JP2000325428A - Medical multi-chamber container - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a multi-chamber container which can form an isolation part of a stable half-sealing strength without requiring neither a complicated material composition nor structure. SOLUTION: This medical multi-chamber container which has the periphery part thereof fully sealed and an isolation part thereof half-sealed employs a single layer film with a thickness of 50-300 μm that comprises a propylene/α- olefin random copolymer with the content of propylene of 50 wt.% or more while the content of α-olefin, which is at least one selected from those having the carbon number of 2-12, is 2-8 wt.% and the melt flow rate of the copolymer is 0.1-20 g/10 min. when measured on the conditions of a load of 2.16 kg at a temperature of 230 deg.C in conformity to JISK 7210. The half sealing is made under the conditions of 4-12% in the forcing rate at a sealing temperature of 122-127 deg.C by a heat seal bar driven by a servo motor.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

TECHNICAL FIELD The present invention relates to a multi-chamber medical container. The multi-chamber medical container according to the present invention is used to isolate and store a plurality of contents in a sealed state, and to peel off the separating part to mix the plurality of contents in a sealed state when used.

[0002]

2. Description of the Related Art In the medical field, it is very common to administer a plurality of drug components to a living body in a mixed state.
Depending on the combination of drug components to be mixed, it may be degraded during autoclaving and during storage. For this reason, these drugs are placed in separate containers and are mixed and administered to patients at the time of use. By the way, the operation of mixing at the time of use may cause dispensing errors, and also has problems such as contamination during mixing. Therefore, a multi-chamber medical container has been proposed.

A multi-chamber medical container has a structure in which a peripheral portion is fully sealed and an isolation portion is half-sealed. Here, a full seal refers to a seal having the same seal strength as the container itself, and a half seal refers to a seal having an appropriate strength that is not opened during transportation or storage, but is opened by applying force during use. To tell.

As the constituent materials of the inner wall surface of the medical multi-chamber container, a composition of a polypropylene-based polymer and a styrene-based elastomer (JP-A-8-22910), a polypropylene-based polymer and an ethylene / α-olefin copolymer-based elastomer (JP-A-8-13151)
No. 5, JP-A-2-4671), and compositions comprising two or more kinds of polyolefin resins having different melting start temperatures are known. Further, a synthetic multilayer sheet has also been proposed (Japanese Patent Application Laid-Open No. 1-240469, Japanese Patent Application Laid-Open
0-71185). As described above, conventionally, it is considered that multi-component composition or multi-layer composition is essential for controlling the heat sealing strength.

[0005] The sealing strength can be changed by the temperature and the application pressure at the time of heat sealing in which a hot plate (heat sealing bar) heated to a certain temperature is press-bonded to the stacked films. However, in the case of the conventional method using a seal bar driven by an air cylinder, it is difficult to obtain a stable half-seal strength, so that a partially strong seal portion remains at the time of peeling, mixing cannot be sufficiently performed, internal pressure during sterilization and during transportation. There are drawbacks such as peeling without being able to withstand the impact of

[0006]

SUMMARY OF THE INVENTION The present invention has been made in view of the above circumstances, and an object of the present invention is to form an isolated portion having a stable half-seal strength without requiring a complicated material composition and structure. To provide a multi-chamber medical container.

[0007]

As a result of various studies, the present inventor has found that the above object can be easily achieved by using a specific copolymer as a material and employing a specific heat sealing means. Obtained knowledge.

[0008] The present invention has been achieved based on the above findings, and the gist of the present invention is to provide a multi-chamber medical container in which the peripheral portion is fully sealed and the isolation portion is half-sealed,
The content of propylene is 50% by weight or more, the content of at least one other α-olefin selected from carbon numbers of 2 to 12 is 2 to 8% by weight, and the temperature is 230 ° C and the load is 2 according to JIS K7210. Consisting of a propylene / α-olefin random copolymer having a melt flow rate of 0.1 to 20 g / 10 minutes measured under conditions of 0.16 kg.
A medical device comprising a single-layer film having a thickness of 50 to 300 μm and half-sealed by a heat seal bar driven by a servomotor at a sealing temperature of 122 to 127 ° C. and an indentation ratio of 4 to 12%. In a multi-chamber container.

[0009]

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, the present invention will be described in detail.
The multi-chamber medical container according to the present invention has a specific propylene
-It is composed of a single-layer film composed of an olefin random copolymer. In addition, a block copolymer is not preferable in terms of transparency and flexibility.

The propylene / α-olefin random copolymer used in the present invention contains at least 50% by weight of propylene and 2 to 8% by weight of at least one other α-olefin selected from C2 to C12. contains. Other α-olefins include ethylene, butene, pentene, hexene, octene and the like, with ethylene being preferred. If the content of the other α-olefin is less than 2% by weight, the flexibility of the obtained container is impaired, while the content of the other α-olefin is 8% by weight.
If the temperature exceeds 1, the low crystalline component in the random copolymer increases, the heat resistance decreases, and it becomes impossible to withstand steam sterilization at 121 ° C.

The propylene / α-olefin random copolymer described above has a temperature of 2 according to JIS K7210.
It is necessary that the melt flow rate measured at 30 ° C. under a load of 2.16 kg has a value of 0.1 to 20 g / 10 minutes. Melt flow rate is 0.1g
In the case of less than / 10 minutes, the appearance and transparency of the container are poor and 2
When it exceeds 0 g / 10 minutes, the stability at the time of molding is lacking. The above melt flow rate is preferably 0.5 to
It is 10 g / 10 min, more preferably 1 to 5 g / 10 min.

The above-mentioned propylene / α-olefin random copolymer is generally produced using a Ziegler-type stereospecific polymerization catalyst in the presence or absence of an inert solvent, and has a crystallinity determined by a density gradient method. Is a crystalline resin of usually 20 to 70%.

The single-layer film composed of the above-mentioned propylene / α-olefin random copolymer can be obtained by various molding methods such as an inflation film molding method and a T-die film molding method. Among these, the blown film molding method is preferred. The thickness of the single-layer film is selected from the range of 50 to 300 μm. Thickness 5
If it is less than 0 μm, it will break during transportation, storage and high-temperature sterilization, and if it exceeds 300 μm, the container loses its flexibility and its self-draining property deteriorates.

The medical multi-chamber container according to the present invention comprises the above-described single-layer film, and has a completely sealed peripheral portion and a half-sealed separating portion. At this time, half-sealing for forming the isolation portion is performed under specific conditions using specific sealing means.

The above-mentioned peripheral portion is formed by attaching a hanging tool or a discharge port to the outer peripheral opening of the single-layer film, and performing strong heat sealing. The peripheral portion must not break when the storage chamber is strongly pressed during use to peel off the isolation portion, and a high heat seal strength is required. In this case, since the accuracy is not a problem, a general air cylinder driven seal bar may be used, and the sealing temperature and pressure conditions may be selected on the safe side. Of course, a heat seal bar driven by a servo motor described later may be used.

It is necessary that the above-mentioned isolation part is formed by a heat seal bar driven by a servo motor. In the case of an air cylinder driven seal bar, the only things that can be controlled are the seal temperature and the applied pressure.
The thickness after sealing fluctuates about ± 15% from the average value.

When the film is strongly pushed in due to an increase in the cylinder pressure, the thickness of the seal portion is reduced and the seal strength is increased, so that an excessive force is required to separate the isolation portion during use. Further, when a partially strong seal portion is formed, a plurality of contents cannot be uniformly mixed without peeling off only that portion. Conversely, when the cylinder pressure drops, the sealing strength decreases, and it becomes impossible to withstand various impacts during product shipment. In order to avoid such inconveniences, in the prior art, efforts have been made to increase the range of allowable sealing strength by making the composition multi-component or the structure multi-layer.

In the present invention, the servomotor
The thickness of the film to be half-sealed, that is, the value of how much the film is pushed in from the total thickness of the two original films (the pushing ratio of the seal bar) is controlled. As a result, even if the seal temperature slightly changes, an isolation portion (half seal portion) having a constant thickness, that is, a constant seal strength is formed. Therefore, by this control, it is possible to form an isolation portion that can be sufficiently peeled even with a single layer and a single material.

FIG. 1 is an explanatory view of an example of the heat sealing device used in the present invention. The illustrated heat-sealing apparatus includes a pair of support plates (2) each set upright on a gantry (1).
a) and (2b), a heat seal bar mounting plate (3) provided on each support plate (2a) so as to be able to move forward and backward, and a rack (4) provided on the back surface of each heat seal bar mounting plate (3). ), A drive servomotor (5) having a pinion attached to each support plate (2b) and meshing with the rack (4), and protruding from the entire surface of each heat seal bar attachment plate (3). And heater (7) and temperature sensor (8)
And a heat seal bar (6) having a built-in heat seal bar.

Each heat seal bar (6) is advanced to a position shown by a dashed line by the above-mentioned rack and pinion mechanism, and heat-sealed by press-fitting the stacked films (not shown). In this case, since the rack and pinion mechanism is driven by the servomotor (5) and the moving distance of the pair of heat seal bars (6) can be set accurately, the pushing ratio of the heat seal bar (6) is highly controlled. Is done.

In the case of the present invention, the above half-sealing must be performed under the conditions of a sealing temperature of 122 to 127 ° C. and an indentation ratio of 4 to 12%. When the sealing temperature is lower than 122 ° C. or when the indentation ratio is lower than 4%, the half-seal strength is reduced, and the package is opened during transportation, storage, and high-temperature sterilization. When the seal temperature exceeds 127 ° C or when the indentation rate is 12
%, The fusion strength becomes too strong, and when a force is applied to open the seal at the time of use, the seal is not opened or other parts such as the peripheral portion are broken.

In the medical double-chamber container according to the present invention,
As in the conventional case, after a plurality of contents are separately filled in the container, steam sterilization is performed. In recent years, conditions of 121 ° C. for 20 minutes have become internationally standard for complete sterility. Accordingly, there is a need for a material that does not cause deformation of the container at high temperature and does not impair transparency, and that does not cause a blocking phenomenon in which films adhere to each other. These requirements can be met by the medical multi-chamber container according to the present invention.

[0023]

EXAMPLES Hereinafter, the present invention will be described in more detail with reference to examples, but the present invention is not limited to the following examples unless it exceeds the gist of the present invention.

Example 1 (1) Production of propylene-ethylene random copolymer:
After sufficiently replacing the inside of a 200 L stainless steel reactor equipped with a stirring blade with propylene gas, 80 L of heptane was charged as a polymerization solvent. The temperature in the reactor was kept at 50 ° C., and 50 g of diethylaluminum chloride and 10 g of titanium trichloride were added as catalysts. Then, 5.83k of propylene
Feed at g / h for 15 minutes. During this time, hydrogen was supplied so that the concentration in the gas phase became 3.0 vol%.

Next, the temperature in the reactor was raised to 55 ° C., and the hydrogen concentration was adjusted to 3.2 vol%. Then, propylene was kept at a rate of 5.83 kg / hour, and ethylene was newly supplied at a rate of 0.152 kg / hour.
After supplying for 360 minutes, the pressure in the reactor was increased to 2.42 kg /
The reaction was completed by lowering to ² cm ² . After removing the by-product amorphous copolymer soluble in the catalyst and the solvent, drying treatment was performed to obtain a propylene-ethylene random copolymer. The ethylene content of the copolymer is 2.8 wt%, and the MFR is 1.0 g / 10
Minutes.

(2) Production of film: Copolymer 1 described above
Of tris (3,5-di-t-butyl-
0.1 part by weight of 4-hydroxybenzoyl) isocyanurate and 0.03 part by weight of calcium stearate were added, mixed, and pelletized at 230 ° C. using an extruder. Using this pellet as a raw material, a tubular sheet is extruded at 200 ° C. by a circular die for a single layer, and then cooled with a water-cooled ring, and has a thickness of 250 μm and a folded diameter of
A single-layer film of 0 mm was obtained. The obtained single-layer film was cut into a length of 350 mm and used for producing a multi-chamber container.

(3) Production of a multi-chamber container: First, a heat seal bar driven by a servomotor was used, and 200 m from one end was used.
After forming a peelable separating portion at the position of m by half sealing, 200 ml of the amino acid solution and 600 ml of the glucose solution were placed in one chamber and the other chamber, respectively. See Table 1 for half seals
The conditions described in were used. In this case, the clearance is set to 3 by a servomotor (“09ASB” manufactured by Yaskawa Electric).
It could be controlled in μm units. The clearance of the half seal was 470 μm, and the indentation rate was 6%. Next, using a seal bar driven by an air cylinder, the periphery was fully sealed at 150 ° C., 5 kg / cm ² , for 3 seconds.

(4) High-pressure steam sterilization: The multi-chamber container obtained above was placed in a high-pressure sterilization chamber, and sterilized at 121 ° C. for 30 minutes.

(5) Evaluation: Using an autograph “S100” manufactured by Shimadzu Corporation, the glucose-filled side was set at 100 cm.
Force required for pressurizing peeling ^second pusher (peeling strength: Kg
f) was measured. This measurement made 20 samples,
The test was performed on ten samples before and after sterilization. The results are shown in Table 2. In consideration of stability until use (easy to open) and operability during use (easy to open), the peel strength of the isolation part is usually 15 to 35 kgf, preferably 20 to 3 kgf.
It must be controlled at 0 kgf. If the weight is less than 15 kgf, the isolation part is opened at the time of liquid filling, transportation, high-temperature sterilization, and the like. If it exceeds 35 kgf, an excessive force is required at the time of use, and the container is partially opened and the mixing becomes insufficient, or the outer peripheral portion is damaged and the content liquid leaks out.

Comparative Example 1 The same operation as in Example 1 was performed, except that a seal bar driven by an air cylinder was used in the half sealing in the manufacturing process of the multi-chamber container. Tables 1 and 2 show the half-sealing conditions and the peel strength of the isolated portion.

[0031]

[Table 1]

[0032]

[Table 2]

Comparative Example 2 In Example 1, the feed ratio of propylene and ethylene was changed in the production process of the copolymer, and the ethylene content was 11% by weight.
The same operation as in Example 1 was performed except that a propylene-ethylene random copolymer having an MFR of 2 g / 10 min was produced. As a result, the container was greatly deformed due to the internal pressure during sterilization, and the voids were fused and did not function as a container.

Comparative Example 3 In Example 1, the indentation ratio at the time of half-sealing is shown in Table 3.
The same operation as in Example 1 was carried out, except for changing as shown in (1). Table 3 shows the measurement results of the peel strength of the isolation part before sterilization.

[0035]

[Table 3]

[0036]

According to the present invention described above, there is provided a double-chamber medical container which can function satisfactorily with a single layer and a single composition and can withstand high-temperature sterilization at 121 ° C.

[Brief description of the drawings]

FIG. 1 is an explanatory diagram of an example of a heat sealing device used in the present invention.

[Explanation of symbols]

 1: Stand 2a: Support plate 2b: Support plate 3: Heat seal bar mounting plate 4: Rack 5: Servo motor 6: Heat seal bar 7: Heater 8: Temperature sensor

 ──────────────────────────────────────────────────続 き Continuing on the front page (72) Inventor Ichihara Umehara 1 Tohocho, Yokkaichi City, Mie Prefecture Mitsubishi Chemical Corporation Yokkaichi Office (72) Inventor Tadao Miyazaki 1 Tohocho, Yokkaichi City, Mie Prefecture Mitsubishi Chemical Corporation Yokkaichi Office

Claims (1)

[Claims] 1. A medical multi-chamber container wherein the peripheral portion is fully sealed and the isolation portion is half-sealed, wherein the content of propylene is 50% by weight or more and at least one other kind selected from C2 to C12. The content of α-olefin is 2 to 8% by weight, and the temperature is 23 according to JIS K7210.
Propylene α having a melt flow rate of 0.1 to 20 g / 10 min measured at 0 ° C. and a load of 2.16 kg
A thickness of 50 to 3 consisting of an olefin random copolymer
It is composed of a single-layer film of 00 μm and has a seal temperature of 122 to 12
A double-chamber medical container characterized by being half-sealed at a condition of 7 ° C. and an indentation ratio of 4 to 12%.