EP2029043A1

EP2029043A1 - Sterilized package, method for its production, and its use in medicine

Info

Publication number: EP2029043A1
Application number: EP07725810A
Authority: EP
Inventors: Christof Merckle; Volker Friedrich
Original assignee: Aesculap AG
Current assignee: Aesculap AG
Priority date: 2006-06-06
Filing date: 2007-06-04
Publication date: 2009-03-04
Also published as: US20090236253A1; WO2007140970A1; DE202007019275U1; DE102006027304A1

Abstract

The invention relates to a sterilized package (1), comprising an inner gas-permeable and germ-proof packaging means (2), which contains at least one sterile article (3), and comprising an outer gas-tight packaging means (4) which surrounds the inner packaging means (2), wherein the package (1) comprises, between the inner packaging means (2) and the outer packaging means (4), a sterile and dry packaging volume (9). The invention further relates to a method for producing the sterilized package (1), and to the use of the sterilized package (1) for dry and sterile storage of the article (3) and for sterile removal of the inner packaging means (2) from the package (1).

Description

description

Sterilized packaging, process for their preparation and their

Use in medicine

The present invention relates to a sterilized package having an inner gas-permeable and germ-proof packaging means containing at least one sterile article, and an outer gas-tight packaging means, a method for producing the sterilized packaging and its use for the dry and sterile storage of the article and their use for sterile Removal of the inner packaging material from the packaging.

The packaging and sterilization of products is of considerable importance, especially in the field of medicine. Usually the products are sterilized before or during the packaging process. Here, the choice of the sterilization method, the respective material of the packaged products or products is crucial. Γ-irradiation is a commonly used method of sterilization. However, certain materials, such as glycolide-based and / or p-dioxanone-based polymers, degrade when exposed to gamma rays for extended periods of time. In these cases, therefore gentler sterilization conditions must be applied. For example, treatment with a sterilizing gas, in particular with ethylene oxide, is suitable for this purpose.

Frequently, the products to be packaged and sterilized are transferred to suitable packaging and then sterilized, the packaging being closed only after sterilization. The disadvantage here, however, is that the sterilization gas has to be removed after sterilization has ended, at least in those cases in which undesired impairments of the sterilized products are caused by Any sterilization gas residues may occur before the packaging is closed. During removal of the sterilization gas, therefore, additional safety precautions are often required to maintain sterility attained.

As a result, products are increasingly being enclosed in suitable packaging and subsequently subjected to a sterilization process. For this purpose, packages are used, which are at least partially made of a gas-permeable and simultaneously impermeable to pathogenic pathogen material. For example, such materials are commercially available under the name Tyvek ^® .

From US 2005/0268573 A1 a method for the packaging and sterilization of articles is known, wherein the articles are first enclosed in a package. The packaging is at least partially permeable to gases, but not to microbial pathogens. Subsequently, the package, including the article therein, is treated with a sterilizing gas. After sterilization, for example, the package is transferred to a second impermeable package and also enclosed therein. Cumbersome here, however, is the required second packaging step, which must also be performed under strictly controlled conditions, so that no traces of sterilization gases or moisture are introduced during the second packaging step. A sterilized double package which can be made in a sterilization step is described in US 4,482,053.

In view of the ever increasing demands on the sterility and quality of packaged products, especially in the medical sector, there is a continuing need for sterilized packaging. systems which meet these requirements and, in particular, contribute to improved medical safety standards.

Thus, the invention has the object to provide a sterilized packaging and a corresponding sterilization process, which each meet the above requirements and in particular avoid the disadvantages mentioned in the prior art.

The object is achieved by a sterilized packaging comprising an inner gas-permeable and germ-proof packaging means which contains at least one sterile article, and an outer gastight packaging material which surrounds the inner packaging material, wherein the packaging between the inner and the outer packaging means a sterile and dry Has packaging volume.

The invention provides sterilized packages having inner and outer packaging means, the inner packaging means having a sterile and dry exterior. By means of the packages provided according to the invention, the article is kept dry and sterile in the inner packaging means. The dry and sterile interior of the inner packaging means is supplemented by a preferably dry as well as sterile interior of the outer vapor-tight packaging means. This contributes with particular advantage to an increased storage stability of the article. The packages provided according to the invention furthermore permit sterile removal of the inner packaging means with the sterile article from the packaging. There is an increased need for this, especially in the medical sector. Thus, the packages of the invention contribute to improved sterilization standards and also offer improved protection against a possible contamination of medical treatment rooms, in particular operating theaters, with pathogenic agents.

Within the meaning of the present invention, germs are to be understood as meaning all microbial pathogens, in particular bacteria and viruses.

In one embodiment of the invention is within a gas-tight wall of the outer packaging means, in particular within the outer packaging means, at least one gas-permeable and germ-tight sterilization opening. The sterilization opening preferably has the shape of a wall part. Conveniently, there are two gas-permeable and germ-tight sterilization openings within the gas-tight wall of the outer packaging means.

In a further embodiment, a sterilization opening of the packaging according to the invention is formed by a gas-permeable and germ-proof wall, in particular by a wall part, of the outer packaging means, and the sterilization opening itself is closed gas-tight. In a further embodiment, a sterilization opening of the packaging according to the invention is formed by a gas-permeable and germ-proof wall, in particular by a wall part, of the inner packaging means.

Particularly preferably, both the inner and the outer packaging means each have a gas-permeable and germ-tight sterilization opening. The sterilization openings can in particular be arranged one above the other. The sterilization openings may, for example, substantially coincide in their dimensions. According to the invention, it is further possible that the sterilization openings are connected to each other, in particular glued together or - -

are sealed. Thus, in particular, the sterilization opening of the outer packaging means can be applied to the sterilization opening of the inner packaging means. Preferably, however, the sterilization openings are spatially separated from each other.

The gastight wall of the packaging according to the invention is preferably a film, in particular a cover film. The gas-tight wall may according to the invention comprise metals or composite materials. As the metal is particularly aluminum in question. In principle, all materials familiar to the person skilled in the art can be considered as composite materials. Composite materials having aluminum as a composite component are particularly suitable because of the vapor-tightness of aluminum. The composite materials may in particular have a layered structure. The composites may further include, for example, sealant layers. The composite materials advantageously have so-called laminates, in particular based on plastics. The gas-tight wall of the packaging according to the invention is preferably formed from composite materials based on metals, paper, plastics and / or paints. The composite materials may for example be formed from the following components: polyethylene, polypropylene, polyethylene terephthalate, polyamide, polyvinyl chloride, paints, paper and / or aluminum. Particularly preferred are the compositions listed below:

Polyethylene-aluminum-polyethylene terephthalate, polyvinyl chloride-aluminum-polyamide, polypropylene-aluminum paints, polyethylene terephthalate-aluminum-polypropylene and paints-aluminum-polyethylene terephthalate paper.

In a preferred embodiment of the invention, the sterilization opening is a gas-permeable film. The gas-permeable film may in particular be a cover or cover film. The - -

Packaging preferably has two gas-permeable films, in particular a gas-permeable cover film and a gas-permeable cover film. The gas-permeable cover film is in particular a sterilization opening of the inner packaging means and, in the case of the gas-permeable cover film, preferably a sterilization opening of the outer packaging means.

In a further embodiment, the packaging according to the invention has a total of three films, of which in particular two films are gas-permeable. According to the invention, it is further provided that two films are formed as cover films. The films are preferably a gas-permeable cover film, a gas-permeable cover film and a gas-tight cover film. For further features and details of the gas-permeable films, reference is made to the previous section. The gas-permeable cover film and the gas-tight cover film suitably substantially coincide in their dimensions. The gas-tight cover film may in particular be applied to the gas-permeable cover film. Adhesive or sealing techniques are particularly suitable as application techniques. For example, sealing seams, in particular weld seams, of the gas-tight cover film can run on the gas-permeable cover film or parallel to the gas-permeable cover film. The packaging according to the invention can furthermore have a so-called peel region, in particular for easier handling. The films, in particular the cover films, may conveniently be welded together in the peel region of the packaging.

In a further embodiment, the sterilization opening of the packaging according to the invention is formed from a nonwoven material, in particular from a polymer nonwoven material. The nonwoven material is preferably made of a polyolefin, in particular of polyols. - -

ethylene or polypropylene, preferably polyethylene. The nonwoven material may further be a high pressure polymer, especially high density polyethylene. The nonwoven material may be, for example, one of the products commercially available under the names Tyvek ^® or TY par ^®.

Conveniently, the inner and / or outer packaging means, preferably the inner and outer packaging means, are free of sterilizing gases. In this way, an undesirable impairment of the sterile article and thus a possible quality or quality loss of the article can be avoided.

In a further embodiment of the invention, the inner and / or outer packaging means, preferably the inner and outer packaging means, are formed at least in part from dimensionally stable materials. The dimensionally stable materials are expediently plastic materials, in particular polyethylene terephthalate (PET) and / or polycarbonate. Preferably, the dimensionally stable materials are so-called blister materials. The packaging means can be in different three-dimensional shapes and in particular have the form of a housing. An example of such a housing shape is shown in FIG. According to the invention, it can furthermore be provided that the inner and outer packaging means of the packaging each have different three-dimensional shapes. For example, the inner packaging means may be in the form of a tube and the outer packaging means in particular in a blister form. The tube may be formed closable, for example, by plug. Furthermore, the plugs can each have at least one gas-permeable and germ-tight sterilization opening. - - o -

The object of the packaging according to the invention is preferably a moisture-sensitive, in particular a sensitive to hydrolysis, object. The article may in particular be a medical-technical object, for example an implant. The article may be screws, clips, sutures or vascular prostheses. Preferably, the article is a vascular prosthesis, which may in particular have a resorbable polymer coating.

In a preferred embodiment of the invention, the so-called SAL (sterile assurance level) of the interiors of the inner and outer packaging means is <10 ^"3 , preferably ≤ 10 ^{" 6} .

The present invention further relates to a method for producing a sterilized packaging, comprising the steps:

Wrapping an inner packaging means with an outer packaging material not yet sealed,

germ-tight and gas-permeable enclosure of the inner packaging means,

Sterilizing the interior of the inner packaging means, at least one sterile (and in particular moisture-sensitive) article contained therein and the interior of the outer packaging means by introducing a sterilization gas,

- Closing the outer packaging means to form the packaging.

In a preferred embodiment, the article is transferred to the inner packaging means and the inner packaging material after passage of the article gas-permeable and germ-tight, before the inner packaging material with the outer packaging - -

encapsulated. The inner packaging material is preferably sealed with a gas-permeable and germ-proof material, in particular in the form of a gas-permeable and germ-proof film, preferably in the form of a cover film.

In a further embodiment, the outer packaging means after wrapping the inner packaging means and prior to sterilization with a gas-permeable and germ-proof material, in particular in the form of a gas-permeable and germ-proof film, preferably in the form of a covering or covering closed. Conveniently, the outer packaging means is closed with a gas-permeable and germ-proof cover film. Thus, the sterilization gas can penetrate during the sterilization process over the entire film surface, in particular over the entire film surfaces of the inner and outer packaging means in the packaging and cause sterilization of the interiors of the packaging and the article.

In a particularly preferred embodiment, the outer packaging material is sealed after sterilization with a gas-tight material, in particular in the form of a gas-tight film, preferably in the form of a gas-tight cover film. In this way, the sterility and the dry of the packaging according to the invention, in particular each of the interior of the inner and outer packaging means, maintained.

In one embodiment of the method according to the invention, ethylene oxide is used as the sterilization gas for the sterilization of the package. After sterilizing the package, the sterilization gas is preferably removed. The removal of the sterilizing gas can be carried out for a period of about 10 minutes to 7 days. To accelerate the degassing, the sterilized r tυ oit ϊϊ - -

Packaging subjected to several vacuum cycles. The vacuum cycles can be performed at regular or irregular intervals. The removal of the sterilization gas preferably takes place with simultaneous drying of the sterilized packaging. The sterilized packaging is expediently at a temperature between 25 ° C and 200 ⁰ C, preferably between 30 ⁰ C and 150 ⁰ C _1, in particular between 30 ⁰ C and 60 ⁰ C, dried. Drying can be done at normal or negative pressure. In the case of drying in vacuo, the normal pressure can be restored by supplying an inert gas, in particular by supplying dried air or a dried inert gas. As a protective gas, for example, argon or nitrogen can be used.

The invention also relates to the use of the packaging according to the invention for the dry and sterile storage of the article and for the sterile removal of the inner packaging means from the packaging, in particular for the sterile removal of the article from the inner packaging means.

Further details and features of the present invention will become apparent from the following description of preferred embodiments with reference to a figure and an example in combination with the subclaims. In these embodiments, individual features of the invention may be realized alone or in combination with other features. The figure is hereby incorporated by express reference into the content of this specification.

Figurenbeschreibunα

FIG. 1 shows a packaging (1) made of an inner blister (2) designed as an inner packaging means and an outer blister (4) designed as an outer packaging means. Both inner blister (2) as Also outer blister (4) each have a housing shape, wherein the housing shape of the outer blister (4) is formed so that it can easily accommodate the housing shape of the inner blister (2). Inside the inner blister (2) a vascular prosthesis (3) is stored as an object. The inner blister (2) has a gas-permeable and germ-proof sterilization opening in the form of a cover film (5) from Tyvek ^®. The outer blister (4) has a designed as a gas-permeable and germ-proof sterilization opening cover sheet (6) from Tyvek ^®. The cover film (6) is gas-tightly closed by a cover film (7) made of a composite material based on aluminum, paper and polyethylene terephthalate (PET) and formed as a gastight wall of the outer blister (4). The packaging volumes (8) and (9) are each sterile and free of residual moisture.

Example 1: Packaging of a vascular prosthesis with a synthetic resorbable polymer coating of poly-D, L-lactide-co-glycolide (50:50)

A vascular prosthesis with a synthetically resorbable polymer coating is placed in an inner blister of polyethylene terephthalate (PET). Then the inner blister is sealed with a cover made of Tyvek ^® . The sealed in this way inner blister is transferred to an outer blister. After the transfer of the outer blister is sealed with a cover sheet of Tyvek ^®. Thereafter, the package is subjected to ethylene oxide sterilization. After completion of the sterilization process, the packaging is replaced by gas exchange over the entire Tyvek ^® film both the inner and the outer blister at a temperature of about 50 ⁰ C for a period of about 6 Hours dried. The drying is accelerated by regular vacuum cycles, each of which is maintained for about 15 minutes. After the packaging has been dried, the outer blister is gas-tightly sealed with a cover sheet of a layered composite material based on aluminum, paper and polyethylene. The gas-tight sealing of the outer blister takes place by welding the layered gas-tight cover foil onto the Tyvek ^® cover foil of the outer blister.

Claims

_ _ _Patent claims

A sterilized package (1) comprising an inner gas-permeable and germ-proof packaging means (2) containing at least one sterile article (3) and an outer gas-tight packaging means (4) surrounding said inner packaging means (2) (1) has a sterile and dry packaging volume (9) between the inner packaging means (2) and the outer packaging means (4).

2. Packaging (1) according to claim 1, characterized in that within a gas-tight wall (7) of the outer packaging means (4), in particular within the outer packaging means (4), at least one gas-permeable and germ-tight sterilization opening, preferably in the form of a Wandungsteils , is located.

3. Packaging (1) according to claim 1 or 2, characterized in that a sterilization opening (6) of the packaging (1) is formed by a gas-permeable and germ-proof wall, in particular a wall part, of the outer packaging means (4) and the sterilization opening (6 ) is sealed gas-tight.

4. Packaging (1) according to one of the preceding claims, characterized in that a sterilization opening (5) of the packaging (1) is formed by a gas-permeable and germ-proof wall, in particular a wall part, of the inner packaging means (2). - -

5. Packaging (1) according to one of claims 2 to 4, characterized in that the gas-tight wall (7) is a film, in particular a cover film.

6. Packaging (1) according to one of claims 2 to 5, characterized in that the gas-tight wall (7) has metals or composite materials.

7. Packaging (1) according to any one of claims 2 to 6, characterized in that the sterilization opening (5; 6) is a gas-permeable film, in particular a cover or cover film.

8. Packaging (1) according to any one of claims 2 to 7, characterized in that the sterilization opening (5; 6) is formed from a nonwoven material, in particular from a polymeric nonwoven material.

9. Packaging (1) according to claim 8, characterized in that the nonwoven material is made of polyethylene, in particular of high-pressure polyethylene.

10. Packaging (1) according to one of the preceding claims, characterized in that the inner packaging means (2) and / or the outer packaging means (4), preferably the inner packaging means (2) and the outer packaging means (4), free of sterilizing gases are.

11. Packaging (1) according to one of the preceding claims, characterized in that the inner packaging means (2) and / or the outer packaging means (4), preferably the inner packaging means (2) and the outer packaging means (4), at least partially made of dimensionally stable materials, in particular of blister materials.

12. Packaging (1) according to one of the preceding claims, characterized in that the article (3) is sensitive to moisture.

13. Packaging (1) according to one of the preceding claims, characterized in that the article (3) is a medical-technical object, in particular an implant, preferably a vascular prosthesis.

14. A method for producing a sterilized packaging (1), in particular according to one of the preceding claims, comprising the steps:

Wrapping an inner packaging means (2) with an outer packaging means (4) not yet closed,

germ-tight and gas-permeable enclosure of the inner packaging means (2),

Sterilizing the interior (8) of the inner packaging means (2), at least one sterile (and especially moisture-sensitive) article (3) contained therein and the interior (9) of the outer packaging means (4) by introducing a sterilizing gas,

- Closing the outer packaging means (4) to form the packaging (1).

15. The method according to claim 14, characterized in that the article (3) in the inner packaging means (2) transferred and the inner packaging means (2) is gas-permeable and germ-tight, before the inner packaging means (2) with the outer packaging means (4 ) is sheathed. - - -

16. The method according to claim 14 or 15, characterized in that the inner packaging means (2) with a gas-permeable and germ-proof material, in particular in the form of a gas-permeable film, preferably a cover, is closed.

17. The method according to any one of claims 14 to 16, characterized in that the outer packaging means (4) after wrapping the inner packaging means (2) and before sterilization with a gas-permeable and germ-proof material, in particular in the form of a gas-permeable film, preferably one Cover foil, is closed.

18. The method according to any one of claims 14 to 17, characterized in that the outer packaging means (4) after sterilization with a gas-tight material, in particular in the form of a gas-tight film, preferably a cover film is closed.

19. The method according to any one of claims 14 to 18, characterized in that ethylene oxide is used as the sterilizing gas.

20. The method according to any one of claims 14 to 19, characterized in that the sterilization gas preferably with simultaneous drying, in particular at a temperature between 25 ⁰ C and 200 ⁰ C, preferably between 30 ⁰ C and 150 ⁰ C, in particular between 30 ⁰ C. and 60 ⁰ C, is removed.

21. Use of a packaging (1) according to any one of claims 1 to 13 for dry and sterile storage of the article (3) and for the sterile removal of the inner Verpackungsmit- from the packaging (1), in particular for the sterile removal of the article (3) from the inner packaging means (2).