Pocket system for the electromagnetic irradiation treatment of a biological fluid

Abstract

Pocket system for the electromagnetic irradiation treatment of a biological fluid. Pocket system (1) for the electromagnetic irradiation treatment of a biological fluid, said pocket system comprising at least one element consisting of an irradiation pocket (2) intended to contain the biological fluid to be irradiated, said irradiation pocket (2) being made of a material permeable to said electromagnetic radiation, the pocket system further comprising one or more other elements made of one or more materials formulated without phthalates or terephthalates. Figure to be published with the abbreviation: Fig. 1

Description

Title of the invention: Pocket system for the electromagnetic irradiation treatment of a biological fluid

[0001] The invention relates to a pouch system for the treatment of a biological fluid by electromagnetic irradiation, as well as an assembly comprising said pouch system and packaging.

[0002] It applies to the medical and biomedical field, in particular to the field of blood transfusion and even more particularly to the field of blood processing.

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

[0004] Document WO 2007 / 076834 describes a method for reducing pathogens such as bacteria, viruses, and / or leukocytes from platelet concentrates. In this method, a bag containing a platelet concentrate is irradiated with UV radiation under agitation. This method has the advantage over other pathogen inactivation methods, such as the commercial Intercept (Cerus) and Mirasol (TerumoBCT) methods, of not using a photosensitive agent such as amotosalen or riboflavin.

[0005] In these processes using light, and in particular in the absence of a photosensitive agent, it is important to ensure that the blood product to be treated receives the necessary and sufficient dose to reduce the level of pathogens to an acceptable level, without deteriorating the biological properties of the blood product.

[0006] Document WO 2008 / 034476 describes a pouch system adapted for implementing the UV radiation pathogen reduction process described in document WO 2007 / 076834. The pouch system essentially comprises an irradiation pouch made of ethylene-vinyl acetate (EVA) copolymer connected to a platelet concentrate storage pouch made of plasticized polyvinyl chloride (PVC). The pouch system also includes tubing made of plasticized PVC.

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

[0008] Other intrinsic factors influence the UV transmittance of an EVA sheet, such as the relative proportion of ethylene and vinyl acetate repeats, the film thickness, or its surface condition. Among the extrinsic factors impacting UV transmittance is measured by heat, humidity, the presence of oxygen, and exposure to UV rays.

[0009] After much research, the applicant identified another previously undescribed factor impacting the UV transmittance of an EVA sheet.

[0010] The applicant has indeed demonstrated that the UV transmittance of an EVA pouch deteriorates due to the migration of certain plasticizers from the PVC of the other elements of the pouch system as well as the migration of certain substances from the packaging in which the pouch system is confined.

[0011] Indeed, pocket systems such as that described in document WO 2008 / 034476 include elements such as connectors or tubing, made of PVC plasticized with di-2-ethylhexyl phthalate (DEHP, di-2-ethylhexyl phthalate).

[0012] DEHP is also known to be an endocrine disruptor with possible effects on the reproductive, hormonal, and immune systems. It is also potentially carcinogenic. Therefore, it is recommended to eliminate DEHP from medical devices such as blood bag systems.

[0013] Rather than removing DEHP from medical devices, document FR 2965812 proposes to remove the migration of DEHP or other plasticizing compound from a plasticized PVC object such as a tube, by coating the object with a layer of metal oxide such as titanium dioxide.

[0014] Finally, a pouch system for separating and reducing pathogens from a biological fluid using a photosensitive agent activated by ultraviolet radiation is known from patent EP 1 972 354, in which the pouch(es) containing the photosensitive agent are arranged in a removable opaque overwrap. This overwrap prevents premature activation of the photosensitive agent by ambient light.

[0015] In order to preserve the transmittance of an irradiation pocket of a pocket system, the invention proposes according to a first aspect a pocket system for the treatment by electromagnetic irradiation of a biological fluid, said pocket system comprising at least one element consisting of an irradiation pocket intended to contain the biological fluid to be irradiated, said irradiation pocket being made of a material permeable to said electromagnetic radiation, said pocket system comprising one or more other elements, each of said other elements being made of one or more materials formulated without phthalate or terephthalate.

[0016] According to a second aspect, the invention relates to an assembly for the electromagnetic irradiation treatment of a biological fluid, comprising packaging made of one or more materials formulated without phthalates or terephthalates and a pouch system according to the first aspect of the invention, said pouch system being confined in a sterile manner within said packaging.

[0017] Other items and advantages will appear during the description that follows.

[0018] [Fig-1] represents a schematic view of an assembly according to an embodiment of the invention comprising a sterile package in which is arranged a pocket system for the UV irradiation of a blood product.

[0019] [Fig.2] represents the UV transmittance rate of a sheet made of EVA between 0 and 1200 days, below which is placed another sheet made of EVA and above which are superimposed one or two sheets made of PVC laminated by DEHP, DEHT, TOTM or DINCH (side A).

[0020] [Fig.3] represents the UV transmittance rate of a sheet made of EVA between 0 and 1200 days, above which are superimposed another sheet made of EVA and one or two sheets made of PVC laminated by DEHP, DEHT, TOTM or DINCH (side B).

[0021] The invention relates to a pocket system and an assembly for the treatment of a biological fluid by electromagnetic irradiation.

[0022] The biological fluid is in particular whole blood or a blood product obtained by filtration and / or centrifugation of whole blood such as plasma, platelet-rich plasma, red blood cell concentrate or platelet concentrate.

[0023] In particular, in order to reduce pathogens such as viruses, bacteria and / or leukocytes in the blood or a blood product, it is known to apply electromagnetic radiation to the blood or blood product, in the presence or absence of a photosensitive agent.

[0024] Electromagnetic radiation is defined as non-ionizing radiation with wavelengths ranging from 10 nm to 10 pm, i.e., visible, ultraviolet (UV), and / or infrared radiation. In particular, electromagnetic radiation is UV radiation with wavelengths ranging from 200 to 340 nm. More specifically, UV radiation is UV-C radiation with wavelengths ranging from 200 to 280 nm. Even more specifically, UV-C radiation has a wavelength of approximately 254 nm.

[0025] According to [Fig.1], the assembly 20 for magnetic irradiation treatment comprises a package 21 and a bag system 1 sterilely contained in said package 21.

[0026] The packaging 21 is suitable for allowing sterilization of the bag system 1 in which it is confined.

[0027] In one embodiment, the packaging is packaging suitable for sterilization by gases, such as ethylene oxide.

[0028] According to one embodiment, the packaging is made of one or more materials formulated without phthalates or terephthalates. For example, the packaging 21 is formed by assembling a porous non-woven sheet and a transparent film sheet. The porous sheet allows the sterilizing gas to pass into the packaging while preventing microbes from entering it. The porous sheet is, for example, made of cellulose non-woven material such as paper or of synthetic non-woven material such as high-density polyethylene fibers (Tyvek®). The transparent film sheet is, for example, made of transparent polymer such as high-density polyethylene, low-density polyethylene, polypropylene, and / or polyester. The porous non-woven sheet and the transparent film sheet are, for example, joined by welding.

[0029] According to [Fig. 1], the pocket system for the electromagnetic irradiation of a biological fluid comprises at least one element consisting of an irradiation pocket 2 intended to contain the biological fluid to be irradiated. The irradiation pocket is made of a material permeable to said electromagnetic radiation.

[0030] According to one embodiment, irradiation by electromagnetic radiation is irradiation by UV radiation, in particular UV-C radiation and the irradiation pocket is made in a material permeable to UV radiation, in particular UV-C radiation.

[0031] The biological fluid to be treated is in particular blood or a blood product such as a platelet concentrate.

[0032] For example, the irradiation pocket 2 is made of EVA. Alternatively, the irradiation pocket 2 is made of a material permeable to UV radiation such as polymethylpentene, polychlorotrifluoroethylene, perfluoroalkoxy, fluorinated ethylene propylene, ethylene tetrafluoroethylene, ethylene chlorotrifluoroethylene, or polyvinylidene fluoride. The material of the irradiation pocket is formulated without phthalates or terephthalates.

[0033] In particular, the irradiation pocket 2 is formed from a sheath or by assembling two sheets permeable to UV radiation, 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 of the sheets is less than 90%, in particular less than 85%.

[0034] By UV transmittance, we mean the ratio, expressed as a percentage, of the transmitted radiation intensity to the incident intensity. The transmittance is determined by spectrophotometry.

[0035] According to a particular embodiment, the irradiation pocket 2 is free of photosensitive agent. In other words, the irradiation pocket 2 does not contain any agent photosensitive such as riboflavin, a psoralen derivative, or a phenothiazine derivative

[0036] According to [Fig.1], the irradiation pocket 2 includes a first access port 3 in fluidic communication with the internal volume 4 of the irradiation pocket 2. The irradiation pocket 2 further includes a second access port 5 in fluidic communication with the internal volume 4 of the irradiation pocket 2.

[0037] The irradiation bag 2 is in fluidic communication with a first tube 6 via the first access port 3. The first tube 6 is provided at its end with two vents 7a, 7b, each comprising a filter membrane allowing air to pass through and forming a sterile barrier. These vents allow gas sterilization of the bag system 1.

[0038] The irradiation pocket 2 further includes openings 19a, 19b, 19c, 19d, 19e made in one or more peripheral edges of the irradiation pocket 2 allowing the suspension and / or maintenance of said irradiation pocket 2.

[0039] The bag system 1 further includes a storage bag 8 for collecting and storing the treated blood component. This storage bag 8 is in fluidic communication with the irradiation bag 2 via the second tube 9, which is connected at one end to a second access port 5 of the irradiation bag 2 and at the other end to an access port 10 of the storage bag 8. The storage bag 8 further includes two outlet ports 22, 23, each closed by a breakable cap 24, 25 having fins.

[0040] A removable plug 27 is disposed in the second access port 5 of the irradiation bag 2, closing the fluidic communication between the internal volume 4 of the irradiation bag 2 and the second tube 9 leading to the storage bag 8. The removable plug 27 can slide out of the second access port 5, into the internal volume 4 of the container 2 in order to allow fluidic communication between the irradiation bag 2 and the storage bag 8.

[0041] The bag system 1 further includes a sampling bag 11 in fluidic communication with the storage bag 8 via a third tube 12 connected at one end to a second access port 13 of the storage bag 8 and at its other end to an access port 14 of the sampling bag 11.

[0042] A fourth tube 15 is connected at one of its ends to the third tube 12 via a three-way connector 16. The other end of this fourth tube 15 is provided with two vents 17a, 17b each comprising a filter membrane allowing air to pass through and forming a sterile barrier.

[0043] Each of the tubes 6,9,12,15 is provided with a clamp 18a,18b,18c,18d which allows the selective control of opening and closing the flow of liquids in each of these tubes.

[0044] The pocket system 1 advantageously comprises at least one protective sheet 26a covering said irradiation pocket. The protective sheet is made of a polymer material formulated without phthalates or terephthalates. The protective sheet 26a is superimposed on the irradiation pocket, completely covering its surface. The protective sheet 26a is, for example, positioned between the irradiation pocket 2 and the porous sheet, in particular made of lacquered paper, of the packaging 21.

[0045] The protective sheet serves to protect the irradiation pocket 2 from substances that could impair the transmittance, in particular the UV transmittance, and even more particularly the UV-C transmittance, of said irradiation pocket. The irradiation pocket 2 is uncovered by this protective sheet at the time of its treatment with electromagnetic radiation.

[0046] This protective sheet thus forms a barrier against leachable substances from other components of the pouch system, which impair the transmittance of the irradiation pouch. A leachable substance is defined as a substance that migrates from a component of the pouch system or its packaging. Examples of leachable substances include PVC plasticizers such as phthalates or terephthalates, cyclohexanedicarboxylic acid esters, or citrate esters.

[0047] Indeed, in its packaging 21, the pocket system 1 is folded so as to place the storage pocket 8 on the irradiation pocket 2. In this configuration, without a protective sheet, the leachable plasticizers of the pocket system migrate towards the irradiation pocket 2. The presence of these leachable substances on the irradiation pocket deteriorates its optical properties, in particular its UV transmittance, and even more particularly its UV-C transmittance.

[0048] This protective sheet also protects the irradiation bag from substances that could impair the transmittance of the irradiation bag and that are present in the environment. Indeed, phthalates, and in particular DEHP, are ubiquitous in the environment and potential sources of contamination for the irradiation bag.

[0049] According to one embodiment, a protective sheet made of a gas-barrier polymer material having an oxygen permeability less than or equal to 100 cm³ / m² / 24 h at a temperature of 23°C and a relative humidity of 50% is used as a barrier medium to leachable plasticizers of polyvinyl chloride, such as DEHP or DEHT. In particular, the material of the protective sheet is also a water vapor barrier polymer material having a vapor permeability water content less than or equal to 10 g / m2 / 24 h at a temperature of 23 °C and a relative humidity of 50%.

[0050] Thus, the protective sheet 26a is made of a gas barrier polymer material having an oxygen permeability less than or equal to 100 cm³ / m² / 24 h, more particularly less than or equal to 90, at a temperature of 23 °C and a relative humidity of 50%. The oxygen permeability is measured in accordance with ASTM D 3985.

[0051] In particular, the polymer material of the protective sheet 26a is a water vapor barrier polymer material having a water vapor permeability less than or equal to 10 g / m² / 24 h, more particularly less than 5 g / m² / 24 h at a temperature of 23 °C and a relative humidity of 50%. The water vapor permeability is measured in accordance with ASTM F 1249.

[0052] In particular, the protective sheet comprises at least one layer made of polyester or polypropylene. For example, the protective sheet comprises a composite multilayer sheet comprising one layer made of polyester and one layer made of polypropylene. Alternatively, the protective sheet comprises a composite multilayer sheet comprising two layers made of polyester or two layers made of polypropylene.

[0053] Advantageously, the protective sheet is transparent, allowing the user to see the irradiation pocket 2.

[0054] The thickness of the protective sheet is between 40 and 70 pm, in particular between 45 and 65 pm.

[0055] According to one embodiment, the pocket system comprises two protective sheets 26a, 26b arranged on either side of the irradiation pocket 2. The irradiation pocket 2 is thus intercalated between the two protective sheets 26a, 26b until the moment of its treatment by electromagnetic radiation.

[0056] According to another embodiment, the two protective sheets 26a, 26b together form A sleeve with at least one open end. The open end of the sleeve allows 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 placed inside this sleeve so as to enclose it. The sleeve surrounds the irradiation bag 2 to protect it from the migration of plasticizers or other leachable substances that could impair the transmittance of the irradiation bag 2.

[0057] For example, the sleeve is made by superimposing the two protective sheets 26a,26b, and by welding together two opposite sides and one transverse side.

[0058] In this embodiment, the irradiation bag 2 is protected from the leachable substances from the bag system 1 and the packaging 21.

[0059] In order to ensure the preservation of the optical properties of the irradiation pocket 2 of the pocket system 1, in addition to the irradiation pocket 2, the other element(s) of the pocket system are made of one or more materials formulated without phthalate or terephthalate.

[0060] Phthalate or terephthalate means a derivative of phthalic or terephthalic acid, such as an ester of phthalic or terephthalic acid.

[0061] A phthalate- or terephthalate-free formulated material is a material in which no phthalate or terephthalate has been added as a plasticizer in the composition.

[0062] The material formulated without phthalate or terephthalate may contain residual traces of phthalate or terephthalate, i.e. a content of less than 1000 ppm, linked for example to contamination during the manufacturing process of the material or the bag system or during its packaging.

[0063] Indeed, it has been identified by the applicant that phthalate and terephthalate esters such as di-2-ethylhexyl phthalate (DEHP) or di-2-ethylhexyl terephthalate (DEHT) which migrate towards irradiation pocket 2 lower the UV transmittance, more particularly the UV-C transmittance, of irradiation pocket 2.

[0064] Thus, each of the other elements of the pocket system 1 is advantageously made of one or more materials other than polyvinyl chloride plasticized by di-2-ethylhexyl phthalate or di-2-ethylhexyl terephthalate.

[0065] Advantageously and for the same reasons, the packaging in which the pocket system is confined is made of one or more materials formulated without phthalate or terephthalate, in particular without di-2-ethylhexyl phthalate (DEHP) or di-2-ethylhexyl terephthalate (DEHT).

[0066] In a particular embodiment, each of the other elements of the pocket system is made either of polyvinyl chloride plasticized by a plasticizer chosen from the group consisting of a cyclohexanedicarboxylic acid ester, a citrate ester, a trimellitate ester or a mixture thereof, or of a material other than plasticized polyvinyl chloride.

[0067] More particularly, each of the other elements of the pocket system is made either of polyvinyl chloride plasticized by a plasticizer selected from the group consisting of 1,2-cyclohexanedicarboxylic acid diisononyl, trihexyl butyl citrate, tri-2-ethylhexyl trimellitate or a mixture thereof, or of a material other than plasticized polyvinyl chloride.

[0068] The other elements of the pocket system include one or more elements selected from the group consisting of a storage pocket 8, a pocket sampling 11, a tubing 6,9,12,15, a connector 16, a clamp 18a,18b, 18c, 18d or a vent 7a, 7b, 17a, 17b.

[0069] The rigid elements of the pocket system, for example the clips and vents, are made of a material other than plasticized polyvinyl chloride, such as polycarbonate, polyester, polyethylene and / or polypropylene.

[0070] For example, the clamps 18a, 18b, 18c, 18d are made of polycarbonate. The vents 7a, 7b, 17a, 17b are made of polypropylene.

[0071] The flexible elements of the pocket system, other than the irradiation pocket 2, are made of polyvinyl chloride plasticized by a plasticizer selected from the group consisting of a cyclohexanedicarboxylic acid ester, a citrate ester, a trimellitate ester or a mixture thereof.

[0072] The storage bag 8 is made of a gas-permeable material to allow the storage of a platelet concentrate for at least 3 to 7 days. For example, the storage bag 8 is made of PVC plasticized with tris(ethylhexyl) trimellitate (or tri-octyl trimellitate, TOTM) or trihexyl butyl citrate (BTHC).

[0073] For example, the sampling pouch 11 is made of PVC plasticized with diisononyl ester of 1,2-cyclohexanedicarboxylic acid (DINCH).

[0074] For example, the tubes 6, 9, 12, 15 and connector 16 are made of PVC plasticized by DINCH.

[0075] The components of the irradiation 2, storage 8 and sampling 11 pockets such as the access ports 3,5,10,13,14, the outlet ports 22,23 and the plugs 24,25,27 are also advantageously made of one or more materials formulated without phthalate or terephthalate.

[0076] In connection with the realization of assembly 20 of [Fig. 1], a method for implementing the pocket system 1 and its packaging 21 is now described.

[0077] The packaging 21 in which the pocket system 1 is confined is opened before removing the pocket system 1.

[0078] A source bag (not shown) containing a biological fluid, for example a platelet concentrate from apheresis or a mixture of platelet concentrates obtained from leukocyte-platelet layers, is sterilely connected to the bag system 1 via the first tubing 6, using a sterile TSCD-II type connection device (Terumo).

[0079] The biological fluid from the source pocket is then transferred by gravity into the internal volume 4 of the irradiation pocket 2 through the first access port 3.

[0080] After the transfer, the air contained in the internal volume 4 of the irradiation pouch 2 is expelled from the irradiation pouch 2 through the first access port 3 by exerting a Pressure is applied to the irradiation pocket. Once the air has been expelled, the first access port 3 is closed by welding.

[0081] These air purging and welding operations are advantageously carried out using the welding apparatus described in document WO2022 / 029040.

[0082] The first tube 6 is welded and cut in order to separate the source bag initially containing the biological fluid from the bag system 1.

[0083] Next, the irradiation pocket 2 is removed from the sleeve formed by the two sheets 26a,26b. Alternatively, this sleeve is removed from the irradiation pocket 2 at any other time before the irradiation operation.

[0084] The irradiation bag 2 is irradiated under agitation with UV light in order to inactivate any pathogens present in the biological fluid.

[0085] The removable cap 27 closing the second access port 5 is pushed inside the irradiation bag 2, then the irradiated biological fluid is transferred into the storage bag 8 to be stored for up to 5 to 7 days.

[0086] After the transfer, the second tube 9 is welded and cut using a hand welder in order to separate the container 2 from the rest of the bag system 1.

[0087] In one embodiment, a sample of the biological fluid is sent into the sampling bag 11 for analysis. It is separated from the storage bag 8 by welding and cutting the third tube 12, using a hand welder.

[0088] Examples

[0089] Example 1: Impact of the packaging and various PVC-coated elements of the pocket system on the UV transmittance of an EVA sleeve

[0090] Six test configurations were carried out and analyzed: - EVA sheath (control); - EVA sheath packaged in a bag made of two transparent composite films of polyester (PET) and polyethylene (PE); - EVA sheath packaged in a bag made of two sheets of lacquered paper; - BTHC-plasticized PVC storage pouch placed on the EVA sheath, and DEHP-plasticized PVC sampling pouch placed across the storage pouch and the EVA sheath, all packed in a bag made of a transparent composite film of PET and PE and a lacquered paper sheet; - EVA sheath protected by a composite polymer sleeve of PET and polypropylene (PP), a storage pouch of TOTM-plasticized PVC placed on the protected EVA sheath, and a sampling pouch of DEHP-plasticized PVC placed over the storage pouch and the protected EVA sheath, all packed in a bag made of a transparent composite film of PET and PE and a lacquered paper sheet. - BTHC-plasticized PVC storage pouch placed on the EVA sleeve, and DEHP-plasticized PVC sampling pouch placed across the storage pouch and the EVA sleeve, all packed in a bag made of a transparent composite film of bi-oriented PET and polypropylene (PP) and a paper sheet.

[0091] The EVA sheath has substantially the dimensions of an irradiation pocket.

[0092] The sleeve made of PET and PP composite polymer has a thickness of approximately 55 pm, an oxygen permeability of less than 91.0 cm3 / m2 / 24h h at a temperature of 23 °C and a relative humidity of 50% and a water vapor permeability of less than 5.0 cm3 / m2 / 24h h at a temperature of 23 °C and a relative humidity of 50%.

[0093] Transmittance measurements are carried out using a spectrophotometer (Perkin Elmer Lamdbda650).

[0094] [Tables 1] UV-C Transmittance (%) Average (%) T0 Average (%) T 1 month Average (%) T 3 months EVA sleeve 64.61 65.09 63.76 EVA sleeve PET / PE bag 64.61 54.90 52.70 EVA sleeve lacquered paper bag 64.61 59.98 56.95 EVA sleeve PVC / DEHP pouch PVC / BTHC pouch PET / PP and lacquered paper bag 64.61 61.08 57.17 EVA sleeve PET / PP sleeve PVC / DEHP pouch PVC / BTHC pouch PET / PP and lacquered paper bag 64.61 65.17 64.02 EVA sleeve PVC / DEHP pouch PVC / BTHC pouch biaxially oriented PET / PP and paper bag 64.61 63.75 63.22

[0095] These results demonstrate the negative impact of a particular packaging bag, both through the transparent film and the lacquered paper sheet, on the UV transmittance of the irradiation pouch. This impact is amplified by the presence of the other elements of the plasticized PVC pouch system.

[0096] The presence of the protective sleeve ensures that the EVA irradiation pouch is not contaminated by PVC plasticizers or other releaseable substances from the packaging, and thus maintains UV transmittance.

[0097] Example 2: Impact of PVC plasticizer migration on the UV transmittance of an EVA sheet.

[0098] Six test configurations were carried out by superimposing rectangular samples of approximately 60 cm2 of sheets of different materials: - two EVA sheet samples; - two samples of EVA sheet and two samples of PVC plasticized with DEHP; - two samples of EVA sheet and two samples of PVC plasticized by BTHC - two samples of EVA sheet and one sample of PVC plasticized by DEHT; - two samples of EVA sheet and one sample of PVC plasticized by TOTM; - two samples of EVA sheet and one sample of PVC plasticized by DINCH.

[0099] The EVA sheet in direct contact with the plasticized PVC sample is identified as "face A", the EVA sheet placed under face A is identified as "face B".

[0100] The UV transmittance of EVA sheets was determined at different times between 0 and 3 years. The results are shown in Figures 2 and 3.

[0101] 2.1 Impact of DEHP

[0102] A sharp drop in the UV transmittance of the EVA sheet is observed in direct contact with a sample of DEHP-coated PVC (side A). By the 14th day of contact, the transmittance of the EVA sheet is less than 60%. After two years, the UV transmittance of the EVA sheet is less than 10%.

[0103] On side B, the loss of transmittance becomes less than 60% after 100 days.

[0104] The EVA sheet slows down but does not prevent the migration of DEHP.

[0105] 2.2 Impact of BTHC and DINCH

[0106] Under the conditions of the study, contact of the EVA sheet (face A and B) with a sample of PVC plasticized by BTHC or DINCH has no influence on the transmittance of the EVA sheet throughout the 3 years.

[0107] 2.3 Impact of DEHT

[0108] Direct contact of the DEHT-plasticized PVC sample with the EVA sheet (side A) causes an even greater loss of UV transmittance of the EVA sheet than with DEHP-plasticized PVC.

[0109] The impact of PVC plasticized by DEHT is less marked on side B, due to the presence of side A which slows down the migration of DEHT.

[0110] 2.4 Impact of TOTM

[0111] A decrease in the UV transmittance of the EVA sheet (side A) is observed in direct contact with a TOTM-plasticized PVC sample, which is known to migrate very little in a PVC matrix. However, this result should be interpreted with caution as it represents the average of three tests: two tests showing a UV transmittance of 55-57% for side A at the end of the study, and one test showing a transmittance of less than 2%. The results for side B are also inconsistent.

[0112] These studies show that DEHT should be avoided in the same way as DEHP in bag systems intended to treat a biological fluid by UV irradiation.

[0113] Example 4: Ability of different materials to protect the UV transmittance of the EVA irradiation pouch

[0114] A single packaging bag made of a transparent composite film of PET and PE and a lacquered paper sheet is welded to form two separate compartments. Each compartment contains a sample of EVA tubing (15 cm x 15 cm) protected by an open sleeve. In addition, in the upper compartment, two samples of DEHP-coated PVC (15 cm x 15 cm) are inserted between the bag and the EVA tubing protected by the sleeve.

[0115] Different materials are tested to make the protective sleeve: PET copolymer sheet, PET and PP copolymer sheet or spun-bonded nonwoven PET sheet. UV-C Transmittance (%) PVC-DEH P Average (%) T0 Average (%) T 1 month Average (%) 12 months PET Copolymer Yes 64.61+0.66 64.68 +0.38 62.60+1.16 PET Copolymer No 64.61+0.66 64.83 +0.63 63.44 +0.54 PET and PP Copolymer Yes 64.61+0.66 64.07 +0.58 63.76 +0.67 PET and PP Copolymer No 64.61+0.66 65.21 +0.41 64.05 +0.62 Non-woven PET Yes 64.61+0.66 62.86 +0.49 49.42+1.53 Non-woven PET No 64.61 + 0.66 59.72 + 0.66 55.64 + 0.59

[0116] These tests show that the PET copolymer film makes it possible to protect, at least in the short term, the irradiation pouch from the diffusion of plasticizers (DEHP) and other contaminating substances from the packaging bag.

[0117] The protective sleeve made of PET and PP copolymer provides stability of UV transmittance over time.

[0118] On the other hand, due to its high porosity, the sleeve made of spun-bonded PET non-woven fabric does not allow the UV transmittance of the EVA sheath to be maintained.

Claims

Demands

1. A pouch system (1) for the treatment of a biological fluid by electromagnetic irradiation, said pouch system comprising at least one element consisting of an irradiation pouch (2) intended to contain the biological fluid to be irradiated, said irradiation pouch (2) being made of a material permeable to said electromagnetic radiation, said system comprising one or more other elements selected from the group consisting of a storage pouch (8), a sampling pouch (11), a tube (6, 9, 12, 15), a connector (16), a clamp (18a, 18b, 18, 18d) or a vent (7a, 7b, 17a, 17b), characterized in that each of said other elements is made of one or more materials formulated without phthalate or terephthalate.

2. Pocket system according to claim 1, characterized in that each of said other elements of the pocket system is made of plasticized polyvinyl chloride without di-2-ethylhexyl phthalate or di-2-ethylhexyl terephthalate.

3. Pocket system according to claim 2, characterized in that each of said other elements of the pocket system is made of polyvinyl chloride plasticized by a plasticizer selected from the group consisting of a cyclohexanedicarboxylic acid ester, a citrate ester, a trimellitate ester or a mixture thereof.

4. A pocket system according to claim 3, characterized in that the polyvinyl chloride is plasticized by a plasticizer selected from the group consisting of 1,2-cyclohexanedicarboxylic acid diisononyl, trihexyl butyl citrate, tri-2-ethylhexyl trimellitate or a mixture thereof.

5. A pocket system according to any one of claims 1 to 4, characterized in that it further comprises at least one protective sheet (26a,26b) covering said irradiation pocket (2), said protective sheet being made of a polymer material formulated without phthalate or terephthalate, said material further being a gas barrier material having an oxygen permeability less than or equal to 100 cm3 / m2 / 24 h at a temperature of 23 °C and a relative humidity of 50 %.

6. A pocket system according to claim 5, characterized in that the polymer material of the protective sheet (26a, 26b) is a material water vapor barrier polymer having a water vapor permeability less than or equal to 10 g / m2 / 24 h at a temperature of 23 °C and a relative humidity of 50%.

7. Pocket system according to any one of claims 5 or 6, characterized in that the protective sheet (26a,26b) is transparent.

8. Pocket system according to any one of claims 5 to 7, characterized in that the protective sheet (26a,26b) comprises at least one layer of polyester or polypropylene.

9. Pocket system according to any one of claims 5 to 8, characterized in that it comprises two protective sheets (26a, 26b) arranged on either side of the irradiation pocket (2).

10. Pocket system according to claim 9, characterized in that the two protective sheets (26a, 26b) together form a sleeve having at least one open end in which the irradiation pocket (2) is disposed.

11. Pocket system according to any one of claims 1 to 10, characterized in that the electromagnetic irradiation treatment is a UV radiation treatment and the irradiation pocket is made of a material permeable to UV radiation.

12. Pocket system according to any one of claims 1 to 11, characterized in that the irradiation pocket (2) is free of photosensitive agent.

13. Assembly (20) for the electromagnetic irradiation treatment of a biological fluid comprising a package (21) made of one or more materials formulated without phthalate or terephthalate and a bag system (1) according to any one of claims 1 to 12, characterized in that said bag system is sterilely confined in said package.

14. Assembly according to claim 13, characterized in that the packaging (21) is formed of a porous non-woven sheet and a transparent film sheet.

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