PHARMACEUTICAL UNIT AND METHOD FOR OPERATING A PHARMACEUTICAL UNIT

1 . A pharmaceutical unit ( 12 ), comprising:

a working space ( 16 ) that is sealed off from its environment,

a filter system ( 10 ) comprising a first flow path ( 11 ) and a first filter ( 18 ), wherein the first filter ( 18 ) is disposed in the first flow path ( 11 ) and is configured to filter air that is directed from the working space ( 16 ) via the first flow path ( 11 ), wherein the filter system ( 10 ) comprises a second flow path ( 13 ) and a switching device ( 22 ), wherein the switching device is configured to direct air from the working space ( 16 ) via the first flow path ( 11 ) and thus via the first filter ( 18 ) during an operating phase of the pharmaceutical unit ( 12 ) and to direct the air from the working space ( 16 ) exclusively via the second flow path ( 13 ) during a decontamination phase of the pharmaceutical unit ( 12 ), so that the first filter ( 18 ) is not exposed to a decontaminant during the decontamination phase in which the decontaminant is supplied to the working space ( 16 ), wherein the air is recirculating air.

2 . The pharmaceutical unit ( 12 ) according to claim 1 , wherein the decontamination phase is a biodecontamination phase in which hydrogen peroxide is introduced into the working space ( 16 ).

3 . The pharmaceutical unit ( 12 ) according to claim 1 , wherein the filter system ( 10 ) comprises a second filter ( 20 ) arranged in the second flow path ( 13 ) and configured to filter air from the working space ( 16 ) that is directed via the second flow path ( 13 ).

4 . The pharmaceutical unit ( 12 ) according to claim 1 , wherein the switching device ( 22 ) comprises at least one valve ( 24 , 23 , 25 ) the at least one valve ( 24 , 23 , 25 ) being configured to fluidically couple and/or decouple the first flow path ( 11 ) and/or the second flow path ( 13 ) to the working space ( 16 ).

5 . The pharmaceutical unit ( 12 ) according to claim 3 , wherein the first filter ( 18 ) and/or the second filter ( 20 ) is arranged within the pharmaceutical unit ( 12 ).

6 . The pharmaceutical unit ( 12 ) according to claim 3 , wherein the first filter ( 18 ) and/or the second filter ( 20 ) is arranged outside the working space ( 16 ).

7 . The pharmaceutical unit ( 12 ) according claim 3 , wherein the switching device is configured to direct air from the working space ( 16 ), via the first filter ( 18 ) and the second filter ( 20 ) during the operating phase of the pharmaceutical unit ( 12 ).

8 . The pharmaceutical unit ( 12 ) according to claim 3 , wherein the first filter ( 18 ) and the second filter ( 20 ) are fluidically arranged in series with each other, wherein the second filter ( 20 ) is arranged downstream of the first filter ( 18 ), wherein the second flow path ( 13 ) directs the air from the working space ( 16 ) in parallel around the first filter ( 18 ) and through the second filter ( 20 ).

9 . The pharmaceutical unit ( 12 ) according to claim 3 , wherein the first filter ( 18 ) and the second filter ( 20 ) are arranged fluidically parallel to each other.

10 . A method of operating a pharmaceutical unit ( 12 ) comprising a working space ( 16 ) that is sealed off from its environment, wherein the pharmaceutical unit ( 12 ) comprises a filter system ( 10 ) having a first flow path ( 11 ) and a first filter ( 18 ), wherein the first filter ( 18 ) is disposed in the first flow path ( 11 ) and is configured to filter air that is directed from the working space ( 16 ) via the first flow path ( 11 ), wherein the filter system ( 10 ) comprises a second flow path ( 13 ) and a switching device ( 22 ) configured such that a flow of air from the working space ( 16 ) can be switched between the first flow path ( 11 ) and the second flow path ( 13 ), wherein the method comprises:

Directing air from the working space ( 16 ) via the first flow path ( 11 ) in an operating phase of the pharmaceutical unit ( 12 ) and directing air from the working space ( 16 ) exclusively via the second flow path ( 13 ) during a decontamination phase of the working space ( 16 ), wherein the air is recirculating air.

11 . The method according to claim 10 , wherein during the operating phase of the pharmaceutical unit ( 12 ), air from the working space ( 16 ) is additionally conducted via the second flow path ( 13 ).

12 . (canceled)

13 . The pharmaceutical unit ( 12 ) according to claim 1 , wherein the pharmaceutical unit ( 12 ) is a clean room ( 14 ).

14 . The pharmaceutical unit ( 12 ) according to claim 1 , wherein the decontaminant is air from the working space ( 16 ).

15 . The pharmaceutical unit ( 12 ) according to claim 1 , wherein the decontaminant is a gaseous contaminant.

16 . The pharmaceutical unit ( 12 ) according to claim 4 , wherein the at least one valve ( 24 , 23 , 25 ) includes two valves ( 24 , 23 , 25 ).

17 . The pharmaceutical unit ( 12 ) according to claim 8 , wherein the second filter ( 20 ) is a police filter ( 21 ).

18 . The method according to claim 10 , wherein during the decontamination phase a decontaminant is introduced into the working space ( 16 ).

19 . The method according to claim 18 , wherein the decontaminant is a gaseous decontaminant.

20 . The method according to claim 18 , wherein the decontaminant is hydrogen peroxide.