WO2003068272A1

WO2003068272A1 - Continuous sterilization system using electron beam irradiation

Info

Publication number: WO2003068272A1
Application number: PCT/JP2003/001525
Authority: WO
Inventors: Takeshi Kobayashi; Morihiko Takeda; Manabu Murakami
Original assignee: Jgc Corporation; Santen Pharmaceutical Co., Ltd.
Priority date: 2002-02-14
Filing date: 2003-02-14
Publication date: 2003-08-21
Also published as: AU2003211976A1; JPWO2003068272A1; JP3840473B2

Abstract

A continuous sterilization system which comprises a means for transporting continuously an article to be sterilized from a generally controlled area to an area controlled for sterilization, and a means for conducting a sterilization treatment wherein the article to be sterilized is placed on a mesh conveyer and irradiated with an electron beam from the upper and lower sides in an air stream from the outlet to the inlet of the means for sterilization and is allowed to slide with a slide guide when it is irradiated from the lower side. The system allows the sterilization at a reduced temperature, is free from the presence of a residual substance in an article to be sterilized, is safe and easy to handle, is excellent in the easiness of maintenance, and can be used for transporting an article while securing the sterilized state thereof.

Description

Specification

Electron beam irradiation continuous sterilization system

The present invention relates to a continuous sterilization system for electron beam irradiation that transports products while ensuring sterility of product containers and sterility of containers in a pharmaceutical (especially aseptic preparation) manufacturing brand. Background art

When transferring product containers from a general control area where sterile control is not performed to a clean room or other sterile control area at a pharmaceutical manufacturing plant, containers must be used to prevent bacteria from entering the drug and contaminating the sterile control area. The outer surface is sterilized

As a method of sterilizing the outer surface of the container,

1: Continuous sterilization system using dry hot air

_{_2:} H 2 0 2 continuous sterilization system by gas

3: Batch sterilization system using electron beam

4: Batch type sterilization system using wire

Are used.

However, these sterilization systems have the following problems.

1: In a continuous sterilization system that uses dry hot air, sterilization is generally performed by blowing hot air at 250 ° C or higher onto the object to be sterilized. It cannot be used.

2: H at the ₂ 0 ₂ gas by a continuous sterilization system, for performing sterilizing H ₂ 0 ₂ gas blown into object to be sterilized, harmful H ₂ 0 ₂ gas into the body, be remaining in the object to be sterilized There is gender, also it takes time step of removing the H ₂ 0 ₂ gas.

3: In a batch sterilization system using electron beams, there are many methods of accelerating electrons at high voltage (for example, 500 O keV) and irradiating the accelerated electron beams to perform batch sterilization. Thick concrete and lead shields are needed to shield secondary X-rays. For this reason, the cost for installing the shielding equipment is high, and There is a problem that continuous processing cannot be performed on the in-line, and it is difficult to maintain the inside of the system easily.

4: In a batch-type sterilization system using y-rays, sterilization is time-consuming because sterilization is performed by irradiating the object to be sterilized with α-rays, which have lower energy per unit time than electron beams. In addition, since radiation is constantly generated, maintenance is poor and it is difficult to handle easily.

Also, in pharmaceutical manufacturing plants, in order to prevent contamination by bacteria during transportation, the outer surface of the product container is continuously sterilized from the general control area, and the product container is kept in a sterile control area while ensuring the sterility of the product. There was a need for a system to transport to

Therefore, according to the present invention, an electron beam that can be conveyed while ensuring sterilization at a low temperature, leaving no residue in the material to be sterilized, safe and easy to handle, excellent in maintainability, and ensuring sterility. It is an object to provide a continuous irradiation sterilization system. Disclosure of the invention

In the continuous electron beam irradiation sterilization system of the present invention, a lower electron beam irradiation device that irradiates an electron beam from below the object to be sterilized, an upper electron beam irradiation device that irradiates the electron beam from above the object to be sterilized, and a loading port A mesh conveyor that conveys the object to be transported to the exit side, and an area on the mesh conveyor that is irradiated with an electron beam from the lower electron beam irradiation device, and slides the object to be sterilized. And a means for forming a flow of air from the carry-out port to the carry-in port, and transporting the object to be sterilized using transport means continuous from a general control area to a sterilization control area. The sterilization is performed by irradiating an electron beam from below while sliding the object to be sterilized, and irradiating an electron beam from above while moving the object to be sterilized. It is characterized by the following.

In this configuration, sterilization is performed using a low-voltage electron beam, so that sterilization can be performed at a low temperature, and there is no residue in the material to be sterilized. In addition, there is a flow of air from the side where the object to be sterilized is carried out to the side where the object is carried in. It is possible to carry while securing Here, the range that can be sterilized is not limited to the surface of the container irradiated with the electron beam, and the inside of the container can be sterilized by increasing the energy of the electron beam.

The continuous transport means refers to, for example, a means for continuously transporting an object to be sterilized using one mesh conveyor or a plurality of conveyors and a mesh conveyor.

In the electron beam irradiation continuous sterilization system of the present invention, a mesh conveyor is used as a container transport means, but the bottom of the container may be a shadow of a mesh portion of the conveyor, and electron beam irradiation may be uneven.

Therefore, as shown in FIG. 4, a slide guide 50 is provided to shift the position of the container on the conveyor so that the bottom of the container can be evenly irradiated with the electron beam.

The angle 0 of the slide guide may be any angle at which the direction of the container is deviated to shift the position of the container on the conveyor so that the electron beam can be irradiated evenly. The angle may be set in the range of 0 ° <0 ^ 90 °, but if the angle is too large, the container will not easily move in the traveling direction, and the transport will be unstable. On the other hand, if the angle is too small, the position of the container cannot be properly shifted, resulting in uneven electron beam irradiation.

This angle setting varies depending on the size and shape of the container. For example, in the case of a small container such as an eye drop container, the angle is set to about 10 ° ≤0 ^ 40 °, and more preferably, 10 ° ≤ It is set to about 0≤30 °, most preferably about 15 °.

Further, in the electron beam irradiation continuous sterilization system of the present invention, a constant bite cutting device is further provided, the object to be sterilized is cut continuously at a constant pitch, and the electron beam irradiated from the upper electron beam irradiation device is cut. By irradiating, the outer surface other than the container bottom surface can be efficiently irradiated with the electron beam irradiated from the upper electron beam irradiation device. Further, in the continuous sterilization system for electron beam irradiation of the present invention, by further providing a 90 ° corner, it is possible to provide a shielding facility for reflecting and attenuating more secondary X-rays.

In the present invention, high-speed continuous sterilization can be performed in-line, reducing the total sterilization time In addition, a large amount of processing can be performed per unit time, and the product can be transported in a state where sterility is ensured.

Since the aseptic area can be minimized, the entire line with the sterilization system can be shortened, and the installation area of the equipment is reduced, leading to a reduction in construction costs.

Furthermore, maintenance and handling after operation is completed can be performed more safely than when gamma rays are used. BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic plan view showing one embodiment of a continuous electron beam irradiation sterilization system according to the present invention.

FIG. 2 is a schematic cross-sectional view of the electron beam irradiation continuous sterilization system in FIG.

FIG. 3 is a schematic cross-sectional view showing the air flow of the continuous electron beam irradiation sterilization system in FIG.

FIG. 4 is a plan view showing a slide guide of the electron beam irradiation continuous sterilization system in FIG.

FIG. 5 is a plan view showing a constant pitch cutting device of the continuous electron beam irradiation sterilization system in FIG.

FIG. 6 is a cross-sectional view showing an example of the shape of an object to be sterilized. BEST MODE FOR CARRYING OUT THE INVENTION

Hereinafter, an embodiment of an electron beam irradiation continuous sterilization system according to the present invention will be described in detail with reference to the drawings.

FIG. 1 is a schematic plan view showing an embodiment of a continuous electron beam irradiation sterilization system according to the present invention, and FIG. 2 is a schematic sectional view of the continuous electron beam irradiation sterilization system in FIG.

In FIGS. 1 and 2, the continuous electron beam irradiation sterilization system of the present invention comprises a lower electron beam irradiation device 40 that irradiates an electron beam with conveyors 10 and 11 for transporting containers, a mesh conveyor 20, and an irradiation section 30. , Irradiation unit 31 A radiation device 41, a slide guide 50, a radiation shielding cover 60, a 90 ° corner 70, and a constant pitch cutting device 80 are provided. As shown in FIG. 3, a high-performance (eg, HEPA) fill 90 is provided.

The mesh conveyor 20 has a mesh-like surface on its surface, and allows irradiation of an electron beam from below to the bottom surface of the container.

The lower electron beam irradiation device 40 sterilizes the container by irradiating the container with an electron beam from below the mesh conveyor 20 at the irradiation section 30.

The upper electron beam irradiation device 41 sterilizes the container by irradiating the container with an electron beam from above the mesh conveyor 20 in the irradiation section 31.

As shown in FIG. 4, the slide guide 50 is inclined at an angle of 0 (0 <0 ^ 90 °) with respect to the container conveying direction 21 by the mesh conveyor 20, and the mesh conveyor 20 of the irradiation unit 30 is inclined. It is installed on the upper side, and by changing the transport direction of the container and sliding it diagonally, it prevents shadows of the grid of the mesh conveyor 20 and the electron beam is not irradiated. .

The shielding cover 60 covers each conveyor and the irradiation device, etc., and prevents the X-rays secondary generated by electron beam irradiation from leaking out of the sterilization system.

The corner 70 is provided in the container conveyance path, and by increasing the number of times X-rays are reflected, attenuates X-rays, thereby providing shielding equipment.

As shown in FIG. 5, the constant pitch cutting device 80 continuously cuts the container at a constant pitch, transports the container to the irradiation unit 31, and transfers the electron beam irradiated from the upper electron beam irradiation device 41 to a part other than the bottom of the container. Is efficiently radiated to the outer surface.

The high-performance filter 90 creates clean air and feeds it into the sterilization system, and also blows the container to maintain the sterility of the sterilized container.

Further, in the sterilization system of the present invention, by controlling the air pressure, as shown in FIG. 3, the air flow (one-way flow) from the carry-out port 100 in the sterilization control area to the carry-in port 101 in the general control area. Is always forming.

Now, in the above configuration, the containers (substances to be sterilized) loaded on the conveyor 10 from the general control area and conveyed are conveyed to the mesh conveyor 20 and slid by the slide guide 50 in the irradiation section 30. While moving, lower electron beam irradiation device 40 After receiving the irradiated electron beam, the outer surface and side surface of the container bottom are sterilized. Further, the irradiation unit 31 receives the electron beam irradiated from the upper electron beam irradiation device 41 and sterilizes the outer surface other than the container bottom surface. Then, the containers are conveyed to the conveyor 11 and taken out to the sterilization control area.

Hereinafter, the electron beam irradiation continuous sterilization system of the present invention will be described in more detail with reference to examples.

Example

FIG. 6 is a cross-sectional view showing an example of a container to be subjected to a sterilization treatment, which has a height of 60 mm and a diameter of 20 mm. The container carried in from the entrance is transported to the irradiation unit 30, where it is irradiated with an electron beam from below at an acceleration voltage of 15 OkE V and a current of 2.0 mA while sliding. The container that has been irradiated with the electron beam from below is cut out by the constant pitch cutting device 80 and transported to the irradiation unit 31 to accelerate the electron beam from above with an acceleration voltage of 11 O keV and a current of 3.0 mA. And transported to the exit (see Fig. 1). In the present embodiment, the sterilization can be performed at a considerable speed by using the above configuration.

As described above, the electron beam irradiation continuous sterilization system of the present invention performs sterilization using an electron beam that does not generate high heat and has a property of wrapping around even in a complicated shape. It is possible to conform to the shape, and since the dose rate is larger than the A-line, the sterilization processing time is short, and the sterilization processing can be performed in combination with the conveyor. Furthermore, there is no residue due to the use of electron beams.

In addition, a mesh conveyor that can irradiate the bottom of the object with the electron beam is used to irradiate the electron beam from the top and bottom of the container. By eliminating the portion, the entire outer surface of the container can be easily sterilized.

And control the flow of air (one-way flow) from the sterile controlled area to the general controlled area at all times to control the unidirectional flow of clean air through a high-performance (e.g., HEPA) filter. By spraying on the sterilized object, the object can be transported to the sterile control area without contacting the contaminated air (germs) after sterilization.

In addition, by providing an inspection door and an inspection window made of lead glass, etc. This makes it easy to perform maintenance and visually confirms the condition in the shielded space.

Here, by providing two (plural) 90 ° corners in the transport path, it is possible to provide a shielding facility that reflects and attenuates more X-rays.

Claims

The scope of the claims

1. A lower electron beam irradiation device for irradiating an electron beam from below the object to be sterilized,

An upper electron beam irradiation device that irradiates an electron beam from above the object to be sterilized,

A mesh conveyor that conveys the object to be sterilized carried in from the carry-in port to an exit side, and a mesh conveyor that is installed in a region on the mesh conveyor where the lower electron beam irradiation device irradiates an electron beam; A slide guide for sliding,

Means for forming a flow of air from the carry-out port to the carry-in port;

With

The object to be sterilized is transported using a continuous transport means from the general control area to the sterilization control area, and

The sterilization is performed by irradiating an electron beam from below while sliding the object to be sterilized,

An electron beam irradiation continuous sterilization system, wherein a sterilization process is performed by irradiating an electron beam from above while moving the object to be sterilized.

2. The slide guide is

It is installed so that the object to be sterilized is turned at an angle of 0 (0 ° <0≤90 °) with respect to the conveying direction of the object to be sterilized by the mesh conveyor.

The electron beam irradiation continuous sterilization system according to claim 1, wherein:

3. The angle 0 is

10 ° ≤0≤40 °

3. The continuous electron beam irradiation sterilization system according to claim 2, wherein:

4. It is further equipped with a constant bite cutting device,

The object to be sterilized is continuously cut out with a constant pitch, and irradiated with an electron beam irradiated from the upper electron beam irradiation device.

5. 90 ° additional corners