PACKAGING AND PROCESS FOR THE STERILE PACKAGING OF OBJECTS FOR MEDICAL, PHARMACEUTICAL OR COSMETIC APPLICATIONS

Abstract

Packaging for the sterile storage and transport of objects for medical, pharmaceutical or cosmetic applications and a packaging process are provided. The packaging includes at least one bag made of a first and a second web, bonded to one another, a feature thereof being that the first web consists of a selectively permeable nonwoven fabric and that the second web consists of a laminated film with at least three layers, where the first layer is a polymer film arranged on the external side of the bag, the second layer is a lamination adhesive and the third layer is a polymer film arranged on the internal side of the bag. At least one of the layers of the second web includes one or more pigments. In an 8-bit greyscale image, the seal seam, imaged in transmitted light and contrast-standardized, is depicted within a greyscale value range of 50-200.

Claims

1. A process for monitoring a seal seam of a bag for the sterile packaging of objects for medical, pharmaceutical, or cosmetic applications, the process comprising: generating an image of the seal seam; processing the image to generate a standardized image such that the seal seam is depicted in a standardized value range; evaluating the standardized image in respect of inhomogeneities in the values of the seal seam.

2. The process of claim 1, wherein the bag comprises a transparent or translucent layer and a white layer, and wherein the step of generating the image comprises directing a camera system at the white layer.

3. The process of claim 2, wherein the step of generating the image comprises generating a transmitted-light image.

4. The process of claim 1, wherein the step of generating the image comprises generating a transmitted-light image.

5. The process of claim 1, wherein the processing step comprises generating the standardized image as a contrast-standardized image.

6. The process of claim 1, wherein the processing step comprises generating the standardized image as an 8-bit greyscale image.

7. The process of claim 1, wherein the processing step depicting the standardized value range as a greyscale value range.

8. The process according to claim 1, further comprising isolating the bag if the evaluating step detects a defect in the seal seam.

9. A process for monitoring a seal seam of a bag for the sterile packaging of objects for medical, pharmaceutical, or cosmetic applications, the process comprising: imaging the seal seam by a camera system in transmitted light to generate an 8-bit greyscale image; contrast-standardizing the 8-bit greyscale image to generate a contrast-standardized 8-bit greyscale image such that the seal seam is depicted in a greyscale range of 50-200; and evaluating the contrast-standardized 8-bit greyscale image in respect of inhomogeneities in greyscale values of the seal seam.

10. The process according to claim 9, further comprising: measuring a remission τ.sub.vis of the seal seam in accordance with DIN 5033-1:2009-5 in remission mode with 2° observer; and evaluating the remission τ.sub.vis of the seal seam to an acceptable range between 10%-40%.

11. The process according to claim 9, further comprising isolating the bag if the evaluating step detects a defect in the seal seam.

12. The packaging according to claim 11, wherein the isolating step results bags not being isolated when the seal seam has a strength that is at least 20 N/15 mm measured in accordance with DIN EN 868-5:2009 Annex D.

13. The process according to claim 9, wherein the seal seam comprises a bond between a first web and a second web, the first web consisting of a selectively permeable nonwoven fabric and the second web consisting of a laminated film with a first layer, a second layer, and a third layer, the first layer is a polymer film arranged on an external side, the second layer is a lamination adhesive, and the third layer is another polymer film arranged on an internal side, the first layer having a melting point that is above a sealing-initiation temperature of the third layer by at least 20° C.

14. The process according to claim 13, wherein at least one of the first, second, and third layers comprising a pigment.

15. The process according to claim 13, wherein the remission τ.sub.vis of the seal seam exhibits a difference of 30-75 percentage points to a remission τ.sub.vis of the first web measured in accordance with DIN 5033-1:2009-5 in remission mode with 2° observer.

16. The process according to claim 9, wherein the seal seam exhibits greyscale values which are at least 30 units above greyscale values of a region surrounding the seal seam.

17. The process according to claim 9, wherein the seal seam exhibits a homogenous colour.

18. The process according to claim 9, wherein the step of imaging the seal seam further comprises imaging the seal seam with a tub or tray arranged in the bag.

19. The process according to claim 18, wherein the tub or tray comprises one or more objects for medical, pharmaceutical or cosmetic applications arranged in the tub or tray.

20. The process according to claim 18, wherein the tub or tray comprises a protective covering of another selectively permeable nonwoven fabric sealed or adhesive bonded thereto.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0042] FIG. 1 shows an exemplary embodiment of a bag.

[0043] FIG. 2 shows the layer structure of a bag of Example 1.

[0044] FIG. 3 shows the layer structure of a bag of Example 2.

[0045] FIG. 4 shows an evaluation profile of a poor seal seam of Example 1.

[0046] FIG. 5 shows an evaluation profile of a good seal seam of Example 1.

DETAILED DESCRIPTION

[0047] FIG. 1 illustrates an exemplary embodiment of a package or bag (10) of the present application that has a first web (1) and a second web (2) for sterile objects for medical, pharmaceutical or cosmetic applications (12). The sterile objects (12) can be, for example, sterile primary pharmaceutical packaging means, including vials, ampoules, syringes or carpules. In the illustrated embodiment, arranged within the bag (10), there is a tray (14) to receive the objects (12). A large number of primary pharmaceutical packaging means (12), for example vials, carpules or syringes, are thus frequently received, and securely arranged, either in the tray (14).

[0048] FIGS. 2 and 3 illustrate a seal region of the first web (1) and the second web (2) to one another. The depiction of the layer thicknesses in FIGS. 2 and 3 is not to scale, but is merely a rough approximation.

[0049] The invention is described below on the basis of Examples. These serve merely to illustrate examples of embodiments of the invention, and are not to be understood as restrictive.

Example 1

[0050] Bags (10) were produced from a first web (1) and a second web (2). The first web (1) consisted of Tyvek® 1073 B uncoated nonwoven HDPE fabric (3) from DuPont with thickness about 180 μm. The second web (2) consisted of, arranged on the external side, a first layer (4) made of a PET film of thickness 12 μm and, bonded thereto by means of the second layer (5) of 2.5 g/m.sup.2 of a PUR-based hotmelt lamination adhesive, a third layer (6) made of LDPE with thickness 50 μm. The third layer (6) made of LDPE had been coloured blue with a pigment, while the other two layers were transparent and colourless. The layer structure is depicted in FIG. 2.

[0051] The bag (10) was formed by using an AccuSeal 6300-25-X impulse sealer at 180-190° C. with pressure 5.5-6 bar and sealing time 3-4 s to apply three seal seams of width 3 mm, 6 mm or 10 mm. Heat was introduced from one side: the polyester film side. A further seal seam was provided for the closure of the filled bag (10), thus then giving a packaging sealed at all sides. In the seal seam achieved during the sealing procedure, the molten nonwoven fabric layer was transparent, and the blue colour of the LDPE layer was clearly discernible. The seal seams were subjected to inspection by camera; cameras recorded images of the seal seams in transmitted light, and the images were then analysed. To this end, evaluation software was used in the standardized greyscale depictions to plot profiles at right angles across the seal seams. Each of FIGS. 4 and 5 shows by way of example an individual sectional profile through the seal seam. The greyscale value across the studied section is plotted here. For assessment at the seal seam in the production process, it will be self-evident that the software evaluates the depiction of the entire seal seam.

[0052] FIG. 4 depicts a defective seam. The transparent areas at the seam edges are clearly visible, revealed by pale peaks. Incorrect temperature and/or incorrect sealing jaw pressure here has caused the coloured LDPE sealable layer to disappear completely as a result of melting, so that the edges are then formed only by the transparent colourless PET film; these then appear in the white region of greyscale values in transmitted light.

[0053] In contrast to the above, FIG. 5 shows a fully satisfactory seal seam, the curve profile of which is very close to the ideal rectangular curve.

Example 2

[0054] Bags were produced from a first web (1) and a second web (2). The first web (1) consisted of Tyvek® 1073 B uncoated nonwoven HDPE fabric (3) from DuPont with thickness about 180 μm. The second web (2) consisted of, arranged on the external side, a first layer (4) made of a PET film of thickness 12 μm and, bonded thereto by means of the second layer (5) of 2.5 g/m.sup.2 of a PUR-based hotmelt lamination adhesive, a third layer (7) made of HDPE with thickness 50 μm. The third layer (7) made of HDPE had been coloured blue with a pigment, while the other two layers were transparent and colourless. The layer structure is depicted in FIG. 3.

[0055] The bag (10) was formed by using an AccuSeal 6300-25-X impulse sealer at 180-185° C. with pressure 5.7-6.2 bar and sealing time 3.5-4.5 s to apply three seal seams of width 3 mm, 6 mm or 10 mm. Heat was introduced from one side: the polyester film side. A further seal seam was provided for the closure of the filled bag (10), thus then giving a packaging sealed at all sides. In the seal seam achieved during the sealing procedure, the molten nonwoven fabric layer was transparent, and the blue colour of the HDPE layer was clearly discernible. As in Example 1, the seal seams were subjected to inspection by camera; cameras recorded images of the seal seams in transmitted light, and the images were then analysed. Here again, the seal seams were extremely easy to detect, and defects could be discerned in a fully satisfactory manner.

Test Methods

[0056] Seal seam strength was determined in accordance with DIN EN 868-5:2009-09. Five strips of width 15 mm and length 5 cm were cut out from the packaging material to be tested. The specimen here was cut out at right angles to the seal seam. The strips were moreover cut out at various positions along the seam to be tested, but with a minimum distance of 2 cm from the external edge. A mark was then made parallel to the seal seam on each strip at a distance of 3 cm from the seal seam towards the interior of the packaging. These marks served for clamping purposes. The entirety of the lower end of the strip was clamped into the lower clamp. The seal seam was parallel to the edge of the upper clamp. The other end of the test sample was clamped into the upper clamp in a manner such that the added markings were directly in contact with the lower edge of the upper clamp while the test sample had not yet been subjected to any stress. The test was then carried out with unsupported tab with test velocity 200 mm/min until failure of the test sample was observed.

[0057] Puncture resistance was determined in accordance with DIN EN 14477:2004. All samples were stored for at least 48 h at 23° C./50% rh. These were then tested under the same temperature/humidity conditions. The test included ten individual measurements per sample. The films were clamped into the tester with the internal side facing upwards. The test probe, diameter 0.8 mm, was forced through the film at a test velocity of 100 mm/min until failure occurred.

[0058] Remission τ.sub.vis measured in remission mode with 2° observer in accordance with DIN 5033-1:2009-5, was measured with a Lambda 900 spectrometer from Perkin Elmer, which was used in remission mode and recorded in the range from 360 nm to 780 nm, equipped with a 60 mm integration sphere and with a sample holder at 11°. A standard D65 illuminant was used. Evaluation with 2° observer was carried out in accordance with DIN 5033-1:2009-5.

Seal Seam Strength

[0059] Sample strips of seal seams were taken as described above for seal seam strength measurement from all sides of the bags (10) formed. The measured values given in TABLE 1 are in each case the smallest values measured.

[0060] The resultant sample strips were tested as described above. A bag (10) in the usual embodiment using a web of DuPont Tyvek® 1073B (130-180 μm) and with a web of HDPE (80 μm) was taken as Comparative Example. TABLE 1 lists the test results.

TABLE-US-00001 TABLE 1 Seal seam strength Sample [N/15 mm] Example 1 30N Example 2 27N Comparative Example  12.5N

[0061] For the bags (10) of the invention with a laminate web, the measured values reveal on average a seal seam strength that is about two to three times greater than for the familiar variant with Tyvek® 1073B and HDPE.

Puncture Resistance

[0062] Samples of the two webs (1, 2) were taken for the bags (10) of Examples 1 and 2 and of Comparative Examples 1 and 2, and tested in accordance with the method described above. Comparative Example 1 here corresponds to the bag (10) with one web (1) of DuPont Tyvek® 1073B and one web (2) of HDPE, and Comparative Example 2 here corresponds to a bag (10) with one web (1) made of a polypropylene microfibre nonwoven (88-98 g/m) and one web (2) of a laminate made of a polyester film (12 μm) and a polypropylene film (38 μm). TABLE 2 collates the results.

TABLE-US-00002 TABLE 2 Puncture resistance [N] Sample Web 1 Web 2 Example 1 16.9N 7.3N Example 2 16.9N 7.2N Comparative Example 1 16.9N 3.5N Comparative Example 2 16.0N 6.8N

[0063] The measured values reveal not only that with the layer structure of the invention the bag (10) permits improved detection of seal seam defects but also at the same time that the robustness of the packaging is further increased. REMISSION τ.sub.vis

[0064] The respective seal seams and the two webs (1) and (2) of bags (10) of Examples 1 and 2 were tested in remission mode as described above. The sample of the webs (1, 2) here were taken at a lateral distance of 10 mm from the tested seal seam area. The results are shown in TABLE 3 below.

TABLE-US-00003 TABLE 3 Remission τ.sub.VIS [%] EXAMPLE 1 Seal seam 18.0 Web (1) 77.1 Web (2) 22.1 EXAMPLE 2 Seal seam 18.0 Web (1) 77.5 Web (2) 22.0

Example 3

[0065] A bag (10) structure as in Example 1 was used for packaging, on an automated packing line, of vials (12) stored in a nest in a trough (14) protectively covered with a layer (16) of Tyvek® 1073 B. The protectively covered trough (14) here was placed into two enclosing bags (10, 10′) as packaging as shown in FIG. 1. Sealing of the bags (10, 10′) here was monitored by the installed camera-inspection system in transmitted light, viewing the Tyvek® side. Here again, the seal seams were extremely easy to detect, and defects could be discerned in a fully satisfactory manner.