DE102020118562A1 - Sterile barrier system with defect indication - Google Patents

Abstract

The present invention relates to a sterile barrier system (1) for a medical product (2), which has an inner primary packaging (4), an outer secondary packaging (6) and at least one oxygen indicator (8). The primary packaging (4), which is oxygen-impermeable in its intact state, is designed to accommodate and enclose the medical product (2), in particular a sterile/sterilized and/or oxygen-sensitive product (2), in its interior (5). The secondary packaging (6), which is impermeable to oxygen in the intact state, separates its interior (7) from the environment outside the secondary packaging (6) and is designed to enclose the primary packaging (4). The at least one oxygen indicator (8), which is designed in particular in the form of a tablet, a gel or a capsule, is arranged inside the secondary packaging (6). In addition, the present invention relates to a method for the sterile packaging of a medical product (2) in such a sterile barrier system (1).

Description

technical field

The present disclosure relates to a sterile barrier system for a medical product with a defect indication option and a method for sterile packaging of a medical product in such a sterile barrier system.

Background of the Invention

Sterile barrier systems are basically known from the prior art and are used in medicine to receive, transport and/or store previously sterilized medical, preferably disposable, products such as surgical instruments, implants and the like. During transport and until the sterile barrier system is deliberately opened, (uncontrolled) contact of the product inside with the environment and also with the ambient air or oxygen should be avoided in order to be able to ensure the sterility of the product until its intended use.

The sterile barrier systems are often made of plastic, which is more or less permeable to air and therefore oxygen and is also prone to defects. Uncontrolled contact with the ambient air means that the sterility of the product contained in the sterile barrier system can no longer be guaranteed. Accordingly, there is a need to check whether ambient air or oxygen has penetrated the sterile barrier system.

State of the art

It is already known from the prior art to pack (single-use) medical products in sterile barrier systems. Systems of this type often do not provide for the possibility of being able to detect or indicate defects in the sterile barrier system (during transport).

To solve this problem disclosed, for example U.S.A. 4,295,566 a package made of a flexible material and having an access opening. One or more cleaned or sterile items can be inserted into the package through this access opening. In addition to the at least one article, a compressible element is placed in the package which remains compressed at a pressure below atmospheric pressure. The packaging filled with the at least one article and the compressible element can then be closed and a vacuum created in the packaging. If air from the environment enters the packaging via a damage/hole, the compressible element expands and the packaging itself expands as well. Thus, whether the expanded packaging is damaged can be determined by visual inspection from the outside.

Such a system requires that the package be flexible, otherwise the expansion of the compressible element will not be visible from the outside in the event of damage to the package. The freedom of choice in the material of the packaging is thus limited to flexible materials in the above case. In addition, the risk of damage to such flexible packaging is great.

Summary of Revelation

Against this background, it is the object of the present disclosure to avoid or at least alleviate the disadvantages mentioned from the prior art. In particular, a sterile barrier system is to be provided in which the integrity of the sterile barrier system can be detected/displayed easily and quickly. In addition, a possibility should also be provided to protect the product even more effectively than previously known from uncontrolled contact with the ambient air or with oxygen.

This object is achieved by the sterile barrier system according to present claim 1 and by a method for sterile packaging of a medical product in such a sterile barrier system according to claim 9. Advantageous embodiments and developments are claimed in the dependent claims and/or explained below.

The core idea of the present disclosure consists in principle of double packaging a product, at least in sections, with the formation of two preferably translucent (transparent) packaging layers and creating an atmosphere between the two packaging layers that is different from that immediately around the product and/or the packaging environment. Furthermore, at least one indicator is arranged in the area between the two packaging layers (hereinafter intermediate area/intermediate space)) and/or within the area immediately around the product (hereinafter inner area/interior), which points to the atmosphere of the other area and/or the packaging environment reacts and thus a leak at least in the packaging layer separating the inner area from the intermediate area and/or the packaging layer separating the intermediate area from the packaging environment.

More specifically, the disclosure initially relates to a (double) sterile barrier system for a medical product. The sterile barrier system according to the invention has an (inner) primary packaging (packaging layer/envelope), an (outer) secondary packaging (packaging layer/envelope) and at least one oxygen indicator. The primary packaging, which is oxygen-impermeable in its intact state, is designed to accommodate the, in particular sterilized/sterile and/or oxygen-sensitive, medical product directly in its interior (i.e. has contact with the product) and to enclose it. The secondary packaging, which is oxygen-impermeable in its intact state, separates its interior (space between the primary packaging and the secondary packaging) from the packaging environment outside of the secondary packaging and is designed to cover the primary packaging at least in sections (for example in the case of a hard shell which is closed on at least one side by the two packaging layers ) to enclose. The at least one oxygen indicator, which is designed in particular in the form of a tablet, a gel or a capsule, is (in any case) arranged inside the secondary packaging.

• · Der Sauerstoffindikator ist in dem vorstehend definierten Zwischenraum platziert. In diesem Fall ist der Zwischenraum zunächst sauerstofffrei, wohingegen der Innenraum (unmittelbar um das Produkt) sauerstoffhaltig ist. Die Verpackungsumgebung betrifft ohnehin normale Atemluft. Ist die primäre (innere) und/oder die sekundäre (äußere) Verpackungsschicht schadhaft, gelangt Sauerstoff in den Zwischenraum, der eine z.B. visuell von außen erkennbare Reaktion des darin angeordneten Sauerstoffindikators bewirkt.
• · Der Sauerstoffindikator ist in dem vorstehend definierten Innenraum platziert. In diesem Fall ist der Innenraum zunächst sauerstofffrei. Der Zwischenraum kann nach einer ersten Variante sauerstoffhaltig und nach einer zweiten Variante ebenfalls sauerstofffrei sein. Ist bei der ersten Variante die innere (primäre) Verpackungsschicht schadhaft, wird dies vom Sauerstoffindikator angezeigt. Eine Beschädigung der äußeren (sekundären) Verpackungsschicht bleibt hingegen unentdeckt. Ist bei der zweiten Variante die innere (primäre) und die äußere (sekundäre) Verpackungsschicht schadhaft, wird dies vom Sauerstoffindikator angezeigt. Eine Beschädigung ausschließlich der inneren (primären) Verpackungsschicht bleibt hingegen unentdeckt.

In principle, at least two cases can be distinguished:

• · The oxygen indicator is placed in the space defined above. In this case, the intermediate space is initially free of oxygen, whereas the inner space (immediately around the product) contains oxygen. The packaging environment affects normal breathing air anyway. If the primary (inner) and/or the secondary (outer) packaging layer is damaged, oxygen gets into the gap, which causes a reaction of the oxygen indicator arranged therein, which can be recognized visually from the outside, for example.
• · The oxygen indicator is placed in the interior space defined above. In this case, the interior is initially oxygen-free. According to a first variant, the intermediate space can contain oxygen and, according to a second variant, can likewise be oxygen-free. If the inner (primary) layer of packaging is damaged in the first variant, this is indicated by the oxygen indicator. Damage to the outer (secondary) packaging layer, on the other hand, remains undetected. If the inner (primary) and the outer (secondary) packaging layer is defective in the second variant, this is indicated by the oxygen indicator. Damage to the inner (primary) packaging layer alone, on the other hand, remains undetected.

In other words, the disclosure thus relates to a sterile barrier system for a medical product which has a primary sterile barrier system, a secondary sterile barrier system and at least one oxygen indicator. The secondary sterile barrier system has a secondary packaging that is (essentially) oxygen-impermeable or oxygen-tight in the intact state, in particular that is vacuumed/retaining a vacuum on the inside, which separates the interior of the packaging from the environment outside of the secondary packaging. The primary sterile barrier system also has a primary packaging that is (essentially) oxygen-impermeable/oxygen-tight in the intact state and is enclosed by the secondary packaging, i.e. the secondary sterile barrier system preferably completely surrounds the primary sterile barrier system. The primary packaging in turn contains, for example, a sterilized and in particular oxygen-sensitive medical product or surrounds such a product. The oxygen indicator, which is in particular in the form of a tablet, a gel or a capsule, is present within the sterile barrier system, i.e. it is either within the primary packaging and/or within the secondary packaging but outside of the primary packaging.

A central aspect of the present disclosure is that the sterile barrier system is designed as a double sterile barrier system that has the oxygen indicator. The advantage of using a double sterile barrier system is that the product to be protected, which is (directly) enclosed by the inner (primary) sterile barrier system, is doubly protected by both packaging of the primary and secondary sterile barrier system. If, for example, a pointed or sharp object gets close to the sterile barrier system from the outside, there is a high probability that only the outer secondary packaging will be damaged in the event of damage, while the primary packaging directly enclosing the product will remain intact and the product inside will therefore remain sterile.

It is also possible that the secondary packaging (intermediate area/space) in its intact state contains a vacuum or another gas such as nitrogen (oxygen-free). In this case, the primary packaging (interior area/interior) can contain oxygen or be oxygen-free in the intact state (eg contain another gas such as nitrogen or be evacuated). But it is also possible that the space contains oxygen, in which case the primary packaging (interior) does not contain oxygen (oxygen-free).

In addition, the oxygen indicator is designed to change a visually verifiable property such as color, texture, shape, size, volume, etc. upon contact with oxygen. It is therefore possible with the sterile barrier system to easily and directly determine a defect, since the oxygen indicator indicates this by changing its property/makes it visually recognizable. The sterility of the product is thus ensured in two respects, by the double packaging and by the oxygen indicator present in the sterile barrier system or within the secondary packaging.

In a preferred embodiment of the disclosure, the at least one oxygen indicator is present within the secondary packaging and thereby outside the primary packaging and/or is present in the primary packaging. In other words, in a first alternative, the oxygen indicator is in the secondary packaging and is outside of the primary packaging. In a second alternative, the oxygen indicator is only present in the primary packaging. In principle, there is also the possibility that the first and the second alternative are combined with one another, i.e. that both the primary packaging and the secondary packaging each enclose/accommodate at least one oxygen indicator. There is also the possibility that the primary and/or the secondary packaging each have/can contain more than one, i.e. two or more, oxygen indicators.

If the at least one oxygen indicator is located exclusively in the secondary packaging (space) in the case of the first alternative, at least one defect in the outer shell of the sterile barrier system can be detected if the oxygen indicator shows oxygen (especially if the interior is oxygen-free). ).

If, on the other hand, the at least one oxygen indicator is only present in the primary packaging, as described in the second alternative, and indicates oxygen, it can be concluded that at least the inner or both the inner and the outer packaging of the double sterile barrier system are defective and the enclosed product is no longer sterile.

If there is at least one oxygen indicator in both the inner primary packaging and the outer secondary packaging of the sterile barrier system, it can be determined if at least one of the oxygen indicators provided shows oxygen (depending on the type of atmosphere in the interior or intermediate space) whether only the secondary packaging or only the primary packaging or both packaging are defective.

For all previously described options for arranging the oxygen indicator within the sterile barrier system, if the oxygen indicator does not show anything, there is no defect in the sterile barrier system and the sterility of the product is thus proven.

In addition, the sterile barrier system can be provided in such a way that it also has at least one oxygen scavenger, which is made in particular from an open-cell PE foam material, which ensures the freedom from oxygen in the space and/or interior space with intact packaging layers. The secondary packaging is designed, for example, to enclose the oxygen scavenger. The oxygen scavenger is suitable and intended for absorbing oxygen or binding oxygen. The oxygen scavenger can be present in the sterile barrier system inside the secondary packaging and outside the primary packaging and/or be present in the primary packaging.

This means that at least one oxygen scavenger can be arranged/provided for only in the primary packaging or only in the secondary packaging. Alternatively, it can be provided that at least one oxygen scavenger is present both in the primary packaging and in the secondary packaging. It is also possible that the primary and/or the secondary packaging can have/accommodate more than one, i.e. two or more, oxygen indicators. Of course, each possible arrangement of the at least one oxygen scavenger listed here can be combined with each previously listed possible arrangement of the at least one oxygen indicator.

The oxygen scavenger can, for example, be spherical, cylindrical or angular. The oxygen scavenger is advantageously able and intended to quickly absorb the incoming oxygen in the event of a defect in the sterile barrier system and thereby potentially ensure the sterility of the product if this defect is quickly rectified. The possible combination of the two, in particular vacuum-tight, primary and secondary packaging with the oxygen indicator and the oxygen scavenger serves to prove the integrity of the (entire) sterile barrier system.

In addition, it is advantageous if the oxygen indicator is designed in such a way that it changes color when it comes into contact with oxygen. this has the advantage that the presence of oxygen in the sterile barrier system can be checked and determined visually particularly quickly and easily. Furthermore, the use of an oxygen indicator, which has/displays a different color depending on the absence or presence of oxygen, has the advantage that one is free to choose the material of the primary and secondary packaging, as long as the color of the indicator is visually different from this material can be checked outside. Thus, no flexible material has to be used for the packaging in the sterile barrier system, but the use of glass, for example, as a material for the packaging would also be conceivable. The change in state of the indicator can preferably be reversible, and can occur again and again when there is a change in the atmosphere in one (oxygen-containing) or the other (oxygen-free) direction.

An oxygen indicator can be used that contains, for example, a compound with an oxazine core, an iron compound, magnesium silicates and water or alcohol. Another possibility would be an oxygen indicator that has resorufin, methylene blue and/or toluidine blue as the organic redox dye, one or more polyols, in particular glycerol, and water, incorporated into one or more auxiliaries. However, oxygen indicators with other (combinations of) ingredients are also conceivable, as long as the oxygen indicator changes color as a reaction to the presence or absence of oxygen.

If the oxygen indicator is present inside the secondary packaging and thereby outside the primary packaging, at least the secondary packaging preferably has at least one transparent section. If the oxygen indicator is present in the interior of the primary packaging, both the primary packaging has at least one first transparent section and the secondary packaging has at least one second transparent section. The first and second transparent sections overlap at least partially, in particular completely, so that the oxygen indicator can be checked visually from the outside. Of course, it is also conceivable that both the primary and the secondary packaging are completely transparent.

The transparency of the packaging has the advantage that a possible visually recognizable change in status or a possible color change of the oxygen indicator is possible quickly and easily through a visual check from outside the sterile barrier system or outside the secondary packaging.

More preferably, the primary packaging and/or the secondary packaging is/are coated with EVOH (ethylene vinyl alcohol), the primary packaging and/or the secondary packaging is/is constructed of multiple layers, ie the packaging(s) or their packaging walls have multiple packaging layers, and preferably, at least one packaging layer can be an EVOH layer sandwiched between packaging layers made of other materials, such as PA (polyamide), PE (polyethylene), PE peel (polyethylene peel/polyethylene shell/layer), is arranged. In particular, the arrangement of PA, PE, EVOH and PE-Peel in this order is conceivable.

Accordingly, the multi-layer primary packaging and/or the multi-layer secondary packaging of the sterile barrier system has/has at least one EVOH layer. The EVOH layer can be the outermost layer or the innermost layer in the multi-layer (primary and/or secondary) packaging or else the EVOH layer is one of the middle layers in the multi-layer (primary and/or secondary) packaging. Of course, several such EVOH layers in the multi-layer (primary and/or secondary) packaging are also conceivable.

This EVOH layer makes the primary and/or secondary packaging impervious to oxygen and is excellent for preventing oxygen transfer.

It is also conceivable that the oxygen indicator is surrounded by an oxygen-permeable membrane, which in particular has PP (polypropylene), PLA (polylactides) or PE. The oxygen-permeable membrane completely encloses the oxygen indicator so that the oxygen indicator never comes into contact with the medical product to be protected. This has the advantage that the biological compatibility of the oxygen indicator does not have to be taken into account and the oxygen indicator can therefore have any conceivable composition as long as it shows a visually recognizable change in state when it comes into contact with oxygen.

A further advantageous embodiment of the disclosure is aimed at the oxygen indicator being designed in such a way that its reaction to oxygen is reversible, as has already been indicated above. This means that the optically recognizable state of the oxygen indicator can change again and again (back and forth) depending on the presence or absence of oxygen. Such a reversible oxygen indicator can thus be used several times.

Such a reversible change of state also has the advantage that the medical product does not have to be packed in the sterile barrier system under low-oxygen conditions. Because if the product is packaged in the sterile barrier system in the presence of ambient air, the oxygen indicator consequently shows the presence of oxygen via its condition/color. If the air is then drawn out of the system, ie a vacuum is created in at least the packaging that contains the oxygen indicator, the status/color of the oxygen indicator changes again, since there is now no more oxygen in the system.

In addition, the sterile barrier system can be designed in such a way that the oxygen content in the primary packaging is at least as high as the oxygen content in the ambient air and the secondary packaging has a vacuum.

It is also conceivable that the oxygen content in the primary packaging is higher than the oxygen content in the ambient air

It is also possible that the primary packaging does not contain oxygen in its intact state, but contains another gas such as nitrogen.

• Einpacken des Produktes (unmittelbar) in die Primärverpackung, sodass das Produkt vorzugsweise vollständig von der Primärverpackung umschlossen wird,
• Einpacken der Primärverpackung in die Sekundärverpackung,
• Einlegen des Sauerstoffindikators in die Sekundärverpackung (in den Innen- und/oder Zwischenraum),
• Einschließen einer sauerstoffhaltigen oder sauerstofffreien Atmosphäre (Vakuum oder sauerstofffreies Gas) in die Primärverpackung, wobei im Fall einer sauerstoffhaltigen Atmosphäre der Sauerstoffgehalt vorzugsweise zumindest so hoch wie der Sauerstoffgehalt in der Umgebungsluft ist,
• Herstellen einer sauerstofffreien Atmosphäre (Vakuum oder sauerstofffreies Gas) in der Sekundärverpackung (Zwischenbereich) im Fall einer sauerstoffhaltigen und sauerstofffreien Atmosphäre in der Primärverpackung (Innenbereich) oder Herstellen einer sauerstoffhaltigen Atmosphäre in der Sekundärverpackung im Fall einer sauerstofffreien Atmosphäre (Vakuum oder sauerstofffreies Gas in der Primärverpackung und
• Platzieren des Sauerstoffindikators in zumindest einem sauerstofffreien Bereich des Sterilverpackungssystems.

Furthermore, the present disclosure relates to a method for sterile packaging of a medical product in the sterile barrier system described above, with the following steps, preferably in the order listed:

• Packing the product (directly) in the primary packaging, so that the product is preferably completely enclosed by the primary packaging,
• packing the primary packaging into the secondary packaging,
• Insertion of the oxygen indicator in the secondary packaging (in the interior and/or intermediate space),
• Enclosing an oxygen-containing or oxygen-free atmosphere (vacuum or oxygen-free gas) in the primary packaging, whereby in the case of an oxygen-containing atmosphere the oxygen content is preferably at least as high as the oxygen content in the ambient air,
• Establishment of an oxygen-free atmosphere (vacuum or oxygen-free gas) in the secondary packaging (intermediate area) in the case of an oxygen-containing and oxygen-free atmosphere in the primary packaging (interior area) or Establishment of an oxygen-containing atmosphere in the secondary packaging in case of an oxygen-free atmosphere (vacuum or oxygen-free gas in the primary packaging). and
• Placing the oxygen indicator in at least one oxygen-free area of the sterile packaging system.

This type of sterile packaging of a medical product is particularly easy and quick to carry out. When packing the medical product in the sterile barrier system, care must be taken to ensure that the ambient air that is present while the medical product is being packed is not contaminated, so that the sterility of the medical product is guaranteed.

It is also conceivable that oxygen is added to the primary packaging, so that the oxygen content in the primary packaging is higher than the oxygen content in the ambient air.

This has the advantage that in the event of a defect in at least the primary packaging, which is caused, for example, by penetration of the primary packaging during transport of the sterile barrier system, the oxygen from the primary packaging to the secondary packaging as a result of the concentration equalization between the oxygen-rich primary packaging and the oxygen-poor secondary packaging diffuses. This means that the oxygen can be displayed using an oxygen indicator in the secondary packaging.

In other words, the disclosure relates to a sterile barrier system that consists of a primary and a secondary sterile barrier. In addition, the sterile barrier system contains an oxygen indicator and preferably an oxygen scavenger, which quickly absorbs the incoming oxygen in the event of a short-term/temporary leak.

Both the primary and the secondary sterile barrier have/consist of an oxygen-tight, transparent (plastic) film. Oxygen-tightness can be achieved, for example, with an EVOH layer that can be sandwiched between films of other materials, such as PA /PE /EVOH /PE-Peel.

The primary sterile barrier encloses a (medical) product, in particular a disposable product, which is therefore in direct contact with the primary sterile barrier. Inside the packaging of the primary sterile barrier, there is preferably oxygen from the enclosed ambient air.

The oxygen can also be explicitly added to the interior of the primary sterile barrier, so that the oxygen content in the primary sterile barrier becomes even higher and makes a possible later indication within the secondary sterile barrier (here, in an intact state preferably a vacuum is present) safer. If the primary packaging/the primary sterile barrier is penetrated (e.g. as a result of transport), oxygen can later be detected in the secondary packaging/secondary sterile barrier. As a result of the concentration equalization between the oxygen-rich (primary packaging) and the oxygen-poor area (secondary packaging), the oxygen diffuses from the primary to the secondary packaging.

In this case, the secondary sterile barrier contains the oxygen indicator and possibly an oxygen scavenger, which consists of/has open-cell PE foam, for example. The geometry of the oxygen scavenger can be spherical, cylindrical or angular.

The oxygen in the secondary packaging should be detected using the oxygen indicator. A conventional oxygen indicator, as described in the literature (e.g. JP56132560 , EP 2 264 448 B1 ), are deployed/used.

The oxygen indicator can be composed in such a way that a reversible color change is possible. This has the advantage that packaging does not have to be carried out under low-oxygen conditions. Once the secondary packaging has been deflated and a vacuum is established, the reversible indicator(s) will change color again.

In principle, however, an irreversible indicator can also be used.

The indicator can be in the form of a tablet, gel or capsule. Optionally, the indicator can also be packaged in an oxygen-permeable membrane made of e.g. PP, PLA or PE if there are concerns about the biological compatibility (of the oxygen indicator).

With the aid of the packaging construction/sterile barrier system described, a defect in the primary, secondary or both packaging layers can be detected simultaneously. The combination of vacuum packaging, oxygen indicator and, if applicable, the oxygen scavenger suggested above can be used to demonstrate the integrity of the packaging/sterile barrier system. In the case of previously sterilized packaging (primary and secondary packaging), this can also serve as indirect proof of sterility.

character list

• 1 eine Vorderansicht des erfindungsgemäßen Sterilbarrieresystems nach einem ersten Ausführungsbeispiel der vorliegenden Offenbarung;
• 2 eine Detailansicht des Ausschnittes I aus 1; und
• 3 eine Vorderansicht des erfindungsgemäßen Sterilbarrieresystems nach einem zweiten Ausführungsbeispiel der vorliegenden Offenbarung.

The disclosure is explained further below using preferred exemplary embodiments with reference to the accompanying figures. Show it:

• 1 a front view of the sterile barrier system according to the invention according to a first embodiment of the present disclosure;
• 2 a detailed view of section I 1 ; and
• 3 a front view of the sterile barrier system according to the invention according to a second embodiment of the present disclosure.

Description of the exemplary embodiments

The figures are only of a schematic nature and serve exclusively for understanding the invention. Identical elements are provided with the same reference symbols.

The (first and second) exemplary embodiments illustrated here correspond to one another unless otherwise described below. In addition, the exemplary embodiments shown here can be combined with one another at least in part.

In 1 a front view of the (medical) sterile barrier system 1 according to the invention is shown.

The front surface of the sterile barrier system 1 is thus shown in this figure. In this case, the front face shown here is rectangular, but other geometries are also conceivable. The sterile barrier system 1 is intended and designed to accommodate a medical product 2 . The product 2 is, for example, a sterilized or sterile medical product. In this case the product 2 is designed as a pair of tweezers. However, any other type of medical product is also conceivable.

The product 2 is completely surrounded by a primary packaging 4 which is part of the sterile barrier system 1 . The front surface of the primary packaging 4 visible here is rectangular, but can also have a different geometry. The primary packaging 4 encloses an interior space 5 . The interior 5 of the primary packaging 4 thus accommodates the medical product 2 directly.

The primary packaging 4 itself is in turn surrounded by a secondary packaging 6 which is also part of the sterile barrier system 1 . In this case, the secondary packaging 6 preferably completely surrounds the primary packaging 4 . The secondary packaging 6 encloses an intermediate space 7. The primary packaging 4 is located in this intermediate space 7 and is preferably completely surrounded by this intermediate space 7 of the secondary packaging 6 or accommodated therein.

Also the in 1 The visible front surface of the secondary packaging 6 is rectangular, but can also have a different geometry. The secondary packaging 6 also separates the outer area outside the secondary packaging 6 from the inner area inside the secondary packaging 6, ie the space 7 . In other words, the primary packaging 4 is in the inner area of the secondary packaging 6, ie in its intermediate space 7, within which or in its interior 5 the product 2 is in turn located. Thus, the secondary packaging can be referred to as "outer" secondary packaging, while the primary packaging can be referred to as "inner" primary packaging.

Provision is also made for both the primary packaging 4 and the secondary packaging 6 to be impermeable to oxygen, ie impermeable to oxygen. The oxygen impermeability of the packaging 4, 6 can be achieved in that the packaging 4, 6 each have at least one EVOH layer. A multi-layer structure of the packaging 4, 6 is conceivable, as later under 2 described.

In 1 It can also be seen that the sterile barrier system 1 also has an oxygen indicator 8 . In this first exemplary embodiment, the oxygen indicator 8 is present inside the secondary packaging 6 (in the space 7 ) and outside the primary packaging 4 . As already mentioned in the introduction to the description, the oxygen indicator 8 can also (exclusively) be present in the primary packaging 4 (in the interior 5). It is also possible for an oxygen indicator 8 to be present both in the primary packaging 4 and in the secondary packaging 6 . Several oxygen indicators 8 can also be present per package 4, 6. If several oxygen indicators 8 are used per package 4, 6, the states of the indicators 8 within a package 4, 6 can be compared with one another and the results of the same can thus be validated. For this purpose, the presence of at least three oxygen indicators 8 per package 4, 6 would be particularly helpful.

The oxygen indicator 8 is round here, but can also have a different shape or geometry. The oxygen indicator can be in the form of a capsule, tablet or gel. It is conceivable that the oxygen indicator will change color when in contact with oxygen compared to when it is not in contact with oxygen. In addition, the reaction of the oxygen indicator can be reversible. Such an indicator, which changes color in the presence of oxygen and whose color change is reversible, can be, for example, a compound with an oxazine nucleus, an iron compound, magnesium silicates and water or alcohol. When in contact with oxygen, this oxygen indicator turns red-violet, in the absence of oxygen the oxygen indicator is white.

However, an oxygen indicator can also be used which does not change color when it comes into contact with oxygen, but instead changes its volume or some other visible property, for example. In addition, it is also not necessary for the change in state of the oxygen indicator to be reversible as a function of the presence and absence of oxygen.

In 1 the oxygen indicator 8 is surrounded by an oxygen-permeable membrane 10 . This membrane 10 can have PP, PLA or PE, for example. The membrane 10 is shown here as rectangular, but it can also have a different geometry. The membrane 10 has the advantage that it shields the oxygen indicator 8 . Contact of the oxygen indicator 8 or contact of its ingredients with the product 2 can be avoided by the membrane 10. This is particularly important if the oxygen indicator 8 contains biologically questionable ingredients that could be transferred through the product 2 without the membrane 10 to a patient on whom this product 2 is used.

In secondary packaging 6 in 1 (outside the primary package 4) an oxygen scavenger 12 is also included. The oxygen scavenger 12 has the task of binding or absorbing oxygen that has briefly entered the sterile barrier system 1, for example through a hole or a defect in one of the packages 4, 6. One oxygen scavenger 12 is embodied here in the form of a cylinder, for example, but can also have a different geometry. Here, the oxygen scavenger 12 is located exclusively in the secondary packaging 6 and outside the primary packaging 4. However, here too, as with the oxygen indicator 8, the arrangement of an oxygen scavenger 12 exclusively in the primary packaging 4, an oxygen scavenger 12 in each case the primary and in the secondary packaging 4, 6 or the use of several oxygen scavengers 12 within a package 4, 6 conceivable.

in the in 1 shown first embodiment is in the intact state also no vacuum (but oxygen) in the interior 5 of the primary packaging 4 and there is a vacuum in the intermediate space 7 of the secondary packaging 6. This means that in the primary packaging 4 in the intact state oxygen is present, which is Packing/wrapping the product 2 into the primary packaging 4 which is/was enclosed in this. Accordingly, there is only an oxygen indicator 8 in the secondary packaging 6; the primary packaging 4 has no oxygen indicator 8 here.

The arrows A and B indicate the direction of the oxygen if there is a defect/leakage/hole in both packages 4, 6 that is not explicitly shown. In the present first exemplary embodiment, the concentration equalization pushes the oxygen out of the oxygen-rich primary packaging 4 into the oxygen-poor secondary packaging 6, which arrow A represents. In addition, the concentration equalization forces the oxygen from the oxygen-rich area with ambient air outside the secondary packaging 6 to penetrate into the inner space 7 of the oxygen-poor secondary packaging 6, which the arrow B shows. In this case, the oxygen indicator 8 arranged in the secondary packaging 6 would detect oxygen.

2 is a detailed view and shows an example of a section I of a wall of the primary packaging 4. The embodiment shown here is only an example based on the primary packaging 4, the secondary packaging 6 can also be multi-layered. In 2 the multi-layer structure of the primary packaging 4 becomes visible. For example, the wall of the primary packaging 4 can have four different layers, each of which consists of, in particular, different materials. So is in the in 2 example shown, the outermost layer of the primary packaging 4, which the primary packaging 4 in 1 and 2 delimited from the intermediate space 7 of the secondary packaging 6, a PA layer, which borders on a PE layer, which in turn borders on an EVOH layer, which in turn adjoins a PE peel layer. In this representation, the PE peel layer forms the innermost layer of the primary packaging 4, which at the same time serves as a boundary to the interior 5 of the primary packaging 4. However, a different number of layers and a different combination of the layers with different materials is also possible. The use of materials not listed here is also conceivable.

The primary and secondary packaging can both be constructed in the same way or differently from one another, i.e. have the same layers in the same order or different layers in a different order, with all conceivable combinations of layers and order of the layers being possible.

3 shows the front view of the sterile barrier system 100, which is shown here as a second embodiment. In contrast to the sterile barrier system 1 of the first exemplary embodiment, the oxygen indicator 8 is arranged exclusively within the primary packaging 4 here. In this case, no oxygen scavenger 12 is provided in the entire sterile barrier system 100 .

In addition, there is nitrogen in the interior 5 of the primary packaging 4, i.e. there is no oxygen in the interior 5 of the primary packaging 4. As in the first exemplary embodiment, in the present second exemplary embodiment, too, oxygen from the ambient air from outside the secondary packaging 6 penetrates into the intermediate space 7 via a defect in the secondary packaging 6, as indicated by the arrow B. In contrast to the first exemplary embodiment, in the present second exemplary embodiment, the oxygen from the secondary packaging 6, which is therefore relatively oxygen-rich, penetrates through a defect in the primary packaging 4 into its interior 5, which arrow A represents. In this case, the oxygen indicator 8 arranged in the primary packaging 4 would indicate oxygen.

Reference List

1

Sterile barrier system according to the first embodiment

2

medicinal product

4

primary packaging

5

Interior/inner area of the primary packaging

6

secondary packaging

7

Space/intermediate area of the secondary packaging

8th

oxygen indicator

10

oxygen permeable membrane

12

oxygen scavenger

100

Sterile barrier system according to the second embodiment

A

Arrow indicating direction of oxygen

B

Arrow indicating direction of oxygen

QUOTES INCLUDED IN DESCRIPTION

This list of documents cited by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent Literature Cited

• US4295566A [0005]
• JP 56132560 [0046]
• EP 2264448 B1 [0046]

Claims (11)

Sterile barrier system (1) for a medical product (2) having: - an inner primary packaging (4) for directly covering or enclosing the medical product (2), - an outer secondary packaging (6) for covering or enclosing the inner primary packaging (4) while forming an intermediate space (7), with an atmosphere in the intermediate space (7) being different from that in an interior space (5) directly accommodating the product (2) the primary packaging (4) and/or to the system environment prevails and - an indicator in the space (7) and/or interior (5), which reacts to the atmosphere in the other space and/or the system environment and thus indicates a leak at least in the primary packaging (4) separating the interior (4 from the space (7)) and/or the secondary packaging (6) separating the space (7) from the system environment. Sterile barrier system (1) according to claim 1 , characterized by the primary packaging (4), which is impermeable to oxygen when intact and is designed to accommodate and enclose the, in particular sterilized/sterile and/or oxygen-sensitive, medical product (2) in its interior (5), the secondary packaging ( 6) which is impermeable to oxygen when intact and separates its interior (7) from the environment outside the secondary packaging (6) and which is designed to accommodate and enclose the primary packaging (4), and at least one indicator in the form of an oxygen indicator (8), which is designed in particular as a tablet, gel or capsule and is arranged inside the secondary packaging (6). Sterile barrier system (1) according to claim 2 , characterized in that the oxygen indicator (8) is present inside the secondary packaging (6) and outside the primary packaging (4) and/or in the interior (5) of the primary packaging (4). Sterile barrier system (1) according to claim 2 or 3 , characterized by at least one oxygen scavenger (12), which is produced in particular from an open-cell PE foam, the secondary packaging (6) being designed to enclose the oxygen scavenger (12), and the oxygen scavenger (12) inside the secondary packaging (6 ) and is present outside of the primary packaging (4) and/or in the interior (5) of the primary packaging (4). Sterile barrier system (1) according to one of the preceding claims 2 until 4 , characterized in that the oxygen indicator (8) changes color on contact with oxygen. Sterile barrier system (1) according to one of the preceding claims 2 until 5 , characterized in that in the case that the oxygen indicator (8) is inside the secondary packaging (6) and outside the primary packaging (4), at least the secondary packaging (6) has at least one transparent section, and in the case that the oxygen indicator (8) is present in the interior (5) of the primary packaging (4), the secondary packaging (6) in each case has at least one first transparent section and the primary packaging (4) has at least one second transparent section, and the first and the second transparent section at least partially , in particular completely overlap so that a visual inspection of the oxygen indicator (8) from the outside is possible. Sterile barrier system (1) according to one of the preceding claims 2 until 6 , characterized in that the primary packaging (4) and/or the secondary packaging (6) is/are EVOH-coated, the primary packaging (4) and/or the secondary packaging (6) is/are constructed in multiple layers, and preferably at least one EVOH layer Sandwich principle type between packaging layers made of other materials, such as PA, PE, PE peel, can be arranged, in particular in the arrangement PA, PE, EVOH and PE peel. Sterile barrier system (1) according to one of the preceding claims 2 until 7 , characterized in that the oxygen indicator (8) is surrounded by an oxygen-permeable membrane (10), which in particular has PP, PLA or PE. Sterile barrier system (1) according to one of the preceding claims 2 until 8th , characterized in that the oxygen indicator (8) is designed so that its reaction to oxygen is reversible. Method for the sterile packaging of a medical product (2) in a sterile barrier system (1) according to one of the preceding claims, with the following steps, preferably taking place in the order listed: gas-tight packaging or covering of the product (2) in or by the primary packaging (4 ), gas-tight packing or covering of the primary packaging (4) in or through the secondary packaging (6), placing the oxygen indicator (8) in the secondary packaging (6) and/or the primary packaging (4), enclosing an oxygen-containing or oxygen-free atmosphere (vacuum or oxygen-free gas) in the primary packaging , whereby in the case of an oxygen-containing atmosphere the oxygen content is preferably at least as high as the oxygen content in the ambient air, creating an oxygen-free atmosphere (vacuum or oxygen-free gas) in the secondary packaging (intermediate area) in the case of an oxygen-containing and oxygen-free atmosphere in the primary packaging (inner area) or creating an oxygen-containing atmosphere in the secondary packaging in case of an oxygen-free atmosphere (vacuum or oxygen-free gas in the primary packaging, with the oxygen indicator placed in at least one oxygen-free area of the sterile packaging system. Optional including a es oxygen content in the primary packaging (4), which is at least as high as the oxygen content in the ambient air, and creating a vacuum in the secondary packaging (6). Method for the sterile packaging of a medical product (2) in a sterile barrier system (1). claim 9 , characterized in that the secondary packaging (6) oxygen is added so that the oxygen content in the primary packaging (4) is higher than the oxygen content in the ambient air.

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