Pressure protection system and method

Abstract

The invention relates to the technical field of pressure protection in the pharmaceutical industry, and particularly discloses a pressure protection system and method which are used for solving the problems that in the prior art, parts of a breather valve fall off due to high-frequency vibration, online cleaning and sterilization (CIP / SIP) are not supported, and sanitation compliance is insufficient. The system comprises a breather valve, a tank body and a gas supply device, the breather valve adopts a valve disc assembly design without a lower fastener, the valve disc is allowed to move vertically through a guide mechanism, and the opening pressure is set through a counterweight adjusting mechanism, so that the breather valve is resistant to high-frequency vibration and prevents parts from loosening. The system supports on-line CIP and SIP operations, does not need to disassemble components, and can automatically maintain the inert gas micro-pressure environment in the tank. The invention further provides a pressure protection method which comprises the steps of providing a breather valve, setting pressure parameters and executing online cleaning and sterilization. The device safety and sanitation compliance are improved, and the device is particularly suitable for a pharmaceutical cleaning system.

Description

TECHNICAL FIELD

[0001] The present application relates to pressure protection devices in the pharmaceutical industry, in particular to a pressure protection system and method. BACKGROUND

[0002] In the pharmaceutical industry, organic solvents are added in the raw material production process, and inert gas is filled into the tank during the production process. The tank cannot produce a combustion explosion environment during the entire production process, and can maintain an oxygen-free state for long-term in the tank for products susceptible to oxidation or anaerobic.

[0003] As Figure 5 , Figure 6 Now the conventional practice is as follows:

[0004] 1. Through the diaphragm pressure sensor on the tank top, the PID regulated diaphragm valve on the tail gas discharge, and the pressure regulating device of inert gas supplement, the micro-pressure working condition of inert gas in the tank is adjusted by automatic control interlocking. However, this method depends on the automatic control system, and the system has a certain reaction time for data acquisition, analysis and processing. In addition, if the power system fails, the system will complete the autonomous reaction. Thus, the safety risk of the equipment and the risk of product quality are increased.

[0005] 2. In order to meet the safety of the equipment and the requirements of regulations, the pharmaceutical industry usually installs an industrial-grade double-interface breather valve on the pipeline of the sanitary tank top gas system. However, the design of this type of industrial-grade breather valve is intended for industrial environments, and its significant structural size and space occupation characteristics are not compatible with the installation requirements of clean systems. The design concept of clean room is to minimize space to reduce the number of air changes, thereby improving hygiene standards and operational efficiency. The industrial breather valve is large in size, not only occupying limited clean space, but also being unable to realize online CIP (clean-in-place) and SIP (sterilization-in-place) because it is not designed specifically for clean systems. This makes it necessary to introduce additional process steps during production to address the potential risks that may arise. These additional process measures aim to ensure compliance and safety of drug production while minimizing the potential health risks caused by equipment mismatch.

[0006] During the entire production process of the product, the air and oxygen in the system need to be replaced frequently by vacuum pumping or other storage tank equipment materials are pumped in by vacuum pumping. Thus, the pressure relief valve disc in the breather valve produces high-frequency vibration. The high-frequency vibration of the pressure relief valve disc will loosen the fastener structure in the breather valve and fall into the tank, thereby damaging the batch of products. SUMMARY

[0007] In view of the above-mentioned shortcomings of pressure protection devices in the current pharmaceutical industry, the present invention provides a pressure protection system and method, which is a hygienic breathing valve that can be CIP / SIP online, can withstand high-frequency vibration, and has no risk of component detachment.

[0008] To achieve the above objectives, the embodiments of the present invention adopt the following technical solutions:

[0009] A pressure protection system suitable for inert gas environments in the pharmaceutical industry includes a breather valve, a tank, and a gas supply device; the tank is connected to the breather valve via an interface; the gas supply device is configured to supply inert gas to the tank; wherein the system automatically maintains a micro-pressure inside the tank through the breather valve and supports online CIP and SIP.

[0010] According to one aspect of the present invention, the breathing valve is used for hygienic pressure protection and is further provided with an air inlet, an exhaust outlet, and a valve disc assembly; the valve disc assembly is disposed in the valve body and includes a guide mechanism and a sealing mechanism, the guide mechanism being configured to allow vertical movement of the valve disc, and the valve disc assembly having no lower fasteners; wherein the opening pressure of the valve disc assembly can be adjusted by a counterweight adjustment mechanism.

[0011] According to one aspect of the invention, the counterweight adjustment mechanism adjusts the opening pressure by replacing the counterweight block.

[0012] According to one aspect of the invention, a control unit is also included, which is linked to a breathing valve for monitoring the pressure inside the tank and triggering gas replenishment.

[0013] A pressure protection method for a cleanroom system includes the following steps:

[0014] A breather valve is provided, whose valve disc assembly adopts a design without lower fasteners to withstand high-frequency vibration and prevent parts from falling off;

[0015] The opening pressure of the breathing valve is set by the counterweight adjustment mechanism of the valve disc assembly;

[0016] The breathing valve can be cleaned in-line (CIP) and / or sterilized in-line (SIP) without disassembling the valve disc assembly.

[0017] According to one aspect of the invention, the online sterilization SIP operation includes discharging condensate through a condensate-hydrophobic interface.

[0018] Advantages of this invention: The above technical solution achieves seamless integration of the pressure protection system with the pharmaceutical clean environment, fundamentally solving the problems of loosening and detaching parts due to high-frequency vibration, insufficient hygiene compliance, and low operational efficiency. Specifically, the valve disc assembly design without lower fasteners ensures the stability of the assembly under high-frequency vibration, completely eliminating the risk of parts detaching and contaminating products. Simultaneously, the system supports online CIP and SIP operations without disassembling the valve disc assembly, significantly improving the convenience and thoroughness of cleaning and sterilization, meeting GMP hygiene standards. Combined with the linkage monitoring function of the control unit, the system can automatically maintain micro-pressure inside the tank and trigger gas replenishment, improving automation and production safety. The method of this invention is simple and efficient, reducing maintenance costs, and is particularly suitable for long-term stable operation in inert gas environments in the pharmaceutical industry, improving overall equipment reliability, compliance, and economic benefits. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 This is a schematic diagram of the structure of a pressure protection system and method according to the present invention;

[0021] Figure 2 This is a schematic diagram of the structure of a hinged positive pressure valve disc assembly according to the present invention;

[0022] Figure 3 This is a schematic diagram of the structure of a pressure relief valve disc assembly according to the present invention;

[0023] Figure 4 This is a schematic diagram of the structure of a guide bracket according to the present invention;

[0024] Figure 5 This is a top view of a guide bracket according to the present invention;

[0025] Figure 6 This is a schematic diagram of a prior art breather valve;

[0026] Figure 7 This is a schematic diagram of an existing industrial breather valve. Detailed Implementation

[0027] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0028] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. These terms are used only for the convenience of describing this application and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting the invention. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0029] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0030] Example 1

[0031] like Figure 1 , Figure 2 , Figure 3 As shown, this embodiment provides a pressure protection system and method. The breathing valve includes a valve body 1, a docking interface 2, an air inlet 3, an exhaust outlet 4, a hinged positive pressure valve disc assembly 5, and a pressure relief valve disc assembly 6. The docking interface 2 is disposed on the valve body 1. The hinged positive pressure valve disc assembly 5 is installed inside the air inlet 3 and can be opened under external gas pressure or vacuum inside the tank. The pressure relief valve disc assembly 6 includes a guide bracket 61, a sealing gasket 62, and a counterweight 63. The lower part of the guide bracket 61 is a through-type circular tube structure, forming a gas channel. The sealing gasket 62 and the counterweight 63 are disposed on the upper part of the guide bracket 61, and the thickness of the sealing gasket 62 is lower than the upper surface of the guide bracket 61. The pressure relief valve disc assembly 6 has no lower fastener structure.

[0032] In this embodiment, the valve body 1 is the main structural component of the entire breathing valve. It is typically made of 316L stainless steel through precision casting or welding. The internal flow channels and cavities are mechanically polished and electropolished, with a surface roughness Ra≤0.8μm, ensuring that it meets hygiene requirements and has no dead corners for cleaning. The valve body 1 has a compact design to minimize its space occupation in the cleanroom.

[0033] The docking interface 2 is specifically located on the top of the valve body 1, serving as a connection port to the top of the pharmaceutical or biological reactor. The air inlet 3 and exhaust outlet 4 are respectively located on both sides of the valve body 1. In this embodiment, both the docking interface 2 and the air inlet 3 adopt a hygienic Tri-Clamp interface conforming to ASME BPE standards to ensure a seamless, fast, and hygienic connection with the clean piping system.

[0034] The hinged positive pressure valve disc assembly 5 includes a hinge seat 51 fixed inside the valve body 1 and a positive pressure valve disc 52 connected to the hinge seat 51 via a rotating shaft. The hinge seat 51 is fixed to the inner wall of the valve body 1 by welding or using sanitary fasteners. The positive pressure valve disc 52 is typically made of 316L stainless steel substrate covered or inlaid with elastic sealing materials such as PTFE or silicone. In this embodiment, the hinge seat 51 and the positive pressure valve disc 52 are detachably connected, specifically through a removable rotating shaft. This design facilitates the quick disassembly of the entire valve disc assembly for individual cleaning, sterilization, or replacement, which is key to achieving online CIP and SIP functions.

[0035] The pressure relief valve disc assembly 6 is the core innovation of this invention. The guide bracket 61 is typically machined from 316L stainless steel, and its lower through-type circular tube serves as a guide mechanism, engaging with the guide hole on the valve body 1 to ensure the assembly can only move vertically up and down. The tube wall has multiple perforated structures, which serve as exhaust channels in case of overpressure. The sealing gasket 62 and the counterweight 63 are fixed to the top of the guide bracket 61 by an upper fastener (such as a bolt). The sealing gasket 62 is made of a high-temperature and corrosion-resistant material, specifically PTFE or silicone. Its sealing surface is designed to be slightly lower than the upper surface of the guide bracket 61 to ensure effective sealing by the pressure of the counterweight 63 when closed. The opening pressure of the pressure relief valve disc assembly 6 is adjusted by replacing the counterweight 63 with different weights or specifications to meet different process pressure settings (such as 2 kPa, 3 kPa, etc.). Most importantly, the lower part of the component, namely the circular tube portion of the guide bracket 61 and below, has no fasteners such as screws, snap rings, or pressure plates, which fundamentally eliminates the risk of parts loosening and falling into the tank due to high-frequency vibration.

[0036] In addition, in this embodiment, the valve body 1 is also provided with a condensate drain port 7. This port is usually a sanitary small-diameter clamp port or threaded port, located at the lower point of the valve cavity, and is used to drain the condensate generated during the online SIP process to prevent water accumulation that could lead to incomplete sterilization.

[0037] The valve body 1 and all internal components of the breathing valve described in this invention are made of 316L stainless steel or other sanitary materials that meet GMP requirements (such as alloy materials that meet relevant standards), ensuring that the entire device meets the requirements of cleanliness and corrosion resistance at the material level.

[0038] The beneficial effects of this embodiment are as follows: by adopting a pressure relief valve disc assembly without any lower fasteners, the risk of parts falling off due to high-frequency vibration is fundamentally eliminated, greatly improving equipment and product safety; at the same time, its all-hygienic materials, Tri-Clamp interface, and detachable hinge design ensure that the valve can be perfectly integrated into the clean piping system and supports efficient online CIP cleaning and SIP sterilization, meeting the stringent compliance and hygiene requirements of the pharmaceutical industry; in addition, the method of adjusting the opening pressure by using a counterweight makes operation and maintenance simpler and more reliable.

[0039] Example 2

[0040] The difference between this embodiment and Embodiment 1 is that, in this embodiment, the valve body 1 is made of a sanitary alloy material that meets GMP requirements and is precision machined, featuring a smooth inner surface and a flow channel design that conforms to fluid dynamics. The docking interface 2 is located on the top of the valve body 1 and uses a quick-release clamp-type sanitary interface. The air inlet 3 and the exhaust outlet 4 are located on both sides of the valve body 1, respectively, and use the same interface standard to ensure the consistency of system connections.

[0041] The hinged positive pressure valve disc assembly 5 includes a hinge seat 51 fixed within the valve body 1 and a positive pressure valve disc 52 that engages with the hinge seat 51 via a connecting mechanism. The positive pressure valve disc 52 employs a structure of a corrosion-resistant metal matrix composite sealing material. The hinge seat 51 and the positive pressure valve disc 52 are connected by an integral hinge, ensuring the reliability and stability of the connection.

[0042] The guide bracket 61 of the pressure relief valve disc assembly 6 is made of corrosion-resistant metal, and its lower penetrating circular tube has multiple vent channels. The sealing gasket 62 uses a hygienic flexible seal and is fixed to the guide bracket 61 together with the counterweight 63 via an upper connecting mechanism. The opening pressure of the pressure relief valve disc assembly 6 is set by adjusting the configuration of the counterweight 63 to meet different working pressure requirements. The entire pressure relief valve disc assembly 6 is completely free of fasteners in its lower region, fundamentally avoiding the risk of parts loosening.

[0043] In addition, the valve body 1 is provided with a condensate drain port 7, which adopts a sanitary connection method to drain the condensate generated during operation.

[0044] All components of the breathing valve in this embodiment are manufactured using sanitary-grade materials that meet GMP standards, ensuring that the equipment meets the requirements for use in clean environments.

[0045] The advantages of this invention are: by adopting different interface forms, connection methods and material selections, it provides another feasible implementation scheme while maintaining the core innovative structure, demonstrating the applicability and scalability of the invention, and avoiding the disclosure of unclaimed technical details.

[0046] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A pressure protection system suitable for use in an inert gas environment in the pharmaceutical industry, characterized in that, The system comprises a breather valve, a tank, and a gas supply device; the tank is connected with the breather valve through an interface; the gas supply device is configured to provide inert gas into the tank; wherein the system automatically maintains micro-pressure in the tank through the breather valve, and supports online CIP and SIP.

2. The pressure protection system of claim 1, wherein, The breather valve is used for sanitary pressure protection, and is further provided with an air inlet, a tail gas discharge port, and a valve disc assembly; the valve disc assembly is arranged in the valve body and comprises a guide mechanism and a sealing mechanism; the guide mechanism is configured to allow the valve disc to move vertically, and the valve disc assembly is free of any lower fastener; wherein the opening pressure of the valve disc assembly can be adjusted through a counterweight adjustment mechanism.

3. The pressure protection system of claim 2, wherein, The counterweight adjustment mechanism adjusts the opening pressure by replacing counterweight blocks.

4. The pressure protection system of claim 2, wherein, The interface of the breather valve meets sanitary standards and supports quick-mounting connection.

5. The pressure protection system of claim 1, wherein, Further comprising a control unit linked with the breather valve, which is used to monitor the pressure in the tank and trigger gas replenishment.

6. A pressure protection method for a clean system, characterized by, The pressure protection system according to any one of claims 1 to 7, comprising the following steps: Providing a breather valve, wherein the valve disc assembly of the breather valve adopts a lower fastener-free design to resist high-frequency vibration and prevent parts from falling off; Setting the opening pressure of the breather valve through a counterweight adjustment mechanism of the valve disc assembly; Performing online cleaning CIP and / or online sterilization SIP operations on the breather valve without disassembling the valve disc assembly.

7. The pressure protection method for a clean system according to claim 1, wherein The online sterilization SIP operation comprises discharging condensed water through a condensed water drainage interface.

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