Sterilizing and filtering system for high-viscosity liquid medicine

Abstract

The utility model discloses a high-viscosity liquid medicine sterilizing and filtering system, relates to the technical field of sterilizing and filtering, and solves the problems that the filtering efficiency is low, the filtering time is prolonged, the filtering pressure is increased in a high-resistance filtering process and the filtering effect is poor due to the fact that the viscosity of liquid medicine is higher and a filtering membrane is easy to block in the filtering process in the traditional sterile filtering method. The filter membrane is easy to damage. Comprising a batching tank, a first-stage prefilter, a second-stage prefilter, a sterilization filter and a liquid medicine storage tank which are sequentially connected, a shearing device is arranged in the batching tank, and the pore diameters of filter elements of the first-stage prefilter, the second-stage prefilter and the sterilization filter are gradually reduced; according to the utility model, the viscosity of liquid medicine is greatly reduced under the action of shear dispersion, and the liquid medicine is filtered step by step through the first-stage prefilter, the second-stage prefilter and the sterilization filter of which the pore diameters are gradually reduced, so that the filtering efficiency is effectively improved, the filter element is not easy to block, and the damage to the filter element is reduced.

Description

Technical Field

[0001] The utility model relates to the technical field of sterilization and filtration, in particular to a high-viscosity liquid sterilization and filtration system. Background Art

[0002] In the pharmaceutical field, for heat-unstable and highly viscous drug liquids, existing aseptic processes usually use physical interception methods to remove microorganisms in the liquid. The industry generally uses sterilizing-grade filters with a pore size of 0.22 microns or smaller for filtration to meet the production requirements of sterile drugs.

[0003] The traditional aseptic process method mainly involves direct sterile filtration of high-viscosity liquids. The disadvantages of this method are: 1. Due to the high viscosity of the liquid, direct filtration can easily clog the filter membrane, resulting in low filtration efficiency and prolonged filtration time, thus affecting the filtration effect and production efficiency; 2. During the high-resistance sterile filtration process, the filtration pressure will increase. When the filtration pressure exceeds 0.5MPa, it will damage the filter membrane, thereby increasing the risk of microbial contamination and the cost of equipment replacement.

[0004] Based on this, a high-viscosity liquid sterilization filtration system is now provided to adapt to the filtration of high-viscosity liquids without causing damage to the filter membrane. Utility Model Content

[0005] The utility model is to solve the technical problems in traditional aseptic filtration methods that, due to the high viscosity of the medicinal liquid, the filter membrane is easily blocked during filtration, resulting in low filtration efficiency and prolonged filtration time, and the high resistance filtration process increases the filtration pressure, which is easy to damage the filter membrane. The utility model aims to provide a high-viscosity medicinal liquid sterilization filtration system, which greatly reduces the viscosity of the medicinal liquid by shear dispersion, and filters the medicinal liquid step by step through a first-level pre-filter, a second-level pre-filter and a sterilizing filter with gradually decreasing pore sizes, thereby effectively improving the filtration efficiency, not easily clogging the filter element, and reducing damage to the filter element.

[0006] The utility model is achieved through the following technical solutions:

[0007] The utility model provides a high-viscosity liquid medicine sterilization and filtration system, comprising a batching tank, a primary pre-filter, a secondary pre-filter, a sterilizing filter and a liquid medicine storage tank connected in sequence, wherein a shearing device is arranged in the batching tank, and the filter element pore diameters of the primary pre-filter, the secondary pre-filter and the sterilizing filter are gradually reduced.

[0008] Furthermore, the batching tank, the primary pre-filter, the secondary pre-filter, the sterilizing filter and the liquid medicine storage tank are connected to each other via a delivery pipeline.

[0009] Furthermore, a pressure gauge is provided on the delivery pipeline.

[0010] Furthermore, the sterilizing filter includes a primary sterilizing filter and a secondary sterilizing filter connected in series.

[0011] Furthermore, the first-level pre-filter and the second-level pre-filter both use hydrophilic filter elements.

[0012] Furthermore, the filter element pore size used by the first-stage pre-filter is 1-10 μm, and the filter element pore size used by the second-stage pre-filter is 0.45-1 μm.

[0013] Furthermore, the sterilizing filter adopts a hydrophilic sterilizing grade filter element.

[0014] Furthermore, the filter element pore size of the first-level sterilizing filter and the second-level sterilizing filter is the same.

[0015] Furthermore, the filter element pore size of the primary sterilizing filter and the secondary sterilizing filter is ≤0.22 μm.

[0016] Furthermore, the batching tank and the first-level pre-filter are connected by a first delivery pipeline, the first-level pre-filter and the second-level pre-filter are connected by a second delivery pipeline, the second-level pre-filter and the first-level sterilizing filter are connected by a third delivery pipeline, and the first-level sterilizing filter and the second-level sterilizing filter are connected by a fourth delivery pipeline.

[0017] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0018] 1. The utility model pre-shears and disperses the non-sterile high-viscosity liquid medicine through the shearing device arranged in the batching tank, and reduces the viscosity of the liquid medicine through the shearing and dispersion effect, so as to avoid increasing the filtration resistance in the subsequent filtration process, reduce the damage to the filter element, and help improve the filtration efficiency. Then the liquid medicine enters the first-level pre-filter and the second-level pre-filter. The first-level pre-filter removes exogenous foreign matter introduced in the process or impurities introduced by the raw materials themselves. The second-level pre-filter reduces the microbial load and removes finer particles at the same time. The liquid medicine is initially filtered step by step through two-stage pre-filters with different filter element pore sizes, which can not only ensure the filtration effect of the liquid medicine, but also improve the filtration efficiency. Finally, the sterilizing filter with a smaller pore size is further filtered to obtain a sterile liquid medicine.

[0019] 2. The utility model sets a shearing device and utilizes the shearing dispersion effect to greatly reduce the viscosity of the medicinal liquid, so as to avoid increasing the filtration resistance in the subsequent filtration process and reduce the damage to the filter element. At the same time, by setting a first-level pre-filter, a second-level pre-filter and a sterilizing filter with gradually decreasing pore sizes, the medicinal liquid is filtered step by step, which effectively improves the filtration efficiency, is not easy to clog the filter element, and reduces the damage to the filter element. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The accompanying drawings described herein are used to provide a further understanding of the embodiments of the present invention, constitute a part of this application, and do not constitute a limitation of the embodiments of the present invention. In the accompanying drawings:

[0021] Figure 1 It is a structural diagram of the system of the utility model;

[0022] Markings and corresponding parts names in the accompanying drawings:

[0023] 1-dosing tank, 2-shearing device, 3-first delivery pipeline, 4-pressure gauge, 5-first-stage pre-filter, 6-second delivery pipeline, 7-second-stage pre-filter, 8-third delivery pipeline, 9-first-stage sterilizing filter, 10-fourth delivery pipeline, 11-second-stage sterilizing filter, 12-fifth delivery pipeline, 13-liquid storage tank. DETAILED DESCRIPTION

[0024] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with embodiments and drawings. The schematic implementation methods of the present invention and their descriptions are only used to explain the present invention and are not intended to limit the present invention.

[0025] In the following description, numerous specific details are set forth to provide a thorough understanding of the present invention. However, it will be apparent to one skilled in the art that these specific details are not necessarily required to practice the present invention. In other embodiments, well-known structures, circuits, materials, or methods are not described in detail to avoid obscuring the present invention.

[0026] Throughout this specification, references to "one embodiment," "an embodiment," "an example," or "an example" mean that a particular feature, structure, or characteristic described in conjunction with the embodiment or example is included in at least one embodiment of the present invention. Therefore, the phrases "one embodiment," "an embodiment," "an example," or "an example" appearing in various places throughout this specification do not necessarily refer to the same embodiment or example. In addition, the particular features, structures, or characteristics may be combined in one or more embodiments or examples in any suitable combination and / or subcombination. Furthermore, it will be understood by those of ordinary skill in the art that the figures provided herein are for illustrative purposes only and are not necessarily drawn to scale. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0027] In the description of the present invention, the indicated orientation or position relationship is based on the orientation or position relationship shown in the accompanying drawings, or is the orientation or position relationship in which the product of the application is usually placed when in use, or is the orientation or position relationship commonly understood by those skilled in the art. It is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0028] At the same time, the terms "dispose," "assemble," "connect," and "connect" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to direct connections, indirect connections through an intermediary, or internal connections between two components. Those skilled in the art will understand the specific meanings of these terms in this utility model based on specific circumstances.

[0029] Example

[0030] This embodiment provides a high viscosity liquid sterilization filtration system, such as Figure 1 As shown, it includes a batching tank 1, a primary pre-filter 5, a secondary pre-filter 7, a sterilizing filter and a liquid medicine storage tank 13 connected in sequence. A shearing device 2 is provided in the batching tank 1, and the filter element pore size of the primary pre-filter 5, the secondary pre-filter 7 and the sterilizing filter gradually decreases.

[0031] When the system of the present invention is in use, the raw materials are first put into the batching tank 1, and the non-sterile high-viscosity medicinal liquid is pre-sheared and dispersed by the shearing device 2 arranged in the batching tank 1. The viscosity of the medicinal liquid is reduced by the shearing and dispersion effect to avoid increasing the filtration resistance in the subsequent filtration process, reducing the damage to the filter element, and helping to improve the filtration efficiency. Then the medicinal liquid enters the first-level pre-filter 5 and the second-level pre-filter 7. The first-level pre-filter 5 removes exogenous foreign matter introduced in the process or impurities introduced by the raw materials themselves. The second-level pre-filter 7 reduces the microbial load and removes finer particles at the same time. The medicinal liquid is preliminarily filtered step by step by two-stage pre-filters with different filter element pore sizes, which can not only ensure the filtration effect of the medicinal liquid, but also improve the filtration efficiency. Finally, the sterilizing filter with a smaller pore size is further filtered to obtain a sterile medicinal liquid.

[0032] The batching tank 1, the primary pre-filter 5, the secondary pre-filter 7, the sterilizing filter and the liquid medicine storage tank 13 are connected to each other via a delivery pipeline; the sterilizing filter includes a primary sterilizing filter 9 and a secondary sterilizing filter 11 connected in series.

[0033] Specifically, the batching tank 1 and the first-level pre-filter 5 are connected via a first delivery pipeline 3, the first-level pre-filter 5 and the second-level pre-filter 7 are connected via a second delivery pipeline 6, the second-level pre-filter 7 and the first-level sterilizing filter 9 are connected via a third delivery pipeline 8, and the first-level sterilizing filter 9 and the second-level sterilizing filter 11 are connected via a fourth delivery pipeline 10. The flow of the liquid medicine in the system is achieved through the various delivery pipelines.

[0034] The delivery pipeline is provided with a pressure gauge 4, through which the system pressure can be monitored in real time.

[0035] Both the primary pre-filter 5 and the secondary pre-filter 7 utilize hydrophilic filter elements. Specifically, the primary pre-filter 5 uses a filter element with a pore size of 1-10 μm, while the secondary pre-filter 7 uses a filter element with a pore size of 0.45-1 μm. The primary pre-filter 5 is designed to remove foreign matter introduced during the process or impurities introduced by the raw materials themselves, while the secondary pre-filter 7 is designed to reduce the microbial load and remove finer particles.

[0036] The sterilizing filter uses a hydrophilic sterilizing grade filter element. The filter element pore size of the first-stage sterilizing filter 9 and the second-stage sterilizing filter 11 is the same. Specifically, the filter element pore size of the first-stage sterilizing filter 9 and the second-stage sterilizing filter 11 is ≤0.22μm. In this embodiment, the first-stage sterilizing filter 9 and the second-stage sterilizing filter 11 use a filter element with a pore size of 0.22μm. Filtering through two stages of sterilizing filters can obtain a sterile liquid.

[0037] Finally, it should be noted that the above specific embodiments are only used to explain in detail the purpose, technical solutions and beneficial effects of the present invention. It should be understood that the above is only a specific implementation method of the present invention and is not used to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to the above specific embodiments, ordinary technicians in this field should understand that it is still possible to modify the technical solutions recorded in the above embodiments, or to replace or improve some or all of the technical features therein. These modifications, equivalent replacements, and improvements do not deviate the essence of the corresponding technical solutions from the scope of the technical solutions of the embodiments of the present invention, and they should all be included in the scope of the claims and description of the present invention.

Claims

1. A high viscosity liquid sterilization filtration system, characterized in that: The invention comprises a batching tank (1), a primary pre-filter (5), a secondary pre-filter (7), a sterilizing filter and a liquid medicine storage tank (13) which are connected in sequence. A shearing device (2) is provided in the batching tank (1). The pore sizes of the filter elements of the primary pre-filter (5), the secondary pre-filter (7) and the sterilizing filter gradually decrease.

2. A high viscosity liquid sterilization filtration system according to claim 1, characterized in that: The batching tank (1), the primary pre-filter (5), the secondary pre-filter (7), the sterilizing filter and the liquid medicine storage tank (13) are connected to each other via a delivery pipeline.

3. A high viscosity liquid sterilization filtration system according to claim 2, characterized in that: A pressure gauge (4) is provided on the delivery pipeline.

4. A high viscosity liquid sterilization filtration system according to claim 1, characterized in that: The sterilizing filter comprises a primary sterilizing filter (9) and a secondary sterilizing filter (11) connected in series.

5. The high viscosity liquid sterilization filtration system according to claim 1, characterized in that: The first-level pre-filter (5) and the second-level pre-filter (7) both use hydrophilic filter elements.

6. A high viscosity liquid sterilization filtration system according to claim 5, characterized in that: The filter element pore size used in the first-stage pre-filter (5) is 1-10 μm, and the filter element pore size used in the second-stage pre-filter (7) is 0.45-1 μm.

7. A high viscosity liquid sterilization and filtration system according to claim 4, characterized in that: The sterilizing filter adopts a hydrophilic sterilizing grade filter element.

8. A high viscosity liquid sterilization and filtration system according to claim 7, characterized in that: The filter core pore diameters of the primary sterilizing filter (9) and the secondary sterilizing filter (11) are the same.

9. A high viscosity liquid sterilization filtration system according to claim 8, characterized in that: The filter element pore diameters of the primary sterilizing filter (9) and the secondary sterilizing filter (11) are ≤0.22 μm.

10. A high viscosity liquid sterilization and filtration system according to claim 4, characterized in that: The batching tank (1) and the first-level pre-filter (5) are connected via a first delivery pipeline (3), the first-level pre-filter (5) and the second-level pre-filter (7) are connected via a second delivery pipeline (6), the second-level pre-filter (7) and the first-level sterilizing filter (9) are connected via a third delivery pipeline (8), and the first-level sterilizing filter (9) and the second-level sterilizing filter (11) are connected via a fourth delivery pipeline (10).

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