DE102014202592A1 - Insulator for processing medical substances and method for decontaminating an insulator - Google Patents

Abstract

The present invention relates to an isolator 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 the working space 2, wherein the second supply system 4 is arranged independently of the first supply system 3 in the insulator and wherein the first outlet openings 30 are arranged in the working space 2 at different positions than the second outlet openings 40. The present invention further relates to a method for decontaminating an insulator 1 with a closed working space 2, a first supply system 3 and a second supply system 4 independent of the first supply system 3, comprising the steps of decontaminating the working space 2, wherein decontamination medium via the first supply system 3 in the working space 2 is supplied and of purging the working space 2 with a flushing medium, in particular compressed air, wherein the flushing medium is supplied via the first supply system 3 and the second supply system 4 in the working space 2 to remove the decontamination medium.

Description

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 process are, for example, from DE 10 2009 012 414 B4 and DE10 2008 041 521 A1 known. 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, a decontamination process must be carried out after closing the door. 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 the decontamination of the production environment, the hydrogen peroxide must be rinsed out again in order to prevent an impairment 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. In addition, hydrogen peroxide and the generally used decontamination media are toxic to humans in certain amounts. 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 using hydrogen peroxide vapor, condensed hydrogen peroxide must be 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 cost-intensive and time-consuming, since the positions with 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 advantage over that a much shorter flushing time and an improvement in Spülhomogenität can be ensured upon reaching the aseptic quality of the production environment and thus that the disadvantages of the prior art can be eliminated. Particularly with very low acceptance criteria for the residual concentration of the decontamination medium, a significant time-saving effect can be achieved with manageable energy and capital expenditures, because the rinsing times can be partially halved. 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 closed working space, a first supply system with first outlet openings for supplying decontamination medium or flushing 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 arranged independently of the first supply system in the insulator. Furthermore, the first outlet openings are arranged in the working space at different positions than the second outlet openings.

The dependent claims show preferred developments of the invention. Preferably, the second supply system is adapted to suck in decontamination medium from the working space. 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 a variety of hard to reach positions can be reached and rinsed with flushing 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 an increase in efficiency of the flushing of the insulator and consequently to a reduction of the flushing time.

In order to provide energy savings and improved decontamination results, the isolator may preferably comprise a pulsation device which promotes the medium in the first supply system and / or in the second supply system pulsating. The pulses or pulse pauses, which can be defined according to the application, can also take place at irregular intervals, that is, 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 the decontamination of the working space (decontamination phase of the working space), wherein decontamination medium is supplied via the first supply system in the working space. The second step of the method according to the invention comprises rinsing the working space (rinsing phase of the working space) with a rinsing medium, in particular compressed air, wherein the rinsing 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 rapidly flush the above-mentioned hard-to-reach areas of the working space from the decontamination medium. 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 flushing of the second supply system can be done actively with decontamination medium either from the working space or from a container. For example, a switchable blower 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 supplies medium in a second mode in the working space. Also conceivable is the use of two individual pressure generating devices, which can be arranged parallel to one another and in opposite directions and can be operated accordingly.

The decontamination medium from the working space is preferably aspirated before flushing the working space with flushing medium in the second supply system (decontamination phase of the second supply system intake phase). Thereby, the decontamination of the second supply system can be done with the already existing in the working space decontamination medium, which also serves to remove a part of the decontamination medium from the working space of the insulator. Thus, the purge time of the insulator can also be reduced by having a smaller amount of decontamination medium removed from the workspace later in the purge phase. In addition, it may be waived to provide an additional or larger container with decontamination medium for the second supply system in order to store a larger amount of decontamination medium can. 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 is brought to the most suitable phase depending on the application can be. 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. It is also conceivable that the decontamination and / or the rinsing of the working space can be carried out 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:

1 a schematic, greatly simplified view of the insulator according to the invention in the decontamination phase of the working space,

2 an enlarged, in 1 circle of the insulator according to the invention,

3 a schematic, highly simplified view of the insulator according to the invention in the decontamination phase of the second supply system (suction phase), and

4 a schematic, greatly simplified view of the insulator according to the invention in the rinsing phase of the entire insulator.

Embodiment of the invention

The following is with reference to the 1 to 4 an insulator 1 according to an embodiment of the present invention described in detail.

How out 1 . 3 and 4 it can be seen, the insulator according to the invention 1 a locked workspace 2 , a first supply system 3 and a second supply system 4 on. Furthermore, the insulator according to the invention comprises 1 a return system 5 , which is not shown in detail. In the workroom 2 are work desks 9 and machines 10 shown schematically.

The first supply system 3 has a first main line 31 on, extending in nine shorter, perpendicular to the first main line 31 arranged, first lines 32 branched. The first lines 32 lead to first outlet openings 30 , At the first outlet openings 30 is a filter 8th arranged with high efficiency against particles, which the exiting air during normal operation of the insulator 1 of possible pathogens such as viruses, germs cleans. The filter 8th which is formed in one piece and in one stage in this embodiment and over the entire length of the outlet openings 30 extends, is made of glass fibers. It should be noted that both the number of first lines 32 , their shape and arrangement, as well as the shape, the material and consequently the effectiveness of the filter 8th can be selected and adjusted depending on the application. At the first main line 31 is as a pressure generating device 33 arranged a first fan, which further comprises a first container 34 and a second container 35 over a line 36 connected is. The first fan is further provided with a pulsation device 7 connected, which may include, for example, a controller and the complete decontamination process of the insulator 1 controls.

The first container 34 contains as a decontamination medium, for example, hydrogen peroxide in the form of a 35 percent solution that offers a very high bactericidal effect, is relatively environmentally friendly and technically feasible. However, other substances also have decontamination properties, such as 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 flushing medium, for example, the use of preconditioned, in other words, tempered and dehumidified air is possible. At the containers 34 and 35 are a shut-off device 37 and a shut-off device 38 arranged to selectively remove hydrogen peroxide and compressed air accordingly. The first container 34 and the second container 35 are each further with a heater 6 connected.

The second supply system 4 is in a wall element 11 and a floor 12 of the insulator 1 installed and has a second main line 45 on which is angled 90 ° and which are in five shorter perpendicular to the main line 45 arranged second lines 42 branched. The second lines 42 lead to second outlet openings 40 , giving access to the work space 2 is ensured. The second outlet openings 40 are at those positions in the workspace 2 arranged, which are difficult to access, such as between the wall element 11 and the work desks 9 and between work desks 9 and the machines 10 , Other hard-to-reach positions, but not shown in detail in the figures, include filter bells, flaps for closing channels, corners in the work space 1 etc.

How out 1 and better 2 it can be seen have the second lines 42 one shut-off device each 43 to the controlled, independent shutting off or operating the second lines 42 on. The shut-off devices 43 For example, they can be shut-off valves. Further, at the second outlet openings 40 one nozzle each 44 arranged, whose profile has the shape of a trapezoid.

It should be noted that the shape, the number and the arrangement of the second main line 45 and the second lines 42 as they are in 1 . 3 and 4 are shown, are not limiting and serve only to simplify the presentation of the present invention. It is also conceivable, for example, a network of in the ceiling of the insulator 1 built-in main lines leading to a variety of lines in the wall panels and / or the bottom of the insulator 1 to lead.

At the other end of the second main line 45 is a second blower 41 arranged, in turn, with a third container 46 and the first container 34 over a line 47 communicates. The fan 41 is switchable, that is, the fan 41 Depending on the setting, medium can conduct in both directions. The fan 41 is further with the pulsation device 7 connected.

The third container 46 contains compressed air, which is used as a detergent. 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 with the heater 6 connected. At the third container 46 is a shut-off device 48 arranged. Furthermore, the first container 34 next to the shut-off device 37 another shut-off device 49 arranged with the pipe 47 connected is.

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 workroom 2 is arranged, but not within the meaning of the present invention and therefore not shown in detail.

The following is with reference to the 1 . 3 and 4 a method of decontaminating the insulator 1 according to an embodiment of the present invention.

1 shows the insulator 1 in the decontamination phase of the working space 2 in which the working space 2 is decontaminated with hydrogen peroxide. In this phase, only the first supply system 3 operated, the second conduit system 4 stands still.

At the beginning of the decontamination phase, the hydrogen peroxide of the container 34 from the heater 6 heated until the hydrogen peroxide becomes steam. Subsequently, the resulting hydrogen peroxide vapor from the first blower 33 through the first outlet openings 30 in the workroom 2 of the insulator 1 blown. This is shown by arrows A. 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 his way to the workroom 2 The hydrogen vapor also decontaminates the pipe 36 , the first main line 31 , the first lines 32 and the filter 8th , 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 needs a certain amount of time in the workspace 2 or in contact with the work tables and machines to ensure their decontamination.

Subsequently, a decontamination of the second supply system 4 , In 3 is the insulator 1 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 workspace 2 of the insulator 1 located in the second conduit system 4 through the switchable fan 41 sucked. This is indicated by the arrows B in the second lines 42 and the second main line 45 shown. In this case, the switchable fan 41 switched so that the switchable blower 41 Medium from the workroom 2 sucks, rather than medium in the work space 2 blow. Switching the fan 41 on the intake function and the individual parameters of the corresponding intake phase such as their duration is controlled by a control unit.

It should be noted that the suction of hydrogen peroxide is carried out in a pulsating or intermittent manner. This means that there are several shorter suction steps, each followed by a stop step. The reason for this is that the effectiveness of the hydrogen peroxide as a decontamination medium can be ensured only after a certain time, in which the hydrogen peroxide in contact with the lines of the second conduit system 4 is. 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 is in the appropriate container 34 led to later re-use. 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 supply system 4 also during the decontamination phase of the workspace 2 and not just after its end can take place. Once a sufficient amount of hydrogen peroxide in the work space 2 is present, the suction of hydrogen peroxide in the second supply system 4 respectively. By almost simultaneous decontamination of the work space 2 and the second supply system 4 The total decontamination time can be reduced.

After the second supply system 4 are decontaminated, both supply systems 3 and 4 flushed with compressed air. At the beginning of this phase, referred to as the rinse phase and in 4 is shown, the compressed air is the container 35 and 46 through the heater 6 heated. This leads to an increase in efficiency of the flushing of the working space 2 from the hydrogen peroxide by allowing the heated compressed air to run faster on the surfaces of the working space 2 condensed hydrogen peroxide evaporates. After heating the compressed air, this is via the first supply system 3 and the second supply system 4 in the workroom 2 of the insulator 1 blown. This is shown by the arrows C. In particular, a large amount of compressed air from the container 35 through the first fan via the first supply system 3 in the workroom 2 fed. To the hard-to-reach positions in the workspace 2 is compressed air from the container 46 via the second supply system 4 fed. This is the blower 41 switched back to the bubble function. The vaporized hydrogen peroxide is passing through the workspace 2 injected compressed air into the return line system 5 repressed. Thus, all three piping systems, namely the first supply system 3 , the second supply system 4 and the return system 5 active during the rinsing phase.

In order to save energy, it is also possible to carry out the rinsing phase in pulsating steps, depending on the application, by means of the pulsation device 7 to be controlled.

By arranging a second supply system 4 next to the first supply system 3 in the insulator described above 1 , which are independent of each other, can a shorter flushing time of the insulator 1 be made without much design and / or energy expenditure compared to the prior art. As a result, the insulator 1 faster to the next start of production is available, which in turn leads to a significant cost savings due to downtime of the production machines.

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

• DE 102009012414 B4 [0002]
• DE 102008041521 A1 [0002]

Claims (12)

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 ), The second supply system ( 4 ) independent of the first supply system ( 3 ) is arranged in the insulator and - wherein the first outlet openings ( 30 ) in the workroom ( 2 ) at different positions than the second outlet openings ( 40 ) are arranged. Insulator according to claim 1, wherein the second supply system ( 4 ), decontamination medium from the working space ( 2 ). Insulator according to claim 1 or 2, wherein the second supply system ( 4 ) a vacuum pump or a blower ( 41 ) having. Insulator according to one of the preceding claims, wherein the second supply system ( 4 ) 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 ) containing the medium in the first delivery system ( 3 ) and / or in the second supply system ( 4 ) is heated. Insulator according to one of the preceding claims, further comprising a pulsation device ( 7 ) containing the medium in the first delivery system ( 3 ) and / or in the second supply system ( 4 ) promotes pulsating. Insulator according to one of the preceding claims, wherein at the second outlet openings ( 40 ) a nozzle ( 44 ) is arranged. Method for decontaminating an isolator ( 1 ) with a closed working space ( 2 ), a first supply system ( 3 ) and one from the first supply system ( 3 ) independent second supply system ( 4 ), comprising the steps of: - decontaminating the working space ( 2 ), wherein decontamination medium via the first supply system ( 3 ) in the working space ( 2 ) 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. Method according to claim 8, wherein before flushing the working space ( 2 ) with flushing medium the second supply system ( 4 ) is flushed through with decontamination medium. Method according to claim 9, wherein prior to rinsing the working space ( 2 ) with flushing medium the decontamination medium from the working space ( 2 ) into the second supply system ( 4 ) is sucked. Method according to one of claims 8 to 10, wherein the decontamination medium and / or the flushing medium by means of a heating device ( 7 ) are heated. Method according to one of claims 8 to 11, wherein the decontamination and / or the flushing of the working space ( 2 ) in a pulsating manner by means of a pulsation device ( 7 ).

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