CN115068639A

CN115068639A - Clean district prevents device of flowing backward

Info

Publication number: CN115068639A
Application number: CN202210830651.8A
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: 2022-09-20

Abstract

The invention discloses a device for preventing backflow in a clean area, which comprises an air blocking pipeline, an emptying pipeline and an emptying port, wherein the air blocking pipeline is arranged in the clean area; 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 vent 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. The device for preventing the clean area from flowing backwards can ensure that an air block exists between equipment and a sewer under the condition of not influencing the temperature, the humidity and the pressure difference of the clean area, thereby effectively avoiding the backflow and avoiding the pollution.

Description

Clean district prevents device of flowing backward

Technical Field

The invention belongs to the field of cleaning and steam disinfection, and particularly relates to a device for preventing backflow in a clean area.

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 in chapter seven factory buildings for aseptic medicines, annex 1, pharmaceutical product quality management specifications (revised 2010), a water pool and a floor drain are forbidden to be arranged in an A/B-level clean area for aseptic production. In other clean areas, the pool or floor drain should be of appropriate design, layout and maintenance, and be fitted with an easy-to-clean device with air blocking 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 structure device, theoretically shown in fig. 1, called "Air break", whose purpose is to prevent water from being sucked back into the trap and even into the inspection well. 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 is 2d or 25mm when d is less than 13 mm. It can be seen that the device avoids back-flow by an open design (preventing the back-flow device 2 from being disconnected from the discharge conduit 1) instead of being in a closed connection with the discharge conduit 1, so that there is no negative pressure, i.e. an air break (the distance of which is H) between the back-flow device 2 and the discharge conduit 1 is prevented. 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 the clean area.

In food processing and pharmaceutical manufacturing enterprises, steam sterilization of clean 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 Air break has the drawbacks of disturbing temperature, humidity and pressure difference as described above, many clean areas 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, with 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.

Disclosure of Invention

In order to avoid backflow when clean process equipment in a clean area discharges liquid, gas and/or steam and simultaneously avoid interference on temperature, humidity and pressure difference of the clean area, the invention 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 hole through the vent pipeline, so that outside air can enter the air blocking pipeline through the vent hole; the horizontal position of the lowest point of the vent 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 floor next to the floor where the clean process equipment is located; 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 air blocking ducts, vents, and/or vents 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 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.

In some embodiments, the diameter of the air blocking conduit is 100-.

As described herein, a "clean zone" comprises four levels of clean zones of a pharmaceutical manufacturing GMP clean shop: one or more of a stage A, a stage B, a stage C, and a stage 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" can be any process equipment within a clean zone that is required to prevent various types of contamination, such as microbial contamination, cross-contamination, etc., such as a fluid dispensing tank, a freeze dryer, a sterilizer/sterilizer, a filter, a bottle washer, a plug washer, 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 air block (air block pipe, vent pipe and vent design) of the present invention can also release the drainage under pressure to prevent one process equipment from being pressed in from the discharge of another process equipment when the other process equipment is under pressure.

2. Regardless of the positive or negative pressure within the sanitary process equipment, the pressure can be released from the air lock line, the vent line and the line connecting the vent.

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 installed 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 invention can have a plurality of clean process equipment to share the design of the air blocking pipeline, the vent pipeline and the vent, only the diameter of the air blocking pipeline needs to be enlarged, and a plurality of vent pipelines and vents can be arranged if 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 drained, water in the trap is pushed out by the action of water pressure, so that the trap does not obstruct the drainage. 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 many kinds of drain valves, for example, mechanical drain valve is also called float type drain valve, which uses the density difference between condensed water and steam to make float lift and drive valve clack to open or close by the change of condensed water level so as to attain the goal of stopping 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 device for preventing the clean area from flowing backwards can ensure that an air block exists between equipment and a sewer under the condition of not influencing the temperature, the humidity and the pressure difference of the clean area, thereby effectively avoiding the backflow and avoiding 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 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 an embodiment of a device for preventing a clean zone from flowing backwards according to the present invention. To facilitate an understanding of the working environment of the apparatus for preventing a back-flow of a clean zone 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 characteristics, the purposes and the functions of the invention easy to understand, the invention is further described with reference to the specific drawings. However, the present invention is not limited to the following embodiments.

It should be understood that the structures, ratios, sizes, and the like shown in the drawings and described in the specification are only used for matching with the disclosure of the specification, so as to be understood and read by those skilled in the art, and are not used to limit the conditions under which the present invention can be implemented, so that the present invention has no technical significance, and any structural modification, ratio relationship change, or size adjustment should still fall within the scope of the present invention without affecting the efficacy 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 vent 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.

The first end of the trap 8 is connected to the air blocking duct 9 and the second end of the trap 8 is connected to the inspection shaft 12 so that liquid and/or vapour draining into the air blocking duct 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 the installation of the air blocking duct 9 in the ground or under the beam on the external environment of the building, the air blocking duct 9 is generally 100 mm and 300mm, preferably 120 mm and 280mm, 150 mm and 250mm, 180 mm and 220mm, or 200 mm.

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 controlled but not classified (CNC) or uncontrolled (NC) regions of the clean zone. The number of air blocking ducts, vents and/or vents is multiple. Otherwise, the procedure was as in example 1.

Example 3

In this embodiment, the means for preventing back-flow in the clean zone comprises an air blocking duct, a vent and an air cleaning element. Otherwise, the procedure was 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 clean process equipment can also be used for sterilizing the air blocking pipeline, so that the sanitary condition of the interior of the air blocking pipeline is kept.

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 detailed description of the preferred embodiments of the invention has been presented. It should be understood that numerous modifications and variations could be devised by those skilled in the art in light of the present teachings without departing from the inventive concepts. Therefore, the technical solutions available to those skilled in the art through logic analysis, reasoning and limited experiments based on the prior art according to the concept of the present invention should be within the scope of protection defined by the claims.

Claims

1. The device for preventing backflow in the clean area is characterized by comprising 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.

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 located; if the clean process equipment is located on a floor, the air blocking duct is disposed underground below the floor.

5. The apparatus of claim 1, wherein the vent is provided in a process sandwich, a CNC area or an NC area 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 area backflow prevention device as claimed in claim 1, further comprising a trap and inspection well; 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 as claimed in 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 zone as claimed in 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 both 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. The device for preventing backflow in a clean area as claimed in any one of claims 1 to 9, wherein the diameter of the air blocking pipe is 100-300 mm.