Abstract
The invention relates to the processing of fluid biological media, especially of culture media or cell- or virus suspensions, potentially containing active pathogens, with the aim of inactivating these pathogens and/or modifying ingredients in these biological media by thermal or radiological treatment.
Claims
1. A cassette for generating a continuous fluid film from supplied biological fluid, suitable for irradiating the generated fluid film and continuously inactivating pathogens in the biological fluid in an arrangement for continuous, dose-controlled irradiation, the cassette comprising: a module housing including: a tub for holding the fluid, an inlet channel for supplying the fluid to the tub, an overflow channel for discharging excess fluid from the tub to fix a fluid level in the tub, a cylindrical roller which dips into the tub and fluid and is rotatable within the tub, a wiper lip on a downward-rotating side of the roller, is the wiper lip in intimate contact with a roller surface of the roller to wipe off the fluid film formed upon rotation of the roller on the rotating roller surface, and an outlet channel for receiving and discharging fluid wiped off by the wiper lip, and a housing cover for tightly closing the module housing, wherein the housing cover has a gas-tight and fluid-tight metal window which is permeable for beta radiation, and wherein the cassette is sterilizable and interchangeable for repeated use in the arrangement for continuous, dose-controlled irradiation.
2. The cassette according to claim 1, wherein the module housing further comprises: a gap-forming element on an upward-rotating side of the roller, for forming and homogenizing the fluid film on the roller surface, wherein the gap-forming element on the upward-rotating side of the roller is spaced from the roller surface in such a manner that it forms a capillary gap, wherein the capillary gap extends to above the fluid level.
3. The cassette according to claim 2, wherein the gap-forming element is positionable at a variable distance from the roller surface, or is exchangble, to regulate a thickness of the fluid film formed thereon.
4. The cassette according to claim 1, which does not contain a gap-forming element.
5. The cassette according to claim 1, wherein the wiper lip on the downward-rotating side of the roller is oriented counter to a downward-rotating direction of the rotating roller.
6. The cassette according claim 1, wherein the wiper lip on the downward-rotating side of the roller is oriented in a downward-rotating direction of the rotating roller.
7. The cassette according to claim 6, wherein the outlet channel is designed as at least one tube projecting into a groove formed between the wiper lip and the downward-rotating side of the roller.
8. The cassette according to claim 1, wherein the module housing has a coupling to drive the rotation of the roller externally via a drive unit which can be coupled and is arranged outside the module housing.
9. The cassette according to claim 8, wherein the roller has magnetic elements for driving the rotation of the roller externally via a mechanical or electromagnetic drive unit which is arranged outside the module housing and which can be magnetically coupled to the roller via the coupling.
10. The cassette according to claim 1, in combination with an arrangement for the continuous, dose-controlled irradiation of biological fluid for continuous inactivation of pathogens in the biological fluid, comprising: a source for beta radiation, wherein the cassette is directly coupled to the radiation source.
11. The cassette in combination with the arrangement according to claim 10, further comprising at least one pump for the continuous, active transport of the fluid through the module housing.
12. The cassette in combination with the arrangement according to claim 10, further comprising a mechanical or electromagnetic drive unit for driving the rotation of the roller in the module.
13. A method for inactivating pathogens in a biological fluid with the cassette according to claim 1, the method comprising the steps of: a) supplying the biological fluid potentially containing active pathogens to the cassette, b) rotating the roller in the module housing of the cassette such that a continuous fluid film of the biological fluid, of predeterminable thickness, is formed on the roller surface, c) irradiating the fluid film on the roller surface with ionizing beta radiation in a dose which causes inactivation of the pathogens of the biological fluid, and d) collecting the irradiated fluid with inactive pathogens from the roller surface.
14. The use of the cassette according to claim 1 for continuous inactivation of pathogens in a biological fluid by means of ionizing beta radiation.
Description
[0043] The invention is explained in more detail by the following figures and embodiments.
[0044] FIG. 1 schematically shows the overall structure for continuous irradiation of pathogen-containing fluids, for the purpose of inactivating the pathogens, using the module according to the invention. A fluid medium 20 which potentially contains pathogens has been furnished in a reservoir 21. The fluid is actively conveyed into the tub 12 via the supply line 15 and the peristaltic pump 94 via the inlet 14 on the module housing 10. An overflow 16 included in the module housing returns excess fluid into the reservoir 21 via line 17, and an optional peristaltic pump 96. The fluid level 24 in the tub 12 is kept constant. The cylindrical roller 30 rotates in the fluid 20 in the tub 12. The gap-forming element 50 arranged according to the invention on the upward-rotating side 34 of the roller forms a capillary gap 52 from the roller surfacethe capillary gap 52 also extending above the fluid level 24. Upon rotation of the roller 30, the capillary gap 52 facilitates the formation and homogenization of a fluid film 22 on the roller surface. The fluid film 22 which is formed is guided past a radiation window 62 and is exposed at that point to the radiation of a radiation source 80. After the irradiation on the upward-rotating side 36 of the roller 30, the fluid film 22 is substantially completely removed or wiped off by a wiping edge 40, which contacts and seals against the roller surface at that position. The removed, irradiated fluid 26 is collected and removed into a collecting vessel 27 via the outlet channel 18 via line 19optionally via peristaltic pump 98. An optional pressure line 28 provides pressure equalization.
[0045] FIG. 2 shows the principle routing of the fluid flow in the overall arrangement analogous to FIG. 1, on the basis of the schematic sectional drawing of a specific embodiment of the module according to the invention.
[0046] FIG. 3 shows a perspective, plan view of a specific embodiment of the module 10 according to the invention, with the tightly-fitted cover 60 with the radiation window 62. A drive element 90 with a coupling element 92 is shown on the module, for driving the roller contained in the module. The roller is driven in the module 10 in this case without contact, via magnetic elements in the coupling element 92 and corresponding magnetic elements in the roller.
[0047] FIG. 4 shows a perspective view of the module 10 according to FIG. 3, with the cover removed, and with a view of the rotatable cylindrical roller 30, the wiping edge 40 in contact with the surface of the cylindrical roller 30in this case in the form of a wiping plate compelled by spring force, and a collecting channel 42 which opens into the outlet channel 18.
[0048] FIG. 5 shows an alternative embodiment of a module 10 according to the invention, with the cover 60 which in this case has an optically transparent radiation window. The cylindrical roller 30 rotatable in the tub of the module housing has at least one revolving paddle wheel ring with paddle elements 38 which are filled with fluid supplied by the module in order to cause the roller 30 to rotate. In this specific embodiment, the wiping edge 40 has a recess 44 at the position of the revolving paddle elements 38 in order to not wipe off fluid circulating at this position, which does not form a defined fluid film.
[0049] FIG. 6 shows a cutaway view of the specific embodiment of FIG. 5. An inlet channel 14 and an overflow channel 16 are formed on the tub 12 in which the cylindrical roller 30 rotates. In the illustrated specific embodiment, the gap-forming element 50 is preferably constructed as a single piece together with the cover 60 which can be placed on the module housing, to form the capillary gap 52. On the downward-rotating side of the roller 30, the wiping edge 40 is designed with a recess 44 in the form of a wiping plate compelled against the roller surface by spring force. The fluid wiped off the roller surface is collected in the collecting channel 42 and discharged from the module via the outlet channel 18.
[0050] FIGS. 7A and 7B are schematic sectional views of a specific embodiment of the module 10 according to FIG. 2. FIG. 7B shows a plan view of the same module as a whole with a section line A included. This designates the sectional plane in the corresponding FIGS. 7A, 6 and 2.
[0051] FIGS. 8A and 8B are schematic sectional views of portions of the embodiments shown in FIGS. 4 and 5 and/or 9 and 10A and 10B. FIG. 8A shows a first embodiment and arrangement of the wiping edge 40 on the roller 30. The wiper 40 is oriented counter to the direction of rotation of the roller 30. FIG. 8B shows an embodiment and arrangement of the wiping edge 40 as an alternative. The wiper 40 designed as a wiper lip is oriented in the direction of rotation of the roller 30. In the case of the embodiment according to FIG. 8A, the fluid wiped off the roller 30 with the wiper 40 can flow past the wiper into the outlet 18 designed as a groove. In the case of the embodiment according to FIG. 8B, the fluid wiped off by the roller 30 with the wiper lip 40 can flow into a groove 19 formed between the roller surface and the wiper lip 40 and can be actively or passively removed therefrom via the outlet 18 designed as a cannula.
[0052] FIG. 9B shows a schematic cross-sectional view of a further embodiment of the cassette. The sectional plane of the view is located in the region of the wiper lip 40. The module housing 10 is closed by the housing cover 60. The radiation window 62 is situated in the housing cover 60. The wiper lip 40 in front of the roller 30 in a preferred embodiment according to the invention has an arcuate form, such that fluid wiped off of the roller 30 primarily collects, due to gravity, in the region of the outlet tube 18, which is preferably arranged centrally. In the illustrated embodiment, the rotation of the roller is facilitated via an axially-disposed coupling 92, comprising the shaft passing through the housing 10, and the drive unit 90. In the illustrated embodiment, the immersion depth of the overflow tubes 16 which project into the tub 12 can preferably and optionally be adjustable, such that the fluid level in the tub 12 can be preset.
[0053] FIGS. 10A and 10B show schematic sectional views of the embodiment of FIG. 9. The sectional plane of FIG. 10A is shown as line A in FIG. 9. The sectional plane of FIG. 10B is shown as line B in FIG. 9. The reference numbers apply accordingly. The fluid inlet 14 is located on the underside of the tub 12. The outlet 18 projects into the groove formed between the roller 30 and the wiper lip 40. The height of the overflow tube 16 can be varied to determine the fluid level in the tub 12.
