TWI628123B - 用於包裝由彈性體製成的部件的包裝方法和裝置 - Google Patents
用於包裝由彈性體製成的部件的包裝方法和裝置 Download PDFInfo
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- TWI628123B TWI628123B TW106110624A TW106110624A TWI628123B TW I628123 B TWI628123 B TW I628123B TW 106110624 A TW106110624 A TW 106110624A TW 106110624 A TW106110624 A TW 106110624A TW I628123 B TWI628123 B TW I628123B
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- 238000004806 packaging method and process Methods 0.000 title claims abstract description 45
- 229920001971 elastomer Polymers 0.000 title claims abstract description 14
- 239000000806 elastomer Substances 0.000 title claims abstract description 13
- 238000000034 method Methods 0.000 title claims abstract description 9
- 239000000463 material Substances 0.000 claims abstract description 16
- 230000001954 sterilising effect Effects 0.000 claims abstract description 14
- 239000003814 drug Substances 0.000 claims abstract description 10
- 229940079593 drug Drugs 0.000 claims abstract description 9
- 238000004659 sterilization and disinfection Methods 0.000 claims description 12
- -1 polyethylene terephthalate Polymers 0.000 claims description 7
- 239000004775 Tyvek Substances 0.000 claims description 6
- 229920000690 Tyvek Polymers 0.000 claims description 6
- 239000004952 Polyamide Substances 0.000 claims description 4
- 239000004698 Polyethylene Substances 0.000 claims description 4
- 229920002647 polyamide Polymers 0.000 claims description 4
- 229920000573 polyethylene Polymers 0.000 claims description 4
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 3
- 229910052782 aluminium Inorganic materials 0.000 claims description 3
- 229920000139 polyethylene terephthalate Polymers 0.000 claims description 3
- 239000005020 polyethylene terephthalate Substances 0.000 claims description 3
- 238000012856 packing Methods 0.000 abstract 2
- 238000010586 diagram Methods 0.000 description 4
- 230000035699 permeability Effects 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 239000013536 elastomeric material Substances 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000001012 protector Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 229920002994 synthetic fiber Polymers 0.000 description 1
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
- B65B55/12—Sterilising contents prior to, or during, packaging
- B65B55/14—Sterilising contents prior to, or during, packaging by heat
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B5/00—Packaging individual articles in containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, jars
- B65B5/06—Packaging groups of articles, the groups being treated as single articles
- B65B5/067—Packaging groups of articles, the groups being treated as single articles in bags
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B32B15/00—Layered products comprising a layer of metal
- B32B15/04—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material
- B32B15/08—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
- B32B15/085—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin comprising polyolefins
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- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
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- B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
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- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Food Science & Technology (AREA)
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- Packages (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
一種用於包裝彈性體部件的包裝方法,例如彈性體部件為用於藥物容器的塞子,這種包裝方法包含以下步驟:將彈性體部件包裝在至少一個主袋中,主袋由對蒸汽大致可滲透的材料製成,將主袋包裝在一大致剛性的支撐件中,以便形成一單元,對此單元進行蒸汽滅菌,以及將滅菌後的單元包裝在至少一個輔助袋中,在此至少一個主袋和此至少一個輔助袋之間施加一真空。
Description
本發明係關於一種用於包裝由彈性體製成的部件的包裝方法和裝置,例如用於藥物容器的塞子。
用於容納藥物的藥物容器在填充後通常透過適當的塞子以密封和無菌的方式封閉,這種塞子通常由彈性體材料例如橡膠製成。這些塞子可準備好用於使用,在這種情況下,它們可封裝在具有良好的蒸汽滲透性的一主包裝袋中,通常是完全或部分地封裝在由Tyvek®製成的袋子中,其中Tyvek®為由聚乙烯纖維製成的非織造合成材料。然後對主袋滅菌,同時在滅菌期間允許蒸汽通過,然後將滅菌的主袋***至一不可滲透的輔助袋中。用語「蒸汽」用於覆蓋用於滅菌目的的任何氣體,包含蒸汽以及化學蒸汽。
這種包裝系統存在缺點。因此,特別是在滅菌之後,主袋相對易碎,具有損壞的風險。此外,主袋,特別是當其由Tyvek®製成時,特別是如果具有缺陷時,可潛在地允許細菌在滅菌之前與/或之後通過。為了克服這些缺點,通常設置複數個相互重疊的主袋,這限制了上述風險,但是不能夠消除這些風險。常規的包裝系統的另一個缺點是不能夠看到主袋與/或輔助袋的完整性的任何損失。
文獻FR 3 014 851、DE 3 717 916、DE 10 2007 056 261以及US 2013/118924描述了習知技術的裝置。
本發明的一目的在於提供一種不具有上述缺點的用於包裝彈性體部件的包裝方法和包裝裝置。
特別地,本發明的一目的為在滅菌之前與/或之後儘可能地避免細菌污染的風險。
因此,本發明提供了一種用於包裝彈性體部件的包裝方法,例如彈性體部件為用於藥物容器的塞子,這種包裝方法包含以下步驟:將彈性體部件包裝在至少一個主袋中,主袋由對蒸汽大致可滲透的材料製成;將主袋包裝在一大致剛性的支撐件中,以便形成一單元;對此單元進行蒸汽滅菌;以及將滅菌後的單元包裝在至少一個輔助袋中,在此至少一個主袋和此至少一個輔助袋之間施加一真空。
本發明還提供了一種用於包裝彈性體部件的包裝裝置,彈性體部件為例如用於藥物容器的塞子,包裝裝置包含接收彈性體部件的至少一個主袋,主袋由對蒸汽可滲透的材料製成,這至少一個主袋包裝在一大致剛性的支撐件中以形成一可滅菌的單元,滅菌後的單元包裝在至少一個輔助袋中,在至少一個主袋和至少一個輔助袋之間施加一真空。
有利地,這至少一個主袋完全或部分地由Tyvek®製成。
有利地,輔助袋包含複數個層,特別是具有由聚對酞酸乙二酯製成的一內層、由鋁製成的一層、由聚醯胺製成的一層、以及由聚乙烯製成的一外層的四層結構。
在一第一有利變型中,支撐件係為一開放室。
在一第二有利變型中,支撐件係為一封閉室。
有利地,支撐件至少部分地由對蒸汽可滲透的一材料製成。
在一變型中,支撐件由不可滲透的一材料製成。
有利地,支撐件包含蒸汽通過的至少一個開口。
1‧‧‧彈性體部件
10‧‧‧主袋
15‧‧‧支撐件
20‧‧‧輔助袋
30‧‧‧滅菌室
圖1係為在初始包裝階段用於包裝彈性體部件的一包裝裝置的示意圖;圖2係為圖1中的裝置在滅菌階段的示意圖;以及圖3係為在最終包裝階段中圖1和圖2中之裝置的示意圖。
圖1至圖3係為示意性的,並且自然地,各種元件的形狀不代表真實的形狀或比例。特別地,這些部件可以是任何數量和任何形狀,並且這些袋子也可以是任何的形狀和尺寸。
在常規的方式下,例如藥物容器之塞子的彈性體部件1封裝在一包裝裝置中,包裝裝置包含直接接收這些部件的一主袋10。可選地,可提供複數個主袋,特別是兩個袋,一個設置在另一個內部,以便加強對彈性體部件的保護。
有利地,如圖3所示,包裝裝置還包含容納主袋10的一輔助袋20。也可設置複數個彼此重疊的輔助袋。
在本發明中,提供一大致剛性的支撐件15,支撐件15在滅菌室30中滅菌之前接收主袋10。
支撐件15可形成例如,開放工作的一開放室。舉例而言,支撐件15可以由一格柵或一箱體形成,其中此格柵或箱體至少部分地穿孔,具有或不具有一蓋。
支撐件15也可形成一封閉室。
優選地,支撐件15由與滅菌方法的參數相容的一材料製成。支撑件15可至少部分地由蒸汽可滲透的一材料製成。在一個變型中,支撑件15可以由不可滲透的材料製成。特別是對於不可滲透的材料,支撐件15應包含例如一格柵或小孔的至少一個開口,蒸汽可通過这至少一个開口。蒸汽可通過的開口的尺寸有利地使得部件在輔助袋受到壓縮時不會受到應力,這個尺寸通常為幾毫米,可能大約為一厘米。任選地,可以將可滲透蒸汽的一材料與蒸汽可
通過的開口結合使用,以優化設置在支撐件內的部件的滅菌。
因此,包含彈性體部件1的主袋10最初設置在支撐件15中,並且然後這個單元在一滅菌室30中滅菌。
然後將滅菌後的單元包裝在輔助袋20中的一受控區域中。
一空氣真空然後在主袋10和輔助袋20之間產生。真空使得可檢測揭示為真空損失的任何可能的完整性問題,導致袋子變得分離。
圍繞主袋10的至少一部分而存在的支撐件15在各種操作期間保護主袋,從而限制主袋10劣解與/或損壞的風險。
由於主袋10至少部分地設置在大致上剛性的支撐件15中,因此還可避免當輔助袋20在真空下時,容納在主袋10中的彈性體部件1受到壓縮。當支撐件15包含蒸汽可通過的開口時,期望開口非常小,以避免輔助袋在施加真空的同時透過拉伸而過度變形。
主袋10優選地由具有對蒸汽具有良好滲透性的材料製成,通常是完全或部分地由Tyvek®製成的一袋。
輔助袋20可包含複數個層,特別是具有由聚對酞酸乙二酯製成的一內層、由鋁製成的一層、由聚醯胺製成的一層、以及由聚乙烯製成的一外層的四層結構。
可設想用於主袋10與/或輔助袋20的其它材料。
上面更具體地參考藥物容器的塞子描述了本發明,但是本發明也可應用於其它類型的彈性體部件,例如注射器活塞或註射器針頭保護件。
以上參照特定實施例描述了本發明,但是本發明並不限於本實施例,相反,本領域技術人員可以對其進行任何有用的修改,而不超出本發明的範圍,本發明的範圍如所附之專利申請範圍限定。
Claims (9)
- 一種用於包裝彈性體部件的包裝方法,該彈性體部件例如係為用於藥物容器的塞子,包含以下步驟:將該彈性體部件包裝在至少一個主袋中,該至少一個主袋係由對蒸汽大致可滲透的材料製成;將該至少一個主袋包裝在一大致剛性的支撐件中,以便形成一單元;對該單元進行蒸汽滅菌;以及將滅菌後的該單元包裝在至少一個輔助袋中,在該至少一個主袋和該至少一個輔助袋之間施加一真空。
- 一種用於包裝彈性體部件的包裝裝置,該彈性體部件係為例如用於藥物容器的塞子,其中該包裝裝置包含接收該彈性體部件的至少一個主袋,該至少一個主袋係由對蒸汽可滲透的材料製成,該至少一個主袋包裝在一大致剛性的支撐件中以形成一可滅菌的單元,滅菌後的該單元包裝在至少一個輔助袋中,在該至少一個主袋和該至少一個輔助袋之間施加一真空。
- 如請求項2所述之用於包裝彈性體部件的包裝裝置,其中該至少一個主袋完全或部分地係由Tyvek®製成。
- 如請求項2或3所述之用於包裝彈性體部件的包裝裝置,其中該輔助袋包含複數個層,特別是具有由聚對酞酸乙二酯製成的一內層、由鋁製成的一層、由聚醯胺製成的一層、以及由聚乙烯製成的一外層的四層結構。
- 如請求項2所述之用於包裝彈性體部件的包裝裝置,其中該支撐件係為一開放室。
- 如請求項2所述之用於包裝彈性體部件的包裝裝置,其中該支撐件係為一封閉室。
- 如請求項2所述之用於包裝彈性體部件的包裝裝置,其中該支撐件至少部分地由對蒸汽可滲透的一材料製成。
- 如請求項2所述之用於包裝彈性體部件的包裝裝置,其中該支撐件係由不可滲透的一材料製成。
- 如請求項2所述之用於包裝彈性體部件的包裝裝置,其中該支撐件包含蒸汽通過的至少一個開口。
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FR1652862A FR3049588B1 (fr) | 2016-04-01 | 2016-04-01 | Procede et dispositif de conditionnement de pieces en elastomere. |
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WO2008141936A2 (de) * | 2007-05-23 | 2008-11-27 | Helvoet Pharma Belgium N.V. | Vielzahl von in einem transportbehältnis zusammengefassten sterilisationsobjekten, transportbehältnis, sowie verfahren zur sterilisierung von derartigen objekten |
CN104220341A (zh) * | 2011-11-11 | 2014-12-17 | 诺玛科公司 | 用于产品保持容器的封堵件 |
WO2015092236A1 (fr) * | 2013-12-16 | 2015-06-25 | Aptar Stelmi Sas | Procede et dispositif de conditionnement de pieces en elastomere |
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US2524162A (en) * | 1945-02-27 | 1950-10-03 | Chavannes Marc Alfred | Desiccant packaging |
DE3717916A1 (de) * | 1987-05-27 | 1988-12-08 | Muenchner Medizin Mechanik | Verfahren zum verpacken von sterilisiergut und sterilisierverpackung |
US6161695A (en) * | 1998-08-21 | 2000-12-19 | Depuy Orthopaedics, Inc. | Protective packaging unit |
JP5095009B2 (ja) * | 2008-06-09 | 2012-12-12 | ベクトン・ディキンソン・フランス・エス.エー.エス. | 滅菌パッケージ及びこのパッケージを用いた滅菌方法 |
FR2965556B1 (fr) * | 2010-09-30 | 2013-08-02 | Sartorius Stedim Biotech Sa | Detection de l'integrite d'une poche souple, fermee, etanche, en matiere plastique, destinee a recevoir et proteger un produit ou un dispositif biopharmaceutique |
JP5919658B2 (ja) * | 2011-06-21 | 2016-05-18 | 三浦工業株式会社 | 薬剤包装体 |
CN105197423A (zh) * | 2015-09-17 | 2015-12-30 | 李祥龙 | 武夷岩茶抽真空防碎保质包装结构 |
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WO2008141936A2 (de) * | 2007-05-23 | 2008-11-27 | Helvoet Pharma Belgium N.V. | Vielzahl von in einem transportbehältnis zusammengefassten sterilisationsobjekten, transportbehältnis, sowie verfahren zur sterilisierung von derartigen objekten |
CN104220341A (zh) * | 2011-11-11 | 2014-12-17 | 诺玛科公司 | 用于产品保持容器的封堵件 |
WO2015092236A1 (fr) * | 2013-12-16 | 2015-06-25 | Aptar Stelmi Sas | Procede et dispositif de conditionnement de pieces en elastomere |
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CN108778950A (zh) | 2018-11-09 |
EP3436367B1 (fr) | 2020-02-19 |
PL3436367T3 (pl) | 2020-07-27 |
KR20180128923A (ko) | 2018-12-04 |
IL261609A (en) | 2018-10-31 |
CN108778950B (zh) | 2020-09-04 |
FR3049588A1 (fr) | 2017-10-06 |
EP3436367A1 (fr) | 2019-02-06 |
DK3436367T3 (da) | 2020-05-18 |
FR3049588B1 (fr) | 2019-07-05 |
TW201736217A (zh) | 2017-10-16 |
US20190092499A1 (en) | 2019-03-28 |
WO2017191383A1 (fr) | 2017-11-09 |
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