Fibrous sterilizable material for packaging medical devices and trays obtained therefrom - Patents.com

Abstract

The present disclosure provides a sterilizable fibrous material for packaging medical devices intended to be sterilized, the sterilizable fibrous material having a mass of at least 180 g / m 2 The sterilizable fibrous material is in the form of cardboard having a basis weight of 1.001 g / cm², wherein the sterilizable fibrous material comprises a mixture of fibers containing at least 75% by weight of natural cellulose fibers, the fibers having a length of less than 5 mm, and the sterilizable fibrous material is characterized in that it has an air permeability of at least 1.7 μm / Pa·s at a pressure of 1.47 kPa, measured according to the ISO 5636-3 standard. The present disclosure also provides a sterilizable tray obtained from the sterilizable fibrous material.

Description

[Technical field]

[0001] The present disclosure relates to the field of sterilizable packaging, preferably heat sealable packaging, for medical devices, particularly reusable medical devices that are intended to be sterilized.

[0002] The packages of the present disclosure are intended to be sterilized by suitable means, particularly but not limited to, steam, ethylene oxide, formaldehyde and / or gamma radiation. [Background technology]

[0003] In most cases, especially in hospitals, two types of sterilizable packaging are available. Firstly, there are metal boxes or rigid containers. Due to their metallic nature, they can be particularly robust. However, these boxes have the drawback of weight and need to be regularly cleaned before use. This therefore leads to substantial handling of them, not to mention that the boxes will eventually wear out and develop leaks. At that time the container needs to be repaired, which leads to not inconsiderable costs.

[0004] Efforts have been made to replace these boxes with disposable flexible packages of the pouch or sheet type. These packages are obviously easier to use due to their weight and their disposable nature. However, they may have insufficient mechanical strength with respect to the particular medical device to be sterilized. Moreover, they are often manufactured from non-renewable resources, especially the majority of those manufactured from polypropylene.

[0005] WO 2017 / 168152 describes a portable disposable tray for surgical instruments. The tray is obtained by thermoforming pulp. In practice, the instruments are stored in a sterilization bag and then placed in the tray before the actual sterilization procedure. The properties of the tray make it permeable to the sterilization means in the same way as the sterilization bag. The drawback of this system is therefore the need for two elements, namely the tray and the bag, which significantly increases the costs.

[0006] European Patent No. 2917408 specifies a range of 40 to 120 g / m 2 describes a cellulose-based paper having a weight of 100 g / m². The paper is reinforced on one surface and has a sealing layer on the other surface, and after the insertion of the instrument to be sterilized the package can be closed, for example by a polypropylene film. In this case, therefore, there is no intermediate bag. The proposed paper has the main drawback of being excessively flexible, which makes it fragile if the instrument to be sterilized has sharp edges.

[0007] GB 2449418 describes a calendered spunbond type sheet composed of fibers of polypropylene and therefore is neither biosourced nor biodegradable. Summary of the Invention [Problem to be solved by the invention]

[0008] To the applicant's knowledge, disposable packaging rigid enough for example to be made into trays for the sterilization of medical instruments has not yet been proposed in hospitals. [Means for solving the problem]

[0009] The problem that the present disclosure seeks to solve is therefore to provide rigid disposable packaging that is particularly resistant to tearing and ideally derived from renewable and / or compostable components.

[0010] More precisely, the objective of the present disclosure is to provide a rigid disposable material that allows sterilization of the instruments intended to be sterilized without the risk of infection by microorganisms, and therefore must be permeable to sterilants, indeed steam, ethylene oxide, formaldehyde and gamma radiation, and also a barrier to bacteria.

[0011] Another object of the present disclosure is to provide a rigid disposable material that complies with the ISO 11607-1 standard.

[0012] To achieve this, the Applicant has succeeded in producing a cardboard whose characteristics make it possible to at least partially achieve the objectives of the abovementioned standards and whose weight allows it to be converted into a tray or any other rigid receptacle.

[0013] More precisely, the present disclosure relates to a sterilizable fibrous material for packaging medical devices intended to be sterilized. The sterilizable fibrous material has a density of at least 180 g / m 2 , advantageously at least 200 g / m 2 and characterized in that it comprises a mixture of fibres containing at least 75% by weight of natural cellulose fibres less than 5 mm in length and has an air permeability, measured according to the ISO 5636-3 standard, of at least 1.7, preferably at least 3.4 and advantageously strictly greater than 3.4 μm / Pa·s (μm / Pascal second) at a pressure of 1.47 kPa.

[0014] The heavier the cardboard, the stiffer it is and the more easily it can be deformed. Thus, for example, the basis weight of the cardboard is advantageously at least 270 g / m 2 and makes it easily deformable, especially by thermoforming.

[0015] As previously mentioned, the main difficulty is to provide a sufficiently rigid material that is both permeable to sterilants such as steam and a barrier to bacteria.

[0016] When reference is made in this application to a standard, the applicable version is the one in effect on the filing date of the priority application.

[0017] The Applicant has determined that particularly interesting performances in this respect are achieved when the mixture of fibres comprises 20% to 100% by weight of long natural cellulose fibres having a length of 1 to 5 mm and 0% to 80% by weight of short natural cellulose fibres having a length of less than 1 mm.

[0018] The cellulosic fibres are, for example, selected from the group comprising pulp (short and long fibre) and fibres of annual plants such as abaca, cotton, flax and hemp.

[0019] Preferably, the long fibers have a length of 1 to 3 mm, preferably 1.4 to 2.5 mm, and the short fibers have a length of 0.2 to 1 mm, preferably 0.3 to 1 mm.

[0020] In one particular embodiment, a portion of the cellulose fibers, preferably 1 to 40% by weight, is treated with soda to form mercerized cellulose fibers.

[0021] The performance of the material according to the present disclosure can be further improved when the blend comprises long and short fibers, with the ratio of long to short fibers being between 2-30.

[0022] In one preferred embodiment, the mixture of fibers comprises 70-80% long fibers and 15-25% short cellulose fibers.

[0023] In order to increase the proportion of biosourced components in the materials of the present disclosure, the cellulose fibers represent at least 30% by weight of the material, preferably at least 50% by weight, more preferably 70% by weight, and even more preferably at least 90% by weight or even 95% by weight.

[0024] In one particular embodiment, the mixture of fibers further comprises at least 1% by weight, advantageously between 1 and 20% by weight, of synthetic fibers.

[0025] In practice, the chemical fibres have a titer of 0.3 to 10 dtex and a length of 2.5 to 20 mm, preferably 2.5 to 6 mm.

[0026] When present, the chemical fibres are advantageously selected from the group comprising man-made fibres such as lyocell and rayon, and synthetic fibres such as polylactic acid, polyhydroxyalkanoates, polybutylene succinate, polybutylene succinate coadipate, polycaprolactone, polybutyrate adipate terephthalate, poly(hydroxybutyrate-cohydroxyvalerate) or copolymers thereof, and other biopolymers.

[0027] The Applicant has observed that the choice of a mixture of Lyocell fibres, preferably of 1.7 dtex and 6 mm, and / or rayon, and in particular Danufil (1.7 dtex, 5 mm or 3 mm), made it possible to improve the permeability of the material.

[0028] Advantageously, the blend of fibers is biosourced and / or recyclable and / or biodegradable.

[0029] Preferably, the materials according to the present disclosure are biodegradable to the extent of 90%, or even 95%, thus meeting the biodegradability requirements of the EN13432 standard.

[0030] According to another feature, in certain embodiments, the material of the present disclosure has pores with a maximum pore diameter of less than 50 μm, measured according to Appendix C of the EN868-3 standard. The material may also have an average pore diameter, also known as the mean pore diameter, of less than 35 μm, preferably between 10 μm and 35 μm, measured according to Appendix C of the EN868-3 standard. These characteristics therefore allow compliance with the ISO11607-1 standard. The material may likewise comply with the EN868 series of standards. It is noted that when tested according to Appendix C of the EN868-3 standard, the average of the pore diameters of 10 specimens must be less than or equal to 35 μm, and the pore diameter must not exceed 50 μm.

[0031] In practice, the material according to the present disclosure further comprises a wet strength agent equivalent to 0.15-1%, preferably around 0.5%, by dry weight with respect to the dry weight of cellulose.

[0032] According to the present disclosure, the wet strength agent is selected from the group including polyamine epichlorohydrin (PAE), glyoxalated resins such as glyoxalated polyamides (GPAM), formaldehyde-based resins.

[0033] Preferably, the material according to the present disclosure further comprises a sizing agent, preferably corresponding to 0.15-1%, preferably around 0.5%, by dry weight with respect to the dry weight of cellulose.

[0034] In practice, the sizing agent is selected from the group comprising alkyl ketene dimers (AKD), alkenyl succinic anhydrides (ASA), and rosin-based resins.

[0035] In a preferred embodiment, the material further comprises cationic starch, representing less than 1% by dry weight relative to the dry weight of cellulose, preferably in the order of 0.5%.

[0036] According to the present disclosure, the material preferably has a hardness of 20 g / m2, measured according to the ISO 535 standard using the COBB test at 60 seconds. 2 has a hydrophobicity of less than 1.

[0037] Advantageously, it complies with the DIN 58953-6 standard, sections 3 and 4, with regard to the bacterial barrier. The bacterial barrier properties can also be evaluated according to the ASTM F2101 standard. The material therefore advantageously has a bacterial filtration efficiency (BFE) in a single layer of more than 80%, preferably more than 95%, more preferably more than 99%.

[0038] As mentioned above, it is advantageously compliant with the ISO 11607-1 standard. According to another feature, the material has a thickness of at least 200, preferably 300 μm, to provide optimal stiffness.

[0039] To make it heat sealable, especially if it is intended to be formed into a tray covered with a heat sealable medical plastic film, the material may further comprise a coating layer, the composition of which may make it heat sealable.

[0040] The coating layer further allows for limiting the surface roughness of the material, thus aiding in the peelability of the film once heat sealed.

[0041] Advantageously, the coating contains at least one component selected from starch, polyvinyl alcohol (PVA), alkyl ketene dimer (AKD), and may further contain other components, such as, for example, acrylic binders, or crosslinkers, such as salts of zirconium and polyamine epichlorohydrin (PAE).

[0042] In practice, coatings range from 4 to 30 g / m 2 , preferably about 5 g / m 2 is applied at a rate of

[0043] To further improve heat sealability, the material is calendered after coating. The present disclosure also relates to trays or equivalent receptacles obtained from the above-mentioned materials.

[0044] The present disclosure also relates to the use of the aforementioned materials for the manufacture of trays. Preferably, the tray is obtained by thermoforming.

[0045] To enhance the thermoforming capabilities of the materials of the present disclosure, the materials of the present disclosure have a moisture level of at least 6% by weight.

[0046] In order to avoid the risk of tearing during thermoforming, the elongation of the material in machine direction (MD) and cross direction (CD), preferably determined according to the ISO 1924-2 standard, is at least 3%.

[0047] The present disclosure also relates to packaging for medical sterilization, comprising the aforementioned tray, or any equivalent means, and a sterilizable sealing means for the tray, such as PET, PP medical film, or any other heat sealable or adhesive means. [Brief description of the drawings]

[0048] [Figure 1] 1 is a photograph of a tray of the present disclosure filled with a dye mixture prior to sterilization. [Diagram 2] 1 is a photograph of a tray of the present disclosure filled with a dye mixture after sterilization. [Diagram 3] 1 is a photograph of a tray of the present disclosure containing metal parts after sterilization. [Figure 4A] Photograph of samples of the present disclosure and comparative samples in a home composter. [Figure 4B] Photograph of samples of the present disclosure and comparative samples in a home composter. [Figure 4C] Photograph of samples of the present disclosure and comparative samples in a home composter. [Figure 4D] Photograph of samples of the present disclosure and comparative samples in a home composter. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0049] The exemplary embodiments disclosed herein are illustrative of the advantageous sterilizable packages and systems of the present disclosure and the methods / techniques thereof. However, it should be understood that the disclosed embodiments are merely exemplary of the present disclosure and may be implemented in various forms. Therefore, the details disclosed herein with reference to the exemplary sterilizable packages and related processes / techniques of assembly and use should not be construed as limiting, but merely as a basis for teaching those skilled in the art how to manufacture and use the advantageous sterilizable packages and / or alternative sterilizable packages of the present disclosure.

[0050] Example 1: Sample composition a. Composition of the samples of the present disclosure Four samples were prepared, and their compositions are shown in Table 1.

[0051] [Table 1]

[0052] b. Comparison sample This is a 90.5 g / m2 grammage paper sold under the ULTRA® trademark by AMCOR095134. 2 The spunbond consisted of polypropylene and polyolefin fibers.

[0053] Example 2: Sample characteristics The main characteristics of the different samples are shown in Table 2.

[0054] [Table 2]

[0055] Samples 1 to 5 were in accordance with the ISO11607-1 standard. Example 3: Tray sealing features according to the present disclosure a. Brugger test Sample 4 was calendered (30 kN / m at 50° C.) and subjected to heat sealing testing with medical film using Brugger clamps at 180° C. and 4 bar force for 10 seconds. No fiber tearing was observed and the seal showed values ​​above 1.5 N / 15 mm.

[0056] b. By injecting dye according to ASTM F 1929 standard i. Sealing quality without sterilization Sample 5 was thermoformed to produce a tray. The tray was sealed with a medical film made of PP / PET for steam or ethylene oxide sterilization. An aqueous solution containing a blue dye and a surfactant was injected into the tray. The colored solution was transferred to the area of ​​the sealing points on each side and maintained for 5 seconds each time for a total of 20 seconds according to the ASTM F 1929 standard. No leakage was observed (see FIG. 1). According to the EN 868-5 standard, the calendered sample 6 was subjected to a heat sealing test similar to the medical film at 190° C. and 5 bar force for 2, 3, 4 and 5 seconds, respectively, using a Brugger clamp. All samples had a peel strength of more than 1.5 N / 15 mm, but remained below 5 N / 15 mm. This indicated that the tray according to the present disclosure was properly sealed with the medical film and could be opened without much effort and without tearing of fibers. As shown in FIG. 1, the tray extends from a first end to a second end (left to right) and from a first side to a second side (top of FIG. 1 to bottom of FIG. 1). The first end includes a first end wall and the second end includes a second end wall. The first side includes a first side wall and the second side includes a second side wall. The first and second end walls and the first and second side walls define a recess or cavity within the interior boundaries of the first and second end walls and the first and second side walls (e.g., the recess / cavity contains a dye mixture), and a bottom wall is at the bottom of the recess / cavity.

[0057] ii. Post-sterilization sealing quality Sample 5 was thermoformed to make a tray. The tray was then sealed with a medical film made of PP / PET for steam or ethylene oxide sterilization, and then steam sterilized at 134°C for 18 minutes. An aqueous solution containing blue dye and surfactant was then injected into the tray. The colored solution was transferred to the area of ​​the sealing points on each side and maintained for 5 seconds each time, for a total of 20 seconds, according to the ASTM F 1929 standard. No leakage was observed (see Figure 2).

[0058] Example 4: Test for evaluation of microbial contamination of trays according to the present disclosure The purpose of this test was to demonstrate the ability of the materials of the present disclosure to pass sterilizing steam, thereby enabling sterilization of the elements contained therein.

[0059] To do this, a tray was prepared from sample 5. 22 metal pieces contaminated with microorganisms contained in saliva were placed on this tray. The tray was then heat sealed with a steam or ethylene oxide sterilization film made of PP / PET. The tray was then steam sterilized at 134°C for 18 minutes. The tray was stored under normal pressure and temperature conditions for 15 days, after which a microbial analysis was performed on three randomly selected metal pieces from the 22 pieces.

[0060] Microbial contamination was assessed by the method of ISO 8784-1 and was based on bacterial and fungal enumeration. The medium used for culturing bacteria was tryptic soy agar incubated at 37°C for 48 hours. The medium used for culturing fungi was PDA incubated at 29°C for 5 days.

[0061] The results are shown in Table 3.

[0062] [Table 3]

[0063] The results show that after sterilization, the metal pieces are no longer contaminated, proving that the material of the present disclosure is permeable to sterilizing steam and remains sterile after 15 days of storage at room temperature. The test also demonstrated the mechanical strength of the tray (see FIG. 3). In fact, it was possible to sterilize 22 metal pieces weighing more than 1 kg and store them in a sterile state without tearing or opening.

[0064] Example 5: Bacterial resistance testing of materials of the present disclosure A. Under humid conditions Testing was performed on four samples according to the present disclosure (samples 1-4) and one comparative sample under the conditions of the DIN 58953-6 standard, section 3. Essentially, the testing involved steam sterilizing each sample at 134°C for 4 minutes. Each sample was then inoculated on one surface with 500 μL of S. epidermidis microorganisms. After drying, the opposite surface of the sample was contacted with culture medium and incubated at 37°C for 24 hours. Two surfaces of each sample were tested.

[0065] The results are shown in Table 4.

[0066] [Table 4]

[0067] No colonies were found in either the samples of the present disclosure or the comparative samples. Thus, the bacterial resistance test under moist conditions according to the DIN 58953-6 standard, section 3, was confirmed.

[0068] b.Dry conditions i.DIN58953-6 Standard, Section 4 Testing was performed under the conditions of DIN 58953-6 standard, section 4, on four samples according to the present disclosure (samples 1-4) and one comparison sample. Essentially, the testing involved steam sterilizing each sample at 121°C for 20 minutes. Each sample was then inoculated with 250 mg of sand contaminated with endospores of B. subtilis. Incubations were then carried out at 8°C and 50°C, with air flow through the contaminated sand and sample to the agar plate. The samples were then incubated at 37°C for 24 hours. Two surfaces of each sample were tested.

[0069] [Table 5]

[0070] As expected, no colonies were found in any of the disclosed or comparative samples, which was expected due to the difficulties in testing in wet environments according to DIN 58953-6 standard, section 3, as water acts as a vector for contamination. Thus, the bacterial resistance test under dry conditions according to DIN 58953-6 standard, section 4 was confirmed.

[0071] ii. Bacterial Filtration Efficiency (BFE) The test was carried out according to the ASTM F2101 standard using an aerosol of Staphylococcus aureus and represents the ratio of the number of bacteria captured per sample divided by the number of bacteria sprayed onto the tested sample.

[0072] [Table 6]

[0073] Compared to the comparative samples, the BFE of sample 5 was 99.9%, 71.24% for the single package, and 93.16% for the double package, as shown in Table 6. The samples according to the present disclosure present a more tortuous path for microorganisms, thus minimizing the risk of contamination.

[0074] Breathability is the ability of a material to allow water vapor to pass while preventing liquid water from passing through, and is interchangeably referred to as "water vapor transmission rate" (WVTR) or "moisture vapor transmission rate" (MVTR). Thus, the materials of the present disclosure have a water vapor transmission rate of at least 400 g / m at 38° C. and 90% relative humidity, as determined by the ISO 2528 standard. 2 / day, preferably at least 800g / m 2 / day, more preferably at least 1000g / m 2 / day total water vapor transmission rate (WVTR).

[0075] Examples of MVTR and Bowie and Dick tests: The WVTR of Sample 6 and the comparative samples were measured according to the ISO 2528 standard and the results are summarized in Table 7.

[0076] [Table 7]

[0077] The samples were measured according to the ISO2528 standard at 38°C and 90% relative humidity. The data show that Sample 6 has a comparable WVTR to the comparative sample, while the basis weight of Sample 6 is more than three times that of the comparative sample. Thus, the materials of the present disclosure can be efficiently sterilized.

[0078] To verify the uniformity and efficiency of steam penetration, Sample 6 was thermoformed into a tray and a Bowie and Dick test kit was placed into the tray. The tray was then sealed with medical film and subjected to a sterilization cycle (Bowie and Dick cycle: 134°C for 3.5 minutes). After sterilization, the Bowie and Dick kit test showed efficient and uniform steam penetration.

[0079] Biodegradable and compostable Two each of Sample 6 (second from the top row and bottom row in Figures 4A-4D) and the Comparative Sample (top row and one above the bottom row in Figures 4A-4D) were placed in a frame and introduced into a home composter. The samples were then visually inspected after 1 week, 2 weeks, and 4 weeks. As can be seen from Figures 4A-4D, Sample 6 was almost completely biodegraded after 4 weeks, while the Comparative Sample remained intact.

[0080] Hardness and Rigidity To form a rigid tray, the material according to the present disclosure had higher rigidity compared to other sterilization materials such as pouches or sterilization wraps. The rigidity or rigidity of the material can be measured by determining the bending resistance of the material according to ISO2493-2-Paper and paperboard-Determination of bending resistance-Part 2: Taber type tester standard. The material according to the present disclosure can have a bending resistance of at least 1000mN in MD and CD directions, preferably at least 2000mN, and even more preferably at least 3000mN.

[0081] Bending resistance example The bending resistance of Sample 6 and the comparative samples was measured in the machine direction (MD) and cross direction (CD) according to the ISO 2493-2 standard (see Table 8 below).

[0082] [Table 8]

[0083] The comparison sample is 90g / m 2 and sample 6 has a basis weight of 332 g / m 2 Although the material had a basis weight of 100 g, the material according to the present disclosure had a much higher bending resistance, which makes Sample 6 suitable for making rigid trays according to the present disclosure.

[0084] The present disclosure further includes the following aspects. Aspect 1. A sterilizable fibrous material for packaging medical devices intended to be sterilized, the sterilizable fibrous material having a fiber mass of at least 180 g / m2 , advantageously at least 200 g / m 2 % of natural cellulose fibres, the length of which is less than 5 mm; characterized in that the sterilizable fibrous material comprises a mixture of fibres containing at least 75% by weight of natural cellulose fibres, the length of which is less than 5 mm; characterized in that the sterilizable fibrous material has an air permeability, measured according to the ISO 5636-3 standard, of at least 1.7, preferably at least 3.4 and advantageously strictly more than 3.4 μm / Pa·s at a pressure of 1.47 kPa; and characterized in that the sterilizable fibrous material has pores with a maximum pore diameter of less than 50 μm, measured according to Appendix C of the EN 868-3 standard.

[0085] Aspect 2. The material according to aspect 1, characterized in that the mixture of fibers comprises 20% to 100% by weight of natural long cellulose fibers having a length of 1 to 5 mm and 0% to 80% by weight of natural short cellulose fibers having a length of less than 1 mm.

[0086] Embodiment 3. The material according to any one of the preceding embodiments, characterized in that the long fibers have a length of 1-3 mm, preferably 1.4-2.5 mm, and the short fibers have a length of 0.2-1 mm, preferably 0.3-1 mm.

[0087] Embodiment 4. The material of any one of the preceding embodiments, wherein the ratio of long fibers to short fibers is between 2 and 30.

[0088] Embodiment 5. The material according to any one of the preceding embodiments, characterized in that the mixture of fibers further comprises at least 1% by weight, preferably 1-20% by weight, of chemical fibers having a titer of 0.3-10 dtex and a length of 2.5-20 mm.

[0089] Embodiment 6. The material according to any one of the preceding embodiments, characterized in that the chemical fibers are selected from the group comprising man-made fibers such as lyocell and rayon, and synthetic fibers such as polylactic acid, polyhydroxyalkanoates, polybutylene succinate, polybutylene succinate coadipate, polycaprolactone, polybutyrate adipate terephthalate, poly(hydroxybutyrate-cohydroxyvalerate) or copolymers thereof, and biopolymers such as polylactic acid, polyhydroxyalkanoates, polybutylene succinate coadipate, polycaprolactone, polybutyrate adipate terephthalate, poly(hydroxybutyrate-cohydroxyvalerate) or copolymers thereof.

[0090] Embodiment 7. The material of any one of the preceding embodiments, characterized in that the mixture of fibers is biosourced and / or recyclable and / or biodegradable.

[0091] Aspect 8. The material of any one of the preceding aspects, characterized in that it is biodegradable to an extent of 90%, or even 95%, and meets the biodegradability requirements of the EN 13432 standard.

[0092] Embodiment 9. The material of any one of the preceding embodiments, characterized in that it has pores with an average pore diameter of less than 35 μm, preferably between 10 μm and 35 μm, as measured according to Appendix C of the EN868-3 standard.

[0093] Embodiment 10. The material of any one of the preceding embodiments, further comprising a wet strength agent in an amount of 0.15 to 1% by dry weight relative to the dry weight of the cellulose.

[0094] Example 11. The material according to example 10, characterized in that the wet strength agent is selected from the group comprising polyamine epichlorohydrin (PAE), glyoxalated resins, such as glyoxalated polyamides (GPAM), formaldehyde-based resins.

[0095] Embodiment 12. The material of any one of the preceding embodiments, further comprising a sizing agent in an amount of 0.15 to 1% by dry weight relative to the dry weight of the cellulose.

[0096] Aspect 13. The material according to aspect 12, wherein the sizing agent is selected from the group including alkyl ketene dimer (AKD), alkenyl succinic anhydride (ASA), and rosin-based resin.

[0097] Aspect 14. The COBB at 60 seconds is 20g / m2, measured according to the ISO 535 standard. 2 23. The material of any one of the preceding aspects, wherein the mass ratio is less than 1:1.

[0098] Aspect 15. The material of any one of the preceding aspects, characterized in that it complies with the DIN 58953-6 standard, sections 3 and 4, with respect to bacterial barrier.

[0099] Aspect 16. The material of any one of the preceding aspects, characterized in that it complies with the ISO 11607-1 standard.

[0100] Embodiment 17. The material of any one of the preceding embodiments, characterized in that it has a thickness of at least 200 μm, preferably 300 μm.

[0101] Embodiment 18. The material of any one of the preceding embodiments, further comprising a coating layer, the composition of which can render it heat sealable.

[0102] Aspect 19. The material of any one of the preceding aspects, characterized in that it is calendered.

[0103] Embodiment 20. The material of any one of the preceding embodiments, wherein the mixture of fibers further comprises 1 to 40% by weight of mercerized cellulose fibers.

[0104] Aspect 21. The material of any one of the preceding aspects, characterized in that the material has a bending resistance in the machine and cross directions of at least 1000 mN, preferably at least 2000 mN, and even more preferably at least 3000 mN according to ISO 2493-2, Paper and board, Determination of bending resistance, Part 2: Taber type tester standard.

[0105] Aspect 22. The material has a thermal conductivity of at least 400 g / m at 38° C. and 90% relative humidity as determined by the ISO 2528 standard. 2 / day, preferably at least 800g / m 2 / day, more preferably at least 1000g / m 2 13. The material of any one of the preceding embodiments, characterized in that it has a total water vapor transmission rate (WVTR) of 100 / day.

[0106] Embodiment 23. A tray obtained from a material identified by any one of embodiments 1 to 22. Embodiment 24. Use of a material as defined by any one of embodiments 1 to 22 for the manufacture of a tray.

[0107] Aspect 25. A packaging for medical sterilization comprising a tray according to aspect 23 and a sterilizable sealing means for the tray.

[0108] Aspect 26. A tray comprising a sterilizable fibrous material, the tray extending from a first end to a second end and from a first side to a second side, the first end comprising a first end wall, the second end comprising a second end wall, the first side comprising a first side wall, the second side comprising a second side wall, the first and second end walls and the first and second side walls defining a recess or cavity within an inner boundary of the first and second end walls and the first and second side walls, and having a bottom wall at a bottom of the recess or cavity, the tray having a modulus of at least 180 g / m 2 , advantageously at least 200 g / m 25. A container for the packaging of medical devices intended to be sterilized, the container having a basis weight of 1.0001 g / cm2 and a tray comprising a mixture of fibers containing at least 75% by weight of natural cellulose fibers, the length of which is less than 5 mm, the tray having an air permeability of at least 1.7, preferably at least 3.4 and advantageously strictly more than 3.4 μm / Pa·s at a pressure of 1.47 kPa, measured according to the ISO 5636-3 standard, and the tray having pores with a maximum pore diameter of less than 50 μm, measured according to Appendix C of the EN 868-3 standard.

[0109] Aspect 27. Providing a sterilizable fibrous material; and forming the sterilizable fibrous material into a tray, the tray extending from a first end to a second end and from a first side to a second side, the first end including a first end wall, the second end including a second end wall, the first side including a first side wall, the second side including a second side wall, the first and second end walls and the first and second side walls defining a recess or cavity within an inner boundary of the first and second end walls and the first and second side walls, and having a bottom wall at a bottom of the recess or cavity, the tray having a modulus of at least 180 g / m 2 , advantageously at least 200 g / m 2 %., the tray comprises a mixture of fibres containing at least 75% by weight of natural cellulose fibres, the length of which is less than 5 mm, the tray having an air permeability, measured according to the ISO 5636-3 standard, of at least 1.7, preferably at least 3.4 and advantageously strictly more than 3.4 μm / Pa·s at a pressure of 1.47 kPa, the tray having pores with a maximum pore diameter of less than 50 μm, measured according to Appendix C of the EN 868-3 standard.

[0110] Embodiment 28. The method of embodiment 27, wherein forming the sterilizable fibrous material in the tray comprises thermoforming the sterilizable fibrous material or molding the sterilizable fibrous material.

[0111] While particular embodiments have been described, alternatives, modifications, variations, improvements, and substantial equivalents that are not presently foreseen or may not be foreseen may occur to applicant or other persons skilled in the art. Accordingly, the appended claims as filed, and as they may be amended, are intended to cover all such alternatives, modifications, improvements, and substantial equivalents.

[0112] All ranges disclosed herein are inclusive of the endpoints, and the endpoints can be combined independently of one another (e.g., the range "up to 25 wt.%, or, more specifically, 5 wt.% to 20 wt.%" includes the endpoints of the range "5 wt.% to 25 wt.%" and all intermediate values). "Combination" includes blends, mixtures, alloys, reaction products, and the like. Terms such as "first", "second", and the like do not denote any order, quantity, or importance, but are used to distinguish one element from another. The terms "a" and "an" and "the" do not denote any limitation on quantity, and should be construed to encompass both the singular and the plural unless otherwise indicated herein or clearly contradicted by context. "Or" means "and / or" unless otherwise indicated. References throughout this specification to "some embodiments", "an embodiment", and the like mean that the particular element described in connection with the embodiment is included in at least one embodiment described herein, and may or may not be present in other embodiments. Moreover, it is to be understood that the described elements can be combined in any suitable manner in the various embodiments. "Combinations thereof" is open and includes any combination that includes at least one of the recited components or features, optionally with similar or equivalent components or features that are not recited.

[0113] Unless otherwise defined, technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this application belongs.All cited patents, patent applications, and other references are incorporated herein by reference in their entirety.However, if the term of this application contradicts or conflicts with the term of the incorporated reference, the term of this application shall take precedence over the conflicting term of the incorporated reference.

[0114] Unless otherwise specified herein, all test standards are the latest standards in effect as of the filing date of this application or, if priority is claimed, as of the filing date of the earliest priority application in which the test standards appear.

[0115] Although the materials, systems, and methods of the present disclosure have been described with reference to exemplary embodiments thereof, the present disclosure is not limited to such exemplary embodiments and / or implementations. Rather, the materials, systems, and methods of the present disclosure are susceptible to many implementations and applications, as will be readily apparent to those skilled in the art from the disclosure herein. The present disclosure expressly encompasses such modifications, enhancements, and / or variations of the disclosed embodiments. Since many changes can be made to the above configurations, and many widely different embodiments of the present disclosure can be made without departing from the scope of the present disclosure, it is intended that all matters contained in the drawings and specification should be interpreted as illustrative and not in a limiting sense. Further modifications, changes, and substitutions are contemplated in the foregoing disclosure. It is therefore appropriate that the scope of the appended claims be interpreted broadly and in a manner consistent with the scope of the present disclosure.

Claims

1. A sterilizable fibrous material for packaging medical devices intended to be sterilized, The sterilizable fibrous material is at least 180 g / m ２ , preferably at least 200 g / m ２ in the form of cardboard having a basis weight of wherein the sterilizable fibrous material comprises a mixture of fibers containing at least 75% by weight of natural cellulose fibers with a length of less than 5 mm, wherein the sterilizable fibrous material has an air permeability of more than 1.47 kPa, preferably at least 3.4, and advantageously exactly 3.4 µm / Pa·s, measured according to ISO 5636-3 standard, wherein the sterilizable fibrous material has pores with a maximum pore diameter of less than 50 µm, measured according to Appendix C of EN 868-3 standard characterized in that it is a sterilizable fibrous material.

2. The mixture of fibers comprises 20% to 100% by weight of natural cellulose long fibers with a length of 1 to 5 mm, and 0% to 80% by weight of natural cellulose short fibers with a length of less than 1 mm characterized in that it is the material according to Claim 1.

3. The long fibers have a length of 1 to 3 mm, preferably 1.4 to 2.5 mm, and the short fibers have a length of 0.2 to 1 mm, preferably 0.3 to 1 mm, characterized in that it is the material according to Claim 1 or 2.

4. The ratio of long fibers to short fibers is between 2 and 30, characterized in that it is the material according to Claim 1 or 2.

5. The mixture of fibers further comprises at least 1% by weight, preferably 1 to 20% by weight, of chemical fibers having a titre of 0.3 to 10 dtex and a length of 2.5 to 20 mm, characterized in that it is the material according to Claim 1 or 2.

6. The chemical fibers are selected from the group comprising synthetic fibers such as man-made fibers such as lyocell and rayon, and biopolymers such as polylactic acid, polyhydroxyalkanoate, polybutylene succinate, polybutylene succinate coadipate, polycaprolactone, polybutylene adipate terephthalate, poly(hydroxybutyrate-co-hydroxyvalerate) or copolymers thereof, characterized in that it is the material according to Claim 1 or 2.

7. The mixture of fibers is biosourced and / or recyclable and / or biodegradable, characterized in that it is the material according to Claim 1 or 2.

8. It is biodegradable to an extent of 90%, or even 95%, and meets the biodegradability requirements of EN 13432 standard, characterized in that it is the material according to Claim 1 or 2.

9. Measured in accordance with Appendix C of EN 868-3 standard, having pores with an average pore diameter of less than 35 μm, preferably 10 μm to 35 μm, the material according to claim 1 or 2.

10. The material according to claim 1 or 2, further comprising a wet strength agent corresponding to 0.15 to 1% by dry weight with respect to the dry weight of cellulose.

11. The material according to claim 10, wherein the wet strength agent is selected from the group comprising polyamine epichlorohydrin (PAE), glyoxalated resin, such as glyoxalated polyamide (GPAM), and formaldehyde-based resin.

12. The material according to claim 1 or 2, further comprising a sizing agent corresponding to 0.15 to 1% by dry weight with respect to the dry weight of cellulose.

13. The material according to claim 12, wherein the sizing agent is selected from the group comprising alkyl ketene dimer (AKD), alkenyl succinic anhydride (ASA), and rosin-based resin.

14. Measured in accordance with ISO 535 standard, the COBB in 60 seconds is less than 20 g / m ２ The material according to claim 1 or 2, characterized in that it is less than this value.

15. The material according to claim 1 or 2, characterized in that it complies with DIN 58953-6 standard, sections 3 and 4, with respect to the bacterial barrier.

16. The material according to claim 1 or 2, characterized in that it complies with ISO 11607-1 standard.

17. The material according to claim 1 or 2, having a thickness of at least 200 μm, preferably 300 μm.

18. The material according to claim 1 or 2, further comprising a coating layer, and the composition thereof can be made thermally weldable.

19. The material according to claim 1 or 2, characterized in that it is calendered.

20. The material according to claim 1 or 2, wherein the mixture of fibers further comprises 1 to 40% by weight of mercerized cellulose fibers.

21. The material has a bending resistance of at least 1000 mN, preferably at least 2000 mN, more preferably at least 3000 mN in the longitudinal and transverse directions, measured in accordance with ISO 2493-2, Paper and board, Determination of bending resistance, Part 2: Taber type testing machine standard, the material according to claim 1 or 2. **Claim 22**: The material according to claim 1 or 2, characterized in that it has a total water vapor transmission rate (WVTR) of at least 400 g / m ２ / day, preferably at least 800 g / m ２ / day, more preferably at least 1000 g / m ２ / day, as determined by the ISO 2528 standard.

23. A tray obtained from the material specified by claim 1 or 2.

24. Use of a material as specified by claim 1 or 2 for the manufacture of a tray.

25. A tray according to claim 23, and sterilizable sealing means for said tray for packaging for medical sterilization.

26. A tray comprising a sterilizable fibrous material, said tray extending from a first end to a second end and from a first side to a second side, said first end including a first end wall, said second end including a second end wall, said first side including a first side wall, said second side including a second side wall, said first and second end walls and said first and second side walls defining a recess or cavity within the inner boundaries of said first and second end walls and said first and second side walls, said recess or cavity having a bottom wall at its bottom, a tray comprising said tray has a basis weight of at least 180 g / m ２ , preferably at least 200 g / m ２ and has a basis weight of said tray comprising a mixture of fibres containing at least 75% by weight of natural cellulose fibres having a length of less than 5 mm, said tray having an air permeability of more than at least 1.7, preferably at least 3.4, advantageously exactly 3.4 μm / Pa·s at a pressure of 1.47 kPa as measured according to ISO 5636-3 standard, said tray having pores with a maximum pore diameter of less than 50 μm as measured according to Appendix C of EN 868-3 standard, a container for packaging a medical device intended to be sterilized.

27. providing a sterilizable fibrous material, forming said sterilizable fibrous material within a tray, said tray extending from a first end to a second end and from a first side to a second side, said first end including a first end wall, said second end including a second end wall, said first side including a first side wall, said second side including a second side wall, said first and second end walls and said first and second side walls defining a recess or cavity within the inner boundaries of said first and second end walls and said first and second side walls, said recess or cavity having a bottom wall at its bottom, The tray has a basis weight of at least 180 g / m ２ , preferably at least 200 g / m ２ and has a basis weight of said tray comprising a mixture of fibres containing at least 75% by weight of natural cellulose fibres having a length of less than 5 mm, said tray having an air permeability of more than at least 1.7, preferably at least 3.4, advantageously exactly 3.4 μm / Pa·s at a pressure of 1.47 kPa as measured according to ISO 5636-3 standard, The tray has pores having a maximum pore diameter of less than 50 μm as measured in accordance with Appendix C of EN 868-3, A method for manufacturing a container for packaging a medical device intended to be sterilized.

28. Forming the sterilizable fibrous material within the tray comprises thermoforming the sterilizable fibrous material or shaping the sterilizable fibrous material, the method according to claim 27.

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