STERILIZING DEVICE AND METHOD FOR STERILIZING AN OUTER FACE OF A RECEPTACLE

Abstract

The present invention relates to a sterilizing device (10) and to a method for sterilizing an outer face of a receptacle (22).

Claims

1. A sterilizing device (10) for sterilizing an outer face (23) of a receptacle (22), the device (10) comprising a transfer lock (12), wherein the receptacle (22) to be sterilized has a gas-permeable lidding foil (26) and a gas-impermeable receptacle body (24) which delimits a receiving space (28) which is accessible via a removal opening (29) in the receptacle body (24), wherein the removal opening (29) is closed by the lidding foil (26), wherein the transfer lock (12) comprises a cover unit (14) having a radiation source (40), which can be arranged relative to the receptacle such that the cover unit (14) covers a region of the receptacle (22) formed by the lidding foil (22) and can irradiate the lidding foil (22) with electromagnetic radiation, wherein the transfer lock (12) also comprises a decontamination unit (15), by which a H2O2-containing atmosphere can be generated in the transfer lock (12), wherein the cover unit (14) comprises a flat cover side which comprises a cover plate (36) that is permeable to the radiation from the radiation source (40).

2. (canceled)

3. The sterilizing device (10) according to claim 1, wherein the radiation source (40) is a UV radiation source (40).

4. The sterilizing device (10) according to claim 1, wherein the decontamination unit (15) in the transfer lock (12) is designed to form a directed, low-turbulence gas flow.

5. The sterilizing device (10) according to claim 1, wherein the decontamination unit (15) for generating the H2O2-containing atmosphere H2O2 in the transfer lock (12) is designed to introduce H2O2 in a gaseous state or as a mist.

6. A method for sterilizing an outer face (23) of a receptacle (22), wherein the receptacle (22) has a gas-permeable lidding foil (26) and a gas-impermeable receptacle body (24) which delimits a receiving space (28) which is accessible via a removal opening (29) in the receptacle body (24), and wherein the removal opening (29) is closed by the lidding foil (26), wherein the method comprises: placing a cover unit (14) in the region of the lidding foil (26) such that a possibility of an inflow of gas (20) between the cover unit (14) and the lidding foil (26) is reduced, and subsequently sterilizing the outer face of the receptacle body (24) by H2O2-containing gas (20) while simultaneously sterilizing the lidding foil (26) by electromagnetic radiation.

7. The method according to claim 6, wherein, in an initial state, the receptacle (22) is initially arranged in outer packaging wherein the method comprises the following steps: step 1: introducing the receptacle (22) in the outer packaging into a removal region in which a cleaned gas circulates around the receptacle (22); step 2: removing the receptacle (22) from the outer packaging with the cleaned gas circulating therearound; step 3: introducing the receptacle (22) into a transfer lock (12); step 4: arranging the receptacle (22) in the region of the cover unit (14) such that the cover unit (14) completely or at least predominantly covers the region of the receptacle (22) formed by the lidding foil (26); step 5: flooding the transfer lock (12) with a H2O2-containing atmosphere with simultaneous and/or prior or subsequent irradiation of the lidding foil (26) of the receptacle (22) by an electromagnetic radiation source (40) arranged in the cover unit (14); step 6: flushing the transfer lock (12) with H2O2-free gas and removing the receptacle (22) from the transfer lock (12).

8. The method according to claim 6, wherein the cover unit (14) comprises a flat cover side which comprises a cover plate (36) that is permeable to the radiation from a radiation source (40), and the lidding foil (26) of the receptacle (22) is designed and arranged so as to extend in a planar manner, and the lidding foil (26) and the cover plate (36) are aligned in parallel with one another before the H2O2-containing atmosphere is generated in the transfer lock (12).

9. The method according to claim 6, wherein while the H2O2-containing atmosphere exists in the transfer lock (12), the cover plate (36) and the lidding foil (26) are in contact with one another or at a distance from one another.

10. The method according to claim 7, wherein the circulation in step 1 takes place with a directed, laminar flow, and/or in that, in step 5, a directed, laminar flow of H2O2-containing gas (20) circulates around the receptacle (22).

11. The method according to claim 6, wherein the receptacle body (24) is a trough, and a holder (30) comprising primary packaging (32) provided for medical substances and accommodated in the holder (30) is arranged in the receiving space (28) that is closed by the lidding foil (26).

12. The sterilizing device (10) according to claim 1, wherein the device further includes a removal region, and wherein, in an initial state, the receptacle (22) is initially arranged in outer packaging, wherein the removal region comprises a circulation device which is designed and arranged to flush a cleaned gas around the receptacle (22) while it is being removed from the outer packaging in the removal region.

13. The sterilizing device (10) according to claim 12, wherein the circulation device in the removal region is designed to form a directed, low-turbulence gas flow.

14. The sterilizing device (10) according to claim 1, wherein the electromagnetic radiation is high-energy light radiation generated by the radiation source (40)

15. The sterilizing device (10) according to claim 14, wherein the high-energy light radiation is UV radiation.

16. The method according to claim 6, wherein the electromagnetic radiation is UV radiation

17. The method according to claim 9, wherein the cover plate (36) and the lidding foil (26) are at a distance (39) from one another, that is constant or decreases over time, of less than 2 cm.

18. The method according to claim 9, wherein the distance (39) is less than 1.5 cm.

19. The method according to claim 18, wherein the distance (39) is less than 1 cm.

20. The method according to claim 18, wherein the distance (39) is less than 0.5 cm.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Further features, possible applications and advantages of the inventions result from the following description of embodiments of the inventions, which are explained with reference to the drawings, where the features may be essential to the inventions, both in isolation and in different combinations, without being explicitly mentioned again. In the drawings:

[0042] FIG. 1 shows a device according to the invention, which carries out a method according to the invention;

[0043] FIG. 2 shows a portion from FIG. 1;

[0044] FIG. 3 is a schematic process sequence.

DETAILED DESCRIPTION

[0045] FIG. 1 shows a sterilizing device 10 and its transfer lock 12 in detail. A removal region of the sterilizing device 10 is not shown in the figure.

[0046] The transfer lock 12 comprises a cover unit 14, a decontamination device 15 and a filter unit 16. The transfer lock 12 is designed having a space 18 that can be sealed in a gas-tight manner. Gas 20 containing hydrogen peroxide, the direction of flow of which is represented by arrows, can be introduced into the space 18 via the decontamination device 15.

[0047] A receptacle 22 to be sterilized and having an outer face 23 is arranged in the space 18 below the cover unit 14. The receptacle 22 comprises a receptacle body 24 and a lidding foil 26 which together form the outer face 23. The receptacle body 24 is designed in the manner of a trough and comprises a receiving space 28. The receiving space 28 opens into a removal opening 29 (pointing upward in the present case), which is closed by the lidding foil 26. In the present example, the receiving space 28 is consequently delimited by the receptacle body 24 and the lidding foil 26, in the present case completely (without further delimiting elements).

[0048] A nest 30 is arranged inside the receiving space 28 and comprises primary packaging 32 designed as syringes. The lidding foil 26 is connected to the receptacle body 24 at a laterally protruding edge 34. The lidding foil 26 is planar and even. The receptacle body 24 is impermeable to both germs and gases, in particular H2O2 in the gas phase (gaseous or as a mist/aerosol). The lidding foil 26 is impermeable to germs. The lidding foil 26 is permeable to gases, in particular H2O2 in the gas phase (gaseous or as a mist/aerosol).

[0049] The region around the cover unit 14 and the receptacle 22 is shown enlarged in FIG. 2.

[0050] In the state shown in FIGS. 1 and 2, the receptacle 22 is arranged such that the lidding foil is arranged in parallel with a cover plate 36 of the cover unit 14. A gap 38 is formed between the lidding foil and the cover plate, which in the present case is formed having a gap width 39 of 0.5 cm.

[0051] The cover unit 14 comprises a plurality of radiation sources 40 which are designed to emit UV radiation and can each emit UV radiation in the direction of the lidding foil 26 through the cover plate 36. For this purpose, the cover plate 36 is designed to be UV-permeable. This is illustrated by corresponding arrows emanating from the radiation sources 40.

[0052] The method according to the invention for sterilizing the receptacle 22 is illustrated schematically in FIG. 3 using the example of the operation of the sterilizing device 10.

[0053] In a first step 100, the receptacle 22 in outer packaging is introduced into a removal region of the sterilizing device 10 and a cleaned gas, for example cleaned air, circulates therearound with a directed, laminar flow.

[0054] In a second step 200, the receptacle 22 is removed from the outer packaging while the cleaned gas is circulating therearound.

[0055] In a third step 300, the receptacle 22 is introduced into the transfer lock 12, as is shown in FIG. 1, for example.

[0056] In a fourth step 400, the receptacle 22 is arranged in the region of the cover unit 14 such that the cover unit 14 covers the region of the receptacle 22 formed by the lidding foil. For this purpose, the cover unit 14 can be held stationary and the receptacle 22 can be moved, or vice versa. It is also possible for receptacle 22 and cover unit 14 to be moved in this step.

[0057] In a fifth step 500, the transfer lock 12 is flooded with a H2O2-containing atmosphere. At the same time (directly before or after is also possible), the lidding foil 26 of the receptacle 22 is irradiated by means of the electromagnetic radiation source 40 arranged in the cover unit 14, which is designed as a UV radiation source in the example from FIG. 1.

[0058] In order to flood the transfer lock with the H2O2-containing atmosphere, the gas 20 flows past the receptacle 22 in a laminar flow from the side of the cover unit 14. On a side of the receptacle 22 arranged opposite the cover unit 14, the gas 20 is carried away from the receptacle 22 via a return air duct 42 or a plurality of return air ducts 42, which are arranged to the side of the cover unit 14. The gas 20 can then be cleaned, for which purpose, for example, catalytic decomposition of the H2O2 in the gas can be used.

[0059] In a sixth step 600, the transfer lock is flushed with H2O2-free gas and the receptacle 22 is removed from the transfer lock 12.