SYSTEM AND METHOD FOR STERILITY TESTING OF RADIOACTIVE MATERIALS

Abstract

The invention relates to a system for testing the sterility of radioactive substances, to the use of the system for testing the sterility of radioactive substances, preferably radioactive pharmaceuticals and/or diagnostic agents, and to a method for testing the sterility of radioactive substances, wherein the system comprises an isolator (8) having a device for membrane filtration (9) and a filter bottle (1) surrounding the shield (5) against ionising radiation.

Claims

1. A method for testing the sterility of radioactive substances, comprising the steps of a) membrane filtration of a solution of a radioactive substance by means of a device for membrane filtration comprising at least one membrane filter in an isolator (8), and extraction by suction through a system comprising a filtrate bottle (1) comprising at least one liquid-conveying line (2) and at least one pressure equalizing line (3), and at least one transport carriage (4), wherein the transport carriage (4) is suitable for receiving the filtrate bottle (1), wherein the transport carriage (4) is movable, wherein at least the filtrate bottle (1) is surrounded by a shield against ionising radiation (5), a vacuum pump (6), wherein the vacuum pump (6) is connected to the liquid-conveying line (2) and is suitable for pumping filtrate containing the radioactive substance into the filtrate bottle (1), at least one self-sealing connecting piece (7), and an isolator (8), wherein the isolator (8) is connected to the filtrate bottle (1) on the transport carriage (4) via the at least one liquid-conveying line (2) and the at least one pressure equalizing line (3), wherein the isolator (8) comprises a device for membrane filtration (9), wherein the at least one self-sealing connecting piece (7) connects the filtrate bottle to the isolator (8) via the liquid-conveying line (2) and/or the pressure-equalising line (3), b) culturing the membrane filters in a culture medium, and c) testing the culture medium for microorganisms.

2. The method according to claim 1, wherein the solution of a radioactive substance is an aqueous solution, alcoholic solution and/or oil-based solution.

3. The method according to claim 1, wherein the culturing the membrane filters in step b) is carried out at a temperature in the range of 20° C. to 37° C., at an air humidity in the range of 30% to 70%, and/or for a duration of 14 days.

4. The method according to claim 1, further comprising sucking the solution of a radioactive substance from the filtrate bottle and allowing the solution of a radioactive substance to decay in a decay tank.

5. A system for testing the sterility of radioactive substances, comprising i. a filtrate bottle (1) comprising at least one liquid-conveying line (2) and at least one pressure equalizing line (3), and ii. at least one transport carriage (4), wherein the transport carriage (4) is suitable for receiving the filtrate bottle (1), wherein the transport carriage (4) is movable, wherein at least the filtrate bottle (1) is surrounded by a shield against ionising radiation (5), iii. a vacuum pump (6), wherein the vacuum pump (6) is connected to the liquid-conveying line (2) and is suitable for pumping into the filtrate bottle (1) filtrate containing the radioactive substance, iv. at least one self-sealing connecting piece (7), and v. an isolator (8), wherein the isolator (8) is connected to the filtrate bottle (1) on the transport carriage (4) via the at least one liquid-conveying line (2) and the at least one pressure equalizing line (3), wherein the isolator (8) comprises a device for membrane filtration (9), wherein the at least one self-sealing connecting piece (7) connects the filtrate bottle to the isolator (8) via the liquid-conveying line (2) and/or the pressure-equalising line (3).

6. The system according to claim 5, wherein the shield against ionising radiation (5) comprises a metal layer and a Plexiglas layer.

7. The system according to claim 5, wherein the shield against ionising radiation (5) comprises a metal having a thickness in the range of 40 mm to 100 mm.

8. The system according to claim 5, wherein the filtrate bottle (1) is made of glass, plastic and/or metal.

9. The system according to claim 5, wherein the filtrate bottle (1) comprises a liquid fill level meter, wherein the liquid fill level meter emits an optical and/or acoustic signal at a predefined fill level of the filtrate.

10. The system according to claim 5, wherein the liquid-conveying line and the at least one pressure equalizing line are made of rubber and/or metal.

11. The system according to claim 5, wherein the connection between the isolator (8) and the filtrate bottle (1) on the transport carriage is designed as a beam trap.

12. The system according to claim 5, wherein the device for membrane filtration (9) comprises at least one membrane filter made of cellulose acetate or cellulose nitrate and/or having pores in the range of 0.2 to 0.45 .Math.m.

13. (canceled)

14. The system according to claim 7, wherein the filtrate bottle (1) is made of glass, plastic and/or metal.

15. The system according to claim 7, wherein the filtrate bottle (1) comprises a liquid fill level meter, wherein the liquid fill level meter emits an optical and/or acoustic signal at a predefined fill level of the filtrate.

16. The system according to claim 7, wherein the liquid-conveying line and the at least one pressure equalizing line are made of rubber and/or metal.

17. The system according to claim 7, wherein the connection between the isolator (8) and the filtrate bottle (1) on the transport carriage is designed as a beam trap.

18. The system according to claim 7, wherein the device for membrane filtration (9) comprises at least one membrane filter made of cellulose acetate or cellulose nitrate and/or having pores in the range of 0.2 to 0.45 .Math.m.

19. The method according to claim 1, wherein the radioactive substances are selected from radioactive pharmaceuticals and/or diagnostic agents.

20. The method according to claim 3, further comprising sucking the solution of a radioactive substance from the filtrate bottle and allowing the solution of a radioactive substance to decay in a decay tank.

21. The method according to claim 3, wherein the radioactive substances are selected from radioactive pharmaceuticals and/or diagnostic agents.

Description

EXEMPLARY EMBODIMENTS

[0126] The invention is explained in more detail below with reference to a number of exemplary embodiments and associated figures. The exemplary embodiments are intended to describe the invention without limiting it.

[0127] FIG. 1 shows a schematic illustration of the system according to the invention for testing the sterility of radioactive substances comprising a filtrate bottle 1, a liquid-conveying line 2 and a pressure equalizing line 3, a movable trolley 4, wherein the filtrate bottle 1 is located within the movable trolley 4 and wherein the movable trolley 4 has four castors on the underside. The housing of the trolley 4 represents a shield against ionising radiation 5. The trolley further comprises a vacuum pump 6. The fluid-conveying line 2 and the pressure equalizing line 3 feature a self-sealing connecting piece 7 and are connected to the isolator 8, in particular the liquid-conveying line 2 is connected to a device for membrane filtration 9 within the isolator 8.

Exemplary Embodiment

Sterile Testing of a .SUP.177.Lu-DOTA-TOC Solution by Means of a System According to the Invention

[0128] A .sup.177Lu-DOTA-TOC solution with an activity of about 7000 MBq and the following composition: [0129] 13 mg sodium ascorbate [0130] 31 mg sodium acetate [0131] 4 mg 2,5-dihydroxybenzoic acid [0132] 6 ml 0.04 M acetic acid [0133] 10 ml 0.9% sodium chloride solution [0134] 115 .Math.g .sup.177Lu-DOTA-TOC in 115 .Math.l 0.04 M acetic acid is introduced into the isolator, in particular the sterile box, and filtered completely or partially via membrane filters (cellulose nitrate, pore size 0.45 .Math.m). The membrane filter is then rinsed with 50 ml to 300 ml of buffer. The membrane filter is then in each case added to 100 ml of casein soya peptone broth and 100 ml of thioglycolate broth. The membrane filters are incubated in the culture medium for 14 days, in casein soya peptone broth at a temperature in the range from 20° C. to 25° C. and in thioglycolate broth at a temperature in the range from 30° C. to 35° C.

[0135] The evaluation is effected by visual assessment of the turbidity. In the case of an absence of turbidity, the sample is negative for microorganism growth and is thus sterile. In the case of turbidity, the sample is positive for microorganism growth and is thus non-sterile.

[0136] The sample solution in the filtrate bottle comprising .sup.177Lu-DOTA-TOC, which is pumped off by means of the system according to the invention, is transported with the trolley to a decay pool and pumped out after the connection of the liquid-conveying line to the decay pool. The solution is left for at least 60 days in the decay pool until decay below the free limit.

TABLE-US-00001 Reference signs 1 Filtrate bottle 2 Liquid-conveying line 3 Pressure equalizing line 4 Trolley 5 Shield against ionising radiation 6 Vacuum pump 7 Self-sealing connecting piece 8 Isolator 9 Device for membrane filtration