Disposable solution rapid split charging system for vaccine production

Abstract

The utility model discloses a disposable solution quick split charging system for vaccine production. The disposable solution quick split charging system comprises a supporting rod, a ribbon, a solution stopping clip, a metal sleeve, a hose plug, a Luer nut, a needleless sampler, a pagoda rotary nut Luer taper, a straight-through joint, a four-way adapter, a thermoplastic pipe, a connector solution storage bag, electric sterile breaking pliers, a sterile pipe connecting machine, a solution weighing device and a degerming filter. According to the rapid solution split charging system, even solution can be obtained by the liquid storage bags with the ten connectors under the participation of the sterile disconnecting clamp, and the requirements of the subsequent production and manufacturing link are met. The problem that the time limit used in the process that a large batch of solutions are subpackaged into a plurality of liquid storage bags is too long is solved.

Description

TECHNICAL FIELD

[0001] The utility model relates to a kind of disposable solution subpackaging equipment of biological product, especially, a system is connected by multiple disposable liquid storage bags, for solution realizes large-scale sterile subpackaging. BACKGROUND

[0002] The solution in prior art for vaccine production is usually prepared by large tank, and then subpackaged to glass bottle or disposable liquid storage bag etc. container through pipeline. It is high in sterile operation requirement under clean environment (A level), and it takes long time to seal pipe using traditional pipe sealing machine after solution is subpackaged to liquid storage bag, and the subpackaging precision is not high, so a set of convenient and fast solution rapid subpackaging system which can effectively control sterile can solve the problem of long time limit during solution subpackaging. SUMMARY

[0003] The purpose of the present application is to provide a kind of solution rapid subpackaging system, solve the problem of too long time limit during the process of subpackaging large quantities of solution to multiple liquid storage bags.

[0004] The present application discloses a kind of solution rapid subpackaging system for vaccine production, the subpackaging system includes: solution weighing device, liquid storage bag, sampling bag, infusion pipeline, electric sterile cutting forceps, wherein:

[0005] The sampling bag is configured at the farthest end of the infusion pipeline, and the other end of the infusion pipeline is connected to an infusion device;

[0006] The infusion pipeline is configured with a four-way adapter at the middle segment, and the liquid storage bags are connected to the infusion pipeline through metal sleeves on both sides of the four-way adapter;A liquid stop clamp is arranged between the liquid storage bags and the infusion pipeline

[0007] The solution weighing device can place all liquid storage bags on the corresponding weighing device to weigh the weight of the liquid storage bags;The electric sterile cutting forceps are configured to cut the metal sleeve after the liquid storage bags are completed subpackaging and the pipeline is locked by the weighing device.

[0008] In a preferred embodiment, the infusion pipeline is configured with a sterilization filter near one end of the infusion device.

[0009] In a preferred embodiment, the subpackaging system further includes a support rod, and the support rod fixes the liquid storage bags and other components by a strap.

[0010] In a preferred embodiment, the solution preparation and subpackaging system further includes a needleless sampler for sampling from the sampling bag.

[0011] In a preferred embodiment, the electric sterile cutting forceps include movable jaws, index pins, fixed jaws, lithium batteries, knife rest molds and blade edge molds.

[0012] In a preferred embodiment, the number of the four-way connection ports is determined by the simultaneous dispensing number of the solution dispensing and dispensing system, and is generally 2-10.

[0013] In a preferred embodiment, liquid-stopping clamps are arranged between the four-way connection ports.

[0014] In a preferred embodiment, the capacity of the sampling bag is 1-2L, and the capacity of the liquid storage bag is 5-10L.

[0015] In a preferred embodiment, the number of the weighing devices is the same as that of the liquid storage bags.

[0016] In a preferred embodiment, a pressure gauge is arranged near the end of the infusion pipeline close to the infusion device.

[0017] The advantages of the utility model include;

[0018] 1) The solution dispensing and dispensing system for vaccine production provided by the utility model interconnects various devices and components involved in the solution dispensing and dispensing process of vaccine production, forms a closed environment, avoids contact with the outside world during the solution dispensing process, and reduces the participation of employees. The solution dispensing process avoids the risk of pollution and improves the controllability of the biological product production process and product quality.

[0019] 2) The solution dispensing and dispensing system for vaccine production provided by the utility model is a disposable liquid storage bag, which shortens the work process and improves the efficiency.

[0020] 3) The traditional solution dispensing method often needs to use a pipe connecting machine to connect the liquid storage bag and the dispensing device, which increases the complexity in the operation process, and the pipe connecting time is long, which is not conducive to the dispensing of a large number of liquid storage bags. The application uses a specially designed disposable liquid storage bag system in the solution dispensing process, thereby reducing the need for complex mechanical equipment such as pipe connecting machines, and improving the controllability of biological product production and product quality.

[0021] The specification of this application contains numerous technical features distributed across various technical solutions. Listing all possible combinations of these technical features (i.e., technical solutions) would make the specification excessively lengthy. To avoid this problem, the various technical features disclosed in the above-described invention, the various technical features disclosed in the following embodiments and examples, and the various technical features disclosed in the accompanying drawings can be freely combined to form various new technical solutions (all of which should be considered as described in this specification), unless such a combination of technical features is technically infeasible. For example, one example discloses feature A+B+C, and another example discloses feature A+B+D+E. Features C and D are equivalent technical means that serve the same function, and technically only one needs to be used; they cannot be used simultaneously. Feature E can technically be combined with feature C. Therefore, the solution A+B+C+D should not be considered as described because it is technically infeasible, while the solution A+B+C+E should be considered as described. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the storage bag in the ten-bag structure of the rapid dispensing system for vaccine production solutions according to the present invention;

[0023] Figure 2 This is a schematic diagram of the structure of a ten-packet system for rapid dispensing of solutions for vaccine production according to the present invention;

[0024] Figure 3 This is a schematic diagram of an embodiment of the rapid solution dispensing system for vaccine production according to this utility model;

[0025] Figure 4 This is a schematic diagram of the structure of an electric aseptic disconnecting forceps.

[0026] Explanation of reference numerals in the attached figures:

[0027] 1-Four-way adapter; 2-Straight-through adapter; 3-Pagoda-shaped Luer connector; 4-Needleless sampler; 5-Luer nut; 6-Hose plug; 7-Metal sleeve; 8-Moving jaws; 9-Indexing pin; 10-Fixed jaws; 11-Lithium battery; 12-Knife die; 13-Cutting edge die; 14-Fixing screw; 15-Support shell; 16-Hydraulic clamp; P4-Support rod; P3-Cable tie; P2-Liquid stop clamp; T1-Connecting pipe; T2-Thermoplastic tubing; A1-Reservoir bag; A2-Sampling bag. Detailed Implementation

[0028] Through in-depth research and extensive screening, the inventors have developed a rapid solution dispensing system for vaccine production. The dispensing system includes: a solution weighing device, a storage bag, a sampling bag, an infusion tubing, and an electric aseptic disconnecting forceps. Compared to existing technologies, this application completely eliminates the need for a connection machine by using disposable storage bags and a special structure during the solution dispensing process, reducing the requirement for complex mechanical equipment and improving the controllability and product quality of biopharmaceutical production.

[0029] To make the objectives, technical solutions, and advantages of this application clearer, the embodiments of this application will be described in further detail below with reference to the accompanying drawings.

[0030] Example

[0031] An embodiment of this application, for example Figures 1-3 As shown, the dispensing system of this embodiment includes: a solution weighing device, a storage bag A1, a sampling bag A2, an infusion pipeline, and an electric aseptic disconnecting forceps, wherein:

[0032] The sampling bag is positioned at the farthest end of the infusion tubing, the other end of which is connected to the infusion device and a pressure gauge. Optionally, in one embodiment, the sampling bag has two openings at the bottom: one opening connects to the infusion tubing and has a stop clamp P2 in the middle; the other opening connects to the outside for obtaining sample solution. From the inside out, the sampling bag contains a thermoplastic tube T2, a pagoda-shaped Luer connector 3, a needle-free sampler 4, and a Luer nut 5. Optionally, in one embodiment, the sampling bag A2 further includes a support rod P4, positioned at the top to secure the sampling bag A2.

[0033] The infusion pipeline is equipped with a four-way adapter 1 in the middle section. The storage bag A1 is disposed on both sides of the four-way adapter 1 and connected to the infusion pipeline through a metal sleeve 7. A stop clamp P2 is disposed between the storage bag A1 and the infusion pipeline. Optionally, in one embodiment, the storage bag has three openings, two of which are located at the bottom of the storage bag and one of which is located at the top of the storage bag. All three openings are connected to the outside through a connecting pipe T1 and a connected hose and cable tie P3, and a stop clamp P2 is disposed in the middle of each opening. The hose connected to the four-way adapter 1 is additionally equipped with a metal sleeve 7.

[0034] The solution weighing device is as follows Figure 2The device shown is positioned below the liquid storage bag for weighing the bag. The electrically operated aseptic cutting forceps are configured to cut the metal sleeve after the liquid storage bag has been dispensed and the tubing has been locked by the weighing device. In this embodiment, the electrically operated aseptic cutting forceps include: a movable jaw 8, an indexing pin 9, a fixed jaw body 10, a lithium battery 11, a cutting die 12, a cutting edge die 13, a fixing screw 14, a support shell 15, and a hydraulic clamp 16. In use, the metal sleeve 7 is inserted into the top opening, and then the aseptic cutting forceps are activated to cut the tube.

[0035] Optionally, in one embodiment, a sterilization filter is provided at one end of the infusion tubing near the infusion device.

[0036] The electric aseptic disconnecting forceps includes: movable jaws, indexing pins, fixed jaw body, lithium battery, cutting tool mold, and cutting edge mold.

[0037] Optionally, in one embodiment, the number of the four-way connectors is determined by the design of the solution dispensing system to handle simultaneous dispensing, and is generally 1-20. In this embodiment, 10 connectors are used.

[0038] Optionally, in one embodiment, the sampling bag has a capacity of 1-2L, and the storage bag has a capacity of 5-10L. Furthermore, the number of weighing devices is the same as the number of storage bags.

[0039] Optionally, in one embodiment, the weighing device is an electronic scale.

[0040] Optionally, in one embodiment, the system of this application further includes a monitoring system configured to monitor the solution weighing device in order to detect in a timely manner that it has reached a specified weight.

[0041] In this embodiment, first, all clamps P2 on the storage bag A1 are closed. Then, the storage bag A1, the sterile filter, and the sterilized outlet tubing are connected in series. Next, the clamps on the tubing of storage bag A1 are loosened, and any one of the storage bags at the end is placed on the weighing device. After zeroing the weight, clamp P2 is opened. Then, the sterile filter is adjusted to a suitable pressure to allow the solution to flow into the storage bag. Once the electronic scale reaches the target weight, clamp P2 is closed. The electric aseptic disconnecting forceps disconnect storage bag A1. Next, the next storage bag is placed on another weighing device, and clamp P2 is opened. The sterile filter is adjusted to a suitable pressure to allow the solution to flow into the storage bag. Once the electronic scale reaches the target weight, clamp P2 is closed. The electric aseptic disconnecting forceps disconnect storage bag A1. Furthermore, the number of weighing devices can be increased, and the storage bags on the weighing devices can be discharged simultaneously, improving the dispensing speed.

[0042] It should be noted that in this patent application, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one" does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element. In this patent application, if it refers to performing an action according to an element, it means performing the action at least according to that element, including two cases: performing the action only according to that element, and performing the action according to that element and other elements. Expressions such as "multiple," "repeatedly," and "various" include two, two times, two kinds, and more than two, more than two times, and more than two kinds.

[0043] This specification includes combinations of various embodiments described herein. Individual references to “one embodiment” or a particular embodiment, etc., do not necessarily refer to the same embodiment; however, these embodiments are not mutually exclusive unless indicated to be mutually exclusive or are readily apparent to those skilled in the art. It should be noted that the word “or” is used in a non-exclusive sense throughout this specification unless the context explicitly indicates or requires it.

[0044] All documents mentioned in this application are considered to be incorporated in their entirety into the disclosure of this application so that they can serve as a basis for modifications if necessary. Furthermore, it should be understood that after reading the foregoing disclosure of this application, those skilled in the art can make various alterations or modifications to this application, and these equivalent forms also fall within the scope of protection claimed in this application.

Claims

1. A rapid dispensing system for disposable solutions in vaccine production, characterized in that, The dispensing system includes: a solution weighing device, a storage bag, a sampling bag, an infusion tubing, and an electric aseptic disconnecting forceps, wherein: The sampling bag is positioned at the farthest end of the infusion pipeline, and the other end of the infusion pipeline is connected to the infusion device; The infusion pipeline is equipped with a four-way adapter in the middle section, and the storage bag is disposed on both sides of the four-way adapter and connected to the infusion pipeline through a metal sleeve; a liquid-stop clamp is provided between the storage bag and the infusion pipeline. The solution weighing device can place all the storage bags on the corresponding weighing device, and the solution weighing device can accurately weigh the storage bags; the electric aseptic disconnecting forceps are configured to cut the metal sleeve after the storage bags have been dispensed and the tubing has been locked by the solution weighing device.

2. The rapid solution dispensing system according to claim 1, characterized in that, A sterilization filter is installed at one end of the infusion pipeline near the infusion device.

3. The rapid solution dispensing system according to claim 1, characterized in that, The dispensing system also includes a support rod, which secures the liquid storage bag with cable ties.

4. The rapid solution dispensing system according to claim 1, characterized in that, The dispensing system also includes a needle-free sampler for taking samples from the sampling bag.

5. The rapid solution dispensing system according to claim 1, characterized in that, The electric aseptic disconnecting forceps includes: movable jaws, indexing pins, fixed jaw body, lithium battery, cutting tool mold, and cutting edge mold.

6. The rapid solution dispensing system according to claim 1, characterized in that, The number of four-way connectors depends on the number of simultaneous packaging units designed for the packaging system, and is generally 2-10.

7. The rapid solution dispensing system according to claim 1, characterized in that, A liquid-stop clamp is provided between the four-way connectors.

8. The rapid solution dispensing system according to claim 1, characterized in that, The sampling bag has a capacity of 1-2L, and the storage bag has a capacity of 5-10L.

9. The rapid solution dispensing system according to claim 1, characterized in that, The number of weighing devices is the same as the number of liquid storage bags.

10. The rapid solution dispensing system according to claim 1, characterized in that, A pressure gauge is installed near the end of the infusion pipeline that is connected to the infusion device.

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