Anti-condensation assembly for bulk drug isolator, sample adding device and bulk drug isolator

Abstract

The utility model provides an anti-condensation component for bulk drug isolator, sample adding device and bulk drug isolator, the anti-condensation component comprises a sample injection needle, the sample injection needle comprises a sample injection needle inner tube, a sample injection needle heat insulation layer and a sample injection needle heat insulation layer sleeve from inside to outside in sequence, the outer diameter of the sample injection needle inner tube is smaller than the inner diameter of the sample injection needle heat insulation layer sleeve; one end of the sample injection needle inner tube is connected with one end of the sample injection needle heat insulation layer sleeve, and the other end of the sample injection needle inner tube is connected with the other end of the sample injection needle heat insulation layer sleeve; and the sample injection needle heat insulation layer is formed between the sample injection needle inner tube and the sample injection needle heat insulation layer sleeve. The anti-condensation assembly for the raw material medicine isolator can be suitable for raw material medicines or auxiliary materials needing to be filled at the temperature ranging from-10 DEG C to-20 DEG C, condensation cannot occur even if the raw material medicines or the auxiliary materials are filled at the low temperature, the quality of products in a filling bottle is not affected during filling, and large dehumidification energy consumption is not needed.

Description

Technical Field

[0001] The present invention belongs to the technical field of API production, and specifically relates to an anti-condensation assembly for an API isolator. Furthermore, the present invention also relates to a sample loading device including the anti-condensation assembly, and an API isolator including the sample loading device. Background Art

[0002] Liquid filling is often involved in the production of APIs. Sterile APIs or APIs with high activity often need to be filled in an isolator. In general isolators, the internal environmental humidity is usually between 40% and 65%, which is suitable for the filling of most API liquids. However, with the development of APIs or their excipients, some innovative APIs or their excipients need to be filled at -10 to -20 degrees Celsius to prevent the filling temperature from affecting product quality. When liquids at -10 to -20 degrees Celsius are filled through pipes and injection needles, condensation can easily occur on the outside of the injection needle due to the high humidity inside the isolator. For example, the dew point temperature is around 6°C when the humidity is 40%. For some water-sensitive APIs, condensation will affect their quality, and there is also a risk of external condensation entering the filling bottle. Therefore, for APIs or excipients that need to be filled at -10 to -20 degrees Celsius, conventional isolators or sample addition devices need to be significantly modified to make them suitable for APIs or excipients that need to be filled at -10 to -20 degrees Celsius.

[0003] There are two main methods for modifying conventional isolators or sampling devices in the existing technology: the first is to add insulation material to the outside of the sampling needle. However, since the sampling needle needs to repeatedly enter the filling bottle, debris generated by the insulation material may enter the filling bottle, posing a greater risk to the quality of the product in the filling bottle; the second is to dehumidify the air supplied to the isolator, so that the humidity in the isolator is reduced to about 5-12% after the air is supplied. However, reducing the humidity in the isolator from 40-65% to 5-12% requires a large amount of dehumidification energy consumption.

[0004] In view of this, developing an anti-condensation component for API isolators, which can be suitable for APIs or excipients that need to be filled at -10 to -20 degrees Celsius, and on the other hand will not affect the quality of the product in the filling bottle and does not require large dehumidification energy consumption, has become an urgent problem to be solved by technical personnel in this field. Utility Model Content

[0005] The purpose of the present utility model is to solve the difficulties existing in the above-mentioned prior art, and to provide an anti-condensation component, a sample adding device and a raw material medicine isolator for a raw material medicine, so as to solve the problems of difficulty in selecting insulation materials and high dehumidification energy consumption when ordinary isolators are used for low-temperature filling in the existing raw material medicine production, while meeting the requirements of being suitable for filling at -10 to -20 degrees Celsius.

[0006] One of the inventive purposes of the utility model is to provide an anti-condensation component for a raw material drug isolator, the anti-condensation component includes a sampling needle, and the sampling needle includes, from the inside to the outside, an injection needle inner tube, an injection needle insulation layer and an injection needle insulation layer sleeve, the outer diameter of the injection needle inner tube is smaller than the inner diameter of the injection needle insulation layer sleeve; one end of the injection needle inner tube is connected to one end of the injection needle insulation layer sleeve, and the other end of the injection needle inner tube is connected to the other end of the injection needle insulation layer sleeve; the injection needle insulation layer is formed between the injection needle inner tube and the injection needle insulation layer sleeve.

[0007] In a preferred embodiment of the present invention,

[0008] The outer diameter of the top of the injection needle insulation layer increases gradually from top to bottom; and / or

[0009] The outer diameter of the top of the injection needle insulation layer sleeve increases gradually from top to bottom.

[0010] In a preferred embodiment of the present invention, a heat insulating material is provided in the heat insulating layer of the injection needle.

[0011] In a preferred embodiment of the present invention, the injection needle insulation layer is a vacuum structure, and the vacuum degree of the injection needle insulation layer is 2-3Pa.

[0012] In a preferred embodiment of the present invention, the anti-condensation component for the bulk drug isolator further includes an instrument air pipeline, and the instrument air pipeline is arranged above the injection needle.

[0013] In a preferred embodiment of the present invention, the anti-condensation component for the bulk drug isolator further includes an instrument air distributor, which is arranged above the injection needle; and the instrument air distributor is connected to the instrument air pipeline.

[0014] In a preferred embodiment of the present invention,

[0015] The instrument air distributor is provided with a plurality of instrument air distribution ports; and / or

[0016] The instrument air distribution port is square.

[0017] In a preferred embodiment of the present invention, a sterile filter is provided on the instrument air pipeline.

[0018] The second purpose of the present invention is to provide a sample adding device for bulk drug isolator, comprising

[0019] The anti-condensation component for the bulk drug isolator according to one of the inventive purposes of the utility model;

[0020] a feed liquid pipeline, one end of which is connected to the injection needle;

[0021] A driving device is connected to the injection needle.

[0022] The third purpose of the invention of this utility model is to provide a bulk drug isolator, comprising

[0023] The anti-condensation component for the bulk drug isolator described in one of the invention objectives of the utility model;

[0024] a feed liquid pipeline, one end of which is connected to the injection needle;

[0025] A driving device connected to the injection needle;

[0026] The filling bottle is arranged below the sampling needle.

[0027] Compared with the prior art, the beneficial effects of the present invention are:

[0028] 1. The anti-condensation component for the API isolator of the utility model can be used for APIs or excipients that need to be filled at -10 to -20 degrees Celsius. Even if low-temperature filling is performed, condensation will not occur. Moreover, the filling process does not affect the quality of the product in the filling bottle and does not require large dehumidification energy consumption. It solves the problems of difficult selection of insulation materials and high dehumidification energy consumption when performing low-temperature filling in ordinary isolators in existing API production.

[0029] 2. The anti-condensation component for the bulk drug isolator of the present invention requires only minor modifications to ordinary isolators, resulting in low modification costs. After the modification, the applicable range of the ordinary isolator for filling temperature is broadened. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 This is a front view of the anti-condensation component, liquid pipeline and filling bottle for the bulk drug isolator of the utility model;

[0031] Figure 2 for Figure 1 Cross-sectional view of the injection needle in the AA direction;

[0032] Figure 3 for Figure 1 Cross-sectional view of the injection needle in the BB direction;

[0033] In the figure, 1 is the instrument air pipeline; 2 is the sterile filter; 3 is the instrument air pipeline after sterilization; 4 is the instrument air distributor; 5 is the injection needle, 51 is the injection needle inner tube, 52 is the injection needle insulation layer, 53 is the injection needle insulation layer sleeve; 6 is the material liquid pipeline; 7 is the filling bottle. DETAILED DESCRIPTION

[0034] The present invention is described in further detail below with reference to the accompanying drawings:

[0035] like Figures 1 to 3 As shown, the utility model provides an anti-condensation component for a bulk drug isolator, which is an injection needle 5. The injection needle 5 is annular and cylindrical, and its axis is perpendicular to the horizontal plane. The through-hole portion of the injection needle 5 is used to cooperate with the feed liquid pipeline 6 to achieve filling. Preferably, the inner diameter of the injection needle 5 matches the outer diameter of the feed liquid pipeline 6. In actual application, the inner diameter of the injection needle 5 is the same as the outer diameter of the feed liquid pipeline 6. The feed liquid pipeline 6 is inserted into the hole of the injection needle 5 from top to bottom. The outer wall of the feed liquid pipeline 6 abuts the inner wall of the injection needle 5, and then the injection needle 5 is fixedly connected to the feed liquid pipeline 6 using a connector (for example, the injection needle 5 can be connected to the feed liquid pipeline 6 by a snap buckle), so that the feed liquid pipeline 6 will not move along the axial direction of the injection needle 5. In this way, the feed liquid pipeline 6 can reciprocate in the vertical direction driven by the injection needle 5, thereby achieving filling of the filling bottle 7 below it.

[0036] The injection needle 5 includes, from the inside to the outside, an injection needle inner tube 51, an injection needle insulation layer 52, and an injection needle insulation layer sleeve 53, that is, the injection needle insulation layer 52 is arranged on the outside of the injection needle inner tube 51, and the injection needle insulation layer sleeve 53 is sleeved on the outside of the injection needle insulation layer 52. The outer diameter of the injection needle inner tube 51 is smaller than the inner diameter of the injection needle insulation layer sleeve 53. The injection needle inner tube 51 is connected to the injection needle insulation layer sleeve 53 (for example, the two can be welded). Specifically, one end of the injection needle inner tube 51 is connected to one end of the injection needle insulation layer sleeve 53, and the other end of the injection needle inner tube 51 is connected to the other end of the injection needle insulation layer sleeve 53; the injection needle insulation layer 52 is formed between the injection needle inner tube 51 and the injection needle insulation layer sleeve 53.

[0037] In the prior art, the injection needle inner tube 51 is generally cylindrical. Therefore, the anti-condensation assembly will be described using the cylindrical injection needle inner tube 51 as an example. The injection needle insulation layer 52 is a toroidal-like structure, with an inner diameter that is the same as the outer diameter of the injection needle inner tube 51. Similarly, the injection needle insulation layer sleeve 53 is a toroidal-like structure, with an inner diameter that is the same as the outer diameter of the injection needle insulation layer 52.

[0038] It should be noted that the aforementioned "injection needle inner tube 51 is connected to the injection needle insulation layer sleeve 53" is specifically in this embodiment. The top surface of the injection needle inner tube 51 is fixedly connected to the top surface of the injection needle insulation layer sleeve 53, and the bottom surface of the injection needle inner tube 51 is fixedly connected to the bottom surface of the injection needle insulation layer sleeve 53. The enclosed space formed between the injection needle inner tube 51 and the injection needle insulation layer sleeve 53 is the injection needle insulation layer 52 (such as Figure 2 and Figure 3As shown). Thus, it can be seen that the toroidal-shaped injection needle insulation layer sleeve 53 and the injection needle inner tube 51 connected thereto completely enclose the injection needle insulation layer 52. Furthermore, because the injection needle insulation layer 52 is used to accommodate the thermal insulation material, this solves the problem in the prior art where debris generated by the thermal insulation material may enter the filling bottle, thereby affecting the quality of the product in the filling bottle. Preferably, the injection needle insulation layer sleeve 53 is made of the same material as the injection needle inner tube 51, for example, steel, to further reduce its impact on the quality of the product in the filling bottle.

[0039] In a preferred embodiment of the present invention, the outer diameter of the top of the injection needle insulation layer 52 gradually increases from top to bottom, and the outer diameter of the top of the injection needle insulation layer sleeve 53 also gradually increases from top to bottom, so as to facilitate welding the injection needle inner tube 51 and the injection needle insulation layer sleeve 53 together.

[0040] The above description of the shape of the injection needle insulation layer 52 and the injection needle insulation layer sleeve 53 is based on the fact that the injection needle inner tube 51 is cylindrical. When the shape of the injection needle inner tube 51 is not cylindrical, those skilled in the art can adjust the shape of the injection needle insulation layer 52 and the injection needle insulation layer sleeve 53 according to "the size of the injection needle insulation layer 52 matches the size of the injection needle inner tube 51, and the size of the injection needle insulation layer sleeve 53 matches the size of the injection needle insulation layer 52".

[0041] In a preferred embodiment of the present invention, the injection needle insulation layer 52 is provided with an insulation material, and the insulation material is a low thermal conductivity material to reduce the mutual influence between the temperature inside the injection needle inner tube 51 and the temperature inside the isolation box to prevent condensation, so that it can be suitable for APIs or excipients with low-temperature filling requirements. Exemplarily, the insulation material can be selected from any one or more of polyurethane foam material, polystyrene foam plastic, polyurethane foam plastic, and foam glass, wherein the polyurethane foam material is preferably porous and has good thermal insulation performance. More preferably, the injection needle insulation layer 52 is a vacuum structure, and its vacuum degree is preferably 2 to 3 Pa, so as to further reduce the mutual influence between the temperature inside the injection needle inner tube 51 and the temperature inside the isolation box to prevent condensation.

[0042] It should be noted that the vacuum level of the injection needle insulation layer 52 is pre-established during the manufacturing process of the anti-condensation component and is not evacuated during its use. Furthermore, the aforementioned statement that "the enclosed space formed between the injection needle inner tube 51 and the injection needle insulation layer sleeve 53 is the injection needle insulation layer 52" further illustrates that the vacuum level of the injection needle insulation layer 52 is pre-established during the manufacturing process of the anti-condensation component. Furthermore, the vacuum level of the injection needle insulation layer 52 of the present invention is not suitable for evacuation during use. This is because the injection needle insulation layer 52 continuously moves up and down with the injection needle inner tube 51 to complete filling. If the injection needle insulation layer 52 is evacuated during the filling process, the vacuum line connected to the injection needle insulation layer 52 must use a hose, but the hoses in the prior art cannot withstand the preset vacuum level. Furthermore, evacuation during use will also affect the sterile environment within the injection needle inner tube 51.

[0043] In a preferred embodiment of the present invention, the anti-condensation component further includes an instrument air pipeline 1. The outlet end of the instrument air pipeline 1 is arranged directly above the injection needle 5, so that the injection needle 5 is purged with the air in the instrument air pipeline 1. In a more preferred embodiment of the present invention, the anti-condensation component further includes an instrument air distributor 4 connected to the instrument air pipeline 1. The instrument air distributor 4 is arranged directly above the injection needle 5, and the instrument air pipeline 1 is arranged above the instrument air distributor 4. Preferably, the instrument air distributor 4 is provided with a plurality of instrument air distribution ports.

[0044] An air delivery pump is provided on the instrument air line 1. Controlling the air delivery pump allows air to enter the instrument air line 1. After being evenly distributed by the instrument air distributor 4, the air is blown past the injection needle 5 located below the instrument air distributor 4, lowering the dew point of the adiabatic air surrounding the injection needle 5 to approximately -40°C, further preventing condensation. Preferably, the instrument air distribution port is square, with a side length greater than the inner diameter of the filling bottle 7, with a difference of approximately 5 mm between the two dimensions. More preferably, the outlet velocity of the instrument air distributor 4 is controlled at 0.5 m / s.

[0045] In a preferred embodiment of the present invention, the instrument air line 1 is provided with a sterile filter 2. Therefore, the pipeline between the sterile filter 2 and the instrument air distributor 4 constitutes the instrument air post-sterilization line 3. One end of the instrument air post-sterilization line 3 is connected to the sterile filter 2, and the other end is connected to the instrument air distributor 4. Therefore, air passes sequentially through the instrument air line 1, the sterile filter 2, and the instrument air post-sterilization line 3 to the instrument air distributor 4, ultimately purging the injection needle 5. Preferably, the sterile filter 2 is a 0.2 μm filter.

[0046] like Figures 1 to 3 As shown, the present invention also provides a sample loading device for a bulk drug isolator, comprising the aforementioned anti-condensation assembly for a bulk drug isolator, a feed liquid pipeline 6, and a drive device. One end of the feed liquid pipeline 6 is inserted into and connected to the injection needle 5. Specifically, one end of the feed liquid pipeline 6 is inserted into a through-hole inside the injection needle inner tube 51. The drive device is connected to the injection needle 5 to drive the injection needle 5 to reciprocate in a vertical direction.

[0047] like Figures 1 to 3 As shown, the present invention also provides a bulk drug isolator, which includes the aforementioned anti-condensation component for bulk drug isolators, a feed and liquid pipeline 6, a driving device and a filling bottle 7. One end of the feed and liquid pipeline 6 is inserted into the injection needle 5 and connected to the injection needle 5. Specifically, one end of the feed and liquid pipeline 6 is inserted into the through hole on the inner side of the injection needle inner tube 51; the driving device is connected to the injection needle 5 to drive the injection needle 5 to reciprocate in the vertical direction; the filling bottle 7 is arranged directly below the injection needle 5, that is, the filling bottle 7 and the injection needle 5 are coaxially arranged. It should be noted that a filling bottle conveying device is provided at the bottom of the filling bottle 7, so that one of the filling bottles 7 on it is arranged directly below the injection needle 5. The filling bottle conveying device is an existing device and will not be described in detail in this utility model.

[0048] Example 1

[0049] The filling process in the production of a certain API requires a filling temperature of -10 degrees Celsius. The API isolator of this utility model is used for low-temperature filling, and the following data are obtained:

[0050] Operating time: intermittent

[0051] Work section personnel setting: 1 operator.

[0052] The isolator is increased by 60Nm by adding instrument air pipeline 1, sterile filter 2, instrument air sterilization pipeline 3, instrument air distributor 4, injection needle inner tube 51, injection needle insulation layer 52, injection needle insulation layer sleeve 53. 3 / h of instrument air consumption (sufficient surplus on site and low cost), replacing the original injection needle, and low modification cost.

[0053] During the filling process, no condensation occurred on the injection needle and the product quality was not affected.

[0054] Example 2

[0055] The filling process in the production of a certain API requires a filling temperature of -20 degrees Celsius. The API isolator of this utility model is used for low-temperature filling, and the following data are obtained:

[0056] Operating time: intermittent

[0057] Work section personnel setting: 1 operator.

[0058] The isolator is increased by 80Nm by adding instrument air pipeline 1, sterile filter 2, instrument air sterilization pipeline 3, instrument air distributor 4, injection needle inner tube 51, injection needle insulation layer 52, injection needle insulation layer sleeve 53. 3 / h of instrument air consumption (sufficient on-site surplus and low cost) to replace the original injection needle.

[0059] During the filling process, no condensation occurred on the injection needle and the product quality was not affected.

[0060] Comparative Example 1

[0061] The filling process in the production of a certain API requires a filling temperature of -10 degrees Celsius and is performed in an isolator with normal humidity. Using traditional equipment, the following data is obtained:

[0062] Operating time: intermittent

[0063] Work section personnel setting: 1 operator.

[0064] Air supply to isolator (1800m 3 / h) to reduce the humidity therein. Specifically, the humidity in the isolator is reduced from 40% to 5%, which consumes a lot of energy.

[0065] During the filling process, no condensation occurred on the injection needle and the product quality was not affected.

[0066] Comparative Example 2

[0067] The filling process in the production of a certain API requires a filling temperature of -20 degrees Celsius and is performed in an isolator with normal humidity. Using traditional equipment, the following data is obtained:

[0068] Operating time: intermittent

[0069] Work section personnel setting: 1 operator.

[0070] An insulation layer is added to the outside of the injection needle.

[0071] During the filling process, there is a risk of insulation material debris contaminating the product quality.

[0072] In the description of this utility model, it should be noted that, unless otherwise specified or limited, the terms "connected" and "connection" should be understood in a broad sense. For example, they can refer to fixed connection, detachable connection, or integral connection; mechanical connection, electrical connection; direct connection, or indirect connection through an intermediary. Those skilled in the art will understand the specific meanings of the above terms in this utility model based on specific circumstances.

[0073] In the description of the present invention, unless otherwise specified, the terms "upper", "lower", "left", "right", "inside", "outside", etc., indicating directions or positional relationships, are based on the directions or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction. Therefore, they cannot be understood as limiting the present invention.

[0074] The above technical solution is only one implementation method of the present invention. For those skilled in the art, it is easy to make various types of improvements or modifications based on the principles disclosed in the present invention, and it is not limited to the technical solution described in the above specific embodiments of the present invention. Therefore, the above description is only preferred and does not have a restrictive meaning.

Claims

1. An anti-condensation component for a bulk drug isolator, characterized in that: The invention comprises an injection needle, which comprises, from the inside to the outside, an injection needle inner tube, an injection needle insulation layer and an injection needle insulation layer sleeve. The outer diameter of the injection needle inner tube is smaller than the inner diameter of the injection needle insulation layer sleeve. One end of the injection needle inner tube is connected to one end of the injection needle insulation layer sleeve, and the other end of the injection needle inner tube is connected to the other end of the injection needle insulation layer sleeve. The injection needle insulation layer is formed between the injection needle inner tube and the injection needle insulation layer sleeve.

2. The anti-condensation component for bulk drug isolator according to claim 1, characterized in that: The outer diameter of the top of the injection needle insulation layer increases gradually from top to bottom; and / or The outer diameter of the top of the injection needle insulation layer sleeve increases gradually from top to bottom.

3. The anti-condensation component for bulk drug isolator according to claim 1, characterized in that: The injection needle insulation layer is provided with heat insulation material.

4. The anti-condensation component for bulk drug isolator according to claim 1, characterized in that: The injection needle heat insulation layer is a vacuum structure, and the vacuum degree of the injection needle heat insulation layer is 2-3Pa.

5. The anti-condensation component for bulk drug isolator according to claim 1, characterized in that: The anti-condensation component for the bulk drug isolator also includes an instrument air pipeline, which is arranged above the injection needle.

6. The anti-condensation component for bulk drug isolator according to claim 5, characterized in that: The anti-condensation component for the bulk drug isolator also includes an instrument air distributor, which is arranged above the injection needle; the instrument air distributor is connected to the instrument air pipeline.

7. The anti-condensation component for bulk drug isolator according to claim 6, characterized in that: The instrument air distributor is provided with a plurality of instrument air distribution ports; and / or The instrument air distribution port is square.

8. The anti-condensation component for bulk drug isolator according to claim 5, characterized in that: A sterile filter is provided on the instrument air pipeline.

9. A sample adding device, characterized in that: include: The anti-condensation component for the bulk drug isolator according to any one of claims 1 to 8; a feed liquid pipeline, one end of which is connected to the injection needle; A driving device is connected to the injection needle.

10. A bulk drug isolator, characterized in that: include The anti-condensation component for the bulk drug isolator according to any one of claims 1 to 8; a feed liquid pipeline, one end of which is connected to the injection needle; A driving device connected to the injection needle; The filling bottle is arranged below the sampling needle.

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