JPH11319032A - Manufacture of bag for pharmaceutical solution, and filling of drug liquid - Google Patents
Manufacture of bag for pharmaceutical solution, and filling of drug liquidInfo
- Publication number
- JPH11319032A JPH11319032A JP10153902A JP15390298A JPH11319032A JP H11319032 A JPH11319032 A JP H11319032A JP 10153902 A JP10153902 A JP 10153902A JP 15390298 A JP15390298 A JP 15390298A JP H11319032 A JPH11319032 A JP H11319032A
- Authority
- JP
- Japan
- Prior art keywords
- filling
- bag
- filling port
- chemical solution
- manufactured
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000011049 filling Methods 0.000 title claims abstract description 65
- 239000003814 drug Substances 0.000 title claims abstract description 13
- 239000007788 liquid Substances 0.000 title claims abstract description 10
- 229940079593 drug Drugs 0.000 title claims abstract description 9
- 238000004519 manufacturing process Methods 0.000 title claims description 14
- 239000003186 pharmaceutical solution Substances 0.000 title abstract 4
- 238000000034 method Methods 0.000 claims abstract description 19
- 238000007789 sealing Methods 0.000 claims abstract description 10
- 239000000126 substance Substances 0.000 claims description 38
- 238000000465 moulding Methods 0.000 claims description 6
- 239000000243 solution Substances 0.000 abstract description 40
- 239000007789 gas Substances 0.000 abstract description 6
- 238000004659 sterilization and disinfection Methods 0.000 abstract description 5
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 abstract description 2
- MYMOFIZGZYHOMD-UHFFFAOYSA-N Dioxygen Chemical compound O=O MYMOFIZGZYHOMD-UHFFFAOYSA-N 0.000 abstract description 2
- 244000052616 bacterial pathogen Species 0.000 abstract description 2
- 229910001873 dinitrogen Inorganic materials 0.000 abstract description 2
- 229910001882 dioxygen Inorganic materials 0.000 abstract description 2
- 239000000428 dust Substances 0.000 abstract description 2
- 239000012467 final product Substances 0.000 abstract description 2
- 238000001125 extrusion Methods 0.000 abstract 2
- 238000005429 filling process Methods 0.000 abstract 1
- 239000000463 material Substances 0.000 abstract 1
- 230000001954 sterilising effect Effects 0.000 description 4
- 238000010586 diagram Methods 0.000 description 3
- -1 polypropylene Polymers 0.000 description 2
- 239000003566 sealing material Substances 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 239000004677 Nylon Substances 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 239000010410 layer Substances 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- 229920000728 polyester Polymers 0.000 description 1
- 229920001225 polyester resin Polymers 0.000 description 1
- 239000004645 polyester resin Substances 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920005672 polyolefin resin Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 239000002356 single layer Substances 0.000 description 1
- 239000008174 sterile solution Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は、薬液用袋の製造方法及
び薬液の充填方法に関するものであり、より詳しくは、
無菌ガスによりインフレーション成形したフィルムチュ
ーブを用いた薬液用袋の製造方法に関し、また、上記袋
を用いた薬液の充填方法に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for manufacturing a chemical solution bag and a method for filling a chemical solution.
The present invention relates to a method for manufacturing a chemical solution bag using a film tube inflation-molded with aseptic gas, and to a method for filling a chemical solution using the bag.
【０００２】[0002]
【従来技術】従来、ポリプロピレン、ポリエチレンとい
ったポリオレフィン系樹脂、共重合ポリエステル等のポ
リエステル系樹脂、ナイロン系樹脂を、単層あるいは多
層でインフレーション成形してフィルムチューブとし、
上記フィルムチューブをシールして袋とした薬液用容器
が広く使用されている。2. Description of the Related Art Conventionally, a single-layer or multi-layer inflation molding of a polyolefin resin such as polypropylene or polyethylene, a polyester resin such as copolymerized polyester, or a nylon resin into a film tube,
A chemical solution container in which the above-mentioned film tube is sealed as a bag is widely used.
【０００３】そして、従来の薬液用袋の製造、薬液の充
填は、インフレーション成形したフィルムチューブを、
栓体、あるいは、栓体とは別の充填口部材を取り付ける
部分を避けてシールして製袋した後、上記栓体、充填口
部材を取り付け、次いで、上記栓体、充填口部材の充填
口から充填し、ゴム栓、あるいは、適宜手段により密封
する工程を、無菌状態下で一貫して行うインライン方式
が採用されている。[0003] Conventionally, the production of a chemical solution bag and the filling of the chemical solution are performed by using an inflation-molded film tube.
The plug, or, after sealing and avoiding a portion to which a filling port member different from the plug is attached, forming the bag, attaching the plug, the filling port member, and then filling the plug, the filling port of the filling port member , And the process of sealing with a rubber stopper or an appropriate means is performed under an aseptic condition.
【０００４】一方、インフレーション成形したフィルム
チューブを、栓体、あるいは、栓体とは別の充填口部材
を取り付ける部分を避けてシールして製袋した後、上記
栓体、充填口部材を取り付け、充填前に、除菌、滅菌、
あるいは、水洗いを行った後に、上記栓体、充填口部材
の充填口から充填し、ゴム栓、あるいは、適宜手段によ
り密封するアウトライン方式も採用されている。On the other hand, after the inflation-molded film tube is sealed and sealed to avoid a plug or a portion where a filling port member different from the plug is attached, the above-mentioned plug and filling port member are attached. Before filling, sterilization, sterilization,
Alternatively, an outline method is also adopted in which after being washed with water, the plug is filled from the filling port of the filling port member, and sealed with a rubber stopper or a suitable means.
【０００５】[0005]
【発明が解決しようとする課題】従来のインライン方式
によれば、栓体、製袋、充填口部材の取り付け、充填、
密封まで、一貫して無菌状態下で行うことから上記無菌
状態の確保が容易でなく、ライン全体としての生産効率
が悪いといった問題がある。According to the conventional in-line method, a plug, a bag-making method, a mounting of a filling port member, filling,
There is a problem that the aseptic condition is not easily ensured since the sealing is performed under aseptic conditions consistently, and the production efficiency of the entire line is poor.
【０００６】また、従来のアウトライン方式によれば、
薬液用袋の充填前の除菌、滅菌、あるいは、水洗いの処
理が必要になるといった問題がある。According to the conventional outline method,
There is a problem that sterilization, sterilization, or washing with water is required before filling the chemical solution bag.
【０００７】また、上記したいずれの方式においても、
充填、密封前に栓体、充填口部材が袋に取り付けられる
ため嵩張り、上記充填前、密封前の袋の搬送がしずら
く、取り扱いにくいといった問題がある。Further, in any of the above methods,
Since the plug and the filling port member are attached to the bag before filling and sealing, there is a problem that the bag before filling and sealing is difficult to transport and difficult to handle.
【０００８】さらに、上記栓体、あるいは、別の充填口
部材は、いずれも充填口が形成されているが、その径が
小さいため、充填時の液こぼれの発生、充填効率が悪い
といった問題がある。[0008] Further, although the above-mentioned plug or another filling port member is formed with a filling port, the diameter thereof is small, so that there is a problem that liquid spills at the time of filling and the filling efficiency is poor. is there.
【０００９】さらに、栓体とは別の他の充填口部材を採
用すると、その取付工程が必要となり、部品数も増加す
るため、コスト高になるといった問題がある。Further, if another filling port member other than the plug is employed, a mounting step is required, and the number of parts increases, resulting in a problem that the cost increases.
【００１０】[0010]
【課題を解決するための手段】本発明によれば、袋への
薬液の充填、密封前に、埃、ゴミ、雑菌等の上記袋内へ
の侵入を防止して無菌状態を保ち、充填前の工程におい
ては嵩張らず、充填時には充填し易い充填口とするた
め、無菌ガスを用いたインフレーション成形でフィルム
チューブを製造し、上記フィルムチューブを四方シール
し、先端部に凸出部を形成する薬液用袋の製造方法が提
供される。According to the present invention, before the bag is filled with a chemical solution and sealed, dust, dirt, germs and the like are prevented from entering the bag to maintain an aseptic state. In order to make a filling port that is not bulky and easy to fill at the time of filling, a film tube is manufactured by inflation molding using aseptic gas, the film tube is sealed four-sided, and a chemical solution that forms a protruding portion at the tip end A method for manufacturing a bag is provided.
【００１１】また、本発明によれば、無菌ガスを用いた
インフレーション成形でフィルムチューブを製造し、上
記フィルムチューブを四方シールして、先端部に凸出部
を有する袋を製造し、薬液の充填前に上記凸出部を切断
開放して充填口とし、次いで、薬液を充填した後に、上
記充填口を栓体で密封する薬液の充填方法が提供され
る。Further, according to the present invention, a film tube is manufactured by inflation molding using a sterile gas, the film tube is sealed on all sides, a bag having a protruding portion at the tip is manufactured, and a chemical solution is filled. A method for filling a chemical solution is provided in which the protruding portion is cut and opened before to form a filling port, and then, after filling with a chemical solution, the filling port is sealed with a stopper.
【００１２】[0012]
【発明の実施の形態】図１は薬液充填前の薬液用袋の参
考図、図２は薬液充填直前の薬液用袋の参考図、図３は
薬液充填、密封後の薬液充填袋の参考図で、１はシール
部、２は収納部、３は凸出部、４は充填口、５は栓体、
６はシール材、７は懸垂孔である。DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 is a reference diagram of a chemical solution bag before filling with a chemical solution, FIG. 2 is a reference diagram of a chemical solution bag immediately before filling with a chemical solution, and FIG. 3 is a reference diagram of a chemical solution filling bag after filling with a chemical solution and sealing. 1 is a seal part, 2 is a storage part, 3 is a protruding part, 4 is a filling port, 5 is a plug,
6 is a sealing material, 7 is a suspension hole.
【００１３】先ず、本発明の薬液用袋の製造方法におい
ては、図示しないが、除菌あるいは滅菌処理した空気、
窒素ガス、酸素ガス等の無菌ガスを用いてインフレーシ
ョン成形してフィルムチューブを製造する。First, in the method for manufacturing a chemical solution bag according to the present invention, although not shown, air that has been sterilized or sterilized is used.
A film tube is manufactured by inflation molding using a sterile gas such as nitrogen gas or oxygen gas.
【００１４】上記フィルムチューブを製造した後に、図
１に示すシール部１で四方全体をシールした収納部２、
大径の凸出部３を有する無菌状態の薬液用袋Ａを製造
し、後工程の充填工程に無菌状態を保ったまま供給す
る。After manufacturing the above-mentioned film tube, a storage part 2 in which all sides are sealed with a seal part 1 shown in FIG.
An aseptic drug solution bag A having a large-diameter projecting portion 3 is manufactured and supplied while maintaining the aseptic state to a subsequent filling step.
【００１５】そして、図２に示すように、薬液の充填直
前に、無菌状態の上記薬液用袋Ａの凸出部３を切断開放
し、上部に大径の充填口４を有する薬液用袋Ｂとし、上
記充填口４から無菌状態の上記薬液用袋Ｂの収納部２に
薬液を充填する。As shown in FIG. 2, immediately before filling with the drug solution, the projecting portion 3 of the sterile drug solution bag A is cut open, and a drug solution bag B having a large-diameter filling port 4 at the top. Then, a chemical solution is filled from the filling port 4 into the storage section 2 of the sterile solution bag B.
【００１６】次いで、薬液を充填後、図３に示すよう
に、上記薬液用袋Ｂの充填口４を、ゴム栓等を内装した
栓体５及びシール材６で密封し、無菌状態で薬液を充填
した薬液充填袋Ｃとし、加熱による殺菌、あるいは、滅
菌処理を行い最終製品とする。Next, after filling the liquid medicine, as shown in FIG. 3, the filling port 4 of the liquid medicine bag B is sealed with a plug body 5 having a rubber stopper or the like and a sealing material 6, and the liquid medicine is sterilized. The filled chemical solution bag C is sterilized by heating or sterilized to obtain a final product.
【００１７】[0017]
【発明の効果】本発明の薬液用袋の製造方法によれば、
薬液用袋の製造、薬液の充填前において、上記薬液用袋
を容易に無菌状態とすることが可能になり、生産効率が
向上する。According to the method for producing a chemical solution bag of the present invention,
Before manufacturing the chemical solution bag and before filling the chemical solution, the chemical solution bag can be easily made into a sterile state, and the production efficiency is improved.
【００１８】また、本発明の薬液用袋の製造方法によれ
ば、充填、密封前に栓体、あるいは、充填口部材を上記
薬液用袋に取り付けないため、充填前の搬送、供給持の
嵩張りが無くなり、その取り扱いが容易になる。According to the method for manufacturing a chemical solution bag of the present invention, the plug or the filling port member is not attached to the chemical solution bag before filling and sealing. The tension is eliminated, and the handling becomes easy.
【００１９】さらに、本発明の薬液の充填方法によれ
ば、充填前に、薬液用袋に比較的大径の充填口が形成さ
れるため、充填時の液こぼれが防止されると共に、充填
効率が向上する。Furthermore, according to the method of filling a chemical solution of the present invention, a filling port having a relatively large diameter is formed in the chemical solution bag before filling, so that liquid spillage at the time of filling is prevented and the filling efficiency is improved. Is improved.
【００２０】さらに、本発目の薬液の充填方法によれ
ば、栓体とは別の他の充填口部材を採用する必要がな
く、その取付工程が不要となり、部品数が減少し、コス
ト削減が図れる。Further, according to the method of filling the chemical solution of the present invention, it is not necessary to employ another filling port member other than the stopper, so that the mounting step is not required, the number of parts is reduced, and the cost is reduced. Can be achieved.
【図１】薬液充填前の薬液用袋の参考図である。FIG. 1 is a reference drawing of a chemical solution bag before filling with a chemical solution.
【図２】薬液充填直前の薬液用袋の参考図である。FIG. 2 is a reference view of a chemical solution bag immediately before filling with a chemical solution.
【図３】薬液充填、密封後の薬液充填袋の参考図であ
る。FIG. 3 is a reference drawing of a chemical filling bag after filling with a chemical and sealing.
１ シール部 ２ 収納部 ３ 凸出部 ４ 充填口 ５ 栓体 ６ シール部 ７ 懸垂孔 ５ DESCRIPTION OF SYMBOLS 1 Seal part 2 Storage part 3 Projection part 4 Filling port 5 Plug body 6 Seal part 7 Hanging hole 5
Claims (2)
フィルムチューブを製造し、上記フィルムチューブを四
方シールして、先端部に凸出部を成形することを特徴と
する薬液用袋の製造方法。1. A method for manufacturing a chemical solution bag, comprising: manufacturing a film tube by inflation molding using a sterile gas; sealing the film tube on all sides; and forming a protruding portion at a tip end.
フィルムチューブを製造し、上記フィルムチューブを四
方シールして、先端部に凸出部を成形した袋を製造し、
薬液の充填前に上記凸出部を切断開放して充填口とし、
次いで、薬液を充填した後に、上記充填口を栓体で密封
することを特徴とする薬液の充填方法。2. A film tube is manufactured by inflation molding using aseptic gas, the film tube is sealed on all sides, and a bag having a protruding portion formed at the tip is manufactured.
Before filling with the drug solution, cut and open the protruding portion to make a filling port,
Next, after filling the liquid medicine, the filling port is sealed with a stopper.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP10153902A JPH11319032A (en) | 1998-05-19 | 1998-05-19 | Manufacture of bag for pharmaceutical solution, and filling of drug liquid |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP10153902A JPH11319032A (en) | 1998-05-19 | 1998-05-19 | Manufacture of bag for pharmaceutical solution, and filling of drug liquid |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPH11319032A true JPH11319032A (en) | 1999-11-24 |
Family
ID=15572614
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP10153902A Pending JPH11319032A (en) | 1998-05-19 | 1998-05-19 | Manufacture of bag for pharmaceutical solution, and filling of drug liquid |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH11319032A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105878014A (en) * | 2014-09-03 | 2016-08-24 | 重庆莱美药业股份有限公司 | One-piece soft bag interface, soft bag having same, and loading method |
| CN106364738A (en) * | 2015-07-16 | 2017-02-01 | 日立造船株式会社 | Sealing bag, sealing package, sterile filling system and manufacture method for sealing package |
-
1998
- 1998-05-19 JP JP10153902A patent/JPH11319032A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105878014A (en) * | 2014-09-03 | 2016-08-24 | 重庆莱美药业股份有限公司 | One-piece soft bag interface, soft bag having same, and loading method |
| CN105878014B (en) * | 2014-09-03 | 2019-07-12 | 重庆莱美药业股份有限公司 | A kind of integral type flexible bag interface, the soft bag and packaging process for having the interface |
| CN106364738A (en) * | 2015-07-16 | 2017-02-01 | 日立造船株式会社 | Sealing bag, sealing package, sterile filling system and manufacture method for sealing package |
| JP2017024727A (en) * | 2015-07-16 | 2017-02-02 | 日立造船株式会社 | Hermetically sealed bag, hermetically sealed package, aseptic charging system and method for manufacturing hermetically sealed package |
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