CN218010401U

CN218010401U - Clean district prevents device of backward flow

Info

Publication number: CN218010401U
Application number: CN202221821685.2U
Authority: CN
Inventors: 欧阳健; 张耀良; 王敦品
Original assignee: Wuxi Yaoming Biotechnology Co ltd
Current assignee: Wuxi Yaoming Biotechnology Co ltd
Priority date: 2022-07-15
Filing date: 2022-07-15
Publication date: 2022-12-13
Anticipated expiration: 2032-07-15

Abstract

The utility model discloses a device for preventing backflow in a clean area, which comprises an air blocking pipeline, a vent pipeline and a vent; the air blocking pipeline is communicated with the vent through the vent pipeline, so that outside air can enter the air blocking pipeline through the vent; the horizontal position of the lowest point of the emptying port is higher than the horizontal position of the highest point of the air blocking pipeline; the air blocking pipe is used for connecting with a discharge port of clean process equipment in the clean zone, so that liquid, gas and/or steam discharged by the clean process equipment can enter the air blocking pipe. The utility model provides a clean district prevents device of flowing backward under the condition that does not influence clean district temperature itself, humidity and pressure differential, can ensure to have an air to block between equipment and sewer to effectively avoid flowing backward, avoided the pollution.

Description

Clean district prevents device of flowing backward

Technical Field

The utility model belongs to wash and steam sterilization field, concretely relates to clean district prevents device of flowing backward.

Background

According to the fiftieth drainage facility in chapter iv "factory building and facilities" in the code for quality management of pharmaceutical products (revised 2010), the drainage facility should be of a suitable size and be equipped with a device for preventing backflow. In twenty-ninth item of factory building, chapter seven in annex 1, aseptic chemicals, in pharmaceutical product quality management Specification (revised in 2010), the A/B-class clean area of aseptic production is forbidden to be provided with a water pool and a floor drain. In other clean areas the pool or floor drain should be of a suitable design, layout and maintenance and be fitted with easy to clean devices with air blocking function to prevent back flow.

Negative pressure may be generated in the chamber when the process equipment is cooled after steam sterilization. Since the drain of the clean process equipment is connected to the sewage, water and air in the sewage are sucked, resulting in pollution.

The american society of mechanical engineers has designed a construction device, theoretically shown in fig. 1, called "airbereak", whose purpose is to prevent and control the back suction of traps and even water inside inspection wells. The device is provided with a funnel-shaped backflow preventing device 2 at the downstream of a discharge pipeline 1 of clean process equipment, the distance from the horizontal position of the highest point of the backflow preventing device 2 to the horizontal position of the lowest point of the discharge pipeline 1 is H, the diameter of the discharge pipeline 1 is d, and H =25mm when H =2d or d < 13 mm. It can be seen that the device is free of underpressure by virtue of the open design (preventing the backflow device 2 from being detached from the discharge conduit 1) instead of being connected in a closed manner to the discharge conduit 1, i.e. by virtue of the air block (the air block being at a distance H) between the backflow device 2 and the discharge conduit 1 being prevented from flowing backwards. However, the open design is such that the device is placed in a clean area, which may interfere with the temperature, humidity and pressure difference of the room, and does not meet the requirements of GMP (good manufacturing practice) for a clean area.

In food processing and pharmaceutical manufacturing enterprises, steam sterilization of cleaning equipment is commonly used. The sterilized equipment is in a high temperature state, and therefore, it is necessary to cool the equipment to a normal temperature state or a use state temperature. Although airbereak has the drawbacks of disturbing temperature, humidity and pressure difference as described above, many clean zones of GMP pharmaceutical factories are still in use, and are generally used in two cases. One is that the condensed water is directly discharged into Air break when the temperature is lower than 45 ℃; the other is that the condensed water is cooled to 45 ℃ by a heat exchanger when the temperature of the condensed water is not lower than 45 ℃ and then discharged into Air break.

Under the condition of the same temperature and pressure, the specific gravity of air is greater than that of steam, so that the steam is under the upper air, and the drainage pipeline is generally arranged below the clean process equipment, so that the steam can be discharged after the air on the lower layer is discharged, the pressure in a drainage pipeline system is increased frequently, and particularly when a plurality of clean process equipment are connected with one main pipeline, the phenomenon that water in the main pipeline is pressed into other equipment connected with the main pipeline when the equipment is sterilized in Situ (SIP) easily occurs, and pollution is caused.

Furthermore, backflow should not be avoided by check valves in the presence of factors affecting SIP and risking contamination. As the check valve may be a pathway for "inoculation" of microorganisms due to the presence of contact with the back-flowing liquid, vapor and/or gas, etc.

SUMMERY OF THE UTILITY MODEL

In order to avoid backflow when clean process equipment in a clean area discharges liquid, gas and/or steam and simultaneously avoid interference with the temperature, humidity and pressure difference of the clean area, the utility model provides a device for preventing backflow in the clean area, which comprises an air blocking pipeline, an emptying pipeline and an emptying port; the air blocking pipeline is communicated with the vent through the vent pipeline, so that outside air can enter the air blocking pipeline through the vent; the horizontal position of the lowest point of the emptying port is higher than the horizontal position of the highest point of the air blocking pipeline; the air blocking duct is adapted to be connected to a discharge of clean process equipment in the clean zone such that liquid, gas and/or vapour discharged by the clean process equipment can enter the air blocking duct.

In some embodiments, further comprising an air purification element; the air purification element is arranged on the vent and used for ensuring that the outside air sucked by the negative pressure of the clean process equipment is relatively clean.

In some embodiments, the air purification element is a respirator or a filter.

In some embodiments, the air blocking duct is disposed at a lower floor of the clean process equipment; if the clean process equipment is located on a floor, the air blocking duct is disposed underground below the floor.

In some embodiments, the vents are disposed in the process sandwich of the denuded zone, controlled but not classified (CNC) regions or uncontrolled (NC) regions.

In some embodiments, the number of the air blocking ducts, the vents, and/or the vent ducts is not limited to 1. In some embodiments, the number of vents and vents is multiple.

In some embodiments, a trap and a manhole; the first end of the trap is connected with the air blocking pipe, and the second end of the trap is connected with the inspection well, so that liquid and/or steam discharged into the air blocking pipe can flow into the inspection well.

In some embodiments, the inspection well is provided with a water outlet.

In some embodiments, further comprising a drain line, a trap, and a manhole; the trap is arranged in the inspection well; the first end of the trap is connected with the air blocking pipeline through a drainage pipeline, so that liquid and/or steam discharged into the air blocking pipeline can flow into the inspection well through the second end of the trap.

In some embodiments, further comprising a main pipeline and a bypass pipeline; the main pipeline is sequentially provided with a first valve, a steam trap and a second valve; a third valve is arranged on the side pipeline; the main pipeline and the bypass pipeline are both connected with a discharge port of the clean process equipment and are also both connected with the air blocking pipeline; the liquid flowing out of the discharge port of the clean process equipment can enter the air blocking pipeline through the first valve, the steam trap and the second valve in sequence, and can also enter the air blocking pipeline through the third valve.

In some embodiments, the air blocking tubing has a diameter of 100 to 300mm, preferably 120 to 280mm,150 to 250mm,180 to 220mm, or 200mm.

As described herein, a "clean zone" comprises four levels of clean zones of a pharmaceutical manufacturing GMP clean shop: one or more of class A, class B, class C, and class D; other regions with higher cleanliness requirements, such as those in certain precision manufacturing, may also be included.

As used herein, a "clean process equipment" may be any process equipment within a clean zone that requires protection from various types of contamination, such as microbial contamination, cross-contamination, etc., such as dispensing tanks, freeze dryers, sterilization cabinets/kettles, filters, bottle washers, plug washers, etc. "clean process equipment" includes the equipment mentioned above that requires SIP and also includes equipment that requires Clean In Place (CIP).

Has the beneficial effects that:

1. the design of the air blocking duct, the emptying duct and the emptying opening is such that the air blocking duct becomes a duct for emptying, i.e. corresponds to an air blocking between the clean process equipment and the sewer. The utility model discloses an air block (the design of air block pipeline, blow-down pipe and drain) can also release the drainage of pressure when avoiding a clean technology equipment to press in when the drainage of pressure, from the discharge port of another clean technology equipment.

2. Regardless of the positive or negative pressure in the sanitary process equipment, the pressure can be released from the air blocking line, the vent line and the line through which the vent communicates.

3. The high-temperature water discharged by the clean process equipment can be directly discharged into the air blocking pipeline without being cooled by the heat exchanger, so that the air blocking pipeline can be sterilized, the aim of keeping the sanitary condition inside the air blocking pipeline is fulfilled, and the device is energy-saving, environment-friendly, simple, convenient and low in cost.

4. The air blocking duct is generally disposed at the next floor of the clean process equipment, which makes construction, operation and maintenance convenient.

5. In order to facilitate later maintenance operation, a trap at the downstream of the air blocking pipeline can be arranged in the inspection well, and the design is convenient for eliminating the blockage fault.

6. The utility model discloses can have a plurality of clean process units to come this air of sharing to block the design of pipeline, blow-down pipeline and drain, only need enlarge the air block the pipeline the diameter can, also can establish several blow-down pipelines and drain more when necessary.

7. The trap plays a role of water sealing, and odor in the inspection well is prevented from returning to pollute the clean process equipment. When water needs to be discharged, water in the trap is pushed out by the action of water pressure, so that the trap does not obstruct the water discharge. The U-shaped pipe structure (such as 2 or more than 2U-shaped pipes) of the trap enables the trap to have a water sealing function.

8. The design of the main pipeline and the bypass pipeline is beneficial to opening the bypass pipeline to complete partial operation when the main pipeline breaks down or is overhauled. The side pipeline is in a closed state at ordinary times. The steam trap (also called as steam trap) only drains water but does not ventilate/steam, thus avoiding steam loss. There are several kinds of steam traps, for example, mechanical steam trap, also called float trap, which uses the density difference between condensed water and steam to make the float lift and drive the valve flap to open or close by the level change of the condensed water, so as to achieve the purpose of blocking steam and draining water. The mechanical trap has small supercooling degree, is not influenced by the working pressure and temperature change, can drain water immediately when water exists, does not store water in heating equipment, and can ensure that the heating equipment achieves the best heat exchange efficiency. The maximum back pressure rate is 80%, the working quality is high, and the trap is the most ideal trap for heating equipment in the production process.

The utility model provides a clean district prevents device of flowing backward under the condition that does not influence clean district temperature itself, humidity and pressure differential, can ensure to have an air to block between equipment and sewer to effectively avoid flowing backward, avoided the pollution.

The conception, the specific structure and the technical effects of the present invention will be further described with reference to the accompanying drawings, so as to fully understand the objects, the features and the effects of the present invention.

Drawings

FIG. 1 is a schematic diagram of the structure of Air break.

Fig. 2 is a schematic structural diagram of a specific embodiment of the device for preventing backflow in a clean area according to the present invention. To assist in understanding the working environment of the device for preventing backflow in a clean area of the present invention, fig. 2 also shows clean process equipment and a foundation.

Wherein the reference numbers are as follows:

1-discharge pipeline, 2-backflow prevention device, 3-clean process equipment, 4-first valve, 5-steam trap, 6-second valve, 7-third valve, 8-trap, 9-air blocking pipeline, 10-vent, 11-vent pipeline, 12-inspection well and 14-foundation.

Detailed Description

In order to make the technical means, the inventive features, the objectives and the functions of the present invention easy to understand, the present invention will be further described with reference to the following specific drawings. However, the present invention is not limited to the following embodiments.

It should be understood that the structure, proportion, size and the like shown in the drawings attached to the present specification are only used for matching with the content disclosed in the specification, so as to be known and read by those skilled in the art, and are not used for limiting the limit conditions of the present invention, so that the present invention does not have the substantial technical significance, and the modification of any structure, the change of the proportion relation or the adjustment of the size should still fall within the scope of the technical content disclosed in the present invention without affecting the function and the achievable purpose of the present invention.

Example 1

Fig. 2 shows that the device for preventing the clean area from flowing backwards of the embodiment comprises an air blocking pipeline 9, a vent pipeline 11, a vent 10, an air purifying element, a trap 8, an inspection well 12, a main pipeline and a bypass pipeline.

The air blocking pipeline 9 is communicated with the vent 10 through the vent pipeline 11, so that outside air can enter the air blocking pipeline 9 through the vent 10; the horizontal position of the lowest point of the emptying port 10 is higher than the horizontal position of the highest point of the air blocking pipeline 9; the air shut-off line 9 is intended to be connected to the discharge of the clean process equipment 3 in the clean zone, so that liquid, gas and/or vapour discharged by the clean process equipment 3 can enter the air shut-off line 9. In this embodiment the process equipment 3 is cleaned to produce steam condensate.

The air cleaning element is mounted on the vent 10 for ensuring relative cleanliness of the ambient air drawn in by the negative pressure of the cleaning process equipment. The air purification element is a respirator in this embodiment.

In this embodiment, since the clean process equipment 3 is located at the bottom floor, the air blocking duct 9 is disposed underground under the bottom floor, i.e., in the foundation 14.

Vents 10 are provided in the process sandwich of the denuded zone.

A first end of the trap 8 is connected to the air shut-off line 9 and a second end of the trap 8 is connected to the inspection shaft 12, so that liquid and/or vapour discharged into the air shut-off line 9 can flow into the inspection shaft 12. The inspection well 12 is provided with a water outlet 13.

A first valve 4, a steam trap 5 and a second valve 6 are sequentially arranged on the main pipeline; a third valve 7 is arranged on the bypass pipeline; the main pipeline and the side pipeline are both connected with a discharge port of the clean process equipment 3 and are also connected with an air blocking pipeline 9; the liquid flowing out of the discharge of the clean process equipment 3 can pass through the first valve 4, the steam trap 5 and the second valve 6 in order into the air-blocking duct 9 and can also pass through the third valve 7 into the air-blocking duct 9.

The diameter of the air-blocking duct 9 is theoretically as large as possible. However, considering the influence of practical factors such as the influence of installing the air blocking duct 9 excessively thick under the ground or a beam on the external environment such as a building, the air blocking duct 9 is generally 100 to 300mm, preferably 120 to 280mm,150 to 250mm,180 to 220mm, or 200mm.

Example 2

In this embodiment, the device for preventing backflow in the clean area comprises an air blocking pipeline, an emptying opening, an air purifying element, a drainage pipeline, a trap, an inspection well, a main pipeline and a bypass pipeline. The trap is arranged in the inspection well; the first end of the trap is connected to the air blocking duct via a drain duct, so that liquid and/or vapor which is discharged into the air blocking duct can flow into the inspection shaft via the second end of the trap. The air cleaning element is a filter. The air blocking pipeline is arranged at the next floor of the floor where the clean process equipment is located. Vents are provided in either the Controlled Not Classified (CNC) or uncontrolled (NC) regions of the denuded zone. The number of the air blocking pipelines, the vent holes and/or the vent pipelines is multiple. The rest of the process was the same as in example 1.

Example 3

In this embodiment, the means for preventing backflow in the clean zone comprises an air blocking duct, a vent and an air cleaning element. The rest of the process was the same as in example 1.

After the cleaning process equipment is subjected to hot water cleaning or steam sterilization, hot water is discharged from the equipment to a sewer. The hot water first enters the air blocking duct where the pressure or vacuum carried is released. The high-temperature water discharged by the cleaning process equipment can also disinfect and extinguish the air blocking pipeline, thereby keeping the sanitary condition in the air blocking pipeline.

The discharged water passes through the air blocking pipeline and then enters the trap to be discharged into the inspection well, and the trap plays a role in preventing the air in the inspection well from being communicated with clean process equipment. And discharging the water from the trap into an inspection well for cooling and then discharging.

The water discharged by the clean process equipment after being subjected to heat sterilization has temperature, and can perform the pasteurization effect on the pipeline through which the water is discharged.

If the air blocking duct has been buried underground, the trap can also be placed in the manhole, which facilitates subsequent dredging and maintenance operations.

The foregoing has described in detail preferred embodiments of the present invention. It should be understood that numerous modifications and variations could be devised by those skilled in the art in light of the teachings of this invention without undue experimentation. Therefore, the technical solutions that can be obtained by a person skilled in the art through logic analysis, reasoning or limited experiments based on the prior art according to the concepts of the present invention should be within the scope of protection defined by the claims.

Claims

1. The device for preventing the backflow of the clean area is characterized by comprising an air blocking pipeline, a vent pipeline and a vent; the air blocking pipeline is communicated with the vent through the vent pipeline, so that outside air can enter the air blocking pipeline through the vent; the horizontal position of the lowest point of the emptying port is higher than the horizontal position of the highest point of the air blocking pipeline; the air blocking duct is adapted to be connected to a discharge of clean process equipment in the clean zone such that liquid, gas and/or vapour discharged by the clean process equipment can enter the air blocking duct.

2. The apparatus for preventing backflow in a clean zone as claimed in claim 1, further comprising an air cleaning element; the air purification element is arranged on the vent and used for ensuring that the outside air sucked by the negative pressure of the clean process equipment is relatively clean.

3. The apparatus of claim 2, wherein the clean zone is a respirator or a filter.

4. The apparatus for preventing backflow in a clean area according to claim 1, wherein the air blocking pipeline is arranged at the next floor of the floor where the clean process equipment is arranged; if the clean process equipment is located on a floor, the air blocking duct is disposed underground below the floor.

5. The clean zone backflow prevention device as claimed in claim 1, wherein the vent is provided in a process interlayer, a CNC region or an NC region of the clean zone.

6. The apparatus for preventing backflow in a clean zone in accordance with claim 1, wherein the number of said air blocking ducts, said vents and/or said vent ducts is not limited to 1.

7. The clean zone backflow prevention device of claim 1, further comprising a trap and a manhole; the first end of the trap is connected with the air blocking pipe, and the second end of the trap is connected with the inspection well, so that liquid and/or steam discharged into the air blocking pipe can flow into the inspection well.

8. The clean area backflow prevention device of claim 1, further comprising a drain pipe, a trap and an inspection well; the trap is arranged in the inspection well; the first end of the trap is connected with the air blocking pipeline through a drainage pipeline, so that liquid and/or steam discharged into the air blocking pipeline can flow into the inspection well through the second end of the trap.

9. The apparatus for preventing backflow in a clean area according to claim 1, further comprising a main pipeline and a bypass pipeline; the main pipeline is sequentially provided with a first valve, a steam trap and a second valve; a third valve is arranged on the side pipeline; the main pipeline and the bypass pipeline are both connected with a discharge port of the clean process equipment and are also connected with the air blocking pipeline; the liquid flowing out of the discharge port of the clean process equipment may enter the air blocking pipe through the first valve, the steam trap and the second valve in this order, or may enter the air blocking pipe through the third valve.

10. An arrangement for preventing backflow in a clean zone as claimed in any one of claims 1 to 9, wherein the diameter of the air-blocking duct is in the range 100 to 300mm.