Dual container system for product reconstitution

Patent metadata

Field	Value
Publication number	US-11318069-B2
Application number	US-201816630994-A
Country	US
Kind code	B2
Filing date	Jul 12, 2018
Priority date	Jul 17, 2017
Publication date	May 3, 2022
Grant date	May 3, 2022

Abstract

A system for reconstituting and sterilizing a concentrate includes a mixing container, a filtration device, and a product bag. The a mixing container has an inlet port and outlet port in fluid communication with a mixing chamber disposed between the inlet port and the outlet port. The mixing chamber is adapted to contain a product concentrate. The filtration device has an inlet and an outlet, the inlet of the filtration device coupled to the outlet port of the mixing container. The filtration device includes a filter membrane with a nominal pore size in a range of approximately 0.1 μm to approximately 0.5 μm. The product bag has an inlet port coupled to the outlet of the filtration device, and has a bladder defining an empty sterile chamber for receiving sterilized and reconstituted product resulting from mixing a diluent with a product concentrate in the mixing chamber to obtain a mixture then introduced through the filtration device to obtain the reconstituted and sterilized product.

First claim

The invention claimed is:

1. A system for reconstituting and sterilizing a concentrate, comprising:
a mixing container having an inlet port and outlet port in fluid communication with a mixing chamber disposed between the inlet port and the outlet port, the mixing chamber adapted to contain a product concentrate;
a filtration device having an inlet and an outlet, the inlet of the filtration device coupled to the outlet port of the mixing container, the filtration device comprising a filter membrane with a nominal pore size in a range of approximately 0.1 μm to approximately 0.5 μm; and
a product bag having an inlet port coupled to the outlet of the filtration device, the product bag having a bladder defining an empty sterile chamber for receiving sterilized and reconstituted product resulting from mixing a pharmaceutical fluid with a product concentrate in the mixing chamber to obtain a mixture then introduced through the filtration device to obtain the reconstituted and sterilized product, wherein the mixing container comprises a vial with a single open end, and the system further comprises a vial adaptor defining the inlet port and outlet port, the vial adaptor further defining a mixing port coupled to the single open end of the vial.

2. The system of claim 1 , wherein the vial adaptor further comprises a first conduit establishing fluid communication between the inlet port and the mixing port, and a second conduit establishing fluid communication between the mixing port and the outlet port.

3. The system of claim 2 , wherein each of the first and second conduits includes a terminal end that is disposed within the vial, the terminal end of the first conduit extending further into the vial than the second terminal end.

4. The system of claim 1 ,
further comprising a syringe with a delivery end adapted to be coupled to the outlet of the filtration device, the syringe having a syringe barrel defining a reservoir, a plunger, and a stopper slidably disposed in the reservoir, the reservoir defining an empty sterile chamber for receiving the reconstituted and sterilized product from the outlet of the filtration device.

5. The system of claim 1 , wherein the filter membrane is shaped as (a) a hollow fiber with a wall and pores residing in the wall of the fiber, or (b) a flat filter disposed within a rectangular, square or box-like filter housing, the flat filter having a wall and pores residing in the wall.

6. The system of claim 1 , wherein the filtration device comprises a stem and the filter membrane is disposed in line with the stem, wherein the stem defines a seal-and-cut area between the filter membrane and the inlet port of the product bag, the seal-and-cut area adapted to allow the stem to be sealed and cut to close the inlet port of the product bag.

7. The system of claim 1 , wherein the filter membrane includes an inlet end and an outlet end, wherein the outlet end is sealed and the inlet end is an open inlet.

8. The system of claim 6 , wherein the stem is one of a flexible stem or a rigid stem.

9. The system of claim 1 , wherein the filter membrane has a nominal pore size in a range of approximately 0.1 μm to approximately 0.22 μm.

10. A system for reconstituting a non-sterile concentrate, comprising:
a mixing container having an inlet port and outlet port in fluid communication with a non-sterile mixing chamber disposed between the inlet port and the outlet port;
a non-sterile product concentrate disposed in the mixing chamber; and
a filtration device having an inlet and an outlet, the inlet of the filtration device coupled to the outlet port of the mixing container, the filtration device comprising a filter membrane disposed between the inlet and outlet of the filtration device and having a nominal pore size in a range of approximately 0.1 μm to approximately 0.5 μm, for producing sterilized and reconstituted product resulting from mixing a pharmaceutical fluid with the non-sterile product concentrate in the mixing chamber to obtain a non-sterile mixture then introduced through the filtration device to obtain the reconstituted and sterilized product, wherein the mixing container comprises a vial with a single open end, and the system further comprises a vial adaptor defining the inlet port and outlet port, the vial adaptor further defining a mixing port coupled to the single open end of the vial.

11. The system of claim 10 , wherein the vial adaptor further comprises a first conduit establishing fluid communication between the inlet port and the mixing port, and a second conduit establishing fluid communication between the mixing port and the outlet port.

12. The system of claim 1 , wherein the filter membrane has a wall thickness in the range of approximately 150 μm to approximately 500 μm.

13. The system of claim 1 , wherein the filter membrane has a longitudinal dimension in the range of approximately 3 cm to approximately 420 cm, an inner diameter in the range of approximately 2 mm to approximately 4 mm, and an outer diameter in the range of approximately 2.3 mm to approximately 5 mm.

14. The system of claim 1 , wherein the filter membrane includes at least one U-shaped hollow fiber filter membrane secured in a U-shaped configuration by a filter membrane housing contained within a filter body.

15. The system of claim 1 , wherein the filter membrane comprises a plurality of parallel hollow fiber membrane filters secured in a side-by-side configuration.

16. The system claim 1 , wherein the filter membrane comprises a plurality of parallel hollow fiber membrane filters arranged in a circular pattern.

17. The system of claim 1 , wherein the product bag further comprises an administration port separate from the inlet port of the product bag for facilitating administration of the reconstituted and sterilized product to a patient.

18. The system of claim 1 , wherein the filter membrane is made of at least one of the following materials: a polyolefin, polyvinylidene fluoride, polymethylmethacrylate, polyacrylonitrile, polysulfone, polyethersulfone, and a polymer containing cationic charges.

19. The system of claim 1 , wherein the stem is made of at least one of the following materials: PVC, PET, a poly(meth)acrylate, a polycarbonate, a polyolefin, a cycloolefin copolymer, polystyrene, or a silicone polymer.

20. The system of claim 11 , wherein each of the first and second conduits includes a terminal end that is disposed within the vial, the terminal end of the first conduit extending further into the vial than the second terminal end.

Assignees

• Baxter Int
• Baxter Healthcare Sa

Inventors

• Ding Yuanpang Samuel
• Lo Ying-Cheng
• Rivett Jacob Daniel
• Bomgaars Grant Anthony
• Dudar Thomas Edward
• Pasmore Mark Edward
• Sadowski Michael Joseph
• Hristakos Anastasios
• Ranalletta Joseph Vincent
• Krause Bernd

Classifications

• B01D69/061

  Membrane bags or membrane cushions · CPC title

• A61M5/3129

  Syringe barrels (A61M5/3205 and A61M5/50 take precedence) · CPC title

• A61J1/2048

  Connecting means · CPC title

• A61J1/2089 Primary

  Containers or vials which are to be joined to each other in order to mix their contents (combinations of vial and syringe for mixing their contents A61J1/2096) · CPC title

• A61J1/2086

  for fluid filtration · CPC title