CN110772653A - 用于吹气/填充/密封机器的消毒系统 - Google Patents

用于吹气/填充/密封机器的消毒系统 Download PDF

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CN110772653A
CN110772653A CN201911075047.3A CN201911075047A CN110772653A CN 110772653 A CN110772653 A CN 110772653A CN 201911075047 A CN201911075047 A CN 201911075047A CN 110772653 A CN110772653 A CN 110772653A
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sterilization
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nitrogen dioxide
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C·H·里德
A·W·戈尔
J·D·斯坦利
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • 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
    • B29C49/02—Combined blow-moulding and manufacture of the preform or the parison
    • B29C49/04—Extrusion blow-moulding
    • 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
    • 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
    • B29C49/46—Component parts, details or accessories; Auxiliary operations characterised by using particular environment or blow fluids other than air
    • C—CHEMISTRY; METALLURGY
    • C01—INORGANIC CHEMISTRY
    • C01B—NON-METALLIC ELEMENTS; COMPOUNDS THEREOF; METALLOIDS OR COMPOUNDS THEREOF NOT COVERED BY SUBCLASS C01C
    • C01B21/00—Nitrogen; Compounds thereof
    • C01B21/20—Nitrogen oxides; Oxyacids of nitrogen; Salts thereof
    • C01B21/36—Nitrogen dioxide (NO2, N2O4)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/14—Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/23—Containers, e.g. vials, bottles, syringes, mail
    • 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
    • B29C49/46—Component parts, details or accessories; Auxiliary operations characterised by using particular environment or blow fluids other than air
    • B29C2049/4602—Blowing fluids
    • B29C2049/4635—Blowing fluids being sterile
    • 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
    • B29C49/42403—Purging or cleaning the blow-moulding apparatus
    • 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
    • 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
    • B65B2210/00—Specific aspects of the packaging machine
    • B65B2210/06—Sterilising or cleaning machinery or conduits
    • B65B2210/08—Cleaning nozzles, funnels or guides through which articles are introduced into containers or wrappers

Abstract

本分案申请利用包含气体的消毒剂的闭环循环的用于吹气/填充/密封机器的填充组件消毒系统。一般的消毒剂是二氧化氮。闭环包括限定了充气室并封闭了填充系统的护罩和至少一个高效微粒吸收(HEPA)过滤器。10‑6的灭菌保证水平可以通过使填充系统受到在大约18℃.至大约30℃.范围的温度下的消毒气体至少20分钟来获得。

Description

用于吹气/填充/密封机器的消毒系统
本申请是申请号为201580013361.2，申请日为2015年01月19日，发明名称为“用于吹气/填充/密封机器的消毒系统”的分案申请。
相关申请的交叉引用
本申请要求2014年01月20日递交的美国临时申请No.61/929,374的权益，该申请的全部内容通过引用的方式结合于此。
技术领域
本发明涉及吹气/填充/密封机器及利用该机器的无菌封装。
背景技术
吹气/填充/密封机器常常用于药物产品的无菌封装；特别是生物制剂、蛋白类及类似物质。为了确保无菌封装条件，必须时常对这些机器的产品路径和填充组件进行消毒。这种消毒通常以110℃.至125℃.的高压蒸汽进行；然而，可用的蒸汽消毒工艺在应用于较大的开放空间时是麻烦的并且是耗时的。
发明内容
用于吹气/填充/密封机器的消毒系统包括在机器的容器填充组件周围的护罩，该护罩限定了充气室，该充气室与外部消毒气体导管有限流体连通。
护罩与气体导管和至少一个高效微粒吸收(HEPA)过滤器一起限定了消毒气体循环的闭环。
特别地，消毒系统包括封闭填充组件并限定了消毒气体入口和消毒气体出口的护罩。外部导管在消毒气体入口与消毒气体出口之间限定了至少一个消毒气体流动通道。在接近消毒气体入口的外部导管上提供了吹风机，用于使消毒气体循环通过位于在吹风机与护罩的消毒气体入口之间的消毒流动通道的护罩和一个或多个HEPA过滤器。与吹风机流体连通的消毒气体源向消毒系统供应消毒气体，该消毒气体包括消毒剂，该消毒剂为诸如二氧化氮、二氧化氯、汽化的过氧化氢等。
优选地，通过将大约50％至大约75％的相对湿度的加湿空气与二氧化氮结合来提供消毒气体，实现了填充组件及其护罩的消毒，每升消毒气体包含大约10到大约20毫克的二氧化氮，以及将填充组件护罩与消毒气体在大约18℃.至大约30℃.范围的温度下接触至少20分钟的时间周期。此后依赖于护罩空间和填充组件几何结构，通过用温度为至少50℃.(大约122℉.)的空气清扫填充组件至少20分钟来移除剩余的二氧化氮，优选为大约30至大约45分钟。
附图说明
图1是示出了本吹气/填充/密封机器消毒系统的示意性流程图。
具体实施方式
吹气/填充/密封工艺是专门的无菌液体封装工艺，该工艺涉及特定容器制造技术，其中在没有人工干预的情况下容器在连续过程中通过热塑性材料形成、填充和密封。容器的填充和密封在吹气/填充/密封机器内的无菌的、封闭的空间中进行。一般的示意性填充组件在Weiler等人的美国专利No.4,671,762和Weiler等人的美国专利No.4,997,014中示出，并且全部内容通过引用的方式结合于此。吹气/填充/密封制造技术提供了在所控制的条件下经以下三个步骤进行的自动化的无菌封装过程：容器消毒、无菌填充和容器密封。
首先，诸如聚丙烯、聚乙烯等的热塑性树脂被挤压成管状(半成品)，其最后变成最终容器。当在打开的模具零件之间挤压所需长度的半成品之后，关闭模具零件，并且从所挤压的半成品切下半成品分段。半成品分段的顶部固定位置并且是开放的，及半成品的底部由关闭的模具零件紧紧夹住。半成品分段和模具然后被转移至填充组件所在的填充区域，填充组件包括一个或多个吹气和填充喷嘴。
吹气和填充喷嘴然后降入到半成品分段中直至在半成品分段与模具颈部之间形成密封。消毒、过滤后的压缩空气被引入半成品分段中，相对模具空腔扩大半成品分段并形成容器本体。在完成吹气循环之后，消毒的空气从容器本体放出并且消毒的液体产品通过填充喷嘴供给至容器中。在填充循环完成时，填充喷嘴缩回且分开的密封模具关闭半成品分段的顶部并密封所形成的填充的容器。
必须时常消毒吹气/填充/密封机器的填充组件以保证无菌的填充条件。迄今为止，将卫生处理过程用于护罩及将内部蒸汽消毒用于产品路径已经影响了消毒过程。图1示出了用于护罩的改进的干燥消毒系统和由护罩包裹的填充组件，其可以在相对较低的温度被利用以利用包含二氧化氮和类似消毒剂的消毒气体获得高达10-6的灭菌保证水平。
参照图1，护罩10封闭吹气/填充/密封机器的填充组件(未示出)并限定了充气室、消毒气体入口12和14及消毒气体出口16，该消毒气体出口16与外部导管18有限流体连通。
接近消毒气体入口12和14的外部导管上的吹风机20用来使消毒气体循环通过护罩10。高效微粒吸收(HEPA)过滤器22和24位于吹风机20与一对消毒气体入口12和14之间。虽然在循环的消毒气体环路中的单个HEPA过滤器是足够的，但是为了最小化穿过HEPA过滤器的压降，并行的两个或多个HEPA过滤器是优选的。
供应诸如二氧化氮等消毒剂的消毒剂源26与外部导管18连接并从而经由有限的流体通路与吹风机20连接，该有限的流体通路通过馈送导管28、气动阀30、外部导管18及导管44、46和88限定。歧管82提供与系统压力释放系统的连通，该系统压力释放系统包括导管86和导管86上的释放阀84。在消毒循环期间的系统压力通常不超过150帕斯卡，并且释放阀84被设定为在系统压力超过该值时打开。在正常消毒循环期间，气动控制阀32打开并且包含二氧化氮的消毒气体通过吹风机20的动作循环通过HEPA过滤器22、24和护罩10。导管18上的压力计34和热敏电阻36分别监测在外部导管18中循环的消毒气体的压力和温度。压力计74监测护罩10内的压力。
湿度传感器38和消毒剂浓度传感器40可操作地经由导管44上的阀42并通过导管46串联连接至导管18。在消毒循环期间，消毒气体的一部分流过导管44、46和88并进入馈送导管28，该馈送导管28与导管18有限流体连通。
为了进行有效消毒，消毒气体必须具有大约50％相对湿度(RH)至大约75％RH范围的预定RH。必要的湿度由加湿器52经由导管56的阀54提供，加湿器52通过水泵60的动作从方便的源(未示出)接收水。
与来自源26的诸如二氧化氮等的消毒剂相结合的空气构成了消毒气体。所有补充空气根据需要经由阀62和导管64供应至消毒系统。源26还根据需要基于来自传感器40的信号供应补充消毒剂。
在完成消毒循环之后，净化空气经由净化导管50上的阀48被引导至系统，净化导管50可操作地连接至吹风机20上游的外部导管18。净化空气循环通过消毒系统至少20分钟，优选地在大约65℃的温度。
净化空气从护罩10经由由阀70控制的净化空气出口端66和出口导管68离开消毒系统，并在被放出之前进入洗涤器72。洗涤器72在已经完成消毒循环之后移除诸如二氧化氮等的剩余消毒剂。可操作地通过阀78和80连接至出口导管68的消毒剂传感器76监测出口导管68上的消毒剂浓度。净化空气通过由填充组件内产品路径的蒸汽消毒产生的热获得的传导或对流或者任何其它方便的形式由加热器进行加热，加热器可以位于HEPA过滤器壳体周围。
通过将加湿的空气与消毒剂结合为使用消毒气体做好准备，该加湿的空气具有大约50％至大约75％的相对湿度，消毒剂为诸如来自合适的源(诸如源26)的二氧化氮。在二氧化氮是消毒剂的情况下，消毒气体中二氧化氮的量为每升消毒气体大约10至大约20毫克(mg/L)。
在消毒循环期间，消毒气体在大约18℃.至大约30℃.范围的温度下接触填充组件至少20分钟，优选地在环境温度下20至大约30分钟。
前面的讨论和示例意为示意性的，而不应当作限制性的。在本发明的思想和范围内的其它变化和零件的重新排列也是可能的并且将容易地将其展示给本领域技术人员。

Claims (6)

1.一种对吹气/填充/密封机器中的填充组件进行消毒的方法，该方法包含使填充组件与消毒气体接触，该消毒气体包括湿空气和二氧化氮，其量为约10至约20毫克/升，并且在至少20分钟的时间内具有在约50％至约75％的范围内的相对湿度。
2.根据权利要求1所述的方法，其中，使所述填充组件与所述加湿的二氧化氮接触20至约30分钟的时间。
3.根据权利要求1所述的方法，其中，所述填充组件在约18℃至约30℃的温度下与所述加湿的二氧化氮气体接触。
4.根据权利要求1所述的方法，其中，所述填充组件在环境温度下与所述加湿的二氧化氮气体接触。
5.根据权利要求1所述的方法，其中，在与所述填充组件接触之前，使所述消毒气体通过HEPA过滤器。
6.根据权利要求1所述的方法，其中，至少65℃的温度的空气对所述填充组件吹扫至少20分钟以在消毒后除去残留的二氧化氮。
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US10335507B2 (en) 2019-07-02
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CN106102783A (zh) 2016-11-09
EP3096802B1 (en) 2021-03-10
EP3096802A4 (en) 2017-10-04
EP3096802A1 (en) 2016-11-30
WO2015109282A1 (en) 2015-07-23
CN106102783B (zh) 2019-12-17
JP2017507762A (ja) 2017-03-23
US10532118B2 (en) 2020-01-14

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