CN219194991U

CN219194991U - Sterile isolator for cell medicine cultivation

Info

Publication number: CN219194991U
Application number: CN202223200374.7U
Authority: CN
Inventors: 钱杨华
Original assignee: Shanghai Jinyu Biotechnology Co ltd
Current assignee: Shanghai Jinyu Biotechnology Co ltd
Priority date: 2022-12-01
Filing date: 2022-12-01
Publication date: 2023-06-16
Anticipated expiration: 2032-12-01

Abstract

The utility model relates to the field of cell medicine preparation, in particular to a cell medicine cultivation sterile isolator which comprises a sterile isolator, wherein the sterile isolator comprises a control cabinet, a transmission window and an operation cabin, a transmission door on the transmission window can be in butt joint with an operation cavity on the operation cabin after being opened, the front surface of the operation cavity is an operation surface, and the back surface of the operation cavity is in butt joint with an incubator; the operating surface of the operating cavity is provided with a glass operating door, and the glass operating door is provided with an inward extending sterile operating glove. According to the utility model, the pollution risk caused by the fact that cell medicines are required to be transferred between the incubator and the aseptic isolator operating cavity in the culturing process frequently through a transfer interface is solved, the incubator is directly in butt joint with the aseptic isolator operating cavity, the door is opened in the operating cavity, when the aseptic isolator operating cavity is required to be operated in an aseptic state, the door is directly opened, and long time is not required to transfer the culture container between the incubator and the aseptic isolator.

Description

Sterile isolator for cell medicine cultivation

Technical Field

The utility model relates to the technical field of cell medicine preparation, in particular to a cell medicine cultivation sterile isolator.

Background

In the existing preparation process for producing cell medicines in a space closed mode, the existing scheme adopts the mode that a blood sample of cells to be prepared is sterilized from the outer surface of a transmission window of an aseptic isolator and then is transmitted into an operation cavity of the aseptic isolator, after operations such as separation, extraction, activation, modification and the like of the cells are completed in the operation cavity, the cells are put into a culture container, a culture medium is added, and then the cells are transferred into an external culture box through a transmission interface for culture. In this way, the following drawbacks mainly exist:

1) When each operation is needed, the incubator needs to be transferred to the sterile isolator for butt joint from the culture position, the transfer workload of the culture container is large, and the time spent for each transfer is long.

2) When the incubator is in butt joint with the aseptic isolator, various aseptic connection modes are required to be designed for realizing aseptic butt joint, but no matter which mode is adopted, a certain pollution risk exists.

Disclosure of Invention

The utility model aims to solve the defects in the prior art, and provides a cell medicine cultivation sterile isolator.

In order to achieve the above purpose, the present utility model adopts the following technical scheme:

the sterile isolator for cell medicine cultivation comprises a sterile isolator, wherein the sterile isolator comprises a control cabinet, a transmission window and an operation cabin, a transmission door on the transmission window can be in butt joint with an operation cavity on the operation cabin after being opened, the front surface of the operation cavity is an operation surface, and the back surface of the operation cavity is in butt joint with an incubator;

the operation surface of the operation cavity is provided with a glass operation door, and the glass operation door is provided with an inward extending sterile operation glove.

Preferably, the transfer door on the transfer window is provided with a openable and closable transfer door cover, and the transfer window is internally provided with a hydrogen peroxide steam sterilizer.

Preferably, the operation cabin of the sterile isolator adopts a unidirectional flow design, and the inside of the operation cavity meets the A-level cleanliness requirement of GMP (good manufacturing practice) requirements.

Preferably, a microscope, a centrifuge, a camera, a material rack, a temperature control box and a pipetting gun are also arranged in the operation cavity.

Preferably, a waste liquid outlet and a waste material outlet are arranged at one side of the bottom of the operation cavity, the waste liquid outlet is connected with an external waste liquid receiving barrel through a conduit, and the waste material outlet is connected with an external waste material collecting bag.

The beneficial effects of the utility model are as follows:

according to the utility model, the pollution risk caused by the fact that cell medicines are required to be transferred between the incubator and the aseptic isolator operation cavity through a transfer interface in the culture process is solved.

Moreover, the incubator is directly in butt joint with the aseptic isolator operating cavity, the door is opened in the operating cavity, when the aseptic isolator operating cavity needs to be operated in an aseptic state, the incubator can be directly opened, and long time is not required to transport the culture container between the incubator and the aseptic isolator.

Drawings

FIG. 1 is a schematic diagram of a cell drug culture sterile isolator according to the present utility model;

FIG. 2 is a schematic view of the back side structure of the operation chamber according to the present utility model;

FIG. 3 is a schematic diagram of the connection structure of the incubator according to the present utility model.

In the figure: 10. a sterile isolator; 40. an incubator; 1. an electrical cabinet; 2. a transfer window; 3. an operation cabin; 201. a transfer window cover; 202. a transfer gate; 301. an operation cavity; 302. a glass operator door; 303. sterile operating gloves; 304. a centrifuge; 305. a temperature control box; 306. a microscope; 307. a material rack; 308. a waste liquid outlet; 309. a waste liquid receiving tank; 310. a waste delivery port; 311. a socket; 312. a camera; 313. a pipette gun.

Detailed Description

The following description of the embodiments of the present utility model will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present utility model, but not all embodiments.

Referring to fig. 1-3, a cell medicine cultivation aseptic isolator comprises an aseptic isolator 10, wherein the aseptic isolator 10 comprises a control cabinet 1, a transmission window 2 and an operation cabin 3, a transmission door 202 on the transmission window 2 can be in butt joint with an operation cavity 301 on the operation cabin 3 after being opened, the front surface of the operation cavity 301 is an operation surface, and the back surface of the operation cavity 301 is in butt joint with an incubator 40;

the transfer door 202 on the transfer window 2 is provided with a openable transfer door cover 201, and the transfer window 2 is internally provided with a hydrogen peroxide steam sterilizer, so that the transfer window 2 has a rapid hydrogen peroxide steam sterilization function, and rapid surface sterilization of materials can be realized.

Moreover, the operation cabin 3 of the aseptic isolator 10 adopts a unidirectional flow design, the interior of the operation cavity 301 meets the A-level cleanliness requirement required by GMP, a glass operation door 302 is arranged on the operation surface of the operation cavity 301, an aseptic operation glove 303 extending inwards is arranged on the glass operation door 302, a microscope 306, a centrifuge 304, a camera 312, a material rack 307, a temperature control box 305 and a pipetting gun 313 are also arranged in the operation cavity 301, and a socket 311 for supplying power is also arranged.

Meanwhile, a waste liquid outlet 308 is arranged at one side of the bottom of the operation cavity 301, the waste liquid outlet 308 is connected with an external waste liquid receiving barrel 309 through a conduit, a waste material outlet 310 is arranged at one side of the bottom of the operation cavity 301, and the waste material outlet 310 is connected with an external waste material collecting bag.

In this example, before cell preparation, various consumables and instruments which are required for preparation and can withstand long-time hydrogen peroxide steam sterilization are placed in an operation chamber 301 of a sterile isolator, and simultaneously a door of a culture chamber unit 403 for cell culture which is expected to be used for the preparation is opened by a centrifuge 304, an operation glass door 302 of the operation chamber 301 is closed, hydrogen peroxide steam sterilization is started, and integral hydrogen peroxide steam sterilization is performed on the inside of the operation chamber 301 and a centrifugal chamber of the centrifuge 304.

After the sterilization of the operation cavity 301 is finished, the transfer window cover 201 is opened, raw materials and consumable materials which cannot withstand long-time sterilization are placed in the transfer window 2, the transfer window cover 201 is closed, the outer surfaces of the transfer window 2 and the raw materials and consumable materials placed in the transfer window 2 are subjected to rapid hydrogen peroxide steam sterilization, after the sterilization is finished, the transfer door 203 is opened, the raw materials and the consumable materials are transferred into the operation cavity 301, then cell preparation operation can be performed according to a cell preparation process, after the cell preparation is finished, cells to be cultured are placed in the incubator 40, and cell culture is started.

In the cell culture process, when the cell needs to be observed, hydrogen peroxide steam sterilization is firstly carried out on the operation chamber 301, after the sterilization is finished, the cell needing to be observed is taken out of the incubator 40, and the cell can be directly observed, or can be directly placed on the microscope 306 for observation and photographing; when the sample is to be observed, the incubator 40 is opened, and a part of the sample is sucked out by the pipette 313 for observation. After the completion of the observation, the incubator 40 was closed, and the cultivation was continued, and the one-time observation was completed.

In the process of cell culture, when the liquid needs to be changed, hydrogen peroxide steam sterilization is firstly carried out on the operation chamber 301, after the sterilization is finished, the incubator 40 where the cells needing to be changed are positioned is opened, the liquid is transferred into a centrifugal bottle by using the liquid transfer gun 313, then the centrifugal bottle is placed into the centrifugal machine 304 for centrifugation, unnecessary liquid is sucked out after the centrifugation and placed into a designated container, and concentrated cells needing to be continuously cultured are added back into the incubator 40 for continuous culture.

The temperature control box 305 can be installed in the operation cavity 301 of the aseptic isolator, so as to store cells or reagents which need to be kept at a low temperature or a high temperature, and avoid the influence on the quality of the reagents or the cells caused by long-time exposure at normal temperature in the operation cavity.

Wherein, on the aseptic isolator operation cavity 301, a solid waste outlet 310 can be installed, and during the cell preparation operation, if more solid waste is generated, the solid waste can be sent out through the solid waste outlet 310.

Wherein, on the aseptic isolator operation cavity 301, a waste liquid outlet 308 can be installed, and if more liquid waste is generated during the cell preparation operation, the waste liquid can be sent out to a waste liquid barrel 309 through the waste liquid outlet 308 and then removed for treatment.

Wherein, in the aseptic isolator operation cavity 301, a camera 312 may be installed, and all operations in the aseptic isolator operation cavity 301 in the whole cell production process are photographed and recorded, so that the manager can watch in real time, and the whole production operation process can be traced.

According to the utility model, the pollution risk caused by the fact that cell medicines are required to be transferred between the incubator and the aseptic isolator operation cavity through a transfer interface in the culture process is solved; and the incubator is directly in butt joint with the aseptic isolator operation cavity, and the door is opened in the operation cavity, and when aseptic isolator operation cavity need operate under aseptic state, the operation of directly opening the door can, need not spend very long time to transport the culture vessel between culture cavity and aseptic isolator.

The foregoing is only a preferred embodiment of the present utility model, but the scope of the present utility model is not limited thereto, and any person skilled in the art, who is within the scope of the present utility model, should make equivalent substitutions or modifications according to the technical scheme of the present utility model and the inventive concept thereof, and should be covered by the scope of the present utility model.

Claims

1. The cell medicine cultivation sterile isolator comprises a sterile isolator (10) and is characterized in that the sterile isolator (10) comprises a control cabinet (1), a transmission window (2) and an operation cabin (3), a transmission door (202) on the transmission window (2) can be in butt joint with an operation cavity (301) on the operation cabin (3) after being opened, the front surface of the operation cavity (301) is an operation surface, and the back surface of the operation cavity (301) is in sealed butt joint with an incubator (40);

the operating surface of the operating cavity (301) is provided with a glass operating door (302), and the glass operating door (302) is provided with an inward extending sterile operating glove (303).

2. The cell medicine cultivation aseptic isolator according to claim 1, wherein the transfer door (202) on the transfer window (2) is provided with a openable transfer door cover (201), and a hydrogen peroxide steam sterilizer is provided in the transfer window (2).

3. The sterile isolator for cell medicine cultivation according to claim 1, wherein the operation cabin (3) of the sterile isolator (10) adopts a unidirectional flow design, and the interior of the operation cavity (301) meets the class a cleanliness requirement of GMP requirements.

4. The cell medicine cultivation aseptic isolator according to claim 1, wherein a microscope (306), a centrifuge (304), a camera (312), a material rack (307), a temperature control box (305) and a pipette gun (313) are also installed inside the operation cavity (301).

5. The cell medicine cultivation aseptic isolator as claimed in claim 1, wherein a waste liquid outlet (308) is disposed at one side of the bottom of the operation cavity (301), and the waste liquid outlet (308) is connected with an external waste liquid receiving barrel (309) through a conduit.

6. A cell culture aseptic isolator according to claim 1, wherein a waste outlet (310) is arranged at one side of the bottom of the operation cavity (301), and the waste outlet (310) is connected with an external waste collecting bag.