EP2236199B1 - Process and installation for automatic sterile dosing and mixing of infusions - Google Patents

Process and installation for automatic sterile dosing and mixing of infusions Download PDF

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Publication number
EP2236199B1
EP2236199B1 EP10158580A EP10158580A EP2236199B1 EP 2236199 B1 EP2236199 B1 EP 2236199B1 EP 10158580 A EP10158580 A EP 10158580A EP 10158580 A EP10158580 A EP 10158580A EP 2236199 B1 EP2236199 B1 EP 2236199B1
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EP
European Patent Office
Prior art keywords
mixing
room
syringe
robot
bottle
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EP10158580A
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German (de)
French (fr)
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EP2236199A2 (en
EP2236199A3 (en
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Ludger Fischer
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    • 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
    • B01F33/85—Mixing plants with mixing receptacles or mixing tools that can be indexed into different working positions
    • 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
    • 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

Definitions

  • the present invention relates to a method as well as a device for the automated sterile dosing and mixing of infusions according to individually prepared recipes. So far, the attending physician defined by his diagnosis, a certain composition or mixture and dosage of an infusion for a particular patient. After this individual recipe, the infusion is then prepared under sterile conditions. Until now, this work had to be done by hand, because no automation seemed possible, because it is about the provision of individual and thus constantly changing recipes. In principle, errors due to human error are possible, and the traceability of the infusions produced in this way is not completely guaranteed. Due to the manual preparation of the infusions, because of the applicable guidelines and regulations, many very expensive active ingredients are disposed of, for example because a bottle that has once been opened may not necessarily be reused. In addition, there is a risk for the staff, because in case of puncture injuries, contamination with antibodies can not be ruled out.
  • doses are determined by the doctors, which unfortunately do not allow the complete exhaustion of drug units. For example, if a drug or drug in a pack size of 150mg offered and prescribed by the doctor in a dosage of 330mg, the third pack only started and 120mg are thrown away or disposed of. Further use is only possible under very specific circumstances. However, if one could work completely sterile and reliably avoid backmixing, then broken portions of the active ingredient could continue to be used. Achieving this is one of the objects of the present automated method and apparatus for its implementation.
  • Dosing and mixing in the clinic would facilitate a patient-oriented, individualized dosage.
  • the communication steps for the delivery of infusions are to be reduced and the manufacture in the clinic should increase the safety and extend the shelf life of the infusions. It should also be ensured traceability of all handling steps.
  • the dosages should be achieved by accurate weighing as a method of measurement, which can be checked again by weighing after completion of the dosage.
  • WO 2008/012596 discloses an apparatus for producing pharmaceutical products, comprising gripping and transport means, by means of which containers can be moved back and forth between a magazine and a dosing station.
  • a device for automated dosing and mixing of active substances for the preparation of patient-friendly infusions for installation in a class B or C clean room, comprising a computer with robot control software, a storage space for educts with a shelf tablet, a clean room class A mixing room with constant ventilation, and therein a shelf tray and a mixing vessel scale and a disposal container, and a storage space for the finished products, with carried by a carousel receptacles, wherein the mixing chamber includes a robot with a gripper and with a suction syringe, with which gripper computer controlled certain vials from the storage room in the mixing room are holbar, as well as with which suction computer-controlled starting materials from the parked in the mixing chamber vials and ejected into a mixing vessel on the mixing vessel scale in the mixing chamber, and with which suction syringe except em mixtures from the mixing vessel and sucked into the receptacle for the finished product can be e
  • FIG. 1 the entire facility is shown. It forms a complete workplace for mixing and providing application-capable infusions.
  • this facility includes a storage room 1 for reactants 2 to be mixed, that is to say for the pure active ingredients or medicaments, as they are to be administered to the patient in certain concentrations and dosages by means of infusions.
  • the vials 3 or also called vials, which contain the educts 2, are in a shelf tray 4 with, for example, as shown here 7 x 3 holes for placing the educt vial 3.
  • each vial 3 at a well-defined location in the shelf. 4 stored.
  • the vials 3 are first sorted by hand in the shelf trays 4 on the table 9 left of the device and afterwards the shelf trays 4 are put into the storage room 1.
  • a scanner 12 on which the individual educt vial 3 can be identified by their barcodes. With a cooling circuit, this cools the bottom of the storage room 1 as well as the adjoining mixing chamber 10, so that it can be maintained at a temperature of about 6 ° ⁇ 2 ° C.
  • the educt vial 3 are within the shelf tray 4 on this cooled floor, so that the reactants 2 are cooled.
  • a mixing chamber 10 connects. This is designed as a class A cleanroom and is therefore constantly flowed through by filtered air.
  • the mixing chamber 10 includes a robot that functions similarly to a bridge crane.
  • the side walls of the mixing chamber are 10 as you can see provided with recesses 25 through which air always flows through from the mixing chamber 1, but never in the opposite direction.
  • a gripper 15 and a syringe 16 reciprocates, and the whole rail 11 also runs along the side rails 14 in the direction of the viewer backwards and forwards.
  • the side rails 14 are partially visible on the outer side walls of the storage room 1 and the discharge space 13.
  • the gripper 15 and the syringe 16 can move on the rail 11 back and forth, and the whole rail 11 can move forward and backward and also, the gripper 15 and the syringe 16 on the rail 11 by means of a mechanical, electrical , pneumatic or hydraulic drive up and drive down.
  • a shelf tray 4 which is empty at the moment.
  • a mixing vessel scale 17 is arranged, and disposed between the shelf tray 4 and the mixing vessel 17, slightly offset to the rear, one recognizes a disposal hole 18 in the bottom of the mixing chamber 10. Through this disposal hole 18 spent vials can be disposed of and then fall into a the disposal hole 18 attached waste container 26.
  • a syringe magazine 22 is housed at the right side wall of the mixing chamber 10.
  • a carousel 19 is arranged, with a shaft 23 as a rotation axis and attached turntables 31,32, which are provided at its edge with incisions so that infusion bottles 20 between these turntables 31,32 are suspended.
  • This carousel 19 is rotatable by motor and the motor is controlled by the computer 6, as well as the entire robot with its gripper 15 and its syringe 16 is controllable in its movements.
  • a scanner 21 Inside the dispensing compartment 13 there is also a scanner 21 which can read the bar codes on the infusion bags 20 as they pass it.
  • FIG. 2 is the storage room 1 seen from the front.
  • Cross rail 11 which is mounted laterally on the side rail 14 and can drive along the same as a whole to the front and rear, that is perpendicular to the drawing sheet level.
  • the electric motor 30 is on the floor of the storage room 1 are three shelf trays 4 side by side.
  • the bottom of the storage room 1 is cooled by means of the cooling circuit already described, so that the active ingredients in the vial 3 are durable.
  • the shelf tray on the right contains mixing vessels 24.
  • FIG. 3 is the mixing chamber 10 seen from the front.
  • the robot gripper 15 can take the vial in the underlying shelf trays 4 or they can place targeted in these shelf trays 4.
  • the robot syringe 16 can be seen, which can enter through the septums in the individual vials in the shelf trays 4.
  • Both elements that is, the robot gripper 15 as well as the robot syringe 16 can move together along the rail 11 back and forth and drive together with the rail 11 forward or backward.
  • the gripper 15 and the syringe 16 can move up and down the rail 11, so they can move in all three spatial directions.
  • the syringe 16 is connected to the robot so that it can be lowered to the bottom of a vial 3 with a certain adjustable contact pressure is.
  • This can be solved so that the electric motor moves the syringe by means of a threaded spindle downwards and then suddenly after impingement of the syringe tip on the bottom of the bottle, the torque on the electric motor of the linear drive increases sharply, which correlates with the absorption current of the electric motor. On the recording current, which can be interrupted when reaching a certain size, therefore, can adjust the torque and thus the contact pressure.
  • Another solution may be that the syringe 16 hangs on the robot via a compression spring.
  • an expansion strip may be attached, which leads to a stationary part above the robot and is fixed there.
  • the syringe is then driven by motor, electric, pneumatic or hydraulic down.
  • motor, electric, pneumatic or hydraulic down When its tip hits the bottom of a vial, further downward movement of the robot is accomplished by compressing the compression spring and at the same time the stretchstrip is stretched. Depending on the strain, it gives off an altered electrical signal, which then gives a measure of the pressure applied.
  • FIG. 4 one sees the carousel 19 for a total of 10 infusion bottles 20.
  • the shaft 23 of the carousel 19, which is mounted above and below in the output space is sealed by Simmeringen and stored in closed ball bearings. It can be easily removed.
  • This carousel 19, which includes two externally provided with cuts turntables 31,32 is hung after the placement of these 10 infusion bottles 20 in the interior of the output space 13, where it is rotatable by motor.
  • the dispensing space 13 is equipped with a scanner 21 which can read the patient-specific barcodes on the infusion bottles 20 and the locations of the individual infusion bottles 20 in the carousel 19 are numbered.
  • the carousel 19 is rotated past the scanner 21 with the infusion bottles 20 and can be stopped in any desired position, with a ⁇ 1mm accuracy over the X and Y coordinates so that a well-defined infusion bottle 20 will ultimately be pierced by the syringe because the System includes a position detection.
  • FIG. 5 is a shelf tray 4 shown in a section. These shelf trays preferably consist of a plurality of spaced apart stacked Plexiglas plates.
  • the adjustment holes 27 are of stepped diameters so that, as shown, vials 3 of different diameters can be received without wobble.
  • These are active ingredient vials 3 from 10ml to 25ml content for highly active substances such as Avastin or Herceptin from Roche or similar substances from other companies. The excipients, however, are present in larger vials 3 of 50ml content.
  • FIG. 1 is a shelf tray 4 shown in a section. These shelf trays preferably consist of a plurality of spaced apart stacked Plexiglas plates.
  • the adjustment holes 27 are of stepped diameters so that, as shown, vials 3 of different diameters can be received without wobble.
  • These are active ingredient vials 3 from 10ml to 25ml content for highly active substances such as Avastin or Herceptin from Roche or similar substances from other companies.
  • FIG. 6 shows, on the left, a shelf tray 4 for active substance vial 3, viewed from above, with 3 ⁇ 7 holes 27 and, to the right, a shelf tray for auxiliary vials with 2 ⁇ 5 larger holes 28 for receiving larger vials 3.
  • the FIG. 7 finally shows a shelf tray 4 for the mixing chamber 10, which has 3 x 5 holes 27 for stock solutions, ie for drug vial 3, and a larger hole 28 for a carrier solution bottle (NaCl).
  • the entire facility as in FIG. 1 is shown in a class B or C clean room, while the mixing vessel space 3 itself forms a class A clean room.
  • the mixing vessel space 3 must have a supply and exhaust air connection, which are connected to an external fan with Hepafilter so that it is constantly flowed through by a defined flow of air.
  • All three rooms 1, 10 and 13 are made of smooth flat surfaces, making them easy to clean, and they can be closed with doors or covers.
  • the doors are electronically interrogated, whether they are open or closed, but must not be locked and lockable.
  • the entire device is operated and controlled via an associated external PC 6 with monitor 8 and keyboard 7 or optionally via a touch screen and the monitor 8 of the device displays its status, for example, which recipe is being mixed.
  • the operator typically a medical-technical assistant or assistant MTA prepares the placement of the storage room 1, which happens on the preparation table 9.
  • the prescriptions come in the form of electronic data, which are read into the computer.
  • the computer calculates afterwards, which Edukte are necessary, and afterwards, like the shelf tray with which educt vial 3 is to be equipped wisely.
  • the vials 3 are provided, prior to insertion into the shelf tray 4, with a bar code which, for example, is glued to the bottom of the vial 3 at the bottom.
  • Some products already have a barcode attached by the manufacturer. In the goods receiving the own barcodes are retrofitted with such products. The most space in this case is the bottom of the bottle.
  • the barcodes are attached to the cylindrical part of the vial. Then the bar code scanner must be sideways and the bottle gripper must make a rotary motion to interrogate the entire cylinder cylinder.
  • the vials are simply held over the upwardly facing scanner, similar to the system used by a purse, and are uniquely identified. This marking on the bottom of the bottle is the superior system as it is technically easier to implement and ensures traceability. It is only more elaborate in the receipt of goods.
  • the software of the computer indicates the MTA when loading the input products by a position specification, where exactly the vial 3 in the shelf tray 4 must be used.
  • the vials 3 are later scanned by the mixing machine with the barcode scanner before use, so that misuse by the MTA is detected immediately prior to mixing. This individualized detection of each vial 3 is the first time a clear traceability is given. This ultimately makes it possible to implement a traceable information chain from the goods receipt to the patient, and this applies to each individual vial 3.
  • the shelf trays 4 are coded with lugs and guide pins and therefore can not be arbitrarily, but only in the correct direction and position in the storage room 1 are inserted.
  • the sealing seals of the vials 3 are removed. It refers to Metal caps that are removed so that afterwards only the septums close the vials 3.
  • a shelf tray 4 When a shelf tray 4 is fully stocked by the MTA, it is inserted into the storage room 1 and hence the starting materials are cooled by the bottom of the storage room 1 and kept at a temperature of about 6 ° ⁇ 2 ° C.
  • the dosing and mixing process starts for a recipe read into the computer and is then carried out completely automatically.
  • the gripper 15 first gets an auxiliary bottle from the storage room 1 and places it after passing the scanner 12 and according to their identification in the larger hole 28 in the shelf tray 4 in the mixing chamber 1. Thereafter, the gripper 15 moves back into the storage room 1 and over the shelf tray 4 and knows in which position (xy coordinate) the required drug vial 3 with the desired starting material 2 inserted.
  • the gripper 15 grips this vial 3 and holds it in front of the scanner 12 in the storage room 1. It rotates it around the axis if the barcode is placed laterally so that it can be safely read by the scanner 12, or if the barcode is on the bottom of the bottle The gripper 15 holds the bottle 3 over the scanner 12. After correctly identifying the bottle 3, the gripper 15 brings it into the mixing chamber 10 and places it there at a position calculated in the shelf tray 4 by the computer 6. Afterwards we fetched the second, third, fourth, etc. vials 3 in the same way from the storage room 1 and, after proper identification, deposited them in the mixing chamber 10. The robot also fetches a mixing vessel 24 in the storage room 1 and places it on the mixing balance 17. Once the necessary vials 3 with their educts 2 and the excipient bottle and the mixing vessel 24 are placed in the mixing chamber 10, the dosage and mixing can begin.
  • the robot gets a new syringe 16 from the syringe magazine 22 in the mixing chamber 10. Then he leads the syringe 16 into the excipient bottle.
  • the tip of the syringe 16 pierces the septum and descends to the bottom of the bottle until the syringe tip applies a certain adjustable force to the bottom of the bottle.
  • the piston in the syringe is controlled by the computer computer controlled a precisely defined measure reduced and the syringe 16 therefore sucks excipient of a very specific volume from the bottle.
  • the syringe 16 is then moved over the mixing vessel 24 on the balance 17 and the piston is moved forward to the stop in the syringe 16, which thereby emits its contents in the mixing vessel 24. In this case, the weight increase of the mixing vessel 24 is measured and recorded.
  • the robot drives the syringe 16 into the first drug vial 3.
  • the tip of the syringe 16 pierces the septum and is driven down to the bottom of the bottle until the syringe tip applies a certain adjustable force to the bottom of the bottle.
  • the piston in the syringe 16 is controlled by the computer controlled a precisely defined Mass reduced and the syringe 16 therefore sucks active substance of a very specific volume from the vial 3.
  • the syringe is then moved over the mixing vessel 24 and the piston is to the front to stop drove in the syringe, which thereby emits their contents in the mixing vessel 24. This process is repeated until the desired amount of active ingredient in the mixing vessel 24 is. Then it is repeated with the next active substance, etc., until all the active ingredients in the desired dose are in the mixing vessel 24 and mix there.
  • the infusion bottle 20 previously rotated to the exceptional position is pierced with the syringe tip, and the plunger in the syringe 16 is moved forward, so that the syringe contents are dispensed into the infusion bottle 20.
  • the robot with the syringe 16 moves back into the mixing chamber 10 and drops it over the disposal hole 18 into the disposal container 26.
  • the gripper 15 then collects the empty active substance bottles 3 together and leaves them fall over the disposal hole 18.
  • the excipient bottle and the mixing vessel 24 are disposed of.
  • the shelf tray 3 is re-stocked in the storage room 1, whereby opened drug vials 3 can be putbenweilt, as well as a broken aid bottle also.
  • a new mixing vessel 24 is placed on the mixing balance 17 each time.
  • a new dosing and mixing passage begins and the next infusion bottle 20 is filled until all the infusion bottles 20 of the carousel 19 are filled.
  • a signal is emitted to allow the MTA to recognize that it can now remove the infusion bottles 20 from the dispensing compartment 13 and populate them with new empty infusion bottles 20.
  • Each infusion bottle 20 contains the infusion mixture defined according to its barcode, which is tailored to a very individual patient. The entire dosage and mixture is documented by the recorded in the computer 6 steps of the mixing process and detectable at any time.
  • the dosage and mixture is safer, faster and more economical. In addition, any danger to personnel caused by stabs and contamination is excluded.

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Description

Die vorliegende Erfindung betrifft ein Verfahren wie auch eine Einrichtung zum automatisierten sterilen Dosieren und Mischen von Infusionen nach individuell erstellten Rezepten. Bisher definiert der behandelnde Arzt aufgrund seiner Diagnose eine bestimmte Zusammensetzung bzw. Mischung und Dosierung einer Infusion für einen bestimmten Patienten. Nach diesem individuellen Rezept wird hernach die Infusion unter sterilen Bedingungen vorbereitet. Diese Arbeiten müssen bisher von Hand durchgeführt werden, weil keine Automatisierung möglich schien, denn es geht ja um die Bereitstellung individueller und somit stets wechselnder Rezepturen. Grundsätzlich sind dabei Fehler wegen menschlichen Versagens möglich, und die Nachverfolgbarkeit der so hergestellten Infusionen ist nicht lückenlos gewährleistet. Aufgrund der händischen Aufbereitung der Infusionen werden wegen der anzuwendenden Richtlinien und Vorschriften auch viele sehr teure Wirkstoffe entsorgt, weil zum Beispiel eine einmal angebrochene Flasche nicht unbedingt wiederverwendet werden darf. Ausserdem besteht ein Risiko für das Personal, denn bei Stichverletzungen können Kontaminationen mit Antikörpern nicht ausgeschlossen werden.The present invention relates to a method as well as a device for the automated sterile dosing and mixing of infusions according to individually prepared recipes. So far, the attending physician defined by his diagnosis, a certain composition or mixture and dosage of an infusion for a particular patient. After this individual recipe, the infusion is then prepared under sterile conditions. Until now, this work had to be done by hand, because no automation seemed possible, because it is about the provision of individual and thus constantly changing recipes. In principle, errors due to human error are possible, and the traceability of the infusions produced in this way is not completely guaranteed. Due to the manual preparation of the infusions, because of the applicable guidelines and regulations, many very expensive active ingredients are disposed of, for example because a bottle that has once been opened may not necessarily be reused. In addition, there is a risk for the staff, because in case of puncture injuries, contamination with antibodies can not be ruled out.

In der Regel werden von den Ärzten Dosierungen bestimmt, welche leider nicht das vollständige Aufbrauchen von Wirkstoffeinheiten ermöglichen. Wird beispielsweise ein Medikament oder Wirkstoff in einer Packungsgrösse von 150mg angeboten und vom Arzt in einer Dosierung von 330mg verschrieben, so wird die dritte Packung nur angebrochen und 120mg werden fortgeworfen bzw. entsorgt. Eine Weiterverwendung ist nur unter ganz bestimmten Umständen möglich. Könnte man aber komplett steril arbeiten und Rückvermischungen zuverlässig vermeiden, so könnten angebrochene Wirkstoffportionen weiter genutzt werden. Dieses zu erreichen ist einer der Aufgaben des vorliegenden automatisierten Verfahrens und der Einrichtung zu dessen Umsetzung.As a rule, doses are determined by the doctors, which unfortunately do not allow the complete exhaustion of drug units. For example, if a drug or drug in a pack size of 150mg offered and prescribed by the doctor in a dosage of 330mg, the third pack only started and 120mg are thrown away or disposed of. Further use is only possible under very specific circumstances. However, if one could work completely sterile and reliably avoid backmixing, then broken portions of the active ingredient could continue to be used. Achieving this is one of the objects of the present automated method and apparatus for its implementation.

Beim händischen Verarbeiten und Mischen von Antikörpern sind aufwändige Sicherheitsmassnahmen zu beachten, um die Personen, welche mit den Spritzen und diesen teils hochwirksamen und daher auch gefährlichen Wirkstoffen arbeiten, zuverlässig zu schützen. Es ist eine weitere Aufgabe dieses Verfahrens und der dazu nötigen Einrichtung, den Schutz der mit dem Mischen und Dosieren betrauten Personen entscheidend zu verbessern, indem diese den Wirkstoffen gar nicht mehr ausgesetzt werden.In the case of manual processing and mixing of antibodies, elaborate safety measures have to be observed in order to reliably protect the persons who work with the syringes and these partly highly effective and therefore also dangerous active substances. It is a further object of this method and the necessary equipment to significantly improve the protection of the entrusted with the mixing and dosing persons by these are no longer exposed to the active ingredients.

Eine Dosierung und Mischung in der Klinik, also direkt beim Patienten, würde eine patientenorientierte, individualisierte Dosierung erleichtern. Die Kommunikationsschritte für die Bereitstellung von Infusionen sollen reduziert und die Herstellung in der Klinik soll die Sicherheit erhöhen und die Haltbarkeit der Infusionen verlängern. Es soll ausserdem eine Rückverfolgbarkeit aller Handhabungsschritte gewährleistet werden. Die Dosierungen sollen durch genaues Wägen als Messmethode erzielt werden, was nach Abschluss der Dosierung nochmals durch Wägen überprüft werden kann.Dosing and mixing in the clinic, ie directly with the patient, would facilitate a patient-oriented, individualized dosage. The communication steps for the delivery of infusions are to be reduced and the manufacture in the clinic should increase the safety and extend the shelf life of the infusions. It should also be ensured traceability of all handling steps. The dosages should be achieved by accurate weighing as a method of measurement, which can be checked again by weighing after completion of the dosage.

Das Dokument WO 2008/012596 offenbart eine Vorrichtung zur Herstellung pharmazeutischer Produkte, umfassend Greif- und Transportmittel, mit deren Hilfe Behälter zwischen einen Magazin und einer Dosierstation hin-und herbewegt werden können.The document WO 2008/012596 discloses an apparatus for producing pharmaceutical products, comprising gripping and transport means, by means of which containers can be moved back and forth between a magazine and a dosing station.

Es ist daher die Aufgabe der vorliegenden Erfindung, ein Verfahren und eine Einrichtung zur automatisierten sterilen Dosierung und Mischung von Infusionen zu schaffen, damit die Bereitstellung von Infusionen im Vergleich zur Bereitstellung von Hand folgende Vorteile erbringt:

  • Schnellere Zubereitung
  • Rezepturüberprüfung und sichere Dosierung aufgrund erfasster und abgespeicherter Patientendaten
  • Genauere Mischung aufgrund gemessener Werte
  • Sterile Bearbeitung (besserer Schutz vor Infektionen)
  • Erhöhte Sicherheit durch Wegfall von Zwischenübertragungen von Dokumenten und damit Eliminierung von damit zusammenhängenden Fehlerquellen
  • Ausnutzung von Restmengen, da Bedingungen hierfür erfüllbar werden (Kosteneinsparung)
  • Rückverfolgbarkeit aller Schritte
  • Zugriff auf Rezepte, Produkte und Berechnungen nur mit Zutrittsberechtigung.
It is therefore the object of the present invention to provide a method and apparatus for automated sterile dosing and mixing of infusions so that the provision of infusions provides the following advantages as compared to the provision of hand:
  • Faster preparation
  • Recipe verification and safe dosage based on recorded and stored patient data
  • More accurate mixing due to measured values
  • Sterile processing (better protection against infections)
  • Increased security by eliminating intermediate transfers of documents and eliminating associated sources of error
  • Utilization of residual quantities, since conditions can be fulfilled (cost savings)
  • Traceability of all steps
  • Access to recipes, products and calculations only with access authorization.

Diese Aufgabe wird gelöst von einem Verfahren zum automatisierten Dosieren und Mischen von Wirkstoffen zur Aufbereitung von patientengerechten Infusionen, mit einer Einrichtung zum Aufstellen in einem Reinraum der Klasse B oder C, bestehend aus einem Lagerraum für Edukte, einem Mischraum der Reinraumklasse A mit ständiger Durchlüftung und einem Lagerraum für die fertigen Produkte, wobei

  1. a) aus einem Regaltablett mit den für die Aufbreitung der benötigten Infusion erforderlichen Edukte in Fläschchen (Vials) mit entfernten Metall-Kappen, aber intaktem Septum (Gummideckel), und vom Computer erfassten Standorten auf dem Regaltablett die nötigen Fläschchen computergesteuert nacheinander von einem Robotergreifer in einem Mischraum der Reinraumklasse A abgelegt werden,
  2. b) ein Mischbehälter vom Robotergreifer auf eine Mischwaage im Mischraum abgestellt und sein Gewicht gemessen und im Computer abgespeichert wird,
  3. c) mit einer Roboterspritze mit Saugkolben nacheinander unter Durchstechens des Septums in die einzelnen im Mischraum bereitgestellten Edukte-Fläschchen eingefahren wird, bis die Roboterspritze den Boden des Edukte-Fläschchens mit einer eingestellten Beaufschlagungskraft beaufschlagt,
  4. d) vom Computer gesteuert der Saugkolben soweit zurückfährt, dass das für die Rezeptur erforderliche gemessene Volumen dem Fläschchen entnommen wird,
  5. e) die Roboterspritze durch Ausfahren des Saugkolbens in das Mischgefäss entleert wird und dessen Gewicht erneut gemessen und erfasst wird, wonach die Schritte c) bis d) wiederholt werden, bis die Mischung in gewünschter Dosis im Mischgefäss erreicht ist,
  6. f) die Roboterspritze den Inhalt des Mischgefässes durch Zurückfahren des Saugkolbens aufnimmt und in eine an einem Karussell hängende, vorbezeichnete Infusionsflasche durch Ausfahren des Saugkolbens abgibt,
  7. g) der Robotergreifer die leeren oder für den nächsten Durchgang nicht mehr benötigten Edukte-Fläschchen sowie das Mischgefäss nacheinander ergreift und durch ein Loch im Mischraum entsorgt.
This object is achieved by a method for automated dosing and mixing of active ingredients for the preparation of patient-friendly infusions, with a device for installation in a clean room class B or C, consisting of a storage room for educts, a mixing room of clean room class A with constant ventilation and a storage room for the finished products, where
  1. a) from a shelf with the educts required for disseminating the required infusion in vials with removed metal caps, but intact septum (rubber lid), and computer recorded locations on the shelf tray the necessary vials computer controlled successively from a robot gripper in a mixing room of clean room class A are stored,
  2. b) a mixing container is parked by the robot gripper on a mixing balance in the mixing chamber and its weight is measured and stored in the computer,
  3. c) using a robot syringe with suction piston is retracted successively by piercing the septum into the individual educt vial provided in the mixing chamber until the robot syringe applies a set force to the bottom of the educt vial,
  4. d) controlled by the computer, the suction piston retracts far enough that the measured volume required for the formulation is taken from the vial,
  5. e) the robot syringe is emptied by extending the suction piston into the mixing vessel and its weight is measured and recorded again, after which steps c) to d) are repeated until the mixture in the desired dose in Mixing vessel is reached,
  6. f) the robot syringe receives the contents of the mixing vessel by retracting the suction piston and dispenses it into a pre-drawn infusion bottle hanging on a carousel by extension of the suction piston,
  7. g) the robotic gripper seizes the empty eductor vial, which is no longer required for the next pass, and the mixing vessel one after the other, and disposes of it through a hole in the mixing chamber.

Die Aufgabe wird weiter gelöst von einer Einrichtung zum automatisierten Dosieren und Mischen von Wirkstoffen zur Aufbereitung von patientengerechten Infusionen, zum Aufstellen in einem Reinraum der Klasse B oder C, bestehend aus einem Computer mit Roboter-Steuersoftware, einem Lagerraum für Edukte mit Regal-Tablett, einem Mischraum der Reinraumklasse A mit ständiger Durchlüftung, und darin einem Regaltablett und einer Mischgefässwaage und einem Entsorgungsbehälter, und einem Lagerraum für die fertigen Produkte, mit von einem Karusell getragenen Aufnahmebehältern, wobei der Mischraum einen Roboter mit einem Greifer und mit einer Saugspritze einschliesst, mit welchem Greifer computergesteuert bestimmte Fläschchen vom Lagerraum in den Mischraum holbar sind, sowie mit welcher Saugspritze computergesteuert Edukte aus den im Mischraum abgestellten Fläschchen saugbar und in ein Mischgefäss auf der Mischgefässwaage im Mischraum ausstossbar sind, und mit welcher Saugspritze ausserdem Mischungen aus dem Mischgefäss saugbar und in den Aufnahmebehälter für das fertige Produkt ausstossbar sind.The object is further achieved by a device for automated dosing and mixing of active substances for the preparation of patient-friendly infusions, for installation in a class B or C clean room, comprising a computer with robot control software, a storage space for educts with a shelf tablet, a clean room class A mixing room with constant ventilation, and therein a shelf tray and a mixing vessel scale and a disposal container, and a storage space for the finished products, with carried by a carousel receptacles, wherein the mixing chamber includes a robot with a gripper and with a suction syringe, with which gripper computer controlled certain vials from the storage room in the mixing room are holbar, as well as with which suction computer-controlled starting materials from the parked in the mixing chamber vials and ejected into a mixing vessel on the mixing vessel scale in the mixing chamber, and with which suction syringe except em mixtures from the mixing vessel and sucked into the receptacle for the finished product can be ejected.

In den Zeichnungen wird diese Einrichtung dargestellt und anhand dieser Zeichnungen wird das Verfahren sowie die Einrichtung selbst nachfolgend beschrieben, wobei die einzelnen Verfahrensschritte erläutert und die Funktionen der Einrichtung erklärt werden.In the drawings, this device is illustrated and with reference to these drawings, the method and the device itself will be described below, wherein the individual method steps are explained and the functions of the device are explained.

Es zeigt:

Figur 1:
Das Gerät mit all seinen Bestandteilen betriebsbereit eingerichtet;
Figur 2:
den Lagerraum von vorne gesehen;
Figur 3:
den Mischraum von vorne gesehen;
Figur 4:
den Ausgaberaum von vorne gesehen;
Figur 5:
ein Regal-Tablett in einem Schnitt gesehen;
Figur 6:
Ein Regal-Tablett für Wirkstoff-Fläschchen und Hilfstoff-Fläschchen;
Figur 7:
Ein Regal-Tablett für den Mischraum;
It shows:
FIG. 1:
The device with all its components ready for use;
FIG. 2:
the storage room seen from the front;
FIG. 3:
seen the mixing room from the front;
FIG. 4:
the output space seen from the front;
FIG. 5:
a shelf tray seen in a cut;
FIG. 6:
A shelf tray for drug vials and adjuvant vials;
FIG. 7:
A shelf tray for the mixing room;

In Figur 1 ist die gesamte Einrichtung dargestellt. Sie bildet einen kompletten Arbeitsplatz zum Mischen und Bereitstellen von applikationsfähigen Infusionen. Grundsätzlich gehört zu dieser Einrichtung ein Lagerraum 1 für zu mischende Edukte 2, das heisst für die reinen Wirkstoffe oder Medikamente, wie sie in bestimmten Konzentrationen und Dosierungen mittels Infusionen den Patienten zu verabreichen sind. Die Fläschchen 3 oder auch Vials genannt, welche die Edukte 2 enthalten, stehen in einem Regaltablett 4 mit zum Beispiel wie hier gezeigt 7 x 3 Löchern zum Hineinstellen der Edukte-Fläschchen 3. Damit ist jedes Fläschchen 3 an einem genau definierten Ort im Regaltablett 4 abgelegt. Die Fläschchen 3 werden zunächst von Hand in die Regaltabletts 4 auf dem Tisch 9 links neben der Einrichtung einsortiert und hernach werden die Regaltabletts 4 in den Lagerraum 1 hineingestellt. Hinten im Lagerraum 1 erkennt man einen Scanner 12, an welchem die einzelnen Edukte-Fläschchen 3 anhand ihrer Barcodes identifiziert werden können. Unterhalb des Lagerraums 1 erkennt man ein Kühlaggregat 5. Mit einem Kühlkreislauf kühlt dieses den Boden des Lagerraumes 1 wie auch des nebenstehenden Mischraumes 10, sodass dieser auf einer Temperatur von ca. 6°±2° C gehalten werden kann. Die Edukte-Fläschchen 3 stehen innerhalb des Regaltabletts 4 auf diesem gekühlten Boden, sodass auch die Edukte 2 gekühlt sind. Links neben dem Kühlaggregat 5 steht hier der Computer in Form eines Personal-Computers 6 mit zugehöriger Tastatur 7 und Monitor 8. Rechts neben dem Lagerraum 1 schliesst ein Mischraum 10 an. Dieser ist als Reinraum der Klasse A ausgelegt und wird daher laufend von gefilterter Luft durchströmt. Der Mischraum 10 enthält einen Roboter, der ähnlich wie ein Brückenkran funktioniert. Die Schiene 11, welche hier quer zur Blickrichtung des Betrachters verläuft, erstreckt sich in den Lagerraum 1 links vom Mischraum 10, sowie auch in den Ausgaberaum 13, der rechts an den Mischraum 10 anschliesst. Die Seitenwände des Mischraumes sind 10 wie man sieht mit Aussparungen 25 versehen, durch welche stets Luft aus dem Mischraum 1 durchströmt, aber niemals in umgekehrter Richtung. An dieser Schiene 11 des Roboters läuft ein Greifer 15 sowie eine Spritze 16 hin und her, und die ganze Schiene 11 läuft auch noch längs der Seitenschienen 14 in Blickrichtung des Betrachters nach hinten und vorne. Die Seitenschienen 14 sind an den äusseren Seitenwänden des Lagerraums 1 und des Ausgaberaums 13 teilweise sichtbar. Der Greifer 15 und die Spritze 16 können sich an der Schiene 11 hin und her bewegen, und die ganze Schiene 11 kann sich nach vorne und hinten bewegen und ausserdem kann der Greifer 15 und kann die Spritze 16 an der Schiene 11 mittels eines mechanischen, elektrischen, pneumatischen oder hydraulischen Antriebs auf- und abwärts fahren. Im Mischraum 10 liegt hier ein Regal-Tablett 4, das im Moment leer ist. Rechts davon ist eine Mischgefässwaage 17 angeordnet, und zwischen dem Regaltablett 4 und der Mischgefässwaage 17, etwas nach hinten versetzt angeordnet, erkennt man ein Entsorgungsloch 18 im Boden des Mischraumes 10. Durch dieses Entsorgungsloch 18 können verbrauchte Fläschchen entsorgt werden und fallen dann in einen unter dem Entsorgungsloch 18 angebrachten Abfallbehälter 26. An der hier rechten Seitenwand des Mischraumes 10 ist ein Spritzenmagazin 22 untergebracht. Im Ausgaberaum 13 ist ein Karussell 19 angeordnet, mit einer Welle 23 als Drehachse und daran befestigten Drehscheiben 31,32, die an ihrem Rand mit Einschnitten versehen sind, sodass Infusionsflaschen 20 zwischen diese Drehscheiben 31,32 einhängbar sind. Dieses Karussell 19 ist motorisch drehbar und der Motor ist vom Computer 6 steuerbar, ebenso wie auch der gesamte Roboter mit seinem Greifer 15 und seiner Spritze 16 in seinen Bewegungen steuerbar ist. Im Innern des Ausgaberaums 13 ist ebenfalls ein Scanner 21 vorhanden, welcher die Barcodes auf den Infusionsbeuteln 20 beim Vorbeidrehen derselben lesen kann.In FIG. 1 the entire facility is shown. It forms a complete workplace for mixing and providing application-capable infusions. Basically, this facility includes a storage room 1 for reactants 2 to be mixed, that is to say for the pure active ingredients or medicaments, as they are to be administered to the patient in certain concentrations and dosages by means of infusions. The vials 3 or also called vials, which contain the educts 2, are in a shelf tray 4 with, for example, as shown here 7 x 3 holes for placing the educt vial 3. Thus, each vial 3 at a well-defined location in the shelf. 4 stored. The vials 3 are first sorted by hand in the shelf trays 4 on the table 9 left of the device and afterwards the shelf trays 4 are put into the storage room 1. In the back of the storage room 1 can be seen a scanner 12, on which the individual educt vial 3 can be identified by their barcodes. With a cooling circuit, this cools the bottom of the storage room 1 as well as the adjoining mixing chamber 10, so that it can be maintained at a temperature of about 6 ° ± 2 ° C. The educt vial 3 are within the shelf tray 4 on this cooled floor, so that the reactants 2 are cooled. To the left of the refrigeration unit 5 here is the computer in the form of a personal computer 6 with associated keyboard 7 and monitor 8. Right next to the storage room 1, a mixing chamber 10 connects. This is designed as a class A cleanroom and is therefore constantly flowed through by filtered air. The mixing chamber 10 includes a robot that functions similarly to a bridge crane. The rail 11, which here extends transversely to the viewing direction of the observer, extends into the storage space 1 to the left of the mixing space 10, as well as into the discharge space 13, which adjoins the mixing space 10 on the right. The side walls of the mixing chamber are 10 as you can see provided with recesses 25 through which air always flows through from the mixing chamber 1, but never in the opposite direction. At this rail 11 of the robot, a gripper 15 and a syringe 16 reciprocates, and the whole rail 11 also runs along the side rails 14 in the direction of the viewer backwards and forwards. The side rails 14 are partially visible on the outer side walls of the storage room 1 and the discharge space 13. The gripper 15 and the syringe 16 can move on the rail 11 back and forth, and the whole rail 11 can move forward and backward and also, the gripper 15 and the syringe 16 on the rail 11 by means of a mechanical, electrical , pneumatic or hydraulic drive up and drive down. In the mixing chamber 10 is here a shelf tray 4, which is empty at the moment. To the right thereof, a mixing vessel scale 17 is arranged, and disposed between the shelf tray 4 and the mixing vessel 17, slightly offset to the rear, one recognizes a disposal hole 18 in the bottom of the mixing chamber 10. Through this disposal hole 18 spent vials can be disposed of and then fall into a the disposal hole 18 attached waste container 26. At the right side wall of the mixing chamber 10, a syringe magazine 22 is housed. In the output space 13, a carousel 19 is arranged, with a shaft 23 as a rotation axis and attached turntables 31,32, which are provided at its edge with incisions so that infusion bottles 20 between these turntables 31,32 are suspended. This carousel 19 is rotatable by motor and the motor is controlled by the computer 6, as well as the entire robot with its gripper 15 and its syringe 16 is controllable in its movements. Inside the dispensing compartment 13 there is also a scanner 21 which can read the bar codes on the infusion bags 20 as they pass it.

In Figur 2 ist der Lagerraum 1 von vorne gesehen gezeigt. Man erkennt die Querschiene 11, welche seitlich an der Seitenschiene 14 gelagert ist und längs derselben als Ganzes nach vorne und hinten fahren kann, das heisst senkrecht zur Zeichnungsblattebene. Hierzu dient der Elektromotor 30. Auf dem Boden des Lagerraumes 1 stehen drei Regal-Tabletts 4 nebeneinander. Der Boden des Lagerraumes 1 ist mittels des schon beschriebenen Kühlkreislaufes gekühlt, sodass die Wirkstoffe in den Fläschchen 3 dauerhaft haltbar sind. Die Wirkstoff-Fläschchen 3 stecken in den beiden Regal-Tabetts 4 links. Das Regal-Tablett rechts enthält Mischgefässe 24.In FIG. 2 is the storage room 1 seen from the front. You recognize that Cross rail 11, which is mounted laterally on the side rail 14 and can drive along the same as a whole to the front and rear, that is perpendicular to the drawing sheet level. For this purpose, the electric motor 30 is on the floor of the storage room 1 are three shelf trays 4 side by side. The bottom of the storage room 1 is cooled by means of the cooling circuit already described, so that the active ingredients in the vial 3 are durable. The drug vials 3 stuck in the two shelf-4 tabs left. The shelf tray on the right contains mixing vessels 24.

In Figur 3 ist der Mischraum 10 von vorne gesehen dargestellt. Zu erkennen ist hier der Robotergreifer 15, welcher die Fläschchen in den darunter liegenden Regal-Tabletts 4 ergreifen kann oder sie in diese Regal-Tabletts 4 gezielt ablegen kann. Rechts daneben ist die Roboterspritze 16 zu sehen, welche durch die Septums in die einzelnen Fläschchen in den Regal-Tabletts 4 einfahren kann. Beide Elemente, das heisst der Robotergreifer 15 wie auch die Roboterspritze 16 können gemeinsam längs der Schiene 11 hin und her fahren und mitsamt der Schiene 11 nach vorne oder nach hinten fahren. Ausserdem können der Greifer 15 sowie die Spritze 16 an der Schiene 11 auf und ab fahren, also können sie sich in allen drei Raumrichtungen bewegen. Diese motorisch mittels Linearmotoren angetriebenen Bewegungen werden vom Computer gesteuert und die Wege werden von Sensoren erfasst, sodass der Computer jederzeit weiss, in welcher Position sich der Greifer 15 und die Spitze der Spritze 16 befindet. Im Mischraum 10 liegt hier ein Regal-Tablett 4 mit abgestuften Lochdurchmessern auf dem Boden des Mischraumes 10. Diese verschiedenen Lochdurchmesser und ihre Funktion werden noch erläutert. Rechts daneben sieht man die Mischgefässwaage 17 und an der rechten Seitenwand das Spritzenmagazin 22 mit 10 bis 12 Spritzen. Im hinteren Bereich des Mischraumes 10 befindet sich das Entsorgungsloch 18 im Boden, durch welches verbrauchtes Material wie Fläschchen 3 oder Spritzen 16 in einen Abfallbehälter 26 entsorgt werden können, der unten am Loch 18 anschliesst, indem diese Dinge über dem Loch 18 fallengelassen werden.In FIG. 3 is the mixing chamber 10 seen from the front. To recognize here is the robot gripper 15, which can take the vial in the underlying shelf trays 4 or they can place targeted in these shelf trays 4. Right next to it, the robot syringe 16 can be seen, which can enter through the septums in the individual vials in the shelf trays 4. Both elements, that is, the robot gripper 15 as well as the robot syringe 16 can move together along the rail 11 back and forth and drive together with the rail 11 forward or backward. In addition, the gripper 15 and the syringe 16 can move up and down the rail 11, so they can move in all three spatial directions. These motor driven by linear motors movements are controlled by the computer and the paths are detected by sensors, so that the computer knows at any time, in which position the gripper 15 and the tip of the syringe 16 is located. In the mixing chamber 10 here is a shelf tray 4 with stepped hole diameters on the bottom of the mixing chamber 10. These different hole diameter and their function will be explained. Right next to it you can see the mixing vessel scale 17 and on the right side wall of the syringe magazine 22 with 10 to 12 syringes. In the rear of the mixing chamber 10 is the disposal hole 18 in the bottom, through which spent material such as vials 3 or syringes 16 can be disposed of in a waste container 26, which adjoins the bottom of the hole 18 by these things are dropped over the hole 18.

Die Spritze 16 ist so mit dem Roboter verbunden, dass sie mit einem bestimmten einstellbaren Anpressdruck auf den Boden eines Fläschchens 3 absenkbar ist. Das kann so gelöst sein, dass der Elektromotor die Spritze mittels einer Gewindespindel nach abwärts bewegt und dann nach Auftreffen der Spritzenspitze am Flaschenboden das Drehmoment am Elektromotor des Linearantriebs plötzlich stark ansteigt, was mit dem Aufnahmestrom des Elektromotors korreliert. Über den Aufnahmestrom, der bei Erreichen einer bestimmten Grösse unterbrochen werden kann, lässt sich daher das Drehmoment einstellen und somit auch der Anpressdruck. Eine andere Lösung kann darin bestehen, dass die Spritze 16 über eine Druckfeder am Roboter hängt. Am Roboterteil, das den oberen Teil der Druckfeder abwärts bewegt, kann ein Dehnungsstreifen angebracht sein, der zum einem stationären Teil oberhalb des Roboters führt und dort befestigt ist. Die Spritze wird dann motorisch, elektrisch, pneumatisch oder hydraulisch nach unten gefahren. Wenn ihre Spitze am Boden eines Fläschchens auftrifft, erfolgt das weitere Abwärtsbewegen des Roboters unter Zusammendrücken der Druckfeder und gleichzeitig wird der Dehnungsstreifen gestreckt. Je nach Dehnung gibt er ein verändertes elektrisches Signal ab, welches dann ein Mass für den Aufpressdruck abgibt.The syringe 16 is connected to the robot so that it can be lowered to the bottom of a vial 3 with a certain adjustable contact pressure is. This can be solved so that the electric motor moves the syringe by means of a threaded spindle downwards and then suddenly after impingement of the syringe tip on the bottom of the bottle, the torque on the electric motor of the linear drive increases sharply, which correlates with the absorption current of the electric motor. On the recording current, which can be interrupted when reaching a certain size, therefore, can adjust the torque and thus the contact pressure. Another solution may be that the syringe 16 hangs on the robot via a compression spring. On the robot part, which moves down the upper part of the compression spring, an expansion strip may be attached, which leads to a stationary part above the robot and is fixed there. The syringe is then driven by motor, electric, pneumatic or hydraulic down. When its tip hits the bottom of a vial, further downward movement of the robot is accomplished by compressing the compression spring and at the same time the stretchstrip is stretched. Depending on the strain, it gives off an altered electrical signal, which then gives a measure of the pressure applied.

In Figur 4 sieht man das Karussell 19 für insgesamt 10 Infusionsflaschen 20. Die Welle 23 des Karussells 19, welche oben und unten im Ausgaberaum gelagert ist, ist mittels Simmeringen abgedichtet und in geschlossenen Kugellagern gelagert. Sie kann leicht ausgebaut werden. Dieses Karussell 19, welches zwei von aussen mit Einschnitten versehene Drehscheiben 31,32 einschliesst, wird nach dem Bestücken mit diesen 10 Infusionsflaschen 20 in das Innere des Ausgaberaumes 13 eingehängt, wo es motorisch drehbar ist. Der Ausgaberaum 13 ist mit einem Scanner 21 ausgerüstet, welcher die patientenspezifischen Barcodes an den Infusionsflaschen 20 lesen kann und die Plätze der einzelnen Infusionsflaschen 20 im Karussell 19 sind nummeriert. Das Karussell 19 wird mit den Infusionsflaschen 20 am Scanner 21 vorbeigedreht und kann in jeder gewünschten Position gestoppt werden, mit einer ±1mm Genauigkeit über die X- und Y-Koordinate, sodass eine genau definierte Infusionsflasche 20 letztlich von der Spritze angestochen wird, weil das System eine Positionserkennung einschliesst.In FIG. 4 one sees the carousel 19 for a total of 10 infusion bottles 20. The shaft 23 of the carousel 19, which is mounted above and below in the output space is sealed by Simmeringen and stored in closed ball bearings. It can be easily removed. This carousel 19, which includes two externally provided with cuts turntables 31,32 is hung after the placement of these 10 infusion bottles 20 in the interior of the output space 13, where it is rotatable by motor. The dispensing space 13 is equipped with a scanner 21 which can read the patient-specific barcodes on the infusion bottles 20 and the locations of the individual infusion bottles 20 in the carousel 19 are numbered. The carousel 19 is rotated past the scanner 21 with the infusion bottles 20 and can be stopped in any desired position, with a ± 1mm accuracy over the X and Y coordinates so that a well-defined infusion bottle 20 will ultimately be pierced by the syringe because the System includes a position detection.

In Figur 5 ist ein Regal-Tablett 4 in einem Schnitt dargestellt. Diese Regal-Tabletts bestehen vorzugsweise aus mehreren beabstandet übereinander montierten Plexiglasplatten. Die Einstell-Löcher 27 sind von abgestuften Durchmessern, sodass wie gezeigt Fläschchen 3 unterschiedlicher Durchmesser wackelfrei aufgenommen werden können. Es handelt sich um Wirkstoff-Fläschchen 3 von 10ml bis 25ml Inhalt für hochaktive Substanzen wie zum Beispiel Avastin oder Herceptin von Roche oder ähnliche Substanzen auch von anderen Firmen. Die Hilfsstoffe liegen hingegen in grösseren Fläschchen 3 von 50ml Inhalt vor. Die Figur 6 zeigt links ein Regal-Tablett 4 für Wirkstoff-Fläschchen 3 von oben gesehen, mit je 3 x 7 Löchern 27 und rechts daneben ein Regal-Tablett für Hilfsstoff-Fläschchen mit 2 x 5 grösseren Löchern 28 zur Aufnahme grösserer Fläschchen 3. Die Figur 7 zeigt schliesslich ein Regal-Tablett 4 für den Mischraum 10, welches 3 x 5 Löcher 27 für Stammlösungen, also für Wirkstoff-Fläschchen 3 aufweist, sowie ein grösseres Loch 28 für eine Trägerlösungs-Flasche (NaCl).In FIG. 5 is a shelf tray 4 shown in a section. These shelf trays preferably consist of a plurality of spaced apart stacked Plexiglas plates. The adjustment holes 27 are of stepped diameters so that, as shown, vials 3 of different diameters can be received without wobble. These are active ingredient vials 3 from 10ml to 25ml content for highly active substances such as Avastin or Herceptin from Roche or similar substances from other companies. The excipients, however, are present in larger vials 3 of 50ml content. FIG. 6 shows, on the left, a shelf tray 4 for active substance vial 3, viewed from above, with 3 × 7 holes 27 and, to the right, a shelf tray for auxiliary vials with 2 × 5 larger holes 28 for receiving larger vials 3. The FIG. 7 finally shows a shelf tray 4 for the mixing chamber 10, which has 3 x 5 holes 27 for stock solutions, ie for drug vial 3, and a larger hole 28 for a carrier solution bottle (NaCl).

Die gesamte Einrichtung wie in Figur 1 gezeigt steht in einem Reinraum der Klasse B oder C, während der Mischgefässraum 3 selbst einen Reinraum der Klasse A bildet. Der Mischgefässraum 3 muss hierzu einen Zu- und Abluftstutzen haben, die an einem externen Ventilator mit Hepafilter angeschlossen sind, damit er ständig von einer definierten Luftströmung durchströmt ist. Alle drei Räume 1, 10 und 13 bestehen aus ebenen glatten Flächen, sodass sie einfach zu reinigen sind, und sie sind über Türen oder Abdeckungen verschliessbar. Die Türen sind elektronisch abfragbar, ob sie offen oder geschlossen sind, dürfen aber nicht verriegelt und abschließbar sein. Die ganze Einrichtung wird über einen zugehörigen externen PC 6 mit Monitor 8 und Tatstatur 7 oder wahlweise über einen Touchscreen bedient und gesteuert Der Monitor 8 der Einrichtung zeigt dessen Status an, zum Beispiel welches Rezept gerade gemischt wird.The entire facility as in FIG. 1 is shown in a class B or C clean room, while the mixing vessel space 3 itself forms a class A clean room. For this purpose, the mixing vessel space 3 must have a supply and exhaust air connection, which are connected to an external fan with Hepafilter so that it is constantly flowed through by a defined flow of air. All three rooms 1, 10 and 13 are made of smooth flat surfaces, making them easy to clean, and they can be closed with doors or covers. The doors are electronically interrogated, whether they are open or closed, but must not be locked and lockable. The entire device is operated and controlled via an associated external PC 6 with monitor 8 and keyboard 7 or optionally via a touch screen and the monitor 8 of the device displays its status, for example, which recipe is being mixed.

Im Folgenden wird nun die Arbeitsweise dieser Einrichtung schrittweise erläutert. Zunächst bereitet die Bedienperson, typischerweise eine Medizinisch-Technische-Assistentin oder -Assistent MTA die Bestückung des Lagerraums 1 vor, was auf dem Vorbereitungstische 9 passiert. Die Rezepte liegen ihr in Form elektronischer Daten vor, die in den Computer eingelesen werden. Der Computer errechnet hernach, welche Edukte nötig sind, und hernach, wie das Regal-Tablett mit welchen Edukte-Fläschchen 3 sinnvoll zu bestücken ist. Die Fläschchen 3 werden vor dem Einsetzen in das Regal-Tablett 4 mit einem Barcode versehen, der zum Beispiel unten auf den Boden des Fläschchens 3 geklebt wird. Manche Produkte haben bereits einen vom Hersteller angebrachten Barcode. In der Warenannahme werden bei solchen Produkten die eigenen Barcodes nachgerüstet. Am meisten Platz bietet in diesem Fall der Flaschenboden.The operation of this device will now be explained step by step. First, the operator, typically a medical-technical assistant or assistant MTA prepares the placement of the storage room 1, which happens on the preparation table 9. The prescriptions come in the form of electronic data, which are read into the computer. The computer calculates afterwards, which Edukte are necessary, and afterwards, like the shelf tray with which educt vial 3 is to be equipped wisely. The vials 3 are provided, prior to insertion into the shelf tray 4, with a bar code which, for example, is glued to the bottom of the vial 3 at the bottom. Some products already have a barcode attached by the manufacturer. In the goods receiving the own barcodes are retrofitted with such products. The most space in this case is the bottom of the bottle.

Im Fall A werden die Barcodes am zylindrischen Teil des Vials angebracht. Dann muss der Barcodescanner seitlich sein, und der Flaschengreifer muss eine Drehbewegung ausführen, um den gesamten Flaschenzylinder abzufragen. Im Fall B klebt man in der Warenannahme softwareunterstützt unter jede Flasche einen kleinen Barcode. Damit ist jede einzelne Flasche voll rückverfolgbar, indem von unten jederzeit der Barcode lesbar ist. Die Vials werden einfach über den nach oben sehend gerichteten Scanner gehalten, ähnlich dem System wie es bei einer Einkaufskasse üblich ist, und sie sind damit eindeutig identifiziert. Diese Markierung am Flaschenboden ist das überlegenere System, da es technisch einfacher zu realisieren ist und eine Rückverfolgbarkeit gewährleistet. Es ist einzig in der Warenannahme aufwändiger.In case A, the barcodes are attached to the cylindrical part of the vial. Then the bar code scanner must be sideways and the bottle gripper must make a rotary motion to interrogate the entire cylinder cylinder. In case B you stick a small barcode under each bottle in the goods receipt under software support. This ensures that every single bottle is fully traceable by allowing the barcode to be read from below at any time. The vials are simply held over the upwardly facing scanner, similar to the system used by a purse, and are uniquely identified. This marking on the bottom of the bottle is the superior system as it is technically easier to implement and ensures traceability. It is only more elaborate in the receipt of goods.

Die Software des Computers gibt der MTA beim Bestücken der Eingangsprodukte durch eine Positionsvorgabe an, wo genau das Fläschchen 3 in das Regal-Tablett 4 eingesetzt werden muss. Die Fläschchen 3 werden später vor dem Gebrauch durch den Mischautomaten mit dem Barcode-Scanner gescannt, sodass eine Fehlbestückung durch die MTA vor dem Mischen sofort erkannt wird. Durch diese individualisierte Erfassung jedes einzelnen Fläschchens 3 ist erstmals eine eindeutige Rückverfolgbarkeit gegeben. Damit gelingt es letztlich, eine rückverfolgbare Informationskette vom Wareneingang bis zum Patienten umzusetzen, und diese gilt für jedes einzelne Fläschchen 3.The software of the computer indicates the MTA when loading the input products by a position specification, where exactly the vial 3 in the shelf tray 4 must be used. The vials 3 are later scanned by the mixing machine with the barcode scanner before use, so that misuse by the MTA is detected immediately prior to mixing. This individualized detection of each vial 3 is the first time a clear traceability is given. This ultimately makes it possible to implement a traceable information chain from the goods receipt to the patient, and this applies to each individual vial 3.

Die Regal-Tabletts 4 sind mit Nasen und Führungsstiften kodiert und können daher nicht beliebig, sondern nur in der richtigen Richtung und Position in den Lagerraum 1 eingeschoben werden. Vor dem Bestücken des Lagerraums 1 werden die Verschluss-Siegel der Fläschchen 3 entfernt. Dabei handelt es sich um Metallkappen, die entfernt werden, sodass hernach nur noch die Septums die Fläschchen 3 verschliessen.The shelf trays 4 are coded with lugs and guide pins and therefore can not be arbitrarily, but only in the correct direction and position in the storage room 1 are inserted. Before loading the storage room 1, the sealing seals of the vials 3 are removed. It refers to Metal caps that are removed so that afterwards only the septums close the vials 3.

Wenn ein Regal-Tablett 4 von der MTA fertig bestückt ist, wird dieses in den Lagerraum 1 eingeschoben und fortan werden die Edukte durch den Boden des Lagerraums 1 gekühlt und auf einer Temperatur von ca. 6°±2° C gehalten. Auf Knopfdruck startet der Dosier- und Mischprozess für ein in den Computer eingelesenes Rezept und wird dann völlig automatisch durchgeführt. Der Greifer 15 holt sich zunächst eine Hilfsstoff-Flasche aus dem Lagerraum 1 und platziert diese nach dem Vorbeifahren beim Scanner 12 und gemäss ihrer Identifikation im grösseren Loch 28 im Regaltablett 4 im Mischraum 1. Hernach fährt der Greifer 15 wieder in den Lagerraum 1 und über das Regaltablett 4 und weiss, in welcher Position (x-y-Koordinate) das benötigte Wirkstoff-Fläschchen 3 mit dem gewünschten Edukt 2 steckt. Der Greifer 15 ergreift dieses Fläschchen 3 und hält es vor den Scanner 12 im Lagerraum 1. Er dreht es rund um die Achse, falls der Barcode seitlich angebracht wird, sodass er vom Scanner 12 sicher gelesen werden kann, oder wenn sich der Barcode am Flaschenboden befindet, hält der Greifer 15 die Flasche 3 über den Scanner 12. Nach dem einwandfreien Identifizieren des Fläschchens 3 bringt es der Greifer 15 in den Mischraum 10 und legt es dort an einer vom Computer 6 errechneten Position im Regal-Tablett 4 ab. Hernach wir das zweite, dritte, vierte etc. Fläschchen 3 in gleicher Weise aus dem Lagerraum 1 geholt und nach einwandfreier Identifikation im Mischraum 10 abgelegt. Der Roboter holt sich im Lagerraum 1 auch noch ein Mischgefäss 24 und stellt dieses auf der Mischwaage 17 ab. Wenn mal die nötigen Fläschchen 3 mit ihren Edukten 2 sowie die Hilfsstoff-Flasche und das Mischgefäss 24 im Mischraum 10 bereitgelegt sind, kann die Dosierung und Mischung beginnen.When a shelf tray 4 is fully stocked by the MTA, it is inserted into the storage room 1 and hence the starting materials are cooled by the bottom of the storage room 1 and kept at a temperature of about 6 ° ± 2 ° C. At the press of a button, the dosing and mixing process starts for a recipe read into the computer and is then carried out completely automatically. The gripper 15 first gets an auxiliary bottle from the storage room 1 and places it after passing the scanner 12 and according to their identification in the larger hole 28 in the shelf tray 4 in the mixing chamber 1. Thereafter, the gripper 15 moves back into the storage room 1 and over the shelf tray 4 and knows in which position (xy coordinate) the required drug vial 3 with the desired starting material 2 inserted. The gripper 15 grips this vial 3 and holds it in front of the scanner 12 in the storage room 1. It rotates it around the axis if the barcode is placed laterally so that it can be safely read by the scanner 12, or if the barcode is on the bottom of the bottle The gripper 15 holds the bottle 3 over the scanner 12. After correctly identifying the bottle 3, the gripper 15 brings it into the mixing chamber 10 and places it there at a position calculated in the shelf tray 4 by the computer 6. Afterwards we fetched the second, third, fourth, etc. vials 3 in the same way from the storage room 1 and, after proper identification, deposited them in the mixing chamber 10. The robot also fetches a mixing vessel 24 in the storage room 1 and places it on the mixing balance 17. Once the necessary vials 3 with their educts 2 and the excipient bottle and the mixing vessel 24 are placed in the mixing chamber 10, the dosage and mixing can begin.

Der Roboter holt sich eine neue Spritze 16 aus dem Spritzenmagazin 22 im Mischraum 10. Danach führt er die Spritze 16 in die Hilfsstoff-Flasche. Die Spitze der Spritze 16 durchsticht das Septum und wird bis zum Boden der Flasche hinuntergefahren, und zwar bis die Spritzenspitze den Boden der Flasche mit einer bestimmten einstellbaren Kraft beaufschlagt. Jetzt wird der Kolben in der Spritze durch den Roboter computergesteuert ein genau definiertes Mass zurückgefahren und die Spritze 16 saugt deshalb Hilfsstoff eines ganz bestimmten Volumens aus der Flasche. Die Spritze 16 wird dann über das Mischgefäss 24 auf der Mischwaage 17 gefahren und der Kolben wird nach vorne zum Anschlag in der Spritze 16 gefahren, die dadurch ihren Inhalt in das Mischgefäss 24 abgibt. Dabei wird die Gewichtszunahme des Mischgefässes 24 gemessen und erfasst.The robot gets a new syringe 16 from the syringe magazine 22 in the mixing chamber 10. Then he leads the syringe 16 into the excipient bottle. The tip of the syringe 16 pierces the septum and descends to the bottom of the bottle until the syringe tip applies a certain adjustable force to the bottom of the bottle. Now, the piston in the syringe is controlled by the computer computer controlled a precisely defined measure reduced and the syringe 16 therefore sucks excipient of a very specific volume from the bottle. The syringe 16 is then moved over the mixing vessel 24 on the balance 17 and the piston is moved forward to the stop in the syringe 16, which thereby emits its contents in the mixing vessel 24. In this case, the weight increase of the mixing vessel 24 is measured and recorded.

Hernach fährt der Roboter die Spritze 16 in das erste Wirkstoff-Fläschchen 3. Die Spitze der Spritze 16 durchsticht das Septum und wird bis zum Boden der Flasche hinuntergefahren, und zwar bis die Spritzenspitze den Boden der Flasche mit einer bestimmten einstellbaren Kraft beaufschlagt. Jetzt wird der Kolben in der Spritze 16 durch den Roboter computergesteuert ein genau definiertes Mass zurückgefahren und die Spritze 16 saugt deshalb Wirkstoff eines ganz bestimmten Volumens aus dem Fläschchen 3. Die Spritze wird dann über das Mischgefäss 24 gefahren und der Kolben wird nach vorne zum Anschlag in der Spritze gefahren, die dadurch ihren Inhalt in das Mischgefäss 24 abgibt. Dieser Vorgang wird sooft wiederholt, bis das gewünschte Mass an Wirkstoff im Mischgefäss 24 liegt. Dann wird das mit dem nächsten Wirkstoff wiederholt, usw., bis alle Wirkstoffe in der gewünschten Dosis im Mischgefäss 24 liegen und sich dort vermischen.Thereafter, the robot drives the syringe 16 into the first drug vial 3. The tip of the syringe 16 pierces the septum and is driven down to the bottom of the bottle until the syringe tip applies a certain adjustable force to the bottom of the bottle. Now, the piston in the syringe 16 is controlled by the computer controlled a precisely defined Mass reduced and the syringe 16 therefore sucks active substance of a very specific volume from the vial 3. The syringe is then moved over the mixing vessel 24 and the piston is to the front to stop drove in the syringe, which thereby emits their contents in the mixing vessel 24. This process is repeated until the desired amount of active ingredient in the mixing vessel 24 is. Then it is repeated with the next active substance, etc., until all the active ingredients in the desired dose are in the mixing vessel 24 and mix there.

Nur wenn sich das Gewicht des Mischgefässes 24 mit seiner Mischung in einem engen, einstellbaren Plus-Minus-Band bewegt, ist das System bereit, die Mischung zum Weitertransport in eine Infusionsflasche 20 freizugeben. Ansonsten kommt eine Fehlermeldung. Wenn aber das Gewicht mit der Vorgabe übereinstimmt, kommt der Roboter mit der Spritze 16 und saugt den Inhalt des Mischgefässes 24 auf. Die Spritze wird in den Ausgaberaum 13 getragen. Als Vorbereitung wurde dort eine Infusionsflasche 20 mit ihrem Barcode am Scanner 21 im Ausgaberaum 13 vorbeigedreht und in die Aufnahmeposition gebracht. Dort wird mit der Spritzenspitze die zuvor an die Ausnahmeposition gedrehte Infusionsflasche 20 angestochen und der Kolben in der Spritze 16 wird nach vorne gefahren, sodass der Spritzeninhalt in die Infusionsflasche 20 ausgegeben wird. Anschliessend fährt der Roboter mit der Spritze 16 zurück in den Mischraum 10 und lässt diese über dem Entsorgungsloch 18 in den Entsorgungsbehälter 26 fallen. Der Greifer 15 sammelt anschliessend die leeren Wirkstoff-Flaschen 3 zusammen und lässt sie über dem Entsorgungsloch 18 fallen. Auch die Hilfsstoff-Flasche sowie das Mischgefäss 24 werden entsorgt.Only when the weight of the mixing vessel 24 moves with its mixture in a tight, adjustable plus-minus band, the system is ready to release the mixture into an infusion bottle 20 for further transport. Otherwise an error message comes. However, if the weight matches the specification, the robot comes with the syringe 16 and sucks up the contents of the mixing vessel 24. The syringe is carried in the dispensing space 13. As preparation, an infusion bottle 20 with its barcode was moved past the scanner 21 in the dispensing space 13 and brought into the receiving position. There, the infusion bottle 20 previously rotated to the exceptional position is pierced with the syringe tip, and the plunger in the syringe 16 is moved forward, so that the syringe contents are dispensed into the infusion bottle 20. Subsequently, the robot with the syringe 16 moves back into the mixing chamber 10 and drops it over the disposal hole 18 into the disposal container 26. The gripper 15 then collects the empty active substance bottles 3 together and leaves them fall over the disposal hole 18. The excipient bottle and the mixing vessel 24 are disposed of.

Bevor eine neue Dosierung und Mischung beginnen kann, wird das Regal-Tablett 3 im Lagerraum 1 neu bestückt, wobei angebrochene Wirkstoff-Fläschchen 3 weiterbenützt werden können, sowie auch eine angebrochene Hilfsstoff-Flasche ebenfalls. Es wird aber jedes Mal ein neues Mischgefäss 24 auf der Mischwaage 17 platziert. Wenn dieses alles bereitliegt, beginnt ein neuer Dosierungs- und Mischdurchgang und die nächste Infusionsflasche 20 wird befüllt, bis alle Infusionsflaschen 20 des Karussells 19 befüllt sind. Ein Signal wird abgegeben, damit die MTA erkennt, dass sie jetzt die Infusionsflaschen 20 dem Ausgaberaum 13 entnehmen kann und ihn mit neuen leeren Infusionsflaschen 20 bestücken kann. Jede Infusionsflasche 20 enthält dem ihrem Barcode gemäss definierte Infusionsmischung, welche auf einen ganz individuellen Patienten zugeschnitten ist. Die ganze Dosierung und Mischung ist durch die im Computer 6 protokollierten Schritte des Mischvorgangs dokumentiert und jederzeit nachweisbar.Before a new dosage and mixing can begin, the shelf tray 3 is re-stocked in the storage room 1, whereby opened drug vials 3 can be weiterbenützt, as well as a broken aid bottle also. However, a new mixing vessel 24 is placed on the mixing balance 17 each time. When this is all ready, a new dosing and mixing passage begins and the next infusion bottle 20 is filled until all the infusion bottles 20 of the carousel 19 are filled. A signal is emitted to allow the MTA to recognize that it can now remove the infusion bottles 20 from the dispensing compartment 13 and populate them with new empty infusion bottles 20. Each infusion bottle 20 contains the infusion mixture defined according to its barcode, which is tailored to a very individual patient. The entire dosage and mixture is documented by the recorded in the computer 6 steps of the mixing process and detectable at any time.

Die Dosierung und Mischung wird dadurch sicherer, schneller und ökonomischer. Ausserdem ist jede Gefährdung des Personals durch Stiche und Kontaminationen ausgeschlossen.The dosage and mixture is safer, faster and more economical. In addition, any danger to personnel caused by stabs and contamination is excluded.

Claims (7)

  1. A process for the automated measuring and mixing of active agents for the preparation of patient-tailored infusions comprising means for the arrangement in a clean room of class B or C consisting of a storage room (1) for reactants, a mixing room (10) of clean room classification A having continuous aeration and a discharge room (13) for the final products, wherein
    a. from a shelf board (4) comprising the reactants required for the preparation of the infusion which is needed, the reactants being present in vials (3) having metal caps removed therefrom but septum intact (rubber cover) and having locations on the shelf board (4) which are detected by computer, the vials (3) which are needed are successively transferred by a robot gripper via computer control into a mixing room (10) of clean room classification A,
    b. a mixing vessel (24) is deposited on a mixing balance (17) in mixing room (10) and its weight is determined and is stored in a computer (6),
    c. a robot syringe (16) including a suction piston is successively inserted into each one of the reactant vials (3) until the robot syringe (16) will apply a set application force to the bottom of the reactant vial (3),
    d. the suction piston is retracted via computer control such that the measured volume required for the formulation is withdrawn from the vial (3),
    e. the robot syringe (16) is emptied by extending the suction piston into the mixing vessel (24) and the weight thereof is remeasured and monitored after which the steps c) to d) are repeated until the mixture is attained in the desired dose in the mixing vessel (24),
    f. the robot syringe (16) will receive the contents of the mixing vessel (24) by retracting the suction piston and will emit them into an infusion bottle (20) which is suspended on a carousel (25) by extending the suction piston,
    g. the robot gripper (15) successively grasps the reactant vessels (3) which are empty or which will not be required in the next cycle as well as the mixing vessel (24) and will dispose them through a hole (18) in mixing room (10).
  2. The process for the automated measuring and mixing of active agents for the preparation of patient-tailored infusions according to claim 1 characterised in that control of the force applied to the syringe is performed after the syringe tip has reached the bottom of the bottle by limiting the current consumption of the electric motor.
  3. The process for the automated measuring and mixing of active agents for the preparation of patient-tailored infusions according to claim 1 characterised in that control of the force applied to the syringe is limited after the syringe tip has reached the bottom of the bottle, in that the syringe (16) is suspended on the robot by way of a compression spring the compression of which causes an expansion of an expansion strip the electrical signal of which is used as a measure for the compression of the compression spring.
  4. A device for the automated measuring and mixing of active agents for the preparation of patient-tailored infusions for the arrangement in a clean room of class B or C consisting of computer (6) including robot control software, a storage room (1) for the reactants having shelf boards (4), a mixing room (10) of clean room classification A and a mixing bottle balance (17) and a disposal container, and a discharge room (13) for the final products, receptacles (20) carried by a carousel (19), the mixing room (10) including a robot having a gripper (15) and a suction syringe (16), by means of which gripper (15) defined vials (3) are transferable from storage room (1) into mixing room (10) by computer control, and by means of which suction syringe (16) reactants are drawable by suction from the vials (3) deposited in mixing room (1) and are ejectable into a mixing vial (3) which is placed on the mixing bottle balance (17) in mixing room (10), and by means of which suction syringe (16) mixtures from the mixing bottle (3) are furthermore drawable by suction and are ejectable into the receptacle (20) for the final product.
  5. The device for the automated measuring and mixing of active agents for the preparation of patient-tailored infusions according to claim 4 characterised in that the robot-controlled gripper (15) and the robot-controlled suction syringe (16) are upwardly and downwardly movably supported on crossbar (11) extending continuously through storage room (1), mixing room (10) and discharge room (13), the extremities of the crossbar (11) being movably supported on lateral bars (14) extending perpendicularly to crossbar (11) such that gripper (15) and syringe (16) is navigable in all three spatial directions.
  6. The device for the automated measuring and mixing of active agents for the preparation of patient-tailored infusions according to one of the claims 4 to 5, characterised in that the bottom of storage room 1 and mixing room 10 is coolable by way of a cooling circuit.
  7. The device for the automated measuring and mixing of active agents for the preparation of patient-tailored infusions according to one of the claims 4 to 6, characterised in that the mixing room (10) is configured as a class A clean room in that air will permanently passed therethrough by way of a filter system.
EP10158580A 2009-04-01 2010-03-31 Process and installation for automatic sterile dosing and mixing of infusions Not-in-force EP2236199B1 (en)

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Application Number Priority Date Filing Date Title
CH00537/09A CH700740A2 (en) 2009-04-01 2009-04-01 Method and apparatus for automated sterile dosing and mixing infusions.

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EP2236199A3 EP2236199A3 (en) 2010-10-20
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EP2913042B1 (en) * 2012-10-25 2019-10-02 Yuyama Mfg. Co., Ltd. Co-infusion device
DE102017005835B4 (en) * 2017-06-20 2020-04-02 Diehl Metering Gmbh Device for the mobile determination of a property of a liquid, solid or gaseous sample
US20210154097A1 (en) 2018-05-11 2021-05-27 Bristol-Myers Squibb Company Serially-connectable drug modules for combinatorial drug delivery device
DE102019214849A1 (en) * 2019-09-27 2021-04-01 Bausch + Ströbel Maschinenfabrik Ilshofen GmbH + Co. KG PRODUCTION EQUIPMENT, ESPECIALLY FOR THE PHARMACEUTICAL INDUSTRY
CN115487716B (en) * 2022-11-22 2023-03-10 莱州市文昌路畜牧兽医站 Animal doctor uses dispensing device

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US5431201A (en) * 1993-12-03 1995-07-11 Technology 2000 Incororated Robotic admixture system
EP1363736B1 (en) * 2000-12-18 2011-03-02 Protedyne Corporation Extruding gel material for gel electrophoresis
EP1291658A1 (en) * 2001-09-07 2003-03-12 The Automation Partnership (Cambridge) Limited Pipette head apparatus for robot
US7783383B2 (en) * 2004-12-22 2010-08-24 Intelligent Hospital Systems Ltd. Automated pharmacy admixture system (APAS)
CA2849553C (en) * 2006-07-26 2015-09-29 Daniele Baldassari Machine for the preparation of pharmaceutical products
US20080169044A1 (en) * 2006-10-20 2008-07-17 Forhealth Technologies, Inc. Automated drug preparation apparatus including syringe loading, preparation and filling
FR2932085B1 (en) * 2008-06-06 2012-08-10 Pharmed Sam AUTOMATED WORKSTATION FOR THE SECURE PREPARATION OF A FINAL PRODUCT FOR MEDICAL OR PHARMACEUTICAL USE

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