Parenteral products automation system (PPAS)

• US 7,260,447 B2
• Filed: 06/05/2002
• Issued: 08/21/2007
• Est. Priority Date: 08/10/1995
• Status: Expired due to Term

• Current Assignee: Baxter Corporation Englewood (Baxter International Inc.)
• Original Assignee: Forhealth Technologies Incorporated (Baxter International Inc.)
• Inventors: Osborne, Joel A.
• Primary Examiner(s): Von Buhr; Maria N.
• Application Number:
  US10/164,288
• Publication Number:
  US 20020198738A1
• Time in Patent Office: 1,903 Days
• Field of Search: 700213-216, 700/218, 700221-227, 700/231, 700239-244, 700/265, 700/266, 222 64- 69, 222129-1294, 705/22, 705/23, 705/28
• US Class Current: 700/216
• 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 to a another location;

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 pharmaceutical product based upon information inputted to the computer, 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, wherein one of the work stations includes 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 holding a plurality of pharmaceutical products that are arranged in drug vials arranged in a plurality of columns, each column having one sensor associated therewith for indicating that the associated column is empty, the work stations also including a station for removal of a cap from one drug vial that contains one pharmaceutical drug, wherein one unit of the pharmaceutical product is prepared at one time in the drug vial by reconstituting the pharmaceutical drug which is then withdrawn therefrom as the resultant pharmaceutical product; 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 passes an inspection, the resultant pharmaceutical product is advanced to another station.

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 performs mechanical functions including selection and retrieval of an 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 one drug 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. The automated system of claim 1, wherein the dispensing apparatus includes:

a storage facility for holding drug vials, each drug vial holding a supply of one pharmaceutical substance;

a device for removing the cap of the drug vial;

a storage facility for holding a number of syringes;

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

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

12. The automated system of claim 11, further including a drug syringe preparation station where the particular drug vial holding the mixed measured pharmaceutical product 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 drug vial holding the measured pharmaceutical product, the measured pharmaceutical product then being withdrawn from the drug vial and delivered to a body of the syringe.

13. The automated system of claim 12, further including:

a pre-inspection station including a weighing device for weighing the syringe containing the measured pharmaceutical product, 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 meets anticipated specifications for weight, the syringe is delivered to the inspection station.

14. The automated system of claim 1, wherein the dispensing apparatus includes:

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

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