Packaging and method for sterile packaging of objects for medical, pharmaceutical or cosmetic applications

Description

[0001] The present invention relates to a packaging for the sterile storage and transport of objects for medical, pharmaceutical or cosmetic applications, in particular sterile pharmaceutical primary packaging materials, such as vials, ampoules, syringes or carpules, as well as a method for packaging. State of the art

[0002] Pharmaceutical primary packaging materials, such as vials, ampoules, syringes, cartridges, and syringes, are delivered by manufacturers to pharmaceutical companies for filling, usually sterile packaged in so-called tubs and trays. These tubs usually consist of a carrier, known as a nest, which holds a plurality of primary packaging materials, and a tub or tray into which the carrier is inserted. In trays, a plurality of primary packaging materials is inserted directly into the tray. The tubs and trays are typically sealed with a flash-spun, ultrafine fiber nonwoven made of high-density polyethylene (HDPE), known under the brand name Tyvek ®< from DuPont. Due to the selectively permeable Tyvek ®< nonwoven, the interior of the tub or tray can be sterilized with ethylene oxide or steam even when sealed, while creating a microbial barrier.Before sterilization, the tubs and trays are usually tightly enclosed in one or two bags.

[0003] At the pharmaceutical company, the sterile primary packaging is unpacked and filled under controlled, sterile conditions. During the transition from higher to lower cleanroom classes, so-called disinfection steps are carried out. These can involve removing a packaging layer, e.g., a bag, or biological decontamination using methods such as e-beam, hydrogen peroxide, or wiping with an alcohol solution. Before the tube or tray is transferred to the aseptic area, where the Tyvek® sealing film is removed and the active pharmaceutical ingredient is subsequently filled into the primary packaging, a further decontamination step takes place. This is necessary because the sterility of the outside of the tube or tray cannot be guaranteed.

[0004] Pouches are generally defined as having at least one of their three sides, apart from the filling opening, that is, not sealed, welded, or glued. This means that they are side-seam pouches or bottom-seam pouches made from a half-tube, a folded flat film, or a solid tube. Pouches, on the other hand, are generally defined as having a welded or sealed seam or an adhesive bond on all three sides, as they are made from two or more separate film webs. The closed pouch therefore has a welded, sealed, or glued bond on all sides. For the purposes of this application, the term "pouch" is used as a collective term for both pouches and bags.

[0005] EP 0 307 173 A1 discloses a sterilizable disposable packaging for hospital supplies. To improve stability and prevent fiber contamination on the packaged items, this packaging uses a nonwoven layer that is steam-permeable but impermeable to bacteria, instead of the usual paper layers, which are damaged during steam sterilization. This nonwoven layer, combined with a perforated plastic film layer as a laminate, forms one side of the packaging. The other side of the packaging is formed by a simple plastic film or a plastic film laminate.

[0006] US 2006 / 016708 A1 discloses an autoclavable sterilization bag that forms a pouch from two composite film laminates. At least the first laminate comprises a layer of a heat-sealable, transparent thermoplastic polymer as the inner layer and a layer of a transparent thermoplastic polymer as the outer layer. A barrier layer of molecularly oriented polychlorotrifluoroethylene (PCTFE), also transparent, is located between the two layers. In some embodiments, the inner layer consists of a polyolefin, and the outer layer of polyethylene terephthalate, nylon, polypropylene, polyethylene, or cellophane.

[0007] One reason why the sterility of bag packaging cannot be guaranteed lies in the tightness and durability of the seal seams. Various defects in the seal seam can occur both during the sealing of the bag during production and during the final sealing of the bag after filling. These defects are caused by sealing outside of optimal parameters, known as undersealing or oversealing. With undersealing, the layers are not sufficiently bonded due to insufficient temperatures, contact pressures, or sealing times, so that the resulting seal seam has only weak adhesion. The resulting defect is separation in the seal seam or the formation of channels and cavities.

[0008] In contrast, when oversealing, small holes known as pinholes are caused in the sealing seam by excessively high temperatures, contact pressures or sealing times. The completely melted polymer is displaced sideways, resulting in a sealing seam that is too thin, which can also be further thinned in the transition area to the remaining film, or in extreme cases the polymer can even be thermally damaged.

[0009] Inspecting the seal seams during the ongoing production process is difficult because conventional camera inspection of the seal seams from the film side is difficult to detect. The crystalline Tyvek® nonwovens melt in the area of ​​the seal seam during sealing, thereby losing their white color. Visual detection of the transparent seal seam and its defects is almost impossible due to the low contrast. Task

[0010] The present invention aims to remedy these disadvantages of the prior art. In particular, it aims to provide a package that reliably and reliably ensures the sterility of the contents, thus eliminating the need for an additional sterilization step at the pharmaceutical company.

[0011] A further aspect is to enable improved detection of seal seam defects. Description of the invention

[0012] This object is achieved by a packaging for the sterile packaging of objects for medical, pharmaceutical or cosmetic applications, comprising at least one bag made of a first and a second web which are connected to one another, which is characterized in that the first web consists of a selectively permeable nonwoven fabric, the second web consists of a laminated film with at least three layers, wherein the first layer is a polymer film arranged on the outside of the bag, the second layer is a laminating adhesive and the third layer is a polymer film arranged on the inside of the bag, wherein at least one of the layers of the second web contains one or more pigments.

[0013] In one embodiment, the polymer of the first layer has a melting temperature that is at least 20 °C above the seal initiation temperature of the third layer.

[0014] For the purposes of this application, the melting temperature of the polymer is defined as the temperature of the peak minimum of the melting peak of the second heating cycle in a differential scanning calorimetric (DSC) measurement at a heating rate of 20 K / min. For the purposes of this application, the seal initiation temperature of the polymer is defined as the temperature at which a seal strength of at least 4 N / 15 mm, measured according to DIN EN 868-5:2009, Annex D, is achieved when sealing the two webs of the bag.

[0015] In one embodiment, the sealing seam is imaged in an 8-bit grayscale image, which was taken in transmitted light and contrast-normalized, in a gray value range of 50 - 200.

[0016] For the purposes of this application, contrast-normalized refers to a linear expansion of the image's grayscale to the full range of 0-255 of the 8-bit scale, so that the contrast is maximized. If g min and g max define the minimum and maximum grayscale values ​​of the image, the expanded grayscale is calculated using the formula: f g = 255 g max − g min ⋅ g − g min

[0017] In one embodiment, the sealed seam has a transmittance τ vis of 10% - 40%, measured in remission with a 2° observer according to DIN 5033-1:2009-5. The transmittance τ vis can also be 12% - 38%, 14% - 36%, 16% - 34%, 18% - 32%, 20% - 30%, 22% - 28%, or 24% - 26%.

[0018] In one embodiment, the transmittances τ vis of the sealed seam and the first web (1), measured in reflectance with a 2° observer according to DIN 5033-1:2009-5, exhibit a difference of 30-75 percentage points. The difference can also be 35-70, 40-65, 45-60, or 50-55 percentage points.

[0019] In one embodiment, the seal seam in an 8-bit grayscale image taken in transmitted light and contrast-normalized has gray values ​​that are at least 30 units, 40 units, 50 units, 60 units, 70 units, 80 units, 90 units, or 100 units above the gray values ​​of the area surrounding the seal seam.

[0020] Preferably, in the second web, the first layer is a polyester film or polyamide film and the third layer is a film of polyethylene, polypropylene or polyester homo- or copolymers.

[0021] This bag design offers several advantages. Constructing the second layer as a laminated film reduces the risk of leaks in the bag due to pinholes that can occur during the extrusion of the individual films. The layer of laminating adhesive applied between the film layers seals any pinholes that may be present, thus eliminating leaks in the film.

[0022] An outer polyester or polyamide layer improves the edge areas of the sealed seam, particularly when the heat is applied from the polyester or polyamide side. The outer first film layer can have a melting temperature that is at least 20 °C, at least 25 °C, at least 30 °C, at least 35 °C or at least 40 °C higher than the seal initiation temperature of the inner third layer. The melting temperature of the first film layer can be, for example, at least 200 °C, at least 210 °C or at least 220 °C. This means that the outer layer does not melt during sealing, but only the inner layer, which acts as the sealing layer. The transition from the sealed seam to the unsealed area of ​​the nonwoven is therefore subjected to considerably less stress than, for example, with the usual simple film layer made of HDPE that is sealed against a Tyvek ®< nonwoven.This reduces the risk of failure of the Tyvek® or nonwoven layer at the seal seam. Furthermore, the nonwoven layer can be completely melted through the seal seam, resulting in a better bond between the layers, increased seal strength, and a transparent or translucent seam. Last but not least, the laminated bond with the polyester or polyamide layer also increases puncture resistance on the film side of the bag.

[0023] Finally, coloring one or more of the film layers improves the contrast, enabling flawless detection of both under- and over-sealing. The transparent or translucent seal allows the seam to be examined in transmitted light with a camera. Combined with the additionally increased contrast provided by the coloring, the seal becomes particularly clear when the camera is directed at the white nonwoven side of the packaging. This allows every type of defect in the seal to be reliably detected in a grayscale analysis of the transmitted light image, and the bag can be rejected. The minimum detectable defect size is then limited only by the resolution of the camera system.

[0024] The pigments to be used are to be selected according to the invention in terms of quantity, particle size, and color to ensure an optimal appearance of the sealed seam for optical detection of the sealed seam and its defects in transmitted or reflected light. To this end, the quantity, particle size, and color of the pigments are preferably adjusted so that, in a contrast-normalized 8-bit grayscale image, the sealed seam is depicted in a grayscale range of 50-200, 60-190, 70-180, 80-170, 90-160, 100-150, or 110-140. The grayscale values ​​are preferably <200, <190, <180, <170, <160, <150. This allows for particularly good contrast with the surrounding area of ​​the unsealed nonwoven layer.

[0025] Furthermore, a transmittance τ vis of 10% - 40%, 12% - 38%, 14% - 36%, 16% - 34%, 18% - 32%, 20% - 30%, 22% - 28%, or 24% - 26% can be adjusted for the sealed seam, particularly by adjusting the quantity and particle size of the pigments in remission with a 2° observer according to DIN 5033-1:2009-5. The combination of the increased contrast and the resulting haze of the seam allows for particularly good detection of individual sealing defects. Uneven degrees of matting in the seam are a sign of inhomogeneous melting behavior or incorrect contact pressure of the sealing elements. Channeling in the sealed seam is also very easy to detect, as it stands out clearly from the matte surroundings.

[0026] It may also be advantageous not to adjust the transmittance τ vis measured in remission solely via the pigments, but also to use a scattering additive that increases the proportion of backscattered light and thus the transmittance τ vis measured in remission, without reducing the transmittance to the same extent. Thus, after passing through the sealed seam, more light remains for absorption in transmitted light, which in turn benefits the possible contrast. Such scattering additives, which may also be colored themselves, are generally known to the person skilled in the art, for example from EP 0 269 324 A2. The scattering additive can be used in the same layer(s) as the pigment or separately.

[0027] Preferably, the polyester or polyamide film of the first layer of the second web is free of pigments. This offers the advantage that the oversealing is particularly easy to detect. The transparent or translucent polyester or polyamide layer does not melt under optimal sealing conditions. If the underlying colored layers of polyethylene and / or laminating adhesive are displaced during oversealing, a colored area bordered on both sides by transparent areas appears in the transmitted light camera image within the otherwise white appearance of the nonwoven fabric.

[0028] The selectively permeable nonwoven fabric of the first web can be a microfiber nonwoven fabric made of high-density polyethylene (HDPE), polypropylene (PP), or polyethylene terephthalate (PET). For example, HDPE nonwoven fabrics from the Tyvek®< series from DuPont are suitable for the purposes of the invention. Their uncoated types are preferably used (e.g., Tyvek®< 1073B). A key requirement for the selection of a nonwoven fabric is its ability to form a sterilizable microbial barrier, i.e., it must exhibit selective permeability with a barrier effect for microbes while simultaneously allowing sterilization media such as ethylene oxide or hydrogen peroxide vapors to pass through.

[0029] The polymer of the third layer of the second web can be polyethylene, polypropylene, or polyester. These polymers can be used as homopolymers or as copolymers consisting of more than 50% of the aforementioned monomers. The polymer is preferably selected to match the polymer of the nonwoven fabric to optimize sealability. This can involve either matching the polymer class or even using the same polymer type.

[0030] The polyethylene of the third layer of the second web can be high-density polyethylene (HDPE), medium-density polyethylene (MDPE), low-density polyethylene (LDPE), or linear low-density polyethylene (LLDPE), or their respective copolymers consisting of more than 50% of the aforementioned monomers. It is preferably HDPE, MDPE, or LDPE. HDPE offers the advantage that the packaging can then be sterilized with steam in addition to ethylene oxide or hydrogen peroxide vapors. Sterilization with radiation is possible for all variants.

[0031] The polyester film of the first layer of the second web can be made of polyethylene terephthalate (PET) or polybutylene terephthalate (PBT). The polyamide film of the first layer of the second web can be made of PA 6, PA 6.6, or PA 12. These ensure good puncture resistance of the bag while maintaining good transparency. They thus contribute in two ways to the desired goal of guaranteed sterility of the packaging. On the one hand, they prevent leaks in the overall surface of the packaging due to defects and film failure under mechanical stress. On the other hand, they contribute to improving defect detection in the packaging's sealed seams.

[0032] The laminating adhesive of the second layer of the second web is preferably a polyurethane-based (PUR) adhesive. In particular, this is preferably a non-reactive PUR hotmelt adhesive. By laminating the two films, a through-hole (pinhole) in the overall film is avoided. In addition, any pinholes that may be present in the individual films are sealed particularly effectively by the PUR-based laminating adhesive. The application quantity of the laminating adhesive can be 0.5 - 15 g / m 2 < or 1.0 - 12 g / m 2 < or 1.2 - 10 g / m 2 < or 1.4 - 8.0 g / m 2 < or 1.6 - 6.0 g / m 2 < or 1.8 - 5.0 g / m 2 < or 2.0 - 4.0 g / m 2 <.

[0033] In embodiments of the invention, the webs of the bag are joined to form the bag by sealing or gluing, and the filled bag is closed by means of a sealed seam. Preferably, both the bag formation and the closure of the filled bag are carried out using sealed seams. In this way, the bag's tightness can be checked on all sides using a camera inspection of the seams in transmitted light. Furthermore, the sealed seam is more robust than the adhesive connection.

[0034] Most preferably, the seal seams of the bag have a seal seam strength measured according to DIN EN 868-5:2009 Annex D of at least 20 N / 15 mm, at least 22 N / 15 mm, at least 25 N / 15 mm or at least 30 N / 15 mm.

[0035] The puncture resistance of the first web of the bag measured according to DIN EN 14477:2004 at a test speed of 100 mm / min and a tip diameter of 0.8 mm is preferably at least 10 N, at least 11 N, at least 12 N, at least 13 N or at least 14 N.

[0036] The puncture resistance of the second web of the bag measured according to DIN EN 14477:2004 at a test speed of 100 mm / min and a tip diameter of 0.8 mm is preferably at least 4.5 N, at least 5.0 N, at least 5.5 N, at least 6.0 N or at least 6.5 N.

[0037] In one embodiment of the invention, a tub in the form of a trough or tray is arranged within the bag for receiving the objects. A carrier, a so-called nest, is preferably arranged within the tub. Optionally, the nest is firmly connected to the tub, preferably in a one-piece design. In another embodiment of the invention, a tray is arranged within the bag for receiving the objects. A variety of pharmaceutical primary packaging materials, such as vials, cartridges, or syringes, are thus often accommodated and securely arranged either in the nest or in the tray.

[0038] Most preferably, the tub or tray is sealed with a selectively permeable nonwoven fabric by sealing or gluing. This can be the same nonwoven fabric used to form the bags. However, a different nonwoven fabric can also be used that has the same selective permeability properties but is made of a material that is better suited for sealing with the material of the tub or tray.

[0039] In a further embodiment of the invention, the bag is enclosed by one or more additional bags. The bags are preferably identical in structure to the first bag and preferably merely correspondingly larger. The resulting overall package is suitable for transporting the contents, free of contamination, to the place of use or filling at a pharmaceutical company in a step-by-step unpacking process in an increasingly clean environment. Accordingly, in a package consisting of a sealed tub or tray with two outer bag packages, the first bag is opened in a Class C cleanroom environment, the second bag in Class B, and finally the tub or tray in Class A.

[0040] A method according to the invention for sterile packaging of objects for medical, pharmaceutical or cosmetic applications is characterized in that one of the packagings described above is used.

[0041] The invention further relates to a method for sealing seam control in a bag made of a first web of a selectively permeable nonwoven fabric and a second web connected thereto, which consists of a laminated film with at least three layers, wherein the first layer is a polymer film arranged on the outside of the bag, the second layer is a laminating adhesive and the third layer is a polymer film arranged on the inside of the bag, wherein the polymer of the first layer has a melting temperature which is at least 20 °C above the sealing initiation temperature of the third layer, and wherein at least one of the layers of the second web contains one or more pigments, which comprises the steps Providing the webs of the bag in such a way that the seal seam is imaged in an 8-bit grayscale image taken in transmitted light and contrast-normalized in a gray value range of 50 - 200, and the seal seam has a transmittance τ vis of 10% - 40% measured in remission with a 2° observer according to DIN 5033-1:2009-5, recording the seal seam with a camera system in transmitted light to generate an 8-bit grayscale image and contrast-normalizing the same, evaluating the contrast-normalized 8-bit grayscale image for inhomogeneities in the gray values ​​of the seal seam.

[0042] The packaging system according to the invention thus makes it possible to establish a visual inspection – both visually and automatically with the help of a camera inspection system – that allows for the reliable detection of sealing defects, both in the case of over-sealing and under-sealing. Accordingly, all bags with defects in the seal seam can be sorted out. Furthermore, the possible optimization of the seal seam not only ensures its transparency or translucency, which improves detection, but also improves the seal seam strength. Short description of the characters

[0043] Figure 1 shows the layer structure of a bag from Example 1. Figure 2 shows the layer structure of a bag from example 2. Figure 3 shows an evaluation profile of a poor seal seam from Example 1. Figure 4 shows an evaluation profile of a good seal seam from Example 1.

[0044] The representation of the layer thicknesses is shown in the Figures 1 and 2 not to scale, but only roughly approximated. Examples

[0045] The invention is illustrated below using examples. These serve merely to illustrate embodiments of the invention and are not to be understood as limiting. Example 1

[0046] Bags were produced from a first web (1) and a second web (2). The first web (1) consisted of an HDPE nonwoven fabric (3) of the type Tyvek®< 1073 B uncoated from DuPont with a thickness of approximately 180 µm. The second web (2) consisted of a first layer (4) arranged on the outside made of a 12 µm thick PET film and a 50 µm thick third layer (6) made of LDPE bonded to it by means of the second layer (5) of 2.5 g / m²< made of a PUR-based hotmelt laminating adhesive. The third layer (6) made of LDPE was colored blue with a pigment, while the other two layers were colorless and transparent. The layer structure is shown in Fig. 1 shown.

[0047] The bag was formed by applying three seal seams with a width of 3 mm, 6 mm, or 10 mm using an Accu Seal 6300-25-X Impulse Sealer at 180–190 °C, a pressure of 5.5–6 bar, and a sealing time of 3–4 s. Heat was applied from one side of the polyester film. A further seal seam is provided to close the filled bag, resulting in a package sealed on all sides. During sealing, a seal seam was achieved in which the nonwoven layer melted transparently, clearly revealing the blue color of the LDPE layer. The seal seams were subjected to camera inspection, with the seal seams being recorded with cameras in transmitted light, and the images were subsequently analyzed. For this purpose, profile plots were created at right angles across the seal seams in the standardized grayscale images using analysis software. Fig. 3 and Fig. 4A single profile section through the sealed seam is shown as an example. The grayscale value is plotted over the examined distance. To assess the sealed seam during the production process, the software naturally evaluates the image of the entire sealed seam.

[0048] In Fig. 3 A defective seam is shown. The transparent areas at the edges of the seam are clearly visible, indicated by bright peaks. In this case, the colored LDPE sealing layer has completely melted away due to incorrect temperature and / or incorrect sealing jaw pressure, so that the edges are now formed only by the colorless-transparent PET film, which then appears in the white range of the grayscale values ​​when viewed through transmitted light.

[0049] In contrast, the Fig. 4 a perfect sealing seam, which in the curve image is very close to the ideal rectangular curve. Example 2

[0050] Bags were produced from a first web (1) and a second web (2). The first web (1) consisted of an HDPE nonwoven fabric (3) of the type Tyvek®< 1073 B uncoated from DuPont with a thickness of approximately 180 µm. The second web (2) consisted of a first layer (4) arranged on the outside made of a 12 µm thick PET film and a 50 µm thick third layer (7) made of HDPE bonded to it by means of the second layer (5) of 2.5 g / m 2< made of a PUR-based laminating adhesive. The third layer (6) made of HDPE was colored blue with a pigment, while the other two layers were colorless and transparent. The layer structure is shown in Fig. 2 shown.

[0051] The bag was formed by applying three seal seams with a width of 3 mm, 6 mm, and 10 mm using an Accu Seal 6300-25-X Impulse Sealer at 180–185°C, a pressure of 5.7–6.2 bar, and a sealing time of 3.5–4.5 s. Heat was applied from one side of the polyester film. A further seal seam is provided to close the filled bag, resulting in a package sealed on all sides. During sealing, a seal seam was achieved in which the nonwoven layer was melted transparently, and the blue color of the HDPE layer was clearly visible. As in Example 1, the seal seams were subjected to camera inspection. The seal seams were recorded using cameras in transmitted light, and the images were subsequently analyzed. Here, too, the seal seams were easily detected, and defects were clearly visible. Measurement methods

[0052] The seal seam strength was determined according to DIN EN 868-5:2009-09. Five strips each 15 mm wide and 5 cm long were cut from the packaging material to be tested. The sample was cut at right angles to the seal seam. The strips were also cut out distributed over the seam to be tested, but with a minimum distance of 2 cm from the outer edge. Subsequently, a distance of 3 cm was drawn on each strip, parallel to the seal seam towards the inside of the packaging. These served as clamping marks. The end of the strip was clamped completely into the lower clamp. The seal seam was parallel to the upper edge of the clamp. The other end of the test specimen was clamped into the upper clamp so that the drawn marks lay directly on the lower edge of the upper clamp and the test specimen was not yet subjected to any stress.The test was then carried out at a test speed of 200 mm / min with an unsupported flag until failure of the test specimen was observed.

[0053] The puncture resistance was determined according to DIN EN 14477:2004. All samples were stored for at least 48 hours at a temperature of 23 °C / 50% RH. They were then tested in this temperature. Ten individual measurements were taken per sample. The films were clamped in the test fixture with the inside facing up. The 0.8 mm diameter probe was pushed through the film at a test speed of 100 mm / min until failure occurred.

[0054] The transmittance τ vis measured in remission with a 2° observer according to DIN 5033-1:2009-5 was measured using a Perkin Elmer Lambda 900 spectrometer equipped with a 60 mm integrating sphere and a sample holder at 11°. The spectrometer was used in remission mode and recorded in the range from 360 nm to 780 nm. Illumination was performed with standard illuminant D65. The evaluation was performed with a 2° observer according to DIN 5033-1:2009-5. Seal seam strength

[0055] As described above, sample strips of the sealed seams were taken from all sides of the formed bags to measure the seal strength. The measured values ​​given in the table represent the minimum values ​​measured in each case.

[0056] The resulting sample strips were measured as described above. A bag in the usual design, consisting of a DuPont Tyvek® 1073B (130-180 µm) and an HDPE (80 µm) sheet, was used as a comparison. The measurement results are listed in Table 1. Table 1 Pattern Seal seam strength [N / 15 mm] Example 1 30 N Example 2 27 N Comparison example 12,5 N

[0057] The measured values ​​show on average a seal seam strength that is approximately two to three times greater for the bags according to the invention with a laminate web than for the common variant with Tyvek ®< 1073B and HDPE. Puncture resistance

[0058] Samples of both webs were taken from the bags of Examples 1 and 2, as well as Comparative Examples 1 and 2, and measured according to the method described above. Comparative Example 1 corresponds to the bag with a DuPont Tyvek® 1073B web and a HDPE web, and Comparative Example 2 corresponds to a bag with a polypropylene microfiber nonwoven web (88-98 g / m²) and a laminated web of a polyester film (12 µm) and a polypropylene film (38 µm). The results are summarized in Table 2. Table 2 Pattern Puncture resistance [N] Lane 1 Lane 2 Example 1 16,9 N 7,3 N Example 2 16,9 N 7,2 N Comparison example 1 16,9 N 3,5 N Comparison example 2 16,0 N 6,8 N

[0059] The measured values ​​show that the layer structure of the bags according to the invention not only enables improved detection of seal seam defects, but at the same time also makes the packaging even more robust. Transmittance τ vis

[0060] On bags from Examples 1 and 2, the seal seams and the two webs (1) and (2) were measured in reflectance as described above. The web samples were taken at a lateral distance of 10 mm from the location of the seal seam being tested. Example 3

[0061] Using a bag structure as in Example 1, vials stored in a nest in a tray sealed with a layer of Tyvek®< 1073 B were packaged on an automated packing line. The sealed tray was packed in two enclosing bags. The bag seal was inspected using the installed camera inspection system in transmitted light, looking toward the Tyvek®< side. Here, too, the seals were easily detectable, and defects were clearly visible.

Claims

1. Package for the sterile packaging of objects for medical, pharmaceutical or cosmetic applications, comprising at least one bag made of a first and a second web that are connected to one another with a sealed seam, characterized in that the first web (1) consists of a selectively permeable non-woven fabric (3); the second web (2) consists of a laminated film comprising at least three layers, wherein the first layer (4) is a polymer film arranged on the outside of the bag, the second layer (5) is a laminating adhesive and the third layer (6, 7) is a polymer film arranged on the inside of the bag, wherein the polymer of the first layer (4) has a melting temperature which is at least 20°C above the sealing initiation temperature of the third layer (6, 7), at least one of the layers of the second web (2) includes one or more pigments, the sealed seam is imaged in a 8-bit greyscale image, which has been taken in transmitted light and contrast-normalized, in a grey-scale value range of 50 - 200, and the sealed seam has a transmittance τvis of 10% - 40% measured in remission with a 2° observer according to DIN 5033-1:2009-5.

2. Package according to claim 1, characterized in that in the second web (2) the first layer (4) is a polyester film or a polyamide film and the third layer (6, 7) is a film made of polyethylene, polypropylene or polyester homo- or co-polymers.

3. Package according to claim 1 or 2, characterized in that the selectively permeable non-woven fabric (3) of the first web (1) is a microfibrous non-woven fabric made of high-density polyethylene (HDPE), polypropylene (PP) or polyethylene terephthalate (PET).

4. Package according to any one of the preceding claims, characterized in that the polyethylene of the third layer (5) of the second web (2) is a high-density polyethylene (HDPE), medium-density polyethylene (MDPE), low-density polyethylene (LDPE) or linear low-density polyethylene (LLDPE).

5. Package according to any of the preceding claims, characterized in that the polyester film or polyamide film of the first layer (4) of the second web (2) is free from pigments.

6. Package according to any one of the preceding claims, characterized in that the polyester film of the first layer (4) of the second web (2) consists of polyethylene terephthalate (PET) or polybutylene terephthalate (PBT).

7. Package according to any one of the preceding claims, characterized in that the sealed seams, in an 8-bit greyscale image taken in transmitted light and contrast-normalized, have grey values which are at least 30 units above the grey values of the area surrounding the sealed seam.

8. Package according to any one of the preceding claims, characterized in that the connection of the webs (1, 2) of the bag to form the bag is carried out by sealing or adhesive bonding and the filled bag is closed by means of a sealed seam.

9. Package according to any one of the preceding claims, characterized in that the sealed seams of the bag have a homogeneous discoloration.

10. Package according to any one of the preceding claims, characterized in that the sealed seams of the bag have a sealed seam strength of at least 20 N / 15 mm, measured according to DIN EN 868-5:2009, Annex D.

11. Package according to any one of the preceding claims, characterized in that the puncture resistance, measured according to DIN EN 14477:2004 at a test speed of 100 mm / min and 0.8 mm tip diameter is at least 10 N for the first web (1) of the bag and at least 4.5 N for the second web (2) of the bag.

12. Package according to any one of the preceding claims, characterized in that a tub, optionally comprising a carrier arranged therein, or a tray for receiving the objects is arranged inside the bag.

13. Package according to claim 12, characterized in that the tub or tray is closed by sealing or gluing with a selectively permeable non-woven fabric.

14. Package according to any one of the preceding claims, characterized in that the bag is wrapped by one or more further bags.

15. Package according to any one of the preceding claims, characterized in that the transmittances τvis of the sealed seam and of the first web (1), measured in remission with a 2° observer according to DIN 5033-1:2009-5, have a difference of 30 - 75 percentage points.

16. Method for sterile packaging of objects for medical, pharmaceutical or cosmetic applications, characterized in that a package according to any one of claims 1 to 15 is used.

17. Method for checking a sealed seam of a bag made from a first web (1) of a selectively permeable nonwoven fabric (3) and a second web (2) connected thereto, which consists of a laminated film comprising at least three layers, wherein the first layer (4) is a polymer film arranged on the outside of the bag, the second layer (5) is a laminating adhesive and the third layer (6, 7) is a polymer film arranged on the inside of the bag, wherein the polymer of the first layer (4) has a melting temperature which is at least 20°C above the seal initiation temperature of the third layer (6, 7), and wherein at least one of the layers of the second web (2) includes one or more pigments, comprising the steps of providing the webs of the bag in such a way that the sealed seam is imaged in a gray-scale value range of 50 - 200 in an 8-bit grayscale image taken in transmitted light and contrast-normalized, and the sealed seam has a transmittance τvis of 10% - 40% as measured in remission with a 2° observer according to DIN 5033-1:2009-5, imaging the sealed seam by use of a camera system in transmitted light to generate an 8-bit grayscale image and contrast normalization of the same, evaluating the contrast-normalized 8-bit grayscale image for inhomogeneities in the gray values of the sealed seam.