CN1859890A - 聚乙烯可挤压袋 - Google Patents
聚乙烯可挤压袋 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/0005—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor characterised by the material
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/42—Component parts, details or accessories; Auxiliary operations
- B29C49/4273—Auxiliary operations after the blow-moulding operation not otherwise provided for
- B29C49/42808—Filling the article
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2023/00—Tubular articles
- B29L2023/20—Flexible squeeze tubes, e.g. for cosmetics
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/712—Containers; Packaging elements or accessories, Packages
- B29L2031/7148—Blood bags, medical bags
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
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- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
- Y10T428/1345—Single layer [continuous layer]
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/31504—Composite [nonstructural laminate]
- Y10T428/31855—Of addition polymer from unsaturated monomers
Abstract
本发明涉及制备聚乙烯无菌可挤压袋的方法。本发明还涵盖所述袋和它们用于医药包装应用的用途。
Description
本发明涉及制备具有高耐温性、良好光学性质和易于挤压的聚乙烯吹制填充密封袋的方法。因而,这些袋可用作药物和医用产品的包装,特别是用于静脉注射溶液或肠胃外注射液的包装。
在制药和医学应用中常常非常希望获得不含杂质的产物。作为液体药物和医用产品的无菌包装的优选方法出现了吹制/填充/密封方法。吹制/填充/密封方法能够在一个连续的整体操作中模塑塑料容器、无菌填充和严格密封。另外对于吹制/填充/密封方法,为了安全,可以通过蒸汽消毒对密封容器进行杀菌。静脉注射液体尤其如此。众所周知,从经济的角度看,非常希望避免长的消毒时间。因此,容器必须能够在足够高的温度下消毒,而不对容器产生任何损坏。
除了耐高温性之外,容器还应该具有良好的光学性能,尤其是良好的接触透明性和高透光性。确实,为了检查任何可能的污染,非常希望能够透过容器目测观察液体。
另外,当容器包含液体,例如静脉注射溶液时,需要容器足够柔软,以便在溶液流出时自动挤压。
EP 0601631涉及由聚乙烯组合物制成的吹塑填充密封容器,所述组合物包含根据自由基高压聚合方法制备的50-80%线性低密度聚乙烯和20-50%低密度聚乙烯。该容器在117℃的温度下消毒。低密度聚乙烯树脂目前在市场上用于生产药物和医用产品用容器。但是,这些容器仅仅耐109℃的温度,当在吹制/填充/密封过程之后进一步消毒时,致使需要长的消毒时间。
因此,仍需要制造聚乙烯吹塑填充密封容器,该容器通过提高它们的消毒温度可以变为无菌的而不引起容器的任何变形。
本发明的一个目的是提供制造无菌吹塑填充密封袋的方法。
本发明的另一个目的是提供在液体流出时易于挤压的吹塑填充密封袋。
本发明的另一个目的是提供具有高度透明性和良好透光性的吹塑填充密封袋。
本发明的发明人发现了制备无菌吹塑填充密封袋的方法,所述方法包括以下步骤:
a)将密度为0.928-0.942g/cm3的金属茂催化的聚乙烯挤成型坯,
b)将步骤a的型坯吹制成袋,
c)将液体注入步骤b得到的袋中,
d)密封步骤c得到的填充袋,以及
e)在最低118℃下对所述袋进行消毒。
对于医药用途,例如对于静脉注射溶液,在所述方法的步骤b)中可以使用无菌空气。
本发明的发明人已经发现本发明的方法实现了本发明的一个或多个目的。
在本发明中使用的金属茂催化的聚乙烯(mPE)是乙烯和以下共聚单体的共聚物,所述共聚单体选自丙烯、1-丁烯、1-己烯、1-辛烯或4-甲基-1-戊烯,优选的共聚单体是1-己烯。
本发明中使用的mPE的密度可以由注入反应器中的共聚单体的量进行调节。mPE的密度可以为0.928g/cm3至0.942g/cm3,优选0.930g/cm3至0.940g/cm3,最优选0.932g/cm3至0.936g/cm3。在本说明书中,使用ASTMD1505方法在23℃测量聚乙烯的密度。
根据ASTM D 1238,在2.16kg/190℃的条件下,本发明中使用的mPE的熔体指数MI2可以由注入反应器中的氢的量调节。mPE的熔体指数可以为0.3g/10min至2.5g/10min,优选0.5g/10min至1.5g/10min,且最优选0.7g/10min至1.05g/10min。
优选地,在本发明中使用的mPE树脂具有流变长链分支指数(rheological long-chain branching index)LCBI,例如R.N.Shroff和H.Mavridis在Macromolecules 2001,34,7362-7367用下面的方程定义的:
其中η0是190℃下的极限零剪切粘度,[η]是在135℃的三氯苯中的特性粘度。
通过如US-A-6114486中描述的流变曲线(复数粘度相对于频率)的最小二乘法分析,使用以下的广义交叉方程,由最佳拟合计算LCBI,即
η=η0/(1+(Yt0)n)
其中η和y分别为测量的粘度和剪切速率数据,η0是零剪切粘度,t0是材料的特征弛豫时间,n是表征材料剪切变稀性能的材料的幂律指数。在190℃下,在氮气中进行动.态流变分析,根据ASTM D 4440的应变振幅为10%。
在本发明中使用的mPE的LCBI大于0.14,优选大于0.50,更优选大于1,最优选大于2。
用于制备本发明所需的mPE的催化剂体系包括金属茂组分,优选桥连的金属茂组分。金属茂组分可以是具有以下通式的任意金属茂组分:
Rn”(CpR′k)2MQZ-2
其中(CpR′k)是环戊二烯基或取代的环戊二烯基,各R′相同或不同且为氢或烃基,例如包含1-20个碳原子和/或两个碳原子连接在一起形成C4-C6环的烷基、链烯基、芳基、烷芳基或芳烷基,R″是桥连两个(CpR′k)环的取代或未取代的C1-C4亚烷基,二烷基或二芳基锗或硅或者硅氧烷,或烷基膦或胺基,n可以为0或1,优选n为1,Q是卤素或具有1-20个碳原子的烃基,例如芳基、烷基、链烯基、烷芳基或芳烷基,或者具有1-20个碳原子的烃氧基或卤素,并且Q可以彼此相同或不同,当n为1时,k为4,或者当n为0时,k为5,z是过渡金属的价数,M是4b、5b或6b族过渡金属,优选为4b族过渡金属,最优选为锆。
优选地,金属茂催化剂是取代的或未取代的二氯化双茚基锆,优选桥连的取代或未取代二氯化双茚基锆,更优选桥连的二氯化双四氢茚基锆。
根据一优选实施方案,该桥连的金属茂催化剂是二氯化亚乙基双(4,5,6,7-四氢-1-茚基)锆。
金属茂可以根据本领域已知的任何方法被负载或活化。
用来制备本发明所需聚乙烯的金属茂催化剂可以用于气体、溶液、淤浆或高压聚合。优选,使用淤浆聚合制备本发明所需的mPE。
还可以向所述树脂中加入标准添加剂例如抗氧化剂、抗静电剂、防雾剂、防UV剂和防结块剂或增滑添加剂。在需要时,还可以添加加工助剂。
袋的消毒温度至少为118℃。优选在119℃进行消毒,更优选在119℃消毒15分钟。
本发明还提供根据本发明的方法制造的可挤压袋。优选制备的袋的透光率根据标准方法ASTM D 1003测量时至少为95%,浑浊度(haze)根据标准方法ISO 14782测量时小于35%,优选小于32%。所述袋的特征还在于具有优异的接触透明性。
本发明另外还提供了根据本发明方法制造的袋用于医药包装应用的用途。
实施例:
使用金属茂催化的聚乙烯树脂(R1)制备无菌的吹塑填充密封袋。所用的金属茂催化剂为桥连的金属茂,二氯化亚乙基双(4,5,6,7-四氢-1-茚基)锆。在充满液体的浆料环管反应器中进行在本发明方法中使用的树脂R1的聚合。将乙烯和催化剂一起注入1-己烯中。异丁烷用作稀释剂。聚合条件如下,其中C2为乙烯,C6为1-己烯,Iso C4为异丁烷,TIBAL为三异丁基铝:
C2进料(Kg/h): 3900,
C6/C2进料比(kg/T): 22,
H2/C2进料比(g/T): 42,
Iso C4进料(kg/h): 1940,
TIBAL浓度(ppm): 100-200,
聚合温度: 90℃。
使用以下物质制备比较例的袋:
1.Atofina出售的聚乙烯树脂(R2),商品名为FinatheneHF513,用铬催化剂制备。
2.Basell出售的聚乙烯(R3),商品名为Lupolen3040D。
3.Atofina出售的聚丙烯树脂(R4),商品名为Atofina聚丙烯3020SM3。
如上述定义测量MI2。在载荷为2.16kg且温度为230℃的条件下,根据标准测试方法ASTM D 1238测量MFI。在表1中归纳了这些树脂的性质。
表1
树脂 | 密度g/cm3 | MI2g/10min190℃ | MFIg/10min230℃ |
R1(实施例) | 0.935 | 0.9 | - |
R2(比较例) | 0.934 | 0.15 | - |
R3(比较例) | 0.930 | 0.3 | - |
R4(比较例) | 0.900 | - | 1.8 |
树脂R1表现出0.60的长链分支指数LCBI。R1的LCBI是根据ASTMD 4440通过拟合所述广义交叉方程测定的。
袋的制备
所有的树脂在一个过程循环中挤压成型坯,吹制成袋,充入水并密封。在Rommelag装置上进行该吹制填充密封过程。之后将袋在高压釜中在119℃下消毒15分钟。所得袋的容量(contenance)为500ml。在表2提及了其它特性。
表2
袋 | 组合物 | 重量(gr) | 厚度(mm) |
P1(实施例) | R1 | 18.5 | 0.45 |
P2(比较例) | R2 | 28 | 0.5 |
P3(比较例) | R3 | 21.9 | 0.5 |
P4(比较例) | R4 | 19.7 | 0.5 |
袋的性质
当袋保持在119℃的温度下15分钟时,通过检测是否发生水的泄漏,测试所有袋对于该温度的耐温性。
进一步测量袋的可挤压性能。当液体流出时根据本发明的方法制备的袋自动挤压。在图1中,可以看到在水流出之前填充密封袋的正视图(1a)和剖面图(1b)。在图2中,可以看到在水流出之后填充密封袋的正视图(2a)和剖面图(2b)。
还测试了袋的光学性能,特别是透光率、浑浊度和接触透明性。根据标准方法ASTM D 1003测量透光率。根据标准方法ISO 14782测量浑浊度。在表3中列出了所有的结果。
表3
袋 | 耐温性 | 透光率(%) | 浑浊度(%) | 接触透明度 | 可挤压性能 |
P1(实施例) | 未漏失 | 95 | 31 | 极好 | 极好 |
P2(比较例) | 漏失 | 89 | 78 | 差 | 非常好 |
P3(比较例) | 漏失 | 91 | n.m. | 非常好 | 非常好 |
P4(比较例) | 未漏失 | 93 | n.m. | 极好 | 差 |
n.m:未测量
根据本发明制备的袋具有良好的耐高温性、极好的光学性质和优异的可挤压性能。
Claims (7)
1.制备可挤压袋的方法,包括以下步骤:
a)将密度为0.928-0.942g/cm3的金属茂催化的聚乙烯挤成型坯,
b)将步骤a的型坯吹塑成袋,
c)将液体注入步骤b得到的袋中,
d)密封步骤c得到的填充袋,以及
e)在最低118℃下对所述袋进行消毒。
2.权利要求1的方法,其中金属茂是桥连的金属茂催化剂。
3.权利要求1或2的方法,其中金属茂是桥连的二氯化双茚基锆。
4.权利要求1-3中任一项的方法,其中根据ASTM D 1238在190℃和2.16kg载荷下测量时,金属茂催化的聚乙烯的熔体指数为0.3-2.5g/10min。
5.权利要求1-4中任一项的方法,其中消毒温度为119℃。
6.可挤压袋,其是根据权利要求1-5中任一项的方法制备的。
7.权利要求6的袋用于医药包装应用的用途。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP03078044.9 | 2003-09-30 | ||
EP20030078044 EP1520573A1 (en) | 2003-09-30 | 2003-09-30 | Polyethylene squeezable pouches |
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Publication Number | Publication Date |
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CN1859890A true CN1859890A (zh) | 2006-11-08 |
CN100411604C CN100411604C (zh) | 2008-08-20 |
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CNB200480028213XA Expired - Fee Related CN100411604C (zh) | 2003-09-30 | 2004-09-29 | 聚乙烯可挤压袋 |
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US (2) | US7892614B2 (zh) |
EP (2) | EP1520573A1 (zh) |
JP (1) | JP4796497B2 (zh) |
KR (1) | KR101142711B1 (zh) |
CN (1) | CN100411604C (zh) |
AT (1) | ATE550045T1 (zh) |
WO (1) | WO2005030112A1 (zh) |
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Publication number | Priority date | Publication date | Assignee | Title |
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CN105366174A (zh) * | 2015-11-30 | 2016-03-02 | 江门市新时代外用制剂有限公司 | 一种医用灭菌包装顶头袋 |
CN108017888A (zh) * | 2017-12-02 | 2018-05-11 | 无锡福尔顺科技有限公司 | 一种密封聚己内酯包装壳及其应用 |
Families Citing this family (5)
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AU2007307301A1 (en) * | 2006-10-05 | 2008-04-17 | Eisai Inc. | Aqueous based pharmaceutical formulations of water-soluble prodrugs of propofol |
EP2083990A4 (en) * | 2006-11-21 | 2010-01-20 | Fina Technology | POLYETHYLENE FOR PRODUCING FILMS AND MOLDED ARTICLES IN A PROCESS USING SOLID STATE VOLTAGE |
EP3310550A1 (en) | 2015-06-18 | 2018-04-25 | SABIC Global Technologies B.V. | Use of polyethylene materials in the production of sterilisable liquid containers |
CN111615409A (zh) | 2017-11-17 | 2020-09-01 | 科斯卡家族有限公司 | 用于流体输送歧管的系统和方法 |
USD992110S1 (en) | 2021-08-10 | 2023-07-11 | Koska Family Limited | Sealed fluid container |
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US4332122A (en) * | 1978-07-24 | 1982-06-01 | Baxter Travenol Laboratories, Inc. | Method of making and filling liquid-containing sterile packages such as blood bags |
EP0601631A1 (en) * | 1992-12-04 | 1994-06-15 | Dsm N.V. | Container made from a polyethylene composition |
JP3727396B2 (ja) * | 1995-01-09 | 2005-12-14 | 三井化学株式会社 | レトルト容器 |
JP3907764B2 (ja) * | 1996-12-27 | 2007-04-18 | 三井化学株式会社 | エチレン系樹脂製耐熱容器 |
JP3834912B2 (ja) * | 1997-02-24 | 2006-10-18 | 東洋製罐株式会社 | ブロー成形容器 |
JPH1119183A (ja) * | 1997-07-01 | 1999-01-26 | Material Eng Tech Lab Inc | 医療用容器 |
JPH11152378A (ja) * | 1997-11-21 | 1999-06-08 | Ube Ind Ltd | 医療用エチレン−α−オレフィン共重合体組成物およびこの組成物を用いた成形物 |
JP2000157611A (ja) * | 1998-11-25 | 2000-06-13 | Material Eng Tech Lab Inc | 耐熱性医療容器 |
KR100635292B1 (ko) * | 1998-12-07 | 2006-10-19 | 미쓰이 가가쿠 가부시키가이샤 | 가열 멸균용 중공 용기 |
JP3464405B2 (ja) * | 1999-02-18 | 2003-11-10 | 阪神化成工業株式会社 | 多層薄肉容器 |
EP1090621B1 (en) * | 1999-10-08 | 2003-08-20 | Nipro Corporation | Heat-resistant plastic sheet for infusion bag |
-
2003
- 2003-09-30 EP EP20030078044 patent/EP1520573A1/en not_active Withdrawn
-
2004
- 2004-09-29 WO PCT/EP2004/052347 patent/WO2005030112A1/en active Application Filing
- 2004-09-29 CN CNB200480028213XA patent/CN100411604C/zh not_active Expired - Fee Related
- 2004-09-29 KR KR1020067006132A patent/KR101142711B1/ko not_active IP Right Cessation
- 2004-09-29 EP EP20040766862 patent/EP1670410B1/en not_active Not-in-force
- 2004-09-29 AT AT04766862T patent/ATE550045T1/de active
- 2004-09-29 US US10/573,952 patent/US7892614B2/en not_active Expired - Fee Related
- 2004-09-29 JP JP2006530258A patent/JP4796497B2/ja not_active Expired - Fee Related
-
2011
- 2011-01-13 US US13/005,703 patent/US20110120058A1/en not_active Abandoned
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105366174A (zh) * | 2015-11-30 | 2016-03-02 | 江门市新时代外用制剂有限公司 | 一种医用灭菌包装顶头袋 |
CN108017888A (zh) * | 2017-12-02 | 2018-05-11 | 无锡福尔顺科技有限公司 | 一种密封聚己内酯包装壳及其应用 |
Also Published As
Publication number | Publication date |
---|---|
US20080272522A1 (en) | 2008-11-06 |
JP4796497B2 (ja) | 2011-10-19 |
EP1670410A1 (en) | 2006-06-21 |
EP1520573A1 (en) | 2005-04-06 |
CN100411604C (zh) | 2008-08-20 |
KR20060081711A (ko) | 2006-07-13 |
ATE550045T1 (de) | 2012-04-15 |
EP1670410B1 (en) | 2012-03-21 |
US7892614B2 (en) | 2011-02-22 |
US20110120058A1 (en) | 2011-05-26 |
WO2005030112A1 (en) | 2005-04-07 |
JP2007509768A (ja) | 2007-04-19 |
KR101142711B1 (ko) | 2012-05-03 |
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