Bag system for treating biological fluids by electromagnetic irradiation

Abstract

The invention relates to a bag system (1) for treating a biological fluid by electromagnetic irradiation, comprising at least one element consisting of an irradiation bag (2) for accommodating the biological fluid to be irradiated, said irradiation bag (2) being made of a material permeable to the electromagnetic radiation, said bag system (1) further comprising at least one protective film (26a, 26b) covering the irradiation bag (2), the protective film (26a, 26b) is made of a gas barrier polymeric material having an oxygen permeability of less than or equal to 100 cm3 / m2 / 24 h at a temperature of 23 DEG C and a relative humidity of 50%.

Description

[0001] The present invention relates to a bag system for treating biological fluids by electromagnetic radiation, and an assembly comprising the bag system and a package.

[0002] The invention is applicable in the medical and biomedical fields, in particular in the field of blood transfusion, and even more particularly in the field of blood treatment.

[0003] In blood transfusion, blood is first collected from a donor and then separated by centrifugation into different blood products, such as concentrated red blood cells, plasma, and concentrated platelets. In order to improve the quality and safety of these different blood products, they may be subjected to various treatments, such as removal of leukocytes and / or reduction of pathogens.

[0004] Document WO2007 / 076834 describes a method for reducing pathogens such as bacteria, viruses and / or leukocytes in platelet concentrates. In this method, a bag containing a platelet concentrate is irradiated with UV radiation under stirring. This method has the advantage of not using photosensitizers such as psoralen (amotosalen) or riboflavin compared to other pathogen inactivation methods such as commercial intercept (Cerus) and Mirasol (TerumoBCT) methods.

[0005] In these light-based methods, and particularly in the absence of a photosensitizer, it is important to ensure that the blood product being treated receives the necessary and sufficient dose to reduce pathogen rates to acceptable levels without compromising the biological properties of the blood product.

[0006] Document WO2008 / 034476 describes a bag system suitable for implementing the method of reducing pathogens by UV radiation described in document WO2007 / 076834. The bag system mainly comprises an irradiation bag made of ethylene-vinyl acetate (EVA) copolymer, which is connected to a platelet concentrate storage bag made of plasticized polyvinyl chloride (PVC). The bag system also includes a tube made of plasticized PVC.

[0007] In this document, it is pointed out that the absorption of UV light by EVA is affected by the degree of polymerization and the degree of crosslinking of the EVA.

[0008] Other intrinsic factors affect the UV transmittance of EVA sheets, such as the relative proportions of ethylene and vinyl acetate units, film thickness, or surface finish. External factors that affect UV transmittance include heat, humidity, the presence of oxygen, and exposure to ultraviolet light.

[0009] After extensive research, the applicant has discovered additional, hitherto undescribed factors that influence the UV transmittance of EVA sheets.

[0010] The applicant has demonstrated that the UV transmittance of EVA bags is degraded by the migration of certain plasticizers from the PVC of other components of the bagging system and by the migration of certain substances from the packaging in which the bagging system is contained.

[0011] In practice, bag systems such as the one described in document WO 2008 / 034476 comprise components such as connectors and tubes made of PVC plasticized with di-2-ethylhexyl phthalate (DEHP).

[0012] DEHP is also known to be an endocrine disruptor that can have effects on the reproductive system, hormones and immune system. It is also potentially carcinogenic. It is therefore recommended to eliminate DEHP from medical devices such as bag systems for blood processing.

[0013] DEHP-free bag systems for blood treatment are known. For example, document JP2003-171288A describes a bag system comprising a filter for removing leukocytes from whole blood and a plurality of bags connected to the filter for containing blood components. At least one bag contains a citrate plasticizer, while the other bags are made of PVC plasticized with citrate or trimellitate.

[0014] Document EP2731425B1 describes a phthalate plasticizer-free bag for storing red blood cell products, which is made of a polymer material plasticized by diisononyl-1,2-cyclohexanedicarboxylate (DINCH) and contains a specific additive solution.

[0015] The PVC bag systems of both references are not suitable for electromagnetic irradiation of blood components and the choice of plasticizer was driven by the reduction of hemolysis of red blood cells in bags that do not contain DEHP.

[0016] Document FR 2 965 812 proposes to inhibit the migration of DEHP or other plasticizing compounds from plasticized PVC objects such as tubes, rather than removing DEHP from medical devices, by coating the objects with a layer of metal oxides such as titanium dioxide.

[0017] Also known from document EP1972354 is a bag system for separating and reducing pathogens from biological fluids using a photosensitizer that can be activated by ultraviolet radiation, wherein one or more bags containing the photosensitizer are arranged in a removable opaque casing. The casing prevents the photosensitizer from being prematurely activated by ambient light.

[0018] Finally, document US2019 / 0230919 describes a kit for reducing the oxygen content in blood or blood components to improve their preservation. These kits mainly include a closed, oxygen-impermeable outer container; a flexible inner bag designed to receive blood or blood components; and an oxygen absorber placed in the outer container. The inner bag is made of an oxygen-permeable material such as polyvinylidene fluoride, silicone or polyurethane. Document WO2021 / 231650 describes a similar kit, in which the inner bag is specifically made of polyvinyl chloride plasticized with di-2-ethylhexyl phthalate (DEHP), diisononyl 1,2-cyclohexanedicarboxylate (DINCH) or tributyl citrate (BTHC). Since the closed outer container encloses the inner bag, these kits are not suitable for treating blood or blood components by electromagnetic irradiation.

[0019] In order to maintain the transmittance of the irradiation bag of the bag system, according to a first aspect, the present invention proposes a bag system for treating biological fluids by electromagnetic irradiation, the bag system comprising at least one element consisting of an irradiation bag for containing the biological fluid to be irradiated, the irradiation bag being made of a material transparent to the electromagnetic radiation, the system comprising one or more other elements selected from the following: at least one storage bag and a tube, at least one of the other elements being made of a polymer material formulated with a plasticizer, and at least one protective film forming a barrier member to the plasticizer and covering the irradiation bag, the protective film being made of a gas barrier polymer material having a thermal conductivity of less than or equal to 100 cm at a temperature of 23°C and a relative humidity of 50%. 3 / m 2 / 24h oxygen permeability.

[0020] According to a second aspect, the invention relates to an assembly for treating a biological fluid by electromagnetic radiation, comprising a package and a bag system according to the first aspect of the invention, said bag system being aseptically contained in said package.

[0021] According to a third aspect, the present invention relates to the use of a film made of a gas barrier polymer material as a barrier medium for polyvinyl chloride releasable plasticizers, the gas barrier polymer material having a relative humidity of less than or equal to 100 cm at a temperature of 23°C and 50% relative humidity. 3 / m 2 / 24h oxygen permeability.

[0022] Additional features and benefits will be described in the description which follows.

[0023] Figure 1 A schematic diagram of an assembly according to one embodiment of the present invention is shown, the assembly comprising a sterile package in which a bag system for UV irradiating a blood product is arranged.

[0024] Figure 2 Shown between 0 and 1200 days is the UV transmission of an EVA sheet beneath which a further EVA sheet is arranged and on which one or two PVC sheets plasticized with DEHP, DEHT, TOTM or DINCH are superimposed (side A).

[0025] Figure 3 Shown is the UV transmission between 0 and 1200 days of an EVA sheet on which is superimposed another EVA sheet and one or two PVC sheets plasticized with DEHP, DEHT, TOTM or DINCH (side B).

[0026] The present invention relates to bag systems and assemblies for treating biological fluids by electromagnetic radiation.

[0027] The biological fluid is in particular whole blood or a blood product obtained by filtering and / or centrifuging whole blood, such as plasma, platelet-rich plasma, red blood cell concentrate or platelet concentrate.

[0028] It is known to apply electromagnetic radiation to blood or blood products in the presence or absence of photosensitizers in order to reduce pathogens such as viruses, bacteria and / or leukocytes in blood or blood products.

[0029] By electromagnetic radiation is meant non-ionizing radiation having a wavelength of 10 nm to 10 µm, i.e. visible, ultraviolet (UV) and / or infrared radiation. Specifically, the electromagnetic radiation is visible radiation having a wavelength of 340 nm to 800 nm and / or UV radiation having a wavelength of 200 to 340 nm. More specifically, the radiation is UV-C radiation having a wavelength of 200 to 280 nm. Even more specifically, the UV-C radiation has a wavelength of the order of 254 nm.

[0030] according to Figure 1 The assembly 20 for treatment by magnetic irradiation comprises a package 21 and a bag system 1 aseptically enclosed in the package 21 .

[0031] The packaging 21 is suitable for sterilization of the bag system 1 it contains.

[0032] In one embodiment, the package is suitable for sterilization by a gas such as ethylene oxide.

[0033] In one embodiment, packaging is made of one or more materials that neither phthalate nor terephthalate is prepared. For example packaging 21 is formed by assembling porous nonwoven sheet and transparent film sheet. Porous sheet allows sterilizing gas to pass through in the packaging, while preventing microorganisms from entering the packaging. Porous sheet is for example made of cellulose nonwoven such as paper or synthetic nonwoven such as high-density polyethylene fiber (Tyvek®). Transparent film sheet is for example made of transparent polymer such as high-density polyethylene, low-density polyethylene, polypropylene and / or polyester. Porous nonwoven sheet and transparent film sheet are for example welded together.

[0034] according to Figure 1 The bag system for electromagnetically irradiating biological fluids comprises at least one element consisting of an irradiation bag 2 for containing the biological fluid to be irradiated. The irradiation bag is made of a material transparent to the electromagnetic radiation.

[0035] In one embodiment, the electromagnetic radiation is UV radiation, in particular UV-C radiation, and the irradiation bag is made of a material transparent to UV radiation, in particular transparent to UV-C radiation.

[0036] The biological fluid to be treated is in particular blood or a blood product, such as a platelet concentrate.

[0037] For example, the irradiation bag 2 is made of EVA. Alternatively, the irradiation bag 2 can be made of a polymer material that is transparent to UV radiation, such as polymethylpentene, polychlorotrifluoroethylene, perfluoroalkoxide, fluorinated ethylene propylene, ethylene tetrafluoroethylene, ethylene chlorotrifluoroethylene or polyvinylidene fluoride. The material of the irradiation bag does not contain phthalates or terephthalates.

[0038] Phthalate or terephthalate refers to a derivative of phthalic acid or terephthalic acid, such as an ester of phthalic acid or an ester of terephthalic acid.

[0039] Phthalate-free or terephthalate-free materials are materials to which no phthalates or terephthalates have been added as plasticizers to the composition of the material.

[0040] Phthalate-free or terephthalate-free formulated materials may contain residual traces of phthalates or terephthalates, ie contents of less than 1000 ppm, for example due to contamination during the manufacturing process of the material or the bag system or during its packaging.

[0041] In particular, the irradiation bag 2 is formed by a UV radiation transparent sheath or by assembling two UV radiation transparent sheets, the sheath or each sheet having a UV-C transmittance greater than 60%, in particular greater than 65%. Even more particularly, the UV-C transmittance of the sheath or each sheet is less than 90%, in particular less than 85%.

[0042] UV transmittance is the percentage of the transmitted radiation intensity to the incident intensity. Transmittance is measured by spectrophotometry.

[0043] In a specific embodiment, the irradiation bag 2 does not contain a photosensitizer. In other words, the irradiation bag 2 does not contain a photosensitizer such as riboflavin, psoralen derivatives or phenothiazine derivatives.

[0044] according to Figure 1 The irradiation bag 2 comprises a first access hole 3 in fluid communication with an inner volume 4 of the irradiation bag 2. The irradiation bag 2 also comprises a second access hole 5 in fluid communication with the inner volume 4 of the irradiation bag 2.

[0045] The irradiation bag 2 is in fluid communication with the first pipeline 6 via the first inlet port 3. The first pipeline 6 is provided at its ends with two vents 7a, 7b, each containing an air-permeable filter membrane, forming a sterile barrier. These vents enable the bag system 1 to be sterilized by gas.

[0046] The irradiation bag 2 further comprises openings 19a, 19b, 19c, 19d, 19e formed at one or more peripheral edges of the irradiation bag 2, and the openings are used to hang and / or hold the irradiation bag 2.

[0047] The bag system 1 further comprises a storage bag 8 for collecting and storing processed blood components. The storage bag 8 is in fluid communication with the irradiation bag 2 via a second tube 9, which is connected at one end to the second inlet port 5 of the irradiation bag 2 and at the other end to the inlet port 10 of the storage bag 8. The storage bag 8 further comprises two outlet ports 22, 23, each of which is closed by a flap-breakable stopper 24, 25.

[0048] A removable plug 27 is arranged in the second access hole 5 of the irradiation bag 2, closing the fluid communication between the inner volume 4 of the irradiation bag 2 and the second tube 9 leading to the storage bag 8. The removable plug 27 can be slid out of the second access hole 5 into the inner volume 4 of the container 2 to allow fluid communication between the irradiation bag 2 and the storage bag 8.

[0049] The bag system 1 further comprises a sampling bag 11 in fluid communication with the storage bag 8 via a third tube 12 connected at one end thereof to a second access opening 13 of the storage bag 8 and at the other end thereof to an access opening 14 of the sampling bag 11 .

[0050] The fourth tube 15 is connected at one end thereof to the third tube 12 via a three-way connector 16. The other end of the fourth tube 15 is provided with two vents 17a, 17b, each of which contains a filter membrane that allows air to pass through and forms a sterile barrier.

[0051] Each tube 6, 9, 12, 15 is provided with a clamp 18a, 18b, 18c, 18d, which allows selectively controlling the opening and closing of the flow of liquid in each of these tubes.

[0052] The bag system 1 advantageously comprises at least one protective film 26a covering the irradiation bag. The protective film is a very thin plastic sheet. It is made of a polymer material formulated without using either phthalates or terephthalates. The protective film 26a is superimposed on the irradiation bag, completely covering its surface. The protective film 26a is arranged, for example, between the irradiation bag 2 and the porous sheet of the package 21, in particular made of varnished paper.

[0053] The function of the protective film is to protect the irradiation bag 2 from substances that could adversely affect its transmittance, in particular UV transmittance, and even more in particular UV-C transmittance. The irradiation bag 2 is not covered with this protective film when treated with electromagnetic radiation.

[0054] The protective film thus forms a barrier to releasable substances from other elements of the bag system, which adversely affect the transmittance of the irradiation bag. Releasable substances are substances that migrate from the bag system or its packaging. Examples of releasable substances are PVC plasticizers, such as phthalates or terephthalates, cyclohexane dicarboxylates or citrates. In other words, the protective film forms a barrier to plasticizers for polymeric materials such as PVC.

[0055] In practice, the bag system 1 is particularly folded in its packaging 21 so that the storage bag 8 is located on the irradiation bag 2. In this configuration, in the absence of a protective film, the releasable plasticizers in the bag system migrate towards the irradiation bag 2. The presence of these releasable substances on the irradiation bag deteriorates its optical properties, in particular its UV transmittance, and more particularly its UV-C transmittance.

[0056] The protective film also protects the irradiation bag from substances present in the environment that could adversely affect its transmittance. In fact, phthalates, and DEHP in particular, are ubiquitous in the environment and are a potential source of contamination for irradiation bags.

[0057] According to one embodiment, a temperature of 23° C. and a relative humidity of 50% is used. 3 / m 2The protective film made of a gas barrier polymer material with an oxygen permeability of less than or equal to 10 g / m at a temperature of 23°C and a relative humidity of 50% is used as a barrier member for releasable plasticizers such as DEHP or DEHT from polyvinyl chloride. Specifically, the material of the protective film is also a water vapor barrier polymer material, which has a water vapor barrier polymer material having a water vapor barrier of less than or equal to 10 g / m at a temperature of 23°C and a relative humidity of 50%. 2 / 24h water vapor permeability.

[0058] Therefore, the protective film 26a is made of a gas barrier polymer material having a thermal conductivity of less than or equal to 100 cm at a temperature of 23°C and a relative humidity of 50%. 3 / m 2 / 24h, more particularly less than or equal to 90cm 3 / m 2 / 24h oxygen permeability. Oxygen permeability is measured according to ASTM D3985 standard.

[0059] Specifically, the polymer material of the protective film 26a is a water vapor barrier polymer material having a water vapor barrier polymer material having a water vapor barrier property of less than or equal to 10 g / m 2 at a temperature of 23° C. and a relative humidity of 50%. 2 / 24h, more particularly less than 5g / m 2 / 24h water vapor permeability. Water vapor permeability is measured according to ASTM F1249 standard.

[0060] Specifically, the protective film comprises at least one layer made of polyester or polypropylene. For example, the protective film comprises a composite multilayer sheet comprising one layer made of polyester and one layer made of polypropylene. Alternatively, the protective film comprises a composite multilayer sheet comprising two layers made of polyester or two layers made of polypropylene.

[0061] Advantageously, the protective film is transparent, which enables the user to see the irradiation bag 2 .

[0062] The thickness of the protective film is 40 to 70 µm, in particular 45 to 65 µm.

[0063] In one embodiment, the bag system comprises two protective films 26a, 26b arranged on both sides of the irradiation bag 2. The irradiation bag 2 is thus sandwiched between the two protective films 26a, 26b until it is treated with electromagnetic radiation. Alternatively, the protective films can be folded on themselves to form a sheet into which the irradiation bag 2 is inserted.

[0064] In another embodiment, the two protective films 26a, 26b together form a sleeve having at least one open end. The open end of the sleeve enables the user to easily slide the sleeve off the irradiation bag 2 just before processing the biological fluid contained in the irradiation bag. The irradiation bag 2 is arranged in the sleeve to enclose it. The sleeve surrounds the irradiation bag 2 to protect it from the migration of plasticizers or other releasable substances that affect the transmittance of the irradiation bag 2.

[0065] For example, the sleeve is made by stacking two protective films 26a, 26b and welding two opposing sides and one lateral side together.

[0066] In this embodiment, the irradiation bag 2 is protected from the bagging system 1 and the releasable substance of the packaging 21 .

[0067] To ensure that the optical properties of the irradiation bag 2 of the bag system 1 are maintained, one or more other elements of the bag system, in addition to the irradiation bag 2, are made of one or more materials formulated using neither phthalates nor terephthalates.

[0068] According to one embodiment, each of the other elements is made of one or more materials selected from the group consisting of materials other than plasticized polyvinyl chloride and polymeric materials formulated with at least one plasticizer other than phthalates such as di-2-ethylhexyl phthalate or terephthalates such as di-2-ethylhexyl terephthalate.

[0069] Indeed, the Applicant has discovered that phthalates and terephthalates such as di-2-ethylhexyl phthalate (DEHP) or di-2-ethylhexyl terephthalate (DEHT) migrating towards the irradiation bag 2 reduce the UV transmittance, more particularly the UV-C transmittance, of the irradiation bag 2 .

[0070] Therefore, each of the other elements of the bag system 1 is advantageously made of one or more materials other than polyvinyl chloride plasticized with di-2-ethylhexyl phthalate or di-2-ethylhexyl terephthalate.

[0071] Advantageously and for the same reasons, the packaging contained in the bag system is made of one or more materials that are formulated neither with phthalates nor with terephthalates, in particular not with di-2-ethylhexyl phthalate (DEHP) or di-2-ethylhexyl terephthalate (DEHT).

[0072] In a specific embodiment, each of the other components of the bag system is made of polyvinyl chloride plasticized with a plasticizer selected from the group consisting of cyclohexane dicarboxylates, citrates, trimellitates, or mixtures thereof, or is made of a material other than plasticized polyvinyl chloride.

[0073] More specifically, each other element of the bag system is made of polyvinyl chloride plasticized with a plasticizer selected from diisononyl-1,2-cyclohexanedicarboxylate, trihexyl butyrate citrate, tri-2-ethylhexyl trimellitate or mixtures thereof, or of a material other than plasticized polyvinyl chloride.

[0074] Other elements of the bag system include one or more elements selected from the following: storage bag 8, sampling bag 11, tubes 6, 9, 12, 15, connector 16, clips 18a, 18b, 18c, 18d, vents 7a, 7b, 17a, 17b and combinations thereof.

[0075] The rigid components of the bag system, such as the clips and vents, are made of materials other than plasticized polyvinyl chloride, such as polycarbonate, polyester, polyethylene and / or polypropylene.

[0076] For example, the clips 18a, 18b, 18c, 18d are made of polycarbonate. The vents 7a, 7b, 17a, 17b are made of polypropylene.

[0077] The flexible elements of the bag system (except the irradiation bag 2) are made of polyvinyl chloride plasticized with at least one plasticizer selected from the group consisting of cyclohexanedicarboxylates, citrates, trimellitates and mixtures thereof.

[0078] The storage bag 8 is made of a breathable material so that the platelet concentrate can be stored for at least 3 to 7 days. For example, the storage bag 8 is made of PVC plasticized with tri(ethylhexyl) trimellitate (or trioctyl trimellitate, TOTM) or tributyryl citrate (BTHC).

[0079] For example, the sampling bag 11 is made of PVC plasticized with diisononyl-1,2-cyclohexanedicarboxylate (DINCH).

[0080] For example, the tubes 6, 9, 12, 15 and the connector 16 are made of DINCH plasticized PVC.

[0081] Components of the irradiation bag 2, storage bag 8 and sampling bag 11 such as inlet apertures 3, 5, 10, 13, 14, outlet apertures 22, 23 and plugs 24, 25, 27 are also advantageously made of one or more materials formulated with neither ortho-phthalates nor terephthalates.

[0082] about Figure 1 With the embodiment of the assembly 20 shown, a method for implementing the bag system 1 and its packaging 21 will now be described.

[0083] Before taking out the bag-like system 1 , the packaging 21 in which the bag-like system 1 is contained is opened.

[0084] A source bag (not shown) containing a biological fluid (e.g., a mixture from apheresis platelet concentrate or platelet concentrate obtained from buffy coats) is aseptically connected to the bag system 1 via a first tube 6 using a TSCD-II (Terumo) type aseptic connection device.

[0085] The biological fluid of the source bag is then transferred into the inner volume 4 of the irradiation bag 2 through the first access hole 3 due to gravity.

[0086] After the transfer, the air contained in the inner volume 4 of the irradiation bag 2 is evacuated from the irradiation bag 2 through the first access opening 3 by the pressure exerted on the irradiation bag. Once the air has been evacuated, the first access opening 3 is closed by welding.

[0087] These air purging and welding operations are advantageously carried out using the welding device described in document WO 2022 / 029040.

[0088] The first tube 6 is welded and cut to separate the source bag initially containing the biological fluid from the bag system 1 .

[0089] The irradiation bag 2 is then taken out of the sleeve formed by the two sheets 26a, 26b. Alternatively, the sleeve is detached from the irradiation bag 2 at any other time before the irradiation operation.

[0090] The irradiation bag 2 is irradiated with UV light under agitation to inactivate any pathogens present in the biological fluid.

[0091] The removable plug 27 closing the second access hole 5 is pushed into the irradiation bag 2 and the irradiated biological fluid is then transferred to the storage bag 8 for storage for up to 5 to 7 days.

[0092] After the transfer, the second tube 9 is welded and cut using a handheld welding machine to separate the container 2 from the rest of the bag system 1 .

[0093] In one embodiment, a sample of the biological fluid is sent to a sampling bag 11 for analysis. The third tube 12 is separated from the storage bag 8 by welding and cutting it using a handheld welder. Example

[0094] Example 1: Effect of bag system packaging and various plasticized PVC components on the UV transmittance of EVA jackets

[0095] Six test configurations were conducted and analyzed:

[0096] -EVA sheath (control);

[0097] - EVA sheath packaged in a pouch made of two transparent composite films of polyester (PET) and polyethylene (PE);

[0098] -EVA sheath, which is packaged in a pouch made of two sheets of painted paper;

[0099] - a BTHC-plasticized PVC storage bag arranged on top of an EVA sheath, and a DEHP-plasticized PVC sampling bag straddling the storage bag and the EVA sheath, the whole packaged in a pouch made of a transparent composite film of PET and PE and a sheet of lacquered paper;

[0100] - an EVA sheath protected by a composite polymer sleeve of PET and polypropylene (PP), a TOTM plasticized PVC storage bag arranged on the protected EVA sheath, and a DEHP plasticized PVC sampling bag spanning the storage bag and the protected EVA sheath, the whole packaged in a pouch consisting of a transparent composite film of PET and PE and a sheet of lacquered paper;

[0101] - A BTHC plasticized PVC storage bag arranged on an EVA sheath, and a DEHP plasticized PVC sampling bag straddling the storage bag and the EVA sheath, the whole packaged in a pouch consisting of a transparent composite film of bi-oriented PET and polypropylene (PP) and a sheet of paper.

[0102] The size of the EVA jacket is basically the same as that of the irradiation bag.

[0103] The sleeve made of a composite polymer of PET and PP has a thickness of about 55 µm and an oxygen permeability of less than 91.0 cm at 23°C and 50% relative humidity. 3 / m 2 / 24h, and the water vapor permeability at 23°C and 50% relative humidity is less than 5.0cm 3 / m 2 / 24h.

[0104] Transmittance measurements were performed using a spectrophotometer (Perkin Elmer Lambda650).

[0105] Table 1

[0106] These results show the negative impact of specific packaging pouches (both transparent film and lacquered paper sheets) on the UV transmittance of irradiated bags. This impact is enhanced by the presence of other elements of the plasticized PVC bag system.

[0107] The presence of the protective sleeve ensures that the EVA irradiation bag is not contaminated by PVC plasticizers or other releasable substances from the packaging, thereby maintaining UV transmittance.

[0108] Example 2: Effect of plasticizer migration from PVC sheet on UV transmittance of EVA sheet.

[0109] Six test configurations were performed by superimposing rectangular samples of approximately 60 cm² sheets of different materials:

[0110] - Two EVA sheet samples;

[0111] - Two EVA sheet samples and two DEHP plasticized PVC sheet samples;

[0112] - Two EVA sheet samples and two BTHC plasticized PVC sheet samples;

[0113] - Two EVA sheet samples and one DEHT plasticized PVC sheet sample;

[0114] - Two EVA sheet samples and one TOTM plasticized PVC sheet sample;

[0115] - Two EVA sheet samples and one DINCH plasticized PVC sheet sample.

[0116] The EVA sheet in direct contact with the plasticized PVC sheet sample was marked as "A side", while the EVA sheet below the A side was marked as "B side".

[0117] The UV transmittance of EVA sheets was measured at different times from 0 to 3 years. Figure 2 and 3 Shown in.

[0118] 2.1 Impact of DEHP

[0119] It has been observed that the UV transmittance of the EVA sheet drops sharply when in direct contact with a DEHP-plasticized PVC sheet sample (side A). On the 14th day of contact, the transmittance of the EVA sheet was less than 60%. After two years, the UV transmittance of the EVA sheet was less than 10%.

[0120] On side B, the transmission loss dropped to less than 60% after 100 days.

[0121] EVA sheet slowed down but did not prevent the migration of DEHP.

[0122] 2.2 Impact of BTHC and DINCH

[0123] Under the conditions studied, contact of EVA sheets (A-side and B-side) with BTHC or DINCH plasticized PVC sheet samples had no effect on the transmittance of the EVA sheets over a 3-year period.

[0124] 2.3 Impact of DEHT

[0125] The direct contact of the DEHT plasticized PVC sheet samples with the EVA sheet (A-side) resulted in an even greater loss in UV transmittance of the EVA sheet compared to the DEHP plasticized PVC sheet.

[0126] The effect of the DEHT-plasticized PVC sheet is less obvious on the B side because the presence of the A side slows down the migration of DEHT.

[0127] 2.4 Impact of TOTM

[0128] It has been observed that the UV transmittance of the EVA sheet (A side) in direct contact with the PVC sheet sample of TOTM plasticization is reduced, but it is known that it migrates very little in the PVC matrix, but absorbs UV radiation, especially UV-C radiation. However, this result should be treated with caution because it represents the average value of three tests, two of which show that the UV transmittance of the A side at the end of the study is 55-57%, and one of which shows that the transmittance is less than 2%. The results on the B side are equally disparate.

[0129] These studies suggest that DEHT, such as DEHP, should be avoided in bag systems designed for treating biological fluids using UV irradiation.

[0130] Example 3: Effect of PVC plasticizer migration in tubes on UV transmittance of EVA sheets.

[0131] Three test configurations were carried out using rectangular samples of an EVA sheath measuring 15 cm × 18 cm, either by itself or superimposed with a 60 cm tube of a different material, the whole packaged in a pouch made of a transparent composite film of biaxially oriented PET and polypropylene and a sheet of paper:

[0132] -EVA sheath sample (control);

[0133] -EVA sheath samples and DINCH plasticized PVC pipe samples;

[0134] -EVA sheath samples and TOTM plasticized PVC pipe samples.

[0135] As with the DINCH plasticized PVC sheet, the contact between the DINCH plasticized PVC tube and the EVA jacket had no effect on the UV transmittance of the EVA jacket.

[0136] Contact of TOTM-plasticized PVC tubing with an EVA jacket resulted in a reduction in the UV transmittance of the EVA jacket of approximately 5% after 90 days. After one year, the reduction was more than 10%.

[0137] Example 4: Protection of different materials against UV transmittance of EVA irradiated bags

[0138] A single packaging pouch made of a transparent PET / PE composite film and a varnished paper sheet was sealed to form two separate compartments. Each compartment contained an EVA tube sample (15 cm x 15 cm) protected by an open sleeve. In addition, in the top compartment, two DEHP-plasticized PVC samples (15 cm x 15 cm) were sandwiched between the pouch and the sleeve-protected EVA jacket.

[0139] Various materials for manufacturing the protective sleeve were tested: PET copolymer film, PET / PP copolymer film or spunbonded nonwoven PET film.

[0140] Table 2

[0141] These tests showed that the PET copolymer film provided at least short-term protection to the irradiated bags against the diffusion of plasticizers (DEHP) and other contaminants from the packaging pouches.

[0142] The protective sleeve made of PET and PP copolymer ensures the stability of the UV transmittance over time.

[0143] On the other hand, the PET spunbond nonwoven sleeve could not maintain the UV transmittance of the EVA sheath due to its high porosity.

Claims

1. A bag system (1) for treating biological fluids by electromagnetic radiation, the bag system comprising at least one element consisting of an irradiation bag (2) for containing the biological fluid to be irradiated, the irradiation bag (2) being made of a material transparent to the electromagnetic radiation, the system comprising one or more other elements selected from the following: at least one storage bag (8) and a tube (9), at least one of the other elements being made of a polymer material formulated with at least one plasticizer, characterised in that the bag system (1) also comprises at least one protective film (26a, 26b) forming a barrier member to the plasticizer and covering the irradiation bag (2), the protective film (26a, 26b) being made of a gas barrier polymer material having a relative humidity of less than or equal to 100 cm at a temperature of 23°C and a relative humidity of 50%. 3 / m 2 / 24h oxygen permeability.

2. The bag system according to claim 1, characterized in that the polymer material of the protective film (26a, 26b) is a water vapor barrier polymer material having a water vapor barrier polymer material having a water vapor barrier polymer material of less than or equal to 10 g / m at a temperature of 23° C. and a relative humidity of 50%. 2 / 24h water vapor permeability.

3. Bag system according to one of claims 1 or 2, characterized in that the protective film (26a, 26b) is transparent.

4. Bag system according to any one of claims 1 to 3, characterized in that the protective film (26a, 26b) comprises at least one layer of polyester or polypropylene.

5. The bag system according to any one of claims 1 to 4, characterized in that it comprises two protective films (26a, 26b) arranged on both sides of the irradiation bag (2).

6. Bag system according to claim 5, characterized in that the two protective films (26a, 26b) together form a sleeve with at least one open end, in which the irradiation bag (2) is arranged.

7. The bag system according to any one of claims 1 to 6, characterized in that the electromagnetic radiation treatment is a UV radiation treatment, and the radiation bag is made of a material transparent to UV radiation.

8. The bag system according to any one of claims 1 to 7, characterized in that the irradiation bag (2) does not contain a photosensitizer.

9. The bag system according to any one of claims 1 to 8, characterized in that each of the other elements is made of one or more materials formulated with neither phthalates nor terephthalates.

10. The bag system according to claim 9 is characterized in that the other elements of the bag system include one or more elements selected from the following: storage bags (8), sampling bags (11), tubes (6, 9, 12, 15), connectors (16), clips (18a, 18b, 18c, 18d), vents (7a, 7b, 17a, 17b) and combinations thereof.

11. Bag system according to one of claims 9 or 10, characterized in that each of the other elements of the bag system is made of one or more materials other than polyvinyl chloride plasticized with di-2-ethylhexyl phthalate or di-2-ethylhexyl terephthalate.

12. A bag system according to any one of claims 9 to 11, characterized in that each of the elements of the bag system is made of polyvinyl chloride plasticized with a plasticizer selected from the following: cyclohexane dicarboxylates, citrates, trimellitates or mixtures thereof, or is made of a material other than plasticized polyvinyl chloride.

13. An assembly (20) for treating a biological fluid by electromagnetic radiation, comprising: A packaging (21) and a bag system (1) according to any one of claims 1 to 12, characterized in that the bag system (1) is aseptically enclosed in the packaging (21).

14. Assembly according to claim 13, characterised in that the package (21) is formed from a porous nonwoven sheet and a transparent film sheet.

15. Use of a film (26a, 26b) made of a gas barrier polymer material having a relative humidity of less than or equal to 100 cm at a temperature of 23°C and 50% relative humidity as a barrier to releasable plasticizers of polyvinyl chloride. 3 / m 2 / 24h oxygen permeability.

16. Use of a film according to claim 15, characterized in that the film is composed of a film having a relative humidity of less than or equal to 10 g / m at a temperature of 23°C and a relative humidity of 50%. 2 / 24h water vapor permeability water vapor barrier polymer material.

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