JPH05113291A - Freezing vacuum dryer - Google Patents

Abstract

PURPOSE:To maintain an airtight chamber of a freezing vacuum dryer in a bacteria reduced or sterile state when a plug is attached. CONSTITUTION:An upper sealing plug frame 4 is fixed to an upper end of a driving rod 2. When the rod 2 is vertically slid up and down, the frame 4 is also vertically slid up and down in an airtight chamber 8. A hanging bolt 7 is merely inserted into a hole formed at each shelf plate 3, but not fixed to the plate 3. Accordingly, when the rod 2 is operated and the frame 4 is moved down, intervals A, B, C, D of the respective plates 3 are narrowed. When a plug is attached to a vial 31 in the chamber 8, the rod 2 is introduced from the chamber 8 into a driving cylinder 9, but not, on the contrary, removed. The rod 2 in the cylinder 9 in which bacteria are not reduced or which is not sterilized is not exposed within the chamber 8, and no bacteria is introduced from the cylinder 9 into the chamber 8.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an FDA-compatible freeze-vacuum drying apparatus which employs steam sterilization of pharmaceuticals.

[0002]

2. Description of the Related Art FIG. 3 shows a vial 31 in which a drug solution 30 as a drug is dispensed. 4A and 4B show a rubber stopper 34 which is a lid of the vial 31. The rubber stopper 34 includes a disk-shaped cap portion 35 and a cylindrical body portion 36 that is a portion to be inserted into the opening 32 of the vial 31.
A notch 37 as shown in the figure is formed with a size of about ⅔ of its height.

As shown in FIG. 3, the vial 31 and the drug solution 30 which have been subjected to steam sterilization and aseptic processing are replaced with the vial 31.
With the body portion 36 of the rubber plug 34 inserted into the opening 32 of the above-mentioned half of the body 32, freeze drying is performed. In the airtight chamber of the freeze / vacuum drying device, which will be described later, the inside of the vial 31 and the space in the freeze / vacuum drying device communicate with each other via the notch 37, and cooling and heating are supplied to the freeze / vacuum drying device. The drug solution 30 in the vial 31 is freeze-dried by the means. Next, the drug solution 30 is freeze-dried, and then the rubber stopper 34 is stoppered (also referred to as a stopper) to completely complete the vial 31.
The lid is closed and the drug solution 30 dispensed inside is sealed.

Hereinafter, a method of inserting the rubber stopper 34 into the vial 31 into which the drug solution 30 has been dispensed in the freeze-vacuum drying apparatus of the conventional rack-lifting system will be described.

The freeze-vacuum drying device 40 shown in FIGS. 5 and 6 is equipped with a shelf 42 into which the vial bottles 31 can be stacked in four stages in an airtight chamber 43. The structure of the shelf 42 will be described below. A lower stopper frame 46, which is located below the shelf 42d, is fixed to the upper end of the drive rod 41, and when the drive rod 41 slides vertically in the drive cylinder 53, the lower stopper frame 46 is also sealed in the airtight chamber. It slides up and down in 43. The upper plugging frame 45 located above the auxiliary shelf 50 is supported by a support member 57 provided on the upper wall of the airtight chamber 43. In the figure, the drive rod 41 is shown in the lowest position.

As shown in the figure, the upper and lower sealing frame 4
Four shelf plates 42 are provided between 5 and 46. The auxiliary shelf 50 provided at the top is fixed to the upper stopper frame 45. This auxiliary shelf 50 has hanging bolts 44a, 44b in holes formed in the metal fittings attached to the sides.
Also, the guide pole 47 is inserted therethrough. The shelf plate 42d provided at the lowermost part is fixed to the lower stopper frame 46, and like the auxiliary shelf 50, this shelf plate 42d is also hung from the hole formed in the metal fitting attached to the side part. Bolt 44
The d and the guide pole 47 are inserted.

Further, the shelf plates 42a, 42b, 42c provided between the auxiliary shelf 50 and the shelf plate 42d are hung on the auxiliary shelf 50 by hanging bolts 44a with metal fittings interposed respectively. , The shelf 42c is the hanging bolt 4
4b suspends it on the auxiliary shelf 50, and the shelf plate 42c is suspended on the shelf plate 42a by suspending bolts 44c.

Each suspension bolt 44 is shown in FIG.
Since 1 is at the lowermost position, the heads of the respective hanging bolts 44 contact the upper surface of the shelf plate 42, and the nuts 54 screwed onto the respective hanging bolts 44 contact the bottom surface of the shelf plate 42. However, the hanging bolts 44 are only inserted into the holes provided in the metal fittings attached to the wall portions of the shelf plates 42, and are not fixed to the shelf plates 42. Therefore,
When the drive rod 41 operates and the lower sealing frame 46 moves upward, the intervals I, J, K, L of the respective shelf plates 42 become narrower than those shown in the drawing.

That is, when the drive rod 41 is actuated and the lower stopper frame 46 moves upward, the shelf plate 42d on the lower stopper frame 46 moves upward, so that the shelf plates 42c and 42 are moved.
The distance I from d becomes narrower.

Further, when the lower stopper frame 46 moves upward and the shelf plate 42c abuts on the rubber stopper 34 of the vial 31,
The shelf 42c is placed on the rubber stopper 34, and then the shelf 42c
Moves upward, and the distance J between the shelves 42b and 42c becomes narrower. In this way, the space between the shelf plates 42 is the space I,
It becomes narrower in the order of J, K, L, and the vial is completely covered as shown in FIG.

The freeze-vacuum drying device 40 is shown in FIG.
In order to freeze-dry the drug solution 30 dispensed in the vial 31 as shown in FIG.
5 is provided, and the heating / cooling medium passes from the inlet 55 to the outlet 56 via the in-tank medium header 59, each shelf 42 and the auxiliary shelf 50. An exhaust port 49 for evacuating the inside of the airtight chamber 43 is provided on the wall portion behind the shelf 42 shown in the drawing. Furthermore, as shown in FIG.
A viewing window 58 for observing the inside of the container 43 is provided.

Next, a method of inserting the chemical solution 30 into the vial 31 and the rubber stopper 34 in the freeze-vacuum drying apparatus of the conventional shelf pushing down movement system will be described.

The freeze-vacuum drying apparatus 60 shown in FIGS. 8 and 9 is provided with a shelf 62 in which the vial bottles 31 can be stacked in four stages in an airtight chamber 63. The structure of the shelf 62 will be described below. An upper sealing frame 65, which is located above the auxiliary shelf 70, is fixed to the lower end of the drive rod 61,
When the drive rod 61 slides vertically in the drive cylinder 73, the upper sealing frame 65 also slides vertically in the airtight chamber 63. A lower plugging frame 66 located at the bottom of the shelf 62d is hung on the shelf plate 62c via a hanging bolt 64d. A cushion material 80 on which the lower plugging frame 66 is placed when the drive rod 61 moves downward is attached to the bottom wall of the airtight chamber 63.

As shown in the figure, the upper and lower sealing frame 6
Four shelves 62 are provided between 5 and 66, and the auxiliary shelf 70 provided at the top is fixed to the upper stopper frame 65, and the auxiliary shelf 70 is hung on the side. Bolt 64
The a, 64b and the guide pole 67 are inserted therethrough. The shelf plate 62d provided at the bottom is fixed to the lower sealing frame 66, and this shelf plate 62d is also similar to the auxiliary shelf 70.
The suspension bolt 64d and the guide pole 67 are inserted through the side portion.

The shelf boards 62a, 62b, 62c provided between the auxiliary shelf 70 and the shelf board 62d are the shelf boards 62.
a is hung from the auxiliary shelf 70 with the hanging bolt 64a interposed therebetween, the shelf board 62b is hung from the auxiliary shelf 70 with the hanging bolt 64b interposed, and the shelf board 62c is suspended with the hanging bolt 64.
It is hung on the shelf plate 62a with c interposed.

Each suspension bolt 64 is shown in FIG.
1 is in the uppermost position, so each suspension bolt 6
The head of No. 4 is in contact with the upper surface of the shelf board 62, and the nut 74 screwed to each hanging bolt 64 is in contact with the bottom surface of the shelf board 62. It is only inserted through the hole provided in the side portion, and is not fixed to each shelf board 62. Therefore, when the drive rod 61 operates and the upper plugging frame 65 moves downward, the intervals M, N, O, P of the respective shelf plates 62 become narrower than those shown in the drawing.

That is, after the drive rod 61 is actuated and the lower sealing frame 66 is placed on the cushion material 80 and stops moving, the shelf plate 62c moves downward, so that the shelf plate 62c The space M with the shelf plate 62d becomes narrower.

Further, the upper stopper frame 65 moves downward so that the shelf plate 62c does not show the rubber stopper 3 of the vial 31.
4, the shelf plate 62c is placed on the rubber stopper 34, then the shelf plate 62b moves downward, and the distance N between the shelf plates 62b and 62c becomes narrow. In this way each shelf 6
The intervals M, N, O and P of 2 become narrower as shown in FIG.

The freeze-vacuum drying device 60 is shown in FIG.
In order to freeze-dry the drug solution 30 dispensed in the vial 31 as shown in FIG.
The heating / cooling medium flows out of the inlet 75 to the outlet 76 via the in-tank medium header 79, each shelf plate 62 and the auxiliary shelf 70. An exhaust port 69 is provided on the right side wall portion of the airtight chamber 63 to evacuate the airtight chamber 63. Furthermore, as shown in FIG. 9, the door 68 is provided with a peep window 78 for observing the inside of the airtight chamber 63.

The conventional freeze-vacuum drying device 40 of the push-up moving type and the freeze-vacuum drying device 60 of the pushing-down moving type according to the prior art have been described above. The airtight chambers 43 and 63 of the freeze-vacuum drying devices 40 and 60 are described above. Aseptic operation is required inside, and according to this method, steam sterilization is performed as shown in parts a and b of the drive rods 41 and 61 shown in FIGS. 7 and 10.
The parts housed in the drive cylinders 53, 73 that have not been subjected to aseptic processing, that is, the parts that have not been sterilized are exposed in the airtight chambers 43, 63. This is the airtight chamber 4
Sterilization and aseptic condition in 3, 63 cannot be maintained.

[0021]

SUMMARY OF THE INVENTION The present invention has been made in view of the above problems, and operates a push-up movement type or push-down movement type rack to cap a vial placed on the rack in an airtight chamber. In this case, it is an object of the present invention to provide a freeze-vacuum drying device having a mechanism in which the sterilized / sterilized part is not exposed in the airtight chamber.

[0022]

[Means for Solving the Problems] The above object is to drive a drive cylinder in which a plurality of shelves are vertically arranged at a predetermined interval in an airtight chamber and are connected to any one of these shelves. In a freeze-vacuum drying apparatus in which the distance between the shelves is reduced by driving a rod, a drive rod of the drive cylinder is slidably penetrated through the plurality of shelves so that the lowermost stage or the uppermost stage. It is achieved by a freeze-vacuum drying device characterized by being fixed to a shelf board.

[0023]

By pulling the drive rod of the drive cylinder for moving the plurality of shelves from the airtight chamber into the drive cylinder, the non-sterilized portion of the drive rod is not exposed in the airtight chamber. The sterilization and aseptic condition of is reliably maintained.

[0024]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A shelf-down moving type freeze vacuum drying apparatus according to a first embodiment of the present invention will be described below with reference to the drawings. The same components as those in the conventional example are designated by the same reference numerals, and detailed description thereof will be omitted.

The freeze-vacuum drying apparatus 1 shown in FIG. 1 is equipped with a shelf 3 into which vials 31 can be stacked in four stages in an airtight chamber 8. The structure of this shelf 3 will be described below.
An upper closure frame 4 located above the auxiliary shelf 10 is fixed to the upper end of the drive rod 2, and when the drive rod 2 slides in the drive cylinder 9 in the vertical direction, the upper closure frame 4 also moves. It slides up and down in the closed chamber 8. The lower plugging frame 5 located below the shelf plate 3d is hung on the shelf plate 3d via suspension bolts 7d. The bottom rod portion of the airtight chamber 8 is attached with a cushion material 14 on which the lower sealing frame 5 is placed when the driving rod 2 moves downward. The hole c formed inside 3d and the holes d formed in the shelves 3a, 3b, 3c are inserted. In the figure, the drive rod 2 is shown in the uppermost position.

As shown in the figure, the upper and lower sealing frame 4,
Each shelf plate 3 is provided between 5 and the auxiliary shelf 10 provided at the uppermost part is fixed to the upper sealing frame 4.
This auxiliary shelf 10 has hanging bolts 7a, 7b and a guide pole 6 in holes formed in metal fittings attached to the sides.
Is inserted. The shelf plate 3d provided at the lowermost part is fixed to the lower sealing frame 5, and like the auxiliary shelf 10, this shelf plate 3d is also hung from the hole formed in the metal fitting attached to the side part. The bolt 7d and the guide pole 6 are inserted.

Further, the shelves 3a, 3d, 3c provided between the auxiliary shelves 10 and the shelves 3d are hung on the auxiliary shelves 10 by hanging bolts 7a with metal fittings interposed respectively. The shelf plate 3b is hung on the auxiliary shelf 10 by the hanging bolts 7b, and the shelf plate 3c is hung on the shelf plate 3a by the hanging bolts 7c.

Since the driving rod 2 is at the uppermost position in the drawing, the head of each hanging bolt 7 abuts the upper surface of each shelf plate 3 and is screwed to each hanging bolt 7. Although the nuts 11 are in contact with the bottom surface of each shelf 3, the hanging bolts 7 are only inserted through the holes formed in the metal fittings provided on the side of each shelf 3. , Each shelf board 3 is not fixed. Therefore, when the drive rod 2 operates and the upper plugging frame 4 moves downward, the intervals A, B, C, D of the respective shelf plates 3 become narrower than those shown in the drawing. That is, after the drive rod 2 is actuated and the lower sealing frame 5 is placed on the cushion material 14 and stops moving, the next shelf 3c moves downward, so that the shelf 3c and the shelf 3d The distance A becomes narrower.

Further, when the upper sealing frame 4 moves downward and the shelf plate 3c contacts the rubber stopper 34 of the vial bottle 31, the shelf plate 3c is placed on the rubber stopper 34, and then the shelf plate 3b. And shelf 3
The distance B from c becomes narrower. In this way, the intervals A, B, C, D of the respective shelf boards 3 are gradually reduced.

The guide pole 6 includes an upper sealing frame 4 and each shelf 3
Each of the shelves 3 can be stably moved when the drive rod 2 is moved by inserting a hole provided in the.

The freeze-drying apparatus 1 is provided with a chemical solution 3
The medium inlet 12 and the medium outlet 13 of the heating / cooling means for adjusting the temperature for freeze-drying 0 are provided, and the heated / cooled medium also flows inside the shelves 3 and the auxiliary shelves 10. There is a road. Further, in order to make the inside of the hermetic chamber 8 a vacuum, an exhaust means (not shown) is provided.

The freeze-vacuum drying apparatus 1 according to the first embodiment of the present invention is constructed as described above. Next, its operation will be described.

The inside of the airtight chamber 8, the vial 31, the rubber stopper 34, and the chemical solution 30 are washed or sterilized in advance, and the shelf 3 of the freeze-vacuum drying apparatus 1 is at the position shown in FIG. 1, that is, the drive rod 2 is at the uppermost position. The vial 31 is placed on the shelf 3 at the position. Inside the vial 31, as shown in FIG.
The chemical solution 30 is dispensed, and about half the body 36 of the rubber stopper 34 is inserted. That is, as shown in the figure, the vial bottle 31 is not completely covered by the rubber stopper 34, and the inside of the vial bottle 31 and the space of the airtight chamber 8 communicate with each other through the notch 37.

In this state, the cooling / heating medium is charged with the medium inlet 1
The chemical liquid 30 is freeze-dried by being circulated from 2 to the medium outlet 13 and further evacuating the airtight chamber 8 by an exhaust device (not shown). Since the chemical solution 30 communicates with the space Q in the vial 31 by the notch 37, the chemical solution 30 is freeze-dried in a vacuum. When the freeze-vacuum drying is completed, the drug solution 30 is completely sealed in the vial bottle 31, so that the rubber stopper 34 opens the opening 3 of the vial bottle 31.
It is plugged to 2. Therefore, the drive rod 2 slides downward in the drive cylinder 9. Since each shelf plate 3 and the hanging bolt 7 are not fixed as described above, when the upper sealing frame 4 attached to the upper end of the drive rod 2 moves downward, the intervals A, B, C of the shelf plates, D becomes narrower. As a result, the cap portion 35 of the rubber stopper 34 of the vial 31 placed on each shelf 3 comes into contact with the lower ends of the shelf 3 and the auxiliary shelf 10. When the upper sealing frame 4 further moves downward, the rubber stopper 34 is pressed downward, the vial bottle 31 is completely covered with the rubber stopper 34, and the drug solution 30 is sealed in the vial bottle 31.

As described above, the drive rod 2 only moves from the upper side to the lower side until the chemical solution 30 is freeze-vacuum dried and the vial 31 is capped with the rubber stopper 34. Therefore, unlike the conventional example, only the portion of the drive rod 2 that has undergone steam sterilization / sterilization in the airtight chamber 8 only enters the drive cylinder 9 from the airtight chamber 8 and vice versa. Bacteria do not enter into the airtight chamber 8 through the drive rod 2 for stoppering, and invasion of various bacteria is completely prevented in the airtight chamber 8 requiring aseptic operation, and sterilization / sterilization is performed. The state is maintained.

After the stoppering work is completed and the shelf 3 is moved, the shelf is returned to the position shown in FIG. 1 and the vial 31 is taken out. Then, the airtight chamber 8 is sterilized by steam and sterilized. Keep it.

Next, a second embodiment of the freeze-drying apparatus of the rack lifting and moving type according to the present invention will be described with reference to the drawings.

The freeze-vacuum drying apparatus 15 shown in FIG. 2 is equipped with a shelf 17 into which the vial bottles 31 can be stacked in four stages in the airtight chamber 22, and the structure of the shelf 17 will be described. The lower closure frame 19 located at the lower part is fixed to the lower end of the drive rod 16, and when the drive rod 16 slides vertically in the drive cylinder 23, the lower closure frame 19 also moves in the airtight chamber 22. Slide vertically. The upper stopper frame 18 located above the auxiliary shelf 24 is an airtight chamber 22.
And the drive rod 16 has a hole e formed inside the upper sealing frame 18 and the auxiliary shelf 24 and the shelf plate 3a.
The holes f formed in 3b and 3c are inserted. In the figure, the drive rod 16 is shown in the lowermost position.

As shown in the figure, the upper and lower sealing frame 1
Each shelf 17 is provided between 8 and 19, and the auxiliary shelf 24 provided at the uppermost part is fixed to the upper sealing frame 18. This auxiliary shelf 24 has a hanging bolt 21 on the side.
The a, 21b and the guide pole 20 are inserted therethrough. The shelf plate 17d provided at the bottom is fixed to the lower sealing frame 19, and this shelf plate 17d, like the auxiliary shelf 24,
The suspension bolt 21d and the guide pole 20 are inserted through the side portion.

Further, the shelves 17a, 17b, 17c provided between the auxiliary shelves 24 and the shelves 17d are the shelves 17
a is suspended from the auxiliary shelf 24 by the suspension bolt 21a, the shelf plate 17c is suspended from the auxiliary shelf 24 by the suspension bolt 21b, and the shelf plate 17c is suspended from the shelf plate 17a by the suspension bolt 21c.

Each suspension bolt 21 is shown in FIG.
Since 6 is at the lowest position, the head of each hanging bolt 21 abuts on the upper surface of each shelf 17, and the nut 25 screwed to each hanging bolt 21 contacts the bottom surface of each shelf 17. Although they are in contact with each other, each hanging bolt 21 is only inserted into a hole provided in each shelf board 17, and is not fixed to each shelf board 17. Therefore, when the drive rod 16 operates and the lower sealing frame 19 moves upward, the intervals E, F, G, and H of the respective shelf plates 17 become narrower than those shown in the drawing.

That is, when the drive cylinder 16 operates and the lower sealing frame 19 moves upward, the shelf plate 17d moves upward. Since the upper plugging frame 18 is fixed, the space E between the shelf plates 17c and 17d becomes narrow.

Further, when the lower stopper frame 19 moves upward and the shelf plate 17c comes into contact with the rubber stopper 34 of the vial bottle 31,
The shelf plate 17c is placed on the rubber stopper 34, and then the shelf plate 17b.
The space F between the rack and the shelf 17c becomes narrower. In this way, the intervals E, F, G, H of the respective shelf plates 17 become narrower in order.

The guide pole 20b is inserted through the upper stopper frame 18 and through the holes provided in each shelf plate 17, so that each shelf plate 17 can be stably moved when the drive rod 16 moves. I am trying.

The freeze-vacuum drying device 15 is provided with a medium inlet 26 and a medium outlet 27 of heating / cooling means for adjusting the temperature for freeze-drying the chemical liquid 30, and also has a shelf 17 and an auxiliary shelf 24. There is also a flow path inside the chamber to allow the heated and cooled medium to flow.
An evacuation means (not shown) is provided to create a vacuum in the inside 2. Further, the reserve bolt 28 in the drawing is a bolt for stacking and co-fastening the auxiliary shelf 24 and the shelf plate 17a, for example, and is used when the space between the shelves 17a is widened when the vial is large.

The freeze-vacuum drying apparatus 15 according to the second embodiment of the present invention is configured as described above, but in this embodiment as well as the first embodiment, unlike the conventional example, after the freeze-drying is completed. In the sealing operation, only the portion of the drive rod 16 in the airtight chamber 22 that has undergone steam sterilization and aseptic processing is
Since it only enters from the inside into the drive cylinder 23 and not the other way around, germs do not enter the airtight chamber 22 via the drive rod 16 for plugging, and a sterile condition is required. Invasion of bacteria and the like is prevented in the airtight chamber 22, and the sterilized and aseptic state is maintained.

Although the respective embodiments of the present invention have been described above, the present invention is not limited to these, and various modifications can be made based on the technical idea of the present invention.

For example, in the above embodiment, the vial 31
Although the lid is a rubber stopper, the material of the lid is not limited to this and may be a material such as synthetic resin or cork.

[0049]

As described above, according to the freeze-vacuum drying apparatus of the present invention, when the vial is stoppered, the drive rod is drawn from the airtight chamber into the drive cylinder.
Even if the shelf is moved to cap the vial, the unsterilized / sterilized part is not exposed in the airtight chamber, and the sterilized / sterilized state can be maintained. Freeze-vacuum drying can be performed efficiently and reliably in a sterile and aseptic state.

[Brief description of drawings]

FIG. 1 is a side view showing the inside of a freeze-vacuum drying apparatus of a shelf pull-down moving type according to a first embodiment of the present invention.

FIG. 2 is a side view showing the inside of a freeze-vacuum drying apparatus of a rack lifting and moving type according to a second embodiment of the present invention.

FIG. 3 is a cross-sectional view showing a vial and a rubber stopper, which is a lid thereof, half of which is inserted into the vial.

FIG. 4A is a side view of a rubber stopper which is a lid of a vial bottle, and B is a bottom view of the rubber stopper.

FIG. 5 is a side view showing the inside of a freeze-vacuum drying apparatus of a shelf pushing-up moving type according to a conventional example.

FIG. 6 is a partially cutaway front view of a conventional shelf push-up moving freeze vacuum drying apparatus.

FIG. 7 is a side view showing a position when a shelf of the conventional shelf pushing up movement type is stoppered.

FIG. 8 is a side view showing a freeze-drying apparatus of a shelf pushing down movement type according to a conventional example.

FIG. 9 is a partially cutaway front view of a conventional shelf pushing down movement type freeze vacuum drying apparatus.

FIG. 10 is a side view showing a position when the shelf of the conventional shelf pushing down movement type is stoppered.

[Explanation of Codes] 1 Freeze Vacuum Drying Device 2 Drive Rod 3 Shelf Plate 9 Drive Cylinder 15 Freeze Vacuum Drying Device 16 Drive Rod 17 Shelf Plate 23 Drive Cylinder

Claims (1)

[Claims] 1. A plurality of shelves are vertically arranged at a predetermined interval in an airtight chamber, and a drive rod of a drive cylinder connected to any one of the shelves drives the shelves to move between the shelves. In a freeze-vacuum drying apparatus with a small interval, the drive rod of the drive cylinder is slidably passed through the plurality of shelves, and is fixed to the lowermost or uppermost shelves. Freeze vacuum dryer.