WO2007110052A2 - Method for inactivating unwanted organisms in blood plasma, especially viruses - Google Patents

Method for inactivating unwanted organisms in blood plasma, especially viruses

Info

Publication number
WO2007110052A2
WO2007110052A2 PCT/DE2007/000525 DE2007000525W WO2007110052A2 WO 2007110052 A2 WO2007110052 A2 WO 2007110052A2 DE 2007000525 W DE2007000525 W DE 2007000525W WO 2007110052 A2 WO2007110052 A2 WO 2007110052A2
Authority
WO
Grant status
Application
Patent type
Prior art keywords
characterized
blood plasma
filter
porphyrin
hydrophobic
Prior art date
Application number
PCT/DE2007/000525
Other languages
German (de)
French (fr)
Other versions
WO2007110052A3 (en )
Inventor
Gerd Heim
Original Assignee
Heim, Heidrun
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0029Radiation
    • A61L2/0052Visible light
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/12Apparatus for isolating biocidal substances from the environment
    • A61L2202/122Chambers for sterilisation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/22Blood or products thereof

Abstract

In order to inactivate with complete reliability the viruses and the like present in blood plasma immediately when it is obtained, it is proposed to add a porphyrin, in particular a chlorin e6, to the blood plasma immediately when it is obtained from blood (B), and to irradiate the mixture (10, 10a) with xenon rays. An apparatus with a special irradiation apparatus is likewise proposed for this purpose.

Description

Methods for inactivating undesirable in blood plasma organisms in particular viruses

The invention firstly relates to a method of inactivating undesired blood plasma in organisms, in particular of viruses.

Throughout the recovery and storage of blood plasma process that eventually no harmful organic components in ready to use blood plasma are no longer present with maximum security must be ensured. Such organic components can be, for example: molecules such as proteins, lipids or DNA, or microorganisms, such as bacteria, viruses and fungi or pathological cells such as cancer cells. The elimination of such ingredients is often carried out through filters using centrifuges. However, these methods do not lead to a truly complete, so owned 100% elimination of constituents. Because of these ingredients, they are still so small, particularly by microbes such. As viruses, however, a variety of life-threatening diseases may be caused, there is a very urgent need for a method of the type mentioned.

The invention is thus a desire of providing a method by which the blood plasma is treated so that with certainty no active organic components, in particular viruses or the like, are no longer present.

In an extensive series of tests, it was found that this principle, the combined use of two measures leads to success:

If the blood plasma was added directly in its production with a porphyrin and irradiated with xenon rays, then all the organic components are inactivated. The blood plasma is z. B. absolutely free of viruses.

The effect of the new process is due to following biological mechanism: When the porphyrin or chlorin e6 staggered blood plasma with xenon rays irradiated, then it is from 02 a Singlet O2 whereby the highest oxidation is effective tion reached. It has been found that this effect is even stronger than when using radicals or peroxides. It was further found that a particularly low e6 sufficient amount of this porphyrin with the use of a chlorin, to achieve the desired effect with certainty.

Particularly advantageous, especially very safe, economical and effective, the method is applicable when the porphyrin or chlorin e6 has the blood in the blood plasma out filtering hydrophobic or hydrophilic filter is added and mixed with the porphyrin or chlorin e6 blood plasma immediately after the exiting the hydrophobic or hydrophilic filter is irradiated. Such filtering method and filter arrangements, even using special hollow fiber filters have become known, for example by the publications DE 297 13 774 U1, DE 197 33 407 A1, DE 20014311 U1, WO 2000062840 A1, WO 2002013888 A1. and US 20020183678 A1. Such a filtering method or such a filter arrangement is also subject to the as yet unpublished German patent application DE 102,005,035,528th

Using the above methods and devices mentioned is proposed in continuation of the invention that the porphyrin or chlorin is added e6 the blood plasma by the hydrophobic or hydrophilic filter is wetted with the porphyrin or chlorin e6 or impregnated, and then the blood through the filter is passed. In this way, the inventive method is integrated in a very established method for the collection of blood plasma and any contaminants from outside of the blood plasma are completely excluded.

When the porphyrin or chlorin e6 mixed with the blood plasma is irradiated drop-shaped, then the blood plasma is irradiated to a certain extent in a delay line, during a certain period of time and also controllable in a very compact volume form completely and thus very effective. In addition, the blood plasma is recovered drop-shaped in the above method according to the prior art, so that an integration of the new process is possible in the above-mentioned, very good practice without problems. In continuation of the invention, the irradiation time can be controlled and in particular increased by the offset e6 with porphyrin chlorin or blood plasma is added after exiting the hydrophobic or hydrophilic filter in a buffer and irradiated in this buffer.

In order to keep the entire system is closed, the blood plasma is passed immediately after irradiation in a collection reservoir.

The invention is further a desire of providing a device for inactivating undesirable in blood plasma organisms with which the blood plasma is treated so that with certainty no active organic components, in particular viruses or the like, are no longer present.

Such a device for inactivating undesirable in blood plasma organisms, in particular of viruses may include the following structure:

a) a reservoir with a mixture of freshly obtained blood plasma and porphyrin, in particular chlorin e6, b) an irradiation chamber for containing the mixture, c) a delay line and / or a buffer for the mixture in the irradiation chamber, d) a radiation source for Xenon rays to irradiate the mixture in the irradiation chamber, e) a collecting container for the irradiated blood plasma.

Is an apparatus for obtaining blood plasma according to the above-mentioned prior art used, then a the blood plasma out be filtered, hydrophobic or hydrophilic from the blood filter may serve as a reservoir for the mixture of blood plasma and porphyrin or chlorin e6.

Such a hydrophobic or hydrophilic filter can be designed in particular as U-shaped hollow fiber filters, are wetted or its membranes with porphyrin or chlorin e6 impregnated. For simple control of the irradiation time and intensity of a delay line may be arranged in the form of a drip line. It can also be arranged a latch in the form of a surface filter. This sheet filter can be arranged, in particular absorb the droplet and collect in a thin planar volume shape, instead of or in addition to the drip line. Then, both the drops and the contaminated surface with drop filter with the same radiation source with xenon rays can be irradiated in particular.

In the already mentioned integration of the hydrophobic or hydrophilic filter and the surface filter can be arranged in a common filter housing, which also include the irradiation chamber or can be used as such.

It has been found that a device for irradiating is very successful if the xenon-rays have a wavelength of 300 to 800 microns, preferably about 630 microns.

Furthermore, an apparatus has proved, in which the distance of the radiation source to the blood plasma is from 30 to 40 mm. Here, it should be noted that the actual effective radiation dose depends not only on the radiation density of the radiation source, but also on the irradiation time and the distance of the radiation source and finally by the radiation permeability of the radiation chamber here for. As the filter housing.

To ensure the distance between the radiation source and to be irradiated blood plasma a special, possibly infinitely adjustable spacer can serve. This spacer z can. For example, be integrated into an upper attaching said filter housing or in the fixing of the radiation source.

The radiation source may be configured to vary as long as the radiation dose sufficient. They can consist of several individual almost point-like or sheet-like radiation sources exist. A very effective irradiation is achieved when the radiation source is substantially designed as an open, closed or overlapping and horizontally arranged ring and the blood plasma only under gravity through the interior, in particular through the center of the ring is guided. Then, the radiation is concentrated on the inside, the center of the ring and thus from all sides and only the left there blood plasma, can be worked so that with a relatively low radiation dose.

If desired or necessary, even two or more such rings may be arranged in parallel. If the ring is open, so closed on the circumference whole or overlapping in part, he can for mounting first a blood plasma line carrying such. , Below the filter housing, to include in its interior. He can then, for example. B. be led up to serving as the irradiation chamber filter housing around and secured in a certain, possibly adjustable distance from the blood plasma.

An aforementioned device can be conveniently and securely mounted by the radiation source and / or a mixture comprising retaining reservoir or optionally the serving this purpose the filter housing and optionally the collecting container are fixed together in a stable holder releasably.

Such a holder can be used to adapt to different shapes or dimensions, especially for receiving different, closed devices with storage and collection containers, comprising a vertical bar on which the radiation source and / or the reservoir and the filter housing and / or optionally the collecting is mounted adjustable in height and are. Similar holders and rods are already known from the aforementioned prior art for holding a filter assembly.

To protect the environment and in particular of persons in front of the xenon-radiation can be provided that the radiation source is covered to completely or at least radially to the outside by a protective shield. Such a shield may be at least partially internally reflective. For continuous radial shield, an annular shield between two overlapping Umfangsbe- can range almost tangential opening for the passage of a conduit having. Such a shield may be attached to the radiation source, or directly to the rod and combined with the above-mentioned spacer.

In the drawing, an embodiment of the invention is illustrated which will now be described in detail.

Fig. 1 shows an apparatus for the irradiation of blood plasma according to the invention, in side view and in a slightly schematic representation.

Fig. 2 shows the section Il - Il in Figure 1, omitting the parts located under the filter housing, in a larger scale..

The apparatus 1 of FIG. 1 comprises a filter container 2, a U-shaped hydrophobic or hydrophilic hollow fiber filter 3 is mounted in the upper inner region 2a, which consists of a vielzähligen fiber bundles. Through a feed line 4 B can be supplied to the interiors of the hollow fibers blood, a first discharge line 5 is used for discharging the cavities passing cellular blood components in a non-illustrated collecting tank.

Inside the lower portion 2b of the filter container 2, a woven surface filter 6 extends over the entire internal, circular cross-section having a mesh size from 20 to 40 microns. Below the surface of the filter 6, a feed line 8 and an outlet 9 are mounted in the bottom 7 of the filter tank. 2 The discharge line 9 serves for discharging the permeated through the membranes of the hollow fiber filter 3 blood plasma 10, which may initially added in the form of drops 10a centrally from the hollow fiber filter 3 out, then under the force of gravity, the surface filter 6 penetrates and fed via the outlet 9 to a header 11 becomes. The supply line 8 is used in particular for the supply of superheated steam for sterilization.

The filter container 2 is detachable and adjustable in height H1 connected to the upper end of the region 2a via a terminal 12 to a vertical rod 13 of a holder 14 which rests stable over a foot 15 on the floor 16th The collecting container 11 is at the bar 13 suspended from the lower inner portion 2b of the filter container 2 serves as an irradiation chamber, and is therefore formed very permeable over a hook 17 at a height H2 adjustable for xenon rays. Conveniently, the entire filter container 2 is formed completely transparent. A xenon radiation emitting radiation source 18 comprises an annular emitter 19 which extends around the lower portion 2b, and thus also to the area around the filter 6 and at a distance A of about 30 to 40 mm to drop 10a. The ring-shaped radiator 19 is not closed but has a radial passage 20 on its circumference. The wavelength of the xenon-radiation is between about 300 to 800 microns, particularly about 630 microns. The radiation source 18 comprises a terminal 21, to which it is adjustably connected in the height H3 to the vertical rod. 13

The clamp 21 may be rotatable and longitudinally adjustable in order to align the annular radiator 19 precisely concentric with the falling in the range 2b drops 10a and the surface of the filter 6, so that the xenon-radiation can be extremely safe and effective utilized. Via an electrical connector cable 22, the radiation source 18 with the usual power supply of 230 volts is connectable.

In order to shield the environment from the intense xenon rays around the radiator 19, a protective shield is disposed 23rd Such a shield 23 is only indicated in phantom in Fig. 1 for clarity of illustration only and drawn only as a line in Fig. 2. It is particularly useful when the xenon beams are not only toward the ring center, but also directed radially outward. However, this is always something is the case due to some unavoidable axial scattering and reflection of the radial annular radiation. Is here the annular shield 23 interior mirror at least in part, as an essential bundling the radiation in the direction of the ring center and thus achieved through to be irradiated blood plasma, in addition to the optical shield. This can achieve a significant energy saving.

A protective shield 23 can, similar to the passage 20 to the annular radiator 19, at its periphery to the already mentioned purpose an opening 24 having which is preferably arranged to keep the radial optical shielding effect in the area of ​​a significant overlap of two circumferential portions 25 and 26 and thus only is approximately tangentially accessible. The protective shield 23 may be mounted for easy fixing to either the radiator 19 or at terminal 21 or also with its own terminal separately on the rod. 13

The irradiation process is running, for example, as follows:

First, the hollow fibers of the hydrophobic or hydrophilic hollow fiber filter 3 are wetted with chlorin e6. Then, the blood B is passed through the feed line 4 into the internal cavities of the hydrophobic or hydrophilic hollow fiber filter 3 in the filter container. 2 Inside the hollow fiber filter 3, the cellular components of blood B to stay back and be passed through the discharge line 5 in a not-shown collection tank.

The blood plasma and other undesirable microorganisms, in particular viruses, in short, the contaminated blood plasma 10 passes under gravity through the membranes of the hollow fibers becomes enriched with chlorin e6 and accumulates in the form of drops 10 in the middle of the lower portion 2b of the Fiiterbehälters 2 and above the surface of the filter. 6

The contaminated and enriched chlorin e6 blood plasma 10 drips onto the surface filter 6, which absorbs the drops 10a, distributed in the surface, and holding for a time in order as it were to serve as a buffer. Of the falling droplets 10a and the surface filter 6 arranged around annular emitter 19 irradiates both the individual falling drops 10a and the soaked with blood plasma 10 surface filter 6 with xenon rays.

By the irradiation of the mixture of contaminated blood plasma and chlorin e6 with xenon rays are undesirable organisms, especially viruses, inactivated, so that the blood plasma 10 ultimately absorbed by the derivative 9 in the Sammelbehälteri 1 'is in particular totally free of viruses.

During the irradiation process, the optical shield 23 shields the environment from the intense xenon rays safely. Since both the radiator 19 and the shield 23 have an opening at the periphery, namely the passage 20 and opening 24 can during the assembly z. For example, the lines are conducted laterally through these openings 8 and 9, so that the entire radiation source 18 can always remain in their holder fourteenth She needs after performing the pipes 8 and 9 on the rod 13 only slightly upward to be moved to the lower portion 2b of the filter housing 2 when the filter housing 2 is secured first. Alternatively, it may be provided that the radiation source is fixedly mounted and the filter housing 18 inserted in the assembly 2 from above in the radiator 19, and then the clamp is tightened 12th

Reference numerals:

1 device

Two filter container

2a upper portion

2b lower portion

3 hydrophobic or hydrophilic filters

4 lead

5 derivative

6 surface filter

7 Base

8 lead

9 derivative

10 blood plasma with chlorin e6

10 'irradiated blood plasma

10a drops

11 Clippings

12 terminal

13 staff

14 holders

15 feet

16 floor

17 hooks

18 radiation source

19 spotlights

20 passage 21 terminal

22 connector line

23 Shield

24 opening

25 circumferential region

26 circumferential region

A distance

B blood

H1 height

H2 height

H3 height

Claims

claims
1. A method for inactivating undesirable in blood plasma organisms, especially viruses, characterized in that the blood plasma immediately upon its extraction from blood (B) mixed with a porphyrin and the mixture (10, 10a) is irradiated with xenon rays.
2. The method according to claim 1, characterized in that chlorin e6 is used as the porphyrin.
3. The method of claim 1 or 2, characterized in that the porphyrin out filtering has the blood (B) in a blood plasma, hydrophobic or hydrophilic filter (3) is added and mixed with porphyrin blood plasma (10, 10a) immediately after the exiting the hydrophobic or hydrophilic filter (3) is irradiated.
4. The method according to claim 3, characterized in that the porphyrin the blood plasma (10, 10a) is added by the hydrophobic or hydrophilic filter (3) is impregnated with the porphyrin and then the blood (B) through the filter (3) is passed.
5. The method according to any one of claims 1 to 4, characterized in that the offset with porphyrin blood plasma drop-shaped (10a) is irradiated.
6. A method according to any one of claims 1 to 5, characterized in that the offset with porphyrin (10) was added after exiting the hydrophobic or hydrophilic filter (3) in an intermediate store (6) and in this latch (6) irradiated blood plasma becomes.
7. A method according to any one of claims 1 to 6, characterized in that the blood plasma (10 ') immediately after irradiation in a collection container (11) is passed.
8. Device (1) for inactivating undesirable in blood plasma organisms, especially viruses, characterized by the following arrangement:
a) a reservoir (3) with a mixture (10) from freshly obtained blood plasma and porphyrin,
b) an irradiation chamber (2b) for receiving the mixture,
c) a delay line (10a) and / or a latch (6) for the mixture (10) in the irradiation chamber (2b),
d) a radiation source (18, 19) for xenon rays for irradiating the mixture (10) in the irradiation chamber (2b),
e) a collecting container (11) (for the irradiated blood plasma 10 ').
9. Apparatus according to claim 8, characterized in that from the blood (B), the blood plasma herausfiltemder, hydrophobic or hydrophilic filter (3) as a reservoir for the mixture is used (10) from blood plasma, and porphyrin.
10. Apparatus according to claim 9, characterized in that the hydrophobic or hydrophilic filter (3) is designed as a U-shaped hollow fiber filter.
11. The apparatus of claim 9 or 10, characterized in that the hydrophobic or hydrophilic filter (3) wetted with porphyrin or impregnated is.
12. Device according to one of claims 8 to 11, characterized in that the delay line is configured as a drip line.
13. Device according to one of claims 8 to 12, characterized in that the latch is constructed as surface filter (6).
14. The apparatus according to claim 13, characterized in that the hydrophobic or hydrophilic filter (3) and the surface filter (6) in a common filter housing (2) are arranged.
15. The device according to claim 14, characterized in that the common filter housing (2) also comprises the irradiation chamber (2b).
16. Device according to one of claims 8 to 15, characterized in that the xenon rays have a wavelength of 300 to 800 microns.
17. Device according to claim 16, characterized in that the rays have a xenon Because length of about 630 microns.
18. Device according to one of claims 8 to 17, characterized in that the distance (A) of the radiation source (19) for blood plasma 30 to 40 mm.
19. The apparatus according to claim 18, characterized in that for ensuring the distance (A) is a spacer.
20. Device according to one of claims 8 to 19, characterized in that the radiation source (18, 19) is substantially designed as an open, closed or overlapping and horizontally disposed ring (19) and the blood plasma (10) only under the force of gravity by the center of the ring (19) is guided.
21. Device according to one of claims 8 to 20, characterized in that the radiation source (18) and / or the mixture leg-holding reservoir or, if the filter (3) and optionally the collecting container (11) (together on a stable holder 14 ) are detachably fastened.
22. An apparatus according to claim 21, characterized in that the holder (14) a vertical rod (13), on which the radiation source (18) and / or the reservoir or filter (3) and / or optionally the collecting container ( 11) is mounted adjustable in height (M, H2, H3) or are.
23. Device according to one of claims 8 to 22, characterized in that the radiation source (18, 19) outwardly by a protective shield (23) is covered.
24. Device (14) according to claim 23, characterized in that the protective shield (23) is at least partially mirrored inside.
25. The device (25, 26) has a tangential opening (24) of claim 23 or 24, characterized in that the annular shield (23) extend between two overlapping Umfangsbe-.
26. The device according to any one of claims 23 to 25, characterized in that the protective shield (23) is fixed to the radiation source (18) or on the rod (13).
PCT/DE2007/000525 2006-03-24 2007-03-21 Method for inactivating unwanted organisms in blood plasma, especially viruses WO2007110052A3 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
DE102006014184.9 2006-03-24
DE200610014184 DE102006014184A1 (en) 2006-03-24 2006-03-24 Deactivating unwanted organisms in blood plasma, especially viruses, involves adding porphyrin to blood plasma immediately after extracting it from blood and irradiating mixture with xenon radiation

Publications (2)

Publication Number Publication Date
WO2007110052A2 true true WO2007110052A2 (en) 2007-10-04
WO2007110052A3 true WO2007110052A3 (en) 2008-03-20

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Family Applications (1)

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Country Status (2)

Country Link
DE (1) DE102006014184A1 (en)
WO (1) WO2007110052A3 (en)

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WO1995000631A1 (en) * 1993-06-23 1995-01-05 New York Blood Center, Inc. System for viral inactivation of blood
US5660731A (en) * 1994-11-08 1997-08-26 Pall Corporation Filter for separating photoactive agent
US5935092A (en) * 1990-12-20 1999-08-10 Baxter International Inc. Systems and methods for removing free and entrained contaminants in plasma
DE20014311U1 (en) * 2000-08-15 2001-02-15 Heim Medizintechnik Gmbh Filter assembly for separating blood into plasma and cellular components
US20020015662A1 (en) * 2000-06-15 2002-02-07 Hlavinka Dennis J. Inactivation of contaminants using photosensitizers and pulsed light

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US5660731A (en) * 1994-11-08 1997-08-26 Pall Corporation Filter for separating photoactive agent
US20020015662A1 (en) * 2000-06-15 2002-02-07 Hlavinka Dennis J. Inactivation of contaminants using photosensitizers and pulsed light
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Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
"Römpp Online" [Online] 24. Juli 2007 (2007-07-24), GEORG THIEME VERLAG , STUTTGART , XP002443782 Gefunden im Internet: URL:http://www.roempp.com/prod/index1.html > [gefunden am 2007-07-24] Schlagwort "Xenon-Lampe" *
SUOMELA H: "INACTIVATION OF VIRUSES IN BLOOD AND PLASMA PRODUCTS" TRANSFUSION MEDICINE, OXFORD, GB, Bd. 7, Nr. 1, 1993, Seiten 42-57, XP000573510 *

Also Published As

Publication number Publication date Type
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DE102006014184A1 (en) 2007-09-27 application

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