Modular disposable priming fluid kit and system therefor

Abstract

The utility model discloses a modularization disposable perfusion fluid suite and system thereof, the suite includes at least one disposable filter module and several connector modules through Gamma irradiation sterilization, and connector module both ends are equipped with equipment interface and suite interface respectively. Equipment interface is used for with external driving gas cavity or biological reactor and can carry out online steam sterilization (SIP) together, and suite interface is used for sterile quick connection between modules. Through the combination of these modules, a variety of flow paths such as series connection, parallel connection or redundant backup can be flexibly constructed. The core of its construction method is that first, the connector module is connected with the equipment and sterilized by SIP, and then the pre-sterilized disposable filter module is integrated with other modules. The utility model simplifies the perfusion system operation, greatly reduces the pollution risk and cell shear force, and can flexibly adapt to different process requirements, realizing the smooth transition of traditional stainless steel system to disposable technology.

Description

Technical Field

[0001] This utility model relates to the field of biopharmaceutical equipment technology, specifically to a modular disposable perfusion fluid kit for perfusion culture in a bioreactor, a perfusion system including the kit, and a method for constructing the same. Background Technology

[0002] Perfusion culture is an advanced mode of cell culture that maintains high-density and high-activity cell growth for extended periods by continuously adding fresh culture medium and removing metabolic waste and some of the medium. Its core component is the tangential flow filtration (TFF) system, used to separate cells from the culture medium.

[0003] Traditional perfusion systems are mainly divided into two categories: one type uses a pump (such as a peristaltic pump) as a power source, which has a complex piping system, is cumbersome to install, and the shear force of the pump can easily damage cells; the other type uses compressed gas to drive a stainless steel chamber to generate power. Although the shear force is small, it requires complex stainless steel clamps and piping, and must be steam-in-place (SIP) before use. The operation is complicated and can easily cause damage to the internal hollow fiber membrane column.

[0004] Furthermore, traditional systems often use rigid pipe connections, which lack flexibility and make it difficult to configure flow paths (such as series, parallel, or redundant backups) according to process requirements. Each replacement or maintenance requires complex cleaning validation and sterilization procedures, posing significant risks of contamination and operating costs.

[0005] Therefore, there is an urgent need in the field for a disposable irrigation solution that can simplify operation, reduce the risk of contamination, improve flexibility, and be compatible with existing equipment. Summary of the Invention

[0006] This invention aims to address the shortcomings of the prior art by providing a modular, disposable perfusion fluid kit and system. This solution simplifies the installation and operation of the perfusion system, completely eliminates the need for cleaning validation, significantly reduces the risk of contamination and cell shear forces, and can be flexibly adapted to different process scales and existing equipment.

[0007] To solve the above-mentioned technical problems, the present invention adopts the following technical solution:

[0008] In a first aspect, this utility model provides a modular disposable irrigation fluid kit for an irrigation system. The kit includes:

[0009] At least one disposable filter module, comprising a hollow fiber membrane and a first port and a second port respectively disposed at both ends of the hollow fiber membrane;

[0010] Several connector modules, each connector module including a fluid passage pipe and device interfaces and kit interfaces disposed at both ends of the passage pipe;

[0011] The device interface is configured to form a detachable sealed connection with an interface of an external drive air chamber, an interface of an external bioreactor, or the first port and the second port of the disposable filter module.

[0012] The kit interface is configured to form a detachable, sealed connection with the kit interface of another of the connector modules;

[0013] By selecting and connecting the disposable filter module and the connector module, a complete perfusion fluid pathway can be constructed from the driving air chamber through the hollow fiber membrane to the bioreactor.

[0014] Preferably, the device interface is a rigid sterile connector that can withstand online steam sterilization together with a matching interface.

[0015] Preferably, the device interface is a chuck connector.

[0016] Preferably, the kit interface is a sterile quick connector.

[0017] Preferably, both the disposable filter module and the connector module are individually packaged Gamma irradiation pre-sterilization components.

[0018] Preferably, the disposable filtration module is further provided with a filtrate port communicating with the interior of the hollow fiber membrane for discharging filtrate.

[0019] Preferably, the kit includes a plurality of disposable filter modules and a plurality of connector modules, wherein the plurality of disposable filter modules are fluidly connected via the connector modules in series, parallel or redundant backup manner.

[0020] More preferably, the kit also includes a multi-port connector for enabling parallel connection or redundant backup of multiple disposable filter modules.

[0021] A second aspect of this utility model provides an irrigation system. The system includes:

[0022] Modular disposable perfusion fluid kit as described above;

[0023] A drive air chamber, the interface of which is connected to the kit via a device interface of the connector module;

[0024] A bioreactor, the interface of which is connected to the kit via a device interface of the connector module.

[0025] This utility model has the following beneficial effects:

[0026] 1. Modularity and flexibility: Through standardized filter modules and connector modules, users can freely configure flow paths like building blocks, easily achieving single-connection, series, parallel, or redundant backup, greatly improving the flexibility of process design.

[0027] 2. Significantly reduced contamination risk: Core disposable components (filter modules, connector modules) are sterilized by Gamma irradiation before leaving the factory, allowing for immediate use. Parts that interface with the equipment can be sterilized using SIP (Self-Installation Injection) technology, and finally integrated through aseptic connection technology, achieving "step-by-step sterilization and aseptic integration," completely avoiding the cleaning and sterilization dead zones of traditional complex piping systems.

[0028] 3. Compatibility and cost-effectiveness: The connector module's equipment interface (such as chuck connector) is designed to perfectly interface with existing stainless steel drive gas chambers and bioreactor standard interfaces, protecting the user's original equipment investment and achieving a smooth and low-cost transition from traditional systems to disposable technology.

[0029] 4. Simplified operation and improved reliability: Pre-sterilized components eliminate the tedious installation, cleaning and sterilization validation work, simplify the operation process, reduce the risk of contamination or membrane column damage due to human error, and improve the reliability and efficiency of the production process.

[0030] Additional aspects and advantages of this invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0031] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0032] Figure 1 This is a schematic diagram of the modular disposable irrigation fluid kit of this utility model.

[0033] Figure 2 This is a schematic diagram of an embodiment of the present invention where disposable filter modules are connected in series.

[0034] Figure 3 This is a schematic diagram of an embodiment of the parallel connection of the disposable filter modules of this utility model.

[0035] Explanation of reference numerals in the attached figures:

[0036] 1- Disposable filter module; 11- First port; 12- Second port; 13- Filtrate port; 2- Connector module; 21- Equipment interface; 22- Kit interface; 23- Fluid passage tube; 3- Drive gas chamber; 4- Bioreactor; 5- Multi-port connector. Detailed Implementation

[0037] The embodiments of this utility model are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain this utility model, and should not be construed as limiting this utility model.

[0038] In the description of this utility model, it should be understood that the terms "upper," "lower," "top," "bottom," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. In the description of this utility model, "a plurality of" means two or more, unless otherwise explicitly specified.

[0039] In this utility model, unless otherwise explicitly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0040] like Figure 1 As shown, the modular disposable irrigation fluid kit provided by this utility model mainly includes a disposable filter module 1 and a connector module 2.

[0041] The core component is a disposable filter module 1, which encapsulates a hollow fiber membrane (not shown in the figure). The housing has a first port 11, a second port 12, and a filtrate port 13. The entire module is sterilized by Gamma irradiation before leaving the factory and sealed in a sterile packaging bag.

[0042] Connector module 2 serves as the bridge for connection, consisting of a fluid passage pipe 23 and device interfaces 21 and kit interfaces 22 at both ends. Device interface 21 is preferably a rigid chuck-type connector capable of SIP (Self-Installation On-Place) for connecting to the ports or interfaces of the drive air chamber 3, bioreactor 4, or disposable filter module 1. Kit interface 22 is preferably a sterile quick connector (such as a screw-lock or plug-in type) for connecting to the kit interface 22 of another connector module 2. Connector module 2 is also pre-sterilized by Gamma irradiation.

[0043] When constructing the perfusion system, firstly, two connector modules 2 are removed from the aseptic packaging, and their device interfaces 21 are respectively connected and locked to the interfaces of the drive air chamber 3 and the bioreactor 4. Then, the entire connected pathway (the interfaces of the drive air chamber 3, the bioreactor 4, and the two connector modules 2) is subjected to in-line steam sterilization (SIP). After SIP, the system is cooled to room temperature.

[0044] Finally, under aseptic conditions, remove the pre-sterilized disposable filter modules 1 and the required number of additional connector modules 2 from the packaging. Quickly and aseptically connect the device interface 21 (or port) of the connector modules 2 to the port of the disposable filter modules 1 to assemble the required flow path. Alternatively, the disposable filter modules 1 can be directly connected to each other through their own ports. Then, connect both ends of this flow path to the kit interface 22 of the two completed SIP connector modules 2 to form a complete, aseptic perfusion loop that starts from the driving air chamber 3, flows through the filter modules 1, and finally returns to the bioreactor 4.

[0045] like Figure 2 As shown, the two disposable filter modules 1 can be connected end to end through the connector module 2 to achieve series connection, thereby increasing the filtration area or flow channel length.

[0046] like Figure 3 As shown, two disposable filter modules 1 can be connected in parallel through a multi-port connector 5 and multiple connector modules 2 to achieve redundancy backup or increase processing flow.

[0047] As mentioned above, the disposable filter module 1 can be set up independently, or it can be connected in series and / or in parallel as needed.

[0048] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. In addition, those skilled in the art can combine and integrate the different embodiments or examples described in this specification.

[0049] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications and variations to the above embodiments within the scope of the present invention.

Claims

1. A modular, disposable, priming fluid kit, characterized in that, include: At least one disposable filter module, comprising a hollow fiber membrane and a first port and a second port respectively disposed at both ends of the hollow fiber membrane; Several connector modules, each connector module including a fluid passage pipe and device interfaces and kit interfaces disposed at both ends of the passage pipe; The device interface is configured to form a detachable sealed connection with an interface of an external drive air chamber, an interface of an external bioreactor, or the first port and the second port of the disposable filter module. The kit interface is configured to form a detachable, sealed connection with the kit interface of another of the connector modules; By selecting and connecting the disposable filter module and the connector module, a complete perfusion fluid pathway can be constructed from the driving air chamber through the hollow fiber membrane to the bioreactor.

2. The modular disposable perfusion fluid set of claim 1, wherein, The device interface is a rigid sterile connector, which can withstand online steam sterilization together with a matching interface.

3. The modular disposable perfusion fluid set of claim 2, wherein, The device interface is a chuck connector.

4. The modular disposable perfusion fluid set of claim 1, wherein, The kit interface is a sterile quick connector.

5. The modular disposable perfusion fluid set of claim 1, wherein, Both the disposable filter module and the connector module are individually packaged Gamma irradiation pre-sterilization components.

6. The modular disposable perfusion fluid set of claim 1, wherein, The disposable filtration module is also provided with a filtrate port that communicates with the interior of the hollow fiber membrane for discharging the filtrate.

7. The modular disposable perfusion fluid set of claim 1, wherein, The kit includes multiple disposable filter modules and multiple connector modules, the multiple disposable filter modules being fluidly connected via the connector modules in series, parallel or redundant backup.

8. The modular disposable perfusion fluid set of claim 7, wherein, It also includes a multi-port connector, the ports of which are configured to connect to the kit interface of the connector module to enable parallel or redundant backup of multiple disposable filter modules.

9. A perfusion system, characterized by include: The modular disposable perfusion fluid kit according to any one of claims 1 to 8; A drive air chamber, the interface of which is connected to the kit via a device interface of the connector module; A bioreactor, the interface of which is connected to the kit via a device interface of the connector module.

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