DECONTAMINATION ARRANGEMENT, SYSTEM AND DECONTAMINATION METHOD

Abstract

A decontamination assembly, for pharmaceutical applications includes at least one chamber to be decontaminated (4) having a decontamination liquid storage tank (36) by which several atomizers (A, B, C. D) disposed in the chamber to be decontaminated (4) for producing a decontaminant aerosol can be supplied with decontamination liquid using valves (27) which can be controlled by electronic control, the atomizers (A, B, C, D) being in fluid communication with a ring conduit (32) having an inlet (33) and a separate outlet (34) by the valves (27), decontamination liquid from the decontamination liquid storage tank (36) being conveyable into the inlet of the ring conduit by a pump (35) and decontamination liquid flowing out of the outlet of the ring conduit back into the decontamination liquid storage tank (36), and a pressure adjustment mechanism (37) for keeping the pressure in the ring conduit (32) at a predefined liquid pressure range assigned to the ring conduit (32). A measuring mechanism (40) for determining a total volume of decontamination liquid dispensed to the atomizers (A, B, C, D) during a decontamination cycle includes a weighing mechanism (41) for determining a decontamination liquid volume in the decontamination liquid storage tank (36).

Claims

1. A decontamination assembly for pharmaceutical applications, comprising at least one chamber to be decontaminated (4), comprising a decontamination liquid storage tank (36) by which several atomizers (A, B, C, D) disposed in the chamber to be decontaminated (4) for producing a decontaminant aerosol can be supplied with decontamination liquid using valve means (27) which can be controlled by means of electronic control means, the atomizers (A, B, C, D) being in fluid communication with a ring conduit (32) having an inlet (33) and a separate outlet (34) by means of the valve means (27), decontamination liquid from the decontamination liquid storage tank (36) being conveyable into the inlet of said ring conduit by means of a pump (35) and decontamination liquid flowing out of the outlet of said ring conduit back into the decontamination liquid storage tank (36), and wherein pressure adjustment means (37) for keeping the pressure in the ring conduit (32) at a predefined liquid pressure range are assigned to the ring conduit (32), wherein measuring means (40) for determining a total volume of decontamination liquid dispensed to the atomizers (A, B, C, D) during a decontamination cycle are provided, and the decontamination assembly being configured in such a manner that between 5 g and 10 g, of decontamination liquid per cubic meter of chamber to be decontaminated is atomized by all atomizers from the ring conduit into the chamber to be decontaminated during a decontamination cycle and the atomizers being realized in such a manner that 90% of the decontamination mist or aerosol droplets leaving the atomizers have a particle size of less than 20 m.

2. The decontamination assembly according to claim 1, wherein the measuring means (40) are configured to determine the total volume of the decontamination liquid dispensed to the atomizers by defining the difference between the weight of the decontamination liquid volume in the decontamination liquid storage tank (36) when the ring conduit (32) is filled with decontamination liquid before the decontamination cycle and the weight of the decontamination liquid volume in the decontamination liquid storage tank (36) when the ring conduit (32) is filled with decontamination liquid after the decontamination cycle.

3. The decontamination assembly according to claim 1, wherein the pressure adjustment means (37) comprise a non-return valve (38) disposed in the ring conduit (32), the valve element being configured to open the non-return valve (38) towards the decontamination liquid storage tank (36) against the spring force of a return spring.

4. The decontamination assembly according to claim 1, wherein the pressure adjustment means (37) are configured and tuned to the pump (35) in such a manner that the decontamination liquid flows through the outlet (34) back into the decontamination liquid storage tank (36) when the valve means (27) are opened.

5. The decontamination assembly according to claim 1, wherein the valve means (27) comprise switch valves (28, 29, 30, 31), which can be controlled in a cyclic manner, in order to supply the respective atomizer (A, B, C, D) with decontamination liquid from the ring conduit (32) and/or wherein at least one group of atomizers (A, B, C, D) is/are assigned such a switch valve (28, 29, 30, 31).

6. The decontamination assembly according to claim 5, wherein the control means are configured to control the switch valves (28, 29, 30, 31) in such a manner that several switch valves (28, 29, 30, 31) or groups of switch valves are simultaneously opened and/or are operated in a cycled manner and/or in such a manner that several switch valves (28, 29, 30, 31) or groups of switch valves are subsequently opened and/or are operated in a cycled manner and/or in such a manner that at least one of the switch valves (28, 29, 30, 31) or at least one of the groups of switch valves is opened for a longer period of time and/or operated in a cycled manner for a longer period of time during a decontamination cycle than at least one other switch valve (28, 29, 30, 31) or one other group of switch valves.

7. The decontamination assembly according to claim 5, wherein the control means are configured to control the switch valves (28, 29, 30, 31) in such a manner that a given total volume of decontamination liquid to be atomized can be dosed by controlling a clocked total opening time of the switch valves (28, 29, 30, 31) and/or in such a manner that a given volume of decontamination liquid to be dosed can be dosed at one of the atomizers (A, B, C, D) or a group of atomizers (A, B, C, D) by controlling a clocked opening time of the corresponding switch valve (28, 29, 30, 31).

8. The decontamination assembly according to claim 1, wherein several atomizers (A, B, C, D) which are connected to the ring conduit (32) are equidistantly spaced apart from the ring conduit (32).

9. The decontamination assembly according to claim 1, wherein the atomizers (A, B, C, D) which are configured as two-component nozzles are connected to a gas pressure source, in a gas-conducting manner to generate a carrier gas flow for the decontaminant aerosol to be produced.

10. The decontamination assembly according to claim 1, wherein the ring conduit (32) is assigned a connector valve (42) behind the pump (35) in order to establish and close a bypass between an area of the ring conduit (32) in front of and behind the atomizers (A, B, C, D) and/or wherein the pressure adjustment means (37) can be bypassed by means of a bypass valve (39) and/or wherein the ring conduit (32) is assigned a compressed gas connection, for emptying the ring conduit (32).

11. A system comprising an isolator (2), comprising a chamber to be decontaminated (4), and comprising a decontamination assembly (3) according to claim 1.

12. A decontamination method for operating a decontamination assembly (3) according to claim 1, wherein, a chamber to be decontaminated (4), being decontaminated by producing a decontaminant aerosol from a decontamination liquid, by means of atomizers (A, B, C, D) which are disposed in the chamber to be decontaminated (4), said atomizers being supplied with the decontamination liquid from a decontamination liquid storage tank (36) via valve means (27), the atomizers (A, B, C, D) being in fluid communication with a ring conduit (32) having an inlet (33) and a separate outlet (34), decontamination liquid from the decontamination liquid storage tank (36) being conveyed into the inlet of said ring conduit by means of a pump (35) and decontamination liquid flowing out of the outlet of said ring conduit back into the decontamination liquid storage tank (36), and wherein a liquid pressure of the decontamination liquid in the ring conduit (32) is kept at a predefined pressure range by means of pressure adjustment means (37), wherein a total volume of the decontamination liquid dispensed to the atomizers (A, B, C, D) is determined by defining the difference between the weight of the decontamination liquid volume in the decontamination liquid storage tank (36) when the ring conduit (32) is filled with decontamination liquid before the decontamination cycle and the weight of the decontamination liquid volume in the decontamination liquid storage tank (36) when the ring conduit (32) is filled with decontamination liquid after the decontamination cycle, the decontamination method atomizing between 5 g and 10 g, of decontamination liquid per cubic meter of chamber to be decontaminated by all atomizers from the ring conduit into the chamber to be decontaminated during a decontamination cycle and 90% of the decontamination mist or aerosol droplets leaving the atomizers having a particle size of less than 20 m.

13. The decontamination method according to claim 12, wherein the ring conduit (32) is filled completely with the decontamination liquid from the decontamination liquid storage tank (36) by means of a pump (35) before the decontamination liquid flows from the ring conduit (32) to the atomizers (A, B, C, D) in a decontamination cycle by a corresponding control of the valve means (27).

14. The decontamination assembly according to claim 1, wherein the chamber is an isolator chamber.

15. The decontamination assembly according to claim 1, wherein the chamber is a manipulator chamber and/or a plenum chamber separated from the manipulator chamber by a membrane.

16. The decontamination assembly according to claim 1, wherein the atomizers (A, B, C, D) are configured as two-component nozzles for producing a decontaminated aerosol.

17. The decontamination assembly according to claim 1, wherein the decontamination liquid is hydrogen peroxide.

18. The decontamination assembly according to claim 1, the measuring means (40) comprises weighing means (41) for determining a decontamination liquid volume in the decontamination liquid storage tank (36).

19. The decontamination assembly according to claim 5, wherein the switch valves (28, 29, 30, 31) are 2-/2-way valves, and wherein individual atomizers (A, B, C, D) are assigned such a switch valve (28, 29, 30, 31).

20. The decontamination assembly according to claim 8, wherein a majority of the atomizers (A, B, C, D) which are connected to the ring conduit (32) are equidistantly spaced apart from the ring conduit (32).

21. The decontamination assembly according to claim 8, wherein all atomizers (A, B, C, D) which are connected to the ring conduit (32) are equidistantly spaced apart from the ring conduit (32).

22. The system according to claim 11, wherein the isolator (2) is an isolator for pharmaceutical applications, and wherein the chamber to be decontaminated is a manipulator chamber and/or a plenum chamber separated from the manipulator chamber by a membrane for laminarizing an airflow of a circulation fan.

23. The decontamination assembly according to claim 12, wherein the atomizers (A, B, C, D) are configured as two-component nozzles supplied with compressed air.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Further advantages, features and details of the invention can be derived from the following description of a preferred exemplary embodiment and from the drawing.

DETAILED DESCRIPTION

[0045] FIG. 1 is a fluid scheme of a preferred exemplary embodiment of a decontamination assembly which is configured according to the idea of the invention and in which the chamber to be decontaminated is an isolator chamber, preferably a manipulator chamber.

[0046] In FIG. 1, an isolator system 1 comprising an isolator 2 for pharmaceutical applications and a decontamination assembly 3 for decontaminating a chamber to be decontaminated 4 being assigned to or integrated into isolator 2 are shown, said chamber 4 being a so-called manipulator chamber of isolator 2, in which a pharmaceutical process such as a dosing, production and/or filling process takes place by means of corresponding machinery or equipment, the manipulator chamber being manually accessible by means of glove ports (not shown). In a manner known per se, the manipulator chamber is connected, via backflow channels, to a circulation generating chamber which is disposed above the chamber to be decontaminated and in which a circulation fan is located, a circulation volume flow being producible by means of the circulation fan when isolator 2 is operated, said circulation volume flow flowing from the circulation chamber via corresponding high efficiency particulate air filters into a so-called plenum chamber and via said plenum chamber through a membrane into the manipulator chamber. The aforementioned backflow channels are preferably disposed between two transparent panes, in particular transparent glass panes.

[0047] In the case at hand, the decontamination assembly comprises several atomizers A, B, C, D which are configured as two-component nozzles (mixing nozzles). For this purpose, each atomizer A, B, C, D is connected to a corresponding compressed air supply line 5, 6, 7, 8 which can be supplied with compressed air from a compressed air source 9. In the case at hand, compressed air supply lines 5, 6, 7, 8 are connected to a compressed air distribution line 10 by means of which chamber 4 to be decontaminated can be supplied with pure and conditioned (temperature-controlled and/or moisture-regulated) compressed air, as well.

[0048] In the case at hand, each compressed air supply line 5, 6, 7, 8 is assigned a pressure measuring device 11, 12, 13, 14 in order to monitor the respective air pressure. Furthermore, a stop valve 15, 16, 17, 18 is disposed in each compressed air supply line 5, 6, 7, 8 in order to be able to stop or to open a connection between a respective atomizer A, B, C, D and compressed air source 9. The air pressure (supply air pressure) at individual atomizers A, B, C, D can be or is defined by means of corresponding throttles or adjusting valves 19, 20, 21, 22. Additionally, there is a filter 23, 24, 25, 26 in each compressed air supply line 5, 6, 7, 8. In any event, atomizers A, B, C, D are supplied with a compressed air carrier air flow to which, as will be described below, decontamination liquid is added, preferably in an intermittent manner, said decontamination liquid being micro-dispersed or nebulized by means of atomizers A, B, C, D, which are located in chamber to be decontaminated 4, by producing a corresponding decontamination liquid aerosol.

[0049] Valve means 27 are disposed upstream of atomizers A, B, C, D in the form of switch valves 28, 29, 30, 31 in the case at hand, which can be controlled in a timed manner by means of control means (not shown) to influence the respective opening and closing time in order to define the volume of decontamination liquid dispensed to atomizers A, B, C, D. In the present exemplary embodiment, switch valves 28, 29, 30, 31 are operated in an intermittent, i.e. clocked manner. The total opening time of individual switch valves 28, 29, 30, 31 is defined by means of control means to define the decontamination liquid volume to be dispensed. The illustration according to FIG. 1 shows that atomizers A, B, C, D are directly adjacent to switch valves 28, 29, 30, 31. Switch valves 28, 29, 30, 31 are directly adjacent to a ring conduit 32 and control the dispensation of decontamination liquid from said ring conduit to the assigned atomizers.

[0050] As explained in the general description, switch valves 28, 29, 30, 31 can be controlled in the same manner or in different manners, for example in a sequential or overlapping manner, in order to influence the decontamination aerosol flow in chamber to be decontaminated 4.

[0051] Ring conduit 32 comprises an inlet 33 and a separate outlet 34, decontamination liquid from a decontamination liquid storage tank 36 being conveyed into inlet 33 by means of a pump 35. Decontamination liquid thus arrives at switch valves 28, 29, 30, 31 and, by means of said switch valves, at assigned atomizers A, B, C, D. The decontamination liquid flows through outlet 34 back into decontamination liquid storage tank 36, i.e. it is conveyed in a circular manner.

[0052] Ring conduit 32 is assigned pressure adjustment means 37 comprising, in the case at hand, a non-return valve 38 which operates in a mechanical manner and which is tuned to the, in particular constant, pump capacity of pump 35 in such a manner that decontamination liquid which is converted into an aerosol by means of at least one of atomizers A, B, C, D flows back into decontamination liquid storage 36 during a decontamination cycle.

[0053] During the decontamination cycle, a bypass valve for a possible bypassing of non-return valve 38 is closed.

[0054] Decontamination liquid storage tank 36 is assigned measuring means 40 which are in the form of weighing means 41 in the case at hand and which can be used to determine the weight of the decontamination liquid located in decontamination liquid storage tank 36 when ring conduit 32 is filled with decontamination liquid before a decontamination cycle and the weight of the decontamination liquid located in decontamination liquid storage tank 36 when ring conduit 32 is filled after completion of the decontamination cycle.

[0055] A connector valve 42 is optionally provided, a starting section and an end section of ring conduit 32 being connectable by means of said connector valve 42 so that, in particular during a decontamination cycle, pump 35 can convey decontamination liquid from two sides into a section of ring conduit 32 from which atomizers A, B, C, D can be supplied or to which atomizers A, B, C, D are connected via valve means 27.

[0056] Furthermore, ring conduit 32 is assigned a compressed air connection 43 for emptying ring conduit 32, for which purpose the line connections are switchable in a corresponding manner by means of provided 3/2 way valves 44, 45.

[0057] As can be seen, ring conduit 32 is assigned a fluid pressure measuring device 46. In the case at hand, said device 46 is only used for monitoring the liquid pressure in ring conduit 32 and is not part of a pressure controlin the present exemplary embodiment, the pressure adjustment of the fluid pressure is exclusively realized through an interaction of pump 35 and non-return valve 38, alternative solutions for adjusting the pressure or for keeping the pressure in a desired range also being conceivable, as is explained in the general description.

REFERENCE SIGNS

[0058] 1 isolator system (system) [0059] 2 isolator [0060] 3 decontamination assembly [0061] 4 chamber to be decontaminated [0062] 5 compressed air supply line [0063] 6 compressed air supply line [0064] 7 compressed air supply line [0065] 8 compressed air supply line [0066] 9 compressed air source [0067] 10 compressed air distribution line [0068] 11 pressure measuring device [0069] 12 pressure measuring device [0070] 13 pressure measuring device [0071] 14 pressure measuring device [0072] 15 stop valve [0073] 16 stop valve [0074] 17 stop valve [0075] 18 stop valve [0076] 19 adjusting valve [0077] 20 adjusting valve [0078] 21 adjusting valve [0079] 22 adjusting valve [0080] 23 filter [0081] 24 filter [0082] 25 filter [0083] 26 filter [0084] 27 valve means [0085] 28 switch valve [0086] 29 switch valve [0087] 30 switch valve [0088] 31 switch valve [0089] 32 ring conduit [0090] 33 inlet of the ring conduit [0091] 34 outlet of the ring conduit [0092] 35 pump [0093] 36 decontamination liquid storage tank [0094] 37 pressure adjustment means [0095] 38 non-return valve [0096] 39 bypass valve [0097] 40 measuring means [0098] 41 weighing means [0099] 42 connector valve [0100] 43 compressed air connection [0101] 44 3/2 way valve [0102] 45 3/2 way valve [0103] 46 fluid pressure measuring device [0104] A atomizer [0105] B atomizer [0106] C atomizer [0107] D atomizer