A freeze dryer with VHP sterilization function

Abstract

This application relates to the field of biopharmaceutical technology, and particularly to a freeze dryer with VHP sterilization function, including a freeze drying chamber, a sterilization system, and a baffle plate. It includes a sterilizer for generating hydrogen peroxide gas, which delivers hydrogen peroxide gas into the freeze drying chamber via an inlet pipe. The outer wall of the inlet pipe is covered with a heating film to maintain the hydrogen peroxide delivery state. The baffle plate is located inside the freeze drying chamber to guide the diffusion of hydrogen peroxide gas within the chamber. This solution, by setting an adjustable-temperature heating film on the outside of the inlet pipe, avoids liquefaction of hydrogen peroxide gas during delivery, thus preventing poor sterilization. Furthermore, the baffle plate inside the freeze drying chamber guides the hydrogen peroxide gas used for sterilization to distribute evenly within the chamber, reducing sterilization dead zones.

Description

Technical Field

[0001] This application relates to the field of biopharmaceutical technology, and in particular to a freeze dryer with VHP sterilization function. Background Technology

[0002] In the fields of pharmaceuticals and biopharmaceuticals, online sterilization using vacuum freeze dryers (referred to as freeze dryers) is a crucial step in ensuring the sterility and safety of products.

[0003] Traditional sterilization methods have significant limitations: while moist heat sterilization is reliable, its high temperature and humidity environment may damage equipment components; and sterilization with chemical gases such as formaldehyde has serious problems such as toxic residues, long removal time, and environmental harm.

[0004] Therefore, vaporized hydrogen peroxide (VHP) sterilization technology, due to its significant advantages of low temperature, high efficiency, and no toxic residue (ultimately decomposing into water and oxygen), has become an ideal choice for freeze dryer sterilization. However, the integration of VHP technology with freeze dryers still faces several technical challenges that urgently need to be addressed:

[0005] Uneven distribution: Due to the complex internal structure of the freeze dryer, VHP vapor cannot evenly cover all surfaces, which can easily create sterilization dead zones.

[0006] Steam condensation: VHP steam is prone to condensation and failure on the low-temperature surfaces of pipes or cavities, leading to local sterilization failure.

[0007] Process out of control: The lack of real-time monitoring and feedback of key parameters (such as concentration and temperature) during the sterilization process makes it impossible to guarantee the reliability and repeatability of the sterilization effect.

[0008] Therefore, there is an urgent need in the field for a new type of VHP sterilization freeze dryer that can overcome the above-mentioned defects in order to achieve rapid, reliable and verifiable comprehensive sterilization. Utility Model Content

[0009] The purpose of this application is to provide a freeze dryer with VHP sterilization function, which can avoid the problems of VHP vapor liquefaction, uneven VHP vapor distribution and incomplete residue removal.

[0010] To achieve the above objective, this application provides a freeze dryer with VHP sterilization function, including a freeze drying chamber, and further comprising:

[0011] The sterilization system includes a sterilizer for generating hydrogen peroxide gas, which delivers hydrogen peroxide gas into the freeze-drying chamber through an inlet pipe, the outer wall of which is covered with a pipe heating film for maintaining the hydrogen peroxide delivery state.

[0012] A flow deflector is installed inside the freeze-drying chamber to guide the diffusion of hydrogen peroxide gas within the chamber.

[0013] A concentration detection device is installed inside the freeze-drying chamber to detect the concentration of hydrogen peroxide gas inside the chamber.

[0014] Preferably, the guide plate is arc-shaped and its surface is provided with multiple through holes to facilitate the dispersion of hydrogen peroxide gas in the freeze-drying chamber.

[0015] Preferably, it also includes a vacuum system, which includes a pressure probe and a vacuum pump. The pressure probe is installed inside the freeze-drying chamber, and the vacuum pump is used to evacuate and remove residues from the freeze-drying chamber.

[0016] Preferably, it also includes a control system and a temperature probe, with the temperature probe installed on the freeze-drying chamber, and the control system electrically connected to the temperature probe, concentration detection device, sterilizer, vacuum system and pipeline heating film.

[0017] Preferably, it also includes an air filtration system, which includes an air filter and a sterile air intake valve. Sterile gas is transported into the freeze-drying chamber through the sterile air intake valve, which is also electrically connected to the control system.

[0018] Preferably, the freeze-drying chamber includes a chamber body and a cold trap section. An inlet valve is installed on the air inlet pipe connected to the chamber body, and a trap inlet valve is installed on the air inlet pipe connected to the cold trap section.

[0019] Preferably, the air intake pipes are arranged in a grid pattern inside the freeze-drying chamber, and nozzles are installed at the grid nodes.

[0020] Preferably, a drain outlet is provided at the bottom of the freeze-drying chamber, the drain outlet is connected to an external wastewater collection device, and a main drain valve is connected to the pipe connecting the drain outlet to the external wastewater collection device.

[0021] Preferably, it also includes a first exhaust pipe connected to the housing, and the first exhaust pipe is provided with a housing exhaust valve;

[0022] A second exhaust pipe is connected to the cold trap section, and a trap exhaust valve is installed on the second exhaust pipe.

[0023] The first and second extraction pipes are combined and then connected to the vacuum pump via the main extraction pipe, which is equipped with a vacuum valve.

[0024] Preferably, a VHP air inlet valve is connected to the air inlet pipe connecting the sterilizer and the freeze dryer.

[0025] Compared to the aforementioned background technology, this solution, by installing a temperature-adjustable heating film on the outside of the air inlet pipe, can avoid the situation where hydrogen peroxide gas liquefies during transportation, resulting in poor sterilization effect; furthermore, a baffle plate is installed inside the freeze-drying chamber to guide the hydrogen peroxide gas used for sterilization to be evenly distributed inside the freeze-drying chamber, reducing sterilization dead zones; and a concentration detection device is installed to ensure the concentration of hydrogen peroxide gas inside the freeze-drying chamber during sterilization, thereby ensuring the sterilization efficiency inside the freeze-drying chamber. Attached Figure Description

[0026] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of this application. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0027] Figure 1 This is a schematic diagram of an embodiment of the freeze dryer with VHP sterilization function according to this application.

[0028] in:

[0029] 1. Air filtration system; 2. Aseptic air inlet valve; 3. Sterilizer; 4. Air inlet pipeline; 5. Pipeline heating membrane; 6. VHP air inlet valve; 7. Chamber inlet valve; 8. Trap inlet valve; 9. Pressure probe; 10. Concentration detection device; 11. Freeze-drying chamber; 12. Baffle plate; 13. Temperature probe; 14. Trap drain valve; 15. Chamber drain valve; 16. Vacuum valve; 17. Vacuum pump; 18. Main drain valve. Detailed Implementation

[0030] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0031] To enable those skilled in the art to better understand the present application, the present application will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0032] It should be noted that the directional terms such as "upper end," "lower end," "left side," and "right side" mentioned below are defined based on the accompanying drawings in the instruction manual.

[0033] A freeze dryer with VHP sterilization function includes a freeze drying chamber 11, a sterilization system, a flow guide plate 12, and a concentration detection device 10.

[0034] The sterilization system is used to deliver hydrogen peroxide gas into the freeze-drying chamber 11 to sterilize the freeze-drying chamber 11. When the hydrogen peroxide gas is delivered into the freeze-drying chamber 11, the guide plate 12 makes the hydrogen peroxide gas evenly distributed in the freeze-drying chamber 11. Then, the concentration of hydrogen peroxide gas in the freeze-drying chamber 11 is monitored by the concentration detection device 10.

[0035] The sterilization system includes a sterilizer 3 for generating hydrogen peroxide gas. The sterilizer 3 supplies hydrogen peroxide gas to the freeze-drying chamber 11 through an air inlet pipe 4. A VHP air inlet valve 6 is connected to the air inlet pipe 4, which connects the sterilizer 3 to the freeze-drying chamber 11. The VHP air inlet valve 6 is used to control the opening and closing of the air inlet pipe 4.

[0036] A flow guide plate 12 is disposed inside the freeze-drying chamber 11 to guide the diffusion of hydrogen peroxide gas within the chamber. The flow guide plate 12 is arc-shaped and has multiple through holes on its surface to facilitate the dispersion of hydrogen peroxide gas within the freeze-drying chamber 11. The flow guide plate 12 is also made of a corrosion-resistant material.

[0037] In some embodiments, the air inlet pipe 4 is arranged in a grid pattern inside the freeze-drying chamber 11, and nozzles are installed at the grid nodes. Through the arrangement of the baffle 12 and the grid pattern of the air inlet pipe 4, the delivered hydrogen peroxide gas can be evenly distributed inside the freeze-drying chamber 11, reducing sterilization dead zones and improving sterilization efficiency.

[0038] In some embodiments, the outer wall of the inlet pipe 4 is covered with a pipe heating film 5 for maintaining the hydrogen peroxide delivery state. A control system and a temperature probe 13 are also included. The temperature probe 13 is mounted on the freeze-drying chamber 11, and the control system is electrically connected to the temperature probe 13, the concentration detection device 10, the sterilizer 3, the vacuum system, and the pipe heating film 5. This enables automated control of the VHP sterilization process of the freeze dryer.

[0039] The control system is preset with sterilization concentration threshold, ultimate vacuum pressure value, residual discharge setting pressure value, door opening standard concentration value, and sterilization time.

[0040] In this process, when hydrogen peroxide gas is introduced into the freeze-drying chamber 11, the concentration detection device 10 monitors the gas concentration. Once the gas concentration reaches the sterilization concentration threshold, the control system initiates the sterilization timing phase. The ultimate vacuum pressure is determined before sterilization by evacuating the freeze-drying chamber 11 using the vacuum pump 17, detecting this pressure under the action of the pressure probe 9, and transmitting the signal to the control system. The residual removal pressure is determined after sterilization by extracting the hydrogen peroxide gas from the freeze-drying chamber 11 using the vacuum pump 17, and transmitting this pressure value to the control system under the action of the pressure probe 9. The concentration of hydrogen peroxide gas after sterilization and residual removal is monitored by the concentration detection device 10. When this concentration reaches the standard concentration value for opening the door, the control system terminates the sterilization process.

[0041] In some embodiments, the control system can adjust the heating power of the pipeline heating film 5 based on the temperature detection signal on the temperature probe 13.

[0042] Since hydrogen peroxide achieves optimal sterilization efficiency in a gaseous state, it is necessary to ensure the stability of the transported hydrogen peroxide gas during the delivery process. Through monitoring by temperature probe 13, when the temperature is below the standard, temperature probe 13, via the control system, causes the pipeline heating film 5 to heat the inlet pipeline 4, preventing condensation of the hydrogen peroxide gas during transport.

[0043] The concentration detection device 10 is installed inside the freeze-drying chamber 11 to detect the concentration of hydrogen peroxide gas inside the freeze-drying chamber 11.

[0044] Specifically, the concentration detection device 10 monitors the concentration of hydrogen peroxide gas introduced into the freeze-drying chamber 11 during sterilization. When the concentration reaches the sterilization concentration threshold, the control system starts the sterilization timer, causing the freeze-drying chamber 11 to enter the sterilization stage. Furthermore, after sterilization, when the hydrogen peroxide gas is discharged from the freeze-drying chamber 11, the concentration of hydrogen peroxide gas inside the freeze-drying chamber 11 must reach the standard concentration value for opening the door before subsequent replacement of sterile gas within the freeze-drying chamber 11 can proceed.

[0045] In some embodiments, the freeze dryer further includes a vacuum system, which includes a pressure probe 9 and a vacuum pump 17. The pressure probe 9 is disposed inside the freeze drying chamber 11, and the vacuum pump 17 is used to evacuate and remove residue from the freeze drying chamber 11.

[0046] Specifically, the vacuum system is used to achieve the ultimate vacuum value inside the freeze-drying chamber 11 before sterilization via the vacuum pump 17. After sterilization, the vacuum pump 17 removes hydrogen peroxide gas from the freeze-drying chamber 11, bringing the chamber to the set pressure value for residue removal. Both the ultimate vacuum value and the set pressure value for residue removal are monitored by the pressure probe 9.

[0047] In some embodiments, an air filtration system 1 is also included, which includes an air filter and a sterile air inlet valve 2. Sterile gas is transported into the freeze-drying chamber 11 through the sterile air inlet valve 2, and the sterile air inlet valve 2 is also electrically connected to the control system.

[0048] Specifically, as described above, after the residual discharge set pressure value is reached in the freeze-drying chamber 11, the control system will further control the sterile air inlet valve 2, so that sterile gas passes through the air filtration system 1 and enters the freeze-drying chamber 11 to replace the gas in the freeze-drying chamber 11.

[0049] The control system is equipped with a communication module, which is used to establish communication connections with external devices. This facilitates the control of the sterilization process within the control system.

[0050] The freeze-drying chamber 11 has a drain outlet at its inner bottom, which is connected to an external wastewater collection device. A main drain valve 18 is connected to the pipe connecting the drain outlet to the external wastewater collection device.

[0051] The freeze-drying chamber 11 includes a chamber body and a cold trap. An inlet valve 7 is installed on the air inlet pipe 4 connected to the chamber body, and a trap inlet valve 8 is installed on the air inlet pipe 4 connected to the cold trap.

[0052] By closing the chamber inlet valve 7, hydrogen peroxide gas can be introduced into the cold trap section separately. Alternatively, by closing the trap inlet valve 8, hydrogen peroxide gas can be introduced into the chamber body section separately, thereby allowing for separate sterilization of either the chamber body section or the cold trap section.

[0053] The freeze dryer also includes a first exhaust pipe connected to the housing, which is equipped with a housing exhaust valve 15, and a second exhaust pipe connected to the cold trap, which is equipped with a trap exhaust valve 14. The first and second exhaust pipes are combined and then connected to a vacuum pump 17 via a main exhaust pipe, which is equipped with a vacuum valve 16.

[0054] When vacuum valve 16 is open, the sterilization process described above can be performed on the cold trap section by closing chamber drain valve 15 and opening trap drain valve 14. Similarly, the sterilization process described above can be performed on the chamber section by closing trap drain valve 14 and opening chamber drain valve 15. Thus, the chamber section or the cold trap section can be sterilized independently.

[0055] In summary, during VHP sterilization in the freeze dryer, the control system initiates the sterilization process according to a preset program. The specific steps are as follows:

[0056] ① Pre-vacuuming stage

[0057] The control system first opens the vacuum valve 16, the chamber exhaust valve 15, and the trap exhaust valve 14, and starts the vacuum pump 17. Then, it evacuates the internal cavity of the freeze-drying chamber 11 to expel the internal air.

[0058] Pressure probe 9 continuously monitors the pressure inside the chamber. When the pressure inside the freeze-drying chamber reaches the set ultimate vacuum pressure value, the control system stops evacuating and closes vacuum valve 16, chamber exhaust valve 15, and trap exhaust valve 14, maintaining a negative pressure state inside the freeze-drying chamber 11. This facilitates the rapid diffusion and uniform distribution of hydrogen peroxide vapor within the freeze-drying chamber 11.

[0059] ②VHP intake and heating preparation stage

[0060] After the vacuuming is completed, the control system activates the pipeline heating film 5 to heat the intake pipeline 4.

[0061] Temperature probe 13 monitors the pipeline temperature in real time to ensure that the pipeline temperature reaches the set temperature, so as to prevent hydrogen peroxide vapor from condensing during transportation.

[0062] After the temperature in the air inlet pipe 4 reaches the standard, the control system controls the sterilizer 3 to start generating hydrogen peroxide vapor.

[0063] ③VHP sterilization steam introduction stage

[0064] After the heating film 5 heats the intake pipe 4 to the set temperature, the control system opens the VHP intake valve 6, the box inlet valve 7, and the trap inlet valve 8.

[0065] Hydrogen peroxide vapor generated by sterilizer 3 is introduced into freeze-drying chamber 11 smoothly and evenly through heated inlet pipe 4, grid-like gas delivery pipe and uniform nozzles within the freeze-drying chamber 11, and guided by baffle plate 12. During this process, concentration detection device 10 monitors the concentration of hydrogen peroxide vapor in the freeze-drying chamber in real time.

[0066] ④ Maintenance sterilization stage

[0067] When the concentration detection device 10 detects that the concentration of hydrogen peroxide vapor in the freeze-drying chamber has reached the sterilization concentration threshold, the control system starts timing and enters the formal sterilization maintenance phase.

[0068] During this stage, the control system maintains the concentration of hydrogen peroxide vapor in the freeze dryer 11 within the effective sterilization range by adjusting the output of the VHP sterilizer 3.

[0069] The sterilization maintenance phase ends when the preset sterilization time is reached.

[0070] ⑤ Pulsating Residual Waste Removal and Sterile Gas Replacement Stage

[0071] After the sterilization stage is completed, the control system immediately closes the VHP inlet valve 6 and starts the vacuum pump 17 to perform the first discharge of residue, while opening the vacuum valve 16, the chamber exhaust valve 15 and the trap exhaust valve 14.

[0072] When the pressure inside the freeze-drying chamber reaches the preset residual discharge pressure value, the control system shuts down the vacuum pump 17, vacuum valve 16, chamber exhaust valve 15 and trap exhaust valve 14, and opens the sterile air inlet valve 2 to introduce sterile gas filtered by the air filtration system 1 to replace the gas inside the chamber and reduce the concentration of hydrogen peroxide vapor.

[0073] The concentration detection device 10 continuously monitors the concentration of hydrogen peroxide vapor inside the chamber. If the concentration still does not reach the standard concentration value for opening the door, the control system will cycle through the operation of vacuuming and introducing sterile gas in a pulsating residual removal process until the concentration of hydrogen peroxide vapor inside the chamber meets the safe opening standard.

[0074] ⑥ Sterilization process ends

[0075] When the concentration of hydrogen peroxide vapor inside the freeze dryer 11 reaches the opening standard, the control system sends a signal, at which point the sterilization process ends.

[0076] It should be noted that in this specification, relational terms such as first and second are used only to distinguish one entity from several other entities, and do not necessarily require or imply any such actual relationship or order between these entities.

[0077] The freeze dryer with VHP sterilization function provided in this application has been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of this application. The descriptions of the embodiments above are only for the purpose of helping to understand the solution and core ideas of this application. It should be noted that those skilled in the art can make several improvements and modifications to this application without departing from the principles of this application, and these improvements and modifications also fall within the protection scope of the claims of this application.

Claims

1. A freeze dryer with VHP sterilization function, comprising a freeze drying chamber (11), characterized in that, Also includes: The sterilization system includes a sterilizer (3) for generating hydrogen peroxide gas, the sterilizer (3) supplying hydrogen peroxide gas into the freeze dryer (11) through an air inlet pipe (4), the outer wall of the air inlet pipe (4) being covered with a pipe heating film (5) for maintaining the hydrogen peroxide supply state. A flow guide plate (12) is disposed inside the freeze-drying chamber (11) to guide the diffusion of hydrogen peroxide gas inside the freeze-drying chamber (11); A concentration detection device (10) is installed inside the freeze-drying chamber (11) to detect the concentration of hydrogen peroxide gas inside the freeze-drying chamber (11).

2. A freeze dryer with VHP sterilization function according to claim 1, characterized in that, The guide plate (12) is arc-shaped and has multiple through holes on its surface to facilitate the dispersion of hydrogen peroxide gas in the freeze-drying chamber (11).

3. A freeze dryer with VHP sterilization function according to claim 1, characterized in that, It also includes a vacuum system, which includes a pressure probe (9) and a vacuum pump (17). The pressure probe (9) is located inside the freeze-drying chamber (11), and the vacuum pump (17) is used to evacuate and remove residue from the freeze-drying chamber (11).

4. A freeze dryer with VHP sterilization function according to claim 3, characterized in that, It also includes a control system and a temperature probe (13), the temperature probe (13) being mounted on the freeze dryer (11), and the control system being electrically connected to the temperature probe (13), the concentration detection device (10), the sterilizer (3), the vacuum system, and the pipeline heating film (5).

5. A freeze dryer with VHP sterilization function according to claim 4, characterized in that, It also includes an air filtration system (1), which includes an air filter and a sterile inlet valve (2), through which sterile gas is transported into the freeze-drying chamber (11), and the sterile inlet valve (2) is also electrically connected to the control system.

6. A freeze dryer with VHP sterilization function according to claim 4, characterized in that, The freeze-drying chamber (11) includes a chamber body and a cold trap. An inlet valve (7) is installed on the air inlet pipe (4) connected to the chamber body, and a trap inlet valve (8) is installed on the air inlet pipe (4) connected to the cold trap.

7. A freeze dryer with VHP sterilization function according to claim 1, characterized in that, The air intake pipe (4) is distributed in a grid pattern inside the freeze-drying chamber (11), and nozzles are installed at the grid nodes.

8. A freeze dryer with VHP sterilization function according to claim 1, characterized in that, The freeze-drying box (11) has a drain outlet at its inner bottom. The drain outlet is connected to an external wastewater collection device. A main drain valve (18) is connected to the pipe connecting the drain outlet to the external wastewater collection device.

9. A freeze dryer with VHP sterilization function according to claim 6, characterized in that, Also includes: A first exhaust pipe connected to the box body is provided with a box exhaust valve (15). A second exhaust pipe connected to the cold trap section, and a trap valve (14) is provided on the second exhaust pipe. The first and second extraction pipes are combined and then connected to the vacuum pump (17) through the main extraction pipe, which is equipped with a vacuum valve (16).

10. A freeze dryer with VHP sterilization function according to claim 1, characterized in that, A VHP air inlet valve (6) is connected to the air inlet pipe (4) that connects the sterilizer (3) to the freeze dryer (11).

Images