JP2000210370A - Sterilization method for container with juncture - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a sterilization method for a container with a juncture which is capable of sufficiently enhancing the sterilizability or axenic property of the juncture of resin containers to each other and is capable of easily sterilizing the juncture without the occurrence of destruction in the juncture and without imparting inconvenience to another portions in a production line. SOLUTION: The inside of a juncture 12 which is the juncture 12 connecting one container member made of a resin and another container member, forms a peelable hermetic sealing part 28 in the juncture of one or both of the container members and allows the communication of the contents in the respective container members with each other by unsealing the hermetic sealing part 28 is sterilized by irradiation of the juncture with high energization pulse rays of a light emitting lamp by a pulse electric field treatment apparatus in the sterilization method for the container with the juncture having the juncture 12 described above.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to the manufacture of medical containers containing drugs and the like. The present invention basically relates to a resin container having flexibility and transparency, in which different contents are temporarily stored in separate container members, and then the connection portions of the medical containers are connected to each other. And a sterilization method.

[0002]

2. Description of the Related Art Recently, resin containers have been widely used as medical containers. The resin of the medical container is polyvinyl chloride, ethylene-vinyl acetate copolymer, polyethylene, polypropylene or the like. Some medical containers contain and store the contents separately until use. As such medical containers, there are provided a container in which a plurality of container members are connected and combined, a container having a plurality of chambers in the container, and the like. These medical containers hold each content separately at the time of storage, and at the time of use, by operating from outside the container, connect the connecting portions of the multiple container members or the isolated portion of the multi-chamber container to mix each content immediately before. Things. The reason for containing the contents separately is that one of the contents is a drug consisting of antibiotics or chemicals that are vulnerable to heat, or a component that quickly changes in electrolyte solutions such as infusion solutions or medical fluids. This is a case in which contents containing, for example, or contents in which different content components react with each other or the like need not be allowed to coexist at the time of storage. Conventionally, there has been proposed a method of manufacturing a medical container in which a peelable weak seal portion is formed on each of a first bag and a second bag and the weak seal portions are connected to each other (Japanese Patent Laid-Open No. Hei 8-21528).
No. 5). In such a medical container, a main component such as an infusion agent is stored in a second bag, and a drug or the like that is easily deteriorated is stored in a first bag. When the medical container is used, the weak seal is peeled off, and the infusion solution and the medicine are mixed.

[0003]

By the way, when connecting a resin container member and a container member in a medical container,
There are mainly two types of structures or methods.
In the first connection method, the connection port of another container member is inserted into the connection port of one container member, and the two are connected by heat sealing from the outside of the connection port of one container member. In the second connection method, the connection port of one container member and the connection port of another container member are abutted, the butted portion is covered with a connection sheet, and the connection sheet and the outer wall of each connection port are heat-sealed to connect the two. Is what you do. Conventionally, such connection between the container members is performed aseptically using a sterile chamber, thereby improving the sterility of the connection portion of the resin container. Further, in order to enhance the sterility of the connection portion, it has been proposed to irradiate the connection portion with ultraviolet rays, gamma rays, electron beams, or the like (Japanese Patent Application Laid-Open No. 9-10283). However, conventional sterilization of the connection portion by irradiation with ultraviolet light cannot achieve high sterility or sterility. That is, even if the connection wall or connection sheet of the connection port of one resin container has transparency, and is a polyolefin resin wall having no polar group,
UV rays do not penetrate sufficiently into the connection. In addition, gamma rays, electron beams, and the like can sufficiently penetrate the connecting wall because the irradiation rays are strong. However, there are many disadvantages with such radiation. The first is that the irradiation apparatus is large and is not suitable for a large-scale production line. Second
However, since X-rays and the like are generated as by-products from the apparatus, there is a disadvantage that the X-rays affect the contents of the container body other than the connection portion. Third, since the temperature of the connection portion may be increased, the heat seal at the connection portion may be broken. Therefore, an object of the present invention is to sufficiently enhance the sterility or sterility of a connection portion between resin containers, and to prevent the connection portion from being broken at another connection portion on a production line without causing the connection portion to break. It is an object of the present invention to provide a method of sterilizing a container with a connecting portion, which can be easily sterilized without giving any trouble to a portion.

[0004]

SUMMARY OF THE INVENTION The present invention relates to a connecting portion for connecting one container member made of resin and another container member,
A connecting portion that forms a peelable hermetic seal portion at one or both of the connecting portions of the container member and opens the hermetic sealing portion to allow the contents in each of the container members to flow when used. A method of sterilizing a container having a connection portion, comprising: irradiating the connection portion with a high-energy pulsed light beam of a light-emitting lamp by a pulse electric field treatment device to sterilize the inside of the connection portion. The object has been achieved by providing a method of sterilizing a container.

A resin container member used in the sterilization method according to the present invention is formed by blow molding, air pressure molding, vacuum molding, or injection molding, or is formed by appropriately cutting a film or sheet and sealing the periphery by heat sealing. It was done. The resin used for the container member is a general-purpose resin such as polyolefin resin, vinyl chloride, vinylidene chloride resin, polyester resin, polyvinyl alcohol resin, polyacrylonitrile resin, polyacrylic resin, and polyamide resin. . Further, the resin wall may be formed in a single layer or a multilayer. Since the purpose of use of the container according to the present invention is mainly for accommodating a medical drug, the innermost layer that comes into contact with the drug in the container member is a resin layer that does not affect the drug and does not generate eluted substances. Desirably. As such a resin, a polyolefin-based resin is desirable, and examples thereof include low-, middle-, and high-density lower-grade olefin resins such as polyethylene and polypropylene. Further, as will be described later, since the connection port of the container member is irradiated with a high-energy pulse light from the outside, it is desirable that the connection port be made of a resin that sufficiently transmits light of a wide wavelength range. As such a resin, a resin such as a polyolefin-based resin is generally desirable, not a polymer having a polar group composed of chlorine, oxygen, nitrogen or the like.

[0006] At least one of the container members is a resin wall having a flexible connection portion. This is because it is difficult to form a peelable hermetic seal at the connection portion without flexibility. In this case, the other container member may be a soft bag or a hard bottle. The peelable hermetic seal of the connection portion is usually called a peel seal or a weak seal, and is a seal portion or a container which can be peeled off when a room or a container is pressed from the outside and the inside is brought into a constant pressure-up state. It is a seal or the like that can be peeled off when each of the outer walls is gripped and pulled. The peel strength of the peelable hermetic seal portion is such that the indoor pressure is 0.01 to 1.0 kgf / cm ² , particularly 0.05
A peeling strength at a pressure of about 0.5 kgf / cm ² is desirable. If the strength is lower than the above range, the safety for maintaining an isolated state during production, transportation, storage, etc. is lacking. If the strength exceeds the above range, there is a possibility that the communication operation of the connecting portion cannot be easily performed at the time of use. When forming a peelable hermetic seal between the inner layers of the wall or forming a completely hermetic seal that cannot be peeled off, the inner layer of the wall is made of a blend of different resins in order to ensure that these are formed differently. Desirably. In particular, different resins
It is desirable to use a resin blend having a different heat-melting start temperature or a biquad softening point and a low compatibility. By having such a blended material layer, it is possible to easily set the sealing temperature conditions for complete hermetic seal bonding with the same inner layer, but also to easily set the sealing temperature conditions for peel seal bonding. In particular, the relationship between the seal strength required for peel seal adhesion, that is, the easy peelability due to external force during use, and the seal strength that does not cause peeling during storage can be strictly set. This is achieved by melting and mixing resins with different compatibility in the inner layer and forming this into a sheet.
The surface is microscopically separated into portions having different thermal adhesive properties. Then, by determining the thermal fusibility of the microscopic portion between the surfaces of the sheet at an arbitrary temperature, the strength of the sealing strength is accurately provided, and the above-mentioned effect is easily achieved.

[0007] The container with a connection part in the sterilization method according to the present invention is a medical container or the like that stores an infusion solution, a dialysate, or the like to be injected into the body or the like. Therefore, the contents in the container member used in the sterilization method according to the present invention are usually stored in a sterilized state or in an aseptic state. In order for such a sterilized or aseptically contained drug to be aseptically mixed at the time of use, the connection portion of the container member that is communicated at the time of mixing is connected in a state where high sterility or sterility is maintained. Must be.

In the method for sterilizing a container having a connection portion having the connection portion according to the present invention, the connection portion is irradiated with a high-energy pulsed light beam of a light-emitting lamp by a pulse electric field processing apparatus. Is to be sterilized. The above-mentioned pulse electric field processing apparatus is generally roughly classified into a charge supply circuit,
The electrode from the charge supply circuit is composed of a controller, a switch, and the like.
It is supplied with an electric field strength of 0 V / cm or more, preferably 5000 V / cm or more, and more preferably 10,000 V / cm or more. The light emitting lamp is connected to the pulse electric field processing apparatus, and the light emitting lamp emits a high-energy pulsed light beam.

The above-mentioned light-emitting lamp comprises a sealed tube and an inert gas, and the light-emitting lamp can emit pulsed light in different wavelength ranges depending on the kind of glass material and the kind of gas of the sealed tube. Cerium glass, gel machine, quartz glass, sapphire glass and the like can be cited as the lamp glass of the above-mentioned light-emitting lamp, and particularly preferred are quartz glass and sapphire glass which can sufficiently contain an ultraviolet region. The sealing gas may include mercury, metahalide, xenon, etc.
Xenon, which emits pulsed light in a wide wavelength range close to natural light, is desirable. In order for the pulsed light beam to become the high-energy light beam, the emission time of the amplified pulse is desirably 1/1000 second or shorter and 1/1000000000 second or longer in view of the function of the pulse electric field processing apparatus. The pulse output intensity of the lamp, i.e. the energy of a single flash per unit area, can be monitored by a silicon photodiode as its ultraviolet (UV) amount. The output intensity (fluence), that is, the amount of light energy per unit area (J / cm ² ) can be represented by the monitor. The output intensity of the pulse light per single flash is in the range of 0.1 to 4.0 J / cm ² .

[0010] In the method for sterilizing a container with a connection portion according to the present invention.
In the middle of the manufacturing process, each container member made of resin is reserved.
Contents are sterile or autoclaved.
Can be And, as a final step, the same
When connecting a container, clean each container
Transported to a computer and easily connected or
Can be docked. And in such a connection part
By irradiating the pulsed light, the light is tens of thousands of sunlight
Since it has twice the intensity of light, the inside of the connection
Light penetrates sufficiently when connecting or docking.
Trace amounts of viable microorganisms that may contaminate the connection
Alternatively, bacteria such as bacterial spores can be sterilized.
In particular, the output intensity at the moment of the ultraviolet light in the pulse light is generally
Compared to the continuous output intensity of ordinary mercury ultraviolet lamps, etc.
1000 times or more. In fact, at ordinary UV
At 10 ³Although only sterilization of the order was possible,
The energy pulsed light is 10⁹More than order
Bacteria can also be formed.

[0011] By repeating a predetermined number of times of irradiation as by transmitting resin wall of the connecting portion sufficiently penetrate the pulse beam to the connection portion, sterilization in the ¹⁰⁶ order is fully enabled. The device that emits the pulsed light does not emit any inconvenient light or the like at all, and therefore does not affect the container body in which the contents are stored at all. In addition, the device is extremely compact. Furthermore, since such a pulsed light beam is repeatedly irradiated instantaneously, there is no possibility that the connection portion will be in a high temperature state and the seal will be damaged. Therefore, the inside of the connection portion of the container is sufficiently sterilized by a simple device, and in the case of the container with the connection portion in which the connection portion is sterilized in such a manner, the sealing portion which can be peeled from the outside is opened when the container is used. As a result, the contents in each container member can be aseptically mixed. Moreover, the contents when flowing through the connection portion are not contaminated with bacteria, and excellent safety as a medical container is obtained.

[0012] The sterilization method according to claim 2 of the present invention is characterized in that the pulse output intensity (single flash energy per unit area) of the lamp by the pulse electric field processing device is 1.25 J / cm ² or more, and the connection portion is The total output received from the lamp is 2.5 J / cm ² or more.

As described above, the pulse output intensity of the lamp, that is, the energy of a single flash per unit area, can be monitored by the amount of ultraviolet rays (UV) by a silicon photodiode. In the present invention, the pulse output intensity is 1.25 J / cm ²
As described above, it is particularly desirable that it be 2.50 J / cm ² or more. If the output intensity is within the above range, the connecting portion inside until high energy of light to penetrate, and the inside of the bacteria adhering to the time of connection can be sterilized ¹⁰⁶ orders or more. If falls below the above range, it is possible to at most in the order of 10 ⁴ orders sterilization. Further, the output amount from the lamp to be illuminated in the connection part 2.5 J / cm ² or more, it is desirable in particular 4.0 J / cm ² or more. If the irradiation is performed within the above range, the inside of the connection portion is reliably sterilized, and the safety at the connection portion is sufficiently obtained.

A sterilization method according to a third aspect of the present invention is the sterilization method according to the second aspect, wherein the lamp is made of xenon gas and quartz glass or sapphire glass. If the gas enclosed in the lamp is xenon, it emits light in the ultraviolet region and other broad wavelength regions closer to natural wavelength light than other gases, and the gas itself is also suitable for pulsed light emission. If the sealing tube is quartz glass or sapphire glass, the wavelength range is 150 to 6000 nm.
And the pulsed light can be used sufficiently for sterilization.

In the sterilization method according to a fourth aspect of the present invention, before connecting the one container member to another container member, the contents in at least one of the container members are autoclaved together with the container member. It is sterilized.
For medical containers, if the contents are infusion or dialysate,
Autoclave sterilization is desirable. On the other hand, contents that easily change such as antibiotics and chemicals must be filled aseptically rather than by autoclave sterilization. In the present invention, one container member containing a solution such as an infusion solution is subjected to autoclave sterilization before connection, and another container member filled aseptically can be easily connected thereto. And the sterilization of the connection part can be made surely, simply and safely.

According to a fifth aspect of the present invention, there is provided the sterilization method according to the first aspect, wherein a connection port of another container member is inserted into a connection port of the one container member. The connection port is characterized in that the thickness of the wall is in the range of 20 to 1000 μm, and the connection portion is formed by heat sealing from the outside of the wall. The sterilization method according to claim 1, wherein a main structure of the connection portion is such that a connection port of another container member is inserted into a connection port of the container member and heat-sealed from outside the overlapping connection portion. Alternatively, as will be described later, the connection ports may be abutted with each other, the joint may be covered with a sheet or the like, and the connection may be made by heat sealing via the sheet.

In the sterilization method of the present invention, when the connection port of another container member is inserted into the connection port of the one container member and heat-sealed, the connection port of the one container member is exposed to outside air when the connection is made. Exposure to contamination. For this reason,
It is necessary to penetrate the pulsed light into such a connection port. The wall thickness of the connection port of the one container member is 20 to 10
It is preferably in the range of 00 μm, especially in the range of 50 to 400 μm. Within the above range, the pulsed light can penetrate into the connection port while maintaining high energy, thereby ensuring sterilization at such a place. If the thickness of the wall of the connection port is less than the above range, the mechanical strength of the connection portion or the mechanical strength of the container member will be weak. If the thickness of the wall of the connection port exceeds the above range, even if the wall is a polyolefin-based resin having transparency, the pulse light cannot penetrate into the connection port while maintaining high energy. The thickness of the resin wall containing a polar element such as vinyl chloride is desirably 300 μm or less in order not to sufficiently transmit light depending on the wavelength range.

According to a sixth aspect of the present invention, there is provided the sterilization method according to the first aspect, wherein the connection port of the one container member and the connection port of the other container member are abutted with each other. It is characterized in that the connection portion is covered with a connection sheet having a thickness in the range of 20 to 1000 μm, and the connection portion is heat-sealed to the outer wall of each connection port to form the connection portion. As described above, the connection portion can be configured via the connection sheet. In this case, the joint portion covered with the connection sheet may be exposed to the outside air at the time of the connection.
For this reason, if the connection sheet is also within the above-described range, the joint portion can be reliably sterilized by the pulsed light.

[0019]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, embodiments of the present invention relating to a method for sterilizing a container with a connection portion will be described in detail. 1A and 1B are a plan view and a schematic partial cross-sectional view of a first embodiment of a medical container used in the method for sterilizing a container with a connection portion according to the present invention. FIG. 2 is a schematic view showing a step of sterilizing a connection portion of the medical container of FIG. FIGS. 3A and 3B show a second example of a medical container used in the method for sterilizing a container with a connection part according to the present invention.
It is the top view of an Example and the schematic partial sectional view of a connection part.

As shown in FIGS. 1 and 2, a method of sterilizing a container with a connecting portion according to the first embodiment is based on a resin container member 16 containing a drug 12 and a container 14 containing a solution 14 of the drug 12. A connecting portion 32 connected to the member 18, wherein the sealing portion 28 is detachable from the connecting portion 32 of the container member 18.
During use, sterilization of the container 10 with the connection portion having the connection portion 32 for opening the hermetically sealed portion 28 to allow the medicine 12 and the solution 14 in each of the container members 16 and 18 to flow therethrough. It is about the method. The container 10 is a medical container, which irradiates the connection portion 32 with the pulsed light beam 34 of high energy of the light emitting lamp 40 by the pulse electric field processing device 42 to sterilize the inside of the connection portion 32.

The pulse output intensity (single flash energy per unit area) of the lamp 40 by the pulse electric field processing device 42 is 1.25 J / cm ² or more,
1. The total output received by the connection unit 32 from the lamp 40
It is assumed to be 5 J / cm ² or more. The lamp 40 is made of xenon gas and quartz glass. Before connecting the container member 18 to another container member 16, the solution 14 in the container member 18 is subjected to autoclave sterilization together with the container member 18. The connection port 28 of the other container member 18 is inserted into the connection port 30 of the container member 16, and the connection port 30 of the container member 16 has a wall thickness of 2.
The connection portion 32 is formed in a range of 0 to 1000 μm and heat-sealed from the outside of the wall.

The present embodiment will be described in more detail. First, the medical container 10 comprises a container member 16 containing the drug 12 and a container member 18 containing the solution 14 of the drug 12. The container member 16 and the container member 18 are manufactured at different places. The container member 16 is made of low-density polyethylene and is formed of an inflation sheet having a thickness of 200 μm and a folded diameter of 80 mm. The inflation sheet is cut to a predetermined length, and one end of the cut open end is heat-sealed so as not to be peeled off. A hanging hole 22 is formed in the seal portion 20 that cannot be peeled off, and the hanging hole 22 serves as a stand hook insertion port of the medical container 10. Drug 1 from the cut open end
2 are stored aseptically and the open ends are sealed with clips 24. Drug 12 comprises an aseptically lyophilized antibiotic. Thereby, the container member 16 is provided to a docking room for docking with the container member 18.

The container member 18 is formed from a two-layer inflation sheet by co-extrusion. The inner layer is composed of a blend layer of a mixture of linear low-density polyethylene and polypropylene at a weight ratio of 2: 1, and the outer layer is composed of a linear layer. Consists of a layer of linear low density polyethylene. The inflation sheet has a folding diameter of 70 mm, an inner layer thickness of 50 μm, and an outer layer thickness of 200 μm. The inflation sheet is cut to a predetermined length, and an outlet port 26 is inserted into one end of the cut open end, and the open end is sealed together with the outlet port 26 with a non-peelable seal. On the other hand, a peelable seal portion 28 is formed at the other open end, and the container member 18 is formed. The solution 14 is filled into the container member 18 from the outlet port 26, and after filling, the outlet port 26 is sealed with a rubber stopper. After sealing, the solution 14 is sterilized in an autoclave together with the container member 18 at a temperature of 110 ° C. Thereby, the container member 18 is provided to a docking room for docking with the container member 16. The non-peelable seal is set by setting the temperature of the heat seal bar to 170 ° C, and the peelable seal seal is set by setting the temperature of the heat seal bar to 130 ° C.

Next, the formation of the connection portion 32 of the medical container 10 and a sterilization method thereof will be described. The docking room is placed in a highly clean environment. The connection port of the peelable seal portion 28 of the container member 18 is inserted into the connection port 30 of the container member 16. After the insertion, as shown in FIG. 2, a non-peelable heat seal is formed between the inner wall surface of the connection port 30 and the outer wall surface of the sealing portion 28 to form the connection portion 32. The heat sealing is performed at a temperature that does not impair the function of the peelable hermetic seal portion 28. In this case, the seal wall 28 which can be peeled off from the inner wall surface of the connection port 30 is used.
Are made of polyethylene resin, whereas the surfaces between the hermetically sealed portions 28 are a blend layer of linear low-density polyethylene and polypropylene, so that the inner and outer wall surfaces cannot be separated. Complete sealing can be performed at relatively low temperatures, and heat sealing bars can be performed at temperatures ranging from 125 ° C to 135 ° C.

The medical container 10 after the docking is completed.
Is carried into the moving conveyor 36 in the generation chamber of the high energy pulse light 34. As shown in FIG. 2, the medical container 10 is sterilized by irradiating only the region L of the connection part 32 with the high-energy pulse light 34. Portions other than the connection part of the medical container 10 are shielded by a shielding plate (not shown). Further, the medical container 10 is mounted on the reversing device 3 on the moving conveyor 36.
By 8, the container 10 itself is inverted, and the region L of the connecting portion 32 on the back surface is also irradiated with the high-energy pulse light 34.

The device for the high-energy pulsed light 34 includes a light-emitting lamp 40 and a pulse electric field processing device 42. The pulse electric field device 42 has a built-in charge supply circuit, a controller, and a switch unit.
Supply is performed with a pulse electric field strength of 00 V / cm or more. The light-emitting lamp 40 is composed of a sealed tube and an inert sealed gas, the sealed gas is xenon, and the sealed tube is made of quartz glass. For this reason, the light-emitting lamp instantaneously emits a high energy of about 20,000 times or more the natural light at a wavelength close to the natural light. The emission time of the amplified pulse from the pulse electric field processing device 42 is 2-3 / 1,000,000 (seconds).

The light emitting lamp 40 is provided with a light detector 44 for measuring the lamp life and the light irradiation amount of the connecting portion 34. The light detector 44 detects by measuring the output voltage of the reverse bias generated when the light hits the light of the photodiode. The output intensity (fluence) of the pulse light 34 by the light detector 44, that is, the energy of light per unit area is 2.1 J / cm ^2.
As described above, the total output received by the connection unit 32 is 10.5 J
/ Cm ² or more. After sterilization, the container 10
From which the clip 24 is removed and provided to the market as a medical container.

The connecting portion 32 of the medical container 10 which has been subjected to the sterilization method according to the first embodiment has no damage at all. In addition, the resin wall in the connection portion 32 did not undergo any oxidation or hydrophilicity at all, and the medical container 10 was sufficiently safe. Therefore, it can be seen that the connection portion 32 of the medical container 10 can be easily sterilized in the manufacturing process.

Next, a sterilization method according to the second embodiment will be described with reference to FIG. The medical container 46 shown in FIG. 3 includes a pair of container members 48 of the same type. The container member 48 is formed by blow molding.
0 (or filling port). The blow molded product has an inner layer formed of a blend layer of linear low density polyethylene and polypropylene, and an outer layer formed of a linear low density polyethylene layer. Further, the bottom of the container member 48 is cut off to form an open end, and then the peelable hermetic seal portion 5 is formed.
2 are formed. Each container member 48 contains a drug solution 54 mainly containing sugar and a drug solution 56 mainly containing amino acids. Each container member 48 is subjected to an autoclave sterilization process and provided to a docking room.

In the docking room, each container member 48
End portions of the hermetically sealed portion 52 are butted against each other. Then, the butted portion is sandwiched between the two connection sheets 58, and the connection sheets 58 and the outer wall surface of the sealing portion 52 sandwiched between the connection sheets 58 are heat-sealed so as not to be separated. Thereby, the connection part 60 of the medical container 46 is formed. The connection sheet is made of a transparent low-density polyethylene sheet having a thickness of 100 μm. Next, similarly to the sterilization conditions according to the first embodiment, only the L region of the connection portion 60 shown in FIG. In the sterilization method having such a configuration, the connection portion 60 of the medical container 48 is easily sterilized. That is, since the pulsed electric field generator and the light emitting lamp are small and do not generate inconvenient ions or X-rays,
Can be easily installed on a production line. Further, the contents 54 and 56 in the shielded container member 58 are not adversely affected. No heat is generated in the connecting portion 60, and the connecting portion 60 is not broken.

Next, the following sterilization or sterility experiments were conducted using the second embodiment. Each container member 48 described above
The liquid thioglycolic acid culture medium I (the medium according to the sterility test method of the general test method listed in the Japanese Pharmacopoeia 13th department)
This was autoclaved at a temperature of 110 ° C. Next, the container members 48 were abutted to each other and connected via a connection sheet 58. Before sealing the connection sheet 58 to each other, bacteria corresponding to 10 ⁷ in the abutting portion of the hermetic seal portion 52 (Bacillus subtile: ATCC 6633) was applied. Ten such containers were manufactured, and irradiation with the high-energy pulsed light was performed under the same conditions. Next, by pressing one of the container members 48, the containers 48 were communicated with each other. The connected vessel 46 was cultured at 31 ° C. for 14 days. As a result, no breeding of bacteria was observed in all cases. Therefore, it can be seen that the connection portion 60 of the container 46 is reliably made by the above sterilization method.

[0032]

As described above, in the method of sterilizing a container with a connection according to the present invention, the connection is sterilized by irradiating the connection with a high-energy pulsed light of a light-emitting lamp by a pulse electric field processing apparatus. By doing so, it is possible to sufficiently enhance the sterility or sterility of the connection portion between the resin containers, and without causing destruction at the connection portion,
The connection can be easily sterilized on the production line without inconveniencing other parts.

[Brief description of the drawings]

1 (A) and 1 (B) are a plan view and a schematic partial cross-sectional view of a first embodiment of a medical container used in the method for sterilizing a container with a connection portion according to the present invention.

FIG. 2 is a schematic view showing a step of sterilizing a connection portion of the medical container of FIG. 1;

3 (A) and 3 (B) are a plan view and a schematic partial cross-sectional view of a second embodiment of the medical container used in the method of sterilizing a container with a connection part according to the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 10 Medical container 12 Drug 14 Dissolution 16 and 18 Container member 28 Peelable hermetic seal part 30 Connection port 32 Connection part 34 High energy ray 40 Light emission lamp 42 Pulse electric field processing apparatus 44 Detector 46 Medical container 48 Container member 52 Sealable seal part that can be peeled off 58 Connection sheet 60 Connection part

Claims (6)

[Claims] 1. A connecting part for connecting one container member made of resin and another container member, wherein one or both of the container members are formed with a peelable sealing seal part and used. Sometimes, in a method of sterilizing a container having a connection portion having the connection portion that allows the contents in each of the container members to be able to flow by opening the hermetically sealed portion, the light-emitting lamp by the pulse electric field processing device is used. A method for sterilizing a container with a connection portion, wherein the connection portion is sterilized by irradiating the connection portion with a high-energy pulsed light beam. 2. The pulse output intensity (single flash energy per unit area) of the lamp by the pulse electric field processing device is set to 1.25 J / cm ² or more, and the total output received by the connection from the lamp is 2.5 J / cm ^2. the method of sterilization according to claim 1, characterized in that the cm ^{2 or} more. 3. The method according to claim 2, wherein said lamp is made of xenon gas and quartz glass or sapphire glass. 4. The method according to claim 1, wherein, prior to connecting said one container member to another container member, the contents in at least one of said container members are subjected to autoclave sterilization together with said container member. The sterilization method according to 1. 5. The connection port of another container member is inserted into the connection port of the one container member, and the connection port of the one container member has a wall thickness in the range of 20 to 1000 μm. 2. The sterilization method according to claim 1, wherein the connection portion is formed by heat sealing from above. 6. A connection port of the one container member and a connection port of another container member are butted, and the butted connection port is covered with a connection sheet having a thickness in a range of 20 to 1000 μm. The sterilization method according to claim 1, wherein the connection portion is formed by heat sealing to an outer wall of the connection port.