DE102017117568A1 - Decontamination arrangement, system and decontamination process - Google Patents

Abstract

The invention relates to a decontamination arrangement, in particular for pharmaceutical applications, comprising at least one space to be decontaminated (4), in particular an isolator space, preferably a manipulator space and / or a plenum space separated from the manipulator space by a membrane, further comprising a decontamination fluid reservoir (22) a plurality of arranged in the space to be decontaminated (4), preferably designed as two-fluid nozzles, atomizers (A, B, C) for generating a Dekontaminationsmittelaerosols with decontamination fluid, preferably hydrogen peroxide, via at least one supply line (25, 26, 27) are supplied, wherein that the decontamination liquid container (22) is designed as a pressure vessel (16) connected to a compressed air source (8) in which a delivery pressure can be generated by pressurizing, in particular sterile, compressed air from the compressed air source (8) through which the decontamination liquid from the pressure vessel (16) through the at least one supply line (25, 26, 27) in the direction of the atomizer (A, B, C) is conveyed.

Description

The invention relates to a decontamination arrangement, in particular for pharmaceutical applications, according to the preamble of claim 1, comprising at least one space to be decontaminated, in particular an isolator space, preferably a manipulator space and / or one of the manipulator space via a membrane (for laminarizing the air flow during operation after decontamination) separate plenum, further comprising a Dekontaminationsflüssigkeitsbehälter from a plurality of arranged in the space to be decontaminated, preferably designed as two-fluid nozzles, atomizer for generating a Dekontaminationsmittelaerosols with decontamination, preferably hydrogen peroxide, are supplied via at least one supply line.

Furthermore, the invention relates to a system according to claim 12, comprising an insulator, which is preferably adapted for pharmaceutical applications, with a space to be decontaminated, in particular a manipulator space and / or a separate from the manipulator chamber via a membrane for laminarizing an air flow of a circulating air blower of the insulator Plenum room and with a decontamination arrangement according to the invention. The circulating air blower is preferably arranged in a recirculation generator space above the abovementioned plenum space. Most preferably, the manipulator space is air-conductively connected to the recirculation generator space via a return flow channel which is more preferably formed between two transparent disks. Preferably, for the realization of the feature of the device of the isolator space for pharmaceutical or pharmaceutical applications in the manipulator space, a metering and / or a filling device for a pharmaceutical agent and / or a manufacturing device for such an active ingredient is arranged. It is particularly preferred if the manipulator space is accessible to an operator via gloves for manual intervention from the outside, wherein the gloves or so-called glove ports are arranged or fixed in a side wall of the manipulator space.

Furthermore, the invention relates to a decontamination method according to the preamble of claim 13, in particular for operating a decontamination arrangement according to the invention and / or a system according to the invention, wherein a space to be decontaminated, in particular an insulator space, preferably a manipulator space and / or a separate from the manipulator space via a membrane Plenum space is decontaminated by a decontamination liquid aerosol from a decontamination liquid, in particular hydrogen peroxide, which is supplied for this purpose with the decontamination liquid from the decontamination liquid container, by means arranged in the space to be decontaminated, preferably designed as two-fluid nozzle can be supplied with compressed air atomizer.

In the WO 2011/085735 A1 or the EP 2 719 962 A1 is a decontamination arrangement comprising a pharmaceutical insulator and a H ₂ O ₂ evaporator described. The H ₂ O ₂ evaporator (flash evaporator) is connected via a supply line directly to a plenum space, which is separated from an underlying manipulator space via a membrane for generating a laminar air flow during operation of the insulator. In a decontamination phase, hydrogen peroxide vapor is introduced into the plenum space via the supply line, the hydrogen peroxide vapor passing through the membrane down into the manipulator space.

From the US 6,010,400 A It is known to promote air in the recirculation mode by an evaporator, ie not to supply it with sterile compressed air from the outside, wherein the hydrogen peroxide vapor is introduced directly into a manipulator space, bypassing a catalyst soaked Hochleistungsschwebstofffilters in an area above the manipulator space.

The WO 2013/003967 A1 describes a decontamination arrangement in which hydrogen peroxide is not vaporized conventionally via a flash evaporator, but in which two-fluid nozzles are used to atomize the liquid hydrogen peroxide, that is to produce an aerosol. In the known decontamination arrangement, a reservoir and an atomizer are an integral part of a device which can be installed as a whole in the space to be decontaminated.

In addition, solutions are known from practice, in which a plurality of atomizers are connected to a common decontamination liquid container via a respective end to the associated atomizer supply line. Each supply line are assigned a pump and a valve. Before starting a decontamination cycle, the individual supply lines are filled via the respective pump; only then does the actual decontamination cycle begin, in which decontamination fluid is indicated via the atomizers in the space to be decontaminated in the form of an aerosol. After completion of the decontamination cycle, the supply lines are again emptied into the decontamination liquid container in order to determine the amount of decontamination liquid delivered via the atomizer total, including the Feed pumps are operated backwards. The total amount of spent or discharged decontamination fluid is determined by subtraction of the container weight before filling the supply lines and the weight of the container after completion of the decontamination cycle and after the emptying of the supply lines. A disadvantage of the known decontamination arrangement or the known decontamination process is the necessary for a validated decontamination process, consuming determination of the total amount of decontamination liquid dispensed because this all the supply lines must be emptied back into the container. In addition, the control of the plurality of pumps is complex and faulty or toleranced.

The EP 2 889 045 A1 describes a pharmaceutical isolator in which an atomizer is operated intermittently and by intermittent operation of a blower, a further finest distribution is achieved. The atomizer sucks in hydrogen peroxide from a pressureless decontamination fluid tank, which in turn is filled via a pump from a decontamination fluid tank. This principle is also in the EP 2 692 848 B1 described. Due to the suction pressure prevailing by the suction of the hydrogen peroxide in the supply line there is a risk of gas bubble formation over the entire conveying path.

Based on the aforementioned prior art, the present invention seeks to provide an improved decontamination arrangement, in particular for pharmaceutical applications and an improved decontamination process, which provides reproducible decontamination results and also has a simple structure. Preferably, the decontamination arrangement according to the invention and the decontamination method according to the invention should make it possible to simplify and accurately determine the total amount of decontamination liquid discharged via the atomizers during a decontamination cycle.

This object is achieved with regard to the decontamination arrangement having the features of claim 1, i. in a generic decontamination arrangement characterized in that the decontamination fluid is formed as connected to a compressed air source pressure vessel in which by pressurizing, in particular sterile, compressed air from the compressed air source, a delivery pressure can be generated by the decontamination fluid from the pressure tank through the at least one supply line in the direction the atomizer, preferably up to the atomizers is conveyed. Preferably, the compressed air source comprises a compressed air compressor and / or a compressed air tank and / or a compressed air cylinder. It is particularly preferred if the compressed air source in the flow direction of the air before the pressure vessel a filter, in particular according to pharmaceutical standards (preferably 0.22mm) is arranged downstream, or alternatively upstream to ensure the supply of the pressure vessel with sterile compressed air.

With regard to the system, the object is achieved with the features of claim 12 and with respect to the decontamination process with the features of claim 13, i. in a generic method, characterized in that the decontamination liquid container is formed as connected to a compressed air source pressure vessel in which by applying, in particular sterile, compressed air from the compressed air source, a delivery pressure is generated, with which the decontamination fluid from the pressure vessel in the direction of the atomizer, preferably until is promoted to the atomizers.

Advantageous developments of the invention are specified in the subclaims. All combinations of at least two of the features disclosed in the description, claims and / or figures fall within the scope of the invention.

In order to avoid repetition, features disclosed according to the device should be regarded as disclosed according to the method and be able to be claimed. Likewise, according to the method disclosed features should also be considered as disclosed device and claimable.

The invention is based on the idea to provide as a decontamination liquid container a pressure vessel in which with, in particular sterile, compressed air from a compressed air source, a delivery pressure is generated or can be generated, with which decontamination fluid from the pressure vessel distributed to the atomizer or in the direction of the atomizer through the at least one supply line, in particular the plurality, in particular a common distribution section dividing supply lines can be conveyed. Advantageously, active, ie electrical feed pumps, are dispensed with in a region between the decontamination liquid container designed as a pressure container and the atomizers for conveying the decontamination liquid from the decontamination liquid container to the atomizers. This simplifies the design and control of the device or of active components considerably. Also, as will be explained later, by simple development of the invention, the total amount during a Decontamination cycle via the atomizer decontamination liquid discharged easily determined without having to promote decontamination fluid from the at least one supply line back into the decontamination liquid container. For this purpose, it is only necessary to deliver the (known and / or certain) amount supplied to the pressure vessel at once or in several filling steps within the scope of a decontamination cycle via the atomizers during the decontamination cycle, wherein the at least one supply line due to the overflow or discharge pressure in the pressure vessel can be emptied or is. Any residual micro-fluid after emptying is of no consequence in terms of the accuracy of the particular amount of decontamination fluid dispensed. Another significant advantage of the invention is that due to the delivery pressure generated by compressed air critical negative pressures in the at least one supply line, at least over most of its longitudinal extension can be avoided, leading to gas bubble formation and thus possibly an uneven distribution of the decontamination on the Nebulizer or a shortage of individual atomizers can lead to decontamination fluid. As will be explained later, can be provided to further hedge against gas bubble formation in a range before, especially shortly before the atomizers throttle means to ensure at least over the majority of the longitudinal extent of the at least one supply line a corresponding overpressure. Such an embodiment with throttling means is particularly useful when a comparatively low delivery pressure is to be selected and / or in the flow direction of the decontamination fluid before the atomizers not one, in particular clocked operable switching valve is arranged.

Overall, the invention provides by the compressed air delivery of decontamination fluid in the direction of the atomizer a simple system structure and a good basis for a variety of possible developments and for a validatable, repeatable and reliable decontamination process.

In principle, it is possible and provided within the scope of the invention for the decontamination arrangement to have a plurality of spaces to be decontaminated. It is possible to assign individual rooms each a pressure tank with this associated atomizers. An alternative embodiment can also be implemented, in which the pressure tank supplies atomizers arranged in different rooms via at least one corresponding supply line.

Most preferably, the delivery pressure is selected from a value range between 0.2 bar and 0.8 bar, even more preferably between 0.25 bar and 0.5 bar. The abovementioned pressure ranges are preferred ranges, which in practice may, however, also deviate from this, in particular it may be preferable to select or set a higher delivery pressure in the case of the provision of switching valves. Basically, the delivery pressure depends on the type or type of atomizer used, in particular the design of the nozzle. Some atomizers require a higher inlet or discharge pressure than others. Furthermore, the delivery pressure is dependent on whether the atomizers a valve, in particular a switching valve is arranged upstream and if so, the optimal delivery pressure in turn depends on the type of valve or the valve type. Basically, valves with a smaller flow cross section or diameter require a higher delivery pressure.

It is very particularly preferred if the delivery pressure is maintained during the delivery of decontamination fluid through the atomizer in the aforementioned range of values or device is durable.

In a further development of the invention is advantageously provided that to the pressure vessel a Dekontaminationsflüssigkeitsvorratsbehälter is connected, from which the pressure vessel with decontamination fluid over, in particular one, even more preferably electrically operated, conveying pump comprehensive, funding is supplied. It is particularly expedient if means for delivering a defined, in particular user-adjustable decontamination fluid quantity to the pressure vessel are provided. In other words, the conveying means are controlled such that the fluid flow is influenced, for example via a valve, so that the pressure vessel is filled with a predetermined amount of decontamination fluid, which can be adjusted in particular by the user, within the scope of a decontamination cycle, either at once or in several filling steps. In this case, the amount of decontaminating fluid can be determined, for example, by arranging the storage container on a balance and detecting the quantity delivered to the pressure container in a classical manner by subtraction. Additionally or alternatively, the use of a flow meter (flow meter) is possible. It is also conceivable to arrange in the pressure vessel a level gauge, in particular a pressure switch, which emits a corresponding signal for stopping the conveying means and / or closing a valve upon reaching a predetermined filling quantity.

Anyway, it is possible after the amount of decontamination fluid in the pressure vessel It is known to promote the entire, in the initially empty pressure vessel supplied Dekontaminationsflüssigkeitsmenge by means of the discharge pressure in the direction of the atomizer during a Dekontaminationszyklus and deliver over this in the space to be decontaminated.

As mentioned, it is preferable to keep the delivery pressure in the pressure vessel as constant as possible or between an upper and a lower limit. For this purpose, the pressure vessel in the invention Druckeinstellmittel for holding the delivery pressure in the pressure vessel in a predetermined, in particular adjustable range associated with the pressure range is preferably selected between 0.2bar and 0.8bar, in particular between 0.25bar and 0.8bar.

In order to ensure the same as possible Dekontaminationsflüssigkeitsdruckverhältnisse in a range immediately before the atomizers, it is preferred if they are located (relative to the respective supply line lengths) as far as possible far away from the pressure vessel. Thus, the pressure losses due to friction and the like are the same for the same line cross-sections. The maximum difference of the supply line lengths is preferably 20%, preferably 10%, even more preferably only 5%, wherein it is very particularly preferred if the line lengths to the atomizers are the same.

In particular when two-component nozzles are used as atomizers, a compressed air pressure below the vapor pressure of the decontamination liquid (in the case of hydrogen peroxide 5 mm Hg, at 30.degree. C.) can generally result from the pressurization of the atomizers in the respective supply line. Either the delivery pressure should be selected so high that the vapor pressure of the decontamination fluid, at least over the largest portion or part of the length of the at least one supply line is not exceeded or in the case of realization of low delivery pressures, it is advantageous in a range in the flow direction of Decontamination fluid in front of the atomizers in the at least one supply line corresponding throttle means to provide in the simplest case, a diaphragm, which is responsible for a correspondingly sufficient pressure between throttle means and pressure tank, in particular over a majority of the longitudinal extent of the at least one supply line concern. The throttle means may not be adjustable in the simplest case, for example, be designed as a diaphragm or throttle valve. Conceivable is alternatively also the realization of adjustable throttle means, for example in the form of a proportional valve for varying the throttle effect and thus the fluid pressure in a region between the throttle means and the pressure tank. Preferably, the throttle means are located immediately in front of the respective atomizer.

Also conceivable is an embodiment without throttle means, in particular as mentioned, with correspondingly high enough delivery pressure. Preferably, in such a solution valve means in the form of switching valves in the flow direction of the decontamination liquid are arranged in front of the atomizers, which can be operated more preferably clocked to deliver pulsed or pulsed aerosol to the room to be decontaminated. Of course, such an embodiment with (additional) throttle means, then preferably in the flow direction of the decontamination fluid upstream of the switching valves, realized.

As indicated above, a further development of the invention is advantageously provided that in the at least one supply line in a region in the flow direction upstream of the atomizers each valve means in the form of, in particular clocked controllable, switching valves, most preferably 2- / 2-way valves provided are over which the atomizer can be supplied with decontamination fluid from the pressure vessel. In the context of the present disclosure, the feature of supplying the atomizers via valve means is to be understood such that the decontamination fluid must pass through or flow through valve means on its flow path from the pressure container to the atomizers. The valve means are controllable via control means (control means), in particular openable and closable. More preferably, the valve means are formed so that with these a fluid-conducting connection between the atomizers and the pressure vessel, in particular clocked, can be interrupted.

The discretely switching switching valves, in particular in the form of the aforementioned 2- / 2-way valves are preferably arranged such that between each atomizers, in particular all atomizers and the pressure vessel each such valve is and / or between the pressure vessel and at least one group of atomizers , In the case of providing a plurality of atomizer groups arranged on the pressure vessel, it is preferable to associate such a valve with each group. For optimum control and influenceability of the decontamination fluid aerosol generation, however, it is preferable to assign each atomizer its own valve, in particular a switching valve, ie a valve that can be switched between a fully closed and a fully open valve position.

In principle, it is possible to have a plurality of individual switching valves, in particular all Leave switching valves open during an entire Dekontaminationszyklus or only over a subsection (period) or more time-spaced periods of the decontamination cycle. However, it is very particularly preferred if at least one of the switching valves, in particular a plurality of switching valves, even more preferably all the switching valves are operated intermittently (clocked or pulsed) or driven by the control means. In principle, it is possible to control all the switching valves in the same way - preference is given to an embodiment in which at least two of the switching valves are actuated differently, ie with mutually different opening and / or closing times, in order to effect a different discharge quantity of decontamination fluid via the atomizer associated with the switching valves , in particular in order to apply a larger amount of decontamination fluid aerosol to particularly critical or infection-prone areas of the at least one space to be decontaminated. It is also possible to operate or open a plurality of switching valves or groups of switching valves in succession, in particular pulsed, in order thus to effect an aerosol flow in at least one space to be decontaminated, thereby ensuring an even better distribution of the decontamination liquid aerosol in the at least one space to be decontaminated can be.

Overall, it is preferred if the distance of the switching valves to the respectively associated atomizer is as short as possible.

With regard to the specific design of the atomizer, there are again different possibilities. Thus, it is conceivable in principle to use ultrasonic atomizers or atomizers working on other physical principles of action. However, it is very particularly preferred to use two-substance nozzles (mixing nozzles) as atomizers, which are connected to a compressed-air source for producing a stream of carrier gas. Alternatively, it is also possible to use single-substance nozzles, in particular for smaller spaces to be decontaminated, which are preferably also operated pulsed or supplied with decontamination fluid. In principle, it is advantageous if the atomizers are in any case designed in such a way that 90% of the decontamination mist or aerosol droplets leaving the atomizers have a particle size of less than 20 μm, preferably less than 10 μm.

In a further development of the invention is advantageously provided that the atomizers detection means, in particular a respective flow switch are assigned to be able to check whether actually decontamination liquid is present and / or discharged into the space to be decontaminated via the respective atomizer.

The invention also leads to a decontamination process, which is disclosed in large part in the foregoing description of the device. According to the invention, it is provided to convey decontamination fluid from a pressure tank via a conveying gas pressure generated by compressed air in the direction of, in particular, as far as the atomizers. In the case of providing the preferred throttling means already disclosed in connection with the device, the decontamination liquid is conveyed by means of or due to the delivery pressure at least up to the conveying means, whereby possibly the minimized distance between the throttling means and the atomizers by or possibly only takes place with the assistance of suction pressure, which can occur in the case of the use of two-fluid nozzles as an atomizer or occurs.

Preference is given to an embodiment of the method in which the (previously emptied) pressure vessel from a decontamination liquid container is filled with a defined amount of decontamination liquid, either at once or in several, in particular temporally spaced filling steps, in any case the entire amount of decontamination fluid filled up at once or in partial steps during a decontamination cycle is delivered via the atomizer to the space to be decontaminated. At the end of dispensing, the at least one supply line is preferably blown over the atomizers by means of the compressed air or the delivery pressure into the space to be decontaminated.

In order to realize the quantitative determination of the decontamination fluid discharged via the atomizers during a decontamination cycle, the corresponding valves of the decontamination arrangement can be controlled or controlled in such a way that a defined amount of decontamination fluid from the decontamination fluid reservoir can be emptied or discharged in one or more steps. emptied pressure vessel is conveyed or is conveyed and this entire amount is promoted by appropriate Druckluftbeaufschlagung of the pressure vessel in the direction of the atomizers or is conveyed and is discharged through these in the decontaminating room or can be dispensed, the total amount (capacity) of Decontamination fluid which is conveyed into the pressure vessel during a decontamination cycle, for example by weighing by means of a balance (difference) can be determined un d / or other means for delivering a defined amount of decontamination fluid, such as a pressure switch, which stops on reaching a predetermined Fülllevels the pressure vessel, the funding and / or closes a valve or the like.

Further preferred embodiments and details of the method will be described in the context in the description of the decontamination arrangement and of the isolator system.

Further advantages, features and details of the invention will become apparent from the following description, preferred embodiments and from the drawing.

This shows in the only one 1 a fluid scheme for preferred embodiments of a trained according to the concept of the invention decontamination arrangement in which the space to be decontaminated an insulator space in the present case is preferably a manipulator space.

In 1 is an isolator system 1 with an insulator 2 for pharmaceutical applications as well as an isolator 2 assigned or in this integrated decontamination arrangement 3 for the decontamination of a decontaminating space 4 shown, which in this case is a so-called manipulator space of the insulator 2 acts by a pharmaceutical process, such as a dosing or manufacturing and / or filling process with appropriate machinery or equipment expires, which can be manually intervened in the manipulator space on glove ports, not shown. The manipulator space is connected in a conventional manner via at least one return flow channel with a arranged above the space to be decontaminated Umlufterzeugerraum, in which there is a circulating air blower, via which during operation of the insulator 2 A recirculation air volume flow can be generated, namely from the recirculation air space via corresponding high-efficiency particulate filter into a so-called plenum space and via it through a membrane into the manipulator space. The aforementioned return flow channels are preferably formed in sections between two transparent panes, in particular transparent glass panes.

The decontamination arrangement here comprises a plurality of atomizers A . B . C , which are each formed as two-fluid nozzles (mixing nozzle). For this purpose, every atomizer A . B . C to an associated compressed air supply line 5 . 6 . 7 connected, in turn, with compressed air from a compressed air source 8th can be supplied, which are in turn assigned filter means according to pharmaceutical standard for producing sterile air or downstream. The compressed air supply lines 5 . 6 . 7 are pressure measuring devices 10 assigned to check the applied pressure. These pressure measuring devices 10 are pressure reducing agents 11 upstream to the supply pressure of the compressed air source 8th of preferably at least 6bar. Via an automatic valve 12 can the compressed air supply to the atomizer A . B . C be opened or closed. The respectively applied pressure of the carrier gas stream can via into the pressure supply line 5 . 6 . 7 integrated, in particular manually operable adjustment can be adjusted. With FS are the adjustment means 13 . 14 . 15 downstream flow switches with an upper and a lower limit downstream, to be able to check whether the carrier gas pressure at the atomizers A . B . C within a given range.

The compressed air source 8th serves at the same time to act as a pressure vessel 16 trained decontamination fluid container. Alternatively, different compressed air sources for supplying the two-fluid nozzles and the pressure vessel 16 be provided. The pressure vessel 16 is in the associated compressed air supply line 17 a pressure reducing valve 18 upstream, wherein the delivery pressure generated by the pressurization in the pressure vessel via a pressure control valve 19 (Holding means) is kept in a predetermined range of values. Via a drain valve 20 can, in particular for filling the pressure vessel 16 with decontamination liquid residual pressure to be released to the atmosphere. The in the pressure vessel 16 prevailing pressure is via appropriate pressure measuring means 21 supervised.

At the pressure vessel is a decontamination fluid reservoir 22 connected. This is the pressure vessel 16 about funding 23 , in the present case an electrically drivable pump, with a predetermined, settable Dekontaminationsflüssigkeitsmenge filled (after the pressure vessel 16 previously completely emptied). The in the pressure vessel 16 For example, a quantity delivered for a decontamination cycle is determined by weighing as an example - this is the decontamination fluid reservoir 22 on a balance 24 on.

From the pressure vessel 16 out in the direction of the atomizers A . B . C decontamination fluid, here hydrogen peroxide is conveyed via the delivery pressure applied, in particular following the filling with decontamination fluid, via supply lines 25 . 26 . 27 that are sized to the atomizers A . B . C related to the respective supply line length equidistant from pressure vessel 16 are spaced. The decontamination liquid transport from the pressure vessel 16 to the atomizers A . B . C can have a valve 28 started and interrupted. In the present embodiment, the pressure tank is still a level gauge 29 assigned.

In an area just before spraying A . B . C are in the respective supply line 25 . 26 . 27 throttling means 30 . 31 . 32 integrated by a sufficiently high pressure in the supply lines 25 . 26 . 27 between the pressure tank and the throttle means 30 . 31 . 32 ensure that gas bubble formation in this area is safely avoided. In one the throttle means 30 . 31 . 32 In the direction of flow of the decontamination fluid subordinate areas, ie only on a very short part of a suction pressure in the preferred use of two-fluid nozzles can form - an inadmissible spread this suction far into the supply lines 25 . 26 . 27 in can through throttle means 30 . 31 . 32 be prevented.

In the embodiment described above, none of the atomizers A . B . C directly assigned switching valves provided. However, such an embodiment is alternatively feasible. In this case, the components are 30 . 31 . 32 no longer prefers throttle means, but to, in particular clocked controllable switching valves 33 . 34 . 35 ,

Due to the fact that during a decontamination cycle the pressure vessel 16 and the supply lines 25 . 26 . 27 by means of the delivery pressure via the atomizers A . B . C is completely emptied and the previously supplied or after feeding in the pressure vessel 16 is known decontamination fluid amount is also the amount of this, delivered via the atomizer A . B . C delivered or atomized amount of decontamination fluid known. An expensive back emptying of the supply lines 25 . 26 . 27 into a container does not have to take place. Similarly, the use of electrically operated liquid pumps to supply the atomizer A . B , C with decontamination fluid from the container 16 be waived.

LIST OF REFERENCE NUMBERS

1

isolator system

2

insulator

3

decontamination arrangement

4

room

5, 6, 7

Compressed air supply line

8th

Compressed air source

10

Pressure measuring equipment

11

Pressure reduction means

12

Valve

13, 14, 15

adjustment

16

pressure vessel

17

Compressed air supply line

18

Pressure reducing valve

19

Pressure control valve

20

drain valve

21

Pressure measuring equipment

22

Decontamination inationsflüssigkeitsvorratsbehälter

23

funding

24

Libra

25

supply line

26

supply line

27

supply line

28

Valve

29

level meter

30, 31, 32

throttling means

33, 34, 35

switching valves

A, B, C

atomizer

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• WO 2011/085735 A1 [0004]
• EP 2719962 A1 [0004]
• US 6010400 A [0005]
• WO 2013/003967 A1 [0006]
• EP 2889045 A1 [0008]
• EP 2692848 B1 [0008]

Claims (14)

Decontamination arrangement, in particular for pharmaceutical applications, comprising at least one space to be decontaminated (4), in particular an isolator room, preferably a manipulator room and / or a plenum space separated from the manipulator room by a membrane, further comprising a decontamination liquid container (22) from the plurality in the decontaminating space (4) arranged, preferably designed as two-component nozzles, atomizers (A, B, C) for generating a Dekontaminationsmittelaerosols with decontamination, preferably hydrogen peroxide, via at least one supply line (25, 26, 27) are supplied, characterized in that the decontamination liquid container (22) as to a compressed air source (8) connected to the pressure vessel (16) is formed, in which by application of, in particular sterile, compressed air from the compressed air source (8), a delivery pressure can be generated by the decontamination fluid from the pressure vessel (16) through the at least one supply line (25, 26, 27) in the direction of the atomizer (A, B, C) is conveyed. Decontamination arrangement according to Claim 1 , characterized in that fluid-conducting with the pressure vessel (16) is a Dekontaminationsflüssigkeitsvorratsbehälter (22) is connected, from which the pressure vessel (16) with decontamination fluid over, in particular a feed pump comprehensive, conveying means (23) can be supplied. Decontamination arrangement according to Claim 2 , characterized in that means for delivering a defined, in particular adjustable, Dekontaminationsflüssigkeitsmenge to the pressure vessel (16) are provided, in particular comprising a Dekontaminationsflüssigkeitsvorratsbehälter (22) receiving balance (24) and / or a pressure vessel (16) associated with level meter (29 ) and / or a flow meter. Decontamination arrangement according to one of the preceding claims, characterized in that the pressure vessel (16) Druckeinstellmittel for holding the delivery pressure in the pressure vessel (16) are assigned in a predetermined, in particular adjustable, area. Decontamination arrangement according to one of the preceding claims, characterized in that measured by the atomizers (A, B, C) to the pressure tank line lengths of at least one supply line (25, 26, 27) a maximum of 20%, preferably at most 10%, most preferably maximum 5% different, most preferably the same. Decontamination arrangement according to one of the preceding claims, characterized in that in a region in the flow direction in front of the atomizers (A, B, C) respectively, in particular adjustable, throttling means (30, 31, 32) for maintaining a Mindestdekontaminationsflüssigkeitsdrucks in a region between the throttle means ( 30, 31, 32) and the pressure vessel (16) for preventing gas bubble formation are arranged. Decontamination arrangement according to one of the preceding claims, characterized in that the atomizers (A, B, C) can be supplied with the decontamination fluid by means of electronic control means controllable valve means and that the valve means, in particular clocked controllable, switching valves, in particular 2- / 2-way valves , wherein preferably individual atomizers (A, B, C), in particular all atomizers (A, B, C) each such a switching valve for supplying the respective atomizer (A, B, C) with decontamination liquid from the at least one supply line (25, 26 , 27), are assigned and / or that at least one group of atomizers (A, B, C), preferably a plurality of groups of atomizers (A, B, C) is assigned in each case such a switching valve / (for clocked switching valves high delivery pressure ) (Valve means in delivery line) Decontamination arrangement according to Claim 7 , characterized in that the control means, the switching valves are designed such that several, in particular all switching valves or switching valve groups are opened simultaneously and / or operated in a clocked and / or such that a plurality of switching valves or switching valve groups are opened sequentially and / or operated in a clocked manner and / or in such a way that at least one of the switching valves or at least one of the switching valve groups is opened longer during a decontamination cycle and / or operated longer than at least one of the switching valves or another of the switching valve groups. Decontamination arrangement according to one of Claims 7 or 8th , characterized in that the control means are designed to control the switching valves such that a predetermined amount of decontamination liquid to be atomized by controlling one, in particular clocked, total opening time of the switching valves can be dosed and / or such that a predetermined at one of the atomizer (A, B , C) or a group of the atomizer (A, B, C) to be metered amount of decontamination fluid by controlling a particular clocked, opening time of the associated switching valve is metered. Decontamination arrangement according to one of the preceding claims, characterized in that means are provided for heating the decontamination fluid, in particular to a temperature above 30 ° C, even more preferably above 40 ° C, very particularly preferably below the vaporization temperature of the decontamination fluid. Decontamination arrangement according to one of the preceding claims, characterized in that the atomizers (A, B, C) from two directions with decontamination fluid from the pressure vessel (16) can be supplied. System comprising an insulator (2), preferably designed for pharmaceutical applications, with a space to be decontaminated (4), in particular a manipulator space and / or a plenum space separated from the manipulator space via a membrane for laminarizing an air flow of a circulating air fan, and with a decontamination arrangement according to one of the preceding claims. Decontamination method, in particular for operating a decontamination arrangement according to one of Claims 1 to 11 and / or a system Claim 12 in which a space (4) to be decontaminated, in particular an isolator space, preferably a manipulator space and / or a plenum space separated from the manipulator space via a membrane, is decontaminated by means disposed in the space to be decontaminated (4), preferably as compressed air Two-fluid nozzle formed, atomizer (A, B, C) a decontamination aerosol from a decontamination fluid, in particular hydrogen peroxide is generated, which are supplied with the decontamination fluid from a decontamination fluid container (22), characterized in that the decontamination fluid container (22) as to a compressed air source ( 8) connected pressure vessel (16) is formed, in which by application of, in particular sterile, compressed air from the compressed air source (8), a delivery pressure is generated, with which the decontamination fluid from the pressure vessel in the direction of the atomizer (A, B, C), is encouraged. Decontamination after Claim 13 , characterized in that the initially empty pressure vessel (16) from a Dekontaminationsflüssigkeitsvorratsbehälter (22) is filled with a defined Dekontaminationsflüssigkeitsmenge and the entire, at one or more filling steps filled, Dekontaminationsflüssigkeitsmenge during a decontamination cycle on the atomizer (A, B, C) is delivered to the space to be decontaminated (4).

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