High-activity drug sterility test isolator

Abstract

The utility model provides a high-activity medicine sterility examination isolator which comprises a glove box, a first air inlet device, a second air inlet device, a first air exhaust device, an air return channel and a filtering air outlet channel. A filtering component and a second air exhaust device are sequentially arranged in the filtering air outlet channel. A channel switching mechanism is arranged among the glove box, the air return channel and the filtering air outlet channel, and the communication state among the glove box, the air return channel and the filtering air outlet channel is controlled through the channel switching mechanism; an air return valve is arranged between the filtering air outlet channel and the air return channel and located between the air exhaust fan and the air exhaust valve. According to the utility model, the requirements of two modes of conventional sterility examination and high-activity medicine sterility examination can be met at the same time, and the power of the air inlet device (fan) can be reduced in the high-activity medicine sterility examination mode.

Description

TECHNICAL FIELD

[0001] The utility model relates to aseptic preparation inspection technical field especially relates to a high activity drug aseptic examination isolator. BACKGROUND

[0002] Aseptic examination isolator is a kind of equipment specially designed for carrying out aseptic examination, to provide a highly controlled and aseptic environment. This kind of isolator is usually used by pharmaceutical enterprises, hospitals and research institutions to ensure that test samples are not contaminated by external microorganisms, so as to ensure the accuracy and reliability of experimental results.

[0003] The existing aseptic examination process isolator usually adopts full-in full-out working mode, that is, after air filtration, all air is discharged after being introduced into glove box by air inlet device. This way has higher requirement for fan air intake, and usually needs larger power fan to meet the aseptic examination requirement of high activity drug, and the energy consumption is larger during equipment use. SUMMARY

[0004] The utility model discloses a high activity drug aseptic examination isolator to solve the deficiency in prior art.

[0005] The utility model discloses a high activity drug aseptic examination isolator, including glove box, first air inlet device, second air inlet device, first air outlet device, return air passage, filter outlet air passage, be equipped with filter component in filter outlet air passage, second air outlet device;Glove box, return air passage and filter outlet air passage between filter outlet air passage are provided with passageway switching mechanism, and the communication state between glove box, return air passage and filter outlet air passage is controlled through passageway switching mechanism.

[0006] Preferably, the second air outlet device includes an air outlet fan and an air outlet valve.

[0007] Preferably, an air return valve is provided between the air outlet fan and the air outlet valve, and the air return valve communicates the return air passage and the filter outlet air passage.

[0008] Preferably, when the aseptic examination isolator is in a conventional aseptic examination mode, the passageway switching mechanism is switched to a first state, so that the glove box is communicated with the return air passage;When the aseptic examination isolator is in a high activity drug aseptic examination mode, the passageway switching mechanism is switched to a second state, so that the glove box is communicated with the filter outlet air passage.

[0009] Preferably, the filter component is a bag-in-bag-out filter device.

[0010] Preferably, the bag-in-bag-out filter device is provided with a bag-in-bag-out device cover plate on the outer side.

[0011] Preferably, a static pressure tank is arranged between the first air inlet device and the glove box and between the second air inlet device and the glove box.

[0012] Preferably, the channel switching mechanism is a three-way switching valve.

[0013] Preferably, the return air valve is a proportional regulating valve.

[0014] Preferably, the first air inlet device and the second air inlet device are connected to an automatic fan frequency conversion system.

[0015] The utility model has the advantages that:

[0016] 1. The utility model has two ventilation modes, which can meet the needs of conventional sterile inspection and high-activity drug sterile inspection through the channel switching mechanism, thereby saving equipment cost.

[0017] 2. When the utility model is in the high-activity drug sterile inspection mode, part of the air is returned to the glove box again through the return air valve and the return air channel after being filtered by the filtering component (i.e. air partial internal circulation), compared with the traditional isolator full-in full-out working mode, the air volume inside the isolator can be improved, so that the power of the air inlet device (fan) can be reduced under the premise of meeting the air volume demand of high-activity drug sterile inspection, thereby reducing the operation power consumption of the isolator.

[0018] 3. In the utility model, the return air channel and the filtered air outlet channel are arranged inside the isolator, i.e. the structure mode of internal air duct is adopted, compared with the external air duct mode of the traditional isolator, the utility model occupies smaller external space. BRIEF DESCRIPTION OF DRAWINGS

[0019] Fig. 1 It is an air flow schematic diagram when the utility model is in the conventional sterile inspection mode.

[0020] Fig. 2 It is an air flow schematic diagram when the utility model is in the high-activity drug sterile inspection mode.

[0021] Fig. 3 It is an external structure schematic diagram of the utility model.

[0022] In the drawing: 1, first air inlet device, 2, first air outlet device, 3, static pressure tank, 4, air outlet valve, 5, return air valve, 6, air outlet fan, 7, glove box, 8, bag-in-bag-out filter device, 9, second air inlet device, 10, channel switching mechanism, 11, return air channel, 12, filtered air outlet channel, 13, bag-in-bag-out device cover plate. DETAILED DESCRIPTION

[0023] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present utility model are within the protection scope of the present utility model.

[0024] like Figs. 1 to 3 As shown, a sterile testing isolator for highly active drugs includes a glove box 7, a first air inlet device 1, a second air inlet device 9, a first exhaust device 2, a return air channel 11, and a filtered air outlet channel 12. A filter component and a second exhaust device are sequentially arranged within the filtered air outlet channel 12. A channel switching mechanism 10 is provided between the glove box, the return air channel 11, and the filtered air outlet channel 12 to control the connection between them. A return air valve 5 is provided between the filtered air outlet channel 12 and the return air channel 11, located between an exhaust fan 6 and an exhaust valve 4. The second exhaust device includes an exhaust fan 6 and an exhaust valve 4.

[0025] This device can switch between a conventional aseptic inspection mode and a highly active drug aseptic inspection mode. Specifically, when the aseptic inspection isolator is in the conventional aseptic inspection mode, the channel switching mechanism 10 switches to the first state, at which time the glove box is connected to the return air channel 11; when the aseptic inspection isolator is in the highly active drug aseptic inspection mode, the channel switching mechanism 10 switches to the second state, at which time the glove box is connected to the filtered air outlet channel 12.

[0026] When the present invention is in the normal aseptic inspection mode, the glove box is connected to the return air channel 11, and the air passes through the first air inlet device 1, the glove box, the return air channel 11, and the first exhaust device 2 in sequence. When the present invention is in the aseptic inspection mode for highly active drugs, the glove box is connected to the filter exhaust channel 12, the return air valve 5 is in the open state, and the air passes through the second air inlet device 9, the glove box, and then enters the filter exhaust channel 12. After being filtered by the filter components in the filter exhaust channel 12, the air passes through the second exhaust device. Part of the air will return to the return air channel 11 through the return air valve 5, and then re-enter the glove box through the return air channel 11 to achieve partial internal air circulation and increase the internal air volume; while the other part of the air will be discharged through the exhaust valve 4.

[0027] The utility model discloses a glove box, which comprises a glove box body, a first air inlet device, a second air inlet device, a return air valve, a return air channel, a filter component and a channel switching mechanism.

[0028] In the utility model, the return air channel 11 and the filter outlet air channel 12 are arranged in the interior of the isolator, that is, the structure mode of the internal air duct is adopted, and compared with the external air duct mode of the traditional isolator, the utility model occupies the smaller external space.

[0029] The utility model discloses possess two kinds of ventilation mode, can satisfy the demand of routine aseptic inspection and high activity drug aseptic inspection simultaneously.

[0030] In the embodiment, the filter component is a bag-in-bag-out filter device 8.

[0031] The bag-in-bag-out filter device 8 is provided with a bag-in-bag-out device cover plate 13 on the outside.

[0032] In some embodiments of the application, a static pressure tank 3 is arranged between the first air inlet device 1 and the glove box and between the second air inlet device 9 and the glove box.

[0033] In some other embodiments of the application, a static pressure tank 3 is shared by the first air inlet device 1 and the glove box and by the second air inlet device 9 and the glove box.

[0034] The first air inlet device and the second air inlet device are connected to an automatic fan frequency conversion system.

[0035] In the embodiment, the channel switching mechanism 10 is a three-way switching valve, and the return air valve 5 is a proportional regulating valve.

[0036] The utility model discloses not limit to the above best implementation, and anyone can draw other various forms of product under the enlightenment of the utility model, but no matter make any change in its shape or structure, all have the same or similar technical scheme with the application, fall in the protection scope of the utility model.

Claims

1. A high activity pharmaceutical aseptic inspection isolator characterized by, The glove box, the first air inlet device, the second air inlet device, the first air outlet device, the air return channel, the filtered air outlet channel, the filter component in the filtered air outlet channel, and the second air outlet device are included.

2. A high activity pharmaceutical aseptic inspection isolator as claimed in claim 1, wherein, The second air outlet device includes an air outlet fan and an air outlet valve.

3. A high activity pharmaceutical aseptic inspection isolator according to claim 2, wherein, An air return valve is arranged between the air outlet fan and the air outlet valve, and the air return valve communicates the air return channel and the filtered air outlet channel.

4. The high activity pharmaceutical aseptic inspection isolator of claim 1, wherein, When the sterile inspection isolator is in a normal sterile inspection mode, the channel switching mechanism is switched to a first state, and at this time the glove box communicates with the air return channel; when the sterile inspection isolator is in a high-activity drug sterile inspection mode, the channel switching mechanism is switched to a second state, and at this time the glove box communicates with the filtered air outlet channel.

5. The high activity pharmaceutical aseptic inspection isolator of claim 1, wherein, The filter component is a bag-in-bag-out filter device.

6. A high activity pharmaceutical aseptic inspection isolator according to claim 5, wherein, An outer side of the bag-in-bag-out filter device is provided with a bag-in-bag-out device cover plate.

7. The high activity pharmaceutical aseptic inspection isolator of claim 1, wherein, A static pressure box is arranged between the first air inlet device and the glove box and between the second air inlet device and the glove box.

8. The high activity pharmaceutical aseptic inspection isolator of claim 1, wherein, The channel switching mechanism is a three-way switching valve.

9. A high activity pharmaceutical aseptic inspection isolator as claimed in claim 3 wherein, The air return valve is a proportional regulating valve.

10. The high activity pharmaceutical aseptic inspection isolator of claim 1, wherein, The first air inlet device and the second air inlet device are connected to an automatic fan frequency conversion system.

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