WO2024017917A1

WO2024017917A1 - Apparatus and method for irradiating a biological fluid

Info

Publication number: WO2024017917A1
Application number: PCT/EP2023/069968
Authority: WO
Inventors: Pierre-Eloi Bontinck; Sébastien VANHELST; Cécile BIRCK
Original assignee: Maco Pharma
Priority date: 2022-07-21
Filing date: 2023-07-18
Publication date: 2024-01-25
Also published as: FR3138040A1

Abstract

The invention relates to an apparatus (21) for the treatment, by electromagnetic irradiation at a predetermined dose, of a biological fluid contained in an irradiation receptacle, the irradiation receptacle having at least one wall which is permeable to the electromagnetic radiation. The apparatus comprises: a recess (22) which is configured to receive the irradiation receptacle (22) containing the biological fluid; one or more light sources which emit the electromagnetic radiation; an information collection device (34) which is configured to collect information regarding a parameter of the irradiation receptacle; and a control unit which is configured to: (i) obtain information regarding a parameter of the irradiation receptacle; (ii) determine a target irradiation dose on the basis of the information regarding the parameter and the predetermined dose; and (iii) irradiate the irradiation receptacle with the target irradiation dose, the information regarding the parameter of the irradiation receptacle comprising the transmittance value of the wall of the irradiation receptacle.

Description

Title of the invention: Apparatus and method for irradiating a biological fluid

[0001] [The present invention relates to an apparatus and a method for the treatment by electromagnetic irradiation of a biological fluid, as well as an irradiation container and a system comprising said apparatus and said irradiation container.

[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 treatment.

[0003] In the context of transfusion, blood is first collected from a donor 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 can undergo different treatments such as the elimination 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 process, a bag containing a platelet concentrate is irradiated with UV radiation, at a predetermined dose and with stirring. This process has the advantage over other commercial pathogen inactivation processes such as the Intercept (Cerus) and Mirasol (TerumoBCT) processes 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 of light to reduce the rate of pathogens to a minimum. acceptable level, without deteriorating the biological properties of the blood product. [0006] Document WO 2009/000445A1 describes an irradiation device for treating a biological fluid with UV-C radiation according to the method described in document WO 2007/076834. The irradiation device comprises a housing, a stirring plate for supporting the irradiation bag and a light source arranged on either side of said plate for irradiating the bag. In order to control the irradiation dose applied to the biological fluid, optical sensors are provided near the light source.

[0007] Document WO 2019/133929A1 describes an irradiation device for specifically implementing the Intercept method for reducing pathogens from a biological fluid using UVA light and amotosalen. According to one embodiment, the device comprises a control circuit configured to establish a treatment profile including the duration and intensity of the irradiation as a function of the characteristics of the biological fluid to be treated. These characteristics include the volume, type or temperature of the biological fluid to be irradiated. They are provided by the operator or determined by sensors arranged in the irradiation device or obtained by a bar code reader.

[0008] In these two prior art documents, the optical properties of the container containing the biological fluid to be irradiated are not taken into account to determine the irradiation dose to be provided by the irradiation device.

[0009] Document WO 2008/034476 describes a bag system adapted to implement the method of reducing pathogens by UV radiation described in document WO 2007/076834. The bag system essentially comprises an irradiation bag made of ethylene-vinyl acetate copolymer (EVA) connected to a platelet concentrate storage bag made of plasticized polyvinyl chloride (PVC).

[0010] In this document, it is indicated that the absorption of UV light by EVA is influenced by the degree of polymerization and crosslinking of the EVA.

Other intrinsic factors influence the UV transmittance of an EVA sheet, such as the relative proportion of ethylene and vinyl acetate units, the thickness of the film or its surface condition. Among the extrinsic factors having an impact on UV transmittance, we note heat, humidity, the presence of oxygen and exposure to UV rays.

[0012] Thus, after numerous tests, the applicant has noted that the UV transmittance of an EVA film used to manufacture irradiation pockets can vary by up to nearly 10% between different production batches of the film. The final irradiation pockets therefore do not all have the same UV transmittance.

[0013] Therefore, there is a risk that the biological fluid to be treated does not receive the sufficient dose of light to inactivate the pathogens or receives too high a dose which can harm the quality of the irradiated biological fluid.

[0014] The invention makes it possible to remedy these drawbacks.

[0015] According to a first aspect, the invention proposes a method for the treatment by electromagnetic irradiation at a predetermined dose of a biological fluid contained in an irradiation container, said irradiation container having at least one wall permeable to said radiation electromagnetic, the process comprising the following steps:

(i) obtain information on a parameter of said irradiation container,

(ii) determining a target irradiation dose from said parameter information and said predetermined dose, and

(iii) irradiating the irradiation container with said target irradiation dose, said information on the parameter of the irradiation container comprising the value of the transmittance of the wall of the irradiation container.

[0016] According to a second aspect, the invention relates to an apparatus for the treatment by electromagnetic irradiation at a predetermined dose of a biological fluid contained in an irradiation container, said irradiation container having at least one wall permeable to said radiation electromagnetic, said apparatus comprising a housing configured to receive said irradiation container containing the biological fluid, one or more light sources emitting said electromagnetic radiation, an information collection device configured to collect information on a parameter of said irradiation container , and a control unit configured to (i) obtain information on a parameter of said irradiation container, (ii) determine a target irradiation dose from said parameter information and said predetermined dose, and (iii) irradiating the irradiation container with said target irradiation dose, the parameter information of the irradiation container comprising the value of the transmittance of the wall of the irradiation container.

[0017] A third aspect of the invention relates to an irradiation container having at least one wall permeable to electromagnetic radiation and comprising information on a parameter of said irradiation container, said information comprising the value of the transmittance of the wall of the irradiation container.

[0018] According to a fourth aspect, the invention comprises a system comprising an apparatus according to the first aspect of the invention and an irradiation container according to the third aspect of the invention.

[0019] The accompanying drawings illustrate the invention:

[0020] [Fig.1] schematically represents a bag system comprising an irradiation container according to one embodiment of the invention.

[0021] [Fig.2] schematically represents an irradiation device according to one embodiment of the invention.

[0022] [Fig.3] represents a partial view of the irradiation device of [Fig. 2],

[0023] According to one aspect, the invention relates to a method for the treatment by electromagnetic irradiation at a predetermined dose of a biological fluid contained in an irradiation container, said irradiation container having at least one wall permeable to said radiation electromagnetic. The process includes the following steps:

(i) obtaining information on a parameter of said irradiation container, said information comprising the value of the transmittance of the wall of the irradiation container,

(ii) determine a target irradiation dose from said information of said parameter and said predetermined dose, and

(iii) irradiating the irradiation container with said target irradiation dose.

[0024] The invention guarantees that the biological fluid contained in the irradiation container receives the appropriate dose of electromagnetic irradiation for a effective treatment taking into account the optical properties of the irradiation container.

[0025] According to one embodiment, the biological fluid is whole blood or a blood product obtained by filtration and/or centrifugation of whole blood such as plasma, plasma rich in platelets, a concentrate of red blood cells or a concentrate of platelets . For example, the biological fluid is a concentrate of platelets obtained by apheresis or derived from a mixture of buffy coats.

[0026] In order to reduce pathogens such as viruses, bacteria, parasites and/or leukocytes in the blood or a blood product, it is known to apply to the blood or the blood product, in the presence or absence of a photosensitive agent, electromagnetic radiation.

By electromagnetic radiation is meant non-ionizing radiation having wavelengths ranging from 10 nm to 10 pm, that is to say visible, ultraviolet (UV) and/or infrared radiation.

[0028] According to one embodiment, the electromagnetic radiation is UV radiation having wavelengths ranging from 200 to 340 nm. More particularly, UV radiation is UV-C radiation having wavelengths ranging from 200 to 280 nm. Even more specifically, UV-C radiation has a wavelength of around 254 nm.

According to one embodiment, the dose of electromagnetic radiation is a dose ranging from 0.01 J/cm ² to 10 J/cm ² .

[0030] For example, for UV-C radiation, the UV-C radiation dose is a dose ranging from 0.01 J/cm ² to 2 J/cm ² , particularly ranging from 0.05 J/cm ² to 0.5 J/cm ² , and even more particularly is of the order of 0.2 J/cm ² .

In particular, the biological fluid intended to be irradiated does not include a photosensitive agent.

To enable its treatment, the biological fluid is contained in an irradiation container having at least one wall permeable to said electromagnetic radiation. According to one embodiment, the irradiation container is an irradiation pocket comprising at least one wall of a flexible film made of a material permeable to electromagnetic radiation. [0032] [Fig.1] represents an example of a bag system 1 comprising such an irradiation container 2, in the form of an irradiation bag, for the treatment by electromagnetic irradiation of a biological fluid.

The bag system 1 for irradiation by electromagnetic radiation of a biological fluid comprises at least one irradiation bag 2 intended to contain the biological fluid to be irradiated. The irradiation pocket has at least one wall permeable to electromagnetic radiation. In particular, the irradiation pocket is made of a material permeable to said electromagnetic radiation.

[0034] According to a very particular embodiment, the bag system 1 allows the irradiation by UV-C radiation of a platelet concentrate contained in the irradiation bag 2.

[0035] For example, the irradiation bag 2 is made of EVA. Alternatively, the irradiation bag 2 is made of a material permeable to UV radiation such as polymethylpentene, polychlorotrifluoroethylene, perfluoroalkoxy, fluorinated ethylenepropylene, ethylene tetrafluoroethylene, ethylene chlorotrifluoroethylene or polyvinylidene fluoride. The material of the irradiation bag is formulated without phthalate.

[0036] In particular, the irradiation pocket 2 is formed from a sheath or by assembling two sheets permeable to UV radiation. The sheath or each of the sheets forming the wall(s) of the irradiation container has a UV-C transmittance greater than 60%, in particular greater than 65%. Even more particularly, the UV-C transmittance of the sheath or of each of the sheets is less than 90%, in particular less than 85%.

By transmittance is meant the percentage ratio between the intensity of the transmitted electromagnetic radiation and the incident intensity. The UV transmittance of a container wall is the percentage ratio between the intensity of UV radiation transmitted through the container wall, to the incident intensity. [0038] The transmittance is determined by spectrophotometry. Advantageously, an integrating sphere spectrophotometer is used to take into account the diffusion of the material.

[0039] According to a particular embodiment, the irradiation pocket 2 is free of photosensitive agent. In other words, irradiation bag 2 does not contain a photosensitive agent such as riboflavin, a psoralen derivative or a phenothiazine derivative.

[0040] According to [Fig.1], the irradiation pocket 2 is in fluid communication with a first tube 3. The first tube 3 is provided at its end with two vents 4a, 4b each comprising a filter membrane allowing passage air and forming a sterile barrier. These vents allow gas sterilization of the bag system 1.

The irradiation pocket 2 further comprises openings 5a, 5b, 6a; 6b, 6c made in one or more peripheral edges of the irradiation pocket 2 making it possible to suspend and/or maintain said irradiation pocket 2 .

The bag system 1 further comprises a storage bag 8 intended to collect and store the treated blood component. This storage bag 8 is in fluid communication with the irradiation bag 2 via a second tube 9.

[0043] A removable plug 10 is placed in an access orifice of the irradiation pocket 2, so as to close the fluid communication between the interior volume of the irradiation pocket 2 and the second tubing 9 leading to the pocket storage 8. The removable cap 10 can slide into the interior volume of the irradiation pocket 2 in order to allow fluid communication between the irradiation pocket 2 and the storage pocket 8.

The bag system 1 also includes a sampling bag 11 in fluid communication with the storage bag 8 via a third tube 12.

A fourth tube 13 is connected at one of its ends to the third tube 12 via a three-way connector 14. The other end of this fourth tube 13 is provided with two vents 15a, 15b 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.

[0046] Each of the tubes 3,9,12,13 is provided with a clamp 16,17,18,19 allowing selective control of opening and closing of the flow of liquids in each of these tubes.

The pocket system 1 advantageously comprises at least one protective sleeve 20 covering said irradiation pocket 2. The protective sleeve is made of a polymer material formulated without phthalate. The irradiation pocket 2 is placed in the protective sleeve so as to envelop it.

[0048] The protective sleeve 20 has the function of protecting the irradiation pocket 2 from external substances which may harm the transmittance, in particular the UV transmittance, and even more particularly the UV-C transmittance, of said irradiation pocket. The irradiation pocket 2 is removed from this protective sleeve at the time of its treatment by electromagnetic radiation, before its installation in the irradiation device.

[0049] According to the invention, the irradiation container 2 comprises information on a parameter of said irradiation container, said information comprising the value of the transmittance of at least one wall of the irradiation container.

[0050] In particular, the information includes the value of the UV or UV-C transmittance of a wall of the irradiation container.

[0051] This value of the transmittance of the irradiation container is variable information specific to each irradiation container, that is to say it takes or can take a distinct value depending on the irradiation container used for treat biological fluid.

[0052] Indeed, the UV or UV-C transmittance varies depending on the manufacturing batch of the sheath or sheets used for the manufacture of the irradiation container.

[0053] In a particular example, the transmittance value of a wall of the irradiation container is the UV or UV-C transmittance value of the sheath or sheets forming the irradiation container. [0054] This transmittance value is the transmittance value of the sheath or sheets forming the irradiation container, determined before the manufacture of the bag, that is to say on the raw material used for the manufacture of the container .

[0055] Alternatively, the transmittance value is the transmittance value of the sheath or sheets forming the irradiation container, determined on the finished product, after the manufacture of the irradiation container.

[0056] According to one embodiment, the information on the parameter of the irradiation container is included in a means of storing and consulting information such as an inscription understandable by humans, a bar code, a QR code or an RFID chip.

[0057] In an advantageous embodiment for securing the information, it is transcribed into a code or a system of symbols comprising a set of numbers and/or letters.

The information storage and consultation means is associated with the irradiation container or with another element of the bag system comprising the irradiation container. For example, the inscription or the bar code or the QR code comprising the information is directly printed on a wall of the irradiation container. According to another example, the RFID chip is integrated into the irradiation container 2.

[0059] Alternatively, the information storage and consultation means is included in a tag or label associated with the irradiation container or with another element of the bag system comprising the irradiation container.

[0060] For example, the inscription or the bar code or the QR code is printed on a label stuck to the irradiation container.

[0061] According to [Fig. 1], the irradiation pocket 2 comprises a bar code 7 printed and placed on a peripheral edge of the irradiation pocket, in particular between two openings 6b, 6c intended to suspend the irradiation pocket. The bar code includes the UV or UV-C transmittance value of the irradiation pocket. [0062] We now describe in connection with the drawings and according to one aspect of the invention, an apparatus for the treatment by electromagnetic irradiation at a predetermined dose of a biological fluid contained in an irradiation container.

[0063] This device is particularly suitable for implementing the method for treatment by electromagnetic irradiation at a predetermined dose of a biological fluid contained in an irradiation container disclosed above.

[0064] With reference to [Fig. 2] and [Fig. 3], the device 21 comprises a housing 22 configured to receive an irradiation container 2 containing the biological fluid to be irradiated, one or more light sources 23,24 emitting electromagnetic radiation and a control unit (not shown).

According to one embodiment, the housing 22 comprises a plate 25 on which the irradiation container 2 is intended to be placed. Advantageously, the central part 26 of the plate is permeable to electromagnetic radiation in order to allow the irradiation of the irradiation container from above and below.

[0066] In particular, the central part 26 of the plate 25 is permeable to UV radiation and even more particularly to UV-C radiation. For example, the central part of the tray is made of quartz.

[0067] Advantageously, the plate 25 is an agitator plate. The stirring plate, for example, performs an orbital rotation movement in order to homogeneously irradiate the contents of the irradiation container.

The rotational movement of the plate 25 is ensured by a motor (not shown).

[0069] The device further comprises at least one light source 23,24 emitting electromagnetic radiation, in particular UV radiation, and even more particularly UV-C radiation.

[0070] According to one embodiment, the device comprises two light sources 23,24 on either side of the housing 22, in particular on either side of the plate 25. Each of the light sources comprises a plurality of lamps 27 emitting electromagnetic radiation, in particular UV radiation, and even more particularly UV-C radiation. [0071] For example, the device comprises two light sources 23,24 with three lamps 27 each, arranged on either side of the plate 24 in order to irradiate the irradiation container from above and below.

[0072] Alternatively, the light source(s) are composed of one or more panels of light-emitting diodes.

[0073] In one embodiment, reflectors 28,29 are provided to reflect the light emitted by the light source(s) 23,24 towards the irradiation container 2.

[0074] In order to control the irradiation dose delivered to the irradiation container, the device comprises one or more optical sensors 30,31,32,33 arranged at the level of the light source(s) 23,24. These optical sensors detect the intensity of the irradiation emitted by the light source(s).

[0075] The device further comprises a control unit. According to one embodiment, the control unit is in the form of an electronic and computer system which includes for example a microprocessor designed to execute a command program. Execution of this program allows the control unit to control the light source(s), depending on the signals received by the optical sensor(s). The control unit determines in particular the dose delivered by integrating up to the target irradiation dose, at regular time intervals, the light intensity detected by the optical sensors during said time interval.

[0076] The device further comprises a device 34 for collecting information. This information collection device 34 is configured to collect information on a parameter of the irradiation container.

[0077] According to one embodiment, the information collection device 34 is a man-machine interface allowing the operator to manually enter an inscription including information on the transmittance of the irradiation container.

[0078] Alternatively, the information collection device 34 is an information reader, such as a camera, a bar code reader or an RFID reader. [0079] For example, this information reader is arranged in the housing 22 of the irradiation device 21 in a fixed manner to be able to read the information from the irradiation container 2 when the latter is placed in said housing 22 .

[0080] According to one embodiment, the information reader is arranged opposite the information storage and consultation means of the irradiation container.

[0081] For example, the information reader is a mobile manual information reader, for example a mobile manual barcode reader. In this case, the operator comes to read the information from the irradiation container before the irradiation treatment.

[0082] Alternatively, the information reader is a fixed bar code reader arranged opposite the bar code integrating the information relating to a parameter of the irradiation container.

[0083] According to another particular mode, the information collection device is a device making it possible to carry out a spectrophotometric measurement on a wall of the irradiation container to determine its transmittance.

[0084] According to the invention and in order to guarantee that the biological fluid is subjected to the predetermined irradiation dose, the control unit of the device is configured to (i) obtain information on a parameter of the container d irradiation, (ii) determining a target irradiation dose from said information of said parameter and the predetermined irradiation dose, and (iii) irradiating the irradiation container with said target irradiation dose.

[0085] According to the invention, the information on a parameter of the irradiation container comprises information comprising the transmittance value of a wall of the irradiation container. In particular, the information includes the value of the UV or UV-C transmittance of a wall of the container. Even more particularly, this information is the value of the UV or UV-C transmittance of a wall of the container, as described above.

[0086] The control unit of the device is configured to obtain this information on a parameter of said irradiation container. This information is notably collected by the information collection device 34 and transmitted to the control unit for processing.

[0087] Then, the control unit determines a target irradiation dose by taking into account the value of the transmittance of the wall of the information container and the predetermined irradiation dose. The target irradiation dose is a dose calculated and corrected according in particular to the UV and/or UV-C transmittance of a wall of the irradiation container.

[0088] For example, if the transmittance of the wall of the irradiation container is lower than that with which the predetermined dose was determined, the target irradiation dose delivered by the device will be higher.

[0089] In a particular embodiment, other information relating to the irradiation container and/or the biological fluid to be irradiated is taken into account to determine the target irradiation dose.

[0090] The applicant noted in particular during numerous tests that certain manufacturing steps such as packaging of the finished product and sterilization could negatively impact the UV and/or UV-C transmittance of the irradiation container.

[0091] For example, when the information relating to a parameter of the irradiation container is the transmittance value of the sheath or sheets forming the irradiation container before manufacturing and/or packaging and/or sterilization of the container, a correction coefficient is applied to this initial transmittance value in order to take into account the impact of the container manufacturing steps.

[0092] This correction coefficient is predetermined. Alternatively, this correction coefficient is variable information relating to the transmittance of the wall of the irradiation container which is integrated into the information storage and consultation means described above.

[0093] Information relating to the biological fluid which can influence irradiation is for example the volume, the platelet concentration or the quantity of plasma. [0094] Once the target irradiation dose has been calculated, the control unit is programmed to irradiate the irradiation container with said target irradiation dose using the light source(s) of the device.

[0095] Thus, it is more certain that the biological fluid receives the necessary and sufficient irradiation dose to inactivate the pathogens, without harming the biological properties of the biological fluid.

[0096] In practice, the method of implementing the device comprises the following steps: a) placing the irradiation container 2 containing the biological fluid to be treated in the housing 22 of the device 21, b) obtaining using the device 34 for collecting information, said information comprising information comprising the value of the transmittance of a wall of the irradiation container, c) determining a target irradiation dose from said information of said parameter and of said predetermined dose, and d) irradiating the irradiation container so as to irradiate the biological fluid with said target irradiation dose, with the light source(s) 23,24 of the device 21.

[0097] Another aspect of the invention is a system comprising on the one hand an apparatus for the treatment by electromagnetic irradiation at a predetermined dose of a biological fluid contained in an irradiation container and on the other hand a container of irradiation as described above.

[0098] In one embodiment, the information collection device 34 of the device is an information reader, such as a camera, a bar code reader or an RFID reader. This information reader is arranged in the housing 22 of the irradiation device 21 in a fixed manner to be able to read the information from the irradiation container 2 when the latter is placed in said housing 22.

[0099] In this same mode, the information on the transmittance of a wall of the irradiation container is included in a means of storing and consulting information such as an inscription, a bar code, a QR code or an RFID chip. [0100] For example, the information reader is arranged opposite the information storage and consultation means.

[0101] For example, the information reader is a fixed bar code reader placed opposite a bar code integrating information on a parameter of the irradiation container.

Claims

[Claim 1] [Process for the treatment by electromagnetic irradiation at a predetermined dose of a biological fluid contained in an irradiation container (2), said irradiation container having at least one wall permeable to said electromagnetic radiation, the method comprising the following steps:

(i) obtain information on a parameter of said irradiation container

(iii) irradiating the irradiation container with said target irradiation dose, said method being characterized in that said irradiation container parameter information includes the transmittance value of the wall of the irradiation container.

[Claim 2] Method according to claim 1 characterized in that the information relating to a parameter of said container is included in a means of storing and consulting information.

[Claim 3] Method according to claim 2 characterized in that the means for storing and consulting information is a bar code (7).

[Claim 4] Method according to any one of claims 1 to 3 characterized in that the electromagnetic radiation is UV or UV-C radiation.

[Claim 5] Method according to any one of claims 1 to 4 characterized in that the irradiation container (2) is an irradiation pocket comprising at least one wall of a flexible film made of a material permeable to radiation electromagnetic.

[Claim 6] Method according to any one of claims 1 to 5 characterized in that the biological fluid is blood or a blood component.

[Claim 7] Apparatus (21) for implementing the method according to any one of claims 1 to 6, said apparatus comprising a housing (22) configured to receive said irradiation container (2) containing the biological fluid, a or several light sources (23,24) emitting said electromagnetic radiation, an information collection device (34) configured to collect information on a parameter of said irradiation container, and a control unit configured to (i) obtain information on a parameter of said irradiation container , (ii) determine a target irradiation dose from said information of said parameter and said predetermined dose, and (iii) irradiate the irradiation container with said target irradiation dose, characterized in that the information on the parameter of the irradiation vessel includes the transmittance value of the wall of the irradiation vessel.

[Claim 8] Apparatus according to claim 7 characterized in that the device (34) for collecting information is an information reader.

[Claim 9] Apparatus according to one of claims 7 or 8, characterized in that the device (34) for collecting information is a bar code reader.

[Claim 10] Apparatus according to any one of claims 7 to 9 characterized in that the housing (22) for receiving the irradiation container (2) comprises a plate (25) on which the irradiation container (2) is intended to be placed.

[Claim 11] Apparatus according to any one of claims 7 to 10, characterized in that it comprises two light sources (23,24) on either side of said housing (22).

[Claim 12] Irradiation container (2) intended to be used in the method according to any one of claims 1 to 6, said irradiation container having at least one wall permeable to electromagnetic radiation and comprising information on a parameter of said irradiation container, characterized in that said information includes the value of the transmittance of the wall of the irradiation container.

[Claim 13] System comprising an apparatus (21) according to any one of claims 7 to 11 and an irradiation container (2) according to claim 12.