EP3104985A1

EP3104985A1 - Insulator for processing medical substances and method for decontaminating an insulator

Info

Publication number: EP3104985A1
Application number: EP14821186.5A
Authority: EP
Inventors: Johannes Rauschnabel; Marcus Eichbauer
Original assignee: Robert Bosch GmbH
Current assignee: Syntegon Technology GmbH
Priority date: 2014-02-13
Filing date: 2014-12-23
Publication date: 2016-12-21
Also published as: CN105980071B; WO2015120943A1; CN105980071A; DE102014202592A1

Abstract

An insulator for processing medical substances, comprising a closed work chamber 2, a first delivery system 3 with first outlet openings 30 for delivering decontamination medium or flushing medium into the work chamber 2, and a second delivery system 4 with second outlet openings 40 for delivering flushing medium into the work chamber 2, wherein the second delivery system 4 is arranged independently of the first delivery system 3 in the insulator, and wherein the first outlet openings 30 in the work chamber 2 are arranged at different positions from the second outlet openings 40. A method for decontaminating an insulator 1 with a closed work chamber 2, a first delivery system 3 and a second delivery system 4 independent of the first delivery system 3, comprising the steps of decontaminating the work chamber 2, wherein decontamination medium is delivered via the first delivery system 3 into the work chamber 2 and said work chamber 2 is flushed with a flushing medium, in particular compressed air, wherein the flushing medium is delivered into the work chamber 2 via the first delivery system 3 and the second delivery system 4 in order to remove the decontamination medium.

Description

Description title

Insulator for processing medical substances and methods for

Decontamination of an insulator

State of the art

The present invention relates to an insulator for processing medical substances and a method for decontaminating such an insulator.

Such an insulator and such a decontamination method are known, for example, from DE 10 2009 012 414 B4 and DE10 2008 041 521 A1. Such isolators are increasingly used in the production of pharmaceuticals, where the production must be performed aseptically. In doing so, the isolator feeds into the direct production environment, consistently separating the production environment from the operator environment through a prevailing overpressure in the isolator. Furthermore, the production environment is kept particle-free and germ-free by means of filtered air, which is blown into the isolator via a supply system in a normally low-turbulence displacement flow. Thus, a sterile packaging can be filled in a disinfected, ideally sterile environment with a sterilized product and sealed with a sterile cap.

To bring the production area back to a sterile state after maintenance work with open doors, you have to close the door after closing the door

Decontamination process are carried out. For this purpose, one makes use of a decontamination medium, usually hydrogen peroxide vapor, which is produced with an evaporator from a 35 percent hydrogen peroxide solution and passed into the insulator on the existing supply system. At the end of decontamination of the production environment, the

Rinse out hydrogen peroxide again to prevent deterioration of the drug to be processed by oxidation processes. In particular, highly sensitive drugs can only be processed in a near decontamination medium-free atmosphere. Also, are hydrogen peroxide and those commonly used

Decontamination media in certain amounts toxic to humans. Therefore, it is of great importance to keep the proportion of the decontamination medium in the production environment of the isolator below a predefined limit.

For this, the decontamination medium must be displaced or diluted. In the case of the use of hydrogen peroxide vapor must be condensed

Hydrogen peroxide vaporized or desorbed from the surfaces. For this purpose, compressed air is used as flushing medium in the prior art and supplied via the existing supply system in the insulator. However, this is costly and time consuming because the positions are the most durable

Hydrogen peroxide adhesion are difficult to flush with the existing supply system and thus increase the total purging time. These positions include, for example, corners in the isolator, filter bells, etc. Longer purge times, in turn, result in later production startup, thereby reducing machine uptime.

Disclosure of the invention

The insulator according to the invention with the features of claim 1 has the opposite on the advantage that a much shorter flushing time and a

Improvement of rinsing homogeneity in achieving the aseptic quality of the

Production environment can be ensured and thus that the disadvantages of the prior art can be eliminated. Especially with very low acceptance criteria for the residual concentration of

Decontamination medium is a significant time saving effect

manageable energy and investment costs achieved by the

Partly halve rinsing times. This is inventively achieved in that the insulator has two independent from each other, in other words not directly interconnected supply systems for supplying a medium into the insulator. Here, the insulator has a

completed work space, a first supply system with first

Outlets for supplying decontamination medium or

Rinsing medium in the working space and a second supply system with second Outlet openings for supplying flushing medium in the working space of the insulator. The second supply system is independent of the first one

Supply system arranged in the insulator. Furthermore, the first

Outlet openings in the working space at different positions than the second outlet openings arranged.

The dependent claims show preferred developments of the invention.

Preferably, the second supply system is set up,

Aspirate decontamination medium from the workspace. Thus, the

Sterility of the lines of the second supply system can be ensured. In particular, when the suction of decontamination medium takes place shortly after the supply of the decontamination medium via the first supply system in the working space of the insulator, the decontamination time for the entire insulator can be kept small.

More preferably, the second supply system to a vacuum pump or a fan, which allow the suction of the decontamination medium in the second supply system.

According to yet another alternative embodiment of the insulator according to the invention, the second supply system has a plurality of lines. Further, in at least one line of the plurality of lines, preferably in all lines, more preferably a shut-off device is arranged. Due to the large number of lines can be a variety of hard to reach

Reached positions and rinsed with rinsing medium. The presence of shut-off devices in the lines is used for independent operation of the lines depending on the application. Particularly preferably, the insulator further comprises a heating device which heats or heats the medium in the first supply system and / or in the second supply system. Thus, the properties or the effect of the media can be controlled or adjusted depending on the application. In particular, the decontamination medium can be brought by heating it to the correct phase to ensure the best possible decontamination of the insulator. On the other hand, the heating of the flushing medium leads to Increasing the efficiency of purging the insulator and consequently reducing the purging time.

In order to provide energy savings and improved decontamination results, the isolator may preferably comprise a pulsation device, which comprises the medium in the first supply system and / or in the second

Supply system pulsating promotes. The pulses or pauses between pulses, which can be defined according to the application, can also be irregular

Intervals, that is, take place in an intermittent manner.

More preferably, a nozzle is arranged at the second outlet openings. Thus, the respective areas of the working space of the insulator are rinsed with flushing medium targeted and at high speed, which facilitates the removal of the decontamination medium and causes a time and energy reduction.

Furthermore, the invention relates to a method for decontaminating an insulator with a closed working space, a first supply system and a second supply system independent of the first supply system. The first step of the method according to the invention comprises

Decontamination of the working space (decontamination phase of the working space), wherein decontamination medium via the first supply system in the

Working space is supplied. The second step of the invention

Method comprises flushing the working space (rinsing phase of the working space) with a flushing medium, in particular compressed air, wherein the flushing medium is supplied via the first supply system and the second supply system in the working space to remove the decontamination medium. Via the first supply system, a large volume of decontamination medium can be supplied to the working space, the second supply system serving to serve the above-mentioned hard-to-reach areas of the working space of the

Flush decontamination medium quickly. Thus, a reduction in the flushing time of the working space of the insulator can be achieved.

Particularly preferably, the second supply system is rinsed with flushing medium with decontamination before flushing the working space. Thus, the second supply system can be decontaminated. The

Rinsing the second supply system can actively with Decontamination medium either done from the work space or from a container. For example, a reversible fan can be used, wherein the operating direction of the blower can be changed, so that the blower sucks in a first mode medium from the working space and possibly dissipates and in a second mode medium in the

Workspace feeds. Also conceivable is the use of two individual pressure generating devices, which are parallel to each other and in

be arranged opposite directions and can be operated accordingly.

The decontamination medium from the working space is preferably aspirated before rinsing the working space with flushing medium in the second supply system (decontamination phase of the second supply system - suction phase). This allows the decontamination of the second

Supply system with the already existing in the workspace

Decontamination medium can be done, which also serves to remove a portion of the decontamination medium from the working space of the insulator. Thus, the rinsing time of the insulator can be reduced by a smaller amount of decontamination medium later in the rinsing phase of the

Workspace must be removed. In addition, it may be omitted to provide an additional or larger container with decontamination medium for the second supply system to a larger amount of

Store the decontamination medium. Furthermore, a more turbulent flow in the working space of the isolator can be ensured if the aspiration of the decontamination medium into the second supply system e.g. intermittently.

Furthermore, the decontamination medium and / or the flushing medium are preferably heated by means of a heating device, whereby the

Decontamination medium and / or the flushing medium can be brought to the most appropriate phase depending on the application. Thus, the insulator can be efficiently decontaminated.

More preferably, the decontamination and / or the rinsing of the working space are performed in a pulsating manner by means of a pulsation device. This results in energy savings. Also conceivable is that the decontamination and / or the flushing of the working space can be performed at irregular intervals depending on the application.

Short description of the drawing

Hereinafter, an embodiment of the invention will be described in detail with reference to the accompanying drawings. In the drawing is:

Figure 1 is a schematic, greatly simplified view of

insulator according to the invention in the decontamination phase of the working space,

FIG. 2 shows an enlarged region of the insulator according to the invention, designated by circle in FIG. 1,

Figure 3 is a schematic, greatly simplified view of the

Insulator according to the invention in the decontamination phase of the second supply system (suction phase), and

Figure 4 is a schematic, greatly simplified view of

Insulator according to the invention in the rinsing phase of the entire insulator.

Embodiment of the invention

Hereinafter, an insulator 1 according to an embodiment of the present invention will be described in detail with reference to FIGS.

As can be seen from FIGS. 1, 3 and 4, the insulator 1 according to the invention has a closed working space 2, a first supply system 3 and a second supply system 4. Furthermore, the isolator 1 according to the invention comprises a return system 5, which is not shown in detail. In the working space 2 work tables 9 and 10 machines are shown schematically.

The first supply system 3 has a first main line 31, which branches into nine shorter, perpendicular to the first main line 31, the first lines 32 branches. The first lines 32 lead to first outlet openings 30. An The first outlet openings 30 a filter 8 is arranged with high efficiency against particles, which cleans the escaping air during normal operation of the insulator 1 of possible pathogens such as viruses, germs. The filter 8, which is formed in one piece and in one stage in this embodiment and extends over the entire length of the outlet openings 30, is made

Made of glass fibers. It should be noted that both the number of first conduits 32, their shape and arrangement, as well as the shape, material and, consequently, the efficiency of the filter 8 can be selected and adjusted according to the field of application. On the first main line 31 is as

Pressure generator 33, a first blower arranged, which is further connected to a first container 34 and a second container 35 via a line 36. The first blower is further connected to a pulsation device 7, which may for example comprise a control device and controls the complete decontamination process of the isolator 1.

The first container 34 contains as decontamination medium e.g.

Hydrogen peroxide in the form of a 35% solution, which offers a very high bactericidal effect, is relatively environmentally friendly and is technically feasible. However, other substances also show

Decontamination properties, e.g. the peracetic acid, chlorine dioxide, etc., which could also be used as a decontamination medium. The second container 35 contains compressed air, which is used as flushing medium. Instead of using compressed air as the flushing medium, for example, the use of

preconditioned, in other words, tempered and dehumidified air possible. On the containers 34 and 35 are a shut-off device 37 and a

Shut-off 38 arranged to selectively remove hydrogen peroxide and compressed air accordingly. The first tank 34 and the second tank 35 are further connected to a heater 6, respectively. The second supply system 4 is in a wall element 11 and a bottom

12 of the insulator 1 and has a second main line 45, which is angled 90 ° and which branches into five shorter perpendicular to the main line 45 arranged second lines 42. The second lines 42 lead to second outlet openings 40, whereby the access to the working space 2 is ensured. The second outlet openings 40 are at those

Positions arranged in the working space 2, which are difficult to access, such as between the wall element 1 1 and the work tables 9 and between the work tables 9 and the machines 10. Other difficult to reach

Positions that are not shown in more detail in the figures include

Filter bells, flaps for closing channels, corners in work space 1 etc.

As can be seen from FIG. 1 and better from FIG. 2, the second lines 42 each have a shut-off device 43 for the controlled,

independent shut-off or operating the second lines 42. The shut-off devices 43 may be, for example, shut-off valves. Further, a nozzle 44 is arranged at the second outlet openings 40, whose profile has the shape of a trapezoid.

It should be noted that the shape, number and arrangement of the second main conduit 45 and the second conduits 42, as shown in Figures 1, 3 and 4, are not limiting and are for the convenience of illustration of the present invention. It is also conceivable, for example, a network of main lines installed in the ceiling of the insulator 1, which lead to a plurality of lines in the wall elements and / or the bottom of the insulator 1.

At the other end of the second main line 45, a second fan 41 is arranged, which in turn with a third container 46 and the first

Container 34 is connected via a line 47 in connection. The blower 41 is switchable, that is, the blower 41 can conduct medium in both directions depending on the setting. The blower 41 is further with the

Pulsation device 7 connected.

The third container 46 contains compressed air, which is used as a rinsing agent. It is obvious that here as well as the container 35 preconditioned, namely tempered and dehumidified air can be used. The third container 46 is also connected to the heater 6. At the third container 46, a shut-off device 48 is arranged. Furthermore, a further shut-off device 49 is arranged on the first container 34 next to the shut-off device 37, which is connected to the line 47.

It should be noted that a plurality of measuring organs, control devices and safety devices along the first supply system 3 and the second supply system 4 or in the working space 2 is arranged, but which do not fall within the meaning of the present invention and are therefore not shown in detail. Hereinafter, a method for decontaminating the insulator 1 according to an embodiment of the present invention will be described with reference to FIGS. 1, 3 and 4.

FIG. 1 shows the insulator 1 in the decontamination phase of its working space 2, in which the working space 2 is decontaminated with hydrogen peroxide. In this

Phase is operated only the first supply system 3, the second line system 4 is stationary.

At the beginning of the decontamination phase, the hydrogen peroxide of the

Container 34 is heated by the heater 6 until the hydrogen peroxide to the

Steam is. Subsequently, the resulting hydrogen peroxide vapor from the first blower 33 is blown through the first outlet openings 30 into the working space 2 of the insulator 1. This is shown by arrows A. Of the

Hydrogen peroxide vapor decontaminates both the worktables 9 and the machines 10, as well as the hard-to-reach positions already described above. On its way to the working space 2, the hydrogen vapor also decontaminates the line 36, the first main line 31, the first lines 32 and the filter 8. As soon as the hydrogen vapor settles on a surface, it condenses on the surface. The decontamination phase lasts until the maximum permissible concentration of microorganisms in the working space 2 is reached. The smaller this concentration has to be, the longer the decontamination phase has to last. Even if the acceptance criteria are not so high, the hydrogen peroxide must remain in the working space 2 or in contact with the work tables and machines for a certain amount of time in order to maintain their acceptance

To ensure decontamination.

Subsequently, a decontamination of the second supply system 4 takes place. In FIG. 3, the insulator 1 is in the decontamination phase of the second

Supply system 4 shown. In this phase, hydrogen peroxide or hydrogen peroxide vapor, which is already in the working space 2 of the insulator 1, is sucked into the second line system 4 by the switchable blower 41. This is indicated by the arrows B in the second lines 42 and second main line 45. In this case, the switchable blower 41 is switched so that the switchable blower 41 medium from the

Working space 2 sucks, instead of blowing medium into the working space 2. Switching the blower 41 to the suction function and the individual

Parameters of the corresponding intake phase, e.g. their duration will be over one

Control unit regulated.

It should be noted that the suction of hydrogen peroxide in

pulsating or intermittent manner is performed. This means that there are several shorter suction steps, each followed by a stop step. Of the

The reason for this is that the effectiveness of the hydrogen peroxide as

Decontamination medium can be ensured only after a certain time, in which the hydrogen peroxide is in contact with the lines of the second conduit system 4. The aspirated hydrogen peroxide is added to the recirculation during the plurality of shorter intake phases by a pump which is not indicated. At the end of the decontamination phase of the second supply system 4, the sucked hydrogen peroxide in the

corresponding container 34 for later Neither use out. It is also possible to remove the sucked hydrogen peroxide in the exhaust air.

It should be noted that the decontamination phase of the second

Zuleitungssystems 4 also during the decontamination phase of

Workspace 2 and not just after the end can take place. As soon as a sufficient amount of hydrogen peroxide is present in the working space 2, the suction of hydrogen peroxide into the second supply system 4 can take place.

Due to the almost simultaneous decontamination of the working space 2 and the second supply system 4, the entire decontamination time can be reduced. After the second supply system 4 is decontaminated, both will

Supply systems 3 and 4 flushed with compressed air. At the beginning of this phase, referred to as rinsing phase and shown in Figure 4, the compressed air of the containers 35 and 46 is heated by the heater 6. This leads to a

Increasing the efficiency of the rinsing of the working space 2 from the hydrogen peroxide, in that the heated compressed air evaporates faster the hydrogen peroxide condensed on the surfaces of the working space 2. After the heating of the compressed air, this is via the first supply system 3 and the second supply system. 4 blown into the working space 2 of the insulator 1. This is shown by the arrows C. In particular, a large amount of compressed air is supplied from the tank 35 through the first blower via the first supply system 3 into the working space 2. At the hard to reach positions in the working space 2 compressed air is supplied from the container 46 via the second supply system 4. For this purpose, the blower 41 is switched back to the bubble function. The vaporized hydrogen peroxide is displaced by the injected into the working space 2 compressed air in the return line system 5. Thus, all three conduit systems, namely the first supply system 3, the second supply system 4 and the return system 5 are active during the purging phase.

In order to save energy, it is also possible to carry out the rinsing phase in pulsating steps, depending on the application

Pulsation device 7 are controlled.

By arranging a second supply system 4 next to the first supply system 3 in the above-described isolator 1, which are independent of each other, a shorter rinsing time of the insulator 1 can be achieved without much design and / or energy expenditure compared to the prior art. This has the consequence that the isolator 1 is available faster to the next production start, which in turn leads to a considerable

Cost savings due to downtime of the production machines leads.

Claims

Insulator for processing medical materials, comprising:

a closed working space (2),

a first supply system (3) with first outlet openings (30) for supplying decontamination medium or flushing medium into the working space (2) and

a second supply system (4) with second outlet openings (40) for supplying flushing medium into the working space (2),

wherein the second supply system (4) is independent of the first

Supply system (3) is arranged in the insulator and

wherein the first outlet openings (30) in the working space (2) are arranged at different positions than the second outlet openings (40).

Insulator according to claim 1, wherein the second supply system (4) is arranged to suck in decontamination medium from the working space (2).

Insulator according to claim 1 or 2, wherein the second supply system (4) comprises a vacuum pump or a blower (41).

Insulator according to one of the preceding claims, wherein the second supply system (4) has a plurality of lines (42) and wherein in at least one line (42) of the plurality of lines (42), preferably in all lines (42), a shut-off device ( 43) is arranged.

Insulator according to one of the preceding claims, further comprising a heating device (6) which heats the medium in the first supply system (3) and / or in the second supply system (4).

6. Insulator according to one of the preceding claims, further comprising a pulsation device (7), which promotes the medium in the first supply system (3) and / or in the second supply system (4) pulsating. 7. Insulator according to one of the preceding claims, wherein the second

Outlet openings (40) a nozzle (44) is arranged.

8. A method for decontaminating an insulator (1) with a

completed working space (2), a first supply system (3) and one of the first supply system (3) independent second

Supply system (4), comprising the steps:

Decontaminating the working space (2), wherein

Decontamination medium via the first supply system (3) in the working space (2) is supplied and

- Rinsing the working space (2) with a flushing medium, in particular

Compressed air, wherein the flushing medium via the first supply system (3) and the second supply system (4) in the working space (2) is supplied to remove the decontamination medium. 9. The method according to claim 8, wherein before rinsing the working space (2) with flushing medium, the second supply system (4)

Flushed decontamination medium.

10. The method according to claim 9, wherein before flushing the working space (2) with flushing medium, the decontamination medium from the working space (2) is sucked into the second supply system (4).

1 1. A method according to any one of claims 8 to 10, wherein the

Decontamination medium and / or the flushing medium by means of a

Heating device (7) are heated.

12. The method according to any one of claims 8 to 11, wherein the

Decontamination and / or flushing of the working space (2) in a pulsating manner by means of a pulsation device (7) are performed.