RU159913U1 - PACKING FOR PRODUCTS TO BE FINISHED STERILIZATION - Google Patents

Abstract

1. Packaging for products to be finished sterilization, made in the form of a flat rectangular bag made of a polymer film, with the formation of longitudinal and transverse seams of the inner cavity, characterized in that the longitudinal and transverse seams are formed by thermal welding, and the polymer film contains a perforation area coated on the inside of the package with gas sterilization paper thermally welded with a polymer film along the perforation area. 2. Packaging according to claim 1, characterized in that the longitudinal welds formed by the polymer film and paper are made in the amount of two, and formed by the edges of the film web in the amount of one. 3. Packaging according to claim 1, characterized in that the number of transverse welds before packing the product is one, and after packing the product - two, which are partially formed by film with film and film with paper. 4. Packaging according to claim 1, characterized in that the polymer film is made single-layer or multilayer. Packaging according to claim 1, characterized in that the polymer film is made transparent or opaque. Packaging according to claim 1, characterized in that the perforation area is made of round holes. Packaging according to claim 1, characterized in that the perforation region is made of through holes in the form of longitudinal and / or transverse stripes. A package according to claim 1, characterized in that the shape, size and number of through holes depend on the characteristics, material, dimensions of the package, product and sterilization method. Packaging according to claim 1, characterized in that the packaging weld is formed by a polymer film and paper for gas sterilization without perforation in the film. Packaging according to claim 1, characterized in that

Description

The utility model relates to the field of packaging and is intended for sterilization of medical devices in various ways (air, steam, gas (ethylene oxide), ultraviolet, radiation (gamma radiation), as well as for their storage and transportation.

A packaging container is known (RF patent No. 2225226, IPC A61L 2/20, publ. March 10, 2004) comprising a housing made of a synthetic resin having gas impermeability and sterile paper capable of passing gaseous hydrogen peroxide and also welded to the housing . At the same time, the case has a special shape, which guarantees a sufficient gas permeability area of sterile paper, which seals the container body, when layering injection kits.

Known packaging for sterilization of medical devices (RF patent No. 133730, IPC A61L 2/26, publ. 10/27/2013), made in the form of a package formed by at least two walls of sheet material connected by airtight seams, with the possibility of sealing after loading the sterilized products into the bag, and part of one of the walls of the bag is made of transparent material.

Known packaging (RF patent No. 97347, IPC B65D 27/00, publ. 09/10/2010), the closest in technical essence and adopted as a prototype, made in the form of a rectangular single-layer bag made of a transparent polymer film with the formation of internal cavities with seams, moreover, in the upper part of the package contains the mouth with a closing valve with an adhesive strip applied to it, closed with a protective tape, and at least one of the sides of the package contains an insert made of vapor-permeable and breathable not rozrachnogo nonwoven.

However, these packages have the following disadvantages:

- the complicated process of manufacturing the packaging material and the packaging itself due to the inclusion of an additional operation of applying an adhesive layer (grating, area) to the film for welding it with gas-permeable paper for ethylene oxide or gas-permeable paper for ethylene oxide for welding it with a film;

- increasing the cost of packaging due to the complicated process of its manufacture;

- printing is applied either on the inner layer, which in the case of poor-quality printing or improperly selected ink, the ink itself may peel off into the internal environment of the packaging, get on the packaging product or inside it, which can lead to distortion of the analysis results, allergic reactions, inflammations or other undesirable consequences ;

- printing is applied either on the outer layer, which in the case of poor-quality printing or improperly selected ink, the ink itself may brighten and lead to fuzzy or incomplete marking, thus leading to a violation of the requirements for marking products (material, product, goods);

- gas-permeable paper for gas sterilization with ethylene oxide, which is located outside the package, can get wet, dirty and make the package unappealing if the consumer does not comply with the transportation conditions;

- The short shelf life of the sterility of packaged medical instruments (material, product, product).

The objective of the claimed utility model is to create a package, mainly for medical devices, of a new design containing a gas-permeable material for sterilization, and with the following advantages:

- the possibility of sterilization of products, goods, etc. predominantly in a transparent package of film polymeric materials, having a through-hole region coated with gas sterilization paper, using a gas mixture of ethylene oxide (100% EtO) or a mixture consisting of ethylene oxide and carbon dioxide;

- the possibility of gas sterilization of ethylene oxide due to the presence of through holes in the film coated with paper for gas sterilization;

- simplification of the production of film production, because it is mass-produced; the costs of its production are reduced; widespread polymer films on the market and their availability;

- simplification of the release process of the package and reduce its time by eliminating additional operations for applying the adhesive layer (grating, area) on a film or paper gas-permeable for gas sterilization;

- simplification of packaging design;

- improving the tightness and increasing the strength of the packaging joints due to the presence of an activated layer on one side of the film (on the inside of the package) and, as a result, reducing the cost of packaging;

- improving the visual control of the contents of the package from all sides through the use of transparent film materials with a one-sided activated layer except for the portion of the film coated with gas-permeable paper for gas sterilization;

- improving the appearance of the packaging due to high-quality seams and interlayer printing;

- improved usability due to the presence of the “easy opening” function: there is a special notch on the horizontal seam of the bag or its edge is made with a zig-zag cut;

- improving the attractiveness of the package due to the fact that the film protects the paper, which, welded along the perforated area, is inside the package, thus preventing accidental wetting and contamination of the printed information; gas-permeable for gas sterilization, covering it from the outside (the side of the film with paper forms its inner region), thus preventing its accidental wetting and contamination;

- maintaining the quality of the products themselves, namely, the operational (functional) properties of the sterile product (medical device, product, etc.) for the entire storage period (at least 5 years) of the sterilized products, due to the fact that ethylene oxide does not cause corrosion of metals, does not spoil and does not decompose the structure of polymer material and packaging materials from paper and polymer films;

- expanded the ability to sterilize medical devices (materials, goods, etc.) in this package in various ways: gas (ethylene oxide), radiation (gamma radiation), steam, air;

- the ability to sterilize medical and other products by a gas method using ethylene oxide in gentle conditions with minimal concentrations, as a result of which the residual dose of ethylene oxide is reduced on the surface of the sterilized product;

- the ability to sterilize heat-sensitive materials (polymers and polymer parts, rubber, implants, vascular prostheses, pacemakers and others, optics, electronic components, medical devices intended for single use, metal products, and others) due to the high penetrating ability of ethylene oxide. To date, many medical devices, for example, “Containers for bioassay polymers” were packed in three-seam bags made of film materials, the sterilization of which was carried out by γ-rays (radiation method).

The technical result achieved by the claimed utility model is to ensure sterilization by various methods of medical devices without opening the package, mainly by gas sterilization with ethylene oxide, improving the strength of the packaging due to the film, and also increasing the reliability during storage of packaged products and their transportation.

The inventive packaging is distinguished by a new combined packaging material consisting of a polymer film, mainly with an activated layer having a perforation region — a through-hole region covered with gas sterilization paper, which is predominantly thermally welded with a polymer single-layer or multilayer film.

Also additionally achieved:

- simplification of the manufacture of packaging,

- simplification of packaging design,

- increase the tightness and strength of the package,

- increased usability,

- improved visual control of the contents of the package,

- improving the appearance of the package, its aesthetic properties,

- the ability to sterilize medical and other products, as well as products from heat-sensitive materials, using the ethylene oxide gas method, preserving the quality of the products after sterilization, namely: operational (functional) properties.

The utility model is illustrated in the figures:

in Fig 1 (a, b, c) shows the packaging made in the form of a package, where

a) a package in which the transverse weld has an edge in the form of a straight cut with a notch,

b) a package in which the transverse weld has a zigzag edge;

c) packaging closed by two transverse welds with contents inside (product).

in FIG. 2 (a, b) shows the combined packaging material for packaging, where a) a sheet with two longitudinal seams, b) a sleeve with three longitudinal seams.

The inventive packaging consists of the following elements.

1 - polymer film with an activated layer.

By activated layer is meant a corona treated film layer. The activated LDPE layer is necessary for good weldability of the film with gas-permeable paper.

2 - gas-permeable paper

3 - region of through holes.

4 - longitudinal welds formed between the film and paper, limiting the area of through holes

5 - holes (in the amount of n).

The number of holes depends on the dimensions of the packaged product and the dimensions of the package itself.

The holes are made mainly round, can also be made in the form of strips.

6 is a longitudinal weld formed by the edges of the polymer film.

7 - transverse weld.

8 - notch.

9 - zigzag edge of the transverse seam.

10 - transverse weld, and the edge of each transverse weld may have a notch (Fig. 1a) or be made in a zigzag shape (Fig. 1b).

11 - the product inside the package with sealed transverse seams.

The inventive package in the form of a bag (Fig. 1a, b, c) has a transparent polymer film 1, mainly with an activated layer, having a perforation region of 3 through holes 5 (where holes 5 are made in the amount of n, covered with paper 2 for gas sterilization, which is predominantly thermally welded with a polymer film 1 with the formation of longitudinal welds 4 and a transverse weld 7, forming with the help of seams 6 and 7 the internal cavity of the bag, where, in advance, before the thermal soldering of the second transverse weld 10 (sealing of the bag), the product 11 (product, product, etc.) is placed, while the inner cavity of the bag contains paper 2 for gas sterilization with ethylene oxide, covering the perforation region 3 in the polymer film 1 and thermally welded with the polymer film 1.

The number of holes 5, their location and diameter, as well as the shape of the region 3 with perforation itself depends on the characteristics of the product being packaged, the dimensions of the package itself and the sterilization method.

At the same time, gas sterilization paper 2 is thermally welded along the perforation region 3 of the polymer film 1 with the formation of a weld, and the weld should not fall onto the perforation in the polymer film 1. The edge of the packaging transverse seam can be made in the form of a straight cut with a notch 8 or a cut in the form of a “zig-zag” 9, facilitating the opening of the package.

Prior to the final sealing of the package, the product 11 (Fig. 1c) is loaded into it manually, or the packaging of the product 11 in a bag is carried out on specialized packaging equipment,

The combined packaging material for packaging in the form of a web (Fig. 2a) contains a transparent polymer film 1, mainly with an activated layer, having a perforation region 3, where the holes 5 are made in an amount n, coated with paper 2 for gas sterilization, which is predominantly thermally welded with a polymer film with the formation of longitudinal seams 4 along the perforation area.

The packaging composite material for packaging in the form of a sleeve (Fig. 2b) is formed by connecting the edges of the web of packaging composite material using a longitudinal weld 6 and contains a web of polymer film 1 having a perforation region 3 - a region of through holes (where holes 5 are made in the amount of n, covered mainly with a strip of paper for gas sterilization 2, the edges of which are thermally welded with a film, forming longitudinal welds 4 along the perforation area.

When forming the sleeve, the side of the polymer film 1 with the paper 2 mainly forms its inner region.

The size of the region 3 of the through holes 5, their shape, quantity, size and location of the holes 5 (frequency) depend on the characteristics of the product being packaged, the dimensions of the package itself and the sterilization method.

The number of holes 5, covered with paper 2, and their shape, size and location create the conditions for the penetration of ethylene oxide into the inner region of the bag, as well as for degassing of the latter in order to remove it from the inside of the package during sterilization.

Claims (11)

1. Packaging for products to be finished sterilization, made in the form of a flat rectangular bag made of a polymer film, with the formation of longitudinal and transverse seams of the inner cavity, characterized in that the longitudinal and transverse seams are formed by thermal welding, and the polymer film contains a perforation region coated on the inside of the package with gas sterilization paper thermally welded with a polymer film along the perforation region. 2. Packaging according to claim 1, characterized in that the longitudinal welds formed by the polymer film and paper are made in the amount of two, and formed by the edges of the film web in the amount of one. 3. Packaging according to claim 1, characterized in that the number of transverse welds before packing the product is one, and after packing the product - two, which are partially formed by film with film and film with paper. 4. Packaging according to claim 1, characterized in that the polymer film is made single-layer or multi-layer. 5. Packaging according to claim 1, characterized in that the polymer film is made transparent or opaque. 6. Packaging according to claim 1, characterized in that the perforation area is made of round holes. 7. Packaging according to claim 1, characterized in that the perforation region is made of through holes in the form of longitudinal and / or transverse strips. 8. Packaging according to claim 1, characterized in that the shape, size and number of through holes depend on the characteristics, material, dimensions of the package, product and sterilization method. 9. Packaging according to claim 1, characterized in that the weld of the package is formed by a polymer film and paper for gas sterilization without perforation in the film. 10. Packaging according to claim 1, characterized in that the edge of the transverse seam is made in the form of a straight cut with a notch or zigzag. 11. Packaging according to claim 1, characterized in that the polymer film in the places intended for its welding contains an activated layer treated by corona discharge for the weldability of the film with gas-permeable paper.

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