Parenteral products automation system (PPAS)

• US 20020198738A1
• Filed: 06/05/2002
• Published: 12/26/2002
• Est. Priority Date: 08/10/1995
• Status: Active Grant

• Current Assignee: Baxter Corporation Englewood (Baxter International Inc.)
• Original Assignee: Forhealth Technologies Incorporated (Baxter International Inc.)
• Inventors: Osborne, Joel A.
• Granted Patent: US 7,260,447 B2
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: B01F 31/20 Mixing the contents of independent containers, e.g. test tubes
• CPC Class Codes: B01F 33/85 Mixing plants with mixing receptacles or mixing tools that can be indexed into different working positions
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 57/00 Automatic control, checking, warning, or safety devices registering wrapping or container-forming material fed from rolls B65B41/18
• CPC Class Codes: B65G 51/34 Two-way operation
• CPC Class Codes: B65G 51/46 according to separate signal systems
• CPC Class Codes: G16H 20/13 delivered from dispensers

Abstract

An integrated, automated system concerning pharmaceutical products is provided. The system comprises an input queue, a dispensing apparatus comprising a robot device and a number of stations from which the robot device works, and an inspection station. A computer interface provides bi-directional communication between the analytical instruments, robots and peripheral devices and a computer. The robot employed by the system is responsive to computer commands and capable of performing mechanical functions including selection and retrieval of a necessary item and manipulation of retrieved items such that the desired product is produced.

Claims

1. An automated system for preparing a pharmaceutical product, the system comprising:

at least one computer having a database for receiving and storing criteria related to the preparation and delivery of the pharmaceutical product in a dosage form suitable for administration to a particular patient;

a dispensing apparatus in bi-directional communication with the at least one computer, the dispensing apparatus including a robotic device for performing a series of operations related to the preparation of the dosage form of the pharmaceutical product based upon the criteria stored in the database for the respective pharmaceutical product, the dispensing apparatus having a plurality of work stations at which the robotic device performs the operations resulting in the pharmaceutical product being prepared in accordance with the stored criteria; and

an inspection station for inspecting the resultant pharmaceutical product to determine whether the resultant pharmaceutical product complies with the stored criteria associated with the resultant pharmaceutical product, wherein if the resultant pharmaceutical product fails to comply with the stored criteria, the resultant pharmaceutical product is discarded.

2. The automated system of claim 1, wherein the robotic device is responsive to commands generated by the at least one computer and has an arm which is movable between the plurality of work stations such that the robotic device is capable of performing mechanical functions including selection and retrieval of a necessary item and manipulation of one or more retrieved items such that the resultant pharmaceutical product is produced.

3. The automated system of claim 1, wherein the plurality of stations includes:

a first pharmaceutical product station storing a pharmaceutical drug in a vial, a syringe station for storing a syringe used to discharge a diluent into the vial holding the pharmaceutical drug;

a diluent station for storing one or more diluents that are mixed with the pharmaceutical drug;

an agitation station for mixing the one or more diluents with the pharmaceutical drug to produce the resultant pharmaceutical product; and

a labeling station for labeling the resultant pharmaceutical product.

4. The automated system of claim 1, further including a computer interface which provides bi-directional communication between one or more analytical instruments, the robotic device, peripheral devices and the at least one computer.

5. The automated system of claim 1, wherein the criteria is stored in a database file associated with a particular patient, the database file including the name, strength, and diluent of a pharmaceutical drug;

a name of the patient for whom the pharmaceutical product is intended; and

temporal information relating to when the pharmaceutical product is to be administered.

6. The automated system of claim 5, wherein the database further includes information relating to a room location of the patient and the temporal information includes a time that the pharmaceutical product is due for administration.

7. The automated system of claim 1, wherein the criteria is encoded onto a label in the form of a barcode which is disposed on the resultant pharmaceutical product.

8. The automated system of claim 1, wherein the inspection station includes gas chromatography testing.

9. The automated system of claim 1, wherein the inspection station includes specific gravity testing of the resultant pharmaceutical product.

10. The automated system of claim 1, wherein the inspection station includes barcode scanning of a label associated with the resultant pharmaceutical product.

11. An integrated automated system for preparing a measured pharmaceutical dose, the system comprising:

at least one computer having a database for receiving and storing criteria related to the preparation and delivery of the measured pharmaceutical dose;

at least one robotic device in bi-directional communication with the at least one computer;

a plurality of stations arranged to cooperate with the at least one robotic device in a sequence of operations to produce the measured pharmaceutical dose from a pharmaceutical drug supply; and

an inspection station for inspecting the measured pharmaceutical dose to determine whether the measured pharmaceutical dose complies with the stored criteria associated with the measured pharmaceutical dose, wherein if the measured pharmaceutical dose fails to comply with the stored criteria, the measured pharmaceutical dose is discarded and a second measured pharmaceutical dose is produced by the system for inspection.

13. The system of claim 12, wherein the dispensing apparatus includes:

a storage facility for holding containers, each container holding a supply of one pharmaceutical substance;

a device for removing a cap of a particular container;

a storage facility for holding a number of syringes;

a device for removing a needle cover of the syringe; and

a mixing station for mixing a selected pharmaceutical substance in the particular container with one or more diluents which are discharged from one or more syringes into the container holding the selected pharmaceutical substance to produce the measured pharmaceutical dose.

14. The system of claim 13, further including a drug syringe preparation station where the particular container holding the mixed measured pharmaceutical dose is delivered to after the mixing has occurred at the mixing station, the drug syringe preparation station including a supply of syringes, the robotic device retrieving one particular syringe and manipulating it such that a needle of the syringe is inserted into the container holding the measured pharmaceutical dose, the measured pharmaceutical dose then being withdrawn from the container and delivered to a body of the syringe.

15. The system of claim 14, further including:

a pre-inspection station including a weighing device for weighing the syringe containing the measured pharmaceutical dose, the weighing device being in communication with the at least one computer through the computer interface, wherein the measured weight of the syringe is compared with inputted specifications and if the measured weight is within an acceptable range, the syringe is delivered to the inspection station.

16. The system of claim 12, wherein the dispensing apparatus includes:

a labeling station for generating a label that is unique to the measured pharmaceutical dose, the label listing at least some of the inputted information; and

a weigh station for weighing the measured pharmaceutical dose, the at least one computer comparing the measured weight to the inputted information to determine whether the measured pharmaceutical dose complies with the inputted information.

17. The system of claim 12, wherein the at least one robotic device includes at least one movable arm and at least one pair of gripping features that are attached to at least one movable arm, the gripping features having sensors for indicating the presence or absence of an object.

18. The system of claim 12, further including a unit for storing at least one pharmaceutical drug, the unit being disposed within a distance from the dispensing apparatus so that the at least one robotic device can access the unit and retrieve a particular pharmaceutical drug that is stored therein, the unit having at least one sensor in communication with the computer interface for indicating when particular pharmaceutical drug needs to be replenished.

19. The system of claim 18, wherein the unit holds a plurality of pharmaceutical products that are arranged in a plurality of columns with each column only containing a pharmaceutical drug of one type, each column having one sensor associated therewith for indicating that the associated column is empty.

12. An integrated automated system for preparing a measured pharmaceutical dose, the system comprising:

an input for entering information related to the preparation and delivery of the measured pharmaceutical dose;

a dispensing apparatus including at least one robotic device and a plurality of stations, each station being arranged to cooperate with the at least one robotic device in a sequence of operations to produce the measured pharmaceutical dose from a supply of pharmaceutical substances;

an inspection station for inspecting the measured pharmaceutical dose to determine whether the measured pharmaceutical dose complies with the inputted information associated with the measured pharmaceutical dose, wherein if the measured pharmaceutical dose fails to comply with the inputted information, the measured pharmaceutical dose is discarded and a second pharmaceutical dose is produced for inspection; and

a computer interface which provides bi-directional communication between at least one computer, the dispensing apparatus, including the robotic device, and the inspection station, wherein the at least one computer stores and processes the information that is entered at the input so that the at least one computer generates command signals that are delivered to the dispensing apparatus to instruct the at least one robotic device to prepare the measured pharmaceutical dose in conformance with the inputted information.