CN101115458B - 无菌填充包装体、其制造方法以及制造装置 - Google Patents
无菌填充包装体、其制造方法以及制造装置 Download PDFInfo
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Abstract
本发明的目的在于,提供改进内容物流出器件(5、5’)的保护性、内容物的流出性以及显窃启性,将内容物的流出器件(5、5’)收纳为一体的无菌填充包装体(1、1’)。本发明通过采用以下工序,可高效制造无菌填充包装体(1、1’)(1)在塑料容器主体用金属模(32)中配置型坯(27);(2)从插入到型坯(27)内的喷嘴(24)吹出无菌空气,进行容器主体的吹塑成型;然后,(3)从该喷嘴(24)向容器主体(2)内填充内容物后,使该喷嘴(24)退出;接着,(4)把内容物的流出器件(5、5’)插入到容器主体(2)的上部型坯之中;然后,(5)对保护壳用金属模(31)合模;(6)用所述容器主体(2)上部的型坯形成保护壳(6)。
Description
技术领域
本发明涉及将内容物的流出器件收纳为一体的无菌填充包装体、其制造方法以及制造装置。
背景技术
以往已知一种带有流出器件的塑料容器,其把一次性使用完毕的小容量医药、医药部外品等内容物收纳在容器内,在容器口部安装流出内容物的注射针等流出器件(参照专利文献1~2)。
另外制造这种带流出器件的塑料容器时,从卫生管理观点考虑,通常在成型容器的同时填充内容物,这一点也是众所周知的(参照专利文献3)。
专利文献1:实公昭35-24295号公报
专利文献2:特公昭61-2380号公报
专利文献3:特开2002-128126号公报
但是这些带有流出器件的容器,存在以下问题,即在制造时和流通时由于坠落撞击等外力作用容器会开封、缺少为防止由于胡乱或不正确而引起开封的显窃启性等。
因此填充内容物的带有流出器件的塑料容器,通过使用包装箱、包装袋等铠装材料,或者使用胶带或收缩标签等其它构件以达到保护流出器件的目的,与此同时还进行了获得显窃启性的研究。但是使用铠装材料和其它构件的方法,必需进行另外的加工工序,造成提高成本。
并且为了一次全部将容器中收纳的内容物用完,必需通过用手指挤压容器主体,才可能将内容物全部流出。但是对于圆筒形等容器,其容器底部会碍事,很难将内容物全部流出。
因此现有的带有流出器件的容器,通过采用没有底部的容器来提高内容物的流出性,并不能使容器具有独立性。
发明内容
发明所要解决的技术问题
因此本发明的目的在于,提供流出器件的保护性、内容物的流出性及以显窃启性得到改进的、将流出器件收纳为一体的无菌填充包装体。本发明的目的还在于,提供可以连续进行填充内容物的塑料容器主体的成型和内容物的无菌填充、与容器主体一体化的保护壳的成型以及将流出器件收纳到保护壳内的所述无菌填充包装体的制造方法及其制造装置。
解决技术问题的方法
为了解决上述技术问题,本发明采用下述1~13的结构。
1.无菌填充包装体,其特征是向形成折叠引导线的塑料容器主体内无菌填充内容物,与此同时,把流出器件收纳到与所述容器主体一体化成型的保护壳内。
2.根据第1项中所述的无菌填充包装体,其中,把所述流出器件无菌收纳到所述保护壳内。
3.根据第1项中所述的无菌填充包装体,其中,在所述保护壳内收纳流出器件,该流出器件是将流出构件无菌收纳在壳内构成的。
4.根据第1~3任意一项中所述的无菌填充包装体,其中,在所述流出器件的下端部设置止回构件。
5.无菌填充包装体的制造方法,其特征是采用以下工序:
(1)在塑料容器主体用金属模中配置型坯;
(2)从插入到型坯内的喷嘴吹出无菌空气,进行容器主体的吹塑成型;然后,
(3)从该喷嘴向容器主体内填充内容物后使该喷嘴退出;接着,
(4)把流出器件插入容器主体上部的型坯之中;然后,
(5)对保护壳用的金属模合模;
(6)由所述容器主体上部的型坯形成保护壳。
6.根据第5项中所述的无菌填充包装体的制造方法,其中,至少在所述工序(2)和(3)中一边从喷嘴向型坯内导入无菌空气,一边进行喷嘴的插入、退出,以使喷嘴与型坯的内壁不接触。从喷嘴导入的无菌空气的压力优选为0.001~0.1MPa左右。
7.根据第5或第6项中所述的无菌填充包装体的制造方法,其中,至少在所述工序(4)中一边从在所述流出器件插入单元上设置的连通孔向型坯内导入无菌空气,一边进行所述流出器件插入单元的插入、退出,以使流出器件插入单元以及流出器件与型坯的内壁不接触。从在所述流出器件插入单元上设置的连通孔导入的无菌空气的压力优选为0.001~0.1MPa左右。
8.根据第5~7任意一项中所述的无菌填充包装体的制造方法,其中,在所述工序(5)中预先对流出器件的下部和塑料容器主体上部之间的型坯进行热封。
9.根据第5~8任意一项中所述的无菌填充包装体的制造方法,其中,在所述工序(6)中通过真空成型形成保护壳。
10.根据第9项中所述的无菌填充包装体的制造方法,其中,在所述工序(6)中从保护壳的侧面向所述壳内刺入吹气针,从吹气针向所述壳内导入无菌空气,并同时进行真空成型。从所述吹气针导入的无菌空气的压力优选为0.1~0.6MPa左右。
11.根据第5~10任意一项中所述的无菌填充包装体的制造方法,其中,所述型坯是含有阻气性树脂层的多层型坯。
12.无菌填充包装体的制造装置,其特征是在无菌箱内具备供给吹塑成型用的无菌空气和填充内容物的两用喷嘴单元和插入流出器件用的单元,并且使与所述无菌箱下方相连的型坯挤塑模、保护壳用金属模、塑料容器主体用金属模按顺序依次排列。
13.根据第12中所述的无菌填充包装体的制造装置,其中,在所述保护壳用金属模和所述塑料容器主体用金属模之间设置热封用金属模。
发明的效果
本发明通过采用上述结构,发挥以下的明显效果。
(1)本发明的无菌填充包装体,其流出器件的保护性和显窃启性优异,在包装体的制造时或流通时,可以防止由外力引起的包装体开封以及由胡乱或不正确操作而引起的包装体开封。
(2)本发明的无菌填充包装体,通过在容器主体上形成折叠引导线,可以很容易将内容物全部流出。
(3)本发明的无菌填充包装体中通过在流出器件的下端部设置止回构件,可以防止流出时内容物的倒流。另外,可以在容器使用后防止吸取兴奋剂等危险品的其它内容物,防止滥用包装体。
(4)本发明无菌填充包装体的制造方法,由于可以连续进行填充内容物的塑料容器主体成型、内容物的无菌填充、与容器一体化的保护壳的成型以及向保护壳内收纳流出器件,因此可以高效并且低成本制造无菌填充包装体。
(5)本发明无菌填充包装体的制造装置,可以实现结构简单、尺寸紧凑,便于对装置的无菌状态进行管理,可以大幅度降低制造成本。
附图说明
[图1]是表示本发明无菌填充包装体(一次性注射剂包装体)一例的图示。
[图2]是表示图1无菌填充包装体的流出器件(针头单元)的放大剖面图。
[图3]是表示本发明无菌填充包装体(一次性注射剂包装体)另一例中流出器件(针头单元)的放大剖面图。
[图4]是表示本发明无菌填充包装体另一例的图示。
[图5]是表示图1的无菌填充包装体制造装置一例的模式图。
[图6]是对使用图5的制造装置制造无菌填充包装体工序一例进行说明的图示。
[图7]是对本发明制造无菌填充包装体工序的另一例进行说明的图示。
符号说明
1、1’无菌填充包装体
2 塑料容器主体
3 折叠引导线
4、15 连接部
5 流出器件(针头单元)
5’ 流出器件(流出构件)
6 保护壳
7 标签
8 薄壁部
9 前端部
11 壳
12 挡块
13 毂
14 两头针(流出构件)
16 栓体
17 止回阀
21 无菌填充包装体的制造装置
22 无菌箱
23 喷嘴单元
24 喷嘴
25 流出器件仓
26 流出器件插入单元
27 型坯
28 模头
29 型坯挤塑机
30 金属模
31 保护壳用金属模
32 容器主体用金属模
33 热封用金属模
34 吹气针
M1、M2驱动装置
P1 无菌空气供给管
P2 内容物供给管
具体实施方案
以下根据附图对在一次性注射剂包装体中使用本发明的例子进行说明,但是以下的具体例子不能对本发明进行限定。
图1和图2是表示本发明无菌填充包装体(一次性注射剂包装体)一例的图示。图1(A)是包装体的主视图,向图中的(B)是一部分的剖面侧视图,同图中的(C)是表示该包装体的流出器件保护壳开封状态的图示。图2是表示该包装体流出器件(针头单元)的放大剖面图。图2(D)是表示使用前流出器件(针头单元)状态的图示。同图的(E)是构成流出器件的流出构件注射针与容器主体连通状态的图示。
该注射剂包装体1是介由连接部4使设置折叠引导线3的容器主体2和保护壳6形成一体的包装体,保护壳6中收纳有包括流出内容物的流出构件的两头针14等和壳11的流出器件(针头单元)5。在对容器主体2进行成型时,在容器主体2内无菌填充注射剂。另外在保护壳6的上部设置表示所填充注射剂的标签。
如图2所看到的该流出器件5,在设置挡块12的壳11内介由含有橡胶等弹性体的毂对两头针14进行固定。在流出器件5与容器主体2的连接部15下端设置含有橡胶等弹性体的栓体16。该流出器件5,其流出内容物的两头针14以无菌状态保持在壳11内。
使用该注射剂包装体1时,如图1(C)中所看到的首先用手指拧断保护壳6开封,接着把流出器件5的壳11按下到图2(E)的位置,则固定在毂13上的流出构件的两头针14的一端穿透栓体16,与容器主体2连通。接着除去壳11,用两头针的另一端刺入患者的静脉等,用手指挤压容器主体2,容器主体2通过折叠引导线而折叠,可以将注射剂完全流出。
该注射剂包装体1,可以在使两头针14与容器主体2连通的状态下保持独立。因此在对包装体的保护壳6开封后至对患者使用前,不会产生污染,可以暂时使包装体在保存壳等中保持独立而放置。
图3是表示另一例本发明无菌填充包装体的图示,对包装体保护壳6开封的流出器件(针头单元)5的放大剖面图。图3中的(A)表示使用前流出器件5状态的图示,同图中的(B)表示向容器主体中压入流出器件构件的两头针14,使两头针14可以与容器主体2连通状态的图示。并且同图中的(C)是表示压入两头针14后除去流出器件5的壳11,可以流出容器主体内注射剂状态的图示。
本实施例的无菌填充包装体1,在流出器件5与塑料容器主体2的连接部15上设置栓体16,在该栓体16的下端部,也就是在流出器件5的下端部设置止回阀17等止回构件。
通过设置该止回阀17,可以介由两头针将内容物从塑料容器主体2流出到容器主体以外,而又可以防止流出到外部的内容物和其它药剂介由两头针14向所述容器主体2内倒流。
通过在流出器件5的下端部设置该止回构件17,可以防止在本发明的无菌填充体使用之后向容器内吸入兴奋剂等危险品的其它内容物,可以防止滥用容器。
图4是表示另一例本发明无菌填充包装体的图示,图4中的(A)表示包装体的主视图,同图中的(B)表示部分剖面侧视图,并且同图中的(C)是表示对该包装体流出器件保护壳开封状态的图示。
在该例中使用只含有前端部被封闭的圆筒状流出构件的流出器件5’替代在图1的无菌填充包装体中含有流出构件两头针14等和壳11的流出器件(针头单元)5。该流出器件5’省去了针头单元5中的壳11,与容器主体2内连通,在其前端部9设置了为开封前端部9的环状薄壁部8。使用该包装体1’时,如图4(C)中所看到的首先用手指拧断保护壳6开封,接着折去薄壁部8以对前端部9开封。接着把流出器件5’用于患者的患部等,用手指挤压容器主体2,容器主体2通过折叠引导线3折叠,可以把内容物完全流出。该无菌填充包装体1’例如优选用于对凝胶状或膏状的栓剂等进行收纳。
下面根据附图对本发明无菌填充包装体的制造装置以及制造工序进行说明。图5是表示本发明无菌填充包装体制造装置一例的模式图。另外,图6是对利用该制造装置制造本发明无菌填充包装体工序一例进行说明的模式图。
这种制造装置21在无菌箱22内收纳喷嘴单元23、及具备流出器件仓25的流出器件插入单元26,所述喷嘴单元具备与吹塑成型用无菌空气供给管P1和内容物供给管P2连接的喷嘴24。喷嘴单元23以及流出器件插入单元26,可以分别通过驱动装置M1以及M2在水平方向上交替进行往复运动。
在无菌箱22的下方设置具备挤出型坯27的模头28的型坯挤塑机29。模头28的内侧侧面设置为了提高无菌箱22内的无菌性、可以吹出无菌空气以使从模头侧向无菌箱22中形成上升气流的气嘴34,和为了对型坯的内部加压以保持型坯形状稳定、可以吹出无菌空气以形成下降气流的气嘴35。在其下方还设置使塑料容主体与流出器件保护壳成型为一体的金属模30。该金属模30设置在保扩壳用金属模31、塑料容器主体用金属模32以及保护壳用金属模31和容器主体用金属模32之间,由对连接部进行热封的热封用金属模33构成(参照图6)。
本发明的无菌填充包装体,例如可以使用该制造装置21,按照以下工序(1)~(11)制造(参照图6)。
(1)在金属模30内挤出型坯27。
(2)对塑料容器主体用金属模32合模。(第1合模)
(3)向型坯27的上部插入喷嘴24。
(4)通过无菌空气对容器主体进行吹塑成型。
(5)通过喷嘴24向容器主体2内填充注射剂(内容物)。
(6)使喷嘴24从型坯27的上部退出之后,使无菌箱22内的喷嘴单元23和流出器件插入单元26进行位置调换。
(7)通过流出器件插入单元26向型坯27的上部插入流出器件5。
(8)对热封金属模33进行合模,对容器主体2和保护壳6的连接部4进行热封。
(9)对保护壳用金属模31进行合模,对保护壳6的上部进行热封,把流出器件5密封在保护壳6内。
(10)在保护壳用金属模31内,通过真空成型,成型保护壳6。
(11)打开所有金属模,裁切容器主体2下部和保护壳6上部的型坯,即得到所需的无菌填充包装体。
因此,容器主体2内的内容物和保护壳6内的无菌性得以保持,当使用如图2和图3所示的在壳11内收纳内容物流出构件的两头针14的流出器件(针头单元)5时,或者是使用如图4所示的只含有封闭前端的圆筒状流出构件的流出器件5’时,在以上两种的任意一种情况下,都不必担心在使用前流出构件被污染。
图7是说明制造本发明无菌填充包装体工序另一例的模式图。
(1)在金属模30内挤出型坯。
(2)对塑料容器主体用金属模32合模(第1金属模合模)。
(3)、(4)从喷嘴前端部向型坯内导入低压(0.001~0.1MPa左右)无菌空气(Parison Control Air:以下称为“PCA”),同时将喷嘴24插入型坯27的上部,并且使喷嘴24与型坯的内壁不接触。
(5)通过无菌空气对容器主体进行吹塑成型。
(6)通过喷嘴24向容器主体2内填充注射剂(内容物)。
(7)向型坯27内导入PCA,同时使喷嘴24从型坯27的上部退出,然后对无菌箱22内的喷嘴单元23和流出器件的插入单元26进行位置调换。
(8)从设置在流出器件插入单元26侧壁上的连通孔向型坯27内导入低压(0.001~0.1MPa左右)的PCA,并同时通过流出器件插入单元26向型坯27的上部插入流出器件5。
(9)向型坯27内导入PCA,同时使流出器件插入单元26退出,对热封金属模33合模,对容器主体2和保护壳6的连接部4进行热封。
(10)对保护壳用金属模31合模,对保护壳6的上部进行热封,把流出器件5密封在保护壳6内。
(11)从保护壳6的侧面向保护壳6内刺入吹气针34,从吹气针34向保护壳6内导入无菌空气(0.1~0.6MPa左右),同时在保护壳用金属模31内通过真空成型成型保护壳6。
(12)打开所有金属模,裁切容器主体2下部和保护壳6上部的型坯,即得到所需的无菌填充注射剂包装体。
上述图7的制造工序(1)~(12)是对图6的制造工序(1)~(11)进行改进的工序。
上述(2)中的第1合模工序和进行喷嘴与流出器件插入单元插入和退出的(3)、(7)、(8)、(9)工序中,由于型坯的延伸或喷嘴以及流出器件插入单元进出引起的压力变化等,形坯的剖面形状会发生变形。结果喷嘴和流出器件插入单元或流出器件与型坯的内壁接触,存在难以成型无菌填充包装体的问题。在图7的制造工序中一边导入PCA,一边进行喷嘴和流出器件插入单元的插入、退出,通过这种方法可以避免上述问题,高效制造无菌填充包装体。
图7制造工序中的PCA导入,可以在上述(3)~(9)的工序之间连续进行。这时没有必要进行每道工序PCA的导入、停止转换,可以避免上述问题,更高效制造无菌填充包装体。
另外只通过真空成型来成型保护壳6时,由于成型时保护壳6内变成减压,所以会产生妨碍壳成型的阻力,难以成型具有精密形状的保护壳。
上述(11)工序,从保护壳6的侧面向保护壳6内刺入吹气针34,从吹气针34向保护壳内导入无菌空气(0.1~0.6MPa左右),使保护壳6内形成正压。因此进行保护壳6的真空成型时不会产生由减压而引起的阻力,可以成型具有精密形状的保护壳6。在拔出吹气针34后的孔处粘贴标签(图中没有示出)等。这时就不会损坏保护壳6内的无菌性。图2和图3的无菌填充包装体中由于使用在无菌状态的壳11内收纳内容物流出构件两头针14的流出器件(针头单元)5,所以不必担心在使用前流出器件5被污染。
在现有技术中使用将多个金属模配置成可以依次旋转的水平旋转式或两个金属模往复运动的梭式制造装置,在金属模内挤出型坯合模后[对应于上述图6或图7的工序(2)]裁切型坯,移动金属模,进行容器主体的吹塑成型和内容物的填充。这样的制造装置,实际上不可能将所有工序置于无菌的环境下,在裁切型坯时或者在移动金属模时,由于外部空气的原因,配置在金属模内的型坯内部有可能受到污染。
本发明采用结构简单、尺寸紧凑的制造装置,无需裁切型坯,就可以制造无菌填充包装体,所以很容易管理装置的无菌状态,并且可以大幅度降低制造成本。
本发明的无菌填充包装体,由于容器主体2和流出器件5的保护壳6形成一体,所以在制造时以及在流通时可以防止由于外力作用而引起包装体开封以及由于胡乱或不正确操作而引起的包装体开封。
另外,本发明中作为构成塑料容器主体2以及与其形成一体的保护壳6的材料,没有特别限制,只要是一般构成塑料容器所使用的热塑性树脂,可以使用任意材料。作为这样的材料,例如可以列举低、中或高密度聚乙烯、聚丙烯、乙烯-丙烯共聚物、乙烯-醋酸乙烯酯共聚物(EVA)、EVA皂化物、乙烯-丙烯酸乙酯共聚物(EEA)、离子交联烯烃共聚物(离聚物)等聚烯烃类;聚苯乙烯、苯乙烯-丁二烯共聚物等芳香族乙烯基共聚物;聚氯乙烯、偏氯乙烯树脂等卤代乙烯基聚合物;聚丙烯酸系树脂;丙烯腈-苯乙烯共聚物、丙烯腈-苯乙烯-丁二烯共聚物等腈聚合物;尼龙6、尼龙66、己二酰对苯撑二甲胺或间苯撑二甲胺等聚酰胺类;聚对苯二甲酸乙二醇酯、聚对苯二甲酸亚丙基酯、聚对苯二甲酸丁二醇酯、聚萘二甲酸乙二醇酯等聚酯类;各种聚碳酸酯、氟系树脂、聚甲醛等聚缩醛类;聚琥珀酸丁二醇酯、聚琥珀酸乙二醇酯、聚羟基丁酸酯、聚己内酯、聚乳酸等生物分解性树脂类等。
作为优选的热塑性树脂,可以列举聚烯烃系树脂,特别是聚丙烯、乙烯-丙烯共聚物等聚丙烯系树脂。
本发明的塑料容器主体和保护壳可以具有含1种树脂层的单层结构或含有多层树脂层的多层结构。
当收纳在容器主体内的内容物是医药品等要求阻气性物质时,优选使容器成为含有聚偏氯乙烯树脂、EVA皂化物、聚酰胺树脂或环状烯烃共聚物等阻气性树脂层作为中间层的多层结构容器。另外,当要求更高的阻气性时,还可以使容器成为同时使用含氧化性聚合物等氧吸收性树脂层的多层结构的容器。这样的多层结构容器,可以通过常规方法使用多层吹塑用模得到多层型坯,通过上述图6或图7所示的工序制造。
Claims (1)
1.无菌填充包装体,其特征是向形成折叠引导线的塑料容器主体内无菌填充内容物,与此同时,把针头单元无菌地收纳到与所述容器主体一体化成型的保护壳内,其特征在于,
上述针头单元具有:
无菌地收纳在针头单元壳内的两头针,
将针头单元壳向着容器主体压入时,通过被两头针的一端穿透而与容器主体连通的栓体、以及
设置在针头单元的容器主体侧的端部的止回部件。
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JP031296/2005 | 2005-02-08 | ||
PCT/JP2006/301872 WO2006085490A1 (ja) | 2005-02-08 | 2006-02-03 | 無菌充填包装体、その製造方法、及び製造装置 |
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EP (1) | EP1847242B1 (zh) |
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KR (1) | KR20070107716A (zh) |
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-
2006
- 2006-02-03 KR KR1020077019345A patent/KR20070107716A/ko not_active Application Discontinuation
- 2006-02-03 EP EP06713015.3A patent/EP1847242B1/en not_active Expired - Fee Related
- 2006-02-03 WO PCT/JP2006/301872 patent/WO2006085490A1/ja active Application Filing
- 2006-02-03 JP JP2007502587A patent/JP4962313B2/ja not_active Expired - Fee Related
- 2006-02-03 US US11/815,751 patent/US7883660B2/en not_active Expired - Fee Related
- 2006-02-03 CN CN2006800043689A patent/CN101115458B/zh not_active Expired - Fee Related
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US20090200191A1 (en) | 2009-08-13 |
EP1847242A1 (en) | 2007-10-24 |
JPWO2006085490A1 (ja) | 2008-06-26 |
KR20070107716A (ko) | 2007-11-07 |
EP1847242A4 (en) | 2013-04-03 |
JP4962313B2 (ja) | 2012-06-27 |
CN101115458A (zh) | 2008-01-30 |
EP1847242B1 (en) | 2015-06-17 |
JP5292603B2 (ja) | 2013-09-18 |
US7883660B2 (en) | 2011-02-08 |
JP2012071606A (ja) | 2012-04-12 |
WO2006085490A1 (ja) | 2006-08-17 |
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