CN112791591A - Alcohol filtering device for sterile workshop - Google Patents

Abstract

The invention discloses an alcohol filtering device for an aseptic workshop, which comprises an alcohol tank, an alcohol filling device and a medium input device, wherein the alcohol filling device and the medium input device are arranged at the upper end of the alcohol tank, a first diaphragm valve is arranged on the alcohol input pipeline, the medium input device comprises a water pipeline for injection, a pure steam pipeline and an aseptic air pipeline, a filtering pipeline is arranged at the lower end of the alcohol tank, two membrane filters are arranged on the filtering pipeline, and one end of the filtering pipeline is respectively communicated with an aseptic alcohol discharging pipeline and a water discharging pipeline. Meets the requirements of the national GMP drug production standard.

Description

Alcohol filtering device for sterile workshop

Technical Field

The invention relates to the technical field of alcohol filtration, in particular to an alcohol filtration device for an aseptic workshop.

Background

Aseptic medicine enterprise is in aseptic preparation in-process, especially when involving production such as injection and bacterin, and all materials that get into aseptic workshop production line all should be sterile state, and present enterprise is after alcohol production finishes, often just wipes the alcohol bucket extranal packing and realizes the disinfection action, and the impurity that contains in the inside alcohol of alcohol bucket does not pass through aseptic filtration, does not accord with the requirement of national GMP medicine production standard, and the quality of dosing brings the risk.

At present, no device capable of filtering alcohol in an aseptic state is available in the market, for example, chinese patent No. CN205461341U, bacterial contamination caused by a mixing process in liquid is removed by adopting a multi-stage filtering mode, but system articles and pipeline connections related in the patent are made of common materials, and the whole equipment cannot ensure that the environment of the whole filtering process is in an aseptic state.

In order to avoid the risk of medicine quality, the invention designs the alcohol filtering device for the sterile workshop, and integrates three using functions of sterile filtration, online cleaning and online sterilization. The system is always kept in an aseptic state, and the filtered material is an aseptic solution which meets the requirements of the national GMP (good manufacturing practice) drug production standard.

Disclosure of Invention

The technical scheme adopted by the invention is as follows: an alcohol filtering device for an aseptic workshop comprises an alcohol liquid tank, wherein an alcohol filling device and a medium input device are arranged at the upper end of the alcohol liquid tank, the alcohol filling device comprises an alcohol input head and an alcohol input pipeline connected between the alcohol input head and the alcohol liquid tank, a first diaphragm valve is arranged on the alcohol input pipeline, the medium input device comprises an injection water pipeline, a pure steam pipeline and an aseptic air pipeline, the injection water pipeline, the pure steam pipeline and the aseptic air pipeline are connected in parallel, one end of the injection water pipeline, the pure steam pipeline and the aseptic air pipeline are converged and connected with a rotary cleaning head, the rotary cleaning head is inserted into the position close to the inside of the alcohol liquid tank, a second diaphragm valve is arranged on the injection water pipeline, a third diaphragm valve is arranged on the pure steam pipeline, and a fourth diaphragm valve is arranged on the aseptic air pipeline, the alcohol filtering device is characterized in that a filtering pipeline is arranged at the lower end of the alcohol tank, two membrane filters are arranged on the filtering pipeline, at least one detention-free diaphragm valve is arranged on the filtering pipeline, pressure gauges are connected to the two membrane filters respectively, one end of the filtering pipeline is connected with a sterile alcohol discharging pipeline and a water outlet pipeline in a penetrating mode respectively, a ninth diaphragm valve is arranged on the sterile alcohol discharging pipeline, one end of the water outlet pipeline, which is far away from the filtering pipeline, is provided with a drain valve and a thermometer, the whole alcohol filtering device for a sterile workshop is placed in a GMP clean area, the GMP clean area comprises a disinfectant configuration room and a sterile disinfectant receiving room, and the sterile alcohol discharging pipeline is arranged inside the sterile disinfectant receiving room.

Preferably, the water pipeline for injection is U-shaped, and both ends are equipped with water inlet and delivery port respectively, the pure steam pipeline is kept away from rotatory cleaning head one end is equipped with the pure steam import, aseptic air pipeline is kept away from rotatory cleaning head one end is equipped with aseptic air inlet, aseptic alcohol ejection of compact pipeline is kept away from filtering pipeline one end is equipped with aseptic alcohol discharge gate.

Through the technical scheme, before alcohol is officially sterilized and filtered, the whole device is firstly cleaned and disinfected. In the cleaning process, open the second diaphragm valve, open the diaphragm valve on the filter tube way and the diaphragm valve on the outlet pipe way simultaneously, all the other diaphragm valves are closed to open the trap, then enter into the alcohol solution jar with the water inlet of water pipe way for injection with water and run through whole set of device, in order to wash completely the inside of whole set of device, the setting of rotatory cleaning ball can be so that the water for injection carries out splash all around to jar internal wall, and the cleaning performance is better. After the cleaning is finished, the source of the injection water is closed, the second diaphragm valve is closed at the same time, the fourth diaphragm valve is opened, the opening and closing states of other diaphragm valves are kept unchanged, sterile air is blown into the sterile filtering device through the sterile air inlet of the sterile air pipeline, the internal pressure in the device is increased, and the residual injection water in the device is driven out of the device and is drained to a workshop drainage pipeline through a drain valve.

After the injection water in the aseptic filtration device is completely drained, the fourth diaphragm valve is closed, the diaphragm valve and the drain valve on the water outlet pipeline are closed, the third diaphragm valve is opened, the opening and closing states of other diaphragm valves are kept unchanged, pure steam is input into the aseptic filtration device through the pure steam inlet of the pure steam pipeline, all parts which can contact alcohol in the aseptic filtration device are disinfected, the disinfection duration is long, and the complete disinfection in the aseptic filtration device is ensured. After the disinfection finishes, close pure steam source and third diaphragm valve, open the fourth diaphragm valve, open the ninth diaphragm valve, through drum into sterile air in the device with the inside moisture of device drive out the device completely for this device is inside for the state after drying, clean and the disinfection finishes, then closes fourth diaphragm valve and ninth diaphragm valve, closes all diaphragm valves on the filtration pipeline simultaneously.

After the preparation work is finished, opening the first diaphragm valve, pouring untreated alcohol into the alcohol tank through the alcohol input head, ensuring that the GMP cleanliness of a disinfectant preparation room at least reaches grade C, the GMP cleanliness of a sterile disinfectant receiving room reaches grade A/grade B, closing the first diaphragm valve after the alcohol is poured, simultaneously ensuring that the diaphragm valve and the drain valve on the water outlet pipeline are in a closed state, quickly opening the fourth diaphragm valve, the ninth diaphragm valve and all the diaphragm valves on the filtering pipeline, inputting sterile air into the device through the sterile air inlet, increasing the internal pressure in the device, and at the moment, having a pressure of 4-6MPa, the compressed sterile air can push the alcohol in the alcohol tank to flow towards the filtering pipeline, two membrane filters arranged in the filtering pipeline can filter the alcohol, ensuring that the alcohol passing through the two membrane filters is in a sterile state, and the alcohol flows out of the sterile alcohol discharge port on the sterile alcohol discharge pipeline to the sterile disinfectant receiving room, so that the alcohol can be ensured to be in a sterile state in the whole filtering process, and the alcohol after filtering is also in a sterile state, thereby meeting the requirements of the national GMP (good manufacturing practice) drug production standard.

In the invention, the numerical value displayed on the pressure gauge can enable people to accurately master the alcohol filtering rate and the injection water passing rate in the cleaning process, and the safety in the production process can be ensured by observing the data of the pressure gauge at any time.

Preferably, the upper end face of the alcohol tank is provided with an alcohol capacity observation window, a reserved opening and a rupture disc, a reserved opening plug is inserted into the reserved opening, and the alcohol capacity observation window is made of glass.

Through the design of the technical scheme, the alcohol capacity observation window is made of transparent glass, in the alcohol sterile filtration process, the residual alcohol amount in the alcohol liquid tank can be conveniently monitored at any time, the adding amount can be mastered in the alcohol adding process, the first diaphragm valve can be closed when the adding amount is enough, the design of the reserved port can be used as a standby port, the pressure in the device can reach 4-6MPa due to pure steam and compressed sterile air, and the design of the rupture disk aims at preventing potential safety hazards caused by overlarge pressure.

Preferably, a fifth diaphragm valve is arranged between the membrane filter and the alcohol solution tank, a sixth diaphragm valve is arranged between the two membrane filters, a seventh diaphragm valve and an eighth diaphragm valve are sequentially arranged at one end, away from the fifth diaphragm valve, of the membrane filter, the seventh diaphragm valve is arranged inside the disinfectant configuration room, and the eighth diaphragm valve is arranged inside the sterile disinfectant receiving room.

Through the design of the technical scheme, the liquid materials after being filtered can be ensured to be in a sterile state by the design of the two membrane filters, the switch positions of the filtering pipelines can be conveniently controlled through the fifth diaphragm valve, the sixth diaphragm valve and the seventh diaphragm valve in a disinfectant preparation room, and the closing of the sterile alcohol discharging pipeline can be controlled and closed through the eighth diaphragm valve in a sterile disinfectant receiving room.

Preferably, the water outlet pipeline comprises a first water outlet pipeline and a second water outlet pipeline, the trap and the thermometer are installed on the second water outlet pipeline, a tenth diaphragm valve and a twelfth diaphragm valve are arranged on the first water outlet pipeline, the twelfth diaphragm valve is arranged inside the sterile disinfectant receiving room, and an eleventh diaphragm valve is arranged on the second water outlet pipeline.

Through the design of the technical scheme, the thermometer is installed at the coldest end of the device and used for calculating F0 during device disinfection, and the switch positions of the water outlet pipelines can be conveniently controlled by the design of the tenth diaphragm valve, the eleventh diaphragm valve and the twelfth diaphragm valve and switched on and off according to actual requirements.

Preferably, the water pipe for injection, the pure steam pipe, the sterile air pipe, the alcohol input pipe, the filtering pipe, the sterile alcohol discharging pipe and the water outlet pipe are all made of 316L stainless steel.

Through the design of the technical scheme, all pipeline objects are made of 316L stainless steel, all related diaphragm valves are non-retention diaphragm valves, and alcohol prepared by the equipment made of the materials can better meet the aseptic requirement and also meet the requirement of the national GMP (good manufacturing practice) drug production standard.

Preferably, an A-grade laminar flow cover is arranged at an outlet at the upper end of the sterile disinfectant receiving room.

Through the design of the technical scheme, if the sterile alcohol received at the sterile disinfectant receiving room is in an exposed state, the A-level laminar flow cover can be protected by the design, and the sterility is ensured.

Preferably, the membrane filter is a 0.22 μm membrane filter.

Through the technical scheme design, the 0.22-micron membrane filter can ensure that the alcohol is filtered more completely in the filtering pipeline, and completely meets the requirements of national GMP (good manufacturing practice) pharmaceutical production standards on alcohol sterility.

Preferably, the number of the second diaphragm valves is two, and the two second diaphragm valves are respectively and sequentially installed at one end, close to the rotary cleaning head, of the lower side of the injection water pipeline.

Through the design of the technical scheme, the two second diaphragm valves can be timely closed when the injection water pipeline breaks down, and the U-shaped design at the upper end of the injection water pipeline can prevent water backflow and air discharge and meet the use specification of injection water.

More preferably, one end of the sterile alcohol discharging pipeline, which is far away from the filtering pipeline, is provided with a downward sliding slope.

Through the design of the technical scheme, the sterile alcohol can be smoother when flowing out of the sterile alcohol discharge hole.

Compared with the prior art, the invention has the following beneficial effects: this device can realize three service functions of alcohol aseptic filtration, on-line cleaning, online sterilization, can control the advance rate of alcohol, can also realize measuring the supply that carries out aseptic alcohol, this device simple structure, the cost is lower, and all pipeline articles in this device all adopt 316L stainless steel material, and the diaphragm valve all is no diaphragm valve that is detained, and final alcohol after this device filters is aseptic condition, accords with the requirement of national GMP drug manufacturing standard.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the structures shown in the drawings without creative efforts.

FIG. 1 is a simplified schematic diagram of the overall structure of an alcohol filtering device for an aseptic plant according to the present invention;

FIG. 2 is a schematic diagram of the structure of an alcohol tank part of an alcohol filtering device for an aseptic workshop according to the present invention;

FIG. 3 is an enlarged view of a portion of an alcohol filtration unit A for use in an aseptic plant according to the present invention;

FIG. 4 is an enlarged view of a portion B of an alcohol filtration unit for use in an aseptic plant according to the present invention;

FIG. 5 is a schematic view of the overall structure of an alcohol filtering device for an aseptic plant according to the present invention.

In the drawings are labeled: 1-alcohol liquid tank, 2-water pipeline for injection, 201-water inlet, 202-water outlet, 3-pure steam pipeline, 301-pure steam inlet, 4-sterile air pipeline, 401-sterile air inlet, 5-alcohol capacity observation window, 6-alcohol input head, 7-reserved hole plug, 8-rupture disk, 9-diaphragm valve, 901-first diaphragm valve, 902-second diaphragm valve, 903-third diaphragm valve, 904-fourth diaphragm valve, 905-fifth diaphragm valve, 906-sixth diaphragm valve, 907-seventh diaphragm valve, 908-eighth diaphragm valve, 909-ninth diaphragm valve, 9010-tenth diaphragm valve, 9011-eleventh diaphragm valve, 9012-twelfth diaphragm valve, 10-rotary cleaning head, 11-filtering pipeline, 12-drain valve, 13-thermometer, 14-membrane filter, 15-pressure gauge, 16-sterile alcohol discharging pipeline, 17-sterile disinfectant receiving room, 18-A level laminar flow cover, 19-water discharging pipeline, 1901-first water discharging pipeline, 1902-second water discharging pipeline, 20-sterile alcohol discharging hole, 21-alcohol input pipeline and 22-disinfectant preparing room.

The implementation, functional features and advantages of the objects of the present invention will be further explained with reference to the accompanying drawings.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

It should be noted that all the directional indicators (such as up, down, left, right, front, and rear … …) in the embodiment of the present invention are only used to explain the relative position relationship between the components, the movement situation, etc. in a specific posture (as shown in the drawing), and if the specific posture is changed, the directional indicator is changed accordingly.

In addition, the descriptions related to "first", "second", etc. in the present invention are for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In addition, technical solutions between various embodiments may be combined with each other, but must be realized by a person skilled in the art, and when the technical solutions are contradictory or cannot be realized, such a combination should not be considered to exist, and is not within the protection scope of the present invention.

The specific implementation scheme is as follows: referring to fig. 1-5, the invention is an alcohol filtering device for an aseptic workshop, comprising an alcohol tank 1, an alcohol filling device and a medium input device are arranged at the upper end of the alcohol tank 1, the alcohol filling device comprises an alcohol input head 6 and an alcohol input pipeline 21 connected between the alcohol input head 6 and the alcohol tank 1, a first diaphragm valve 901 is arranged on the alcohol input pipeline 21, the medium input device comprises an injection water pipeline 2, a pure steam pipeline 3 and an aseptic air pipeline 4, the injection water pipeline 2, the pure steam pipeline 3 and the aseptic air pipeline 4 are connected in parallel, one end of the injection water pipeline 2, the pure steam pipeline 3 and the aseptic air pipeline 4 is converged and connected with a rotary cleaning head 10, the rotary cleaning head 10 is inserted and connected at an upper position in the alcohol tank 1, a second diaphragm valve 902 is arranged on the injection water pipeline 2, a third diaphragm valve 903 is arranged on the pure steam pipeline 3, a fourth diaphragm valve 904, the lower extreme of alcohol solution jar 1 is equipped with filtering pipeline 11, be equipped with two membrane filter 14 on the filtering pipeline 11, be equipped with a no diaphragm valve that detains on the filtering pipeline 11 at least, be connected with manometer 15 on two membrane filter 14 respectively, filtering pipeline 11 one end through connection has aseptic alcohol ejection of compact pipeline 16 and outlet conduit 19 respectively, be equipped with ninth diaphragm valve 909 on the aseptic alcohol ejection of compact pipeline 16, outlet conduit 19 keeps away from filtering pipeline 11 one end and is equipped with trap 12 and thermometer 13, an alcohol filter equipment for aseptic workshop is whole to be placed in GMP clean area, GMP clean area includes that antiseptic solution configuration room 22 and aseptic antiseptic solution receive room 17, aseptic alcohol ejection of compact pipeline 16 settles inside aseptic disinfectant receive room 17.

Specifically, the upper side part of the injection water pipeline 2 is in a U shape, the two ends of the injection water pipeline are respectively provided with a water inlet 201 and a water outlet 202, one end of the pure steam pipeline 3, which is far away from the rotary cleaning head 10, is provided with a pure steam inlet 301, one end of the sterile air pipeline 4, which is far away from the rotary cleaning head 10, is provided with a sterile air inlet 401, and one end of the sterile alcohol discharging pipeline 16, which is far away from the filter pipeline 11, is provided with a sterile alcohol.

In the present invention, the entire set of apparatus must first be cleaned and sterilized before the alcohol is properly sterile filtered. In the cleaning process, the second diaphragm valve 902 is opened, the diaphragm valves on the filtering pipeline 11 and the diaphragm valves on the water outlet pipeline 19 are opened simultaneously, the rest diaphragm valves are closed, the drain valve 12 is opened, then the injection water enters the alcohol solution tank 1 through the water inlet 201 of the injection water pipeline 2 and penetrates through the whole set of device, so that the inside of the whole set of device is completely cleaned, the arrangement of the rotary cleaning ball 10 can enable the injection water to spray all around to the inner wall of the tank body of the alcohol solution tank 1, and the cleaning effect is better. After the cleaning is ensured, the source of the injection water is closed, the second diaphragm valve 902 is closed, the fourth diaphragm valve 904 is opened, the opening and closing states of other diaphragm valves are kept unchanged, sterile air is blown into the sterile filtering device through the sterile air inlet 401 of the sterile air pipeline 4, the internal pressure in the device is increased, and the residual injection water in the device is driven out of the device and is drained to a workshop drainage pipeline through the drain valve 12.

After the injection water in the sterile filtering device is completely drained, the fourth diaphragm valve 904 is closed, the diaphragm valve on the water outlet pipeline 19 and the drain valve 12 are closed, the third diaphragm valve 903 is opened, the opening and closing states of other diaphragm valves are kept unchanged, and pure steam is input into the sterile filtering device through the pure steam inlet 301 of the pure steam pipeline 3 so as to disinfect all parts, which can contact alcohol, in the sterile filtering device, the disinfection duration is long, and the complete disinfection in the device is ensured. After the sterilization is finished, the pure steam source and the third diaphragm valve 903 are closed, the fourth diaphragm valve 904 is opened, the ninth diaphragm valve 909 is opened, the sterile air is blown into the device to completely expel the moisture in the device out of the device, so that the inside of the device is in a state of being dry, clean and sterilized, then the fourth diaphragm valve 904 and the ninth diaphragm valve 909 are closed, and all the diaphragm valves on the filtering pipeline 11 are closed at the same time.

After the preparation work is finished, the first diaphragm valve 901 is opened, unprocessed alcohol is poured into the alcohol tank 1 through the alcohol input head 6, at this time, the GMP cleanness of the disinfectant preparation room 22 at least reaches grade C, the GMP cleanness of the sterile disinfectant receiving room 17 reaches grade A/grade B, after the alcohol is poured, the first diaphragm valve 901 is closed, meanwhile, the diaphragm valve and the drain valve 12 on the water outlet pipeline 19 are ensured to be in a closed state, the fourth diaphragm valve 904, the ninth diaphragm valve 909 and all the diaphragm valves on the filtering pipeline 11 are quickly opened, sterile air is input into the device through the sterile air inlet 401, the internal pressure in the device is increased, at this time, the pressure in the device is 4-6MPa, the compressed sterile air can push the alcohol in the alcohol tank 1 to flow towards the filtering pipeline 11, two membrane filters 14 arranged in the filtering pipeline 11 can filter the alcohol, the alcohol passing through the two membrane filters 14 is ensured to be in a sterile state, and flows out to the sterile disinfectant receiving room 17 through the sterile alcohol discharge hole on the sterile alcohol discharge pipeline 16, so that the alcohol can be ensured to be in the sterile state in the whole filtering process, and the alcohol after filtering is also in the sterile state, thereby meeting the requirements of the national GMP (good manufacturing practice) drug production standard.

In the invention, the value displayed on the pressure gauge 15 can enable people to accurately master the alcohol filtering rate and the injection water passing rate in the cleaning process, and the safety in the production process can be ensured by observing the data of the pressure gauge 15 at any time.

As a preferred embodiment of the invention, the upper end surface of the alcohol liquid tank 1 is provided with an alcohol capacity observation window 5, a reserved opening and a rupture disk 8, a reserved opening plug 7 is inserted into the reserved opening, and the alcohol capacity observation window 5 is made of glass.

In the invention, the alcohol capacity observation window 5 is made of transparent glass, so that the residual alcohol amount in the alcohol liquid tank 1 can be conveniently monitored at any time in the alcohol sterile filtering process, meanwhile, the addition amount can be controlled in the alcohol adding process, the first diaphragm valve 901 can be closed when the addition amount is enough, the reserved opening can be used as a standby opening, the pressure in the device can reach 4-6MPa due to pure steam and compressed sterile air, and the design of the rupture disk 8 is used for preventing potential safety hazards caused by overlarge pressure.

In another preferred embodiment of the present invention, a fifth diaphragm valve 905 is disposed between the membrane filter 14 and the alcohol tank 1, a sixth diaphragm valve 906 is disposed between the two membrane filters 14, a seventh diaphragm valve 907 and an eighth diaphragm valve 908 are sequentially disposed at an end of the membrane filter 14 away from the fifth diaphragm valve 905, the seventh diaphragm valve 907 is disposed inside the disinfectant configuration room 22, and the eighth diaphragm valve 908 is disposed inside the sterile disinfectant receiving room 17.

In the invention, the design of the two membrane filters 14 can ensure that the filtered liquid material is in a sterile state, the opening and closing positions of the filtering pipeline 11 can be conveniently controlled through the fifth diaphragm valve 905, the sixth diaphragm valve 906 and the seventh diaphragm valve 907 in a disinfectant preparation room, and the closing of the sterile alcohol discharging pipeline 16 can be controlled and closed through the eighth diaphragm valve 908 in the sterile disinfectant receiving room 17.

Specifically, the water outlet pipeline 19 includes a first water outlet pipeline 1901 and a second water outlet pipeline 1902, the trap 12 and the thermometer 13 are installed on the second water outlet pipeline 1902, the first water outlet pipeline 1901 is provided with a tenth diaphragm valve 9010 and a twelfth diaphragm valve 9012, the twelfth diaphragm valve 9012 is disposed inside the sterile disinfectant receiving room 17, and the second water outlet pipeline 1902 is provided with an eleventh diaphragm valve 9011.

In the invention, the thermometer 13 is installed at the coldest end of the device and is used for calculating F0 when the device is disinfected, and the tenth diaphragm valve 9010, the eleventh diaphragm valve 9011 and the twelfth diaphragm valve 9012 can be designed to conveniently control the opening and closing positions of the water outlet pipeline 19 and open and close according to actual requirements.

The water injection line 2, the pure steam line 3, the sterile air line 4, the alcohol input line 21, the filter line 11, the sterile alcohol discharge line 16, and the water discharge line 19 are all made of 316L stainless steel.

In the invention, all pipeline articles are made of 316L stainless steel, all related diaphragm valves are non-retention diaphragm valves, and the alcohol prepared by the equipment made of the material can better meet the aseptic requirement and also meet the requirement of the national GMP (good manufacturing practice) drug production standard.

Specifically, an A-level laminar flow cover 18 is arranged at an outlet at the upper end of the sterile disinfectant receiving room 17.

In the present invention, the class a laminar flow hood 18 is designed to protect the sterile alcohol received at the sterile disinfectant receiving room 17 from exposure, ensuring sterility.

In the present invention, the membrane filter 14 is a 0.22 μm membrane filter, and the 0.2 μm membrane filter is designed to allow the alcohol to be filtered in the filtering pipeline 11 more completely, which completely meets the requirements of the national GMP pharmaceutical production standard for alcohol sterility.

Specifically, two second diaphragm valves 902 are provided, and the two second diaphragm valves 902 are respectively attached to one end of the rotary cleaning head 10 on the lower side of the injection water pipe 2 in sequence.

In the present invention, the two second diaphragm valves 902 are designed to be closed in time when the water injection pipeline 2 fails, and the U-shaped design of the upper end of the water injection pipeline 2 can prevent water from flowing back and exhaust air, so as to meet the use specification of water for injection.

More specifically, the end of the sterile alcohol discharging pipe 16 away from the filtering pipe 11 is provided with a downward sliding slope, and the design of the downward sliding slope can make the sterile alcohol flow out of the sterile alcohol discharging hole 20 more smoothly.

The above-mentioned description of the present invention is only a preferred embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications and equivalents of the present invention as embodied in the present specification and drawings, or used directly or indirectly in other related fields, are encompassed by the present invention.

Claims (10)

1. An alcohol filtering device for an aseptic workshop is characterized by comprising an alcohol liquid tank, wherein an alcohol filling device and a medium input device are arranged at the upper end of the alcohol liquid tank, the alcohol filling device comprises an alcohol input head and an alcohol input pipeline connected between the alcohol input head and the alcohol liquid tank, a first diaphragm valve is arranged on the alcohol input pipeline, the medium input device comprises an injection water pipeline, a pure steam pipeline and an aseptic air pipeline, the injection water pipeline, the pure steam pipeline and the aseptic air pipeline are connected in parallel, one end of the injection water pipeline, the other end of the pure steam pipeline and the aseptic air pipeline are converged and connected with a rotary cleaning head, the rotary cleaning head is inserted into the inner upper position of the alcohol liquid tank, a second diaphragm valve is arranged on the injection water pipeline, a third diaphragm valve is arranged on the pure steam pipeline, and a fourth diaphragm valve is arranged on the aseptic air pipeline, the alcohol filtering device is characterized in that a filtering pipeline is arranged at the lower end of the alcohol tank, two membrane filters are arranged on the filtering pipeline, at least one detention-free diaphragm valve is arranged on the filtering pipeline, pressure gauges are connected to the two membrane filters respectively, one end of the filtering pipeline is connected with a sterile alcohol discharging pipeline and a water outlet pipeline in a penetrating mode respectively, a ninth diaphragm valve is arranged on the sterile alcohol discharging pipeline, one end of the water outlet pipeline, which is far away from the filtering pipeline, is provided with a drain valve and a thermometer, the whole alcohol filtering device for a sterile workshop is placed in a GMP clean area, the GMP clean area comprises a disinfectant configuration room and a sterile disinfectant receiving room, and the sterile alcohol discharging pipeline is arranged inside the sterile disinfectant receiving room.

2. The alcohol filtering device for the sterile workshop according to claim 1, wherein the upper part of the water pipeline for injection is U-shaped, and is provided with a water inlet and a water outlet at two ends respectively, the end of the pure steam pipeline away from the rotary cleaning head is provided with a pure steam inlet, the end of the sterile air pipeline away from the rotary cleaning head is provided with a sterile air inlet, and the end of the sterile alcohol discharging pipeline away from the filtering pipeline is provided with a sterile alcohol discharging hole.

3. The alcohol filtering device for the sterile workshop according to claim 2, wherein an alcohol capacity observation window, a reserved opening and a rupture disc are arranged on the upper end face of the alcohol tank, a reserved opening plug is inserted into the reserved opening, and the alcohol capacity observation window is made of glass.

4. The alcohol filtering device for the sterile workshop according to claim 3, wherein a fifth diaphragm valve is arranged between the membrane filter and the alcohol tank, a sixth diaphragm valve is arranged between the two membrane filters, a seventh diaphragm valve and an eighth diaphragm valve are arranged at one end of the membrane filter, which is far away from the fifth diaphragm valve, in sequence, the seventh diaphragm valve is arranged inside the disinfectant configuration room, and the eighth diaphragm valve is arranged inside the sterile disinfectant receiving room.

5. The alcohol filtering device for the sterile workshop according to claim 4, wherein the water outlet pipeline comprises a first water outlet pipeline and a second water outlet pipeline, the steam trap and the thermometer are installed on the second water outlet pipeline, a tenth diaphragm valve and a twelfth diaphragm valve are arranged on the first water outlet pipeline, the twelfth diaphragm valve is arranged inside the sterile disinfectant receiving room, and an eleventh diaphragm valve is arranged on the second water outlet pipeline.

6. The alcohol filter device for sterile workshop according to any one of claims 1-5, wherein the water injection line, the pure steam line, the sterile air line, the alcohol input line, the filter line, the sterile alcohol discharge line and the water outlet line are all made of 316L stainless steel.

7. The alcohol filtering device for an aseptic plant according to claim 1, wherein an upper end outlet of said sterile sterilizing liquid receiving room is provided with a class A laminar flow cover.

8. The alcohol filtering device for an aseptic plant according to claim 1, wherein said membrane filter is a 0.22 μm membrane filter.

9. The alcohol filtering device for the aseptic workshop according to claim 1, wherein the number of the second diaphragm valves is two, and the two second diaphragm valves are respectively and sequentially installed at one end of the lower side of the water injection pipeline, which is close to the rotary cleaning head.

10. The alcohol filtering device for the sterile workshop according to claim 1, wherein a downward sliding slope is arranged at one end of the sterile alcohol discharging pipeline far away from the filtering pipeline.

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