Testing device for filtration and adsorption of liquid preparation

Abstract

The utility model relates to a filtration and adsorption test device for a liquid preparation, which comprises a preparation tank for storing the liquid preparation; one or more groups of filters, wherein filter elements are arranged in the filters; the circulating pipeline is respectively connected with the filter and the preparation tank to form a closed loop; the circulating pump is arranged on the circulating pipeline, is positioned on the rear side of the filter and is used for realizing circulating flow of the liquid preparation; and the pressure device is arranged on the circulating pipeline, is positioned on the front side of the filter and is used for displaying the pressure of the circulating pipeline. The device has the beneficial effects that the production environment is simulated through a miniaturized circulating filtration state, so that the adsorbability test on the filter element is realized, and the filter element is ensured to meet the productive requirement; a parallel combined structure is adopted by multiple groups of filters, so that adsorbability tests can be simultaneously carried out on filter elements of various models; and through the application of the moving device, moving is facilitated, and conveying to a workshop is facilitated.

Description

TECHNICAL FIELD

[0001] The utility model relates to the technical field of degerming filtration, especially to a filter adsorption test device for liquid preparation. BACKGROUND

[0002] In the production process of pharmaceutical preparation, the raw material liquid needs to be degermed and filtered. Degerming and filtering is a process of removing microorganisms in liquid or gas by physical interception to meet the quality requirements of sterile drugs.

[0003] When designing the filtering process, the appropriate filter should be selected and the process parameters should be determined according to the properties of the medium to be filtered and the process purpose. The degerming filter with a pore size of 0.22 microns (or smaller or the same filtering efficiency) should be selected according to the process purpose. The whole process of sterile drug production should be controlled to avoid microbial contamination. The microbial contamination level of the medium to be filtered before the final degerming and filtering is generally less than or equal to 10 cfu / 100 ml. When selecting the filter material, the compatibility of the filter material with the medium to be filtered should be fully considered. The filter should not adversely affect the quality of the product due to reaction, release of substances or adsorption. The degerming filter should not shed fibers, and the filter containing asbestos should be strictly prohibited. The filter should not adversely affect the quality of the product due to reaction, release of substances or adsorption.

[0004] In actual production process, although the filter core manufacturer is entrusted to carry out adsorption test, the manufacturer cannot provide the adsorption test results of the filter core for each raw material product. Therefore, the relevant adsorption test should be completed by the company according to the actual needs. Therefore, the utility model provides a small filter adsorption test device for liquid preparation. UTILITY MODEL CONTENT

[0005] The utility model provides a filter adsorption test device for liquid preparation, which simulates the production environment by miniaturized circulating filtration, and realizes the adsorption test of the filter core to ensure that the filter core meets the production requirements.

[0006] The technical problem solved by the utility model is solved by the following technical scheme:

[0007] A filter adsorption test device for liquid preparation comprises:

[0008] A preparation tank is used to store liquid preparation.

[0009] One or more groups of filters are provided with filter cores.

[0010] A circulating pipeline is connected with the filters and the preparation tank and forms a closed loop.

[0011] A circulating pump is arranged on the circulating pipeline and located at the rear side of the filter, and is used to realize the circulating flow of the liquid preparation.

[0012] A pressure device is arranged on the circulating pipeline and located at the front side of the filter, and is used to display the pressure of the circulating pipeline.

[0013] As a preferred technical solution, the preparation tank is provided with a heat preservation layer outside, which is used to maintain the temperature of the liquid preparation in the preparation tank.

[0014] As a preferred technical solution, the circulating pump is a diaphragm pump. Further, the circulating pump 3 is a diaphragm pump, and the diaphragm pump is a pneumatic diaphragm pump connected with an air compressor, which can provide the pneumatic diaphragm pump with an air source.

[0015] As a preferred technical solution, when the filter is multiple groups, the filters are arranged in parallel.

[0016] As a preferred technical solution, a control valve is arranged in front of each filter, so as to control whether to enable the filter.

[0017] As a preferred technical solution, the control valve is an electromagnetic valve or a mechanical valve.

[0018] As a preferred technical solution, the filter elements in different filters are made of the same material but different models.

[0019] As a preferred technical solution, the filter elements in different filters are made of different materials.

[0020] As a preferred technical solution, the mobile device includes a chassis and a support for fixing the preparation tank, the circulating pump and the filter, and universal wheels arranged below the chassis, so as to move.

[0021] As a preferred technical solution, the mobile device further includes a push handle, so as to move.

[0022] The present application has the following beneficial effects:

[0023] (1) The small-sized circulating filter state simulation production environment is used to realize the adsorption test of the filter element, so as to ensure that the filter element meets the production requirements;

[0024] (2) The parallel combination structure of multiple filters can simultaneously perform the adsorption test on multiple models of filter elements;

[0025] (3) The mobile device is used to move and facilitate transportation to the workshop. BRIEF DESCRIPTION OF DRAWINGS

[0026] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0027] Figure 1 This is a side view schematic diagram of the first experimental device for filtering and adsorption of liquid formulations.

[0028] Figure 2 This is a schematic diagram of the first experimental device for filtering and adsorption of liquid formulations.

[0029] Figure 3 This is a schematic diagram of the second type of device for filtration and adsorption testing of liquid formulations.

[0030] in:

[0031] 1-Preparation tank

[0032] 2-Circulation Pipeline

[0033] 3-Circulation Pump

[0034] 4-Filter

[0035] 5-Pressure device

[0036] 6-Mobile devices

[0037] 7-Control Valve

[0038] 61-Chassis

[0039] 62-Universal Wheel

[0040] 63-Pushing hands. Detailed Implementation

[0041] To make the technical means, creative features, objectives and effects of this utility model easier to understand, the following description, in conjunction with specific illustrations, further elaborates on this utility model.

[0042] Example 1

[0043] Reference Figures 1-2 As shown, a liquid preparation filtration and adsorption test device includes: a preparation tank 1, a circulation pipeline 2, a circulation pump 3, a filter 4, a pressure device 5, and a moving device 6.

[0044] The preparation tank 1 is used to store liquid preparations. In this embodiment, a set of filters 4 is provided, and a filter element is provided in the filters 4. The circulation pipeline 2 is connected to the filters 4 and the preparation tank 1 respectively, forming a closed loop. The circulation pump 3 is placed on the circulation pipeline 2 and is located behind the filters 4 to realize the circulation flow of the liquid preparations. The pressure device 5 is placed on the circulation pipeline 2 and is located in front of the filters 4 to display the pressure of the circulation pipeline 2.

[0045] The preparation tank 1 of this invention is provided with an insulation layer on the outside to maintain the temperature of the liquid preparation inside the preparation tank 1. The design of the insulation layer ensures the temperature stability of the liquid preparation during the preparation process, which is especially important for some temperature-sensitive liquid preparations and can effectively avoid the impact of temperature fluctuations on the quality of the preparation.

[0046] The circulating pump 3 of this invention is a diaphragm pump. The diaphragm pump is a pneumatic diaphragm pump, which is connected to an air compressor to provide an air source for the pneumatic diaphragm pump.

[0047] The mobile device 6 of this invention includes a chassis 61 and a support for fixing the preparation tank 1, the circulating pump 3, and the filter 4, as well as casters 62 placed under the chassis 61 for easy movement. The mobile device 6 also includes a push handle 63 for further movement; the push handle 63 is ergonomically designed, making it easier and more comfortable for operators to push the entire device. The casters 62 are made of high-quality wear-resistant material, ensuring the stability and durability of the device during movement. Additionally, the casters 62 have a braking function, ensuring that the device will not slide when it needs to be fixed in a fixed position, increasing safety. Through this design of the mobile device 6, the entire liquid preparation filtration and adsorption experimental device can not only be moved flexibly within the laboratory but also easily transported to the workshop for field operation, greatly improving work efficiency and convenience.

[0048] The specific experimental procedure is as follows:

[0049] 1. Prepare 20L of the pharmaceutical solution according to the production prescription and place it in preparation tank 1. Keep preparation tank 1 warm and maintain it within the standard production environment temperature.

[0050] 2. Place the filter element and turn on the circulation pump 3 to perform circulation filtration.

[0051] 3. Take multiple samples at the beginning and during the filtration process to determine the adsorption saturation endpoint.

[0052] 4. After filtration, the integrity of the filter element is confirmed by the bubble point method and microscopic examination.

[0053] The performance test of the filter element can be completed through the above test process, and the test results can be used to determine whether it meets the production requirements.

[0054] Example 2

[0055] Reference Figure 3 As shown, this embodiment 2 proposes another device for liquid formulation filtration and adsorption testing, which differs from embodiment 1 in that it includes multiple sets of filters 4. When there are multiple sets of filters 4, the filters 4 are arranged in parallel, and each filter 4 is provided with a control valve 7 in front of it to control whether the filter 4 is activated. The control valve 7 is a solenoid valve or a mechanical valve.

[0056] Among them, the filter elements in different filters 4 are made of the same material but different models; or, the filter elements in different filters 4 are made of different materials.

[0057] The specific experimental procedure is as follows:

[0058] 1. Prepare 20L of the pharmaceutical solution according to the production prescription and place it in the preparation tank. Keep the preparation tank warm and maintain it within the standard production environment temperature.

[0059] 2. Place the filter element according to actual needs and turn on the circulation pump to perform circulation filtration.

[0060] 3. Take multiple samples at the beginning and during the filtration process to determine the adsorption saturation endpoint.

[0061] 4. After filtration, the integrity of the filter element is confirmed by the bubble point method and microscopic examination.

[0062] The above testing process can be used to test the performance of multiple filter elements, and the test results can be used to determine whether they meet production requirements.

[0063] The beneficial effects of this utility model are:

[0064] (1) The production environment is simulated by miniaturized circulating filtration state, so as to realize the adsorption test of the filter element to ensure that the filter element meets the production requirements;

[0065] (2) By using a parallel combination structure of multiple filters, adsorption tests can be conducted simultaneously on various types of filter elements;

[0066] (3) The use of mobile devices facilitates movement and transport to the workshop.

[0067] The foregoing has shown and described the basic principles, main features, and advantages of this utility model. Those skilled in the art should understand that this utility model is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of this utility model. Various changes and modifications can be made to this utility model without departing from its spirit and scope, and all such changes and modifications fall within the scope of the claims. The scope of protection of this utility model is defined by the appended claims and their equivalents.

Claims

1. A device for filtration and adsorption testing of liquid formulations, characterized in that, include: Preparation tanks are used to store liquid preparations; One or more sets of filters, wherein filter elements are provided within the filters; The circulation pipeline is connected to the filter and the preparation tank respectively, forming a closed loop; A circulation pump, placed on the circulation pipeline and located behind the filter, is used to realize the circulation flow of the liquid preparation; A pressure device, placed on the circulation line and located in front of the filter, is used to display the pressure of the circulation line.

2. The apparatus for filtration and adsorption testing of liquid formulations according to claim 1, characterized in that, The preparation tank is equipped with an insulation layer on the outside to maintain the temperature of the liquid preparation inside the tank.

3. The apparatus for filtration and adsorption testing of liquid formulations according to claim 1, characterized in that, The circulating pump is a diaphragm pump.

4. The apparatus for filtration and adsorption testing of liquid formulations according to claim 1, characterized in that, When there are multiple sets of filters, the filters are arranged in parallel.

5. The apparatus for filtration and adsorption testing of liquid formulations according to claim 4, characterized in that, Each of the filters is equipped with a control valve at the front to control whether the filter is activated.

6. The apparatus for filtration and adsorption testing of liquid formulations according to claim 5, characterized in that, The control valve is either a solenoid valve or a mechanical valve.

7. The apparatus for filtration and adsorption testing of liquid formulations according to claim 1, characterized in that, It also includes a moving device, which includes a chassis and bracket for fixing the preparation tank, circulation pump, and filter, as well as casters placed under the chassis.

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