and, therefore, to a non-optimal production process by virtue of the fact that they allow making only one preparation at a time.
  • a further drawback of such known automated apparatuses is represented by the fact that they require a substantial contribution from the operator to insert the material necessary to prepare the individual preparation into the machine, to constantly unload the finished preparations and for various and repeated operations next to the machine.
  • a further drawback of such known apparatuses is represented by the fact that the material loading and unloading operations are linked to the individual pharmaceutical preparation and, in particular, for each individual preparation the operator must load all the necessary materials into the apparatus and must also unload the finished product; therefore, the presence of the operator next to the machine is always necessary and, moreover, it is not possible to carry out several preparations in the same cycle since, as described, each cycle includes loading the material necessary for a single preparation.
  • a further drawback which affects the production capacity of the known apparatuses is represented by the fact that the materials necessary for a pharmaceutical preparation can only be loaded in the face of a specific prescription, for example a prescription by the hospital computer system or the like; therefore, once receiving the prescription, the operator views the material to be loaded in the storage area and labels it with a specific and unique code prior to the insertion thereof in the warehouse, thereby without being able to pre-load the warehouse of the storage area. More in particular, when the material is loaded, it is already linked to a specific prescription and, therefore, to a specific patient and this implies that, to make a preparation, it is always necessary to have a specific medical prescription and it is not possible to generically pre-load material during the preparation step to proceed with a material-prescription association after loading.
  • a further drawback is represented by the fact that the known automatic apparatuses use syringes with a needle and this, as is known, involves nebulization and dispersion problems of the drugs being prepared and, consequently, increases the contamination risk of the preparations, of the work surfaces and of the assigned staff; in fact, such apparatuses use syringes with a needle for the purpose of withdrawing the components from the drug bottles according to the prescribed doses and for each preparation, the elastomer of the drug bottle is punctured by means of the needle, the component is withdrawn and the needle is subsequently extracted from the bottle, consequently, there is an inevitable dispersion of the component both by nebulization and by the repeated puncturing of the elastomer
  • a further drawback of the traditional automatic apparatuses is represented by a lack of flexibility regarding the management of materials in different formats, and as there are dimensional constraints for the gripper of the manipulator which is not capable of gripping very small sizes (for example, small volume drug bottles).
  • the known automatic apparatuses for preparing drugs also have dimensional drawbacks in terms of footprint, ergonomics, lay-out management, installation difficulties, handling, maintenance and the like.
  • a further drawback is represented by the fact that the known apparatuses always need to have a sterile and aseptic environment, for example a clean room, or to have to equip suitable spaces for the purpose, with consequent increases in costs and time.
  • CA2725622 refers to an automated workstation for preparing, starting from different substances each of which is contained in a vessel, a final product for medical or pharmaceutical use packaged in a container, comprising at least one isolated chamber delimiting several internal functional areas, a loading area comprising rapid decontamination means, a locking device for the introduction of the vessels and containers into the loading area, an area for the storage of the filled vessels and containers which communicates with the loading area, a transfer area, an area for preparing final products which communicates at least with said storage area through said transfer area and comprising rapid decontamination means, a locking device for unloading final products from the workstation; and at least one robot or a programmable logic controller for handling the objects contained in the storage area and/or in the preparation area.
  • a further drawback of the known automatic apparatuses is represented by the fact that the bottles containing the active ingredients, the bags or containers containing the diluents necessary for the pharmaceutical preparations have an overfilling with respect to the declared nominal volume and, in the case of the bags containing the diluents, such overfilling can result in a deviation of the desired concentrations for the pharmaceutical preparation.
  • a further drawback of the known apparatus is represented by the fact that they require channeling the air flows expelled from the machine and, therefore, are characterized by structural constraints.
  • a further drawback is represented by the fact that the traditional apparatuses, due to the problems related to the management of the condensate which forms as a result of the heating of the appliance, have considerable dimensions and require tanks for collecting water due to the formation of said condensate.
  • a further drawback of the traditional apparatuses is represented by the fact that they are not modular and, therefore, generate difficulties both during installation and during transport.
  • a further drawback is represented by the fact that the traditional apparatuses are not ergonomic, and the operator is always forced to work standing up, with all the disadvantages which such a situation entails.
  • an apparatus for preparing drugs is provided, more in particular for the automated preparation (or compounding) of injectable pharmaceutical solutions in a safe and controlled environment, comprising a casing or frame comprising two zones adjacent to each other and defined by a warehouse zone or area and a set-up zone or area which are separate from each other and communicating, the warehouse zone or area defining an area assigned for the loading and storage, via a warehouse, of the materials required for pharmaceutical preparations of the drug and diluent type and the set-up zone or area defining an area in which the preparation of the drug is carried out with the materials picked up from the warehouse zone or area by means of a first robotic manipulator and a second robotic manipulator simultaneously cooperating with each other and with functional devices for the pharmaceutical preparation, carrying out mutually different actions to perform set-up and preparation operations in "masked time".
  • the apparatus for preparing drugs of the invention indicated overall with 10 in the aforementioned figures, comprises a casing or frame 12 resting on the ground by means of a support base 14 provided with wheels 16 (or equivalent movement means) adapted to allow movements of said casing or frame 12.
  • the casing or frame 12 comprises two mutually adjacent zones (as better detailed below) and defined by a warehouse zone or area 18 and a set-up zone or area 20 which are separated from each other by a wall 22 and which are communicating by means of an opening 24 formed in said wall 22.
  • the warehouse zone or area 18 forms the area assigned for the loading and storage of the materials necessary for the preparations, while the set-up zone or area forms the area in which the drug preparation is carried out with the materials picked up from the warehouse zone or area.
  • the warehouse zone or area 18 is closed by means of a hatch 18' and the set-up zone or area 20 is closed by means of a further hatch 20', with said hatch 18' and further hatch 20' openable/closable automatically by means of actuators 21.
  • the warehouse zone or area 18 comprises a front part 18" provided with a work surface 17 for an operator who carries out product loading and unloading actions and a rear part 18"' comprising a warehouse 26 consisting of a rotating structure (or revolver) better described below.
  • the front part 18" is separated from the external environment by means of a glass panel (not depicted in the drawings) which only leaves free a sufficient space for the operator operating at said warehouse zone or area 18 to introduce his/her hands; such a glass panel can be sliding in an automated manner by means of guides stabilized at the hatch 18'.
  • a glass panel not depicted in the drawings
  • the front part 18 in which the work surface 17 is present, is hit by a vertical laminar air flow under which the operator carries out the material loading and unloading procedures
  • the vertical laminar air flow is also present in the rear part 18"' and is different with respect to the one characterizing the front part with reference to speed; by way of example, the laminar air flow in said rear part can have a speed of 0.4 m/s (meters per second), while the laminar air flow in the front part 18" can have a speed of 0.25 m/s (meters per second).
  • the air is partly expelled and partly recirculated, with the intrinsic filtration system of the apparatus which ensures the possibility of not channeling said air, but of expelling it into the environment.
  • the internal air can be 70% recirculated while 30% is expelled by means of an exhausted air filter; the expelled volume is supplemented by a continuous supply of 30% air from the front opening of the glass with the air which is circulated by means of motor fans (not depicted) and which is continuously decontaminated by passing through H14 HEPA (High Efficiency Particulate Air) filters.
  • H14 HEPA High Efficiency Particulate Air
  • a monitor 28 is stabilized defining a human-machine interface for operator use.
  • the front part 18" and the rear part 18"' of the warehouse zone or area are separated from each other by a hinged openable door consisting of an intermediate openable door 19 between two perforated panels 19' ; the openable door 19 is transparent and openable in an automated sliding manner, while the panels are perforated to allow a passage of air and are integral with the hinged openable door.
  • Said front part 18 as described above and with reference to the preferred embodiment referred to in the figures, comprises a work surface 17 for loading and unloading actions carried out by an operator and, on the left inner wall, comprises three pairs of hooks (not depicted) placed at different heights and functional to allow the operator to organize the materials necessary for the preparations, while on the right inner wall there is a door which allows the extraction of a trolley 25 carrying completed preparations in bottle or bag format as better described below (the trolley 25 is a removable type trolley on which a manipulator (described below) deposits bottles containing the ready-made preparation and which is extracted by the operator for picking up the finished products).
  • a code reader 23 barcode or QR code or similar
  • a recognition of the diluent bottles by means of the special label with which they are provided.
  • the warehouse 26 is housed in the same rear part 18"', consisting of a rotating structure (or revolver) which is formed by one or more discs on top of and parallel to each other and stabilized with respect to a central rotating shaft 26A arranged vertically, with said discs being provided with inserts for loading the materials required to prepare the drugs and, more in particular, functional for housing drugs and diluents; the number of discs in the warehouse 26 is a function of the specific production needs.
  • a rotating structure or revolver
  • the warehouse 26 (or revolver) can comprise a first disc 26B stabilized at an upper end of the shaft 26A, a second disc 26C arranged below the first disc 26B, a third disc 26D arranged below the second disc 26C, a fourth disc 26E arranged below the third disc 26D, a fifth disc 26F arranged below the fourth disc 26E, with said discs arranged parallel to each other and at different distances along the longitudinal extension of the shaft 26A.
  • the described discs of the warehouse 26 comprise inserts or pockets, formed on the outer circumferential extension of each disc and functional for the housing of bottles/bags or drugs; for example and with reference to the preferred embodiment, the second disc 26C and the fifth disc 26F comprise inserts 26G for housing diluents, the third disc 26D and the fourth disc 26E comprise inserts 26H for housing drugs and the first disc 26B comprises inserts or pockets 26L for housing reusable-type drugs, as better described below (said first disc, as better described below is used only by a manipulator described below).
  • the set-up zone or area 20 likewise comprises a front part 20" and a rear part 20"' which are separated from each other by openable doors 27 of the hinge type; the front part 20" defines a work zone for the operator, while the rear part 20"' forms a work zone for anthropomorphic-type manipulators (defined by a first manipulator 30 and by a second manipulator 31); said front part 20" and rear part 20"', like the front part 18" and rear part 18"' of the warehouse zone or area 18, are hit by a vertical laminar air flow, with said air flow being different for the two front and rear parts.
  • the front part 20 as previously described for the front part 18" of the warehouse zone or area 18, is separated from the external environment by means of a glass panel (not depicted in the figures) which only leaves sufficient space for the operator operating at said set-up zone or area 20 to introduce his/her hands; said glass panel can be sliding in an automated manner by means of guides stabilized at the hatch 20'.
  • the front part 20" comprises a work surface 32 for handling syringes and syringe preparations, a syringe warehouse 33 (stabilized at the openable door 27) which consists of an IN syringe warehouse 33' (input syringes) and an OUT syringe warehouse 33" (output syringes) as better described below.
  • the IN-syringe warehouse 33' comprises a plurality of guides 51 (in the preferred embodiment referred to in the figures ( figure 9 ), there are nine such guides, of which two dedicated to 60 ml (milliliter) syringes, one for 30 ml syringe, two are dedicated to 20 ml syringes, a further two are dedicated to 10 ml syringes, one guide is functional to 3 ml syringes and, finally, one is functional to 1 ml syringes) preferably inclined downwards in the direction of the rear part 20"' to allow a feed (slide) in the rear part for the use of the manipulators as better described below.
  • the OUT syringe warehouse 33' comprises guides 52 for the storage of syringes filled with the preparation and, therefore, with the finished product; such guides are preferably inclined downwards from the rear part 20"' to the front part 20" .
  • the rear part 20"' defines the drug set-up/preparation area in which the two manipulators (first manipulator 30 and second manipulator 31) are arranged parallel to each other and in which the functional devices for a cooperation with said manipulators are present.
  • the functional devices for a cooperation with the aforementioned manipulators comprise a first scale 36 arranged at the partition wall 22 between the warehouse zone or area 18 and the set-up zone or area 20, a second scale 38 arranged at a right wall of said set-up zone or area opposite to the partition wall 22, a diluent rack 40 arranged at the first scale 36 (it is a stand-by station for a diluent in any format consisting of a "U" hook where the first manipulator 30 rests the diluent between one processing step and the next as better described below), a bottle-drug turntable 42 (defines a rotating support on which the first manipulator rests the drug bottle for scanning the drug label thereof, with the rotation allowing a visual acquisition means to scan the entire label), a first dosing device 44 arranged between the first manipulator 30 and the second manipulator 31, a second dosing device 46, a first rack 48 stabilized at the openable door 27 on the internal front facing said rear part 20"' (said first rack
  • the dispensing device can consist of a group comprising three nozzles and three peristaltic pumps for the removal of diluent (in particular, a nozzle is included for each treated diluent to avoid cross-contamination (saline, glucose solution and water)); the features of the dispensing device can vary according to specific production needs.
  • the first scale 36 forms a high precision gravimetric control group for weighing diluents
  • the second scale 38 forms a high precision gravimetric control group for weighing drug bottles and syringes.
  • the first dosing device 44 is shown in greater detail in figure 6 and defines a functional device for infusing (infusion dosing) the drug contained in the pre-filled syringe of the second dosing device 46 (described below) into the diluent or drug bottle (in the event of a preparation method including the reconstitution of powdered drugs).
  • the first dosing device 44 comprises a base body 58 stabilized at an internal bottom wall of the rear part 20′′′ of the set-up area or zone 20 and defining a support body for functional means to empty a vertically arranged syringe and comprising an engagement assembly 60 for a syringe 59 (shown in dashed line in figure 6 ), a screwing assembly 61 arranged at the bottom with respect to the engagement assembly 60 and functional to rotate the syringe stabilized at the engagement assembly, a housing assembly 62 for diluents/drugs arranged below the screwing assembly 61 and a pusher assembly 64 arranged above the engagement assembly 60 movable vertically downward and upward (as indicated by the arrow "Y" in figure 6 ) in the direction of the syringe stabilized to the engagement assembly 60, with said assemblies being arranged along a same vertical line.
  • the second dosing device 46 forms a functional device to a withdrawal, by means of a syringe, of a drug from a mother bottle containing it (extraction dosing device).
  • Said second dosing device 46 comprises a base body 64 stabilized at an internal bottom wall of the rear part 20′′′ of the set-up area or zone 20 to which the functional means to carry out the aforementioned extraction operation are stabilized and which comprise a drug bottle housing assembly 66, a syringe engagement assembly 68 for a syringe 59 (shown in dashed line in figure 7 ), a screwing assembly 69 adapted to rotate a syringe to be filled with the contents of a drug bottle arranged in-between the drug bottle housing assembly 66 and the syringe engagement assembly 68 and a pusher assembly 70 comprising a pusher 70' vertically movable upwards/downwards (as indicated by the arrow "Y” in figure 7 ) and a pusher engagement site 70" movable according to a horizontal direction (as indicated by the arrow "X” in figure 7 ) and provided with an engagement element for the syringe (specifically for the plunger of the syring
  • the transfer of the drug between the mother bottle and the syringe and between the syringe and the diluent/reconstituted bottle (which occurs in the first dosing assembly and in the second dosing assembly) is actuated by means of a closed coupling system by screwing between a "spike" connector affixed to the drug/diluent bottle and a "luer-lock" connector affixed to the syringe (such connectors, being known, are not described and are not depicted in the figures) and the passage of the drug from the mother bottle to the syringe and from the syringe to the diluent is subject to a screwing between the "spike” connector and the "luer-lock" connector.
  • the extraction dosing device or second dosing device 46 has the function of preparing a withdrawal, by means of a syringe, of a drug from a mother bottle containing it and the operation thereof comprises the steps of:
  • the infusion dosing device or first dosing device 44 has the function of infusing the liquid product withdrawn with the second dosing unit into a diluent bottle (or any other type of diluent container) or into a drug bottle with the steps of:
  • the described extraction dosing device prior to operation, defines an automatic calibration step which can be started by the operator.
  • a dosing and weighing cycle is carried out and, based on the actual weight recorded, an automatic calibration of the dosing device stroke is carried out to always ensure an optimal dosing.
  • Said work cycle consists of a series of macro-operating steps defined by a preparation and loading macro-step, as set-up macro-step and an unloading macro-step.
  • the preparation and loading macro-step comprises automated preparation operations of the apparatus (calibration of the processing devices) and the subsequent manual preparation of the material and guided loading thereof into the apparatus for preparing drugs.
  • the operator views the validated prescriptions present in the hospital computer system on a monitor, defines the priority to be assigned and starts the process, sees the products and materials required for the productions started and prepares them, prints and applies a unique internal barcode (or QR code) to each bottle, selects the drug bottles to be loaded and carries out the guided manual loading on the warehouse 26 according to the coordinates established by the system, reads the barcode (or QR code) of the diluent labels and carries out the manual loading on the warehouse 26 according to the coordinates established by the system, loads the syringe warehouse 33 taking care to apply the internal barcode (or QR code) on each syringe.
  • a unique internal barcode or QR code
  • the set-up macro-step starts once the preparation and loading macro-step has been completed and is a fully automated step in which the manipulators described operate, mutually cooperating and with the preparation devices of which a detailed description has been given above; as better described below, the manipulators pick up diluents, drugs and syringes following an order of priority defined by the programming of the production cycle respecting, for example, the order of arrival of the prescriptions; however, there is no pre-established order in the "jobs" which the apparatus will carry out.
  • the set-up macro-step takes place as described below with the two manipulators (first manipulator 30 and second manipulator 31) operating simultaneously, carrying out different actions with respect to each other (in a logic of parallelization of the production process, optimization of cycle times and production) so as to carry out the set-up and preparation operations in "masked time” with consequent advantages from a production cycle time perspective.
  • the above-described overfilling is also managed, with the possibility of weighing the initial materials and knowing the exact value of the internal volumes.
  • the unloading macro-step comprises the step of the operator picking up the finished product which can consist of the bottle of finished product (which the operator picks up from the trolley 25 that moves by sliding from the front part 20" of the set-up zone or area 20 to the front part 18" of the warehouse zone or area 18" and/or from the syringe filled with the drug which is picked up from the OUT syringe warehouse 33" of the syringe warehouse 33; the unloading of the finished product in this macro-step occurs separately and independently, i.e., there is the possibility of unloading multiple productions of drugs in both diluent containers and syringes.
  • the manipulators can continue with the set-up and preparation of further drugs in accordance with the planned production cycles.
  • a label is generated with all the information related to the prescription to be used during the validation step of the prepared drug.
  • a label includes a data matrix containing all the information related to a specific patient and the prescriptions associated therewith; the association of such a data matrix to the preparation, readable by the infusion pumps used for administration in the wards, allows the preparation to be tracked from the set-up thereof to the infusion to the patient, eliminating possible administration errors which can occur in the ward with the traditional labels not provided with such a data matrix.
  • the operator manually prepares the diluent containers, the drug bottles and applies spike connectors thereto and loads everything into the warehouse 26.
  • the operator also prints the internal barcodes (or QR codes), applies them to the diluents already provided with an identification barcode thereof on the label, scans the barcodes of the label and loads them into the warehouse in the position dedicated thereto; with regard to the drug bottles, the operator follows the same method without the application of the internal barcode (or QR code) and without scanning the barcode of the label.
  • QR codes internal barcodes
  • the operator prints the dedicated internal barcodes (or QR codes) and applies them on the syringes, applies them to the same luer-lock connectors and loads them in the syringe warehouse 33 of the set-up zone or area 20 and in particular in the IN syringe warehouse 33'.
  • the first manipulator 30 picks up a drug bottle from the warehouse 26, positions it on the vial-drug turntable 42 and the first visual acquisition means (or first camera) 52 detects the label of said drug, verifying the specifications thereof (batch, expiration, correctness of the drug contained, etc.) and after reading, the first manipulator 30 picks up the above-mentioned drug from the vial-drug turntable 42 and deposits it on the first rack 48.
  • the second manipulator 31 picks up a syringe from the IN syringe warehouse 33' of the syringe warehouse 33, weighs it on the second scale 38 for empty weight detection and then positions it on the second dosing device 46.
  • the second manipulator 31 picks up the drug bottle from the first rack 48 and positions it on the second scale 38 which detects the weight of the bottle which is then picked up by the second manipulator and positioned on the second dosing device 46.
  • the first manipulator 30 picks up a diluent from the warehouse 26 and positions it for verification by the first visual acquisition means (or first camera) 52 which detects the batch, the expiration and the internal barcode (or QR code) affixed and associates the latter with a specific prescription/patient and subsequently positions it on the first scale 36 which detects the weight thereof and, if the volume contained in the diluent was different from that required for the drug preparation cycle, the first manipulator picks up said diluent and positions it on the spike 56 which removes the excess volume from said diluent container which is then picked up by the first manipulator and positioned again on the first scale 36 for a new control and, subsequently, is positioned on the first dosing device 44.
  • the first visual acquisition means or first camera
  • QR code internal barcode
  • the second manipulator 31 positions the drug bottle on the second dosing device 46 to which the syringe is connected, which is filled with the contents of the bottle in the preset amount and, subsequently, the second manipulator 31 picks up the drug bottle and deposits it on the second scale 38 to verify the weight thereof, picks up the syringe from the second dosing device and positions it on the second scale 38 which detects the weight thereof and, subsequently, picks up the bottle from the second scale 38 and positions it on the second rack 50 and, subsequently picks up the syringe from the second scale 38 and positions it on the first dosing device 44 where the contents of the syringe are placed in the preset diluent container.
  • the medicated container filled with the contents of the syringe is then picked up by the first manipulator and deposited on the first scale 36 which checks the weight thereof and, subsequently, the same first manipulator 30 picks up the final product from the first scale and positions it on the trolley 25 for the finished product unloading operations as described below.
  • the second manipulator 31 picks up the empty syringe from the first dosing device and transports it to the used or depleted material unloading device defined by the cylindrical conduit 34 and, subsequently, picks up the drug bottle from the second rack 50 and transports it to the used or depleted material unloading device or to the first rack 48 depending on whether said bottle is empty or still contains drug and, in this case, the non-empty bottle is then picked up by the first manipulator 30 and deposited in the warehouse 26.
  • the operator will then pick up the finished product from the trolley 25 and finalize the product preparation by removing the spike element and affixing a possible tail, reading the internal barcode (or QR code) affixed and displaying the information related to the specific preparation carried out, printing and affixing a label (containing hospital information related to the patient and the prescription both in written form and as a QR code) and will carry out a new simultaneous scan of the two labels for a verification of correctness and matching of the information related to the product with consequent validation of the production.
  • QR code internal barcode
  • the unloading of the finished product in this macro-step takes place separately and independently, i.e., there is the possibility of unloading multiple drug productions of the type unloading drugs in diluent containers and unloading syringes.
  • the apparatus of the invention for which a production cycle has been described by way of example and referred to the preparation of drugs diluted in a bottle, is also used for the preparation of drugs in a syringe which has all the procedural steps described above and differs in that the internal barcode (or QR code) is applied to the syringe and is read by the second visual acquisition means (or second camera) 54 and the syringe, once filled with the drug, is deposited by the second manipulator 31 in the OUT syringe warehouse 33' of the syringe warehouse 33.
  • the internal barcode or QR code
  • the apparatus for preparing drugs of the invention and the related method advantageously allows the automated preparation of chemotherapy drugs and, in general, of any injectable drug in a safe and controlled environment.
  • a further advantage of the apparatus of the invention is represented by the fact that the automation characterizing it and the simultaneity in executing the operations allows the production of even several different preparations within the same production cycle and this is also linked to the presence of two manipulators working simultaneously and in "masked time” and which are managed in accordance with a "job” logic.
  • a further advantage of the apparatus of the invention is represented by the fact that the dosing (dispensing and infusion) devices do not use needles and, therefore, no problems arise related to product nebulization and dispersion, and, at the same time, there is no dripping or the like of the substances.
  • a further advantage is that the apparatus of the invention is highly flexible as regards handling the consumables used for the preparations with particular reference to the formats of drug bottles and syringes.
  • a further advantage is that the apparatus of the invention allows managing the overfilling of the drug components and diluents.
  • Another advantage is that it allows, by virtue of the manipulators working simultaneously and in "masked time", managing the warehouse and other elements/components, a reduction in downtime and, consequently, a high productivity (in particular an hourly productivity).
  • a further advantage of the apparatus of the invention is that it is highly flexible and easily installable without problems of footprint and lay-out, is easily movable within the dedicated spaces and, moreover, is improved and optimized with reference to aspects related to ergonomics.
  • a further advantage of the apparatus of the invention is a high operating autonomy (by virtue of the high automation, the possibility of being able to carry out different preparations within the same cycle without the need for machine stops, etc.) and by a remote control (by virtue also of the presence of colored LED warning lights which make it possible to distinguish between the warehouse zone or area and the set-up zone or area - for example, white light indicating regular operation, orange light if warning an alert state that does not affect the normal working cycle of the apparatus (as in the case of the outgoing bottle warehouse defined by the sliding trolley 25 which, if full or almost full, requires intervention by the operator to provide the emptying thereof), red light if an alarm is in progress (the lights are integrated in the two warehouse and set-up zones or areas).
  • the apparatus of the invention comprises an internal work architecture with an order of actions not defined a priori and this allows an optimization of the process ("job" type process logic). Further advantageous is the fact that the apparatus of the invention comprises a diluent warehouse and a syringe warehouse which are mutually separated (the diluent warehouse located in the warehouse zone or area and the syringe warehouse in the set-up zone or area) and this allows simultaneous processing and the production of several different preparations within the same production cycle as well as optimizing spaces to increase capacity and ensure operating autonomy.
  • a further advantage of the apparatus of the invention is the separation of the loading and unloading areas which allows unloading several preparations simultaneously (bottles and syringes) without the need to interrupt the normal operations of the apparatus.
  • a further advantage of the apparatus of the invention is that it allows handling even small format drug bottles.
  • a further advantage of the apparatus of the invention is that the apparatus of the invention is ergonomic with reference to the structuring of the warehouse zone or area and the set-up zone, allowing the operator to be able to work seated.
  • a further advantage of the apparatus of the invention is the spacious warehouse of the warehouse zone or area and the separation between the environments (between the warehouse zone or area and the set-up zone or area and between the front parts and the rear part of each of such zones) which allow optimizing the work cycle management.
  • a further advantage is that the apparatus of the invention, by virtue of the configuration described above and the work cycle organization and execution logic ("job” logic) allows the pre-loading and association of materials for drug preparation for the patient not a priori, but in-machine.
  • a further advantage deriving from the advantages listed above is fact that the apparatus of the invention is highly flexible, with easy mobility in the installation spaces by virtue of the presence of wheels and easy installation, making it unnecessary, for example, to modify the environments of the structures and the installation rooms of the apparatus (the modularity of the apparatus allows it to pass through standard-sized doors without the need for disassembly or variation thereof).
  • a further advantage of the apparatus of the invention is that it does not need to be installed in a sterile and aseptic chamber of the clean room type and the like (by virtue of the structure and features of the warehouse and set-up areas described above) and does not need to equip spaces suitable for the purpose and, moreover, does not need to channel the air flows expelled from the machine and, therefore, is not subject to structural constraints which, differently, characterize the known apparatuses.
  • a further advantage is that the apparatus of the invention has smaller dimensions with respect to the traditional apparatuses for preparing drugs and this is also a consequence of the absence of problems related to the formation of condensation caused by machine overheating which, for the traditional apparatuses, requires the presence of a management system thereof which requires positioning the apparatus at a certain distance from the walls of the installation room and which also requires the presence of water collection tanks with a consequent and further impact on the footprint of the structure and with the need for an operator to empty them.

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • General Physics & Mathematics (AREA)
  • Mechanical Engineering (AREA)
  • Fluid Mechanics (AREA)
  • Nutrition Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Warehouses Or Storage Devices (AREA)

Claims (16)

  1. Vorrichtung (10) zum Herstellen von Arzneimitteln, insbesondere für die automatisierte Herstellung (oder Zubereitung) von injizierbaren pharmazeutischen Lösungen in einer sicheren und kontrollierten Umgebung, umfassend ein Gehäuse bzw. Rahmen (12), umfassend zwei aneinander angrenzende Zonen und definiert durch eine Lagerzone oder -fläche (18) und eine Einrichtungszone oder -fläche (20), die voneinander getrennt sind und miteinander in Verbindung sind, die Lagerzone oder -fläche (18) eine Fläche definiert, die zum Laden und Speichern von Materialien bestimmt ist, die für die pharmazeutischen Präparate erforderlich sind, und wobei die Einrichtungszone oder -fläche (20) einen Bereich definiert, in dem die Arzneimittelherstellung mit den Materialien durchgeführt wird, die mittels eines ersten Robotermanipulators (30) und eines zweiten Robotermanipulators (31), die miteinander und mit für die Arzneimittelherstellung funktionalen Vorrichtungen zusammenwirken, die gleichzeitig verschiedene Aktionen in Bezug aufeinander ausführen, um Einrichtungs- und Zubereitungsvorgänge in "maskierter Zeit", das heißt parallel zueinander, durchzuführen, aus der Lagerzone oder -fläche entnommen werden, dadurch gekennzeichnet, dass die Lagerzone oder -fläche (18) einen vorderen Teil (18") und einen hinteren Teil (18"') umfasst, die durch eine öffnungsfähige Tür voneinander getrennt sind, wobei der vordere Teil (18") durch eine Glasscheibe von der äußeren Umgebung getrennt ist, die nur einen Raum zum Einführen der Hand eines Bedieners frei lässt, wobei der vordere Teil (18") und der hintere Teil (18"') von einem unterschiedlichen vertikalen laminaren Luftstrom zwischen den zwei Teilen getroffen werden, und dass die Einrichtungszone oder -fläche (20) einen vorderen Teil (20") und einen hinteren Teil (20"') umfasst, die durch eine öffnungsfähige Tür (27) voneinander getrennt sind, wobei der vordere Teil (20") durch eine Glasscheibe von der äußeren Umgebung getrennt ist, die nur einen Raum für das Einführen der Hände des Bedieners frei lässt, der vordere Teil (20") und der hintere Teil (20"') von einem unterschiedlichen vertikalen laminaren Luftstrom zwischen den zwei Teilen getroffen werden.
  2. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass der vordere Teil (18") in der Lagerzone oder -fläche (18) mit einer Arbeitsfläche (17) für einen Bediener versehen ist und der hintere Teil (18"') ein Lager (26), den vorderen Teil (20") und den hinteren Teil (20"') der Einrichtungszone oder -fläche (20) umfasst, wobei der vordere Teil (20") eine Arbeitszone für den Bediener definiert und der hintere Teil (20"') einen Arbeitsbereich für den ersten Manipulator (30) und den zweiten Manipulator (31) und für die zur Herstellung funktionalen Vorrichtungen definiert.
  3. Vorrichtung nach einem der vorherigen Ansprüche, dadurch gekennzeichnet, dass das Lager (26), das in dem hinteren Teil (18"') der Lagerzone oder -fläche (18) angeordnet ist, eine drehende Struktur (oder Revolver) umfasst, die aus einer oder mehreren Scheiben besteht, die übereinander und parallel zueinander angeordnet und in Bezug auf eine mittlere, vertikal angeordnete Drehwelle (26A) stabilisiert sind, die eine oder die mehreren Scheiben mit Einsätzen zum Laden der Materialien versehen sind, die zum Herstellen der Arzneimittel erforderlich sind.
  4. Vorrichtung nach einem der vorherigen Ansprüche, dadurch gekennzeichnet, dass der vordere Teil (20") der Einrichtungszone oder -fläche (20) ein Spritzenlager (33) umfasst, umfassend ein Eingang-Spritzenlager oder IN-Spritzenlager (33') und ein Ausgang-Spritzenlager oder OUT-Spritzenlager (33"), das IN-Spritzenlager (33') umfassend eine Vielzahl von geneigten Führungen (51) zum Aufnehmen von zu befüllenden leeren Spritzen, und das OUT-Spritzenlager (33') umfassend geneigte Führungen (52) zum Speichern von Spritzen, die mit einem Arzneimittelpräparat oder einem Fertigprodukt gefüllt sind.
  5. Vorrichtung nach einem der vorherigen Ansprüche, dadurch gekennzeichnet, dass der hintere Teil (20"') der Einrichtungszone oder -fläche (20) einen ersten Manipulator (30) und einen zweiten Manipulator (31) sowie funktionale Vorrichtungen zum Zusammenwirken mit den Manipulatoren umfasst und eine erste Waage (36) umfasst, die an einer Trennwand (22) zwischen der Lagerzone oder -fläche (18) und der Einrichtungszone oder -fläche (20) angeordnet ist, eine zweite Waage (38), die einer rechten Wand der Einrichtungszone oder -fläche (20) gegenüber der Trennwand (22) angeordnet ist, ein Verdünnungsmittelgestell (40), das an der ersten Waage (36) angeordnet ist, ein Fläschchen-Arzneimittel-Drehtisch (42), eine erste Dosiervorrichtung (44), die zwischen dem ersten Manipulator (30) und dem zweiten Manipulator (31) angeordnet ist, eine zweite Dosiervorrichtung (46), ein erstes Gestell (48), das an einer öffnungsfähigen Tür (27) an einer inneren Vorderseite stabilisiert ist, die der Richtung des hinteren Teils (20"') zugewandt ist, ein zweites Gestell (50), das an der zweiten Waage (38) angeordnet ist, eine erste visuelle Erfassungseinrichtung (oder erste Kamera) (52), die an der Arbeitsbereich des ersten Manipulators (30) angeordnet ist, einen Spritzendrehtisch (53), der an einer rechten Wand der Einrichtungszone oder -fläche (20) gegenüber der Trennwand (22) angeordnet ist, eine zweite visuelle Erfassungseinrichtung (oder zweite Kamera) (54), die an dem Spritzendrehtisch (53) angeordnet ist, ein Abgabesystem (56), das an dem Fläschchen-Drehtisch (42) angeordnet ist.
  6. Vorrichtung nach Anspruch 5, dadurch gekennzeichnet, dass die erste Dosiervorrichtung (44) eine Dosiervorrichtung für die Infusion eines Arzneimittels mittels eines geschlossenen Kupplungssystems definiert und einen Basiskörper (58) umfasst, der an einer inneren unteren Wand des hinteren Teils (20"') der Einrichtungszone oder -fläche (20) stabilisiert ist und einen Trägerkörper für Einrichtungen bildet, die zum Füllen einer Spritze (59) funktional sind, vertikal angeordnet sind und eine Eingriffsanordnung (60) für eine Spritze (59) umfassen, eine Schraubanordnung (61), die an der Unterseite in Bezug auf die Eingriffsanordnung (60) angeordnet ist und funktional ist, die an der Eingriffsanordnung (60) stabilisierte Spritze zu drehen, um ein Kuppeln eines handelsüblichen "Luer-Lock"-Verbinders davon mit einem "Spike"-Verbinder für Verdünnungsmittel/Arzneimittel zu ermöglichen, eine Gehäuseanordnung (62) für Verdünnungsmittel/Arzneimittel, die unterhalb der Schraubanordnung (61) angeordnet ist, und eine Schieberanordnung (64), die oberhalb der Eingriffsanordnung (60) angeordnet und in Bezug auf die Eingriffsanordnung (60) vertikal nach unten und nach oben bewegbar ist.
  7. Vorrichtung nach Anspruch 5, dadurch gekennzeichnet, dass die zweite Dosiervorrichtung (46) eine Extraktionsdosiervorrichtung mittels eines geschlossenen Kupplungssystems definiert, umfassend einen Basiskörper (64), der an einer inneren Bodenwand des hinteren Teils (20"') der Einrichtungszone oder -fläche (20) stabilisiert ist, an dem die funktionalen Einrichtungen zum Durchführen des Extraktionsvorgangs stabilisiert sind, umfassend eine Arzneimittelflasche-Aufnahmeanordnung (66) und eine Spritzeneingriffsanordnung (68) für eine Spritze (59), eine Schraubanordnung (69), die angepasst ist, um eine Spritze zu drehen, um ein Koppeln eines handelsüblichen "Luer-Lock"-Verbinders an einen "Spike"-Verbinder der Arzneimittelflasche zu ermöglichen, die mit dem Inhalt einer Arzneimittelflasche gefüllt werden soll, die zwischen der Arzneimittelflasche-Aufnahmeanordnung (66) und der Spritzeneingriffsanordnung (68) angeordnet ist, und eine Drückeranordnung (70), umfassend einen vertikal nach oben/unten bewegbaren Drücker (70) und eine Drückereingriffsstelle (70"), die gemäß einer horizontalen Richtung bewegbar und mit einem Eingriffselement für die Spritze versehen ist, wobei die Drückereingriffsstelle (70") mit dem Drücker (70') gekoppelt ist, wobei die Drückeranordnung (70') unterhalb der Spritzeneingriffsanordnung (68) angeordnet ist.
  8. Verfahren zum Herstellen von Arzneimitteln mittels der Vorrichtung nach einem der vorherigen Ansprüche, dadurch gekennzeichnet, dass es betriebliche Makroschritte umfasst, umfassend einen Vorbereitungs- und Lademakroschritt, einen Einrichtungsmakroschritt und einen Entladungsmakroschritt, wobei es möglich ist, die Makroschritte gleichzeitig durchzuführen.
  9. Verfahren nach Anspruch 8, dadurch gekennzeichnet, dass der Vorbereitungs- und Lademakroschritt Vorgänge zum Vorbereiten der Vorrichtung mit automatischer Kalibrierung der Verarbeitungsvorrichtungen, manuellem Einrichten des Materials und dessen geführtem Laden in die Vorrichtung zum Herstellen von Arzneimittel umfasst, mit einem Bediener auf der Arbeitsoberfläche (17) des vorderen Teils (18") der Lagerzone oder -fläche (18), der die Verdünnungsmittelbehälter und die Arzneimittelflaschen vorbereitet, sie mit handelsüblichen Spike-Verbindern versieht und alles in das Lager (26) lädt, und der die Spritzen vorbereitet und sie in das IN-Spritzenlager (33') des Spritzenlagers (33) der Einrichtungszone oder -fläche (20) lädt.
  10. Verfahren nach Anspruch 8, dadurch gekennzeichnet, dass die Vorbereitung des Materials und dessen Laden in die Maschine ohne das notwendige Vorhandensein von validierten Rezepten erfolgt und den Schritt eines Druckens interner Strichcodes (oder QR-Codes) und deren Anbringen auf den endgültigen Behältern (Verdünnungsmittel und Spritzen) vor Einsetzen in die Maschine mit der Zuordnung zu dem spezifischen Rezept des Patienten umfasst, was in dem Einrichtungs-Makroschritt mittels visueller Erfassungssysteme (oder Kameras) erfolgt.
  11. Verfahren nach Anspruch 8, dadurch gekennzeichnet, dass in dem Einrichtungs-Makroschritt, da der erste Manipulator (30) und der zweite Manipulator (31) miteinander und mit den Herstellungsvorrichtungen zusammenwirken und da diese Elemente unterschiedliche Aktionen in Bezug zueinander, aber gleichzeitig ausführen, die Einrichtungs- und Vorbereitungsvorgänge in "maskierter Zeit" gemäß einer Produktionszyklus-Ausführungslogik erfolgen, die den Abschluss mehrerer Vorbereitungen in der kürzest möglichen Zeit beinhaltet.
  12. Verfahren nach Anspruch 10, dadurch gekennzeichnet, dass der Einrichtungs-Makroschritt einen optionalen Schritt eines Entfernens des Verdünnungsmittels mittels einer Dosiervorrichtung (56) umfasst, der darauf abzielt, die vorgeschriebenen Konzentrationen von Wirkstoff-Verdünnungsmittel durch mögliches Entfernen der Überfüllung einzuhalten.
  13. Verfahren nach Anspruch 10, dadurch gekennzeichnet, dass der Einrichtungs-Makroschritt einen Schritt eines automatischen Kalibrierens des Hubs der zweiten Dosiervorrichtung (46) abhängig von dem für die Spritzen erfassten tatsächlichen Gewicht umfasst.
  14. Verfahren nach Anspruch 8, dadurch gekennzeichnet, dass der Einrichtungs-Makroschritt einen Schritt eines Aufnehmens des Fertigprodukts durch den Bediener umfasst, wobei das Fertigprodukt, im Fall einer Fertigproduktflasche, von dem Wagen (25) aufgenommen wird, der gleitend von dem vorderen Teil (20") der Einrichtungszone oder - fläche (20) zu dem vorderen Teil (18") der Lagerzone oder -fläche (18") bewegt wird, und/oder von der mit Medikamenten gefüllten Spritze, die von dem OUT-Spritzenlager (33") des Spritzenlagers (33) aufgenommen wird.
  15. Verfahren nach Anspruch 14, dadurch gekennzeichnet, dass das Entladen des Fertigprodukts in diesem Makroschritt separat und unabhängig von der Einrichtung erfolgt, mit der Möglichkeit, mehrere Produktionen von fertigen Präparaten in Verdünnungsbehälter und Spritzen zu entladen.
  16. Verfahren nach Anspruch 9 oder 10, dadurch gekennzeichnet, dass der Einrichtungs-Makroschritt des fertigen Produkts einen Schritt eines Erzeugens eines Etiketts mit allen Informationen über die Verschreibung umfasst, die zum Validieren des hergestellten Arzneimittels zu verwenden sind, wobei das Etikett eine Datenmatrix beinhaltet, die alle Informationen über einen bestimmten Patienten und die damit assoziierbaren Verschreibungen enthält und von den Infusionspumpen lesbar ist.
EP24190105.7A 2023-08-02 2024-07-22 Vorrichtung und verfahren zur herstellung von arzneimitteln Active EP4501301B1 (de)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IT102023000016383A IT202300016383A1 (it) 2023-08-02 2023-08-02 Apparato e procedimento per la preparazione di farmaci

Publications (3)

Publication Number Publication Date
EP4501301A1 EP4501301A1 (de) 2025-02-05
EP4501301C0 EP4501301C0 (de) 2025-12-24
EP4501301B1 true EP4501301B1 (de) 2025-12-24

Family

ID=88413459

Family Applications (1)

Application Number Title Priority Date Filing Date
EP24190105.7A Active EP4501301B1 (de) 2023-08-02 2024-07-22 Vorrichtung und verfahren zur herstellung von arzneimitteln

Country Status (3)

Country Link
EP (1) EP4501301B1 (de)
ES (1) ES3060636T3 (de)
IT (1) IT202300016383A1 (de)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2932085B1 (fr) * 2008-06-06 2012-08-10 Pharmed Sam Station de travail automatisee pour la preparation securisee d'un produit final a usage medical ou pharmaceutique
ITUA20161408A1 (it) * 2016-03-07 2017-09-07 Swisslog Italia Spa Macchina e procedimento per la preparazione di medicamenti intravenosi
KR101875013B1 (ko) * 2016-06-28 2018-07-05 주식회사 엔티로봇 약제 조제장치 및 조제방법
GB202104761D0 (en) * 2021-04-01 2021-05-19 3P Innovation Ltd Method of Filling Pharmaceutical Containers

Also Published As

Publication number Publication date
EP4501301A1 (de) 2025-02-05
IT202300016383A1 (it) 2025-02-02
EP4501301C0 (de) 2025-12-24
ES3060636T3 (en) 2026-03-27

Similar Documents

Publication Publication Date Title
EP1889197B1 (de) Automatisches apotheken-mischsystem (apas)
EP2465483B1 (de) Automatisiertes Arzneimittelzubereitungssystem (APAS)
EP1830782B1 (de) Automatisches Apotheken-Mischsystem (APAS)
EP3038926B1 (de) Robotersystem zum mischen von medikamenten
US7681606B2 (en) Automated system and process for filling drug delivery devices of multiple sizes
CA2756095C (en) Automated pharmacy admixture system
EP3427238B1 (de) Maschine und verfahren zur herstellung intravenöser medikamente
CA2607449C (en) Automated pharmacy admixture system (apas)
EP4501301B1 (de) Vorrichtung und verfahren zur herstellung von arzneimitteln
CN119014679A (zh) 智能药柜、智能配药系统及自动出药方法
HK1226374B (en) Robotic system for compounding medication
HK1226374A1 (en) Robotic system for compounding medication

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION HAS BEEN PUBLISHED

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC ME MK MT NL NO PL PT RO RS SE SI SK SM TR

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE

17P Request for examination filed

Effective date: 20250416

GRAP Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOSNIGR1

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: GRANT OF PATENT IS INTENDED

INTG Intention to grant announced

Effective date: 20250606

GRAS Grant fee paid

Free format text: ORIGINAL CODE: EPIDOSNIGR3

GRAA (expected) grant

Free format text: ORIGINAL CODE: 0009210

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE PATENT HAS BEEN GRANTED

AK Designated contracting states

Kind code of ref document: B1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC ME MK MT NL NO PL PT RO RS SE SI SK SM TR

REG Reference to a national code

Ref country code: CH

Ref legal event code: F10

Free format text: ST27 STATUS EVENT CODE: U-0-0-F10-F00 (AS PROVIDED BY THE NATIONAL OFFICE)

Effective date: 20251224

Ref country code: GB

Ref legal event code: FG4D

REG Reference to a national code

Ref country code: DE

Ref legal event code: R096

Ref document number: 602024001817

Country of ref document: DE

U01 Request for unitary effect filed

Effective date: 20260109

U07 Unitary effect registered

Designated state(s): AT BE BG DE DK EE FI FR IT LT LU LV MT NL PT RO SE SI

Effective date: 20260116

REG Reference to a national code

Ref country code: ES

Ref legal event code: FG2A

Ref document number: 3060636

Country of ref document: ES

Kind code of ref document: T3

Effective date: 20260327

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: NO

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20260324

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: HR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20251224

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: RS

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20260324