System for on-demand manufacturing of parenteral solutions

Patent metadata

Field	Value
Publication number	US-2025099663-A1
Application number	US-202318852914-A
Country	US
Kind code	A1
Filing date	Apr 4, 2023
Priority date	Apr 4, 2022
Publication date	Mar 27, 2025
Grant date	—

Abstract

A system for manufacturing parenteral solutions includes a drug dosage module and a mixing module. The drug dosage module includes a source of one or more parenteral drug solutes, and one or more metering devices configured to discharge a metered dosage of each of the parenteral drug solutes. The mixing module includes a container configured to receive water-for-injection (WFI) and the parenteral drug solutes discharged from the one or more metering devices, and a mixer configured to mix water-for-injection (WFI) and the parenteral drug solutes in the container to form a parenteral solution.

First claim

1 . A system for manufacturing parenteral solutions comprising:
a drug dosage module comprising:
a source of one or more parenteral drug solutes; and
one or more metering devices configured to discharge a metered dosage of each of the parenteral drug solutes; and
a mixing module comprising:
a container configured to receive water-for-injection (WFI) and the parenteral drug solutes discharged from the one or more metering devices; and
a mixer configured to mix water-for-injection (WFI) and the parenteral drug solutes in the container to form a parenteral solution.

2 . The system according to claim 1 , wherein the mixing module comprises at least one conductivity sensor, each configured to sense a conductivity of the parenteral solution in the container and produce a conductivity output that is indicative of the sensed conductivity.

3 . The system according to claim 2 , further comprising a controller configured to control the discharge of the metered dosage of each of the parenteral drug solutes to the container by the one or more metering devices based on each conductivity output produced by the at least one conductivity sensor.

4 . The system according to claim 3 , wherein:
the system comprises a water module including a water pump configured to deliver a flow of the WFI to the container; and the controller is configured to control the delivery of the flow of the WFI to the container by the water pump based on each conductivity output produced by the at least one conductivity sensor.

5 . The system according to claim 4 , wherein:
the at least one conductivity sensor comprises a plurality of the conductivity sensors, each positioned at a different height within the container; and the controller controls the discharge of the metered dosage of each of the parenteral drug solutes by the one or more metering devices and the flow of the WFI to the container by the water pump based on the conductivity outputs.

6 . The system according to claim 5 , wherein the water module comprises a water purifier configured to filter or sterilize a flow of water to produce the flow of the WFI.

7 . The system according to claim 6 , wherein the water purifier comprises a water filter, through which the flow of water travels, and/or an ultraviolet (UV) sterilization device comprising one or more UV light sources configured to expose the flow of water to UV light.

8 . The system according to claim 1 , further comprising a bagging module configured to deliver a flow of the parenteral solution into each of one or more fluid storage bags through a corresponding fluidic coupling.

9 . The system according to claim 8 , wherein each fluidic coupling comprises a first coupler configured to receive the flow of the parenteral solution and a second coupler attached to the fluid storage bag, the first and second couplers configured to cooperate to form the fluidic coupling.

10 . The system according to claim 9 , wherein:
the first coupler comprises a needle, and the second coupler comprises a septum; the first and second couplers comprise cooperating tubing fittings; or the first and second couplers comprise cooperating Luer fittings.

11 . The system according to claim 10 , wherein the bagging module comprises a solution pump configured to drive the flow of the parenteral solution from the container into each of the one or more fluid storage bags through the corresponding fluidic coupling.

12 . The system according to claim 11 , wherein the bagging module comprises a fluidic coupling drive mechanism configured to move each of the first couplers relative to the second couplers between a retracted position, in which each of the first couplers is recessed from the corresponding second coupler, and a filling position, in which each of the first couplers cooperates with the corresponding second coupler to form the fluidic couplings.

13 . The system according to claim 9 , wherein the bagging module further comprises a sterilizer configured to sterilize the first coupler and/or the second coupler of each fluidic coupling comprising:
a first sterilizer comprising:
at least one sterilization chamber, wherein the first coupler and/or the second coupler of each fluidic coupling is contained in one of the sterilization chambers; and
one or more UV lamps contained in each of the sterilization chambers and configured to expose the first coupler and/or the second coupler of each fluidic coupling to UV light; or
a second sterilizer comprising:
at least one sterilization chamber, each containing a sterilization fluid; and
the first coupler and/or the second coupler of each fluidic coupling is contained in one of the sterilization chambers and the sterilization fluid.

14 . (canceled)

15 . (canceled)

16 . The system according claim 12 , wherein:
the bagging module comprises a plurality of the fluid storage bags and a plurality of the fluidic couplings; the first coupler of each fluidic coupling comprises a needle; the second coupler of each fluidic coupling comprises a bag septum fluidically coupled to an interior cavity of the corresponding fluid storage bag; and the fluidic coupling drive mechanism is configured to move the plurality of needles relative to the corresponding bag septa between a retracted position, in which each of the needles is recessed from the corresponding bag septum, and a filling position, in which each of the needles pierces the corresponding bag septum and is configured to deliver the flow of the parenteral solution to the interior cavity of the corresponding fluid storage bag.

17 . (canceled)

18 . A bagging module configured to fill one or more fluid storage bags with parenteral solution, the bagging module comprising:
a source of parenteral solution; one or more fluid storage bags, each having an interior cavity; and a fluidic coupling corresponding to each fluid storage bag to facilitate delivery of a flow of the parenteral solution from the source into the one or more fluid storage bags.

19 . The bagging module according to claim 18 , wherein each fluidic coupling comprises a first coupler configured to receive the flow of the parenteral solution and a second coupler attached to the fluid storage bag, the first and second couplers configured to cooperate to form the fluidic coupling.

20 . The bagging module according to claim 19 , wherein:
the first coupler comprises a needle, and the second coupler comprises a septum; the first and second couplers comprise cooperating tubing fittings; or the first and second couplers comprising cooperating Luer fittings.

21 . The bagging module according to claim 20 , wherein the bagging module comprises a solution pump configured to drive the flow of the parenteral solution from the source into each of the one or more fluid storage bags through the corresponding fluidic coupling.

22 . The bagging module according to claim 21 , wherein the bagging module comprises a fluidic coupling drive mechanism configured to move each of the first couplers relative to the second couplers between a retracted position, in which each of the first couplers is recessed from the corresponding second coupler, and a filling position, in which each of the first couplers cooperates with the corresponding second coupler to form the fluidic couplings.

23 . The bagging module according to claim 18 , wherein the bagging module further comprises a sterilizer configured to sterilize the first coupler and/or

Assignees

• Univ Minnesota

Inventors

• Wright Natasha C
• Yekinni Ibrahim
• Szot Benjamin
• Bernemann Carolyn F

Classifications

• A61L2103/15

  Laboratory, medical or dentistry appliances, e.g. catheters or sharps · CPC title

• A61L2202/122

  Chambers for sterilisation · CPC title

• A61L2202/11

  Apparatus for generating biocidal substances, e.g. vaporisers, UV lamps · CPC title

• A61L2/186

  Peroxide solutions · CPC title

• A61L2/18

  Liquid substances · CPC title