WO2022042324A1 - 一种组合包装及其灭菌方法 - Google Patents

一种组合包装及其灭菌方法 Download PDF

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WO2022042324A1
WO2022042324A1 PCT/CN2021/112331 CN2021112331W WO2022042324A1 WO 2022042324 A1 WO2022042324 A1 WO 2022042324A1 CN 2021112331 W CN2021112331 W CN 2021112331W WO 2022042324 A1 WO2022042324 A1 WO 2022042324A1
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layer
product
isolation
package
sterilization method
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PCT/CN2021/112331
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English (en)
French (fr)
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王占国
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美昕医疗器械(昆山)有限公司
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Publication of WO2022042324A1 publication Critical patent/WO2022042324A1/zh

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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D77/00—Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/04—Articles or materials enclosed in two or more containers disposed one within another
    • 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
    • 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
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D31/00—Bags or like containers made of paper and having structural provision for thickness of contents
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D31/00—Bags or like containers made of paper and having structural provision for thickness of contents
    • B65D31/04—Bags or like containers made of paper and having structural provision for thickness of contents with multiple walls
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D65/00—Wrappers or flexible covers; Packaging materials of special type or form
    • B65D65/38—Packaging materials of special type or form
    • B65D65/40—Applications of laminates for particular packaging purposes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D77/00—Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/10—Container closures formed after filling
    • B65D77/20—Container closures formed after filling by applying separate lids or covers, i.e. flexible membrane or foil-like covers

Definitions

  • the invention relates to the field of sterilization of medical instruments, in particular to a combined package and a sterilization method thereof.
  • the technical problem to be solved by the embodiments of the present invention is to provide a sterilization method for a combination package and a combination package, so that the combination package containing a prefilled solution, especially a physiological saline, during the ETO sterilization process, reduces the sterilization of the prefilled solution, especially the physiological saline.
  • the effect of saline pH is to provide a sterilization method for a combination package and a combination package, so that the combination package containing a prefilled solution, especially a physiological saline, during the ETO sterilization process, reduces the sterilization of the prefilled solution, especially the physiological saline.
  • the effect of saline pH is to provide a sterilization method for a combination package and a combination package, so that the combination package containing a prefilled solution, especially a physiological saline, during the ETO sterilization process, reduces the sterilization of the prefilled solution, especially the physiological saline.
  • the effect of saline pH is to provide a steriliz
  • the embodiment of the present invention provides a sterilization method for combined packaging, including:
  • the isolation assembly can block ethylene oxide gas
  • the combined package is sterilized with ethylene oxide.
  • the isolation component is a packaging bag or an inner packaging box
  • the packaging bag or inner packaging box includes one or more layers of high-barrier composite films.
  • each layer of the one or more high-barrier composite films includes at least a base layer, an isolation layer and an inner layer.
  • the base layer is a PET layer or a coated PET layer.
  • the coating of the coated PET layer is aluminum oxide or silicon oxide coating.
  • the inner layer is a CPP layer.
  • each layer of the high-barrier composite film is the base layer, the isolation layer and the inner layer respectively from the outside to the inside.
  • the sterilization method further includes: performing irradiation sterilization on a saline receptacle or syringe filled with physiological saline, wherein the first product is a saline receptacle or syringe filled with physiological saline.
  • the prefilled liquid is physiological saline;
  • the first product is a saline bottle or a prefilled syringe.
  • an embodiment of the present invention provides a combined package containing a first product that requires secondary sterilization with a pre-filled liquid, including:
  • an isolation assembly wherein the first product after irradiation sterilization is sealed in the isolation assembly, and the isolation assembly is configured to block ethylene oxide gas;
  • the combined package is a combined package obtained by sterilizing the sealed outer packaging box with ethylene oxide.
  • the isolation component is a packaging bag or an inner packaging box
  • the packaging bag or inner packaging box includes one or more layers of high-barrier composite films.
  • each layer of the high-barrier composite film at least includes a base layer, an isolation layer and an inner layer.
  • the base layer is a PET layer or a coated PET layer.
  • the coating of the coated PET layer is aluminum oxide or silicon oxide coating
  • the isolation layer is a NY layer
  • the inner layer is a CPP layer.
  • each layer of the high-barrier composite film is the base layer, the isolation layer and the inner layer respectively from the outside to the inside.
  • the prefilled liquid is physiological saline;
  • the first product is a saline bottle or a prefilled syringe.
  • the sterilization method of the combination package and the package of the combination package provided by the present invention can combine the product containing the prefilled liquid, especially the physiological saline, with other products, and can effectively reduce the amount of the combination package in the ETO sterilization process. Influence on the pH value of the prefilled solution, especially the physiological saline.
  • FIG. 1 is a schematic diagram of an external structure of a combined package provided by an embodiment of the present invention.
  • FIG. 2 is a schematic diagram of the internal structure of the first embodiment of the combined package provided by the embodiment of the present invention.
  • FIG. 3 is a schematic structural diagram of the first embodiment of the combination package provided by the embodiment of the present invention including a prefilled syringe.
  • FIG. 4 is a schematic structural diagram of a salt water bottle applied to a second embodiment of combined packaging provided by the present invention.
  • FIG. 5 is a schematic diagram of the double-layer structure of the isolation component package provided by the present invention.
  • FIG. 6 is a schematic diagram of a single-layer structure of the isolation assembly provided by the present invention.
  • Fig. 7 is a flow chart of the sterilization method of the combined package provided by the present invention.
  • FIG. 1 is a schematic diagram of the external structure of the combined package provided by the embodiment of the present invention
  • FIG. 2 is a schematic diagram of the internal structure of the first embodiment of the combined package provided by the embodiment of the present invention
  • FIG. The first embodiment of the combination package provided by the embodiment of the invention contains a schematic structural diagram of a pre-filled syringe.
  • the combination package 10 shown in FIG. 1 contains a first product 20 that requires pre-filled liquid for secondary sterilization.
  • the first product 20 is a syringe prefilled with normal saline.
  • the combined package 10 includes: an isolation component 200 , a first product 20 , an outer packaging box 100 , and a second product 30 packaged together in the outer packaging box 100 .
  • the first product 20 after irradiation sterilization is sealed in the isolation assembly 200, and the isolation assembly 200 is used for blocking ethylene oxide gas.
  • the sealed outer packaging box is sterilized by ethylene oxide.
  • the first product 20 is a syringe prefilled with saline. Further, the first product 20 may be a syringe prefilled with physiological saline at a concentration of 0.9%.
  • the prefilled syringes with 0.9% saline can have different sizes, eg 3ml, 5ml, 10ml, 20ml, etc.
  • concentration of physiological saline is 0.9%, which is only an example to illustrate the technical solutions of the embodiments of the present invention, and other concentrations of physiological saline can also be used according to experimental or clinical requirements.
  • FIG. 4 is a schematic structural diagram of a saline bottle applied to a second embodiment of combined packaging according to an embodiment of the present invention.
  • the saline bottle 60 shown in FIG. 4 can also be placed in the isolation assembly 610 as the first product and then placed together in a combination package.
  • the spacer assembly 200 is the inner box relative to the outer box.
  • the inner packaging box includes an isolation box body 221 and an isolation cover 222 , wherein the isolation box body 221 and the isolation cover 222 are configured to contain the high-barrier composite film 70 .
  • the isolation box body 221 and the isolation cover 222 are sealed by blistering, or are directly made of a high-barrier composite film.
  • the high-barrier composite film 70 at least includes a base layer 71 , an isolation layer 72 and an inner layer 73 .
  • the base layer 71 is a PET (Polyethylene Terephthalate, polyethylene terephthalate) layer or a coated PET layer.
  • a coated PET layer is preferably used, and the coating of the coated PET layer is an aluminum oxide or silicon oxide coating.
  • the isolation layer 72 is a NY (Nylon, nylon) layer, or called PA (Polyamide, polyamide).
  • the inner layer 73 is a CPP (Current Polypropylene, cast polypropylene) layer.
  • the high-barrier composite film 70 is respectively a base layer 71 , an isolation layer 72 and an inner layer 73 from the outside to the inside. Wherein, the thickness of the high-barrier composite film 70 is in the range of 80-130 ⁇ m, preferably 103 ⁇ m.
  • the high-barrier composite film may also be an EVOH (Ethylene vinyl alcohol copolymer, ethylene/vinyl alcohol copolymer) high-barrier composite film.
  • EVOH Ethylene vinyl alcohol copolymer, ethylene/vinyl alcohol copolymer
  • the isolation box body 221 and the isolation cover 222 of the isolation assembly 200 may each include two high-barrier composite film layers 70 , as shown in FIG. 5 .
  • the box body 221 and the cover 222 can also be fabricated using more high-barrier composite film layers.
  • the isolation assembly 610 in the second embodiment can also be a packaging bag, and the packaging bag can also be made of the high-barrier composite film 70 .
  • the outer packaging box 100 includes an outer box body 110 and an outer cover body 120 , which are sealed by means of blister.
  • the outer packaging box 100 in addition to the isolation component 200 containing the first product 20 , the outer packaging box 100 also accommodates the second product 30 .
  • a third product 40 and a fourth product 50 may be placed in the outer packaging box, and the above-mentioned second product 30, third product 40 and fourth product 50 may include disposable gloves, Gauze or other accessories.
  • Sterilization methods for the packaging components shown in Figures 1-3 include:
  • Step S10 the first product containing the pre-filled liquid after irradiation sterilization is loaded into an isolation assembly capable of blocking ethylene oxide gas and sealed;
  • Step S20 the isolation assembly containing the first product and the second product are put into the outer packaging box together to form a sealed combined package
  • Step S30 performing ethylene oxide sterilization on the sealed combined package.
  • the pH value of the unpackaged pre-filled saline bottle 60 after ETO sterilization will rise to more than 9, which is far beyond the required value. This proves that the saline bottle using this packaging method is suitable for use in other packages. ETO sterilization is carried out in equipment packages such as , boxes, etc., to inhibit the increase of the pH value of physiological saline.
  • Table 1 shows the pH value test data of the unpackaged and sterilized saline bottle 60 and the pH value test data of ETO sterilization after being sealed in the isolation assembly 610 and formed into a combined package.
  • the pH value test of ETO sterilization is carried out after the pre-filled physiological saline syringe 20 is sealed in the isolation assembly and formed into a combined package, and it is found that the pre-filled liquid can be effectively reduced compared with the packaging provided by the embodiment of the present invention.
  • the sterilization method of the combination package and the package of the combination package provided by the present invention can combine the product containing the prefilled liquid, especially the physiological saline, with other products, and can effectively reduce the amount of the combination package in the ETO sterilization process. Influence on the pH value of the prefilled solution, especially the physiological saline.

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  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
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  • General Chemical & Material Sciences (AREA)
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Abstract

一种组合包装（10）的灭菌方法，包括：将辐照灭菌后的装有预装液体的第一产品（20）装入隔离组件（200）内并进行密封，隔离组件（200）能够阻隔环氧乙烷气体；将装有第一产品（20）的隔离组件（200）和第二产品（30）一同装入外包装盒（100）内形成密封的组合包装（10）；对组合包装（10）进行环氧乙烷灭菌。相应的，还公开了一种组合包装（10）。组合包装（10）的灭菌方法以及组合包装（10）可以将含有预装液的产品和其他产品组合，能够有效降低在ETO灭菌过程中对预装液的pH值的影响。

Description

一种组合包装及其灭菌方法
本申请要求于2020年8月25日提交中国国家知识产权局、申请号为202010862106.8、发明名称为“一种组合包装及其灭菌方法”的中国专利申请的优先权，上述专利的全部内容通过引用结合在本申请中。
技术领域
本发明涉及医疗器械灭菌领域，尤其是一种组合包装及其灭菌方法。
背景技术
在医用领域，常常需要一种组合器械以方便医疗过程中使用，其中含有预装液的产品尤其是预充生理盐水的产品，需求广泛。但由于目前市场上的预灌装0.9％生理盐水的注射器及盐水瓶在经过ETO(Ethylene Oxide，环氧乙烷)灭菌后，生理盐水的pH值均会升高，因此，如果将预装液产品和其他产品例如纱布等作为一个组合包产品，则需要对整个产品包进行再次灭菌，而这类产品往往采用ETO灭菌，实验表明，经过ETO灭菌后，预装液尤其是生理盐水的pH值会升高，对人体会有一定影响。而为了保证预装液尤其是生理盐水的pH值时，则无法进行组包，给生产商以及医护使用者带来不变。
发明内容
本发明实施例所要解决的技术问题在于，提供一种组合包装的灭菌方法以及组合包装，使得含有预装液尤其是生理盐水的组合包在 ETO灭菌过程中，降低对预装液尤其是生理盐水的pH值的影响。
为了解决上述技术问题，本发明实施例提供了一种组合包装的灭菌方法，包括：
将辐照灭菌后的装有预装液体的第一产品装入隔离组件内并进行密封，所述隔离组件能够阻隔环氧乙烷气体；
将装有所述第一产品的所述隔离组件和第二产品一同装入外包装盒内形成密封的组合包装；
对所述组合包装进行环氧乙烷灭菌。
进一步的，所述隔离组件为包装袋或内包装盒，所述包装袋或内包装盒包括一层或多层高阻隔复合膜。
进一步的，所述一层或多层高阻隔复合膜的每一层至少包括基层、隔离层以及内层。
进一步的，所述基层为PET层或镀膜PET层。
进一步的，所述镀膜PET层的镀膜为氧化铝或氧化硅镀膜。
进一步的，所述内层为CPP层。
进一步的，每层所述高阻隔复合膜从外到内分别为所述基层、所述隔离层以及所述内层。
进一步的，所述灭菌方法还包括：对灌装有生理盐水的盐水甁或注射器进行辐照灭菌，其中所述第一产品为灌装有生理盐水的盐水甁或注射器。
进一步的，所述预装液体为生理盐水；所述第一产品为盐水瓶或预灌装注射器。
相应的，本发明实施例提供一种组合包装，含有需要二次灭菌的预装液体的第一产品，包括：
隔离组件，该隔离组件内密封有辐照灭菌后的所述第一产品，所 述隔离组件被构造成能够阻隔环氧乙烷气体；
外包装盒，其内密封有所述第一产品的所述隔离组件和第二产品；
其中，所述组合包装是对密封的所述外包装盒进行环氧乙烷灭菌后得到的组合包装。
进一步的，所述隔离组件为包装袋或内包装盒，所述包装袋或内包装盒包括一层或多层高阻隔复合膜。
进一步的，每层所述高阻隔复合膜至少包括基层、隔离层以及内层。
进一步的，所述基层为PET层或镀膜PET层。
进一步的，所述镀膜PET层的镀膜为氧化铝或氧化硅镀膜；
进一步的，所述隔离层为NY层，所述内层为CPP层。
进一步的，每层所述高阻隔复合膜从外到内分别为所述基层、所述隔离层以及所述内层。
进一步的，所述预装液体为生理盐水；所述第一产品为盐水瓶或预灌装注射器。
由上述技术方案可知，本发明提供的组合包装的灭菌方法以及组合包的包装可以将含有预装液尤其是生理盐水的产品和其他产品组合，且能够有效降低组合包在ETO灭菌过程中对预装液尤其是生理盐水的pH值的影响。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，根据这些附图获 得其他的附图仍属于本发明的范畴。
图1为本发明实施例提供的组合包装的外部结构示意图。
图2为本发明实施例提供的组合包装的第一实施例的内部结构示意图。
图3为本发明实施例提供的组合包装的第一实施例含有预灌装注射器的结构示意图。
图4为本发明提供的应用于组合包装第二实施例的盐水瓶的结构示意图。
图5为本发明提供的隔离组件包装的双层结构示意图。
图6为本发明提供的隔离组件的单层结构示意图。
图7为本发明提供的组合包装的灭菌方法的流程图。
具体实施方式
以下各实施例的说明是参考附图，用以式例本发明可以用以实施的特定实施例。本发明所提到的方向用语，例如「上」、「下」、「前」、「后」、「左」、「右」、「内」、「外」、「侧面」等，仅是参考附加图式的方向。因此，使用的方向用语是用以说明及理解本发明，而非用以限制本发明。
为使本发明的目的、技术方案和优点更加清楚，下面将结合附图对本发明作进一步地详细描述。
如图1-图3所示，图1为本发明实施例提供的组合包装的外部结构示意图，图2为本发明实施例提供的组合包装的第一实施例的内部结构示意图，图3为本发明实施例提供的组合包装的第一实施例含有 预灌装注射器的结构示意图，图1所示的组合包装10，含有需要二次灭菌的预装液体的第一产品20。在一个实施例中，该第一产品20为预灌装了生理盐水的注射器。如图2所示，组合包装10包括：隔离组件200、第一产品20、外包装盒100，以及一同包装于外包装盒100内的第二产品30。隔离组件200内密封有辐照灭菌后的第一产品20，隔离组件200用于阻隔环氧乙烷气体。外包装盒100内封装有第一产品20的隔离组件200和其他产品后对密封的外包装盒进行环氧乙烷灭菌。
在图示的实施例中，第一产品20为预灌装生理盐水的注射器。进一步的，第一产品20可以是预灌装浓度为0.9％的生理盐水的注射器。预灌装的浓度为0.9％的生理盐水的注射器可以具有不同规格，例如3ml、5ml、10ml、20ml等。
本领域技术人员能够理解生理盐水的浓度为0.9％仅为示例用于说明本发明实施例的技术方案，根据实验或临床的要求也可以是其他浓度的生理盐水。
图4为根据本发明实施例提供的应用于组合包装第二实施例的盐水瓶的结构示意图。图4所示的盐水瓶60也可以作为第一产品装入隔离组件610内后一起置放到组合包装内。
在如图2所示的本发明第一实施例的组合包装内，隔离组件200是相对于外包装盒的内包装盒。该内包装盒包括隔离盒体221以及隔离封盖222，其中隔离盒体221以及隔离封盖222被构造为包含高阻隔复合膜70。隔离盒体221以及隔离封盖222通过吸塑方式密封，或直接由高阻隔复合膜制成。参见图7，高阻隔复合膜70至少包括基层71、隔离层72以及内层73。在本发明实施例中，基层71为PET (Polyethylene Terephthalate，聚对苯二甲酸乙二醇酯)层或镀膜PET层。本发明实施例优选使用镀膜PET层，镀膜PET层的镀膜为氧化铝或氧化硅镀膜。隔离层72为NY(Nylon，尼龙)层，或称为PA(Polyamide，聚酰胺)。内层73为CPP(Current Polypropylene，流延聚丙烯)层。高阻隔复合膜70从外到内分别为基层71、隔离层72以及内层73。其中，高阻隔复合膜70的厚度范围在为80-130μm，优选的为103μm。
在其他实施方式中，高阻隔复合膜还可以是EVOH(Ethylene vinyl alcohol copolymer,乙烯/乙烯醇共聚物)高阻隔复合膜。
为了达到更好的隔离效果，隔离组件200的隔离盒体221和隔离封盖222各自可以包含两个高阻隔复合膜层70，参见图5所示。然而，盒体221和封盖222还可以采用更多层高阻隔复合膜层来制造。参见图4，第二实施例中的隔离组件610还可以为包装袋，该包装袋也可以由高阻隔复合膜70制成。
参见图2和图3，外包装盒100包括外部盒体110以及外部盖体120，二者采用吸塑方式密封。在一实施方式中，外包装盒100内除了置放含有第一产品20的隔离组件200外，还置放有第二产品30。进一步地，在另一种实施方式中，外包装盒内还可以置放第三产品40以及第四产品50，上述第二产品30、第三产品40以及第四产品50可以包括一次性手套、纱布或其他辅料。
对于图1-图3所示的包装组件的灭菌方法包括：
步骤S10，将辐照灭菌后的装有预装液体的第一产品装入能够阻隔环氧乙烷气体的隔离组件内并进行密封；
步骤S20，将装有第一产品的隔离组件和第二产品一同装入外包装盒内形成密封的组合包装；
步骤S30，对密封的组合包装进行环氧乙烷灭菌。
经多次实验证明，预灌装生理盐水的盐水甁采用高阻隔复合膜制成的预制包装进行包装，在ETO灭菌过程中，可有效地抑制生理盐水pH值升高，而且本发明实施例不仅仅使pH值保持在4.5-7.0之间,如表1所示，灭菌后与原pH值之间的变化量也非常少。
而未包装的预灌装生理盐水的盐水瓶60在ETO灭菌之后，pH值会升高至9以上，远远超出要求值，进而证明采用此包装方式的盐水瓶适用于配置在其它包类、盒类等器械包中进行ETO灭菌，用来抑制生理盐水pH值升高。
表1为盐水瓶60未包装和灭菌情形下的pH值试验数据以及密封在隔离组件610内并形成组合包装后进行ETO灭菌的pH值试验数据。
表1
Figure PCTCN2021112331-appb-000001
同样地，对预灌装生理盐水的注射器20密封在隔离组件内并形成组合包装后进行ETO灭菌的pH值试验，发现与未进行本发明实施例提供的包装相比能够有效降低预装液如生理盐水的pH值。
由上述技术方案可知，本发明提供的组合包装的灭菌方法以及组合包的包装可以将含有预装液尤其是生理盐水的产品和其他产品组合，且能够有效降低组合包在ETO灭菌过程中对预装液尤其是生理盐水的pH值的影响。
以上所揭露的仅为本发明一种较佳实施例而已，当然不能以此来限定本发明之权利范围，因此依本发明权利要求所作的等同变化，仍属本发明所涵盖的范围。

Claims (17)

  1. 一种组合包装的灭菌方法，包括：
    将辐照灭菌后的装有预装液体的第一产品装入隔离组件内并进行密封，所述隔离组件能够阻隔环氧乙烷气体；
    将装有所述第一产品的所述隔离组件和第二产品一同装入外包装盒内形成密封的组合包装；
    对所述组合包装进行环氧乙烷灭菌。
  2. 如权利要求1所述的灭菌方法，其特征在于，所述隔离组件为包装袋或内包装盒，所述包装袋或内包装盒包括一层或多层高阻隔复合膜。
  3. 如权利要求2所述的灭菌方法，其特征在于，每层所述一层或多层高阻隔复合膜至少包括基层、隔离层以及内层。
  4. 如权利要求3所述的灭菌方法，其特征在于，所述基层为PET层或镀膜PET层。
  5. 如权利要求4所述的灭菌方法，其特征在于，所述镀膜PET层的镀膜为氧化铝或氧化硅镀膜。
  6. 如权利要求4所述的灭菌方法，其特征在于，所述隔离层为NY层，所述内层为CPP层。
  7. 如权利要求3-6任一项所述的灭菌方法，其特征在于，每层所述高阻隔复合膜从外到内分别为所述基层、所述隔离层以及所述内层。
  8. 如权利要求1所述的灭菌方法，其特征在于，所述灭菌方法还包括：
    对灌装有生理盐水的盐水甁或注射器进行辐照灭菌，其中所述第一产品为灌装有生理盐水的盐水甁或注射器。
  9. 如权利要求1所述的灭菌方法，其特征在于，所述预装液体 为生理盐水；所述第一产品为预灌装好的盐水瓶或注射器。
  10. 一种组合包装，包括：
    经辐照灭菌后的第一产品，所述第一产品灌装有预装液体，
    隔离组件，该隔离组件内密封有辐照灭菌后的所述第一产品，所述隔离组件被构造成能够阻隔环氧乙烷气体；
    外包装盒，其内密封有所述第一产品的所述隔离组件和第二产品；
    其中，所述组合包装是对密封的所述外包装盒进行环氧乙烷灭菌后得到的组合包装。
  11. 如权利要求10所述的组合包装，其特征在于，所述隔离组件为包装袋或内包装盒，所述包装袋或内包装盒包括一层或多层高阻隔复合膜。
  12. 如权利要求11所述的组合包装，其特征在于，每层所述高阻隔复合膜至少包括基层、隔离层以及内层。
  13. 如权利要求12所述的组合包装，其特征在于，所述基层为PET层或镀膜PET层。
  14. 如权利要求13所述的组合包装，其特征在于，所述镀膜PET层的镀膜为氧化铝或氧化硅镀膜。
  15. 如权利要求13所述的组合包装，其特征在于，所述隔离层为NY层，所述内层为CPP层。
  16. 如权利要求12-15任一项所述的组合包装，其特征在于，每层所述高阻隔复合膜从外到内分别为所述基层、所述隔离层以及所述内层。
  17. 如权利要求10所述的组合包装，其特征在于，所述预装液体为生理盐水；所述第一产品为盐水瓶或预灌装注射器。
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