CN210000843U

CN210000843U - simulation filling bag for culture medium of disposable system

Info

Publication number: CN210000843U
Application number: CN201920458729.1U
Authority: CN
Inventors: 何国强; 王奎波; 孙文轩
Original assignee: Pall Aoxing Packaging Technology (beijing) Co Ltd
Current assignee: Pall Aoxing Packaging Technology (beijing) Co Ltd
Priority date: 2019-04-04
Filing date: 2019-04-04
Publication date: 2020-01-31
Anticipated expiration: 2029-04-04

Abstract

The utility model provides a inferior nature use system culture medium simulation filling bag, including culture medium storage bag, culture medium sample bag, the front end of culture medium storage bag is connected with into liquid pipeline, drainage pipeline, culture medium sample branch pipeline, and culture medium sample branch pipeline is provided with cross joint, is connected with three culture medium sample bag through cross joint, the utility model discloses can effectively simulate culture medium and filter culture medium storage, partial shipment stage from the degerming, carry out the microorganism culture experiment through the culture medium sample to 3 times samples to verify the aseptic guarantee level when using this type of inferior nature use system.

Description

simulation filling bag for culture medium of disposable system

Technical Field

The utility model relates to an carry out culture medium simulation filling experiment to inferior use system and use the bag, especially relate to kinds of inferior use system culture medium simulation filling bag.

Background

The culture medium simulation filling test refers to adopting a sterile culture medium or a proper medium to simulate the whole process (not only the filling process) of the sterile operation in the drug production so as to evaluate series activities of the sterility assurance level of the sterile process.

Sterile production process and simulated range sterile production process of sterile products generally comprises the steps of obtaining sterile liquid medicine or sterile powder through sterile filtration or other methods, filling liquid or powder under sterile conditions, and sealing, wherein a culture medium simulated filling test is started from the step of sterile operation until the sterile product is completely sealed, and if the sterile production process is adopted in the preparation stage of the product, the part of the process is also used as part of simulation verification.

If the medicine enterprises use -time use systems, the aseptic production process is combined, is kept as much as possible with the actual aseptic operation process, and the test result truly reflects the aseptic guarantee level of the production process.

SUMMERY OF THE UTILITY MODEL

The utility model provides a inferior nature use system culture medium simulation filling bag, when solving and using inferior nature use system (SUS), store, partial shipment stage from the aseptic filtration to the culture medium, aseptic production technology's simulation for verify aseptic filter's biological load clearance and the aseptic guarantee ability of aseptic connecting tube in filter low reaches, aseptic disconnect-joint and airtight stock solution bag, its technical scheme as follows:

type time use system culture medium simulation filling bag, including culture medium storage bag, culture medium sample bag, the front end of culture medium storage bag is connected with into liquid pipeline, drainage pipeline, culture medium sample branch pipeline, and culture medium sample branch pipeline is provided with four way connection, is connected with three culture medium sample bags through four way connection.

The tail part of the culture medium storage bag is provided with a support rod for lifting the culture medium storage bag to assist emptying.

The liquid inlet pipeline comprises an th hose, an aseptic disconnector, a second hose, a sterilization filter and a joint which are sequentially connected, a liquid inlet flow limiting clamp is arranged on the th hose, a liquid inlet flow limiting clamp PVC protective sleeve is matched with the liquid inlet flow limiting clamp, and the joint is connected with an upstream equipment input pipeline through a hoop and is sealed at the joint through a gasket.

The sterilizing filter is an -time disposable filter.

The liquid discharge pipeline comprises a liquid discharge hose, a liquid discharge flow limiting clamp PVC protective sleeve and an aseptic connecting joint, wherein the end of the liquid discharge hose is connected with the culture medium storage bag, the end of the liquid discharge hose is connected with the aseptic connecting joint, and the liquid discharge hose is provided with the liquid discharge flow limiting clamp and the liquid discharge flow limiting clamp PVC protective sleeve matched with the liquid discharge flow limiting clamp.

The culture medium sampling branch pipeline comprises sampling hoses, sampling flow-limiting clamps and a four-way joint, wherein the sampling hoses are connected with joints of the four-way joint, and the remaining three joints of the four-way joint are correspondingly connected with three culture medium sampling bags.

The sampling current-limiting clamp is provided with a sampling current-limiting clamp PVC protective sleeve in a matching manner.

Culture medium sample bag includes the sample bag body, blind stifled pipeline, connecting line and sample pipeline, and the sample bag body is connected with blind stifled pipeline, connecting line, sample pipeline, and connecting line includes the coupling hose at both ends, is provided with aseptic disconnect-joint in the middle of two sections coupling hoses.

The volume of the sampling bag body is 50mL to 250 mL.

The blind plugging pipeline is a pipeline with a blind plug at the tail end.

The utility model has the advantages of it is following:

1. the films for the sampling bag body and the liquid storage bag body all use the films for the biological process, are the same as those of an -time use system, meet the relevant specifications and have good chemical compatibility;

2. the culture medium simulation filling bag can effectively simulate the culture medium from sterilization and filtration to culture medium storage and subpackage stages, and verify the sterility guarantee level when using the -time use system by carrying out a microorganism culture test on a culture medium sample sampled for 3 times;

3. the culture medium simulation filling bag uses sterile filters, a sterile connector, a sterile disconnector, disposable hoses and a sampling joint, and comprises most of components required for storing and transporting sterile liquid in a disposable system;

4. the simulated filling of the culture medium is close to the actual production process, and the culture medium can be used without redundant treatment after being opened, so that the verification operation time is saved.

Drawings

FIG. 1 is a schematic structural diagram of the time use system culture medium simulated filling bag;

FIG. 2 is a schematic diagram of the liquid inlet line of the culture medium mock filling bag;

FIG. 3 is a schematic view showing the structure of a drain line of the medium storage bag;

FIG. 4 is a schematic view of the structure of a branched medium sampling line;

FIG. 5 is a schematic view of the structure of a medium sampling bag.

Detailed Description

As shown in FIG. 1, the -time use system culture medium simulation filling bag comprises a liquid inlet pipeline 1, a liquid outlet pipeline 2, a culture medium sampling branch pipeline 3, a culture medium sampling bag 4 and a culture medium storage bag 6, wherein a support rod 5 is arranged at the tail part of the culture medium storage bag 6, the liquid inlet pipeline 1, the liquid outlet pipeline 2 and the culture medium sampling branch pipeline 3 are all connected with the front end of the culture medium storage bag 6, and the culture medium sampling branch pipeline 3 is provided with a four-way joint and is connected with the three culture medium sampling bags 4.

The liquid inlet pipeline 1 is provided with a sterilizing filter, the culture medium is connected with the liquid inlet pipeline 1 after the equipment configuration is completed, and the culture medium is stored in the culture medium storage bag 6 after the sterilizing filtration.

The liquid discharge pipeline 2 is a discharge pipeline of the culture medium storage bag 6, the tail end of the liquid discharge pipeline 2 is provided with a sterile joint, and the culture medium is connected with the subpackaging pipeline through the sterile joint when being subpackaged.

Culture medium sample branch line 3 is provided with cross joints (cross) and connects with culture medium sample bag 4 (3), can divide 3 times (different storage duration) to sample the culture medium sample and store and examine examining.

The culture medium storage bag 6 can store sterile culture medium after sterilization and filtration, the volume is 50L like , the tail of the culture medium storage bag 6 is provided with 1 support rod 5, the liquid storage bag can be lifted when the liquid storage bag is about to be emptied, and the emptying of the liquid storage bag is assisted.

As shown in figure 2, a liquid inlet pipeline 1 of the culture medium simulation filling bag comprises an -th hose 11, a liquid inlet limiting clamp 12, a liquid inlet limiting clamp PVC protective sleeve 13, an aseptic disconnector 14, a second hose 15, a sterilization filter 16, a joint 17, a clamp 18 and a gasket 19, wherein two ends of the aseptic disconnector 14 are respectively connected with the -th hose 11 and the second hose 15, the -th hose 11 is provided with the liquid inlet limiting clamp 12, the liquid inlet limiting clamp 12 is matched with the liquid inlet limiting clamp PVC protective sleeve 13, the other end of the second hose 15 is connected with the sterilization filter 16, the sterilization filter 16 is connected with the joint 17, and the joint 17 is connected with an upstream equipment input pipeline through the clamp and sealed through the gasket 19.

The th hose 11 is connected with the culture medium storage bag 6, the th hose 11 is provided with the liquid inlet flow limiting clamp 2 which can control the flow rate of liquid to the storage bag or cut off the flow of the liquid, and the matched liquid inlet flow limiting clamp PVC protective sleeve 3 can prevent the sharp part of the flow limiting clamp from damaging other accessories during the product transportation.

The sterility disconnect 4 can disconnect the th hose 11 and the second hose 15 on the left and right sides, and close the th hose 11 and the second hose 15 after disconnection, thereby ensuring the sterility of the th hose 11 connected with the liquid storage bag.

The sterilizing filter 6 is used for times, can realize bacterial interception and ensure the sterile state of liquid flowing through the filter, and the filter is kept to be consistent with the specification model of the filter used in the actual production process.

As shown in FIG. 3, the drainage line of the medium storage bag comprises a drainage tube hose 21, a drainage restriction clip 22, a drainage restriction clip PVC protective sleeve 23 and a sterile connection joint 24.

The liquid discharge tube hose 21 is connected with the culture medium storage bag 6, and is provided with a liquid discharge flow limiting clamp 22 and a liquid discharge flow limiting clamp PVC protective sleeve 23 matched with the liquid discharge flow limiting clamp 22 on the upper surface, and the flow limiting clamp 22 can control the flow rate of liquid to the storage bag or cut off the flow of the liquid; the PVC protective sleeve 23 of the liquid discharge flow-limiting clamp matched with the liquid discharge flow-limiting clamp 22 prevents the sharp part of the flow-limiting clamp from damaging other accessories during product transportation. Aseptic attach fitting 24 can carry out aseptic butt joint with the culture medium partial shipment pipeline of low reaches, avoids the inside liquid of pipeline to receive bacterial contamination when the articulate.

As shown in FIG. 4, the branched medium sampling line 3 comprises a sampling hose 31, a sampling flow-limiting clamp 32 and a four-way (cross-shaped) joint 34, wherein the sampling hose 31 is connected with joints of the four-way joint 34, the remaining three joints of the four-way joint 34 are correspondingly connected with 3 medium sampling bags 4, and a sampling flow-limiting clamp PVC protective sleeve 33 is arranged on the sampling flow-limiting clamp 32 in a matching manner.

As shown in fig. 5, the culture medium sampling bag 4 comprises a sampling bag body 41, a blind pipe 42, a connecting pipe 43, a sampling pipe 44,

the sampling bag body 41 can be changed from 50mL to 250mL according to the sample amount required by each test. A blind plugging pipeline 42, a connecting pipeline 43 and a sampling pipeline 44 are connected.

The blind pipe 42 is a pipe with a blind end, and can be connected with other joints if other connection requirements are met.

Connecting line 43 is the pipeline of being connected with culture medium sample branch pipeline 3, and connecting line 43 includes the connecting hose at both ends, has aseptic disconnect-joint in the middle of two sections connecting hose, can fill the sample bag after culture medium sample, with culture medium sample bag 4 and culture medium storage bag 6 disconnection and send the laboratory suggestion to guarantee the sterile condition of culture medium in whole culture medium sample bag 4.

The sampling pipeline 44 is used for sampling, and a needle-free sampling joint at the tail end of the pipeline can be connected with the sampling pipeline for extracting a sample for testing in a laboratory.

The upper parts are respectively assembled and connected with the culture medium storage bags 6 to form complete culture medium simulation filling bags which can be used after irradiation sterilization.

The utility model has the advantages of it is following:

Claims

kinds of disposable use system culture medium simulation filling bags are characterized by comprising a culture medium storage bag and a culture medium sampling bag, wherein the front end of the culture medium storage bag is connected with a liquid inlet pipeline, a liquid discharge pipeline and a culture medium sampling branch pipeline, and the culture medium sampling branch pipeline is provided with a four-way joint and is connected with the three culture medium sampling bags through the four-way joint.
2. The SIMULTANCE FILLING BAG FOR USE IN A SYSTEM FOR SIMULATING CULTURE MEDIA as claimed in claim 1, wherein a support bar is provided at the end of the media reservoir bag for lifting the media reservoir bag to assist in evacuation.
3. The repeated-use system culture medium simulation filling bag as claimed in claim 1, wherein the liquid inlet pipeline comprises a th flexible pipe, a sterile disconnector, a second flexible pipe, a sterilization filter and a joint which are connected in sequence, the th flexible pipe is provided with a liquid inlet flow limiting clamp which is matched with a liquid inlet flow limiting clamp PVC protective sleeve, and the joint is connected with an upstream equipment input pipeline through a clamp and sealed at the joint through a gasket.
4. The SIMILAR FILLING BAG WITH SYSTEM FOR USE IN SEVERAL CULTURE MEDIA of claim 3, wherein the sterilizing filter is a SECONDARY-USE FILTER.
5. The model media filling bag for use as a disposable system according to claim 1, wherein the drain line comprises a drain hose, a drain restrictor clip, a PVC sheath for the drain restrictor clip, and a sterile connector, the drain hose has a end connected to the media storage bag and a end connected to the sterile connector, and the drain hose has the drain restrictor clip and the PVC sheath for the drain restrictor clip.
6. The SIMULTANEOUS SYSTEM MEDIUM SIMULATING FILLING BAG of claim 1, wherein the media sampling branch line comprises a sampling hose, a sampling restrictor clip and a four-way connector, the sampling hose is connected to of the four-way connector, and the remaining three connectors of the four-way connector are connected to three media sampling bags.
7. The SIMULATING FILLING BAG OF SYSTEM CULTURE MEDIUM FOR USE AS A TIME OF DISPOSABLE, according to claim 6, wherein a PVC protective sleeve is provided over the sampling restrictor clip.
8. The time-use system culture medium simulation filling bag according to claim 1, wherein the culture medium sampling bag comprises a sampling bag body, a blind plugging pipeline, a connecting pipeline and a sampling pipeline, the sampling bag body is connected with the blind plugging pipeline and the connecting pipeline, the sampling pipeline is connected with the connecting pipeline, the connecting pipeline comprises connecting hoses at two ends, and sterile disconnection joints are arranged between the two connecting hoses.
9. The SIMULATING FILLING BAG OF SYSTEM AND CULTURE MEDIUM FOR USE as claimed in claim 8, wherein the sampling bag body has a capacity of 50-250 mL.
10. The SIMULTANCE FILLING BAG WITH USE SYSTEM AND CULTURE MEDIUM as in claim 8, wherein the blind tubing is blind-ended tubing.