A multifunctional freeze dryer that can be used for production and freeze drying process development

Abstract

The present invention relates to the field of freeze-drying technology, specifically to a multifunctional freeze-drying machine that can be used for production and freeze-drying process development, including a cold trap frost catching cavity, a freeze-drying sublimation cavity arranged on one side of the cold trap frost catching cavity, and a plug and a closed system. A vent is provided between the freeze-drying sublimation cavity and the cold trap frost catching cavity. The plug and closed system include a lifting drive mechanism and a plug plate. The lifting drive mechanism is arranged inside the cold trap frost catching cavity, the plug plate is arranged inside the freeze-drying sublimation cavity, the area of ​​the plug plate covers the vent to cover the vent, a sealing ring is arranged on the circumference of the lower outer periphery of the vent or the upper part of the plug plate, and the end of the telescopic component of the lifting drive mechanism is connected to the surface of the plug plate. The present invention is convenient for testing pressure rise, convenient for detecting whether the freeze-dried preparation is completely dry, and is conducive to the development of freeze-drying process. At the same time, it also has high reliability, and can effectively preserve biological preparations in the case of abnormal power failure and individual system downtime, reducing the loss of biological preparations.

Description

Technical Field

[0001] The invention relates to the technical field of freeze drying, in particular to a multifunctional freeze drying machine which can be used for production and freeze drying process development. Background Art

[0002] For the batch production of freeze-dried preparations with mature production processes, large-scale freeze-drying equipment can be used and the corresponding process parameters can be set, but the freeze-drying process is often developed in the laboratory. In the process of laboratory development, the raw materials of biopharmaceutical products are relatively expensive and in small quantities. The storage and preparation process must be very cautious and the process risks must be fully considered. If a power outage or equipment fault light problem occurs during the freeze-drying process, causing the refrigeration system to shut down, the interruption of freeze-drying will not only lead to test failure, but also cause waste of biological preparations, such as biological solutions, especially antigens, antibodies, enzymes, nucleic acids and other raw materials used in in vitro diagnostic reagents. The amount of each batch is small, but the price cost is very high. If it is wasted, it will increase the cost. Therefore, a small and sufficiently safe freeze-drying equipment is needed.

[0003] Secondly, in the process of developing the production process of freeze-dried preparations, it is necessary to test the water content of freeze-dried preparations by testing the pressure rise to determine whether the freeze-dried products are dry. At present, a full-function laboratory freeze dryer can be used to complete this task, but the full-function freeze dryer is expensive and general companies cannot afford it, which is not conducive to the innovation of freeze-dried preparations and biological preparations. Modification of ordinary equipment, such as adding valves and control mechanisms, will increase the number of equipment accessories, reduce environmental cleanliness, increase water vapor channel resistance, etc. Therefore, for laboratory freeze dryers, it is also necessary to design a freeze drying device that is easy to detect whether the preparation is freeze-dried.

[0004] In summary, it is an urgent requirement to design a multifunctional freeze dryer that is highly reliable and easy to measure pressure rise and can be used in production and freeze-drying process development. Summary of the invention

[0005] The technical problem to be solved by the present invention is to provide a multifunctional freeze dryer which has high reliability and is convenient for measuring pressure rise and can be used for production and freeze drying process development.

[0006] The technical solution to the technical problem to be solved by the present invention is: a multifunctional freeze dryer that can be used for production and freeze-drying process development, including a freeze dryer assembly, the freeze dryer assembly including a vacuum pump, characterized in that: the freeze dryer assembly also includes: a cold trap frost catching cavity; the cold trap frost catching cavity is connected to the vacuum pump; a freeze-drying sublimation cavity arranged on one side of the cold trap frost catching cavity; a plug and a closed system; the closed system includes a lifting drive mechanism and a plug plate; a vent is provided between the freeze-drying sublimation cavity and the cold trap frost catching cavity; the freeze-drying sublimation cavity is connected to a vacuum probe; the lifting drive mechanism is arranged at the end of the cold trap frost catching cavity away from the vent, the plug plate is arranged inside the freeze-drying sublimation cavity, the end of the telescopic component of the lifting drive mechanism is connected to the surface of the plug plate, and the lifting drive mechanism drives the plug plate to rise to the position of the vent to achieve sealing of the vent.

[0007] More preferably, a sealing ring is provided on the circumference of the lower outer periphery of the vent hole or on the upper part of the pressing plate.

[0008] More preferably, a sealing groove or a sealing protrusion is provided on the circumference of the outer side of the vent hole, the pressing plate is correspondingly provided with a sealing protrusion or a sealing groove, and a sealing ring is provided inside the sealing groove.

[0009] Preferably, a sealing plate or a sealing gasket is provided on the upper portion of the pressing plate.

[0010] Better yet, the vent hole is larger at the lower end and smaller at the upper end, and a sealing plug matching the shape of the vent hole is provided on the upper part of the pressure plate, the sealing plug has a smaller upper end and a larger lower end, and the lower end is larger than the lower end of the vent hole, and the sealing plug is inserted into the vent hole during sealing.

[0011] Better yet, the freeze dryer assembly includes independently operated cold trap circulation refrigeration system and refrigerant circulation system; the cold trap circulation refrigeration system includes a cold trap circulation pump, a cold trap refrigeration device and a cold trap frost catcher connected in series in sequence, and the cold trap frost catcher is arranged inside a cold trap frost catcher cavity; the refrigerant circulation system includes a freeze drying plate layer, a heater, a refrigerant circulation pump, a refrigerant internal circulation solenoid valve, a first refrigerant inlet and outlet connected to one end of the refrigerant internal circulation solenoid valve, a refrigerant external circulation solenoid valve connected to the other end of the refrigerant internal circulation solenoid valve, and a second refrigerant inlet and outlet arranged at the other end of the refrigerant external circulation solenoid valve.

[0012] Preferably, the freeze dryer assembly is provided with a power storage device, and the power storage device is connected in parallel with the power supply of the refrigerant circulation system.

[0013] Better yet, it also includes a refrigerant refrigeration and cold storage system; the refrigerant refrigeration and cold storage system includes a silicone oil storage device and a silicone oil refrigeration system; the silicone oil storage device is provided with an agitator, and the silicone oil storage device is provided with two inlets and outlets, and the two inlets and outlets are respectively connected to the first refrigerant inlet and outlet and the second refrigerant inlet and outlet through pipelines.

[0014] Preferably, the stirrer is a magnetic stirrer.

[0015] A method for testing the water content of a multifunctional freeze dryer that can be used for production and freeze drying process development, characterized in that:

[0016] When the residual moisture content of the product needs to be tested during the freeze-drying process;

[0017] Control the lifting drive mechanism to move upward so that the pressing plate can seal the vent hole;

[0018] Test the data inside the freeze-drying sublimation chamber through sensors;

[0019] After the test is completed:

[0020] When the product does not meet the standard, the lifting drive mechanism is controlled to move downward and stay on the upper part of the vial stopper;

[0021] When the product reaches the standard, the lifting drive mechanism is controlled to move downward, and the pressing plate is pressed against the vial stopper to complete the sealing of the vial by the vial stopper.

[0022] A control method for a multifunctional freeze dryer that can be used for production and freeze-drying process development is characterized in that: during the freeze-drying process development process, firstly, a cold trap circulation refrigeration system, a refrigerant circulation system, a refrigerant refrigeration and cold storage system, and a vacuum pump are started to cool and evacuate the internal space of the freeze dryer; wherein when the temperature of the freeze-drying plate layer is controlled, when one of the refrigerant internal circulation solenoid valve and the refrigerant external circulation solenoid valve is turned on, the other is turned off.

[0023] Preferably, before the freeze-drying operation, the refrigerant refrigeration and cold storage system is started to cool the silicone oil in the silicone oil storage to a low temperature, and the inside of the silicone oil storage is evenly cooled by a stirrer;

[0024] When freeze drying begins, the refrigerant external circulation solenoid valve is turned on, and the refrigerant internal circulation solenoid valve is closed, so as to quickly cool down the freeze drying plate layer;

[0025] During constant temperature control, the heater, the refrigerant internal circulation solenoid valve and the refrigerant external circulation solenoid valve are controlled to operate intermittently to keep the plate layer temperature constant;

[0026] When there is an abnormal power outage or equipment shutdown, the power storage device is started to supply power to the refrigerant circulation system.

[0027] Better yet, when the vacuum pump fails, the refrigerant circulation pump of the refrigerant circulation system starts to operate, and the super-cold silicone oil of the refrigerant refrigeration and cold storage system enters the freeze-drying plate layer through the refrigerant external circulation solenoid valve, so that the freeze-drying plate layer is quickly cooled down. At the same time, the pressure plate is lifted to block the vent hole, and the vacuum pump is maintained.

[0028] Better yet, when the cold trap circulation refrigeration system fails, the pressure plate is controlled to close the vent 300, and the refrigerant circulation system controls the temperature of the freeze-drying plate layer to the product freezing temperature and maintains it. At this time, the cold trap circulation refrigeration system is repaired or the product is transferred.

[0029] Better yet, when the refrigerant refrigeration and storage system fails, the circulation pump of the refrigerant refrigeration and storage system is turned off, and no energy is transferred to the products in the freeze drying chamber. At this time, the sublimation speed is reduced, and freeze drying is completed by increasing the sublimation drying time.

[0030] The beneficial effects of the present invention are:

[0031] 1. It has high reliability and can effectively preserve biological agents in the event of abnormal power outages or system downtime, thus reducing the loss of biological agents;

[0032] 2. It is convenient to test the pressure rise and detect whether the freeze-dried preparation is completely dry, which is conducive to the development of freeze-drying process. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 It is a schematic diagram of the overall system structure of an embodiment of the present invention;

[0034] Figure 2 is a schematic diagram of a sublimation chamber sealed by a plugging plate according to an embodiment of the present invention;

[0035] Figure 3 The diagram is a schematic diagram of a plugging plate according to an embodiment of the present invention plugging a vial.

[0036] In the figure:

[0037] 310, sealing ring; 620, pressing plate; 610, lifting drive mechanism; 600, pressing plug and closed system; 730, agitator; 720, silicone oil refrigeration system; 710, silicone oil storage device; 700, refrigerant refrigeration and storage system; 210, vacuum probe; 110, vacuum pump; 552, second refrigerant inlet and outlet; 560, refrigerant external circulation solenoid valve; 551, first refrigerant inlet and outlet; 540, refrigerant internal circulation solenoid valve; 530, refrigerant circulation pump; 520, heater; 510, freeze-drying plate layer; 500, refrigerant circulation system; 430, cold trap frost catcher; 420, cold trap refrigeration device; 410, cold trap circulation pump; 400, cold trap circulation refrigeration system; 300, vent; 200, freeze-drying sublimation cavity; 100, cold trap frost catcher cavity; DETAILED DESCRIPTION

[0038] In order to make the technical solutions and beneficial effects of the present invention clearer, the embodiments of the present invention are further explained in detail below.

[0039] A multifunctional freeze dryer that can be used for production and freeze drying process development includes a freeze dryer assembly. In the prior art, the freeze dryer is provided with a refrigeration system, a negative pressure system, and related detection and control systems. Based on the prior art and combined with the application environment of a laboratory micro freeze dryer, the following improvements are made to the freeze dryer.

[0040] The freeze dryer includes a cold trap frost catching chamber 100 and a freeze drying sublimation chamber 200. Figure 1 As shown, in this embodiment, the cold trap frost catching chamber 100 is arranged on the upper part of the freeze-drying sublimation chamber 200, and a partition is arranged between the two chambers, and a vent 300 is arranged on the partition. The vent 300 is a large round hole or a square hole to achieve the effect of reducing the flow resistance of water vapor. In order to achieve the closed isolation between the cold trap frost catching chamber 100 and the freeze-drying sublimation chamber 200, a pressure plate 620 is provided. The pressure plate 620 is located inside the freeze-drying sublimation chamber 200. The pressure plate 620 has two functions. One is that after the freeze-drying is completed, the rubber plug on the vial is pressed into the vial by pressing the pressure plate 620 downward to achieve the sealing of the vial; the second is that during the freeze-drying process, when a pressure rise test is required, the vent 300 is blocked to separate the cold trap frost catching chamber 100 and the freeze-drying sublimation chamber 200. In order to achieve the above two functions, a lifting drive mechanism 610 is also required to be provided. The lifting drive mechanism 610 and the pressing plate 620 constitute a pressing and sealing system 600 .

[0041] like Figure 1 As shown, the lifting drive mechanism 610 is arranged at one end of the cold trap frost catching cavity 100 away from the vent hole 300. In this embodiment, the lifting mechanism adopts a hydraulic cylinder, which is arranged at the upper part of the cold trap frost catching cavity 100 and embedded in the upper wall of the cold trap frost catching cavity 100. The hydraulic cylinder is sealed and connected to the upper wall of the cold trap frost catching cavity 100. Similarly, an electric telescopic rod can be used as the lifting drive mechanism 610, and the electric telescopic rod can be arranged at the upper end of the interior of the cold trap frost catching cavity 100.

[0042] The pressing plate 620 is arranged inside the freeze-drying sublimation chamber 200, and the area of ​​the pressing plate 620 covers the vent hole 300 to cover the vent hole 300. In this embodiment, the vent hole 300 is set as a round hole or a square hole, the pressing plate 620 is round or square, the length direction of the telescopic part of the lifting drive mechanism 610 coincides with the axial center line of the vent hole and the pressing plate 620, and the minimum inner diameter of the pressing plate 620 is greater than the maximum outer diameter of the vent hole 300, so as to achieve the closure of the vent hole 300 by the pressing plate 620.

[0043] In order to achieve better sealing, a sealing ring 310 is provided on the circumference of the lower outer periphery of the vent hole 300 or on the upper part of the pressing plate 620. The end of the telescopic component of the lifting drive mechanism 610 is connected to the surface of the pressing plate 620.

[0044] Furthermore, for better sealing, a sealing groove or a sealing protrusion is provided on the interval outside the vent hole 300, and the pressing plate 620 is correspondingly provided with a sealing protrusion or a sealing groove, and a sealing ring 310 is provided inside the sealing groove.

[0045] Preferably, a sealing plate or a sealing gasket is provided on the upper portion of the pressing plate 620 .

[0046] The compression plate 620 requires a certain strength for compression or sealing, but the flexible rubber material has better sealing properties, so the compression plate 620 is set as a rigid plate, and a sealing plate or sealing gasket is set on the upper part of the compression plate 620 to seal the vent hole 300.

[0047] Furthermore, the vent hole 300 is sealed by blocking. The vent hole 300 is set as a channel with a larger lower end and a smaller upper end. The upper part of the pressure plate 620 is provided with a sealing plug that matches the shape of the vent hole 300. The sealing plug has a smaller upper end and a larger lower end, and the lower end of the sealing plug is larger than the lower end of the vent hole 300. When sealing, the sealing plug is inserted into the vent hole.

[0048] The application of the present invention can greatly improve the efficiency of the freeze-drying process. In the process of freeze-drying process development, it is often necessary to detect whether the biological preparation is completely freeze-dried, and the water content is detected by using a pressure rise test. At this time, the freeze-drying sublimation chamber 200 needs to be sealed, and then the pressure change is tested. If the pressure rises significantly, it means that the biological preparation still contains a certain amount of water and needs to continue to be freeze-dried. Based on the above detection principle, the freeze-drying process adopts the following method:

[0049] When it is necessary to test the residual moisture content of the product during the freeze-drying process.

[0050] like Figure 2 As shown, the lifting drive mechanism 610 is controlled to move upward so that the pressing plate 620 seals the vent hole 300 .

[0051] The data inside the freeze-drying sublimation chamber 200 is tested by the sensor; at this time, the pressure inside the freeze-drying sublimation chamber 200 is detected by the vacuum probe 210 or the vacuum pressure gauge.

[0052] After the test is completed:

[0053] When the product does not meet the standard, that is, when the product still contains moisture, the lifting drive mechanism 610 is controlled to move downward and stay on the upper part of the vial stopper;

[0054] When the product reaches the standard, Figure 3 As shown, the lifting drive mechanism 610 is controlled to move downward, and the pressing plate 620 is pressed against the vial stopper to complete the sealing of the vial by the vial stopper.

[0055] In order to ensure more reliable operation and reduce the loss of biological products, an independently operated cold trap circulation refrigeration system 400 and a refrigerant circulation system 500 are provided in the freeze dryer.

[0056] The cold trap circulation refrigeration system 400 includes a cold trap circulation pump 410, a cold trap refrigeration device 420 and a cold trap frost catcher 430 connected in series, and the cold trap frost catcher 430 is arranged inside the cold trap frost catcher cavity 100. The cold trap refrigeration device 420 can use a Freon compressor for refrigeration, or a vacuum stacking refrigeration module developed by the company using refrigeration sheets for refrigeration.

[0057] The refrigerant circulation system 500 includes a freeze-drying plate layer 510, a heater 520, a refrigerant circulation pump 530, a refrigerant internal circulation electromagnetic valve 540, a first refrigerant inlet and outlet 551 connected in series to one end of the refrigerant internal circulation electromagnetic valve 540, a refrigerant external circulation electromagnetic valve 560 connected in parallel to the other end of the refrigerant internal circulation electromagnetic valve 540, and a second refrigerant inlet and outlet 552 provided at the other end of the refrigerant external circulation electromagnetic valve 560. The first refrigerant inlet and outlet 551 and the second refrigerant inlet and outlet 552 are respectively connected to an external cold storage device.

[0058] In the above system, a power storage device is provided, and the power storage device is connected in parallel with the power supply of the refrigerant circulation system 500. Specifically, the power storage device is a battery, which is connected to the power input terminal of the refrigerant circulation pump 530 of the refrigerant circulation system 500 through a switching switch. When the equipment is powered off, the cold silicone oil in the silicone oil storage 710 can be introduced into the plate through the refrigerant circulation pump 530 to cool and freeze the biological agent.

[0059] Preferably, the external cold storage device includes a refrigerant refrigeration storage system 700; the refrigerant refrigeration storage system 700 includes a silicone oil storage device 710 and a silicone oil refrigeration system 720; the silicone oil storage device 710 is provided with an agitator 730, and the silicone oil storage device 710 is provided with two inlets and outlets, which are respectively connected to the first refrigerant inlet and outlet 551 and the second refrigerant inlet and outlet 552 through pipelines.

[0060] Furthermore, the stirrer 730 is a magnetic stirrer.

[0061] Preferably, in order to better control the temperature, an interlocking mechanism is also provided. When the interlocking mechanism controls one of the refrigerant internal circulation solenoid valve 540 and the refrigerant external circulation solenoid valve 560 to be turned on, the other is turned off. The interlocking mechanism can be controlled by a relay with normally open and normally closed contacts, wherein the normally open contact of the relay is connected in series with the power supply circuit of the refrigerant internal circulation solenoid valve 540, the normally closed contact is connected in series with the power supply circuit of the refrigerant external circulation solenoid valve 560, and the coil winding of the relay is connected to the power supply through the control switch, so as to realize the locking control at one time.

[0062] When developing the freeze-drying process, the cold trap circulation refrigeration system 400, the refrigerant circulation system 500 and the refrigerant refrigeration storage system 700 are started. The cold trap circulation pump 410 starts the circulation, the cold trap refrigeration device 420 starts refrigeration, and the vacuum pump 110 starts to evacuate. After reaching the set temperature, the cold trap frost catcher 430 can catch frost.

[0063] After the refrigerant circulation pump 530 is started, it begins to provide cold energy to the freeze-drying plate layer 510, so that the biological agent begins to freeze. At the same time, the refrigerant refrigeration and cold storage system 700 is started to continuously cool the silicone oil storage device 710.

[0064] During the control process of the refrigerant circulation system 500 , when one of the refrigerant internal circulation solenoid valve 540 and the refrigerant external circulation solenoid valve 560 is turned on, the other is turned off.

[0065] When using this system for freeze drying:

[0066] Before the freeze-drying operation, the refrigerant refrigeration and cold storage system 700 is started to cool the silicone oil in the silicone oil storage 710 to a low temperature, and the agitator 730 is used to evenly cool the inside of the silicone oil storage 710;

[0067] When freeze drying begins, the refrigerant external circulation solenoid valve 560 is turned on, and the refrigerant internal circulation solenoid valve 540 is closed, so as to quickly cool the plate layer;

[0068] During constant temperature control, the heater 520, the refrigerant internal circulation solenoid valve 540 and the refrigerant external circulation solenoid valve 560 are controlled to operate intermittently to keep the plate layer temperature constant.

[0069] When there is an abnormal power outage or equipment downtime, the power storage device is started to supply power to the refrigerant circulation system 500, which can provide time for emergency treatment. The core components of the freeze-drying equipment include the vacuum system and the refrigeration system. The specific situations include the following:

[0070] When the vacuum system fails, mainly when the vacuum pump 110 fails, the refrigerant circulation pump 530 of the refrigerant circulation system 500 operates, and the ultra-cold silicone oil of the refrigerant refrigeration and cold storage system 700 enters the freeze-drying plate layer 510 through the refrigerant external circulation solenoid valve 560 to quickly cool down. After the pressure plate 620 is lifted to block the vent hole 300, the vacuum system behind the cold trap is maintained, and the spare vacuum pump 110 can be replaced routinely. The product will not be subject to any risk during the fault handling process.

[0071] When the cold trap circulation refrigeration system 400 fails, the pressure plug plate 620 is controlled to close the vent hole 300. The refrigerant circulation system 500 controls the plate layer temperature to maintain the product freezing temperature. The refrigeration system can be repaired or the product can be transferred to another sterile environment.

[0072] When the refrigerant refrigeration and cold storage system 700 fails, the circulation pump of the refrigerant refrigeration and cold storage system 700 is turned off, and heat is not transferred to the products in the box, the sublimation speed is reduced, and the sublimation drying time is increased, so that the products can be safely freeze-dried.

[0073] In summary, the above are only preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Through the above description, relevant staff can make various changes and modifications without departing from the technical concept of the present invention. The technical scope of the present invention is not limited to the contents of the specification. All so-called equal changes and modifications of the shapes, structures, features and spirits described in the scope of the claims of the present invention should be included in the scope of the claims of the present invention.

Claims

1. A multifunctional freeze dryer that can be used for production and freeze drying process development, comprising a freeze dryer assembly, wherein the freeze dryer assembly comprises a vacuum pump (110), Features: The freeze dryer assembly also includes: A cold trap frost catching cavity (100); the cold trap frost catching cavity (100) is connected to a vacuum pump (110); A freeze-drying sublimation chamber (200) disposed on one side of the cold trap frost capturing chamber (100); A plugging and sealing system (600); the plugging and sealing system (600) comprises a lifting drive mechanism (610) and a plugging plate (620); A vent hole (300) is provided between the freeze-drying sublimation cavity (200) and the cold trap frost catching cavity (100); the freeze-drying sublimation cavity (200) is connected to a vacuum probe (210); The lifting drive mechanism (610) is arranged at one end of the cold trap frost catching chamber (100) away from the vent hole (300), the pressing plate (620) is arranged inside the freeze-drying sublimation chamber (200), the end of the telescopic component of the lifting drive mechanism (610) is connected to the surface of the pressing plate (620), and the lifting drive mechanism (610) drives the pressing plate (620) to rise to the position of the vent hole (300) to achieve sealing of the vent hole (300); The freeze dryer assembly comprises a cold trap circulation refrigeration system (400) and a refrigerant circulation system (500) which operate independently; The cold trap circulation refrigeration system (400) comprises a cold trap circulation pump (410), a cold trap refrigeration device (420) and a cold trap frost catcher (430) which are sequentially connected in series, and the cold trap frost catcher (430) is arranged inside the cold trap frost catcher cavity (100); The refrigerant circulation system (500) comprises a freeze-drying plate layer (510), a heater (520), a refrigerant circulation pump (530), a refrigerant internal circulation solenoid valve (540), a first refrigerant inlet and outlet (551) connected in series to one end of the refrigerant internal circulation solenoid valve (540), a refrigerant external circulation solenoid valve (560) connected in parallel to the other end of the refrigerant internal circulation solenoid valve (540), and a second refrigerant inlet and outlet (552) provided at the other end of the refrigerant external circulation solenoid valve (560); The freeze dryer assembly is provided with a power supply energy storage device, and the power supply energy storage device is connected in parallel with the power supply of the refrigerant circulation system (500); Also included is a refrigerant refrigeration and cold storage system (700); The refrigerant refrigeration and cold storage system (700) comprises a silicone oil storage device (710) and a silicone oil refrigeration system (720); The silicone oil storage (710) is provided with a stirrer (730), and the silicone oil storage (710) is provided with two inlets and outlets, and the two inlets and outlets are respectively connected to the first refrigerant inlet and outlet (551) and the second refrigerant inlet and outlet (552) through pipelines; During the freeze-drying process development, the cold trap circulation refrigeration system (400), the refrigerant circulation system (500), the refrigerant refrigeration and cold storage system (700) and the vacuum pump (110) are first started to cool down and evacuate the internal space of the freeze dryer; when the temperature of the freeze-drying plate layer (510) is controlled, when one of the refrigerant internal circulation solenoid valve (540) and the refrigerant external circulation solenoid valve (560) is turned on, the other is closed; Before the freeze-drying operation, the refrigerant refrigeration and cold storage system (700) is started to reduce the silicone oil in the silicone oil storage (710) to a low temperature, and the inside of the silicone oil storage (710) is evenly cooled by the stirrer (730); When freeze drying begins, the refrigerant external circulation solenoid valve (560) is turned on, and the refrigerant internal circulation solenoid valve (540) is closed, so as to quickly cool the freeze drying plate layer (510); During constant temperature control, the heater (520), the refrigerant internal circulation electromagnetic valve (540) and the refrigerant external circulation electromagnetic valve (560) are controlled to operate intermittently to keep the plate layer temperature constant; When there is an abnormal power outage or equipment shutdown, the power storage device is started to supply power to the refrigerant circulation system (500); When the vacuum pump (110) fails, the refrigerant circulation pump (530) of the refrigerant circulation system (500) operates, and the super-cold silicone oil of the refrigerant refrigeration and cold storage system (700) enters the freeze-drying plate layer (510) through the refrigerant external circulation solenoid valve (560), so that the freeze-drying plate layer (510) is quickly cooled. At the same time, the pressure plate (620) is lifted to block the vent hole (300), and the vacuum pump (110) is maintained; When the cold trap circulation refrigeration system (400) fails, the pressure plug plate (620) is controlled to close the vent hole (300), and the refrigerant circulation system (500) controls the temperature of the freeze-drying plate layer (510) to the product freezing temperature and maintains it. At this time, the cold trap circulation refrigeration system (400) is repaired, or the product is transferred; When the refrigerant refrigeration and cold storage system (700) fails, the circulation pump of the refrigerant refrigeration and cold storage system (700) is turned off, and no energy is transferred to the product in the freeze drying chamber. At this time, the sublimation speed is reduced, and the freeze drying is completed by increasing the sublimation drying time; A sealing ring (310) is provided on the circumference of the lower outer periphery of the vent hole (300) or on the upper part of the pressure plate (620).

2. A multifunctional freeze dryer according to claim 1 that can be used for production and freeze drying process development, Features: A sealing groove or a sealing protrusion is provided on the circumference of the outer side of the vent hole (300), and the pressing plate (620) is correspondingly provided with a sealing protrusion or a sealing groove, and a sealing ring (310) is provided inside the sealing groove.

3. A multifunctional freeze dryer according to claim 1 that can be used for production and freeze drying process development, Features: A sealing plate or a sealing gasket is provided on the upper portion of the pressing plate (620).

4. A multifunctional freeze dryer for production and freeze drying process development according to claim 1, Features: The vent hole (300) has a larger lower end and a smaller upper end. The upper portion of the pressure plate (620) is provided with a sealing plug that matches the shape of the vent hole (300). The sealing plug has a smaller upper end and a larger lower end, and the lower end is larger than the lower end of the vent hole (300). When sealing, the sealing plug is inserted into the vent hole.

5. A multifunctional freeze dryer for production and freeze drying process development according to claim 1, Features: The stirrer (730) is a magnetic stirrer.

6. A method for testing water content of a multifunctional freeze dryer that can be used for production and freeze drying process development according to claim 1, Features: When the residual moisture content of the product needs to be tested during the freeze-drying process; Controlling the lifting drive mechanism (610) to move upward so that the pressing plate (620) seals the vent hole (300); Testing the data inside the freeze-drying sublimation chamber (200) through sensors; After the test is completed: When the product does not meet the standard, the lifting drive mechanism (610) is controlled to move downward and stay on the upper part of the vial stopper; When the product reaches the standard, the lifting drive mechanism (610) is controlled to move downward, and the pressing plate (620) is pressed against the vial rubber stopper, so that the vial rubber stopper seals the vial.

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