Sterile package, process for producing the same, and production apparatus

The present invention is directed to providing a sterile package (1, 1′) integrally housing a contents-pouring device (5, 5′) which has improved contents pourability and tamper evidence. According to the present invention, the sterile package (1, 1′) can be efficiently produced by adopting the following steps of: (1) disposing a parison (27) in a mold (32) for a plastic container main body, (2) blowing sterile air from a nozzle (24) inserted in the parison (27) to blow-mold the plastic container main body, (3) filling the plastic container main body (2) with contents through the nozzle (24) and retracting the nozzle (24), (4) inserting a contents-pouring device (5, 5′) in the parison located above the plastic container main body (2), (5) clamping a mold (31) for a protective case, and (6) forming a protective case (6) with the parison located above the container main body (2).

This application is a 371 of PCT/JP2006/301872, filed Feb. 3, 2006.

1. Technical Field

The present invention relates to a sterile package which includes a contents--pouring device integrally housed therein, a method of producing the sterile package, and its production apparatus.

2. Background Art

Conventionally, a plastic container with a pouring device is known, in which the contents such as drugs and unregulated drugs are housed in a small volume to be used up at one time in the container, and a pouring device such as a needle for pouring the contents is attached to an inlet of the container (for example, see Patent Documents 1 and 2)

Further, it is also known that, when such a plastic container with a pouring device is produced, the container is filled with contents simultaneously at the time of molding the container in terms of sanitary supervision (see Patent Document 3)Patent Document 1: Japanese Examined Utility Model Publication No. Sho 35-24295Patent Document 2: Japanese Examined Patent Publication No. Sho 61-2380Patent Document 3: JP 2002-128126 A

However, those containers with a pouring device have problems in that the container is opened due to an external force caused by a drop impact or the like in the course of production and distribution, and the container lacks a tamper-evident property for preventing mischief and unauthorized opening, and the like.

Therefore, in the plastic container with a pouring device filled with contents, an attempt is made so as to protect a pouring device and obtain a tamper-evident property by using a cladding such as a carton or a pouch, or by using another part such as a tape and a shrink-label. However, a method using a cladding and another part requires additional steps, which causes an increase in cost.

Then, in order to use up the contents housed in such a container at one time, it is necessary that the whole amount of contents be poured by crushing a container main body with fingers. However, in a case of a container in a cylindrical shape or the like, a bottom portion of the container becomes an obstacle, which makes it difficult to pour the contents completely.

Thus, in a conventional container with a pouring device, the pourability of contents is enhanced by adopting a container without a bottom portion, and thus, the container is not allowed to be self-supported.

DISCLOSURE OF THE INVENTION

Problem to be Solved by the Invention

Accordingly, the object of the present invention is to provide a sterile package which includes a pouring device integrally housed therein, in which the protection property of the pouring device, and the pourability of contents and tamper-evident property are enhanced. Another object of the present invention is to provide a method of producing the sterile package and its production apparatus, capable of continuously performing molding of a plastic container main body to be filled with contents, sterile filling of the contents, molding of a protective case that is formed integrally with the container main body, and storage of a pouring device in the protective case.

Means for Solving the Problem

In order to solve the above-mentioned problems, the present invention provides at least the following embodiments.

In one aspect, a sterile package is provided, comprising: a plastic container main body with a folding guide line formed to be filled with contents sterilely; a protective cast integrally molded with the plastic container main body; and a pouring device stored in the protective case.

In one embodiment, a sterile package is provided, in which the pouring device is stored in the protective case sterilely.

In another embodiment, a sterile package is provided, wherein the pouring device comprises a pouring part stored in a case sterilely and stored in the protective case.

In another embodiment, a sterile package is provided, further including a check part provided to a lower end of the pouring device.

In another aspect, a method is provided for producing a sterile package, including the following steps:

(1) disposing a parison in a mold for a plastic container main body;

(2) blowing sterile air from a nozzle inserted in the parison to blow-mold the plastic container main body;

(3) filling the plastic container main body with the contents from the nozzle and retracting the nozzle;

(4) inserting a pouring device in the parison located above the plastic container main body;

(5) clamping a mold for a protective case; and

(6) forming the protective case with the parison located above the plastic container main body.

In one embodiment of the method, the nozzle is inserted or retracted while the sterile air is blown into the parison through the nozzle in such a manner that the nozzle does not come into contact with an inner wall of the parison. It is preferable that the pressure of the sterile air blown through the nozzle be set to be about 0.001 to 0.1 MPa.

In another embodiment, the method includes a pouring device insertion unit inserted or retracted while the sterile air is blown into the parison through an air hole provided to the pouring device insertion unit in such a manner that the pouring device insertion unit and the pouring device do not come into contact with an inner wall of the parison. It is preferable that the pressure of the sterile air blown through the air hole provided in the pouring device insertion unit be set to be about 0.001 to 0.1 MPa.

In another embodiment of the method, the parison between a lower portion of the pouring device and an upper portion of the plastic container main body is heat-sealed previously.

In another embodiment of the method, the protective case is formed by vacuum molding.

In another embodiment of the method, a blow pin is pierced in the protective case from a side surface of the protective case, and vacuum molding is performed while the sterile air is blown into the case from the blow pin. It is preferable that the pressure of the sterile air blown from the blow pin be set to be about 0.1 to 0.6 MPa.

In another embodiment of the method the parison is a multi-layered parison including a gas barrier resin layer.

In another aspect, a production apparatus for a sterile package is provided, the apparatus including a nozzle unit that supplies sterile air for blow molding and fills the contents of the container main body and a pouring device insertion unit in a sterile box, in which a parison extrusion die to be connected below the sterile box, a mold for a protective case, and a mold for a plastic container main body are successively disposed.

In one embodiment, the production apparatus comprises a mold for heat sealing provided between the mold for the protective case and the mold for the plastic container main body.

EFFECTS OF THE INVENTION

The present invention exhibits the following remarkable effects by employing the above-mentioned constituents.

(1) A sterile package of the present invention is excellent in a protection property of a pouring device and a tamper-evident property, and can prevent the opening of the package due to an external force in the course of production and distribution of the package, and the mischief and unauthorized opening of the package.

(2) In the sterile package of the present invention, a folding guide line is formed in a container main body, thereby contents can be easily poured completely.

(3) In the sterile package of the present invention, a backflow during pouring of the contents can be prevented by providing a check part to a lower end of the pouring device. Further, other contents such as a hazardous material (e.g., a stimulant) are prevented from being aspired after the use of the container and abusing of the package is prevented.

(4) According to a method of producing a sterile package of the present invention, molding of a plastic container main body to be filled with contents, sterile filling of the contents, molding of a protective case that is formed integrally with the container main body, and storage of a pouring device in the protective case can be performed continuously. Therefore, the sterile package can be produced efficiently at a low cost.

(5) A production apparatus of a sterile package of the present invention can be designed to be a compact size with a simple configuration, and the sterile state of the apparatus is managed easily, which can reduce a production cost significantly.

DESCRIPTION OF REFERENCE NUMERALS

2plastic container main body

3folding guide line

21sterile package production apparatus

25pouring device magazine

26pouring device insertion unit

31mold for protective case

32mold for container main body

33mold for heat sealing

P1supply pipe of sterile air

P2contents supply pipe

BEST MODE FOR CARRYING OUT THE INVENTION

Hereinafter, an example in which the present invention is applied to a disposable injection substance package will be described with reference to the drawings. It should be noted that the present invention is not limited to the following specific examples.

FIGS. 1 and 2are views showing one example of a sterile package (disposable injection substance package) of the present invention.FIG. 1(A)is a front view of a package,FIG. 1(B)is a partial cross-sectional side view, andFIG. 1(C)is a view showing a state in which a protective case of a pouring device of the package is opened. Further,FIG. 2are enlarged cross-sectional views of a pouring device (needle unit) of the package.FIG. 2(D)is a view showing a state of the pouring device (needle unit) before being used, andFIG. 2(E)is a view showing a state in which an injection substance needle of a pouring part constituting the pouring device is communicated with a container main body.

The injection substance package1is obtained by integrally molding a container body2provided with a folding guide line3and a protective case6storing a pouring device (needle unit)5composed of a double-ended needle14or the like of the pouring part for pouring contents and a case11. The container body2is filled with an injection substance sterilely during molding of the container body2. Further, a label7displaying the filled injection substance is provided on an upper portion of the protective case6.

As shown inFIG. 2, in the pouring device5, the double-ended needle14is fixed in the case11provided with a stopper12through a hub13composed of an elastic material of rubber or the like. At a lower end of a connecting portion15with respect to the container body2of the pouring device5, a stopper16made of an elastic material of rubber or the like is set. In the pouring device5, the double-ended needle14pouring contents is held in a sterile state in the case11.

As shown inFIG. 1(C), when the injection substance package1is used, first, the protective case6is opened by twisting it with fingers. Next, when the case11of the pouring device5is pressed down to a position ofFIG. 2(E), one end of the double-ended needle14of the pouring part fixed to the hub13passes through the stopper16to be communicated with the container body2. Then, when the case11is removed and the other end of the double-ended needle14is inserted into the vein or the like of a patient, and the container body2is held with fingers, the container main body2is folded at the folding guide line3, thereby the injection substance can be poured completely.

The injection substance package1can be self-supported under the condition that the double-sided needle14is communicated with the container main body2. Thus, before used for a patient after the opening of the protective case6of the package, the package can be self-supported temporarily in a storage case or the like without being contaminated.

FIG. 3are enlarged cross-sectional views showing another example of the sterile package of the present invention, in which the pouring device (needle unit)5is shown in an enlarged state with the protective case6of the package being opened.FIG. 3(A)shows a state of the pouring device5before being used, andFIG. 3(B)shows a state in which the double-ended needle14of the pouring part is pushed in toward the container main body, thereby the double-ended needle14can be communicated with the container main body2. Then,FIG. 3(C)shows a state in which the case11of the pouring device5is removed after the double-ended needle14is pushed in, thereby the injection substance in the container main body can be poured.

In the sterile package1of the present example, a check part such as a check valve17is provided to a lower end of the stopper16provided in the connecting portion15with respect to the plastic container main body2of the pouring device5, that is, at the lower end of the pouring device5.

By providing the check valve17, the contents can be poured out of the container main body from the plastic container main body2via the double-ended needle14, and the contents poured out or other drugs can he prevented from flowing back to the container main body2via the double-ended needle14.

Then, by providing the check valve17to a lower end of the pouring device5, other contents such as a hazardous material (e.g., stimulant) can be prevented from being aspired in the container after the use of the sterile package of the present invention and abusing of the container can be prevented.

FIG. 4show another example of the sterile package of the present invention, andFIG. 4(A)is a front view of the package,FIG. 4(B)is a partial cross-sectional side view of the package, andFIG. 4(C)shows a state in which the protective case of the pouring device of the package is opened.

In this example, in the sterile package ofFIG. 1, a pouring device5′ only composed of a cylindrical pouring part with a tip end blocked is used in place of the pouring device (needle unit)5composed of the double-ended needle14of the pouring part or the like and the case11. The pouring device5′ is communicated with the container main body2, without the case11in the needle unit5, and a tip end9thereof is provided with an annular thin portion8for opening the tip end9. When a package1′ is used, as shown inFIG. 4(C), the protective case6is opened by twisting it with fingers, and the thin portion8is folded to be removed to open the tip end9. Then, when the pouring device5′ is applied to an affected portion of a patient, and the container main body2is held with fingers, the container main body2is folded at the folding guide line3, thereby the contents can be poured completely. The sterile package1′ can be used preferably for storing, for example, a gel-shaped or cream-shaped suppository.

Next, referring to the drawings, the production apparatus and production steps of the sterile package of the present invention will be described.FIG. 5is a schematic view showing one example of the production apparatus of the sterile package of the present invention.FIG. 6are schematic views illustrating one example of the steps of producing the sterile package of the present invention, using the production apparatus.

A production apparatus21stores, in a sterile box22, a nozzle unit23having a nozzle24connected to a supply pipe P1of sterile air for blow molding and a content supply pipe P2, and a pouring device insertion unit26having a pouring device magazine25. The nozzle unit23and the pouring device insertion unit26can reciprocate alternately in a horizontal direction by driving devices M1and M2, respectively.

A parison extruder29having a die head28extruding a parison27is set below the sterile box22. On an inner side surface of the die head28, there are provided an exit port34capable of discharging sterile air so that it becomes an ascending airstream from the die head side to the sterile box22so as to enhance sterility in the sterile box22, and an exit port35capable of discharging sterile air so that it becomes a descending airstream so as to stabilize the shape of the parison by pressuring the inside of the parison. Further, a mold30for integrally molding the plastic container body and the protective case of the pouring device is provided below the parison extruder. The mold30is composed of a mold31for a protective case, a mold32for a plastic container main body, and a mold33for heat sealing for heat-sealing a connecting portion, which is disposed between the mold31for a protective case and the mold32for a container main body (seeFIG. 6).

The sterile package of the present invention can be produced by the following steps (1) to (11), for example, using the production apparatus21(seeFIG. 6).

(1) The parison27is extruded to the mold30.

(2) The mold32for a plastic container main body is clamped (first mold clamping).

(3) The nozzle24is inserted into the upper portion of the parison27.

(4) The container main body is blow-molded with sterile air.

(5) The injection substance (contents) is filled in the container main body2from the nozzle24.

(6) After the nozzle24is retracted from the upper portion of the parison27, the position of a nozzle unit23in the sterile box22is exchanged with the position of a pouring device insertion unit26.

(7) The pouring device5is inserted into the upper portion of the parison27by the pouring device insertion unit26.

(8) The mold33for heat sealing is clamped, and the connecting portion4of the container main body2and the protective case6is heat-sealed.

(9) The mold31for a protective case is clamped, and the upper portion of the protective case6is heat-sealed, thereby the pouring device5is sealed in the protective case6.

(10) The protective case6is molded by vacuum molding in the mold31for a protective case.

(11) All the molds are opened, and the parisons in the lower portion of the container body2and the upper portion of the protective case6are cut to obtain an intended sterile package.

Accordingly, the sterility of the contents of the container main body2and the inside of the protective case6is kept, and in a case where the pouring device (needle unit)5storing the double-ended needle14that is a pouring part of contents in the case11as shown inFIGS. 2 and 3is used, or in a case where a pouring device5′ only composed of a cylindrical pouring part with a tip end blocked as shown inFIG. 4is used, there is no fear that the pouring part may be contaminated before being used.

FIG. 7are schematic views illustrating another example of the steps of producing the sterile package of the present invention.

(1) The parison27is extruded to the mold30.

(2) The mold32for a plastic container main body is clamped (first mold clamping).

(3), (4) The nozzle24is inserted into the upper portion of the parison27, while sterile air (Parison Control Air: hereinafter, referred to as “PCA”) at a low pressure (about 0.001 to 0.1 MPa) is blown from a nozzle tip end portion to prevent the nozzle24from coming into contact with the inner wall of the parison.

(5) The container main body is blow-molded with sterile air.

(6) The injection substance (contents) is filled in the container main body2from the nozzle24.

(7) While the PCA is blown into the parison27, after the nozzle24is retracted from the upper portion of the parison27, the position of a nozzle unit23in the sterile box22is exchanged with the position of a pouring device insertion unit26.

(8) While the PCA at a low pressure (about 0.001 to 0.1 MPa) is blown into the parison27through air holes provided on the side wall of the pouring device insertion unit26, the pouring device5is inserted into the upper portion of the parison27by the pouring device insertion unit26.

(9) While the PCA is blown into the parison27, the pouring device insertion unit26is retracted to clamp the mold33for heat sealing, thereby the connecting portion4of the container main body2and the protective portion6is heat-sealed.

(10) The mold31for a protective case is clamped, and the upper portion of the protective case6is heat-sealed, thereby the pouring device5is sealed in the protective case6.

(11) A blow pin34is pierced into the protective case6from the side surface of the protective case6, and while sterile air (about 0.1 to 0.6 MPa) is blown from the blow pin34to the protective case6, the protective case6is molded by vacuum molding in the mold31for a protective case.

(12) All the molds are opened, and the parisons in the lower portion of the container body2and the upper portion of the protective case6are cut to obtain an intended sterile package.

The above-mentioned production steps (1) to (12) corresponding toFIG. 7are obtained by modifying -the production steps (1) to (11) corresponding toFIG. 6.

In the first mold clamping step (2) and in the steps (3), (7), (8), and (9) of the insertion and retraction of the nozzle and the pouring device insertion unit, the cross-sectional shape of a parison may be deformed due to a change in an internal pressure or the like caused by the drawdown of the parison or the taking in/out of the nozzle and the pouring device insertion unit. Consequently, there arise a problem that the nozzle and the pouring device insertion unit or the pouring device come into contact with the parison inner wall, which makes it difficult to mold a sterile package. In the production steps ofFIG. 7, the nozzle and the pouring device insertion unit are inserted/retracted while the PCA is blown, thereby a sterile package can be produced with good efficiency while avoiding such a problem.

The introduction of the PCA in the production steps ofFIG. 7may be performed continuously between the above-mentioned steps (3) and (9). In this case, it is not necessary to switch the introduction and suspension of the PCA for each step, and a sterile package can be produced with good efficiency while avoiding the above-mentioned problem.

Further, in a case of molding the protective case6only by vacuum molding, the protective case6is reduced in a pressure during molding. Therefore, a resistance preventing the molding of the case is generated, which makes it difficult to mold the protective case having a precise shape.

In the above-mentioned step (11), the blow pin34is pierced into the protective case6from the side surface of the protective case6, and sterile air (about 0.1 to 0.6 MPa) is blown from the blow pin34to the protective case6, thereby the inside of the protective case6is set in a positive pressure. Thus, when the vacuum molding of the protective case6is performed, the protective case6having a precise shape can be molded without a resistance caused by a reduced pressure. A label (not shown) or the like is attached to a hole remaining after the blow pin34is pulled out. At this time, the sterility in the protective case6may be impaired. However, in the sterile packages ofFIGS. 2 and 3, by using the pouring device (needle unit)5storing the double-ended needle14that is a contents-pouring device in the case11in a sterile state, there is no fear that the pouring device5may be contaminated.

In the conventional technique, a production apparatus of a horizontal rotary system in which a number of molds are arranged successively so as to rotate or a shuttle system in which two molds reciprocate is used, the parison is extruded into the mold and the mold is clamped (corresponding to the step (2) ofFIG. 6orFIG. 7), the parison is cut, and the mold is moved, thereby the blow molding of the container main body and the filling of the contents are performed. It is practically impossible to dispose all the steps of such a production apparatus under a sterile environment, and thus, during cutting of the parison or the movement of the mold, the inside of the parison disposed in the mold may be contaminated with an outside air.

According to the present invention, a sterile package is produced without cutting a parison, using a production apparatus of a compact size with a simple configuration. This can greatly reduce the production cost with a simple management of the sterile state of the apparatus.

Further, in the sterile package of the present invention, the container main body2and the protective case6of the pouring device5are formed integrally. Therefore, the opening of the package caused by an external force during production or distribution, and the mischief and unauthorized opening of a package can be prevented.

In the present invention, there is no particular limitation on a material constituting the plastic container main body2and the protective case6formed integrally therewith, and any of the thermoplastic resin used for constituting a plastic container can be generally used. Examples of such a material include polyolefins such as low, middle, or high-density polyethylene, polypropylene, an ethylene-propylene copolymer, an ethylene-vinyl acetate copolymer (EVA), a saponified EVA, an ethylene-ethyl acrylate copolymer (EEA), an ion cross-linked olefin copolymer (ionomer); an aromatic vinyl copolymer such as polystyrene, a styrene-butadiene copolymer; a vinyl halide polymer such as polyvinyl chloride and vinylidene chloride resin; polyacrylic resin; a nitrite copolymer such as an acrylonitrile-styrene copolymer and an acrylonitrile-styrene-butadiene copolymer; polyamides such as nylon 6, nylon 66, and para or methaxylyleneadipamide; polyesters such as polyethylene terephtharate, polytrimethylene terephthalate, polybutylene terephtharate, and polyethylene naphtharate; various kinds of polycarbonates; fluorine resin; polyacetals such as polyoxymethylene; biodegrative reins such as polybutylene succinate, polyethylenesuccinate, polyhydroxybutyrate, polycaprolactone, and polylactic acid.

Examples of the preferable thermoplastic resin include polyolefin resin, in particular, polypropylene resin such as polypropylene, an ethylene-propylene copolymer.

The plastic container main body and the protective case of the present invention can have a single-layer configuration composed of one kind of resin layer or a multi-layered configuration composed of a plurality of resin layers.

In a case where the contents stored in the container main body require a gas barrier property as in medical drugs, it is preferable to produce a container with a multi-layered configuration including a gas barrier resin layer made of polyvinylidene chloride, a saponified EVA, polyamide resin, or a cyclic olefin copolymer, as an intermediate layer. Further, in a case where a much higher gas barrier property is required, a container with a multi-layered configuration including an oxygen absorbing resin layer containing an oxidizable polymer or the like can he used. Such a container with a multi-layered configuration can be produced using a multi-layered parison obtained using a die for multi-layer blowing by a conventional method in the steps shown inFIG. 6orFIG. 7.