Ultraviolet Sanitization in Pharmacy Environments

• US 20110172810A1
• Filed: 03/28/2011
• Published: 07/14/2011
• Est. Priority Date: 12/22/2005
• Status: Active Grant

• Current Assignee: ArXium, Inc. (Van Humbeck Family)
• Original Assignee: Intelligent Hospital Systems, Inc. (Van Humbeck Family)
• Inventors: Eliuk, Walter W., Rob, Ronald H., Mlodzinski, Lance R., Reinhardt, Alex H., Davidson, Robert Keith
• Granted Patent: US 8,182,744 B2
• Time in Patent Office: Days
• US Class Current: 700/230
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: A61J 2200/74 for weight
• CPC Class Codes: A61J 2205/10 Bar codes
• CPC Class Codes: A61J 2205/30 Printed labels
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• CPC Class Codes: A61L 2/10 Ultraviolet radiation
• 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 55/08 by irradiation
• CPC Class Codes: G07F 11/165 using xyz-picker or multi-dimensional article picking arrangements
• CPC Class Codes: G07F 11/1657 the picking arrangements using suction
• CPC Class Codes: G07F 11/44 in which magazines the articles are stored in bulk
• CPC Class Codes: G07F 11/48 the storage containers or supports, e.g. magazine, being pivotally mounted
• CPC Class Codes: G07F 11/54 about vertical axes
• CPC Class Codes: G07F 11/62 in which the articles are stored in compartments in fixed receptacles
• CPC Class Codes: G07F 17/0092 for assembling and dispensing of pharmaceutical articles medical dispensers for private use, A61J7/00
• CPC Class Codes: G07F 9/10 Casings or parts thereof, e.g. with means for heating or cooling
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: Y10S 604/905 : Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

Systems and methods to reduce bioburden on at least a portion of a fluid transfer port include supplying a dose of radiation to the portion in optical communication with at least one source of radiation. In an illustrative example, a medical container, such as a vial or IV bag, receives a dose of ultraviolet (UV) energy substantially at a predetermined region of a fluid transfer site. In some examples, such a sanitization process may precede a fluid transfer operation in which a fluid is transferred into or out of the medical container by passing through the sanitized region. Such fluid transfers may be used in automated or semi-automated pharmaceutical processes, such as drug reconstitution. Various embodiments may further include one or more seal assemblies, each seal assembly having an aperture through which the radiation dose is supplied from the source to a controlled region on the fluid transfer port.

Claims

1. A system to automate medical compounding, the system comprising:

a compounding chamber;

an air handling system arranged to provide air flow through the compounding chamber, the air handling system being arranged to produce a substantially uniform airflow from a ceiling of the compounding chamber toward a floor of the compounding chamber to inhibit contamination of medical containers;

an automated system to transport medical containers amongst a plurality of positions within the chamber;

a recognition system to identify medical containers using one or more verification operations;

a compounding system disposed in the chamber to transfer medicaments between medical containers; and

a sanitization system to substantially reduce bioactivity on at least a first portion of a first fluid transfer port of a first form of a first medical container, the sanitization system comprising;

a first radiation source to supply a dose of radiation, and

an actuator to bring at least the first portion of the first fluid transfer port into optical communication with the first radiation source.

2. The system of claim 1, wherein the sanitization system further comprises a controller that applies a first configuration of the sanitization system to apply radiation to at least the first portion of the first fluid transfer port of the first medical container and subsequently applies a second configuration of the sanitization system to apply radiation to at least a second portion of a second fluid transfer port of a second form of a second medical container, wherein the controller changes the configuration of the sanitization system depending upon the form of the medical container to be sanitized.

3. The system of claim 2, wherein the controller changes the configuration of the sanitization system to apply radiation to a portion of the fluid transfer port to be sanitized based upon a sanitizing profile, wherein

the sanitizing profile is based in part on at least one of a size, a type or a shape of the medical container to be sanitized, and

the sanitizing profile includes at least one of a waveform, an amplitude, a time, and a pulse repetition number.

4. The system of claim 2, wherein the controller determines a distance that the actuator moves the first fluid transfer port into a first exposure aperture based in part on at least one of a size, a type or a shape of the medical container to be sanitized.

5. The system of claim 4, wherein the first exposure aperture comprises a receptacle with a concave opening adapted to receive fluid transfer ports having a range of dimensions.

6. The system of claim 2, further comprising:

a first exposure port in optical communication with the first radiation source, the first exposure port comprising a seal assembly with an adjustable aperture, wherein

the controller causes actuation of the adjustable aperture based on at least one of a size, a shape, and an exposure region of the fluid transfer port to be sanitized.

7. The system of claim 2, wherein

the sanitization system further comprises a first baffle and a second baffle, and

the controller selects the first baffle or the second baffle based on the form of the medical container to be sanitized and directs the sanitization system to position the selected baffle in proximity to the first radiation source.

8. The system of claim 2, wherein at least one of the first form of the first medical container and the second form of the second medical container comprises a drug vial, an IV bag, or a syringe.

9. A sanitization system in an automated pharmaceutical compounding system to substantially sanitize at least a portion of a first fluid transfer port of a first form of medical container and at least a portion of a second fluid transfer port of a second form of medical container, wherein the second form of medical container has a particular size, type, or shape substantially different from the first form of medical container, the sanitization system comprising:

a first UV source to supply a dose of radiation;

a processor to determine a profile of UV output corresponding to a third fluid transfer port to be sanitized, wherein

the third fluid transfer port is part of a third medical container, the third medical container having one of the first form and the second form,

the profile of UV output is based in part on at least one of a size, type, or shape of the third medical container, and

the profile of UV output includes at least one of a waveform, an amplitude, a time, and a pulse repetition number; and

a first exposure orifice to supply radiation to the third fluid transfer port, wherein the processor configures the sanitization system to apply radiation through the first exposure orifice according to the profile of UV output.

10. The sanitization system of claim 9, further comprising a second UV source, wherein the profile of UV output includes an offset for combining output patterns of the first UV source and the second UV source.

11. The sanitization system of claim 9, further comprising a second UV source, wherein the profile of UV output includes a first location for focusing the first UV source and a second location for focusing the second UV source.

12. The sanitization system of claim 9, wherein the profile of UV output is further based on one or more of access requirements of the third fluid transfer port to the first UV source, light containment requirements, and a distance of the third fluid transfer port from the first UV source.

13. The sanitization system of claim 9, wherein at least one of the first form of medical container and the second form of medical container comprises a drug vial, an IV bag, or a syringe.

14. A robotic automated pharmaceutical processing system comprising:

a processor-based interface configured to receive requests to prepare one or more pharmaceutical prescriptions; and

a controller coupled to the interface and configured to operate an automated prescription preparation device in response to the received requests, the automated prescription preparation device comprising;

a scale station to verify a weight of a filled medical container,

a fluid transfer station for performing a fluid transfer operation, and

a sanitization station including a first radiation source to supply a dose of radiation, wherein

the controller changes the configuration of the sanitization station to apply radiation to a first fluid transfer port of a first medical container based upon one or more parameters associated with the first medical container, and

a robotic manipulator configured to

convey the first medical container to the sanitization station for sanitizing, and

convey the first medical container to the fluid transfer station for filling.

15. The robotic automated pharmaceutical processing system of claim 14, wherein the controller further changes the configuration of the sanitization station to apply radiation to a second medical container, a first form of the first medical container having a particular size, type, or shape substantially different from a second form of the second medical container, wherein the configuration of the sanitization station differs depending upon the form of the medical container to be sanitized.

16. The robotic automated pharmaceutical processing system of claim 15, wherein

the controller changes the configuration of the sanitization station to apply radiation to the fluid transfer port to be sanitized based upon a sanitizing profile;

the sanitizing profile is based in part on at least one of the size, type or shape of the medical container to be sanitized; and

the sanitizing profile includes at least one of a waveform, an amplitude, a time, and a pulse repetition number.

17. The robotic automated pharmaceutical processing system of claim 15, wherein at least one of the first form of the first medical container and the second form of the second medical container comprises a drug vial, an IV bag, or a syringe.

18. The robotic automated pharmaceutical processing system of claim 14, wherein the the sanitization station further comprises a first exposure port having a concave opening receptacle capable of receiving a range of sizes of fluid transfer ports.

19. The robotic automated pharmaceutical processing system of claim 14, wherein

the sanitization station further comprises a first exposure port comprising a seal assembly with an adjustable aperture;

and

the controller configures the adjustable aperture based on at least one of a size, shape, and exposure region of the first fluid transfer port.

20. The robotic automated pharmaceutical processing system of claim 14, wherein

the sanitization station further comprises a first baffle and a second baffle;

and

the controller selects the first baffle or the second baffle based on at least one of the size, shape, and exposure region of the first fluid transfer port.