JP2013013434A - Quick freezing system for raw chemical - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a quick freezing system for raw chemicals which can quickly freeze a raw chemical being housed in a plurality of bags for frozen storage collectively under an approximately uniform state.SOLUTION: The quick freezing system for raw chemicals includes: a freezer (10); and a raw chemical housing-moving apparatus (50) which can enter/exit the freezer. The freezer includes: a freezing chamber (11); a freezing apparatus; and a differential pressure booth (15) which is arranged in the freezing chamber. The raw chemical housing-moving apparatus can house the raw chemical which is housed in bags for frozen storage in multiple stages under a state in which the raw chemical is mounted on a tray, and at the same time, can move the raw chemical. The differential pressure booth includes a cabinet section (60) which is equipped with an opening (61) through which the raw chemical housing-moving apparatus can enter/exit. The cabinet section includes: a front chamber (65) which is located in an area being closer to the opening; and a rear chamber (67) which is located in an area being away from the opening. In the front chamber, the raw chemical housing-moving apparatus is housed. On the top of the rear chamber, a differential pressure fan (69) for placing the cabinet section under a negative pressure state is installed to constitute the quick freezing system for raw chemicals.

Description

  The present invention relates to a rapid freezing system for a pharmaceutical stock solution, and more particularly to a system for rapidly freezing a liquid drug substance contained in a frozen storage bag.

  A pharmaceutical used for diagnosing, treating, or preventing a disease is generally manufactured through the following manufacturing process.

  First, a predetermined chemical substance as a starting material is subjected to processing operations including various processing steps such as a reaction step, a purification step, a drying step, a pulverization step, a pharmaceutical water addition step, etc. The drug substance (hereinafter simply referred to as the drug substance) is made as the raw material. Next, using this drug substance as a main raw material, a pharmaceutical product is finally produced through a formulation process operation including a formulation process, a packaging process, and the like.

  As the form of the drug substance, there are, for example, a powder form and a liquid form. Among these, in particular, liquid drug substances need to be cryopreserved to ensure stability. Moreover, since it is a liquid, when it accommodates in a flexible resin bag, it may be said that handling property is not enough.

JP 2008-195443 A

  Conventionally, a liquid drug substance that is a raw material of an active ingredient of a drug is often frozen. It can be said that there is no specific system for rapidly freezing the drug substance. In the case of a drug substance in the form of a liquid substance, if it can be frozen while being stored in a frozen storage bag, it can be stored for a long period of time, and the handling can be simplified. However, when the frozen storage is divided into small bags for cryopreservation of about 200 to 400 ml, the management and handling of the drug substance becomes complicated. In addition, due to the background that the amount of drug substance has increased due to recent development, a large volume of frozen storage is required. For this reason, it is considered preferable to store in a frozen storage bag divided into at least 10 liters or more.

  Based on such an idea, the present invention has been devised, and the present invention is capable of rapidly freezing a drug substance stored in a plurality of frozen storage bags at a time in a substantially uniform state. It is to provide a drug substance quick freezing system. In addition, because the drug substance is the main ingredient of pharmaceuticals, it must be handled with great care and can be quickly frozen without damaging the bag, preventing condensation and frosting in the cabinet as much as possible. There is a need for a system that can be used as a freezer storage and that does not require defrosting during quick freezing operation and during storage operation after completion. Furthermore, it is desired that the running cost is low and that the temperature control of the internal temperature is excellent.

  Incidentally, in the so-called low-temperature liquefied gas (liquid nitrogen) method in which liquid nitrogen vaporized in an insulated freezer is directly sprayed and frozen on the drug substance bag, for example, 1) partial breakage of the bag occurs. It has been confirmed that inconveniences such as :) control accuracy of the internal temperature is poor, 3) high running cost, 4) liquid nitrogen tank equipment is required, and 5) it is difficult to prevent complete condensation on the structure. ing.

  In order to solve the above-mentioned problems, the present invention provides a rapid freezing system for an active pharmaceutical ingredient in which a drug substance stored in a cryopreservation bag is to be frozen, and the quick freezing system includes a freezer and a freezer. A drug substance storage and transfer device that can be moved in and out, the freezer has a freezing chamber, a freezing device, and a differential pressure booth disposed in the freezing chamber, the drug substance storage and movement device, The drug substance stored in the cryopreservation bag can be stored in multiple stages in a state of being placed on the tray and can be moved, and the differential pressure booth is an opening through which the drug substance storage / transfer device can enter and exit The housing has a front chamber located in an area near the opening, and a rear chamber located in an area far from the opening, and the drug substance is contained in the front chamber. A storage / transfer device is stored above the rear chamber. The configured as a differential pressure fan for the casing in the negative pressure is installed.

  In a preferred embodiment of the drug substance rapid freezing system of the present invention, cold air is applied to the drug substance in the bag arranged in multiple stages in the drug substance storage / transfer device between the front chamber and the rear chamber. A partition plate is provided for efficient contact.

  The drug substance quick refrigeration system of the present invention is configured to forcibly circulate cold air in the freezer compartment by the differential pressure fan as a preferred embodiment.

  In addition, the drug substance rapid freezing system of the present invention is preferably set to a temperature Tp lower than room temperature in order to prevent condensation and frost formation in the freezer before entering the freezer. And a front room having a temperature Tf that is lower than the temperature Tp in the freezer and higher than the temperature in the freezer, and is configured to enter the freezer room sequentially through the pass room and the front room.

  In addition, the drug substance rapid freezing system of the present invention is preferably configured such that the temperature Tp is in the range of 2 to 8 ° C and the temperature Tf is in the range of -15 to -5 ° C.

  Moreover, the rapid freezing system of the drug substance of the present invention is configured so that the drug substance to be frozen stored in the frozen storage bag is 10 liters or more as a preferred embodiment.

  In addition, in the drug substance rapid freezing system of the present invention, as a preferred aspect, the tray has a rectangular bottom portion, a pair of opposed first side surfaces erected from the periphery of the bottom portion, and a pair of opposed first side portions. The first side surface portion corresponds to a surface disposed so as to be positioned in the width direction of the opening of the differential pressure booth, and the first side surface portion efficiently contacts cold air. In order to reduce the freezing time, a plurality of holes for ventilation are arranged.

  In a preferred embodiment of the rapid freezing system for drug substances according to the present invention, when the height of the first side surface portion is H1, and the maximum height of the frozen storage bag stored in the tray is HG, H1 = It is configured to be in the range of (0.7 to 0.95) HG.

  Further, as a preferred aspect of the rapid freezing system for drug substances according to the present invention, the ratio of the total area of the plurality of vent holes formed in the first side surface portion to the area of the first side surface portion is as follows: It is comprised so that it may be 40-60%.

  In a preferred embodiment of the drug substance rapid freezing system of the present invention, the relationship between the arrangement interval Tp of the trays stored in multiple stages and the height of the first side surface portion of the tray H1 is Tp = (1. 3-2.5) configured to be H1.

  The present invention is a rapid freezing system for an active pharmaceutical ingredient in which a drug substance stored in a cryopreservation bag is to be frozen, and the quick freezing system includes a freezer, and an active ingredient storage and transfer device that can enter and exit the freezer. The freezer has a freezer compartment, a freezer, and a differential pressure booth arranged in the freezer compartment, and the drug substance storage / transfer device is stored in a cryopreservation bag. The medicine can be stored in multiple stages in a state where it is placed on a tray and is movable, and the differential pressure booth has a housing portion having an opening through which the drug substance storage and movement device can enter and exit, The housing portion includes a front chamber located in an area close to the opening, and a rear chamber located in an area far from the opening, in which the drug substance storage and movement device is stored, In the upper part of the rear chamber, the housing part has a negative pressure. Since the differential pressure fan is configured as being installed in a plurality of refrigeration storage of the storage drug substance to the bag at a time, it can be frozen in a state of substantially uniform.

  In the present invention, in particular, quick freezing can be performed without damaging the bag, dew condensation and frosting in the storage can be prevented as much as possible, and after freezing it can also be used as a freezer storage. Defrost during the quick freezing operation and during the storage operation after completion can be made unnecessary. Furthermore, the running cost is low and the temperature control of the inside temperature is excellent.

FIG. 1 is a plan view of a drug substance rapid refrigeration system. In particular, FIG. 1 schematically shows the arrangement of a differential pressure booth and the like inside a freezer, and the arrangement of a front room and a pass room attached to the freezer. is there. FIG. 2 is a cross-sectional view taken along the line AA in FIG. 1, and is a diagram schematically showing the structure in the differential pressure booth, the state in which the drug substance storage / transfer device is stored, and the cold air circulation state. It is. FIG. 3 is a perspective view showing a state in which trays are stored in multiple stages in the drug substance storage / transfer device. FIG. 4 is a perspective view schematically showing a structure of a tray for storing and placing the drug substance stored in the cryopreservation bag. FIG. 5 (A) is a plan view schematically showing an example of a cryopreservation bag in which the drug substance is stored, and FIG. 5 (B) shows the end surface of the α-α arrow in FIG. 5 (A). It is drawing which showed typically.

  Hereinafter, a rapid freezing system for drug substances according to the present invention will be described with reference to FIGS. FIG. 1 is a plan view of a rapid freezing system for drug substances according to the present invention, and FIG. 2 is a sectional view taken along the line AA in FIG.

  The drug substance quick freezing system of the present invention is intended for freezing the drug substance stored in a cryopreservation bag, and there has been no proposal of a technique related to freezing such a drug solution. The drug substance in the present invention is preferably packed in a frozen storage bag in units of 10 liters or more, particularly in units of 12.5 to 20 liters. This is to prevent the management and handling of the drug substance from becoming complicated as described in the section of the prior art.

  FIG. 5 (A) shows a plan view of an example of a cryopreservation bag 80 in which the drug substance 1 is stored, and FIG. 5 (B) shows an end view of the α-α arrow in FIG. 5 (A). It is. The cryopreservation bag 80 is, for example, a bag formed by laminating two sheets of resin sheet material such as polyethylene and adhering the periphery thereof. The preferred effective capacity in the present invention is about 20 liters, and the thickness is About 0.25 mm, heat resistant temperature is about −80 to 60 ° C., and bag plane size is about (600 to 800) mm × (450 to 550) mm.

  In addition, the code | symbol 81 shown by FIG. 5 (A) is the tube provided so that it might communicate with the inside of a bag body, and the code | symbol 82 is a cap attached to the front-end | tip of a tube. The frozen storage bag 80 is used as a disposable that is discarded after one use. Further, it is desirable that the temperature at which the stock solution is considered to be completely frozen is the temperature at which the drug substance reaches −20 ° C., and the time to reach this temperature is as short as possible (for example, within 3 hours).

  The quick freezing system of the present invention includes, as shown in FIG. 1, a freezer 10 for freezing an active ingredient stored in a cryopreservation bag, and an active ingredient stored in a freezing storage bag. And an active ingredient storage / transfer device 50 for carrying out the product.

  In the embodiment shown in FIG. 1, an example is described in which the two-chamber freezer 10 is arranged in a mirror image relationship with the partition plate 19 as the center, but is not necessarily limited to such a form. Absent. The number of freezers installed is not limited to two rooms, and may be one room or three or more rooms.

  In the case of the present embodiment shown in FIG. 1, each freezer 10 includes a freezer compartment 11, a refrigerating apparatus (not shown) (including an outdoor unit and an indoor unit), and a differential pressure booth arranged in the freezer compartment 11. 15.

<Description of freezer compartment 11>
The freezer compartment 11 is a space for freezing the drug substance, and, for example, around −45 ° C. so that the drug substance stored in the frozen storage bag can be frozen as quickly and uniformly as possible. It is configured to be maintained at a substantially constant temperature. In particular, it is desirable to enable temperature control within a range of ± 2 ° C. even in a temperature environment of −45 ° C. In general, a heat insulating material is incorporated in the wall panel forming the freezer compartment 11.

  The size (volume) of the freezer compartment 11 is not particularly limited, and is appropriately set in consideration of the total capacity of the drug substance stored in the frozen storage bag to be frozen, the freezing capacity of the freezer, and the like. Is done.

<Description of refrigeration equipment>
The refrigeration apparatus is preferably of a refrigerator type that uses electricity, and includes, for example, an outdoor unit including a compressor, a condenser, and the like, and an indoor unit including a heat exchanger that vaporizes refrigerant gas. As the capacity of the refrigeration apparatus, it is desirable that the drug substance can be rapidly frozen and can be used as a freezer storage at a preset temperature after the rapid freezing operation. In particular, it is desirable that the storage temperature can be arbitrarily set between -20 and -45 ° C.

<Description of differential pressure booth 15>
For example, as shown in FIG. 1, four differential pressure booths 15 are arranged in one freezer 10 and a total of eight differential pressure booths 15 are arranged in the two freezers 10. In the embodiment shown in FIG. 1, a configuration is adopted in which two adjacent differential pressure booths 15 are paired across the partition wall 15a to form one set (4 sets × 2 = 8), not particularly limited to the form and quantity shown in FIG.

  As shown in FIG. 2, the differential pressure booth 15 has a housing part 60 (chamber) having an opening 61 through which the drug substance storage / movement device 50 can enter and exit, and the housing part 60 is an area close to the opening 61. And a rear chamber 67 located in an area far from the opening 61.

  A space for storing and installing the drug substance storage / movement device 50 is formed in the front chamber 65, and a space for forming a negative pressure atmosphere is formed in the rear chamber 67. In the upper part of the chamber 67, a differential pressure fan 69 (a blower that sends wind upward) for making the internal space of the housing portion 60 (particularly, the rear chamber 67) a negative pressure is inserted into the internal space of the rear chamber 67. It is installed in a state.

  As shown in FIG. 2, the front chamber 65 and the rear chamber 67 are connected in a spatially connected state, but at the boundary, trays 90 arranged in multiple stages in the drug substance storage / movement device 50 are connected. It is preferable to provide partition plates 71 and 72 for efficiently bringing cold air into contact with the inner bag 80 (with the drug substance inside). In the present embodiment, the partition plates 71 and 72 are installed in a manner that allows air to flow through the area where the bags 80 in the tray 90 arranged in multiple stages exist intensively. Is in the form of blocking as much as possible. In other words, as shown in FIG. 2, the lower part and the upper part where the bag 80 of the drug substance storage / transfer apparatus 50 does not exist are configured to be shielded by the partition plates 71 and 72, respectively. Due to the presence of the partition plates 71 and 72, the opening area at the boundary between the front chamber 65 and the rear chamber 67 is narrowed down and smaller than the opening area of the opening 61 that is the entrance of the differential pressure booth 15. When the opening area of the opening 61 is Ao and the opening area at the boundary between the front chamber 65 and the rear chamber 67 is Ab, it is preferable that Ab = (0.5 to 0.9) Ao.

  The differential pressure fan 69 acts to forcibly circulate the cold air in the freezer compartment 10. That is, for example, when a motor-driven differential pressure fan 69 installed at the upper portion of the rear chamber 67 rotates around its main shaft, the air in the rear chamber 67 of the housing unit 60 is wound upward, and the rear chamber 67 is negatively pressurized. become. Therefore, the cold air blown out from the cold air blowing port 17a of the indoor unit 17 of the refrigeration apparatus shown in FIG. 2 once sinks downward and enters the front chamber 65 of the housing 60 from the opening 61 of the differential pressure booth 15, A series of cold air circulation flows are formed such that they pass through the rear chamber 67 and are wound upward. That is, a cold air circulation flow as shown by the arrow in FIG. 2 occurs. This makes it possible to cool the drug substance in a shorter time without unevenness.

<Description of Drug Substance Storage / Transfer Device 50 and Tray 100>
Next, the drug substance storage / movement device 50 and the tray 100 that is stored in multiple stages in the vertical direction of the device 50 will be described. In the freezing operation, the tray 100 stores a frozen storage bag in which the drug substance is stored. FIG. 3 is a perspective view showing a state in which the tray 100 is stored in multiple stages in the drug substance storage / movement device 50. FIG. 4 is a perspective view schematically showing a structure of a tray for storing and storing a cryopreservation bag in which the drug substance is stored.

  As shown in FIG. 3, the drug substance storage / movement device 50 includes, for example, a frame 51 assembled using a bar and a plate as a main structure. Four free casters 52 that can be rotated 360 degrees are attached to the corners, and a pair of left and right guide rails 55 (back side) for inserting and removing the tray 100 are attached to the side of the frame 51. These rails are not visible in the drawing), but are installed in five steps at predetermined intervals in the vertical direction. In the case of the present embodiment, as the specification of the drug substance storage / transfer device 50, the number of stages on which the tray can be installed is five, but the number of stages is not necessarily limited to this, and is a target for freezing. The number of stages may be set as appropriate in consideration of the processing amount of the drug substance and the processing capacity of the refrigeration system. Preferably, it is preferably about 4 to 7 stages. This is because the object to be frozen arranged in the vertical direction within such a range tends to be frozen at a substantially uniform freezing speed.

  Further, as shown in FIG. 3, a handle 58 is attached to and removed from each side surface of each of the four bar members 51a which are the main members in the vertical direction of the frame 51 of the drug substance storage / movement device 50. A pair of upper and lower attachment members 59a and 59b that can be attached in a formula are fixed. A through hole for attachment and detachment is formed inside the attachment members 59a and 59b. By adopting such a specification, for example, the two handles 58 can be attached to all four corners by attaching and detaching. For example, when transporting, one surface on the left side is the front as shown in FIG. When mounting and storing in the front chamber 61 of the differential pressure booth 15, if it is mounted so that the other surface on the right next to it is the front, the operability during transportation and storage is greatly improved. .

Next, the tray 100 will be described with reference to FIG.
The tray 100 has a rectangular bottom portion 101, a pair of opposed first side surface portions 103 erected from the periphery of the bottom portion 101, and a pair of opposed second side surface portions 105. A concave storage portion is formed.

  The first side surface portion 103 corresponds to a surface arranged so as to be positioned in the width direction of the opening 61 of the differential pressure booth 60 described above during the freezing operation (corresponding to a back surface or front surface in FIG. 2). To do). A plurality of holes 104 for ventilation are arranged in the first side surface portion 103. By providing the plurality of holes 104 for ventilation, the cool air can be efficiently brought into contact with the bag, and the freezing time can be shortened.

  In the present embodiment, as a suitable example of the hole 104, eight circular holes are formed at approximately equal intervals, but there is no particular limitation on the shape, number, arrangement, and the like. These specifications can be appropriately selected in consideration of cold air permeability, reduction in surface strength caused by making a hole in the first side surface portion 103, and the like. Preferably, the ratio of the total area of the plurality of ventilation holes 104 formed in the first side surface portion 103 to the area of the first side surface portion is 40 to 60%. This is because cold air can be efficiently brought into contact with the bag and the freezing time can be shortened.

  The frozen storage bags stored in the tray 100 are shown in FIGS. In the relationship with the maximum height HG (see FIG. 5A) of the frozen storage bag stored in the tray 100, when the height of the first side surface portion is H1 (see FIG. 4), H1 = (0 0.7 to 0.95) HG is preferable. This is because cold air can be efficiently brought into contact with the bag and the freezing time can be shortened.

  The second side surface portion 105 shown in FIG. 4 corresponds to a surface arranged so as to be positioned perpendicular to the width direction of the opening 61 of the differential pressure booth 60 described above during the freezing operation (the paper surface of FIG. 2). Corresponds to a plane parallel to In such a second side surface portion 105, it is preferable to form a handle opening portion 106 for gripping so that the operation of taking in and out of the drug substance storage / movement device 50 is facilitated.

  Note that the material constituting the tray 100 is preferably made of aluminum in consideration of weight, thermal conductivity, and the like.

  Further, as shown in FIG. 3, the relationship between the arrangement interval Tp of the trays stored in multiple stages and the height of the first side surface portion of the trays H1 is Tp = (1.3 to 2.5) H1. It is preferable to do. This is because cold air can be efficiently brought into contact with the bag and the freezing time can be shortened.

<Explanation about the front room and the pass room attached to the freezer>
As shown in FIG. 1, in order to prevent dew condensation and frost formation in the freezer 10 before entering the freezer room 11, a pass room 120 set at a temperature Tp lower than normal temperature, and the pass room It is preferable that a front chamber 140 having a temperature Tf that is lower than the temperature Tp of 120 and higher than the temperature in the freezer 10 is provided, and that the room enters the freezer compartment 11 sequentially through the pass room 120 and the front chamber 140. .

  The temperature Tp of the pass room 120 is preferably in the range of 2 to 8 ° C. Further, the temperature Tf of the front chamber 140 is desirably in the range of −15 to −5 ° C. In addition, the code | symbol 121 in FIG. 1 is the door for entrance / exit of the pass room 120, and an air curtain is provided inside the said door as a preferable aspect. Reference numeral 141 denotes an entrance door for the front chamber 140, and an air curtain is provided inside the door as a preferred mode. Reference numeral 12 denotes a door for entering and exiting the freezer compartment 11.

  By adopting a configuration in which the front room 140 and the pass room 120 are provided in the freezer compartment 11 in this way, moisture from outside can be prevented from flowing into the freezer 10 as much as possible, and condensation, frost in the freezer Sticking can be prevented.

  Using the drug substance rapid freezing system of the present invention as shown in FIG. 1 and FIG. In other words, after storing the drug substance storage / transfer device containing 5 stages of frozen storage bags filled with the stock solution in the front room of the differential pressure booth in the freezing room through the pass room and the front room, the quick freezing test Went. The specifications for the system etc. are as follows.

(Freezer specification)
・ Freezer: 2 rooms ・ Refrigerator: Air-cooled integrated inverter-controlled refrigerator ・ Differential pressure booth: 4 units / room
(Ab = 0.8 Ao, where Ao is the opening area of the opening 61 and Ab is the opening area at the boundary between the front chamber 65 and the rear chamber 67)
・ Set freezer temperature: -45 ℃

(Front room specification)
-Refrigeration equipment: Air-cooled integrated refrigerator-Air curtain installation-Pre-room setting temperature: -10 ° C

(Passroom specification)
・ Refrigerator: Air-cooled integrated refrigerator ・ Air curtain installed ・ Passroom set temperature: 5 ℃

(Frozen storage bag specifications)
・ Effective capacity: 20 liters ・ Material: Main material polyethylene ・ Sheet thickness: 0.25 mm
・ Heat-resistant temperature: -80 ~ 60 ℃
・ Bag dimensions: 610mm x 460mm
・ Drug filling amount: 12.5 liters ・ Bag height HG at filling: 50 mm

(Tray specification)
・ Material: Aluminum ・ Hole shape and number of first side parts: Circular shape with 8 pieces ・ Total number of holes for ventilation formed on the first side part relative to the area of the first side part Area ratio: 50%
-Height of the first side surface portion: H1 = 60 mm

(Specifications of drug substance storage / transfer device 50)
-Number of tray installation steps: 5-Tray placement interval: Tp = 80 mm

  Based on the above specifications, we performed a rapid freezing experiment of the drug substance, and measured the time until the stock solution sample in the frozen storage bag of 5 × 4 × 2 chambers = 40 ° C. reached −20 ° C. Completed in about 3 hours. In addition, it was confirmed that there was almost no unevenness in the frozen state based on the difference in the position of the stage on which the sample was placed, and almost uniform freezing treatment was performed.

  The effects of the present invention are clear from the above experimental results. That is, the drug substance rapid freezing system of the present invention includes a freezer and a drug substance storage / transfer device that can enter and exit the freezer, and the freezer is disposed in the freezer room, the freezer, and the freezer room. The drug substance storage and transfer device is capable of storing the drug substance stored in the cryopreservation bag in multiple stages while being placed on the tray and is movable. The differential pressure booth has a housing portion having an opening through which the drug substance storage and movement device can enter and exit, and the housing portion is located in a front chamber located in an area close to the opening and in an area far from the opening. And a rear chamber, in which the drug substance storage / movement device is stored in the front chamber, and a differential pressure fan is installed in the upper portion of the rear chamber to make the casing part negative pressure. Multiple frozen storage bars Collectively housed in grayed the drug substance at a time, it can be frozen in a state of substantially uniform.

  In the present invention, in particular, quick freezing can be performed without damaging the bag, dew condensation and frosting in the storage can be prevented as much as possible, and after freezing it can also be used as a freezer storage. Defrost during the quick freezing operation and during the storage operation after completion can be made unnecessary. Furthermore, the running cost is low and the temperature control of the inside temperature is excellent.

DESCRIPTION OF SYMBOLS 10 ... Freezer 11 ... Freezer compartment 15 ... Differential pressure booth 50 ... Active ingredient storage and moving device 60 ... Housing part 61 ... Opening 65 ... Front room 67 ... Rear room 69 ... Differential pressure fan

Claims (10)

A drug substance quick-freezing system for freezing the drug substance stored in a cryopreservation bag,
The quick freezing system has a freezer and an active ingredient storage / transfer device that can enter and exit the freezer.
The freezer has a freezing room, a freezing device, and a differential pressure booth disposed in the freezing room,
The drug substance storage and transfer device can be stored in multiple stages with the drug substance stored in the cryopreservation bag placed on the tray and is movable,
The differential pressure booth has a housing portion having an opening through which the drug substance storage / movement device can go in and out, and the housing portion is located in a front chamber located in an area close to the opening and an area far from the opening. A rear chamber,
A drug substance storing and moving device is stored in the front chamber, and a differential pressure fan is installed in the upper part of the rear chamber to make the casing part negative pressure. Quick refrigeration system.   2. The partition plate for efficiently bringing cold air into contact with the drug substance in the bag arranged in multiple stages in the drug substance storage / transfer device exists between the front chamber and the rear chamber. Drug substance quick refrigeration system.   The rapid-refrigeration system for drug substances according to claim 1 or 2, wherein cold air in the freezer compartment is forcibly circulated by the differential pressure fan.   In order to prevent dew condensation and frost formation in the freezer before entering the freezer, the freezer is set to a temperature Tp lower than normal temperature and lower than the temperature Tp in the freezer. The rapid movement of the drug substance according to any one of claims 1 to 3, wherein a front chamber having a temperature Tf higher than the inner temperature is provided, and the free chamber is sequentially entered through the pass room and the front chamber. Refrigeration system.   5. The drug substance rapid freezing system according to claim 4, wherein the temperature Tp is in a range of 2 to 8 ° C., and the temperature Tf is in a range of −15 to −5 ° C. 6.   6. The drug substance rapid freezing system according to claim 1, wherein the drug substance to be frozen stored in the cryopreservation bag is 10 liters or more. The tray has a rectangular bottom portion, a pair of opposing first side portions erected from the periphery of the bottom portion, and a pair of opposing second side portions.
The first side surface portion corresponds to a surface arranged so as to be positioned in the width direction of the opening of the differential pressure booth so that cold air can be efficiently contacted with the first side surface portion and the freezing time can be reduced. The rapid freezing system for drug substances according to any one of claims 1 to 6, wherein a plurality of holes for ventilation are arranged.   The height of the first side surface portion is H1, and the maximum height of the frozen storage bag stored in the tray is HG, and H1 = (0.7 to 0.95) HG. A rapid refrigeration system for the drug substance described in 1.   The ratio of the total area of a plurality of holes for ventilation formed in the first side surface portion to the area of the first side surface portion is 40% to 60%. Medicine quick freezing system.   10. The relationship between the arrangement interval Tp of the trays stored in multiple stages and the height of the first side surface portion of the tray is H1 is Tp = (1.3 to 2.5) H1. A rapid freezing system for drug substances according to any one of the above.

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