CN215798398U

CN215798398U - Sterile filling system suitable for microorganism choosing method

Info

Publication number: CN215798398U
Application number: CN202122025828.0U
Authority: CN
Inventors: 贾玉香; 张晨; 杨伟兴; 李发田; 刘春霞
Original assignee: Qingdao Kechuang Quality Detection Co ltd
Current assignee: Stande Kechuang Pharmaceutical Technology Qingdao Co ltd
Priority date: 2021-08-26
Filing date: 2021-08-26
Publication date: 2022-02-11
Anticipated expiration: 2031-08-26

Abstract

The application provides an aseptic filling system suitable for a microorganism choosing method, which comprises a liquid storage bottle, a tee joint, a hose and an aseptic packaging material; the liquid storage bottle is used for containing the prepared culture medium, and a liquid storage bottle cap is arranged at the bottle mouth of the liquid storage bottle for sealing; a first passage of the tee joint penetrates through the liquid storage bottle cap to be communicated with the liquid storage bottle, a filter and a first switch are arranged on a second passage, and a second switch is arranged on a third passage; one end of the hose is communicated with the liquid storage bottle, the other end of the hose is connected with an injection needle, and the hose is provided with a peristaltic pump; the injection needle may be in communication with the sterile package. The application provides an aseptic filling system has labour saving and time saving, convenient operation, requires characteristics such as low to environment aseptic level.

Description

Sterile filling system suitable for microorganism choosing method

Technical Field

The utility model belongs to the technical field of tightness detection, and particularly relates to an aseptic filling system suitable for a microorganism choosing method.

Background

The hermeticity of the package, also known as the integrity of the package, refers to the ability of the package to prevent loss of product, to prevent ingress of microorganisms, to limit ingress of harmful gases or other substances, and thereby ensure that the product meets all necessary safety and quality standards. In 2020, the national drug administration has issued technical guidelines for research on sealability of chemical drug injection packaging systems (trial), which requires the research on sealability of injection packages. The tightness detection method comprises a physical method and a microorganism challenge method, and the guideline clearly indicates that if the sensitivity of the method cannot reach the maximum allowable leakage limit level of a product or the maximum allowable leakage limit of the product is not clear, at least two methods (one of the recommended microorganism challenge methods) are suggested to be adopted for tightness research, and the microorganism challenge method test is an essential part for tightness research because the current domestic tightness methods cannot reach the maximum allowable leakage limit.

The test process of the microorganism choosing method comprises 2 steps: 1) filling a culture medium in the medicine sterile packaging material, sealing, and enabling the sterile packaging material containing the culture medium to be sterile by a certain means; 2) after the sterility is confirmed, the sterile packaging material is soaked in the bacteria liquid for a period of time and cultured, and whether the culture medium in the sterile packaging material grows bacteria or not is observed to judge the sealing performance of the sterile packaging material. In the first step of filling the culture medium and sealing, the sterile packaging material capable of adopting terminal sterilization can be subjected to terminal sterilization after the culture medium is filled and sealed; however, some preparations do not undergo a terminal sterilization process, or the sterile packaging materials of the preparations may be deformed or damaged by terminal sterilization, such as co-extruded film bags, plastic infusion bottles, plastic ampoules, plastic eye drops and the like, and for the sterile packaging materials, ethylene oxide sterilization, irradiation sterilization, disinfection and the like are required to sterilize the air sterile packaging materials during a microorganism challenge test, the culture medium is sterilized separately by moist heat sterilization, and finally the culture medium is filled into the sterile packaging materials to prepare sterile samples, which is called as sterile filling. In the test operation, sterile filling is generally carried out on an ultra-clean bench, the sterilized culture medium is transferred into a sterile packaging material by a manual means, the process has very high requirements on the sterility degree of the environment and the operation proficiency of testers, and the risk of contamination is also high in the filling process; for large-package sterile packing materials, particularly for some sterile packing materials which are sealed, a culture medium needs to be injected by a syringe through a sealing rubber plug, the whole filling time is long, the culture medium needs to be moved for many times, and the culture medium can be infected in the operation process by carelessness, so that the test fails.

Therefore, designing a set of automatic aseptic filling to improve filling efficiency and shield the environment from microbial contamination is of great significance for microbial challenge method tests and medicine tightness research.

SUMMERY OF THE UTILITY MODEL

In order to solve the technical problems, the utility model provides an aseptic filling system suitable for a microorganism choosing method.

The aseptic filling system suitable for the microorganism choosing method comprises a liquid storage bottle, a tee joint and a hose;

the liquid storage bottle is used for containing the prepared culture medium, and a liquid storage bottle cap is arranged at the bottle mouth of the liquid storage bottle for sealing;

a first passage of the tee joint penetrates through the liquid storage bottle cap to be communicated with the liquid storage bottle, a filter and a first switch are arranged on a second passage, and a second switch is arranged on a third passage;

one end of the hose is communicated with the liquid storage bottle, the other end of the hose is connected with an injection needle, and the hose is provided with a peristaltic pump.

In some embodiments of the present application, the injection needle comprises a cap and a first injection needle.

In some embodiments of the present application, the liquid storage bottle is communicated with a glass tube, a third switch is installed on the glass tube, and the free end of the glass tube is connected with the hose.

In some embodiments of the present application, the glass tube is in communication with the bottom of the side of the reservoir.

Compared with the prior art, the utility model has the beneficial effects that:

1. realizing automatic filling: only need open the switch of filling system and control peristaltic pump button alright in order to realize automatic filling, can set for the pump speed according to the filling volume, control filling time to can press at any time and stop, labour saving and time saving, convenient operation.

2. The microorganisms in the environment can be shielded: the culture medium is always in an aseptic system in the whole process from the sterilization of the culture medium to the filling of the aseptic packaging material, and is not contacted with the outside; in the filling process, gas which needs to be supplemented into the system from the environment due to the volume loss of the culture medium flows through the filter and then enters the system, so that external microorganisms are effectively prevented from entering the system. Therefore, the filling system has low requirement on the sterility grade of the environment, can realize sterile filling in laboratories with lower sterility grade, and has wide application range.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application.

Drawings

In order to more clearly explain the technical solution of the present application, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious to those skilled in the art that other drawings can be obtained according to the drawings without creative efforts.

Fig. 1 is a schematic diagram illustrating an aseptic filling system adapted to a microorganism challenge method according to an embodiment of the present invention.

The reference numbers illustrate: the injection device comprises a liquid storage bottle 1, a liquid storage bottle 2, a liquid storage bottle cap 3, a tee joint 4, a hose 5, a peristaltic pump 6, an injection needle 7, a sterile packing material 8, a second injection needle 11, a glass tube 12, a third switch 31, a first switch 32, a second switch 33, a filter 61, a cap 61 and a first injection needle 62.

Detailed Description

In order to make those skilled in the art better understand the technical solutions in the present application, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Fig. 1 is a schematic diagram illustrating an aseptic filling system adapted to a microorganism challenge method according to an embodiment of the present invention. An aseptic filling system adapted to the microorganism challenge method provided by the embodiment of the present invention is described in detail below with reference to fig. 1.

As shown in fig. 1, the aseptic filling system adapted to the microorganism challenge method mainly includes a liquid storage bottle 1, a tee joint 3 and a hose 4.

Specifically, stock solution bottle 1 is used for holding the culture medium of preparing, and 1 bottleneck of stock solution bottle is equipped with stock solution bottle lid 2 sealedly. Wherein the first expert of tee bend 3 passes the stock solution bottle lid 2 and communicates with stock solution bottle 1, installs filter 33 and first switch 31 on the second expert, and the order of connection is once outward from stock solution bottle 1 for first switch 31 and filter 33, installs second switch 32 on the third tee bend. The filter 33 is used for filtering and removing microorganisms in the air, and is a replaceable component, and a new filter 33 needs to be replaced each time the filter is used.

One end of the hose 4 is communicated with the liquid storage bottle 1, the other end of the hose is connected with an injection needle 6, and the hose 4 is provided with a peristaltic pump 5. In some embodiments of the present application, the liquid storage bottle 1 is communicated with a glass tube 11, a third switch 12 is installed on the glass tube 11, and the free end of the glass tube 11 is connected with the hose 4. Further, the glass tube 11 is communicated with the bottom of the side surface of the liquid storage bottle 1. The injection needle 6 comprises a cap 61 and a first injection needle 62, the cap 61 is tightly connected with the bottom of the first injection needle 62, and the first injection needle 62 is ensured to be in a closed environment.

When in use, the injection needle 6 can be communicated with the sterile packing material 7, and the sterile packing material 7 is also communicated with the outside through a second injection needle 8.

The working principle is as follows:

and (3) sterilization: and storing the prepared culture medium in a liquid storage bottle, wherein the third switch is in a closed state. And covering a liquid storage bottle cap, opening a second switch in the tee joint, closing the first switch, placing the whole set of devices except the peristaltic pump in a sterilization cabinet, and sterilizing the culture medium and the whole set of devices. The second switch is a ventilation switch, and the opening state of the second switch can allow the inside of the bottle and the outside of the bottle to be kept smooth in the sterilization process so as to prevent the explosion caused by overhigh pressure in the bottle.

Filling preparation: and after the sterilization is finished, the second switch is closed, so that the whole system is in a closed state, and the condition that the culture medium is contacted with the external environment to contaminate the bacteria is avoided. The cover cap of the injection needle head is opened, the first injection needle is rapidly inserted into the sealing plug of the sterile packing material, the second injection needle is additionally inserted into the sterile packing material and is connected with the outside through the second injection needle, redundant gas in the sterile packing material is discharged through the second injection needle due to the injection of liquid in the filling process, and the culture medium in the sterile packing material cannot be infected with bacteria due to the fact that the gas is discharged outwards in the process. The hose is connected with the peristaltic pump, the pump speed of the peristaltic pump is set according to the required filling amount, and the pump speed can be increased by the aid of the large filling amount, so that filling time is shortened.

Filling: open third switch, first switch, open the peristaltic pump, the culture medium gets into aseptic package material at the uniform velocity through the hose under the effect of peristaltic pump, causes the headspace increase pressure to reduce because the culture medium flows out in the stock solution bottle for gas in the environment gets into the stock solution bottle after through first switch and filter degerming, ensures that the stock solution bottle maintains the ordinary pressure. And when the filling volume meets the requirement, the peristaltic pump is stopped, and the first injection needle is pulled down, so that the whole filling system is disconnected with the sterile packing material. The second injection needle on the sterile packing material is pulled out, the needle hole can be automatically closed due to the elastic action of the sealing plug of the sterile packing material, and the needle hole can be sealed by sealant if necessary.

And (3) continuous filling: continuous filling can be accomplished by burning the first needle with an alcohol burner flame to remove any microorganisms that may be contaminated by exposure to air, inserting the needle into another sterile wrapper, and repeating the filling process.

Since the above embodiments are all described by referring to and combining with other embodiments, the same portions are provided between different embodiments, and the same and similar portions between the various embodiments in this specification may be referred to each other. And will not be described in detail herein.

It should be noted that, unless otherwise specified and limited, the terms "connected" and "connected" are to be interpreted broadly, and may be, for example, mechanically or electrically connected, or may be communicated between two elements, directly or indirectly through an intermediate medium, and specific meanings of the terms may be understood by those skilled in the relevant art according to specific situations. The terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a circuit structure, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such article or apparatus. Without further limitation, the presence of an element identified by the phrase "comprising an … …" does not exclude the presence of additional like elements in the article or device comprising the element. In the description of the present invention, it is to be understood that the terms "bottom", "one end", "top", "middle", "other end", "one side", "top", "inner", "front", "center", "both ends", and the like, indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience of describing the present invention and simplifying the description, but do not indicate or imply that the device or element referred to must have a particular orientation, be constructed in a particular orientation, and be operated, and thus, should not be construed as limiting the present invention. Relational terms such as "first" and "second," and the like, may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. In addition, as used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Other embodiments of the present application will be apparent to those skilled in the art from consideration of the specification and practice of the disclosure of the utility model disclosed herein. This application is intended to cover any variations, uses, or adaptations of the utility model following, in general, the principles of the application and including such departures from the present disclosure as come within known or customary practice within the art to which the utility model pertains. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the application being indicated by the following claims.

The above-described embodiments of the present application do not limit the scope of the present application.

Claims

1. An aseptic filling system adapted for a microbiological challenge method, comprising: a liquid storage bottle (1), a tee joint (3) and a hose (4);

the liquid storage bottle (1) is used for containing a prepared culture medium, and a liquid storage bottle cap (2) is arranged at the opening of the liquid storage bottle (1) for sealing;

a first passage of the tee joint (3) penetrates through the liquid storage bottle cap (2) to be communicated with the liquid storage bottle (1), a filter (33) and a first switch (31) are arranged on a second passage, and a second switch (32) is arranged on a third passage;

one end of the hose (4) is communicated with the liquid storage bottle (1), the other end of the hose is connected with an injection needle (6), and the hose (4) is provided with a peristaltic pump (5).

2. Sterile filling system adapted to the microbiological challenge according to claim 1, wherein said injection needle (6) comprises a cap (61) and a first injection needle (62).

3. The aseptic filling system adapted to the microorganism choosing method according to claim 1, wherein the liquid storage bottle (1) is communicated with a glass tube (11), a third switch (12) is installed on the glass tube (11), and the free end of the glass tube (11) is connected with the flexible tube (4).

4. An aseptic filling system adapted to the microbial challenge method according to claim 3, wherein the glass tube (11) is communicated with the bottom of the side surface of the liquid storage bottle (1).