Pack containing medical sterilization material

Abstract

The invention relates to a pack containing medical sterilization material, comprising a tub which receives the sterilization material (4) and has a base and an encircling side wall, which adjoins the base and has a terminating edge surrounding a tub opening on the side located opposite the base. The pack has a cover (18), which is fixed all the way round the edge (12) of the tub (6) and closes the tub opening (13) in a gas-tight manner. The distance (B) of the sterilization material (4) from the cover (18) is less than 10 mm. Spacers (22), which have a gap (24) between them, are arranged on the inner side (20) of the cover (18), the inner side facing the sterilization material (4), wherein, in at least half of the possible cross sections through the cover (18), the sum of the surface areas A1 of the spacers (22) in relation to the sum of the surface areas A2 of the gap (24) located between the spacers (22) in section is 1:25 to 3:1.

Description

[0001] Packaging containing medical sterilization goods

[0002] The invention relates to packaging for medical items to be sterilized, comprising a tray for receiving the items, which has a base and an adjoining, circumferential side wall with a closing rim that encloses a tray opening on the side opposite the base. The base has at least one recess which is closed with a cover element made of a porous, gas-permeable material. The packaging has a lid that is fixed around the rim of the tray and seals the tray opening gas-tight. The distance between the items to be sterilized and the lid is less than 10 mm.

[0003] Such packaging is known from EP 4 309 696 A1. To sterilize the items inside the tray, a sterilizing gas with sterilizing properties is introduced into the interior of the tray through the porous, gas-permeable cover element and then extracted. This process is repeated several times. During this process, the cover alternately bulges outwards when the gas is introduced and inwards when the gas is extracted. A disadvantage of this packaging, however, is that the items inside are sometimes not sufficiently sterilized, and the position of the items within the tray is altered by the sterilization process. The invention aims to provide a packaging of the type mentioned above in which the items are sterilized more effectively and their position within the tray is altered less.

[0004] The object of the invention is achieved by packaging medical sterilization goods according to the preamble of claim 1 and the features of the characterizing part of claim 1. Further advantageous embodiments of the invention can be found in the dependent claims.

[0005] According to the invention, spacers are arranged on the inner side of the lid facing the item to be sterilized, with a gap between them. In at least half of the possible cross-sections through the lid, the ratio of the area of ​​the spacers to the sum of the areas of the gap between the spacers is 1:25 to 3:1. The spacers are an integral part of the lid. Due to the small distance between the lid and the item to be sterilized, the lid lowers, at least in some areas, onto the item and rests on it when air or gas is drawn out of the interior of the tray via the cover element, creating a vacuum inside the packaging. In the packaging according to EP 4 309 696 A1, the lid adheres to the item to be sterilized due to the vacuum if the item has an upwardly open hollow shape, for example, a bottle shape.This results in insufficient sterilization of the interior of the hollow form, and furthermore, when the sterilizing gas is subsequently blown through the cover element, the item being sterilized is pulled outwards by the resulting bulging of the lid, thus changing its position. Due to the aforementioned inventive design of the lid with spacers of defined geometry relative to each other, the spacers partially rest on the item being sterilized when there is negative pressure inside the tank. However, the sterilizing gas can flow between the spacers into the interior of any open hollow forms of the item being sterilized. This also sterilizes the hollow forms, and simultaneously, when the sterilizing gas subsequently flows into the tank, the item being sterilized is no longer pulled outwards by the lid as it bulges outwards and its position is altered.The ratio of the total area of ​​the spacers to the total area of ​​the free space between the spacers, in at least half of the possible cross-sections through the lid, of 1:25 to 3:1, ensures that the spacers provide sufficient surface area for support against the items being sterilized and that there are sufficient channels between the spacers resting on the items for the gas flowing in or out. If the spacers themselves are hollow, the cavity is also included as a proportion of the spacer's cross-sectional area.

[0006] Advantageously, the distance between the item to be sterilized and the lid is less than 5 mm, preferably 0 mm. This design improves the stability of the item inside the tray, as it provides better support against the lid. In an advantageous embodiment of the invention, the item to be sterilized is at least partially formed by containers with openings enclosed by a rim. Particularly preferably, the containers are positioned in holders within the tray, with the openings facing the lid and the spacers resting at least temporarily on the rim. The item to be sterilized is preferably a small, upward-facing vial. With this type of item and its aforementioned positioning, the advantages of the packaging according to the invention over the packaging of EP 4 309 696 A1 are particularly significant.

[0007] In a preferred embodiment of the invention, for at least 90%, and in particular 95%, of the possible cross-sections through the lid, the sum of the areas of the spacers (sum A1) in relation to the sum of the areas of the free space between the cut spacers (sum A2) is 1:25 to 3:1. This embodiment is particularly advantageous when the material to be sterilized is evenly distributed and small in size within the tray.

[0008] Advantageously, for more than 50%, particularly for more than 90%, and especially preferably for more than 95% of the possible cross-sections through the lid, the sum of the areas of the spacers (sum A1) in relation to the sum of the areas of the free space between the cut spacers (sum A2) is 3:10 to 7:5. These ratios have proven particularly advantageous for achieving secure support of the lid against the item being sterilized via the spacers, while simultaneously ensuring sufficient gas exchange through the spacers into the interior of hollow shapes containing the item being sterilized.

[0009] Advantageously, at least 50% of the spacers have a cross-sectional diameter of 20–250 pm, preferably 40–180 pm, and particularly preferably 60–120 pm. These diameters have proven particularly suitable for ensuring sufficient stability of the spacers while simultaneously allowing good gas exchange through the spaces between them when the spacers come into contact with the items being sterilized.

[0010] In an advantageous embodiment of the invention, the lid has at least one inner layer facing the tub and one outer layer facing away from the tub, wherein the inner layer has a melting range that is at least 10 °C, preferably at least 20 °C, lower than the melting range of the outer layer. The lid can thus be sealed onto the edge of the tub, whereby only the inner layer of the lid melts temporarily and not the outer layer.

[0011] Advantageously, the ratio of the thickness of the inner layer in the area of ​​the free spaces without spacers to the total thickness of the other layers of the lid at this point is less than 1:6 and preferably less than 1:16. This results in a particularly flat lid and thus improved workability. In an advantageous embodiment of the invention, the lid has a bending stiffness between 0.3 and 2 N, preferably between 0.35 and 1.5 N, and particularly preferably between 0.4 and 1 N. The bending stiffness is measured according to the method specified in DIN 53121. It has been shown that precisely this range of bending stiffness prevents the lid material between the spacers from sagging towards the items being sterilized when there is negative pressure inside the tank. At the same time, the lid is not so stiff as to be difficult to work with.

[0012] Preferably, the cover in the area of ​​the free spaces without spacers is 100 to 250 pm thick, preferably 140 to 180 pm and particularly preferably 160 to 170 pm.

[0013] Advantageously, the lid is secured to the tub by means of a fully circumferential sealing seam. This allows for a simple, gas-tight connection between the tub and lid. The sealing seam strength is preferably 2 to 15 N / 15 mm and particularly preferably 3 to 8 N / 15 mm, measured according to DIN 55529.

[0014] In a preferred embodiment of the invention, the spacers are formed by particles that are partially embedded in the inner layer of the lid and partially protrude from it. Advantageously, the particles are a granular material. This embodiment allows the spacers to be manufactured particularly easily and reliably as part of the lid. Advantageously, the particles consist of HDPE with a molecular weight of more than 3 x 10 6 g / mol. This material has proven to be particularly suitable in practice for forming spacers.

[0015] Preferably, the spacers are made of a plastic polymer with a Shore hardness D greater than 40, particularly greater than 60. The Shore hardness D is measured according to DIN ISO 868. This ensures that the spacers are sufficiently rigid to prevent them from yielding under negative pressure and contact with the items being sterilized, thus avoiding excessively narrowing the spaces between the spacers.

[0016] The cover elements are continuously and firmly connected to the tray and completely cover the recesses in the base. The cover elements preferably consist of a nonwoven fabric made of HDPE fibers. The cover element is preferably resistant to the penetration of liquids and bacteria, but at the same time porous enough to allow the inflow and outflow of sterilization gas from the goods being sterilized inside the packaging. The cover element preferably consists of Tyvek, a material that possesses the aforementioned properties and is widely used for sterilization purposes in the medical field. The cover material is advantageously the same material that is also referred to as "insert" in EP 4 309 696 A1 and designated with reference numeral 104 in the figures. Reference is expressly made to EP 4 309 696 A1 in this regard.

[0017] Reference is made to the above. Further advantageous embodiments of the invention will become apparent from the schematically illustrated exemplary embodiments described below. These show:

[0018] Fig. 1 a packaging according to the invention,

[0019] Fig. 2 shows the object from Fig. 1 from a different perspective,

[0020] Fig. 3 shows the object from Fig. 1 in an exploded view,

[0021] Fig. 4 shows a detailed side view of the packaging with a sterilization item and the lid portion above it.

[0022] Fig. 5 shows the object from Fig. 4 in a cross-sectional view,

[0023] Fig. 6 is a detail enlargement from Fig. 5,

[0024] Fig. 7 shows a lid according to the invention in an illustration of the inside and

[0025] Fig. 8 shows the object from Fig. 7 in a close-up.

[0026] Subsequently, identical packaging elements are designated with a uniform reference numeral, where appropriate. The packaging features described below can also be the subject of the invention individually or in other combinations.

[0027] Figures 1 to 3 show a packaging 2 according to the invention from different perspectives as well as in an exploded view. Medical sterilization items 4 are positioned inside the packaging 2. The sterilization items 4 are held in a tray 6, which has a base 8 and an adjoining, circumferential side wall 10 with a closing rim 12. The rim 12 encloses a tray opening 13. The base 8 has recesses 14 which are closed with cover elements 16 made of a porous, gas-permeable material. In the exploded view in Figure 3, the cover elements 16 are shown separately for better visibility. The cover elements 16 completely cover the recesses 14 in the base 8 and are firmly fixed to the base 8. The packaging 2 has a lid 18 which is gas-tightly connected to the rim 12 of the tray 6. The item to be sterilized 4 is positioned in a holder 19 in Figs. 1 to 3, which is shown in Fig.3 is shown.

[0028] Figures 4, 5, and 6 each show sections of the lid 18 and the item to be sterilized 4 located beneath it in a side view and in cross-sectional views along line 11 in Figure 4. There is a distance B between the item to be sterilized 4 and the lid 18, which is 0 mm in this embodiment. The lid 18 therefore rests on the item to be sterilized 4. Spacers 22 are arranged on the inner surface 20 of the lid 18 facing the item to be sterilized 4, with a space 24 between them. In Figures 4 to 6, the item to be sterilized 4 is formed by containers 4 with a rim 23 and an opening 25. The spacers 22 rest on the rim 23. The containers 4 form the aforementioned hollow shapes via the opening 25. However, the hollow shapes are not limited to the specific shape of the containers 4.

[0029] Fig. 7 shows the lid 18 from its inside 20. Fig. 8 shows a section magnification from Fig. 7 corresponding to section circle II. The positioning of the spacers 22 and the free spaces 28 between these spacers 22 are shown schematically.

[0030] Figure 4 shows an exemplary side view of the lid 18 with spacers 22 attached to it, which are supported on a vial 4 to be sterilized. Figures 5 and 6 show cross-sections through the lid 18 and the vial in Figure 4 at different magnifications. The area A1 of the spacers 22 resting on the vial 4 is shown. The area A2 between two sectioned spacers 22 is also shown. In at least half of the possible cross-sections through the lid 18, the ratio of the sum of the areas A1 of the spacers 22 to the sum of the areas A2 of the free space 24 between the sectioned spacers 22 is 1:25 to 3:1.

[0031] The diameter D of the spacers 22 is 20 pm to 250 pm, preferably 40 pm to 180 pm, and particularly preferably 60 pm to 120 pm. The cover 18, in the area of ​​the clearances 24 without spacers 22, is 100 pm to 250 pm thick, preferably 140 pm to 180 pm, and particularly preferably 160 pm to 170 pm. The location for determining this thickness is illustrated by reference numeral 26.

[0032] The lid 18 has an inner layer 28 and an outer layer 30. The ratio of the thickness E of the inner layer 28 to the sum of the thickness F of the other layers (here only the outer layer 30) at a point without spacers 22 is less than 1:6 and preferably less than 1:16. In the exemplary embodiment, the spacers 22 are formed by particles that are partially embedded in the inner layer 28 of the lid 18 and partially protrude from it. For the sake of simplicity, the particles are not distinguished as a separate material from the rest of the lid material in the sectional views by means of a different hatching pattern.

[0033] Reference figures

[0034] 2 packages

[0035] 4. Medical sterilization items

[0036] 6 tubs

[0037] 8 Floor

[0038] 10 side wall

[0039] 12 Rand

[0040] 13 Bathtub opening

[0041] 14 Exclusion

[0042] 16 Cover element

[0043] 18 lids

[0044] 19 bracket

[0045] B. The distance between the item being sterilized and the lid is...

[0046] 20 Inside of the lid

[0047] 22 spacers

[0048] 24 Free space between spacers

[0049] A1 Area of ​​the spacer in cross-section

[0050] A2 area between cut spacers

[0051] 23 Vessel edge

[0052] 25 Vessel opening

[0053] D diameter of the spacers

[0054] 26 Thickness of the lid in the area of ​​the free spaces without spacers

[0055] 28 Inner layer of the lid

[0056] 30 Outer layer of the lid

[0057] E Thickness of the inner layer

[0058] F Thickness of the other layers of the lid

Claims

Patent claims 1. Packaging (2) containing medical items to be sterilized, comprising a tray (6) receiving the items to be sterilized (4), the tray having a base (8) and an adjoining circumferential side wall (10) with a closing rim (12) enclosing a tray opening (13) on the side opposite the base (8), the base (8) having at least one recess (14) which is closed with a cover element (16) made of a porous, gas-permeable material, and a lid (18) which is fixed circumferentially to the rim (12) of the tray (6) and seals the tray opening (13) gas-tight, wherein the distance (B) of the items to be sterilized (4) to the lid (18) is less than 10 mm, characterized in that spacers (22) are arranged on the inner side (20) of the lid (18) facing the items to be sterilized (4), between which a free space (24) is,wherein in at least half of the possible cross-sections through the cover (18) the sum of the areas A1 of the spacers (22) in relation to the sum of the areas A2 of the free space (24) located between the cut spacers (22) is 1 :25 to 3:

1.

2. Packaging (2) according to claim 1 , characterized in that the distance (B) of the item to be sterilized (4) to the lid (18) is less than 5 mm, preferably 0 mm.

3. Packaging (2) according to one of the preceding claims, characterized in that the sterilization material (4) is at least partially formed by vessels with vessel openings (25) enclosed by a vessel rim (23), wherein the vessels are positioned in the tub (6) in holders (19), the vessel openings (25) point towards the lid (18) and the spacers (22) rest at least temporarily on the vessel rim (23).

4. Packaging (2) according to one of the preceding claims, characterized in that for at least 90%, in particular 95%, of the possible cross-sections through the lid (18), the sum of the areas A1 of the spacers (22) in relation to the sum of the areas A2 of the free space located between the cut spacers (22) is 1 :25 to 3:

1.

5. Packaging (2) according to one of the preceding claims, characterized in that for more than 50%, in particular for more than 90% and especially preferably for more than 95% of the possible cross-sections through the lid (18) the sum of the areas A1 of the spacers (22) in relation to the sum of the areas A2 of the free space located between the cut spacers (22) is 3:10 to 7:

5.

6. Packaging (2) according to one of the preceding claims, characterized in that at least 50% of the spacers (22) have a cross-sectional diameter (D) of 20 - 250 pm, preferably 40 - 180 pm and particularly preferably 60 - 120 pm.

7. Packaging (2) according to one of the preceding claims, characterized in that the lid (18) has at least one inner layer (28) facing the tub (6) and one outer layer (30) facing away from the tub (6), wherein the inner layer (28) has a melting range which is at least 10 °C, preferably at least 20 °C, lower than the melting range of the outer layer (30).

8. Packaging (2) according to claim 7, characterized in that the ratio of the thickness E of the inner layer in the area of ​​the free spaces (24) without spacers (22) to the thickness F of the sum of the further layers of the lid (18) at this point is less than 1 :6 and preferably less than 1 :

16.

9. Packaging (2) according to one of the preceding claims, characterized in that the lid (18) has a bending stiffness between 0.3 and 2 N, preferably between 0.35 and 1.5 N and particularly preferably between 0.4 and 1 N.

10. Packaging (2) according to one of the preceding claims, characterized in that the lid (18) in the area of ​​the free spaces (24) without spacers (22) is 100 to 250 pm thick, preferably 140 to 180 pm and particularly preferably 160 to 170 pm.

11. Packaging (2) according to one of the preceding claims, characterized in that the lid (18) is fixed to the tub (6) by means of a fully circumferential sealing seam.

12. Packaging (2) according to one of the preceding claims, characterized in that the spacers (22) are formed by particles which are each partially embedded in the inner layer of the lid (18) and partially protrude from the inner layer.

13. Packaging (2) according to claim 12, characterized in that the particles are made of HDPE with a molecular weight of more than 3*10 6 consist of g / mol.

14. Packaging (2) according to one of the preceding claims 12 or 13, characterized in that the spacers (22) consist of a plastic polymer with a Shore hardness D of greater than 40, in particular greater than 60.

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