KR-102962490-B1 - FLUID DISTRIBUTION SYSTEM WITH SINGLE USE MANIFOLD ASSEMBLY FOR SCALED FILLING

Abstract

A fluid distribution system comprises disposable distributor manifolds, each having a distributor manifold inlet and a plurality of distributor manifold outlets fluidly communicating with the distributor manifold inlet. A set of disposable injector manifolds may be sequentially connected to one of the outlets of a disposable distributor manifold located immediately upstream of the connection point of the set of disposable injector manifolds. In embodiments, an upstream distributor manifold may be used to supply fluid to a set of intermediate distributor manifolds, wherein the set of intermediate distributor manifolds corresponds to the number of outlets of the upstream distributor manifold.

Inventors

• 실 마이클 비.
• 이사일로빅 보얀
• 플리자르 로베르트
• 라우텐바흐 제레미

Assignees

• 싸이티바 유에스 엘엘씨

Dates

Publication Date

20260508

Application Date

20221230

Priority Date

20220923

Claims (20)

1. Fluid distribution system including the following: A first disposable manifold having a first manifold inlet and a plurality of first manifold outlets in fluid communication with the first manifold inlet; A skid comprising a pump, wherein the first disposable distributor manifold is removablely mounted on the skid and is fluidly arranged with the pump to deliver a fluid supply to the inlet of the first distributor manifold; A first distributor valve array, wherein the first distributor valve array comprises a plurality of valves mounted on the skid and arranged with the first disposable distributor manifold, such that each of the first distributor manifold outlets can be independently closed through one of the individual valves of the first distributor valve array; and A set of single-use filler manifolds, wherein the single-use filler manifolds of the set correspond to the number of first distributor manifold outlets, and each of the single-use filler manifolds has a filler manifold inlet, a plurality of filler manifold outlets fluidly communicating with the filler manifold inlet, and an aseptic fluid connector configured to fluidly connect the filler manifold inlet to one of the plurality of first distributor manifold outlets.
2. A fluid distribution system according to claim 1, further comprising the following: A second disposable manifold, wherein the second disposable manifold has a second manifold inlet and a plurality of second manifold outlets in fluid communication with the second manifold inlet, the second disposable manifold is removablely mounted on the skid, one of the plurality of second manifold outlets is in fluid communication with the first manifold inlet, and the second disposable manifold is fluidly arranged with the pump for delivering the fluid supply through the second disposable manifold to the first manifold inlet; and A second distributor valve array, wherein the second distributor valve array comprises a plurality of valves mounted on the skid and arranged with the second disposable distributor manifold, such that each of the second distributor manifold outlets can be independently closed through one of the individual valves of the second distributor valve array.
3. A fluid distribution system according to claim 2, wherein the first disposable distributor manifold is one of a set of first disposable distributor manifolds, the first disposable distributor manifolds of the set correspond to the number of second distributor manifold outlets, and each of the first disposable distributor manifolds has a sterile fluid connector configured to fluidly connect the first disposable distributor manifold inlet to one of the plurality of second distributor manifold outlets.
4. In any one of claims 1 to 3, one of the disposable injector manifolds of the set is mounted on the skid, and the fluid distribution system is: An injector valve array, wherein the injector valve array comprises a plurality of valves mounted on the skid and arranged with the disposable injector manifold, such that each of the injector manifold outlets can be independently closed through one of the individual valves of the injector valve array. A fluid distribution system including further
5. A fluid distribution system according to claim 4, wherein the valves of the injector valve array are arranged along a vertical axis in a spaced-apart relationship relative to one another.
6. A fluid distribution system according to claim 4, wherein the valves of the injector valve array are arranged along a horizontal axis in a spaced-apart relationship relative to one another.
7. A fluid distribution system according to any one of claims 1 to 3, further comprising the following: As a distribution tower, one of the disposable injector manifolds of the set is mounted on the distribution tower; and An injector valve array, wherein the injector valve array comprises a plurality of valves mounted on the distribution tower and arranged with the disposable injector manifold mounted on the distribution tower, such that each of the injector manifold outlets can be independently closed through one of the individual valves of the injector valve array.
8. In claim 7, the fluid distribution system comprises a distribution tower and a trolley, wherein the tower extends from the trolley, and one of the disposable injector manifolds of the set and the injector valve array are mounted on the tower.
9. In claim 7, the distribution tower comprises a gantry including a first upright, a second upright, and a beam extending between the upper ends of the first upright and the second upright, and one of the disposable injector manifolds of the set and the injector valve array are mounted on the beam, a fluid distribution system.
10. A fluid distribution system according to any one of claims 1 to 3, further comprising the following: A plurality of disposable containers, wherein each of the disposable containers has an access port fluidly connected to one of the individual injector manifold outlets through a sterile fluid connector; and A control unit comprising a non-transient computer-readable medium having a fluid distribution program and a processor, wherein the processor is arranged with the computer-readable medium to execute the fluid distribution program, and the processor electrically communicates with the first distributor valve array to selectively operate the valves of the first distributor valve array based on instructions from the fluid distribution program, and the control unit having a scaling module configured to sequentially open one of the first distributor manifold outlets and close another of the first distributor manifold outlets to perform a corresponding sequential series of injection operations to one of the disposable injector manifolds of the set.
11. A method for aseptically distributing a fluid, comprising the following steps: A step of supplying fluid into the inlet of a disposable distributor manifold; A step of discharging a first fluid supply from a first outlet among a plurality of distributor manifold outlets of the disposable distributor manifold to an injector manifold inlet of the first disposable injector manifold through a first sterile fluid path; A step of discharging portions of the first fluid supply individually, from a plurality of injector manifold outlets of the first disposable injector manifold, to one of a first set of disposable containers individually fluid-connected in a sterile state to the plurality of injector manifold outlets of the first disposable injector manifold; After discharging the portions of the first fluid supply, the step of separating the first disposable injector manifold from the disposable distributor manifold; A step of discharging a second fluid supply from a second outlet among the plurality of distributor manifold outlets of the disposable distributor manifold to an injector manifold inlet of the second disposable injector manifold through a second sterile fluid path; and A step of discharging portions of the second fluid supply individually, from a plurality of injector manifold outlets of the second disposable injector manifold, to one of a second set of disposable containers individually fluid-connected in a sterile state to the plurality of injector manifold outlets of the second disposable injector manifold.
12. In claim 11, a method further comprising the following steps: A step of sequentially discharging additional fluid supplies from each other distributor manifold outlet port of the disposable distributor manifold to the injector manifold inlet of an individual other disposable injector manifold through individual separate sterile fluid paths; A step of individually discharging portions of the additional fluid supply from a plurality of injector manifold outlets of each individual different disposable injector manifold to one of an additional set of disposable containers individually fluid-connected aseptically to the plurality of injector manifold outlets of each individual different disposable injector manifold; and After individually discharging the portions of the additional fluid supply, the step of separating each individual different disposable injector manifold from the disposable distributor manifold.
13. In claim 12, a method further comprising the following steps: Before supplying the above fluid into the inlet of the above disposable distributor manifold, the step of installing the above disposable distributor manifold on a filling skid; and A step of sequentially discharging the additional fluid supply from each other distributor manifold outlet port of the disposable distributor manifold, and then removing the disposable distributor manifold from the injection skid.
14. In any one of claims 11 to 13, the disposable distributor manifold comprises a first disposable distributor manifold, and discharging the first fluid supply from the first outlet among a plurality of distributor manifold outlets of the disposable distributor manifold is: A step of supplying the first fluid supply into the inlet of a second disposable distributor manifold, wherein the second disposable distributor manifold of the first sterile fluid path is interposed between the first outlet among the plurality of distributor manifold outlets of the first disposable distributor manifold and the inlet of the first disposable injector manifold; and A step of discharging the first fluid supply through the first sterile fluid path from the first outlet among the plurality of distributor manifold outlets of the second disposable distributor manifold to the injector manifold inlet of the first disposable injector manifold. A method including
15. A method for dispensing a fluid under sterile conditions, comprising the following steps: A step of supplying a first fluid supply into the distributor manifold inlet of a first disposable distributor manifold; A step of discharging a first fluid supply from a first outlet among a plurality of distributor manifold outlets of the first disposable distributor manifold to a distributor manifold inlet of the second disposable distributor manifold through a first sterile fluid path; A step of discharging the first fluid supply through a second sterile fluid path from a first outlet among a plurality of distributor manifold outlets of the second disposable distributor manifold to an injector manifold inlet of the first disposable injector manifold; A step of discharging portions of the first fluid supply individually, from a plurality of injector manifold outlets of the first disposable injector manifold, to one of a first set of disposable containers individually fluid-connected in a sterile state to the plurality of injector manifold outlets of the first disposable injector manifold; After discharging the portions of the first fluid supply, the first disposable injector manifold is separated from the second disposable distributor manifold, and the second disposable injector manifold is connected to the second outlet among the plurality of distributor manifold outlets of the second disposable distributor manifold through a third sterile fluid path; A step of supplying a second fluid supply to the inlet of the first disposable distributor manifold; A step of discharging the second fluid supply through the first sterile fluid path from the first outlet among the plurality of distributor manifold outlets of the first disposable distributor manifold to the distributor manifold inlet of the second disposable distributor manifold; A step of discharging the second fluid supply through the third sterile fluid path from the second outlet among the plurality of distributor manifold outlets of the second disposable distributor manifold to the injector manifold inlet of the second disposable injector manifold; and A step of discharging portions of the second fluid supply individually, from a plurality of injector manifold outlets of the second disposable injector manifold, to one of a second set of disposable containers individually fluid-connected in a sterile state to the plurality of injector manifold outlets of the second disposable injector manifold.
16. In claim 15, a method further comprising the following steps: A step of sequentially discharging additional fluid supplies from each other distributor manifold outlet port of the second disposable distributor manifold to the injector manifold inlet of an individual other disposable injector manifold through individual separate aseptic fluid paths; and A step of individually discharging portions of the additional fluid supply from a plurality of injector manifold outlets of each individual different disposable injector manifold to one of an additional set of disposable containers individually fluid-connected aseptically to the plurality of injector manifold outlets of each individual different disposable injector manifold.
17. In claim 16, a method further comprising the following steps: After individually discharging the portions of the additional fluid supply, the step of separating each individual different disposable injector manifold from the second disposable distributor manifold; and After sequentially discharging the additional fluid supply from each other distributor manifold outlet port of the second disposable distributor manifold, the second disposable distributor manifold is separated, and the second outlet among the plurality of distributor manifold outlets of the first disposable distributor manifold is connected to the distributor manifold inlet of the third disposable distributor manifold through a fourth sterile fluid path.
18. In claim 17, a method further comprising the following steps: A step of supplying a third fluid supply into the inlet of the distributor manifold of the first disposable distributor manifold; A step of discharging the third fluid supply through the fourth sterile fluid path from the second outlet among the plurality of distributor manifold outlets of the first disposable distributor manifold to the distributor manifold inlet of the third disposable distributor manifold; A step of discharging the third fluid supply through a fifth sterile fluid path from a first outlet among a plurality of distributor manifold outlets of a third disposable distributor manifold to an injector manifold inlet of a third disposable injector manifold; and A step of discharging portions of the third fluid supply individually, from a plurality of injector manifold outlets of the third disposable injector manifold, to one of a third set of disposable containers individually fluid-connected in a sterile state to the plurality of injector manifold outlets of the third disposable injector manifold.
19. In claim 18, a method further comprising the following steps: A step of sequentially discharging additional fluid supplies from each other distributor manifold outlet port of the third disposable distributor manifold to the injector manifold inlet of an individual other disposable injector manifold through individual separate aseptic fluid paths; and A step of individually discharging portions of the additional fluid supply from a plurality of injector manifold outlets of each individual different disposable injector manifold to one of an additional set of disposable containers individually fluid-connected aseptically to the plurality of injector manifold outlets of each individual different disposable injector manifold.
20. In claim 19, a method further comprising the following steps: A step of sequentially discharging one of the additional sets of fluid supplies from each other distributor manifold outlet port of the first disposable distributor manifold to a set of intermediate disposable distributor manifolds.

Description

Fluid distribution system with single-use manifold assembly for scaled filling Cross-reference regarding related applications This patent application claims priority to U.S. Regular Patent Application No. 17/934,962 (filing date: September 23, 2022, title: "Fluid Distribution System with Single Use Manifold Assembly for Scaled Filling"), claiming priority to U.S. Provisional Patent Application No. 63/295,483 (filing date: December 30, 2021, title: "Fluid Distribution System with Single Use Manifold Assembly for Scaled Filling"), the entirety of which is incorporated herein by reference. The use of single-use systems (SUS), such as biological container bags, is becoming increasingly widespread in biopharmaceutical applications. SUS can be used in systems such as bioreactors and mixing systems. Exemplary raw material sector SUS applications include media preparation processes such as mixing and filtration, including, for example, tangential flow filtration (TFF). Examples of downstream sector SUS applications include chromatographic concentration, diafiltration, and buffer preparation. Adopting SUS can provide several advantages over conventional reusable stainless steel systems. Disposable technology can: increase process flexibility and reduce the risk of cross-contamination; reduce or eliminate the need for cleaning; reduce requirements such as in-house sterilization by autoclaving and cleaning of chemical stocks; and reduce process downtime. One mode of biopharmaceutical processing involves a step of managing the movement of liquids through numerous elements, including tubes, valves, and sensors. There are specific requirements regarding bulk injection processes for dispensing fluids from a large container into a number of individual containers while maintaining sterile conditions. Conventional systems available on the market include manifolds with a fixed number of outlets and do not allow for scalability. For example, if the requirement is to inject 20 vessels from a single large tank, a conventional system would include a manifold with a single inlet and 20 outlets. While this array enables sterile injection, it is limited to injecting a maximum of 20 vessels per manifold. There is a continuing demand in the art for single-use applications involving dispensing fluid from a source into a number of smaller containers. For example, there is a continuing demand in the art for providing additional solutions to dispense liquid in a sterile manner into a significant number of outlets and thus into containers such as bags and bottles. As may be recognized, the background description in this section is intended to assist the reader, and none of the problems indicated are to be construed as an indication that they are known in the art. While the described principles may mitigate problems inherent in other systems in some aspects and embodiments, as may be recognized, the scope of the novel invention protected is limited by the appended claims and is not limited by the ability of any disclosed feature to solve any specific problem mentioned herein. The present disclosure relates to embodiments of a fluid distribution system in one aspect. In one embodiment, the fluid distribution system comprises a first disposable distributor manifold, a skid, a first distributor valve array, and a set of disposable injector manifolds. The first disposable distributor manifold has a first distributor manifold inlet and a plurality of first distributor manifold outlets in fluid communication with the first distributor manifold inlet. The skid includes a pump. The first disposable distributor manifold is removablely mounted on the skid, and the first disposable distributor manifold is also fluidly arranged with the pump to deliver a fluid supply to the first distributor manifold inlet. The first distributor valve array comprises a plurality of valves mounted on the skid and arranged with the first disposable distributor manifold, wherein each of the first distributor manifold outlets is configured to be independently closed through one of the individual valves of the first distributor valve array. The disposable injector manifolds of the above set correspond to the number of first distributor manifold outlets. Each disposable injector manifold has an injector manifold inlet, a plurality of injector manifold outlets in fluid communication with the injector manifold inlet, and an aseptic fluid connector configured to fluidly connect the injector manifold inlet to one of the plurality of first distributor manifold outlets. In another aspect, the present disclosure relates to embodiments of techniques for dispensing fluids aseptically. In one embodiment, a method for dispensing fluids aseptically comprises the step of supplying fluids into a dispensing manifold inlet of a disposable dispensing manifold. A first fluid supply is discharged from a first outlet among a plurality of dispensing manifold outlets of the disposable dispensing