JP3871957B2 - Freeze vacuum drying method and freeze vacuum drying apparatus - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a freeze vacuum drying apparatus that vacuum-drys an object to be dried in a frozen state.
[0002]
[Prior art]
FIG. 4 shows a vial bottle 1 into which a drug solution 2 is dispensed as an example of an object to be dried. Reference numeral 3 denotes a rubber stopper 3 that is a lid of the vial 1. The rubber stopper 3 includes a disc-shaped cap portion 4 and a cylindrical body portion 5 which is a portion inserted into the opening 1 a of the vial 1, and the body portion 5 is formed with a notch 5 a.
[0003]
As shown in FIG. 4, the vial 1 and the chemical solution 2 that have been subjected to steam sterilization / sterilization treatment are frozen as will be described later, with the barrel 5 of the rubber stopper 3 being inserted about halfway into the opening 1 a of the vial 1. Freeze-dry in the freeze-drying chamber of the vacuum dryer. In the freeze-drying chamber, the inside of the vial 1 and the space in the freeze-drying chamber are communicated with each other through a notch 5a. The chemical solution 2 in the vial 1 is freeze-dried and the solvent is sublimated. The solute remains. After freeze-drying, the rubber stopper 3 is plugged (sealed), the lid of the vial 1 is completely closed, and the medicine dispensed inside is sealed.
[0004]
FIG. 5 shows an example of a conventional freeze-drying apparatus 10. A plurality of stages (six stages in the figure) shelf boards 12 are arranged in the freeze-drying cabinet 11. An opening 13 is formed on one side wall of the freeze-drying chamber 11, and a gate 14 for opening and closing the opening 13 is provided. The gate 14 is driven by a gate drive cylinder 15.
[0005]
A warehousing conveyor 17 is disposed in front of the opening 13 (outside the freeze-drying chamber 11). Between the shelf board 12 in the freeze-drying store | warehouse | chamber 11 and the warehousing conveyor 17, the leveling of the warehousing conveyor 17 and an upper surface is made to correspond, and the linking board 16 for warehousing is provided. The gaps between the warehousing conveyor 17 and the warehousing board 16 and between the warehousing board 16 and the shelf board 12 are smaller than the thickness (diameter) of the vial 1, respectively. Further, a warehousing pusher 18 for pushing the vial bottle 1 conveyed by the warehousing conveyor 17 onto the shelf board 12 via the warehousing transition board 16 is disposed outside the freeze-drying warehouse 11. The warehousing pusher 18 includes a cylinder 18c, a drive rod 18b driven by the cylinder 18c, and a pusher portion 18a that is attached to the tip of the drive rod 18b and is in contact with the vial bottle 1.
[0006]
On the lower side of the warehousing board 16, a warehousing board 19 similar to this is provided with a gap smaller than the thickness of the vial 1 from the shelf board 12. A delivery conveyor 20 is disposed with a gap smaller than the thickness. A delivery pusher 21 is attached via a seal 22 to the side wall facing the side wall of the freeze-drying warehouse 11 on the side where the delivery board 19 and the delivery conveyor 20 are disposed. The delivery pusher 21 includes a cylinder 21c, a drive rod 21b driven by the cylinder 21c, and a pusher portion 21a that is attached to the tip of the drive rod 21b and that is in contact with the vial 1.
[0007]
As shown in, for example, Japanese Patent Application Laid-Open No. 5-113291 by the applicant of the present invention, the shelf plate 12 having a plurality of steps is sequentially aligned with the upper surface level of the warehousing bridge plate 16 at the time of warehousing by the elevating means, The position is sequentially aligned with the unloading transition board 19.
[0008]
The conventional freeze vacuum drying apparatus 10 is configured as described above. Next, the operation thereof will be described.
[0009]
First, with reference to FIG.5 and FIG.6, the receipt of the vial 1 to the freeze-drying warehouse 11 is demonstrated. FIG. 6 is a schematic diagram illustrating the inside of the freeze-drying chamber 11 in FIG. 5 in order to make it easy to understand the operation at the time of warehousing, but the vials that have been conveyed in one or two rows by the warehousing conveyor 17. In the bottle 1, the gate 23 on the warehousing conveyor 17 is opened and closed at a predetermined timing, and a predetermined number is arranged between the warehousing board 16 and the warehousing pusher 18. Then, the drive rod 18b of the warehousing pusher 18 is driven to push the pusher portion 18a against the vials 1 arranged in a horizontal row, and is pushed onto the shelf board 12 in the freeze-drying warehouse 11 via the warehousing transition board 16. Put it on. By repeating this, the vials 1 are successively placed on the shelf 12 as shown in FIG. 6B. For the shelf plate 12 at the other stage, the shelf plate 12 is aligned with the warehousing position by elevating means described later, and the vials 1 are similarly placed. When the storage of the vial bottle 1 is completed, the opening 13 is closed by the gate 14 and freeze-drying is performed. In addition, the effect | action about leaving is abbreviate | omitted.
[0010]
The above is the freeze-drying apparatus of the conventional example. The apparatus shown in FIGS. 7 and 8 clarifies the method of supplying the refrigerant to each shelf board, but the operation is different from that of the conventional example. And the function is the same.
The corresponding parts are somewhat different in shape, so that the same reference numerals are given and dashes (') are added thereto. 'In the above conventional example and the shelf plate 12 in a plurality of stages in the same manner' freeze drying oven 11 _{1-12 '5} are disposed vertically, which is adapted to be driven up and down by the elevating mechanism 38 Yes. A front wall 11'a is attached to the front wall of the freeze-drying warehouse 11 'via a seal member, and a gate 14' for opening and closing an opening 13 'formed slightly below the center is provided. Yes. Further, on the left side, a pusher device 18 'is provided, and a bridge plate 16' is attached to the front end.
An inlet header 30 and an outlet header 32 are disposed in the freeze-drying cabinet 11 ′, and the respective refrigerant introduction pipes 30a and refrigerant outlet pipes 32a are formed integrally therewith. A cooling device 34 is provided outside the freeze-drying chamber 11 ′, and the refrigerant is sucked by the circulation pump 36 from this. Accordingly, the refrigerant is introduced into the inlet header 30, and from there, the refrigerant flows into the shelf plates 12 ′ _{1 to} 12 ′ ₅ through the pipe line 40, and flows out to the outlet header 32 side through the pipe line 40 ′. From here, it returns to the cooling device 34 through the outlet pipe 32a. Therefore, the refrigerant is circulated in the order of the outer conduit 42, the inlet header 30, the inner conduit 40, the shelf 12 ', the conduit 40' and the outlet header 32, and the shelf 12 'is cooled before the vial 1 is received. Has been.
[0011]
Next, warehousing of the vial bottle 1 will be described.
In FIG. 8, the gate 14 ′ is released upward, and the vial bottle 1 is received by the pusher device 18 ′ in the same manner as in the conventional example. Incidentally, in the illustrated shows a place that is goods receipt vial 1 on the shelf 12 _'3. The shelf 12 _'2 illustrates a situation where the vial 1 having a predetermined number has already been receipts. A predetermined number of vials 1 are sequentially stored in each shelf 12 '. Therefore, when a predetermined number of vials 1 are stored in all the shelves 12 ', the gate 14' is closed and the interior is exhausted by a vacuum device (not shown). Therefore, although freeze-drying is performed, it has the following problems.
That is, since the shelf plates 12 _{'1-12' 5} from the previous Receipt By A Le bottle 1 As apparent in FIG. 7 is cooled, liquid chemical in the vial 1 which is receipts as in FIG 2 Becomes overcooled. When the vial bottle 1 to be stored later is pushed by the pusher device 18 'and the vial bottles collide with each other, and the vial bottle in the supercooled state is subjected to an impact, the supercooled state of the chemical solution 2 is broken. Freeze at once. If all the warehousing is completed while repeating this state and vacuum drying is performed, the quality of the obtained medicine becomes non-uniform.
[0012]
Also, during warehousing apparent as the vial 1 in Figure 7, since the outside air and 'the internal 11 through the' opening 13 are communicated, water each shelf plate 12 in the atmosphere _'1-12 'Condensed to ₅ and became dew, obstructing the receipt of vial 1. Furthermore, there is a concern that cold air flows out from the opening 13 'during warehousing, cooling the warehousing device including the pusher 18', causing condensation and hindering the automatic warehousing mechanism.
[0013]
[Problems to be solved by the invention]
This invention is made | formed in view of the above problems, and makes it a subject to provide the freeze vacuum drying apparatus which can give a uniform freeze-drying effect | action with respect to all the vial bottles.
[0014]
[Means for Solving the Problems]
The above-described problems include a shelf plate arranged in a plurality of stages in the freeze-drying chamber, an opening formed on one side wall of the freeze-drying chamber, and a gate that opens and closes the opening. The freeze-drying method in which the freeze-dried product is supplied to the shelf board sequentially from the upper stage by the storage means into the freeze-vacuum drying chamber from the opening, and the freeze-dried product is freeze-vacuum dried. In the freeze-drying method, the coolant is allowed to flow in the shelf plate supplied with the predetermined number of freeze-dried bodies, but the coolant is not allowed to flow to the other empty shelf plate, Solved by.
[0015]
Or, a shelf plate arranged in a plurality of stages in the freeze vacuum drying cabinet, an opening formed on one side wall of the freeze vacuum drying cabinet, and a gate for opening and closing the opening, the gate is opened. In the freeze-vacuum drying method, the freeze-dried product is supplied to the shelf board sequentially from the upper stage through the opening into the freeze-vacuum drying chamber through the opening, and the freeze-dried product is freeze-vacuum dried. Until a predetermined number of freeze-dried bodies are supplied to the shelf plates of the stage, the shelf is bypassed by the refrigerant so that the refrigerant does not flow into the shelf plate, This is solved by a freeze-drying method characterized in that when a predetermined number of freeze-dried bodies are supplied, the refrigerant is simultaneously flown to each shelf and the freeze-dried bodies are cooled equally .
[0016]
Alternatively, a freeze vacuum drying cabinet having an opening for introducing a material to be lyophilized and containing a plurality of upper and lower shelves, a refrigerant circulating means for circulating the refrigerant, and a gate for opening and closing the opening A supply device for opening the gate and supplying the freeze-dried material to one or a row from the outside, supplying the freeze-dried material to one of the shelves in the freeze-drying chamber, and up and down each shelf. A freezing / vacuum drying apparatus that includes a shelf raising / lowering mechanism that moves the refrigerant in the shelf by the refrigerant circulation means to freeze the freeze-dried material on the shelf, and bypasses the refrigerant circulation means. A number of gate valves corresponding to the number of the valves and the shelves are provided, and the gate valves corresponding to the shelves not supplied with the predetermined number of freeze-dried products are closed so that no refrigerant flows through the shelves. And let the refrigerant bypass the shelf through the bypass valve. It was so. In particular, when the shelves that have completed warehousing are sequentially rapidly cooled, the opening of the bypass valve for keeping the refrigerant flow rate constant is controlled so that the shelves of all the stages can be rapidly cooled uniformly. This is solved by a freeze-drying apparatus characterized by attaching a mechanism.
[0017]
With the above configuration, the vials 1 are supplied from one to the next without being cooled on the shelves only by pre-cooling the device portion excluding the shelves until a predetermined number of vials 1 are supplied. . Therefore, the chemical solution 2 in the vial bottle 1 is not overcooled. In addition, there is no risk of damage due to moisture in the atmosphere during storage. Therefore, even if an impact occurs at the time of warehousing, the drug solution 2 does not freeze, so that the product characteristics of the vial can be made uniform.
[0018]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, a freeze vacuum drying apparatus according to an embodiment of the present invention will be described with reference to FIG. 1, FIG. 2, and FIG.
[0019]
FIG. 1 shows a freeze-drying apparatus according to an embodiment of the present invention, but the same reference numerals are given to portions corresponding to the conventional example, and detailed description thereof is omitted.
According to the embodiment of the present invention, the inlet header 30 and the outlet header 32 are disposed not on the inside but on the outside. Shelves 12 _'1, rack 12' of the inlet header 30 and the refrigerator _2, the shelf 12 _'3, the shelf 12' _4, the shelf 12 'between the ₅ connected conduit 40 are each shelf 12' _1, shelves Pipe lines 40 ′ are connected between 12 ′ ₂ , shelf 12 ′ ₃ , shelf 12 ′ ₄ , shelf 12 ′ ₅ and the outlet header 32. In addition, a bypass valve / flow rate control valve 80 is provided in a bypass pipe 71 connecting the inlet header 30 and the outlet header 32, and a pressure between the control unit 80 a and the inlet header 30 is provided. A regulator 82 is provided. Thereby, the pressure in the inlet header 30 is detected, and the opening degree of the bypass valve / flow rate control valve 80 is adjusted according to the detection output.
Shelf plate partition valves 60, 62, 64, 66, and 68 are disposed in the conduit 40 between the inlet header 30 and each of the shelves 12 ′ ₁ to the shelves 12 ′ ₅ .
Further, a cold trap 50 provided for condensing the solvent sublimated during vacuum drying is connected to the outlet of the outlet header 32 for pre-cooling, and further, a medium cooler constituting the cooling device 34. 51, a refrigerant circulation pump 36 is connected. A refrigerator 52 is connected to the medium cooler 51.
[0020]
The freeze vacuum drying apparatus according to the embodiment of the present invention is configured as described above. Next, this operation will be described.
[0021]
In FIG. 1, FIG. 2, and FIG. 3, the shelves or headers shown in a mouse color are shown to indicate the presence of refrigerant or the passage of refrigerant. Moreover, what is shown by a solid line in each pipeline is a state where the refrigerant is passing, and what is shown by a chain line is a state where the refrigerant is not passed. Next, this operation will be described with reference to the drawings. The vials 1 are stored in the shelves 12 ′ ₁ to 12 ′ ₅ in the same manner as in the above conventional example. In FIG. 2, the refrigerant is stored in the shelves 12 ′ ₂ to 12 ′ ₅ below the second level. Indicates a state that is not washed away. That is, in FIG. 1, the bypass / flow rate control valve 80 is fully open (the valve is painted black indicating fully open, and white is fully closed).
[0022]
According to the embodiment of the present invention, the cold trap 50, the medium cooler 51, and the refrigerant circulation pump 36 are operated as shown in FIG. Be started. As a result, the refrigerant is supplied from the refrigerant circulation pump 36 to the inlet header 30, and the valves 60, 62, 64, 66, 68 are now fully closed. The refrigerant circulates through the cold trap 50, the medium cooler 51, the refrigerant circulation pump 36, and the pipe line 42 through the pipe 32 to the inlet header 30. Thereby, each apparatus part 36, 50, 51 of a freeze vacuum drying apparatus is pre-cooled. However, since the partition valves 60, 62, 64, 66, and 68 are closed, no refrigerant is passed through each of the shelves 12 ′ ₁ to 12 ′ ₅ . When the pre-cooling for a predetermined time is completed, the gate 14 'is released, and the vial bottles 1 are sequentially stored in the shelf at the same level as the bridge plate 16' by the pusher device 18 'as in the conventional example. . At this time, the refrigerant is not passed through the shelves in which the vials 1 are stored like the shelves 12 ′ in FIG. 2 and the shelves 12 ′ ₃ in FIG. There is no cooling from the vial 1 previously received as in the prior art.
[0023]
According to the embodiment of the present invention, when a predetermined number of vials 1 are stored in the shelf 12 ', the lifting mechanism 38 is driven to move the shelf plate upward. FIG. 3 shows a situation in which the first and second shelves 12 ′ ₁ and 12 ′ ₂ are raised to predetermined positions. In this position, the valves 60, 62 corresponding to these shelves 12 ′ ₁ , 12 ′ ₂ are fully opened, so that the refrigerant passes through the inlet header 30 and the conduit 40 to the shelves 12. _'1, 12' ₂ refrigerant is introduced, it is cooled. Therefore, cooling of the vial 1 and this built-in item is started.
[0024]
According to the embodiment of the present invention, as in the conventional example, the vials 1 are sequentially brought into contact with the shelves through the opening 13 ′ by the pusher device 18 ′ as shown in the figure. 1 is not cooled most strongly, and a predetermined number of vials 1 on the shelf are cooled equally, so there is no partial overcooling as in the prior art. The warehousing operation of the vial bottle 1 is performed smoothly, and vibrations caused by the impact between the vial bottles 1 are not generated, and the built-in objects in the supercooled state are not frozen, and uniform quality can be ensured.
[0025]
FIG. 3 shows a state in which the vial bottle 1 is being supplied to the _third shelf 12′3. However, the same effect can be obtained and the uniformity can be ensured. Vial 1 having a predetermined number in this case is the shelf 12 is a refrigerant in ₃ 'when supplied to _3, the valve 64 together with the driven this shelf 12 is opened upward' is passed. The elevating mechanism 38 may be driven simultaneously with the start of the introduction of the refrigerant. However, the valve 64 may be opened after the upward movement to a predetermined position to allow the refrigerant to pass therethrough. When the valve 64 is opened, since the upper valves 60 and 62 are already opened, the flow resistance of the refrigerant varies depending on the opening of the valve 64. Therefore, according to the embodiment of the pressure of the refrigerant introduced into the shelf 12 _'3 is but the present invention varies, the bypass valve and flow control valve 80 senses the pressure in the inlet header 30, thereby a predetermined pressure Since the control unit 80a of the bypass valve / flow rate control valve 80 is adjusted so as to be, the same cooling action as the first and second stages is given to the _third shelf 12'3.
[0026]
After the above freezing, the inside of the freeze-drying cabinet 11 ′ is exhausted by driving a vacuum exhaust system (not shown). Further, the refrigerant supply source is switched to a heat medium supply source (not shown), and all the gate valves 60, 62, 64, 66, 68 are opened and heated. Thereby, the solvent or water | moisture content in the vial bottle 1 sublimates or evaporates, and drying is accelerated | stimulated. In this case, the vapor generated by the above-described sublimation and evaporation is condensed and collected by the cold trap 50 (where a refrigerant is flowing) so that the vacuum exhaust system after the cold trap 50 is not adversely affected. I have to. In this case, the bypass valve / flow rate control valve 80 is fully closed so that 12 ′ _{1 to} 12 ′ ₅ are not bypassed.
[0027]
The embodiment of the present invention has been described above. Of course, the present invention is not limited to this, and various modifications can be made based on the technical idea of the present invention.
[0028]
For example, in the above embodiment, the vial bottles 1 are stored in the shelves 12 ′ _{1 to} 12 ′ _{5 one} by one from the top, and the corresponding partition valves are sequentially opened to cool the vials. In the case of a product with low heat sensitivity, it may be cooled and frozen at the same time after all stages of goods storage. That is, as shown in FIGS. 2 and 3, even if the first and second shelves are at the illustrated positions, the other valves 64 and 66 do not pass through the refrigerant, that is, without opening the valves 60 and 62. , 68, it is still closed. In this state, the vial bottle 1 is stored in the _third shelf 12 ′ ₃ as shown in FIG. By driving the elevating mechanism 38 to be a predetermined number goods receipt it is raised into position, following the shelf 12 _'3 shown in FIG. 3 leave this same level as the' bridging plate 16 a ₅ 'shelves 12 of the bottom Similarly, when a predetermined number of vials 1 are received, the gate 14 'is closed here and the valves 60, 62, 64, 66, and 68 are simultaneously opened. Therefore, the refrigerants are simultaneously flown to the respective shelves from 12 ′ _{1 to} 12 ′ ₅ so that the vials 1 ′ are equally cooled. In the modification of the embodiment of the present invention, the valves 60, 62, 64, 66 and 68 are opened all at once, so that the pressure regulator 82 is unnecessary.
[0029]
In the above embodiment, the vials 1 are stored one by one, and when the predetermined number of vials are stored, the vials are raised to a predetermined position, and the corresponding valve is opened to allow the refrigerant to flow. However, the refrigerant may be urged when it rises to a predetermined position every two stages instead of every one stage. Of course, the refrigerant may be caused to flow up to a predetermined position every two or more stages. The valves 60 to 80 may be opened according to the position of each shelf.
[0030]
Moreover, in the above embodiment, although the vial bottle 1 was demonstrated as a to-be-freeze-dried thing, it may be food and a foodstuff instead of a chemical | medical agent.
[0031]
【The invention's effect】
As described above, according to the freeze-drying apparatus of the present invention, it is possible to freeze-dry all the products to be lyophilized, for example, vials with guaranteed uniform quality.
In addition, even when warehousing using an automatic warehousing device, since all the vials for one shelf are received, rapid cooling is performed, so that the cooling characteristics of the product do not differ due to the impact (vibration) of the warehousing, and the entire shelf is uniform. The effect that a sufficient cooling characteristic is acquired is produced.
Since it is not necessary to pre-cool the shelf deeply in advance, frosting on the shelf does not occur at the time of warehousing, and there is no possibility of hindering the vial and the warehousing mechanism. Moreover, since moisture absorption (condensation) of excess moisture from the outside of the drying cabinet does not occur, the effect of maintaining high sterility is achieved.
Since parts other than the shelf are pre-cooled in advance, the shelf can be rapidly cooled.
Since the shelves can be individually cooled rapidly, the shelves that have completed the warehousing can be rapidly cooled while the warehousing is performed, so that it is possible to quickly cool the heat-sensitive product.
A pressure sensor is installed at the medium inlet header, and the opening of the bypass valve is feedback controlled so that the pressure remains constant. Has the effect of becoming. Furthermore, it is possible to use a smaller refrigerator capacity.
[Brief description of the drawings]
FIG. 1 is a cross-sectional view of a freeze vacuum drying apparatus according to an embodiment of the present invention.
FIG. 2 is a cross-sectional view for illustrating the same operation according to the embodiment of the present invention.
FIG. 3 is a sectional view for illustrating the same operation according to the embodiment of the present invention.
FIG. 4 is a cross-sectional view of a vial as a freeze-dried product applied to an embodiment of the present invention and a conventional example.
FIG. 5 is a cross-sectional view of a conventional freeze-drying apparatus.
6A is a plan view showing a situation before the vial bottle 1 is received in the cabinet, and FIG. 6B shows a situation where the vial bottle 1 is introduced into the cabinet.
FIG. 7 is a cross-sectional view for illustrating a cooling action of each device portion of a conventional example.
FIG. 8 is a cross-sectional view showing the state of each device portion during the operation.
[Explanation of symbols]
11 'freeze drying oven 12' _1, 12 _'2, 12' _3, 12 _'4, 12' ₅ shelves 30 inlet header 32 outlet header 40, 40 'conduit 60,62,64,66,68 Shelf for partition Valve 71 Bypass line 80 Bypass valve and flow control valve 82 Pressure regulator

Claims (7)

A shelf board arranged in a plurality of stages in the freeze vacuum drying cabinet, an opening formed on one side wall of the freeze vacuum drying cabinet, and a gate for opening and closing the opening, and opening the gate In the freeze-vacuum drying method in which the freeze-dried body is supplied into the freeze-drying chamber through the opening from the top in order from the upper stage onto the shelf plate, and the freeze-dried body is freeze-vacuum dried. A freeze-drying method according to claim 1, wherein the refrigerant is allowed to flow through the shelf board supplied with the material to be freeze-dried, but the refrigerant is not allowed to flow through the other empty shelf board. A shelf board arranged in a plurality of stages in the freeze vacuum drying cabinet, an opening formed on one side wall of the freeze vacuum drying cabinet, and a gate for opening and closing the opening, and opening the gate In the freeze-vacuum drying method in which the freeze-dried material is supplied into the freeze-drying chamber from the opening by the storage means in order from the upper stage on the shelf plate, and the freeze-dried material is freeze-vacuum dried. Until the predetermined number of freeze-dried bodies are supplied to the shelf plates, the shelf is bypassed by the refrigerant so that the refrigerant does not flow into the shelf plates, and the shelf plates of all stages are respectively predetermined. When a number of freeze-dried bodies are supplied, the refrigerant is simultaneously flown to the shelves to cool the freeze-dried bodies equally . A freeze-drying chamber having a plurality of upper and lower shelves, a refrigerant circulation means for circulating refrigerant, a gate for opening and closing the opening; The gate is opened and the freeze-dried material is addressed to one or a horizontal row from the outside, the supply device for supplying the freeze-dried material to one of the shelves in the freeze vacuum drying chamber, and each shelf is moved up and down A freezing and vacuum drying apparatus comprising: a shelf elevating mechanism, wherein a refrigerant is caused to flow in the shelf by the refrigerant circulation means, and the freeze-dried material on the shelf is frozen. Provide the number of gate valves according to the number of the shelves, close the gate valve corresponding to the shelf to which the predetermined number of freeze-dried products are not supplied, so that no refrigerant flows in the shelf, So that the shelf is bypassed by the refrigerant through the bypass valve. Vacuum freeze-drying apparatus, characterized in that the. The refrigerant circulation means includes an inlet header and an outlet header, the headers are connected by a bypass line, the inlet header and the outlet header are connected to each of the shelves by a pipe line, and the bypass valve is the bypass 4. The freeze vacuum drying apparatus according to claim 3, wherein each of the gate valves is provided in a pipe line, and each of the gate valves is provided in a pipe line on the inlet header side. A freeze-drying chamber having a plurality of upper and lower shelves, a refrigerant circulation means for circulating refrigerant, a gate for opening and closing the opening; The gate is opened and the freeze-dried material is addressed to one or a horizontal row from the outside, the supply device for supplying the freeze-dried material to one of the shelves in the freeze vacuum drying chamber, and each shelf is moved up and down A freezing and vacuum drying apparatus comprising: a shelf elevating mechanism, wherein a refrigerant is caused to flow in the shelf by the refrigerant circulation means, and the freeze-dried material on the shelf is frozen. Provide the number of gate valves according to the number of the shelves, close the gate valve corresponding to the shelf to which the predetermined number of freeze-dried products are not supplied, so that no refrigerant flows in the shelf, So that the shelf is bypassed by the refrigerant through the bypass valve. When the racks that have been stored are rapidly cooled sequentially, the opening of the bypass valve for keeping the refrigerant flow constant is controlled so that the shelves in all stages can be rapidly cooled uniformly. The freeze vacuum drying apparatus according to claim 4, further comprising a mechanism. 6. The freeze vacuum drying apparatus according to claim 5, wherein the bypass valve has a flow rate adjusting function, and an opening degree of the valve is adjusted in response to an output of a pressure controller connected to the inlet header. The freeze-drying apparatus according to claim 1, wherein the object to be lyophilized is a vial.

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