JP2017001699A - Powder container and method for filling powder container with powder - Google Patents

Abstract

PROBLEM TO BE SOLVED: To simplify an excipient charging operation into a powder container with a split valve and to a container with a split valve connected to an isolator in an excipient weighing operation of a solid preparation process for handling a highly pharmacologically active substance. Provided are a powder container capable of improving the efficiency of the powder charging operation and the powder filling rate in the powder container, and a method for filling the powder container with powder. A powder container in which a powder charging opening A having a split valve and a powder charging opening B having a lid are arranged at positions deviated from the center of the upper surface of the powder container. [Selection diagram] Fig. 3

Description

  The present invention provides a novel powder that simplifies the weighing of excipients and improves the efficiency of powder loading into a container with a split valve connected to an isolator in a solid pharmaceutical process that handles highly pharmacologically active substances. The present invention relates to a container shape and a method for filling a powder container with a highly pharmacologically active substance and an excipient.

In the fields of fine chemicals and pharmaceuticals, powders are sometimes handled as raw materials and / or products at the production site. This powder contains products and intermediates with high pharmacological activity, such as anticancer agents, but these are harmful to healthy people. It is necessary to ensure the safety of workers handling in For this reason, it is widely practiced to use a so-called containment facility to transfer the powder between the devices in a state of containing the powder and prevent the powder from being scattered to the surroundings.
As equipment used for this containment technology, for example, Non-Patent Documents 1 and 2 include an isolator composed of an airtight box-shaped main body and a rubber glove for internal work, and a valve body as a passive valve. A split valve having a structure in which the active valve is separated into two layers is described.
At manufacturing sites that use powders with high pharmacological activity, powders with high pharmacological activity or excipients with no pharmacological activity are placed in containers for powder handling via containment equipment such as isolators and split valves. It has been done. When putting powder into the powder container via the split valve, the active valve used in combination with the passive valve attached to the powder container, the support that supports the active valve, the docking of the passive valve and the active valve In addition, it is necessary to secure an additional facility such as a lifter for lifting the powder container and a working space.

IHI Technical Report, Vol.54, No.3, 2014 "Containment technology for highly pharmacologically active drugs" Powder technology, Vol.5, No.12, 2013 "Powder handling using powder container system"

  Therefore, the present invention simplifies the excipient charging operation into the powder container with the split valve in the excipient weighing operation in the solid preparation process that handles the high pharmacologically active substance, and to the container with the split valve connected to the isolator. An object of the present invention is to provide a powder container that improves the efficiency of the powder charging operation and a method of filling the powder container with powder.

  As a result of diligent studies to solve the above problems, the present inventor used a solid pharmaceutical process for handling a highly pharmacologically active substance, a powder container having a high pharmacologically active powder and an excipient, By arranging two powder input openings, powder input opening A with split valve and powder input opening B with lid, at positions shifted from the center of the upper surface of the powder container, powder with split valve is provided. The present invention has been completed by discovering that the excipient charging operation into the body container can be simplified and the efficiency of the powder charging operation into the container with the split valve connected to the isolator can be improved.

The gist of the present invention is specifically as follows.
1. A powder container made of metal or resin having two powder input openings A and B on the upper surface and consisting of four side surfaces or cylindrical side surfaces connected to the upper surface, the lower surface, and both surfaces. Are arranged at positions shifted from the center of the upper surface of the container, and further, the powder charging opening A has a split valve, and the powder charging opening B has a lid. It relates to body containers.
2. The center of the powder input opening A having the split valve is disposed at a position considering workability shifted from the center of the upper surface of the powder container, and the powder input opening B has the powder input having the split valve. 1. It is arranged at a position where it does not interfere with the opening A, and further has a powder discharge part on the lower surface of the powder container. This relates to the described powder container.
3.1. Or 2. The powder container described above has a capacity of 200 L or more.
4). In a method of filling a powder container with a high pharmacologically active substance and excipients in a solid preparation process that handles a highly pharmacologically active substance,
Open the lid of the powder charging opening B having the lid, close the lid after weighing the excipient and weighing it,
Subsequently, after the high pharmacologically active substance is charged and weighed into the powder loading opening A having the split valve, the split valve is closed.
It is a method of filling a powder container with a highly pharmacologically active substance and an excipient.

1. In a solid pharmaceutical process that handles highly pharmacologically active substances, powders that require containment of highly pharmacologically active substances are weighed from the powder loading opening A having a split valve, and there is no need for containment of excipients, etc. By weighing the powder from the powder loading opening B, it is possible to simplify the operation of loading the excipient into the powder container with a split valve.
Conventional powder containers have a single powder inlet, so excipients that do not require containment must also be introduced into the powder container via the containment facility. However, the powder container of the present invention can simplify this complicated operation and improve the work efficiency.

2. When the powder input opening A having the split valve is arranged closer to the upper end than the center of the upper surface of the powder container, when connected to an isolator which is one of the containment facilities, the glove port and the powder input opening The operability is improved because the distance to the part A is reduced.
The conventional powder container has a glove port and a powder input opening that have a limited operating range when connected to an isolator because the powder input port with a split valve is located at the center of the upper surface of the powder container There was a problem in operability because the distance to the part A was increased.
In the powder container of the present invention, since the excipient can be introduced without using a containment facility such as a split valve, it is not necessary to use an auxiliary facility such as a lifter when the excipient is introduced. improves.

3. In a powder container having a capacity of 200 L or more, which is a general commercial scale, the powder input opening A having a split valve is disposed closer to the upper end than the center of the upper surface of the powder container, that is, near the operator. Therefore, operability is good and work efficiency is improved.

4). Depending on the necessity of containment, the powder input opening A and B can be used properly, so the workability of the powder weighing work in the solid pharmaceutical process that handles highly pharmacologically active substances can be improved. Will improve.

It is the conceptual diagram which looked at the powder container of this invention from the front. It is the conceptual diagram which looked at the powder container of this invention from the upper surface. It is the conceptual diagram which connected the powder container and isolator of this invention. It is the conceptual diagram which connected the conventional powder container and the isolator. It is the figure which showed the position and angle of repose of the powder input opening part A of the powder container. It is the conceptual diagram which compared the powder filling amount of the input opening part with one powder container and two powder containers.

The present invention has two openings, ie, a powder input opening A having a split valve and a powder input opening B having a lid, in a powder weighing operation of a solid pharmaceutical process that handles highly pharmacologically active substances. It is characterized by using a powder container. Since the openings A and B can be used properly according to the necessity of containment, the efficiency of powder charging and weighing work is improved.
Hereinafter, embodiments of the present invention will be described with reference to the drawings, but the technical scope of the present invention is not limited thereto.

1 and 2 schematically show the outline of the powder container of the present invention. The supporting outer frame is omitted.
The powder container 1 of the present embodiment is provided with two powder input openings A and B at positions shifted from the center X on the upper surface of the container. The powder input opening A provides the split valve 2 and the powder input. The opening B includes a lid 3.

The powder container 1 can be made of a metal material such as stainless steel or aluminum or a synthetic resin molded body such as polyethylene depending on the properties of the powder to be used.
The volume of the powder container 1 can be appropriately set according to the purpose, but when a solid preparation having pharmacological activity is produced, a capacity of 200 L or more which is a general commercial scale can be preferably used.

The split valve 2 is composed of two valves, an active valve on the drive mechanism side with an open / close lever, and a passive valve on the other side. The split valve 2 functions only when both valve bodies are combined and rotated. If the powder is separated into two layers after the powder is charged, the external environment will not be contaminated because the powder does not contact the portion appearing from the separation surface.
The lid portion 3 is selected from a metal material or a synthetic resin as in the case of the powder container 1, and may have any shape that can be easily opened and closed while preventing powder leakage.
The diameters of the powder input opening A having the split valve 2 and the powder input opening B having the lid 3 can be appropriately determined according to the amount and properties of the powder to be input. In the case where the length of one side Y on the upper surface of the powder container or the upper surface of the powder container is circular, those having a diameter in the range of 1/10 to 1/2 of the length corresponding to the diameter are preferable.

Further, the center of the powder input opening A having the split valve is within 500 mm from the upper end of the container in consideration of the glove operability in the isolator, and the powder input opening B is the powder having the split valve. The powder container 1 having such a configuration is preferably disposed at a position that does not interfere with the body loading opening A, and is preferably connected to an isolator as a containment facility.
Furthermore, the powder container 1 is preferably provided with a discharge port 4, and the discharge port is preferably a split valve, but can be selected from known discharge structures according to the purpose.
The powder container 1 is preferably attached with an outer frame 5 (not shown in FIGS. 1 and 2) in order to be set on a lifter or placed on a cart with casters.

FIG. 3 is a conceptual diagram in which the powder container 1 of the present invention and the isolator 6 are connected.
Since the powder loading opening A for loading the highly pharmacologically active substance connected to the isolator 6 is attached at a position shifted from the center of the powder container 1, from the glove box where the work is performed to the powder loading opening A As the distance is close, the operability is improved and the work efficiency is improved. Moreover, not only the operation | work which introduce | transduces a highly pharmacologically active substance but also when performing a washing | cleaning operation, since the opening part A is installed in the range which can be reached from a work space, it is easy to wash | clean.
On the other hand, FIG. 4 is a conceptual diagram in which a conventional powder container in which the powder input opening is attached to the center of the powder container and the isolator 6 are connected, but the distance between the operator and the powder opening is Since it is far away, the workability of both the powder charging operation and the container cleaning operation is poor, and as the container capacity increases, the distance between the operator and the powder opening increases and the work efficiency decreases.

  In general, when manufacturing a pharmaceutical solid preparation, a powder which is a drug substance having high pharmacological activity and a powder added as an excipient are mixed in a single powder container, An operation of mixing the powder inside by sealing and rotating is performed. Since this excipient is not harmful to the human body, it is not necessary to use so-called containment equipment and put it into the powder container. Since the powder container 1 of the present invention has the powder input opening B having a lid, in addition to the powder input opening A having a split valve, an excipient that is not harmful to the human body is used. The powder container 1 can be charged from the powder charging opening B. The conventional powder container with only one powder input opening needs to input excipients that are not harmful to the human body into the powder container using a containment facility. However, by using the powder container 1 having the powder input opening B of the present invention, the operation can be simplified and the work efficiency can be remarkably improved.

FIG. 5 is a view showing the angle of repose of the powder container 1 having the powder input opening A. Although the angle of repose is derived from the properties of the powder, it is generally known that the amount of powder filled in the container decreases as the angle of repose of the stored powder increases.
FIG. 6 is a conceptual diagram comparing the powder filling amounts of two powder containers and one powder container with an input opening. As shown in FIG. 6, the two openings of the powder input opening A and the powder input opening B of the present invention are arranged at positions shifted from the center of the upper surface of the powder container 1. The powder container 1 is effective as a method for improving the filling amount because the powder filling amount is increased only in the part of the hatched portion and it is not necessary to change the shape and capacity of the powder container.

(1) Powder container (2) Split valve (3) Lid (4) Discharge port (5) Supporting outer frame (6) Isolator (7) Lifter (A) Powder input opening with split valve (B ) Powder input opening with lid (X) Center of powder container upper surface (Y) One side of powder container upper surface

Claims (4)

  A powder container made of metal or resin having two powder input openings A and B on the upper surface and consisting of four side surfaces or cylindrical side surfaces connected to the upper surface, the lower surface, and both surfaces. Are arranged at positions shifted from the center of the upper surface of the container, and further, the powder charging opening A has a split valve, and the powder charging opening B has a lid. Body container.   The center of the powder input opening A having the split valve is disposed at a position considering workability shifted from the center of the upper surface of the powder container, and the powder input opening B has the powder input having the split valve. 2. The powder container according to claim 1, wherein the powder container is disposed at a position where it does not interfere with the opening A, and further has a powder discharge part on the lower surface of the powder container.   The powder container according to claim 1 or 2, wherein the capacity is 200L or more. In a method of filling a powder container with a high pharmacologically active substance and excipients in a solid preparation process that handles a highly pharmacologically active substance,
Open the lid of the powder charging opening B having the lid, close the lid after weighing the excipient and weighing it,
Subsequently, after the high pharmacologically active substance is charged and weighed into the powder loading opening A having the split valve, the split valve is closed.
A method of filling a powder container with a highly pharmacologically active substance and an excipient.

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