Biological indicator protection device and bioreactor

Abstract

The utility model discloses a biological indicator protection device and a bioreactor, and belongs to the technical field of biological medicine equipment. In order to solve the problems that a biological indicator accidentally falls off in the sterilization process and is hit by a stirring paddle and the like, structures such as a hollow pipe, a plug and an indicator placing bin are mainly adopted, and the indicator placing bin is fixed on a bioreactor tank cover through a sealing ring and a threaded structure. The biological indicator protection device ensures that the position of the biological indicator is stable in the sterilization process, the indicator is prevented from being damaged or polluting reaction substances, and meanwhile operation efficiency and verification accuracy are improved. According to the utility model, the safety protection of the biological indicator and the high efficiency and reliability of sterile verification can be realized.

Description

TECHNICAL FIELD

[0001] The utility model belongs to the technical field of biological medicine equipment, specifically relates to a biological indicator protection device and biological reactor. BACKGROUND

[0002] Biological reactors have important applications in cell culture processes in the field of biological medicine, involving processes such as cell growth, proliferation, and differentiation. By precisely controlling the culture conditions, cell products such as antibiotics and gene-mediated drugs can be produced in large quantities. To ensure that the use of biological reactors in biopharmaceuticals meets the sterility requirements, sterilization and sterilization validation must be performed to ensure the safety and effectiveness of the products. Biological indicators usually use non-pathogenic spores as indicator bacteria to confirm the sterilization effect by observing whether the spores are killed. This method has been widely used in sterilization process validation and monitoring in biological fermentation processes.

[0003] Currently, when verifying the sterilization effect, biological indicators are usually hung into the biological reactor tank through a string. During the sterilization process, the agitator of the equipment is in an open state, and the liquid in the tank forms a whirling state. Since the biological indicators are placed in the tank by being tied with a string, the rotation of the agitator can cause the indicators to float with the liquid, resulting in up-and-down floating, and even the possibility of falling off the string and falling into the tank. This situation can lead to inaccurate validation data, waste of time, and the need for re-operation. Therefore, there is an urgent need for a biological indicator protection device to solve the above technical problems. UTILITY MODEL CONTENTS

[0004] The utility model aims to provide a biological indicator protection device and a biological reactor using the biological indicator protection device, which aims to prevent accidental falling of biological indicators during sterilization, ensure the accuracy of sterilization validation results, prevent the indicators from being broken by the impact of equipment such as agitator paddles, avoid contamination of reaction materials, ensure sterile conditions in the biological reactor, improve work efficiency, and simplify the operation process.

[0005] To achieve the above-mentioned purpose, the utility model adopts the following technical solutions:

[0006] A biological indicator protection device, comprising a plug, a hollow tube, an opening, and an indicator placement bin; the plug is connected to the end of the hollow tube, and the indicator placement bin is connected to the head end of the hollow tube; a threaded structure is provided at the connection between the hollow tube and the plug; the opening is provided on the hollow tube and is connected to the indicator placement bin, serving as a channel for the biological indicators to enter and exit the indicator placement bin.

[0007] Further, a groove is provided at the connection between the threaded structure and the hollow tube, and a sealing ring is installed in the groove.

[0008] Further, the indicator placement bin is provided with a plurality of through holes.

[0009] Further, the length of the opening along the axis of the hollow tube is greater than the length of the biological indicator, and the radius of the indicator placement bin is greater than the radius of the biological indicator.

[0010] A biological reactor comprises the biological indicator protection device, a tank cover, a tank body and a stirrer; the tank cover is provided with a threaded hole and is threadedly connected with the threaded structure of the biological indicator protection device.

[0011] Further, the diameter of the plug of the biological indicator protection device is greater than the diameter of the threaded hole on the tank cover.

[0012] Further, the outer diameter of the hollow tube of the biological indicator protection device and the indicator placement bin is less than the diameter of the threaded hole on the tank cover.

[0013] The biological indicator protection device has the following beneficial effects:

[0014] 1. The biological indicator protection device can effectively prevent the biological indicator from falling accidentally during the sterilization process, thereby ensuring the accuracy of the sterilization verification.

[0015] 2. The biological indicator protection device has a simple structure, is convenient to disassemble and assemble, improves the work efficiency, and saves time and manpower.

[0016] 3. The biological indicator protection device prevents the biological indicator from being hit by the stirring paddle and other equipment, avoids the indicator from being broken, and thereby prevents the pollution of the reaction material.

[0017] 4. The biological indicator protection device adopts a sealing ring structure, ensures that the biological reactor is isolated from the external environment, maintains a sterile condition, and ensures the safety and effectiveness of the product.

[0018] 5. The biological indicator protection device has a reasonable structure design, ensures the entry, placement and observation of the biological indicator, and adapts to the complex operating environment in the biological reactor. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 is a perspective view of the biological indicator protection device in the embodiment.

[0020] Figure 2 is a front view of the biological indicator protection device in the embodiment.

[0021] Figure 3 is a side view of the biological indicator protection device in the embodiment.

[0022] Figure 4 is a structural schematic view of the biological reactor provided with the biological indicator protection device in the embodiment.

[0023] REFERENCE SIGNS

[0024] 10 - biological indicator protection device, 11 - plug, 12 - hollow tube, 13 - opening, 14 - indicator placement chamber, 15 - threaded structure, 16 - sealing ring, 17 - groove;

[0025] 20 - bioreactor, 21 - tank cover, 22 - tank body, 23 - stirrer. DETAILED DESCRIPTION

[0026] In order to make the above technical features and advantages or technical effects of the technical scheme of the present application more obvious and easy to understand, the following will be described in detail in conjunction with the embodiments and drawings.

[0027] The present embodiment specifically discloses a biological indicator protection device, which has the structure as shown in the figure. Figures 1-3 The plug 11 is connected to the end of the hollow tube 12, and the indicator placement chamber 14 is connected to the head end of the hollow tube 12. The opening 13 is provided on the hollow tube 12 and is connected to the indicator placement chamber 14, serving as a channel for the biological indicator to enter and exit the indicator placement chamber 14.

[0028] The connection between the hollow tube 12 and the plug 11 is provided with a threaded structure 15. The connection between the threaded structure 15 and the hollow tube 12 is provided with a groove 17, and a sealing ring 16 is arranged in the groove 17. The indicator placement chamber 14 is provided with a plurality of through holes for the biological indicator placement chamber 14 to exchange with the substances in the bioreactor 20 and observe the changes of the biological indicator. The length of the opening 13 along the axis of the hollow tube 12 is greater than the length of the biological indicator, and the radius of the indicator placement chamber 14 is greater than the radius of the biological indicator, so as to facilitate the entry and placement of the biological indicator.

[0029] The present embodiment also discloses a bioreactor provided with the biological indicator protection device, which has the structure as shown in the figure. Figure 4 The bioreactor includes a tank cover 21, a tank body 22, and a stirrer 23. The diameter of the plug 11 of the biological indicator protection device 10 is greater than the diameter of the screw hole on the tank cover 21, and the plug 11 is located outside the tank cover 21 of the bioreactor 20. The outer diameters of the hollow tube 12 and the indicator placement chamber 14 are both smaller than the diameter of the screw hole on the tank cover 21, and both are located in the tank body 22.

[0030] The threaded structure 15 of the biological indicator protection device 10 is used to extend into the screw hole on the tank cover 21, so as to fix the biological indicator protection device 10 on the tank cover 21. The sealing ring 16 seals the biological indicator protection device 10 and the tank cover 21, so as to ensure the isolation of the tank body 22 of the bioreactor 20 from the outside.

[0031] Although the utility model has disclosed as above with examples, but it is not used to limit the utility model, the ordinary skill in the art to the technical scheme of the utility model makes proper modification or equivalent replacement, should be covered in the protection scope of the utility model, the protection scope of the utility model is limited by claim.

Claims

1. A biological indicator protection device, characterized in that, It includes a plug, a hollow tube, an opening, and an indicator placement chamber; the plug is connected to the end of the hollow tube, and the indicator placement chamber is connected to the beginning of the hollow tube; a threaded structure is provided at the connection between the hollow tube and the plug; the opening is opened on the hollow tube and connected to the indicator placement chamber, serving as a channel for the biological indicator to enter and exit the indicator placement chamber.

2. The biological indicator protection device as described in claim 1, characterized in that, A groove is provided at the connection between the threaded structure and the hollow tube, and a sealing ring is installed in the groove.

3. The biological indicator protection device as described in claim 1, characterized in that, The indicator placement chamber has multiple through holes.

4. The biological indicator protection device as described in claim 1, characterized in that, The length of the opening along the axial direction of the hollow tube is greater than the length of the biological indicator, and the radius of the indicator placement chamber is greater than the radius of the biological indicator.

5. A bioreactor, characterized in that, It includes the biological indicator protection device as described in any one of claims 1-4, as well as a can lid, a can body, and a stirrer; the can lid is provided with a screw hole for threaded connection with the threaded structure of the biological indicator protection device.

6. The bioreactor as described in claim 5, characterized in that, The diameter of the plug on the biological indicator protection device is larger than the diameter of the screw hole on the can lid.

7. The bioreactor as described in claim 5, characterized in that, The outer diameter of the hollow tube of the biological indicator protection device and the indicator placement chamber is smaller than the diameter of the screw hole on the can lid.

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