CN212681806U

CN212681806U - Cleaning and sterilizing equipment

Info

Publication number: CN212681806U
Application number: CN202021454312.7U
Authority: CN
Inventors: 李鉴墨; 李罗浩
Original assignee: Kangxi Biomedical Shenzhen Co ltd
Current assignee: Kangxi Biomedical Shenzhen Co ltd
Priority date: 2020-07-21
Filing date: 2020-07-21
Publication date: 2021-03-12
Anticipated expiration: 2030-07-21

Abstract

The application provides a wash sterilization equipment relates to medical collagen solution production technical field for degerming filtration system, degerming filtration system includes: a containment device and a filtration system; the cleaning and sterilizing equipment is used for cleaning and sterilizing the sterilizing and filtering system; the receiving device is formed as a dispensing device for dispensing the solution to be filtered; the preparation device comprises a preparation mechanism and a temperature adjusting mechanism; the communication path includes a first path, the filter system is communicated with the preparation mechanism via the first path, and the cleaning and sterilizing device includes: the injection water source is communicated with the preparation mechanism through a sixth path and is used for conveying injection water; washing sterilization equipment still includes pH adjustment mechanism, and pH adjustment mechanism includes: and the acid liquid source is communicated with the preparation mechanism through the seventh path and conveys acid liquid into the preparation mechanism. The cleaning and sterilizing equipment ensures the cleanness of the equipment and guarantees the sterility of the filtrate obtained in the continuous filtration operation process of the collagen solution.

Description

Cleaning and sterilizing equipment

Technical Field

The application relates to the technical field of production of medical collagen solution, in particular to a cleaning and sterilizing device.

Background

The medical collagen solution cannot be sterilized by means of internal terminal sterilization including heat sterilization and gas sterilization due to the instability of the solution, and the sterilization process needs to be sterilized by means of filtration. Medical collagen solutions often have certain requirements on concentration, and high concentration directly causes high viscosity of the collagen solution, and the high viscosity causes great difficulty in the filtration sterilization process.

Therefore, after the filtration operation of the highly viscous collagen solution, the collagen inevitably adheres to the equipment and piping. Collagen remains in equipment and pipeline, has increased the risk that equipment and pipeline are blockked up, has increaseed the degree of difficulty of filtration operation, lets the aseptic difficult assurance that obtains of filtrating. Meanwhile, the collagen is degraded, and impurities are continuously released in the filtering process, so that the purity of the collagen is reduced, the impurities are increased, and the pollution is continuously caused in the filtering process.

In this regard, the cleaning equipment and process used in the prior art are difficult to cope with the above-mentioned problems caused by the collagen residue.

SUMMERY OF THE UTILITY MODEL

In view of this, the present application provides a cleaning and sterilizing apparatus, which aims to solve the above technical problems to some extent.

The application provides a wash sterilizing equipment for aseptic filteration system, aseptic filteration system includes:

the containing device is used for containing the solution to be filtered;

a filtration system communicating with the housing device via a communication path to filter the solution to be filtered;

the cleaning and sterilizing equipment is used for cleaning and sterilizing the sterilization and filtration system, and the solution to be filtered is a collagen solution;

the receiving device is formed as a dispensing device for dispensing the solution to be filtered; the preparation device comprises a preparation mechanism for preparing the solution to be filtered and a temperature adjusting mechanism arranged at the outer side part of the preparation mechanism;

the communication path includes a first path via which the filter system communicates with the dispensing mechanism, and the washing and sterilizing apparatus includes: and the injection water source is communicated with the preparation mechanism through a sixth path and is used for conveying the injection water.

The washing and sterilizing equipment further comprises a pH adjusting mechanism, and the pH adjusting mechanism comprises: and the acid liquid source is communicated with the preparation mechanism through a seventh path and conveys acid liquid into the preparation mechanism.

Preferably, the pH adjusting mechanism further comprises:

and the alkali liquor source is communicated with the preparation mechanism through an eighth path and conveys alkali liquor into the preparation mechanism.

Preferably, a vapor source for delivering vapor communicates with the temperature adjustment mechanism via a ninth path and communicates with the first path via a tenth path.

Preferably, the washing and sterilizing apparatus further comprises:

and the refrigerant source is communicated with the temperature adjusting mechanism through an eleventh path and is used for conveying a refrigerant.

Preferably, the communication path further comprises a second path, the filtration system further comprising:

the first filtering device is communicated with the preparation mechanism through the first path and is used for filtering the solution to be filtered;

and the second filtering device is communicated with the first filtering device through the second path and is used for further filtering the solution filtered by the first filtering device.

Preferably, the washing and sterilizing apparatus further comprises:

the compressed gas source is communicated with the preparation mechanism through a third path, is communicated with the first path through a fourth path and is also communicated with the second path through a fifth path, and the compressed gas source is used for providing compressed gas with adjustable pressure to realize material transfer.

Preferably, the first filter device is formed as a pre-filter device which pre-filters the solution to be filtered.

Preferably, the second filtering device is formed as a main filtering device which further filters the solution filtered by the pre-filtering device to obtain a sterile filtrate.

The cleaning and sterilizing equipment ensures the cleanness of the equipment and guarantees the sterility of the filtrate obtained in the continuous filtration operation process of the collagen solution.

In order to make the aforementioned objects, features and advantages of the present application more comprehensible, preferred embodiments accompanied with figures are described in detail below.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are required to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present application and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained from the drawings without inventive effort.

FIG. 1 shows a schematic view of a cleaning and sterilizing apparatus assembled with a sterilizing filtration system.

Reference numerals:

1 a-a preparation mechanism; 1 b-a temperature adjustment mechanism; 2 a-a first path; 3 a-a pre-filtration device; 2 b-a second path; 3 b-a main filtration device;

4-water source for injection; 5 a-a source of acid liquor; 5 b-a source of caustic; 6-a source of vapour; 7-a refrigerant source; 8-compressed gas source.

Detailed Description

The technical solutions of the present application will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are only some embodiments of the present application, but 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 application.

In the description of the present application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present application. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present application, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present application can be understood in a specific case by those of ordinary skill in the art.

In addition, technical solutions between various embodiments may be combined with each other, but must be realized by a person skilled in the art, and when the technical solutions are contradictory or cannot be realized, such a combination should not be considered to exist, and is not within the protection scope of the present application.

The cleaning and sterilizing process in this embodiment is used for a sterilizing and filtering system. The sterile filtration system comprises a receiving device for receiving a solution to be filtered, which receiving device can be formed as a dispensing device for dispensing the solution to be filtered. Referring to fig. 1, for example, the dispensing apparatus may include a dispensing mechanism 1a and a temperature adjustment mechanism 1 b. The preparation mechanism 1a may be formed with a cavity for preparing the solution, in an embodiment, the solution to be filtered in the preparation mechanism 1a may be, for example, a medical collagen solution, and the temperature adjustment mechanism 1b may be disposed at an outer side portion of the preparation mechanism 1a, and the temperature adjustment principle of the temperature adjustment mechanism 1b will be specifically described in the following description. In an embodiment, the sterilizing filtration system further comprises a filtration system that can be in communication with the dispensing mechanism 1a via a communication path, the specific structure and manner of communication of which will also be described in the following description.

In an embodiment of the present application, the filtration system includes a pre-filtration device 3a and a main filtration device 3b, the communication path includes a first path 2a, the pre-filtration device 3a communicates with the preparation mechanism 1a via the first path 2a, and the pre-filtration device 3a performs pre-filtration on the solution to be filtered prepared by the preparation mechanism 1 a. The communication path further comprises a second path 2b, the main filtration device 3b being in communication with the pre-filtration device 3a via the second path 2b for further filtering of the solution to be filtered, so as to obtain a sterile filtrate in accordance with the requirements. The following describes the cleaning and sterilizing process using a collagen solution as an example of the solution to be filtered.

For the above sterilizing filtration system, the cleaning and sterilizing process includes a cleaning step and a sterilizing step, and specifically, the cleaning and sterilizing process may include the following processes or steps performed in sequence:

before the filtering operation is carried out, a first acid liquor cleaning step or an alkali liquor cleaning step is carried out, and the method specifically comprises the steps of cleaning the preparation mechanism 1a, the first path 2a, the pre-filtering device 3a, the second path 2b and the main filtering device 3b by using acid liquor or alkali liquor;

then, a first water washing step is executed, which specifically comprises washing the preparation mechanism 1a, the first path 2a, the pre-filtering device 3a, the second path 2b and the main filtering device 3b by using water for injection;

then, a sterilization step is performed, wherein the communication part between the first path 2a and the preparation mechanism 1a is closed, and the first path 2a, the pre-filtering device 3a, the second path 2b and the main filtering device 3b are subjected to online steam sterilization;

after the sterilization step, interrupting the cleaning and sterilizing process, opening a communication part between the first path 2a and the preparation mechanism 1a, executing a filtering operation by using the pre-filtering device 3a and the main filtering device 3b, and after the filtering operation, executing a second acid liquid cleaning step or an alkali liquid cleaning step, wherein the cleaning step specifically comprises cleaning the preparation mechanism 1a, the first path 2a, the pre-filtering device 3a, the second path 2b and the main filtering device 3b by using acid liquid or alkali liquid;

subsequently, a second water washing step is performed, comprising washing the dosing means 1a, the first path 2a, the pre-filtering device 3a, the second path 2b and the main filtering device 3 b.

In addition, for different medical collagen solutions, one of an acid solution and an alkali solution may be selected for cleaning, for example, the acid solution may be hydrochloric acid with a low concentration, and the alkali solution may be sodium hydroxide with a low concentration.

For the convenience of the following description, it may be defined that one end of the first path 2a communicating with the dispensing mechanism 1a is a first end, and one end communicating with the pre-filtering device 3a is a second end. The first end and the second end of the first path 2a can be both provided with valves, so that flexible on-off operation can be conveniently carried out on the pipeline.

Similarly, the second path 2b is defined and arranged in a manner similar to the first path 2a, i.e., the end of the second path 2b communicating with the pre-filter unit 3a is a first end, and the end communicating with the main filter unit 3b is a second end. Valves may be provided at both the first and second ends of the second path 2 b. Further, both the first path 2a and the second path 2b are provided with a drain line, the function of which will be explained in the following description.

In the first acid cleaning step or the alkali cleaning step, the accommodating device, the communication path and the filtering system are cleaned by using acid liquid or alkali liquid, in the process, taking alkali liquid as an example, firstly, the valve at the first end of the first path 2a can be closed, then, the alkali liquid can be directly introduced into the preparation mechanism 1a, stirring operation is carried out for a certain time, and the inside of the preparation mechanism 1a can be effectively and comprehensively cleaned. On the basis, a valve at the first end of the first path 2a is opened, so that the alkali liquor sequentially passes through the first path 2a, the pre-filtering device 3a, the second path 2b and the main filtering device 3b and is finally discharged from the rear section of the main filtering device 3 b.

The acid solution or alkali solution cleaning is performed on the collagen solution with high viscosity, and the collagen remained in the equipment and the pipeline is difficult to clean only by cleaning with water for injection. The alkali liquor or the acid liquor is adopted for cleaning, so that the dissolution of the adhered collagen and degradation products thereof can be rapidly realized, the cleaning effect is improved, the time consumption for cleaning is reduced, and the cost is saved.

In addition, the cleaning of the alkali liquor or the acid liquor avoids the problem that the collagen solution is difficult to convey and filter in subsequent production batches due to high viscosity of the collagen solution, easy adhesion and easy blockage of the filtering, reduces dead angles in the pipeline caused by the adhesion of the collagen in the use process, and also promotes the service life of the equipment.

After the washing with alkali liquor or acid liquor, the washing and sterilizing process continues to perform steam on-line sterilization, and the flow direction of steam in each device and pipeline is the same as that of the injection water, except that each drainage pipeline is opened to assist in discharging condensed water formed by steam in the pipeline. By steam sterilization, the piping and equipment are ensured to be clean and sterile in combination with the previous cleaning process.

It should also be noted that during the washing with alkaline or acidic solution, the valve at the second end of the first path 2a may be closed by closing a valve, for example, before opening the valve at the first end of the first path 2a, so that it is contemplated to hold the alkaline or acidic solution in the first path 2a for a certain (predetermined) time, which facilitates sufficient contact between the alkaline or acidic solution and the adhered collagen and its degradation products, and thus facilitates reduction of consumption of the alkaline or acidic solution. Similarly, the valve at the first end of the second path 2b may be closed before the valve at the second end of the first path 2a is opened, and the above process is repeated, and then the valve at the second end of the second path 2b is closed before the valve at the first end of the second path 2b is opened, and the above process is also repeated.

Further, the above mentioned rear section of the main filtering means 3b may be a pipe connecting the main filtering means 3b, and this pipe may also be provided with a valve for closing the valve before opening the valve at the second end of the second path 2b, thereby ensuring that the main filtering means 3b is sufficiently cleaned.

The following cleaning process of the second acid solution cleaning step or the alkali solution cleaning step is also the same as the cleaning process of the first acid solution cleaning step or the alkali solution cleaning step, and the beneficial effects are also the same, and are not described herein again. The first water cleaning step and the second water cleaning step can also realize a cleaning process similar to the first acid cleaning step by opening or closing the valves, and as the water cleaning step, all the valves can be opened compared with the acid or alkali cleaning step, so that equipment and pipelines are intensively washed.

In addition, in the embodiment, for the current filtering operation which is closer to the time interval of the previous filtering operation, since the second acid liquid cleaning step or the alkali liquid cleaning step and the second water cleaning step are performed after the previous filtering operation, the first acid liquid cleaning step or the alkali liquid cleaning step and the first water cleaning step can be performed before the current filtering operation of the equipment and the pipeline, so that the time and the process steps are saved to a certain extent, and the overall operation efficiency is improved.

In an embodiment, the cleaning step may further comprise a sampling process. The sampling process can be implemented in two ways. The first embodiment may correspond to the above cleaning method in which cleaning is performed only after the filtering operation, or may be performed in an embodiment in which cleaning is performed both before and after filtering. In the first embodiment, the sampling occurs in the second water washing step, and the first path 2a and the second path 2b are sampled respectively to obtain two first water samples, and the sampling is performed in the rear pipeline of the main filtering device 3b to obtain a second water sample. In an embodiment, the sampling point on the first path 2a may be closer to the second end of the first path 2a, and the sampling point on the second path 2b may also be closer to the second end, so that the sampling points on the two paths are relatively closer to the rear end of the process flow, which is beneficial to avoiding sampling one-sidedness. On the basis, the sampling process can be performed in a state that the valves of the above-mentioned pipelines are all opened, the extraction of the water sample is performed after the injection water is flushed for a preset time, it is further ensured that the extracted water sample is not influenced by residues (such as residual acid liquor or alkali liquor and impurities which are separated from the equipment and the pipelines but not discharged out of the equipment or the pipelines along with the acid liquor or the alkali liquor) in the second acid liquor cleaning step or the alkali liquor cleaning step, and then the substance residue detection is performed on the first water sample and the second water sample, which will be described in detail below.

The substance residue detection refers to detection including organic substance residue detection and bacteria detection, and compares a first detection result obtained by detecting a first water sample and a second water sample with a standard in the field, so as to judge the cleaning degree of corresponding sampling point front-stage equipment and pipelines, and provide direct reference for optimizing specific quantities such as the cleaning time of injection water and the concentration of alkali liquor or acid liquor in a second acid liquor cleaning step or an alkali liquor cleaning step and a second water cleaning step.

The second embodiment of the sampling process is implemented in an embodiment of cleaning before and after filtration, that is, in the first water cleaning step before the filtration operation, two third water samples of the first path 2a and the second path 2b and a fourth water sample of the rear-stage pipeline of the main filtration device 3b are obtained by using the same sampling points as those described above, and substance residue detection is performed, so as to obtain a second detection result, which is also compared with the standard in the art. The sampling and detection process after the filtering operation is the same as that in the first embodiment. The second embodiment ensures the cleanliness of the long-term equipment and piping, in addition to the same advantageous effects as the first embodiment described above, in which the process parameters can be optimized.

In addition, the collagen solution in this embodiment can further reach the level of the sterile implantable medical material, the control of impurities in the collagen solution is particularly strict, and the above sampling, detecting and comparing have an important guiding role for the control of impurities in the cleaning and sterilizing step (specifically, the main source of impurities is the degradation of collagen), that is, the quality of the collagen solution, especially the content of impurities, can more easily reach the standard required by the sterile implantable medical material.

In addition, after the steam sterilization operation is completed, the valve at the first end of the first path 2a and the valve at the rear-stage pipeline of the main filtering device 3b are closed, and then the first path 2a, the pre-filtering device 3a, the second path 2b and the main filtering device 3b are placed under the pressure of clean gas to prevent the inside of the equipment after cleaning and sterilization from being polluted due to poor sealing.

The embodiment also provides a cleaning and sterilizing device which is used for implementing the cleaning and sterilizing process.

Note that, in fig. 1, valves on paths other than the first path 2a and the second path 2b (hereinafter, referred to as other paths) are not shown, and the process of transferring substances of other paths may be realized by a transfer pump, which is also not shown. In addition, it should be noted that, in other paths, the paths leading from the same source may be communicated, and the remaining paths are separated from each other, and only the paths communicated with each other are shown in fig. 1 for simplifying the illustration.

That is, in practice, for example, the injection water source 4, the acid liquid source 5a, the alkali liquid source 5b, the vapor source 6, the refrigerant source 7, and the compressed gas source 8 described below may be respectively communicated with the preparation mechanism 1a via different independent paths; the vapor source 6 and the refrigerant source 7 may be respectively communicated with the temperature adjusting mechanism 1b via different independent paths, and the vapor source 6 and the refrigerant source 7 may be respectively communicated with the first path 2a via different independent paths; the compressed gas source 8 may communicate with the first path 2a and the second path 2b via different independent paths, respectively. Hereinafter, the communication manner of the paths will be described in further detail.

Furthermore, in an embodiment, the washing and sterilizing device may comprise a source of compressed gas 8, the source of compressed gas 8 being adapted to provide a compressed gas, which may be, for example, clean air. The source of compressed gas 8 can be in communication with the dosing means 1a via a third path, thus providing a pressure to the pre-filtering device 3a and the main filtering device 3b for the collagen solution to be filtered. The compressed gas source 8 may also communicate with the first path 2a via the fourth path and with the second path 2b via the fifth path, thus facilitating the above-described pressure holding operation. The third path, the fourth path, and the fifth path are each provided with a flow rate control valve for controlling the flow rate of the compressed gas flowing through the corresponding path, and the paths mentioned below are also provided with such a flow rate control valve for controlling the flow rate of the corresponding transported substance flowing through the corresponding path.

In an embodiment, the washing and sterilizing apparatus may further include an injection water source 4, and the injection water source 4 is used to deliver injection water. The source of water for injection 4 may communicate with the preparation mechanism 1a via a sixth path, so that the preparation mechanism 1a, the first path 2a, the pre-filtering device 3a, the second path 2b and the main filtering device 3b may be subjected to a water washing step.

In addition, the washing and sterilizing device can also comprise a pH adjusting mechanism, and the pH adjusting mechanism can comprise an acid liquid source 5a and a lye liquid source 5 b. The acid liquid source 5a communicates with the preparation mechanism 1a via the seventh path, and delivers the acid liquid into the preparation mechanism 1 a. The lye source 5b is communicated with the preparation mechanism 1a through an eighth path and conveys lye into the preparation mechanism 1 a. Thus, the pH adjusting mechanism can adjust the pH of the collagen solution in the process of preparing the collagen solution, and can also complete the alkali liquor or acid liquor cleaning steps of the preparing mechanism 1a, the first path 2a, the pre-filtering device 3a, the second path 2b and the main filtering device 3 b.

In addition, the cleaning and sterilizing equipment can also comprise a steam source 6 and a refrigerant source 7. The vapor source 6 communicates with the temperature adjusting mechanism 1b via a ninth path and communicates with the first path 2a via a tenth path, the vapor source 6 serving to deliver vapor, so that the sterilization step can be completed. The refrigerant source 7 communicates with the temperature adjustment mechanism 1b via an eleventh path, and is used for conveying a refrigerant. Both the steam and the refrigerant can enter the temperature adjustment mechanism 1b in a circulating manner (the steam or the refrigerant circulation outlet of the temperature adjustment mechanism 1b is not shown in the figure), and exchange heat with the collagen solution contained in the preparation mechanism 1a, thereby adjusting the temperature of the collagen solution.

The communication relationship of the paths as described above is merely illustrative, and the communication relationship of other paths is also within the scope of the present application as long as the desired washing sterilization can be achieved.

The above description is only a preferred embodiment of the present application, and not intended to limit the scope of the present application, and all changes that can be made in the details of the present application and the equivalents thereof, or directly or indirectly applied to other related technical fields, without departing from the spirit of the present application are intended to be embraced therein.

Claims

1. A washer-disinfector for use in a sterilizing filtration system, said sterilizing filtration system comprising:

the containing device is used for containing the solution to be filtered;

a filtration system communicating with the housing device via a communication path to filter the solution to be filtered; it is characterized in that the preparation method is characterized in that,

the communication path includes a first path via which the filter system communicates with the dispensing mechanism, and the washing and sterilizing apparatus includes: the injection water source is communicated with the preparation mechanism through a sixth path and is used for conveying injection water;

2. The washing and sterilizing apparatus according to claim 1, wherein the pH adjusting mechanism further comprises:

3. The washing and sterilizing apparatus according to claim 2,

a vapor source in communication with the temperature adjustment mechanism via a ninth path and in communication with the first path via a tenth path, the vapor source for delivering a vapor.

4. The washing and disinfecting apparatus of claim 3, characterized in that the washing and disinfecting apparatus further comprises:

5. The washing and sterilizing apparatus according to any one of claims 1 to 4, wherein the communication path further includes a second path, and the filtering system further includes:

6. The washing and disinfecting apparatus of claim 5, further comprising:

7. The washing and sterilizing apparatus according to claim 5,

the first filter device is formed as a pre-filter device which pre-filters the solution to be filtered.

8. The washing and sterilizing apparatus according to claim 7,

the second filtering device is formed as a main filtering device which further filters the solution filtered by the pre-filtering device to obtain sterile filtrate.