Combined or batch degerming filtering liquid inlet system

Abstract

The utility model relates to the technical field of biopharmacy degerming and conveying, in particular to a combined or batch degerming and filtering liquid inlet system which comprises a degerming filter, a liquid inlet of the degerming filter is connected with a pre-filtering liquid inlet pipeline, a liquid outlet of the degerming filter is connected with a post-filtering liquid inlet pipeline, and the post-filtering liquid inlet pipeline is connected with a liquid outlet of the degerming filter. The filtered liquid inlet pipeline is respectively connected with at least two liquid inlet branches, and each liquid inlet branch is provided with a valve; the device further comprises a product storage tank, liquid inlets corresponding to the liquid inlet branches in number are formed in the product storage tank, and the liquid inlet branches are connected with the liquid inlets in a one-to-one correspondence mode. According to the device, cleaning and sterilization of the pre-filtration liquid inlet pipeline, the sterilization filter and the post-filtration liquid inlet pipeline can be completed under the condition that the liquid inlet branch and the product storage tank are not disassembled and assembled, biological agents in the product storage tank can be prevented from being polluted by the external environment in the disassembling and assembling process, meanwhile, the production cost is reduced, and the production efficiency is improved.

Description

Technical Field

[0001] The utility model relates to the technical field of biopharmaceutical sterilization and transportation, in particular to a combined or batched sterilization and filtering liquid inlet system. Background Art

[0002] In the biopharmaceutical industry, large-scale commercial production and storage of biologics generally involve merging or batch production, that is, the same biologic is produced in batches, and different batches of biologics are transported to the same storage container (such as a storage tank) for mixing during the production process. The merging or batch production of biologics can centrally store multiple batches of the same product for further processing or transportation, which can avoid frequent transfer and transportation of small batches of a batch, reduce repeated investment in equipment and manpower, and improve production efficiency.

[0003] At the same time, there are often sterility requirements in the production of biological preparations. According to the production process, they can be divided into terminally sterilized products and non-terminally sterilized products. Terminally sterilized products refer to products obtained by sterilizing the drug solution at the end of the production process (such as after filling), while non-terminally sterilized products require sterilization and filtration of liquid products during the production process, which has high requirements for environmental conditions during the production process. The production of non-terminally sterilized products often uses a sterilizing filtration inlet system with a sterilizing filter to sterilize and transport biological preparations. The entire system needs to be cleaned and sterilized before and after use, and the sterile environment of all pipelines and equipment in the system must be strictly controlled during use.

[0004] In the process of combining or batching biological preparations using a sterilizing filtration inlet system, due to the long time interval between the delivery of different batches of products, for the sake of sterility, it is necessary to clean and sterilize all the equipment and pipelines in the entire sterilizing filtration inlet system after each batch of product delivery and before the next batch of product delivery. However, since the liquid delivery system is connected to the storage container through only one inlet pipeline, when cleaning and sterilizing this inlet pipeline, in order not to affect the existing products in the storage container, it is necessary to disconnect this inlet pipeline from the storage container and then clean and sterilize it, and then connect the inlet pipeline to the storage container after the cleaning and sterilization. On the one hand, this treatment method will cause the closed environment in the storage container to be destroyed, and the biological preparations in the storage container are easily contaminated by the external environment; on the other hand, the inlet pipeline and the storage container need to be repeatedly disassembled and assembled, which consumes a lot of manpower and material resources and has low production efficiency. Utility Model Content

[0005] In view of the technical problem that in the combined or batch production process of biological preparations using a sterilizing filtration liquid inlet system, the liquid inlet pipeline and storage container need to be repeatedly disassembled and assembled for the purpose of cleaning and sterilization, resulting in the biological preparations in the storage container being easily contaminated and the production efficiency being low, the utility model provides a combined or batched sterilizing filtration liquid inlet system, which can complete the cleaning and sterilization of the pre-filtration liquid inlet pipeline, the sterilizing filter and the post-filtration liquid inlet pipeline without disassembling the liquid inlet branch and the product storage tank, and can prevent the biological preparations in the product storage tank from being contaminated by the external environment during the disassembly and assembly process, while reducing the production cost and improving the production efficiency.

[0006] The technical solution of the utility model is:

[0007] A combined or batched sterilizing filtration liquid inlet system comprises a sterilizing filter, wherein the liquid inlet of the sterilizing filter is connected to a liquid inlet pipeline before filtration, the liquid outlet of the sterilizing filter is connected to a liquid inlet pipeline after filtration, the liquid inlet pipeline after filtration is respectively connected to no less than two liquid inlet branches, each of which is provided with a valve; and further comprises a product storage tank, wherein the product storage tank is provided with liquid inlets corresponding to the number of the liquid inlet branches, and the liquid inlet branches are connected to the liquid inlets in a one-to-one correspondence.

[0008] Preferably, the filtered liquid inlet pipeline is respectively connected to the first liquid inlet branch, the second liquid inlet branch, and the third liquid inlet branch; the product storage tank is provided with a first liquid inlet, a second liquid inlet, and a third liquid inlet; the first liquid inlet branch is connected to the first liquid inlet, the second liquid inlet branch is connected to the second liquid inlet, and the third liquid inlet branch is connected to the third liquid inlet.

[0009] Furthermore, the liquid inlet pipeline before filtration and the liquid inlet pipeline after filtration are connected through a filter bypass, and a valve is provided on the filter bypass. When the sterilizing filtration liquid inlet system is subjected to CIP (online cleaning), the sterilizing filter can be removed for offline CIP, and the passage of the liquid inlet pipeline before filtration-filter bypass-liquid inlet pipeline after filtration can be subjected to online CIP.

[0010] Furthermore, it also includes a drainage main pipeline, and the filtered liquid inlet pipeline is connected to the drainage main pipeline. When the sterilizing filtration liquid inlet system is subjected to CIP (online cleaning) or SIP (online sterilization), the cleaning agent, disinfectant or steam can be discharged through the drainage main pipeline.

[0011] Furthermore, a first drain interface is provided on the drainage main pipeline, the first drain interface is connected to the first drain terminal pipeline, and a valve is provided on the first drain terminal pipeline; a first drain valve is provided on the drainage main pipeline, and the first drain valve is located downstream of the drain interface. When performing CIP, the first drain valve can be closed to allow the cleaning agent to be discharged through the first drain terminal pipeline, thereby realizing segmented CIP.

[0012] Furthermore, a drain port is provided on the product storage tank, and a branch pipe interface is provided on the drain main pipe. The branch pipe interface is located downstream of the drain valve. The drain port and the branch pipe interface are connected through the drain branch pipe, so that segmented CIP and SIP of the product storage tank can be realized.

[0013] Furthermore, a second drain interface is provided on the drainage branch pipe, the second drain interface is connected to the second drain terminal pipe, and a valve is provided on the second drain terminal pipe; a second drain valve is provided on the drainage branch pipe, and the second drain valve is located downstream of the second drain interface.

[0014] The beneficial effects of the utility model are:

[0015] The utility model sets a plurality of liquid inlet branches connected to the post-filtration liquid inlet pipeline, and each liquid inlet branch is provided with a valve. When the biological preparations are combined or batched, each batch uses a liquid inlet branch to transport the biological preparations to the product storage tank. After each batch is transported, the current liquid inlet branch is closed, and then the pre-filtration liquid inlet pipeline, the sterilizing filter and the post-filtration liquid inlet pipeline are cleaned and sterilized. When transporting the next batch of biological preparations, another liquid inlet branch is used to transport the liquid. The utility model can use different liquid inlet branches to transport different batches of biological preparations. Each batch of biological preparations corresponds to a liquid inlet branch. The cleaning and sterilization of the pre-filtration liquid inlet pipeline, the sterilizing filter and the post-filtration liquid inlet pipeline can be completed without disassembling the liquid inlet branch and the product storage tank, reducing the steps of disassembling the liquid inlet branch and the product storage tank. On the one hand, it can prevent the biological preparations in the product storage tank from being contaminated by the external environment during the disassembly process. On the other hand, it saves the manpower and material resources required for the disassembly process, saves the cost and time required for disassembly, and improves production efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the utility model or the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0017] Figure 1 This is a schematic diagram of the structure of the sterilizing and filtering liquid inlet system in Example 1.

[0018] In the figure, 1-pre-filtration liquid inlet pipeline, 2-sterilizing filter, 3-post-filtration liquid inlet pipeline, 4-first liquid inlet branch, 5-second liquid inlet branch, 6-third liquid inlet branch, 7-product storage tank, 8-filter bypass, 9-drainage main pipeline, 10-first hydrophobic terminal pipeline, 11-drainage branch, 12-second hydrophobic terminal pipeline. DETAILED DESCRIPTION

[0019] In order to enable those skilled in the art to better understand the technical solutions in the present invention, the following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the present invention.

[0020] Example 1

[0021] A combined or batched sterilizing filtration liquid inlet system, comprising a sterilizing filter 2, the liquid inlet of the sterilizing filter 2 is connected to a pre-filtration liquid inlet pipeline 1, the liquid outlet of the sterilizing filter 2 is connected to a post-filtration liquid inlet pipeline 3, the post-filtration liquid inlet pipeline 3 is respectively connected to a first liquid inlet branch 4, a second liquid inlet branch 5, and a third liquid inlet branch 6; further comprising a product storage tank 7, the product storage tank 7 is provided with a first liquid inlet, a second liquid inlet, and a third liquid inlet; the first liquid inlet branch 4 is connected to the first liquid inlet, the second liquid inlet branch 5 is connected to the second liquid inlet, the third liquid inlet branch 6 is connected to the third liquid inlet, the first liquid inlet branch 4, the second liquid inlet branch 5, and the third liquid inlet branch 6 are respectively provided with valves; the pre-filtration liquid inlet pipeline 1 is connected to the post-filtration liquid inlet pipeline 3 through a filter bypass 8, and the filter bypass 8 is provided with a valve; further comprising The main drainage pipeline 9 is connected to the filtered liquid inlet pipeline 3; the main drainage pipeline 9 is provided with a first drain interface, which is connected to the first drain terminal pipeline 10, and a valve is provided on the first drain terminal pipeline 10; the main drainage pipeline 9 is provided with a first drain valve, and the first drain valve is located downstream of the drain interface; the product storage tank 7 is provided with a drain port, the main drainage pipeline 9 is provided with a branch pipe interface, and the branch pipe interface is located downstream of the drain valve, and the drain port and the branch pipe interface are connected through a drain branch pipe 11; the drain branch pipe 11 is provided with a second drain interface, which is connected to the second drain terminal pipeline 12, and a valve is provided on the second drain terminal pipeline 12; the drain branch pipe 11 is provided with a second drain valve, and the second drain valve is located downstream of the second drain interface.

[0022] The working steps of embodiment 1 are:

[0023] (1) Before use, remove the sterilizing filter 2 from the sterilizing filtration inlet system and clean it separately; open the valve on the filter bypass 8 to connect the pre-filtration inlet pipeline 1, the filter bypass 8, and the post-filtration inlet pipeline 3; open the valves on the first inlet branch 4, the second inlet branch 5, the third inlet branch 6, and the second hydrophobic terminal pipeline 12; perform CIP on the pre-filtration inlet pipeline 1, the filter bypass 8, the post-filtration inlet pipeline 3, the first inlet branch 4, the second inlet branch 5, the third inlet branch 6, and the product storage tank 7; and discharge the CIP cleaning agent from the second hydrophobic terminal pipeline 12;

[0024] (2) Install the cleaned sterilizing filter 2 back into the sterilizing filtration liquid inlet system, and perform SIP on the pre-filtration liquid inlet pipeline 1, the sterilizing filter 2, the filter bypass 8, the post-filtration liquid inlet pipeline 3, the first liquid inlet branch 4, the second liquid inlet branch 5, the third liquid inlet branch 6, and the product storage tank 7, and the SIP disinfectant or steam is discharged from the second hydrophobic terminal pipeline 12;

[0025] (3) Close the valves on the filter bypass 8, the second liquid inlet branch 5, the third branch 6, the second drain terminal pipe 12, and the second liquid discharge valve, and then carry out the first batch of product delivery, input the biological agent from the pre-filtration liquid inlet pipe 1, and sequentially pass through the sterilizing filter 2, the post-filtration liquid inlet pipe 3, and the first liquid inlet branch 4 into the product storage tank 7;

[0026] (4) After the first batch of product delivery is completed, the sterilizing filter 2 is removed from the sterilizing filtration liquid inlet system and cleaned separately; the valve on the first liquid inlet branch 4 is closed, the valves on the filter bypass 8 and the first hydrophobic terminal pipe 10 are opened, and the pre-filtration liquid inlet pipe 1, the filter bypass 8, and the post-filtration liquid inlet pipe 3 are CIP-treated, and the CIP cleaning agent is discharged from the first hydrophobic terminal pipe 10; then the sterilizing filter 2 is reinstalled, and the pre-filtration liquid inlet pipe 1, the sterilizing filter 2, the filter bypass 8, and the post-filtration liquid inlet pipe 3 are SIP-treated, and the SIP disinfectant or steam is discharged from the first hydrophobic terminal pipe 10;

[0027] (5) The valves on the filter bypass 8 and the first hydrophobic terminal pipe 10 are closed, and the valve on the second liquid inlet branch 5 is opened. Then, the second batch of products is transported, and the biological agent is input from the pre-filtration liquid inlet pipe 1, and sequentially passes through the sterilizing filter 2, the post-filtration liquid inlet pipe 3, and the second liquid inlet branch 5 into the product storage tank 7;

[0028] (6) After the third batch of products is delivered, the sterilizing filter 2 is removed from the sterilizing filtration liquid inlet system and cleaned separately; the valve on the second liquid inlet branch 5 is closed, the valve on the filter bypass 8 and the first hydrophobic terminal pipe 10 is opened, and the pre-filtration liquid inlet pipe 1, the filter bypass 8, and the post-filtration liquid inlet pipe 3 are CIP-treated, and the CIP cleaning agent is discharged from the first hydrophobic terminal pipe 10; then the sterilizing filter 2 is reinstalled, and the pre-filtration liquid inlet pipe 1, the sterilizing filter 2, the filter bypass 8, and the post-filtration liquid inlet pipe 3 are SIP-treated, and the SIP disinfectant or steam is discharged from the first hydrophobic terminal pipe 10;

[0029] (7) Close the valves on the filter bypass 8 and the first hydrophobic terminal pipe 10, open the valve on the third liquid inlet branch 6, and then carry out the third batch of product delivery. The biological agent is input from the pre-filtration liquid inlet pipe 1, and passes through the sterilizing filter 2, the post-filtration liquid inlet pipe 3, and the third liquid inlet branch 6 in sequence into the product storage tank 7.

[0030] Although the utility model is described in detail by referring to the accompanying drawings and in combination with the preferred embodiments, the utility model is not limited thereto. Without departing from the spirit and essence of the utility model, a person skilled in the art may make various equivalent modifications or substitutions to the embodiments of the utility model, and these modifications or substitutions shall be within the scope of the utility model. Any person skilled in the art who is familiar with the technical field can easily think of changes or substitutions within the technical scope disclosed in the utility model, and they shall be within the scope of protection of the utility model.

Claims

1. A combined or batched sterilizing filtration liquid inlet system, comprising a sterilizing filter, wherein the liquid inlet of the sterilizing filter is connected to a pre-filtration liquid inlet pipeline, and the liquid outlet of the sterilizing filter is connected to a post-filtration liquid inlet pipeline, It is characterized in that The filtered liquid inlet pipeline is respectively connected to no less than two liquid inlet branches, each of which is provided with a valve; it also includes a product storage tank, which is provided with liquid inlets corresponding to the number of liquid inlet branches, and the liquid inlet branches are connected one by one with the liquid inlets.

2. The sterilizing filtration liquid inlet system according to claim 1, It is characterized in that The filtered liquid inlet pipeline is connected to the first liquid inlet branch, the second liquid inlet branch and the third liquid inlet branch respectively; the product storage tank is provided with a first liquid inlet, a second liquid inlet and a third liquid inlet; the first liquid inlet branch is connected to the first liquid inlet, the second liquid inlet branch is connected to the second liquid inlet, and the third liquid inlet branch is connected to the third liquid inlet.

3. The sterilizing filtration liquid inlet system according to claim 1, It is characterized in that The liquid inlet pipeline before filtration and the liquid inlet pipeline after filtration are connected through a filter bypass, and a valve is arranged on the filter bypass.

4. The sterilizing filtration liquid inlet system according to claim 1, It is characterized in that It also includes a main drainage pipeline, and the filtered liquid inlet pipeline is connected to the main drainage pipeline.

5. The sterilizing filtration liquid inlet system according to claim 4, It is characterized in that A first drain interface is arranged on the drainage main pipeline, the first drain interface is connected to the first drain terminal pipeline, and a valve is arranged on the first drain terminal pipeline; a first drain valve is arranged on the drainage main pipeline, and the first drain valve is located downstream of the drain interface.

6. The sterilizing filtration liquid inlet system according to claim 4, It is characterized in that A liquid discharge port is arranged on the product storage tank, a branch pipe interface is arranged on the liquid discharge main pipeline, the branch pipe interface is located downstream of the liquid discharge valve, and the liquid discharge port and the branch pipe interface are connected through a liquid discharge branch pipe.

7. The sterilizing filtration liquid inlet system according to claim 6, It is characterized in that A second drain interface is provided on the drainage branch pipe, the second drain interface is connected to the second drain terminal pipe, and a valve is provided on the second drain terminal pipe; a second drain valve is provided on the drainage branch pipe, and the second drain valve is located downstream of the second drain interface.

Images