CN212922712U

CN212922712U - Combined package

Info

Publication number: CN212922712U
Application number: CN202021790472.9U
Authority: CN
Inventors: 王占国
Original assignee: Amsino Medical Kunshan Co ltd
Current assignee: Amsino Medical Kunshan Co ltd
Priority date: 2020-08-25
Filing date: 2020-08-25
Publication date: 2021-04-09
Anticipated expiration: 2030-08-25

Abstract

Embodiments of the present invention provide a combination package containing a liquid-prefilled first product requiring secondary sterilization, comprising: the isolation assembly is internally sealed with the first product after irradiation sterilization and is used for blocking ethylene oxide gas; the isolation assembly is a packaging bag or an inner packaging box, and the packaging bag or the inner packaging box comprises an EVOH high-barrier composite film; an outer packaging box containing the insulation assembly of the first product and a second product for ethylene oxide sterilization. The combined bag provided by the invention can combine a product containing a pre-filled liquid, particularly normal saline, with other products, and can effectively reduce the influence of the combined bag on the pH value of the pre-filled liquid, particularly normal saline, in the ETO sterilization process.

Description

Combined package

Technical Field

The invention relates to the field of sterilization of medical instruments, in particular to a combined package.

Background

In the medical field, there is often a need for a combination device to facilitate use during medical procedures, where products containing pre-filled fluids, particularly pre-filled saline, are in wide demand. However, since the pH of the normal saline in the syringes and saline bottles pre-filled with 0.9% normal saline in the current market is increased after ETO (Ethylene Oxide) sterilization, if the pre-filled liquid product and other products such as gauze are used as a packaged product, the whole product package needs to be sterilized again, and these products are often sterilized by ETO. In order to ensure the pH value of the pre-filled liquid, especially the physiological saline, the pre-filled liquid cannot be packaged, so that the packaging is not changed for manufacturers and medical care users.

Disclosure of Invention

The technical problem to be solved by the embodiments of the present invention is to provide a method for sterilizing a combined bag and a combined package, so that the influence of a pre-filled liquid, especially a physiological saline solution, on the pH of the pre-filled liquid is reduced during ETO sterilization.

In order to solve the technical problem, an embodiment of the present invention provides a sterilization method for a combination package, including:

filling the first product filled with the pre-filled liquid after irradiation sterilization into an isolation assembly and sealing, wherein the isolation assembly is used for blocking ethylene oxide gas; the isolation assembly is a packaging bag or an inner packaging box, and the packaging bag or the inner packaging box comprises an EVOH high-barrier composite film;

placing the barrier assembly containing the first product and a second product together in an outer packaging box to form a combined package;

the combination package is ethylene oxide sterilized.

Further, the packaging bag or the inner packaging box comprises at least two layers of EVOH high-barrier composite films.

Furthermore, the EVOH high-barrier composite film comprises a printing layer, a PA layer, a polyurethane adhesive layer, an EVOH co-extrusion film layer, a polyurethane adhesive layer and a PE layer;

furthermore, the EVOH co-extrusion film layer is sequentially PE, PA, EVOH, PA and PE.

Further, the pre-filled liquid is normal saline; the first product is a saline bottle or a pre-filled syringe.

Accordingly, the present invention provides a combination package containing a liquid-prefilled first product requiring secondary sterilization, comprising:

the isolation assembly is internally sealed with the first product after irradiation sterilization and is used for blocking ethylene oxide gas; the isolation assembly is a packaging bag or an inner packaging box, and the packaging bag or the inner packaging box comprises an EVOH high-barrier composite film;

an outer packaging box containing the insulation assembly of the first product and a second product for ethylene oxide sterilization.

Furthermore, the EVOH high-barrier composite film comprises a printing layer, a PA layer, a polyurethane adhesive layer, an EVOH co-extrusion film layer, a polyurethane adhesive layer and a PE layer.

According to the technical scheme, the sterilization method of the combined package and the package of the combined package can combine a product containing a pre-filled liquid, particularly normal saline, with other products, and can effectively reduce the influence of the combined package on the pH value of the pre-filled liquid, particularly the normal saline, in the ETO sterilization process.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is within the scope of the present invention for those skilled in the art to obtain other drawings based on the drawings without creative efforts.

Fig. 1 is a schematic external structural view of a combination package according to an embodiment of the present invention.

Fig. 2 is a schematic view of the internal structure of a first embodiment of the combination package according to the present invention.

Fig. 3 is a schematic diagram of a first embodiment of a combination package according to the present invention including a pre-filled syringe.

Fig. 4 is a schematic structural diagram of a saline bottle of a second embodiment of the combination package provided by the invention.

Fig. 5 is a schematic view of a two-layer structure of the insulation package according to the present invention.

Fig. 6 is a schematic view of a single-layer structure of the isolation device provided by the present invention.

Fig. 7 is a flow chart of a sterilization method for the combination package provided by the present invention.

Detailed Description

The following description of the embodiments refers to the accompanying drawings that illustrate specific embodiments in which the invention may be practiced. In the present invention, directional terms such as "up", "down", "front", "back", "left", "right", "inner", "outer", "side", etc. refer to directions of the attached drawings. Accordingly, the directional terms used are used for explanation and understanding of the present invention, and are not used for limiting the present invention.

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in further detail with reference to the accompanying drawings.

As shown in fig. 1 to 3, fig. 1 is a schematic external structure diagram of a combination package provided by an embodiment of the present invention, fig. 2 is a schematic internal structure diagram of a first embodiment of the combination 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 containing a prefilled syringe, fig. 1 is a combination package 10, the first product 20 containing a prefilled liquid requiring secondary sterilization is a syringe prefilled with physiological saline, and the combination package comprises: a barrier assembly 200, a first product 20 after radiation sterilization, an outer package 100, and a second product 30 packaged simultaneously within the outer package 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 outer box 100 contains the insulation assembly 200 of the first product 20 along with the ethylene oxide sterilization.

In this embodiment, the first product 20 is a syringe pre-filled with physiological saline, further, the first product 20 is a syringe pre-filled with 0.9% physiological saline, and the syringe pre-filled with 0.9% physiological saline may have different specifications, such as 3ml, 5ml, 10ml, 20ml, and the like. Fig. 4 is a schematic structural diagram of a saline bottle according to a second embodiment of the combination package provided by the present invention, and the saline bottle 60 shown in fig. 4 can also be filled into the combination package of the insulation assembly 60 as a second product.

The isolation assembly 200 shown in fig. 2 is an inner package box, and includes an isolation box 221 and an isolation cover 222, wherein the isolation box 221 and the isolation cover 222 include an EVOH high barrier composite film 70, and the isolation box 221 and the isolation cover 222 are sealed by a blister method or directly made of the EVOH high barrier composite film. Referring to fig. 7, the evohcoevoh (Ethylene Vinyl Alcohol Copolymer) high barrier composite film 70 includes a printing layer, a PA (Polyamide) layer, a polyurethane adhesive layer, a EVOH co-extrusion film layer, a polyurethane adhesive layer, and a PE (Polyethylene) layer, wherein the EVOH co-extrusion film layer is PE, PA, EVOH, PA, PE in this order. Preferably, for better insulation, the insulation box 221 and the insulation cover 222 of the insulation assembly 200 comprise two EVOH high-barrier composite film layers 70, as shown in fig. 6, and more EVOH high-barrier composite film layers may be used. Referring to fig. 4, the isolation assembly 610 may also be a packaging bag made of EVOH high barrier composite film, preferably two high barrier composite films 70 are used, and the thickness of the single high barrier composite film 70 may be flexibly adjusted according to experimental data and actual requirements.

Referring to fig. 2 and 3, the external packing box 100 includes an external box body 110 and an external cover body 120, which are sealed by vacuum forming, and include a second product 30, a third product 40 and a fourth product 50 in addition to a separation assembly 200 containing a first product 20, wherein the second product 30, the third product 40 and the fourth product 50 may be disposable gloves, gauze or other accessories.

The sterilization method for the package assembly shown in fig. 1-3 is:

step S10, placing the first product 20 filled with the pre-filled liquid after radiation sterilization into an isolation assembly 200 and sealing, wherein the isolation assembly 200 is used for blocking ethylene oxide gas;

step S20, placing the spacer assembly 200 with the first product 20 and the second product into the outer packaging box 100 together to form the combination package 10;

step S30, ethylene oxide sterilization is performed on the combination package.

The following table is a pH test of ETO sterilization of saline bottle 60 in isolation assembly 610:

multiple experiments prove that the saline bottle 60 packaged by the prefabricated packaging bag 610 of the high-barrier PA/PE co-extrusion film can effectively inhibit the pH value of the physiological saline from rising in the ETO sterilization process (the pH value of the unpacked prefabricated saline bottle 60 can rise to more than 9 after the ETO sterilization and is far beyond the required value), not only can the pH value be kept between 4.5 and 7.0, but also the variation between the sterilized saline bottle and the original pH value is very small, the experimental result of the prefabricated packaging box 200 packaged by the injector 20 of the prepacked physiological saline by adopting the high-barrier composite film also obtains the same conclusion, and further proves that the saline bottle adopting the packaging method is suitable for being configured in other bags, boxes and other instrument bags for ETO sterilization and is used for inhibiting the pH value of the physiological saline from rising.

While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.

Claims

1. A combination package containing a first product prefilled with a liquid requiring secondary sterilization, comprising:

2. The combination package according to claim 1, wherein the packaging bag or the inner pack comprises at least two layers of EVOH high barrier composite film.

3. The combination package according to claim 2, wherein the EVOH high barrier composite film comprises a printed layer, a PA layer, a polyurethane adhesive layer, an EVOH co-extruded film layer, a polyurethane adhesive layer, a PE layer.

4. A combination package according to claim 3, wherein the co-extruded EVOH film layer is in the order PE, PA, EVOH, PA, PE.

5. The combination package of claim 4, wherein the pre-filled liquid is saline; the first product is a saline bottle or a pre-filled syringe.

6. The combination package of claim 2, wherein the inner package comprises a containment box and a containment flap, the containment box and the containment flap being blister seals.

7. The combination package of claim 2 wherein the outer box comprises an outer box and an outer lid, the outer box and the outer lid being sealed with a blister.