System capable of being used for producing multiple preparations
By designing a system that can be used to produce multiple formulations, sharing tanks and pipelines, the high cost and high energy consumption problems caused by multiple independent production systems in the prior art are solved, and more efficient production and maintenance are achieved.
Patent Information
- Application Number
- CN202421028991.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-05-13
- Publication Date
- 2025-03-07
- Estimated Expiration
- 2034-05-13
AI Technical Summary
When producing a variety of liquid pharmaceutical preparations, the prior art needs to be equipped with multiple independent production systems, resulting in high production costs, large space, low maintenance efficiency and high energy consumption.
Design a system that can be used to produce a variety of formulations, and switch the fluid flow path through a shared tank and pipeline, combining the start and stop of valves and pumps to reduce equipment and land occupation needs.
The production and sharing of multiple formulations has been achieved, which reduces equipment costs and floor space, improves maintenance efficiency and energy consumption management, and significantly reduces production costs.
Smart Images
Figure CN222567748U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the field of online liquid preparation systems, and in particular to a system that can be used to produce a variety of preparations, including aqueous solutions, emulsions, suspensions, and the like. Background Art
[0002] Pharmaceutical preparations refer to drugs processed through specific processes and formulas into a form suitable for clinical application to meet the needs of treating or preventing diseases. Pharmaceutical preparations not only involve the chemical properties of the drug itself, but also include the release, absorption, distribution, metabolism and excretion of the drug.
[0003] Pharmaceutical preparations can be classified according to their form, route of administration, duration of action and other characteristics. Common dosage forms include solid preparations (such as tablets, capsules, granules), liquid preparations (such as solutions, emulsions, suspensions), semi-solid preparations (such as ointments, gels), gas preparations (such as aerosols, inhalants), etc.
[0004] Among them, the process steps required to prepare different types of liquid drug preparations are not the same. For example, the preparation of suspension preparations usually requires homogenization and self-circulation during the process to avoid sedimentation of active ingredients; the preparation of emulsions involves the mixing of water phase and oil tank in proportion. Usually, the preparation of various types of liquid drug preparations is basically completed in a single preparation system, that is, each is prepared by a relatively independent preparation system.
[0005] Therefore, if the production process of various liquid pharmaceutical preparations including aqueous solutions, suspensions, and emulsions is to be completed, multiple independent production systems are often required from a hardware perspective, which brings a large production cost investment to the enterprise, such as plant investment, equipment investment, manpower investment, etc. Therefore, how to solve the deficiencies of the above-mentioned prior art has become the subject to be studied and solved by the present utility model. Utility Model Content
[0006] The utility model aims to provide a system which can be used for producing at least two different types of liquid drug preparations.
[0007] In order to achieve the above purpose, the technical solution adopted by the utility model is:
[0008] A system that can be used to produce a variety of formulations includes two tanks;
[0009] The first tank body includes a top stirring device and at least two output pipelines; wherein at least one of the first output pipelines is provided with a filtering device, the output end of which is connected to the input end of the second tank body; at least one of the second output pipelines is provided with a homogenizing device, the output end of which is respectively connected to the input ends of the two tank bodies;
[0010] A circulation pump is provided on the output pipeline of the second tank body, which is used for self-circulation of the second tank body, or for pumping the output of the second tank body into a filling device;
[0011] The system also includes valves and pumps for adjusting the flow path of the fluid in the pipeline.
[0012] In a further technical solution, the homogenizing device is a homogenizing pump or a high-pressure homogenizer. The high-pressure homogenizer can be selected from commercially available products according to the production requirements of the target liquid preparation, for example, a high-pressure homogenizer sold by GEA, a Dyhydromatics HL60 high-pressure homogenizer, etc., or a customized product. The working pressure is preferably 300-2500 bar.
[0013] According to a further technical solution, the filtering device is preferably a double-stage filter.
[0014] In a further technical solution, the first tank body 1 is also equipped with a shearing and dispersing device. The shearing and dispersing device can be selected from commercially available products according to the production requirements of the target liquid preparation, such as a high shear homogenizer sold by IKN, a ROTFLOW series shearing and dispersing machine sold by METVOX, a MY series high shearing and dispersing machine, etc., or a customized product. The rotation speed is preferably 1000-4000RPM.
[0015] The terms used herein are only for describing specific embodiments and are not intended to be limiting of the present invention. Singular forms such as "a", "this", "here", "this" and "the" as used herein also include plural forms.
[0016] The terms “first”, “second”, etc. used in this document do not specifically refer to an order or sequence, nor are they used to limit the present case. They are only used to distinguish components or operations described with the same technical terms.
[0017] As used herein, “connected” or “positioned” may refer to two or more components or devices being in direct physical contact with each other, or being in indirect physical contact with each other, or may refer to two or more components or devices operating or moving with each other.
[0018] The terms “include,” “including,” “have,” etc. used in this document are open-ended terms, meaning including but not limited to.
[0019] The terms used in this document generally have the ordinary meaning of each term used in this field, in the context of the case and in the specific context, unless otherwise noted. Certain terms used to describe the present invention will be discussed below or elsewhere in this specification to provide additional guidance to those skilled in the art in describing the present invention.
[0020] The working principle and advantages of this utility model are as follows:
[0021] 1. Reduce system costs
[0022] The utility model innovatively extracts the equipment (such as tanks) that may or can be shared during the production of different preparations, and connects valves and pumps in series on the corresponding pipelines, and switches the fluid flow lines by starting and stopping the corresponding valves and / or pumps, and puts the required tanks into production at the same time. With this design, the number of tanks and pipelines can be greatly reduced, achieving the purpose of reducing costs;
[0023] 2. Reduce floor space
[0024] In order to ensure the quality and safety of pharmaceutical preparations, in addition to the equipment itself, the pharmaceutical production environment also has clear regulations. Multiple sets of independent production equipment not only increase the floor space, but also further increase the requirements for the construction of clean areas in the factory. The utility model avoids the problem that the production process of one preparation must correspond to an independent production system under traditional processes by sharing the same equipment involved in the production of different preparations, thereby achieving the purpose of reducing the space requirements of the factory, especially the clean area;
[0025] 3. Improve the overall maintenance efficiency of various preparations
[0026] The utility model reduces the number of tanks required and simplifies the pipeline design by sharing the same equipment involved in the production of different preparations, making it more time-saving and labor-saving than traditional solutions in terms of system maintenance and cleaning;
[0027] 4. Reduced energy consumption
[0028] The utility model reduces the number of tank bodies required by the shared tank body, reduces the total amount of water and electricity consumption, is more energy-saving and environmentally friendly, and reduces enterprise costs.
[0029] In summary, the utility model can realize the processing of multiple preparations with one system through an innovative system design. Specifically, the switching of different production preparations can be achieved by starting and stopping the corresponding valves and pumps, and when producing any preparation, common tanks, pipelines and other components will be used.
[0030] Compared with the prior art, the utility model can greatly simplify the system structure under various preparation processing requirements, thereby achieving the goals of reducing equipment costs, improving processing efficiency, and reducing space requirements. BRIEF DESCRIPTION OF THE DRAWINGS
[0031] Attached Figure 1 This is a system schematic diagram of Embodiment 1 of the present utility model;
[0032] Attached Figure 2 This is a schematic diagram of the fluid flow direction when producing an aqueous solution in Example 2 of the utility model;
[0033] Attached Figure 3 This is a schematic diagram of the fluid flow direction when producing a suspension in Example 3 of the utility model;
[0034] Attached Figure 4A Schematic diagram of the fluid flow direction when producing emulsion in Example 4 of the utility model Figure 1 ;
[0035] Attached Figure 4B Schematic diagram of the fluid flow direction when producing emulsion in Example 4 of the utility model Figure 2 .
[0036] In the above drawings: 1. First tank; 2. Filter; 3. Second tank; 4. Homogenizing pump; 5. Circulating pump; 6. Fourth tank; 7. Third tank; 8. High-pressure homogenizer; 9. Fifth tank. DETAILED DESCRIPTION
[0037] The utility model is further described below in conjunction with the accompanying drawings and embodiments:
[0038] Embodiment: The present invention will be clearly described below with diagrams and detailed descriptions. After understanding the embodiments of the present invention, any person skilled in the art can make changes and modifications based on the techniques taught by the present invention without departing from the spirit and scope of the present invention.
[0039] Example 1: A system for producing at least two formulations
[0040] See attached Figure 1 As shown, it includes two tanks. The first tank 1 includes a top stirring device and at least two output pipelines; wherein at least one of the first output pipelines is provided with a filtering device, the output end of which is connected to the input end of the second tank 3; at least one of the second output pipelines is provided with a homogenizing device, the output end of which is respectively connected to the input ends of the two tanks.
[0041] A circulation pump 5 is provided on the output pipeline of the second tank body 3 , and the output end of the circulation pump is respectively connected to the input end of the second tank body 3 and the input end of a filling device.
[0042] The system also includes valves and pumps for adjusting the flow path of the fluid in the pipeline.
[0043] Preferably, the first tank body 1 is also equipped with a shearing and dispersing device, such as a high shear homogenizer from IKN.
[0044] Preferably, the input end of the homogenizing device is also connected to the output ends of the third tank 7, the fourth tank 6, and the fifth tank 9 respectively; the output end of the homogenizing device is also connected to the input ends of the third tank 7 and the fifth tank 9 respectively. Preferably, the homogenizing device is a homogenizing pump 4 or a high-pressure homogenizer 8.
[0045] Specifically, by selectively opening corresponding valves and pumps, the system can realize the preparation of aqueous solutions, suspensions and emulsions respectively, each preparation sharing the first tank body 1 and the second tank body 3, and realizing the sharing of some pipelines, valves and pumps.
[0046] When used as an aqueous solution preparation module, it comprises a first tank body 1, a homogenizing pump 4 and a second tank body 3 which are connected in series in sequence.
[0047] When used as a suspension preparation module, it includes the first tank body 1, the second tank body 3 and a circulation pump 5; wherein the homogenizing pump 4 is connected in series between the liquid inlet and the liquid outlet of the first tank body 1 to form a first circulation channel; the circulation pump 5 is connected in series between the liquid inlet and the liquid outlet of the second tank body 3 to form a second circulation channel.
[0048] When used as an emulsion preparation module, it includes a third tank body 7 , a fourth tank body 6 , a homogenizing device, the first tank body 1 , a fifth tank body 9 and the second tank body 3 .
[0049] The liquid outflow pipelines of the third tank body 7 and the fourth tank body 6 are both connected to the liquid inlet of the first tank body 1 through a homogenizing device.
[0050] The liquid outflow pipeline of the first tank body 1 is connected to the liquid inlet of the fifth tank body 9 through the homogenizing device in sequence.
[0051] The liquid outflow pipeline of the fifth tank body 9 is connected to the liquid inlet of the third tank body 7 through the homogenizing device in turn.
[0052] The liquid outflow pipeline of the homogenizing device is connected to the liquid inlet of the second tank body 3 .
[0053] Preferably, the third tank body 7 is an oil phase storage tank, the fourth tank body 6 is a water phase storage tank, and the volume of the fourth tank body 6 is at least twice that of the third tank body 7. By increasing the volume of the fourth tank body 6, the large-volume water phase tank (1000L) in the conventional process can be omitted, so that the fourth tank body 6 also has the function of water phase storage, although it will cause a certain degree of cost increase of the tank body itself.
[0054] Preferably, the volume of the fourth tank body 6 is at least five times that of the third tank body 7 .
[0055] Preferably, the filtering device is a filter 2, preferably a double-stage filter.
[0056] Example 2: Process for producing aqueous solution based on the system of Example 1
[0057] like Figure 2As shown, by adjusting the corresponding valve Figure 2 The dotted line in the above embodiment is below the line, and the aqueous solution product preparation process includes:
[0058] S1, completing the preparation of the aqueous solution product through a common first tank body 1;
[0059] S2, transporting the prepared aqueous solution product to a shared second tank 3;
[0060] S3, conveying the aqueous solution product to a common filling machine for filling through the second tank body 3;
[0061] The flow direction of aqueous solution products is shown in Figure 2 As shown by arrow A in FIG.
[0062] Example 3: Process for producing suspension based on the system of Example 1
[0063] like Figure 3 As shown, by adjusting the corresponding valve Figure 3 The dotted line in the figure is below the line, and the suspension product preparation process includes:
[0064] S1, putting the material into the first tank 1 and starting stirring for pre-dispersion;
[0065] S2. After the dispersion is completed, self-circulation homogenization is carried out, and the flow direction is shown in Figure 3 As shown by arrow B;
[0066] S3, after the cycle homogenization is completed, the liquid medicine is transferred to the second tank 3;
[0067] S4, then the suspension product in the second tank 3 is cyclically filled, and the flow direction is shown in Figure 3 As shown by arrow A.
[0068] Example 4: Process for producing emulsion based on the system of Example 1
[0069] like Figure 4A , Figure 4B As shown, by adjusting the corresponding valves, the dotted line portion in the figure is removed from the line. At this time, the emulsion product preparation process includes:
[0070] S1, the water phase material and the oil phase material are homogenized according to the set ratio and then transported to the first tank 1, the flow direction is shown in FIG. Figure 4A As shown by the arrow A in the middle; the water phase material comes from the fourth tank body 6. At this time, the fourth tank body 6 is used as a water phase tank;
[0071] S2, the first tank body 1 receives the liquid medicine and starts stirring to obtain a preliminary emulsified liquid medicine;
[0072] S3. After the stirring is completed, the liquid medicine sent out from the first tank 1 is homogenized and then transported to the fifth tank 9. The flow direction is shown in FIG. Figure 4B As shown by arrow B;
[0073] S4, when the liquid medicine is homogenized to the fifth tank 9, the liquid medicine is homogenized to the fourth tank 6, and the flow direction is shown in FIG. Figure 4B As shown by the arrow C, the fifth tank body 9 and the fourth tank body 6 are circulated and homogenized; at this time, the fourth tank body 6 is used as a homogenizing tank;
[0074] S5, after circulating the average value until the particle size meets the set requirements, the homogenized qualified liquid medicine is transferred to the second tank 3, and the flow direction is shown in FIG. Figure 4B As shown by arrow B;
[0075] S6. After the liquid medicine is transferred to the second tank body 3, the emulsion product in the second tank body 3 is cyclically filled. The flow direction is shown in FIG. Figure 4A As shown by the arrow D.
[0076] The process of this embodiment 4 requires Figure 4A and Figure 4B After combining, observe the whole. And, Figure 4B This is just a demonstration. Based on the spirit of this application, as long as the product meets the filling requirements, the fourth tank body 6 and the fifth tank body 9 can be used as outlets to connect to the second tank body 3 and perform cyclic filling.
[0077] Preferably, the first tank body 1, the second tank body 3, the filling machine, and the inlet and outlet pipelines corresponding to the three are all the common devices.
[0078] Preferably, in S2 of the aqueous solution product preparation process, the prepared aqueous solution product is filtered through a double-stage filter 2 and then transferred to the second tank 3 .
[0079] Preferably, in S2 of the suspension product preparation process, after dispersion is completed, a common homogenizing device is turned on to perform self-circulating homogenization.
[0080] In S3, the drug liquid is transferred to the second tank 3 through the homogenizing device.
[0081] Preferably, the homogenizing device is a homogenizing pump 4.
[0082] Preferably, in S4 of the suspension product preparation process, the circulation filling of the suspension product in the second tank body 3 is achieved by a shared circulation pump 5 .
[0083] Preferably, in S1 of the emulsion product preparation process, the water phase material and the oil phase material are homogenized by a homogenizing device according to a set ratio and then transported to the first tank 1;
[0084] In S3, the liquid medicine sent out from the first tank 1 is homogenized by the homogenizing device and then transferred to the fifth tank 9;
[0085] In S4 , after the liquid medicine is completely homogenized in the fifth tank 9 , the liquid medicine is homogenized in the third tank 7 through a homogenizing device.
[0086] Preferably, the homogenizing device includes a homogenizing pump 4 and a homogenizer 8.
[0087] Preferably, in S6 of the emulsion product preparation process, the circulating filling of the emulsion product in the second tank 3 is achieved by a shared circulating pump 5 .
[0088] Example 5: Cleaning and Sterilization
[0089]
[0090] Taking a specific implementation method shown in Example 1 as an example, the average cleaning and sterilization time and average energy consumption of a single tank of each capacity and the pipelines required to be equipped with the tank of each capacity are shown in the above table.
[0091] Sometimes, in order to meet process requirements, it is necessary to clean and sterilize each tank one by one during the CIP and SIP processes. Therefore, reducing one tank and the corresponding pipeline can save about 85 minutes of CIP time and about 150 minutes of SIP time.
[0092] In terms of energy consumption, in a specific implementation, the CIP online cleaning of a 1000L tank usually requires 3 purified water washes and 1 injection water wash, with a single wash water consumption of 890L. Theoretically, 3560L of water is consumed in 4 washes, and the actual water consumption in operation will reach 3738L. However, the average water consumption saved will decrease with each additional tank reduction, that is, the reduction in water consumption is not absolutely proportional to the reduction in the number of tanks. For example, reducing two tanks can save a total energy consumption of about 5600L of water per batch, 100 minutes of pure steam.
[0093] In the scheme of Example 4, the fourth tank body 6, which originally played the role of the water phase tank, also played the role of the homogenization tank in the subsequent process steps. Therefore, the volume of the tank body needs to be enlarged to a certain extent, resulting in a slight increase in the cost of cleaning and sterilizing a single tank. However, the overall system level greatly saves the cleaning and sterilization time and energy consumption of a tank body and the corresponding pipeline. In the spirit of the present utility model, according to the specific requirements of the target preparation product, the tank body and pipeline can be further reduced by, for example, single tank circulation, changing the pipeline layout, etc., thereby saving time and energy consumption to a greater extent.
[0094] The above embodiments are only for illustrating the technical concept and features of the utility model, and their purpose is to enable people familiar with the technology to understand the content of the utility model and implement it accordingly, and they cannot be used to limit the protection scope of the utility model. Any equivalent changes or modifications made according to the spirit of the utility model should be included in the protection scope of the utility model.
Claims
1. A system for producing a variety of preparations, characterized in that: Including two tanks; The first tank body (1) comprises a top stirring device and at least two output pipelines; wherein at least one of the first output pipelines is provided with a filtering device (2), the output end of the filtering device (2) being connected to the input end of the second tank body (3); and at least one of the second output pipelines is provided with a homogenizing device, the output end of the homogenizing device being connected to the input ends of the two tank bodies respectively; A circulation pump (5) is provided on the output pipeline of the second tank body (3) for self-circulation of the second tank body (3) or for pumping the output of the second tank body (3) into a filling device; The system also includes valves and pumps for adjusting the flow path of the fluid in the pipeline.
2. A system for producing a variety of preparations according to claim 1, characterized in that: The input end of the homogenizing device is also respectively connected to the output ends of the third tank body (7), the fourth tank body (6), and the fifth tank body (9); the output end of the homogenizing device is also respectively connected to the input ends of the third tank body (7) and the fifth tank body (9).
3. A system for producing a variety of preparations according to claim 2, characterized in that: The third tank body (7) is an oil phase storage tank, the fourth tank body (6) is a water phase storage tank, and the volume of the fourth tank body (6) is at least twice that of the third tank body (7).
4. A system for producing a variety of preparations according to claim 3, characterized in that: The volume of the fourth tank body (6) is at least five times that of the third tank body (7).
5. A system for producing a variety of preparations according to any one of claims 1 to 4, characterized in that: The homogenizing device is a homogenizing pump or a high-pressure homogenizer.
6. A system for producing a variety of preparations according to any one of claims 1 to 4, characterized in that: The filtering device (2) is a double-stage filter.
7. A system for producing a variety of preparations according to claim 5, characterized in that: The filtering device (2) is a double-stage filter.
8. A system for producing a variety of preparations according to any one of claims 1 to 4, characterized in that: The first tank (1) is also equipped with a shearing and dispersing device.
9. A system for producing a variety of preparations according to claim 5, characterized in that: The first tank (1) is also equipped with a shearing and dispersing device.