EP3104985A1 - Isolator zur verarbeitung medizinischer stoffe und verfahren zum dekontaminieren eines isolators - Google Patents
Isolator zur verarbeitung medizinischer stoffe und verfahren zum dekontaminieren eines isolatorsInfo
- Publication number
- EP3104985A1 EP3104985A1 EP14821186.5A EP14821186A EP3104985A1 EP 3104985 A1 EP3104985 A1 EP 3104985A1 EP 14821186 A EP14821186 A EP 14821186A EP 3104985 A1 EP3104985 A1 EP 3104985A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- supply system
- medium
- working space
- insulator
- decontamination
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B08—CLEANING
- B08B—CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
- B08B15/00—Preventing escape of dirt or fumes from the area where they are produced; Collecting or removing dirt or fumes from that area
- B08B15/02—Preventing escape of dirt or fumes from the area where they are produced; Collecting or removing dirt or fumes from that area using chambers or hoods covering the area
- B08B15/026—Boxes for removal of dirt, e.g. for cleaning brakes, glove- boxes
Definitions
- Insulator for processing medical substances and methods for
- 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.
- a sterile packaging can be filled in a disinfected, ideally sterile environment with a sterilized product and sealed with a sterile cap.
- Decontamination process are carried out.
- a decontamination medium usually hydrogen peroxide vapor
- evaporator from a 35 percent hydrogen peroxide solution and passed into the insulator on the existing supply system.
- the decontamination medium must be displaced or diluted.
- hydrogen peroxide vapor must be condensed
- 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.
- 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
- the insulator has two independent from each other, in other words not directly interconnected supply systems for supplying a medium into the insulator.
- the insulator has a
- the second supply system is independent of the first one
- Outlet openings in the working space at different positions than the second outlet openings arranged.
- the second supply system is set up,
- Sterility of the lines of the second supply system can be ensured.
- 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.
- the second supply system to a vacuum pump or a fan, which allow the suction of the decontamination medium in the second supply system.
- 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
- 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.
- the decontamination medium can be brought by heating it to the correct phase to ensure the best possible decontamination of the insulator.
- the heating of the flushing medium leads to Increasing the efficiency of purging the insulator and consequently reducing the purging time.
- the isolator may preferably comprise a pulsation device, which comprises the medium in the first supply system and / or in the second
- 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.
- a nozzle is arranged at the second outlet openings.
- flushing medium targeted and at high speed, which facilitates the removal of the decontamination medium and causes a time and energy reduction.
- 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
- 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.
- a flushing medium in particular compressed air
- the flushing medium is supplied via the first supply system and the second supply system in the working space to remove the decontamination medium.
- 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
- the second supply system is rinsed with flushing medium with decontamination before flushing the working space.
- the second supply system can be decontaminated.
- Rinsing the second supply system can actively with Decontamination medium either done from the work space or from a container.
- 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
- 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
- Decontamination medium can be done, which also serves to remove a portion of the decontamination medium from the working space of the insulator.
- 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
- 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.
- the insulator can be efficiently decontaminated.
- 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.
- Figure 1 is a schematic, greatly simplified view of
- 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 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.
- 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
- first conduits 32 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.
- 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
- shut-off device 37 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
- the 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
- the second lines 42 each have a shut-off device 43 for the controlled
- the shut-off devices 43 may be, for example, shut-off valves.
- a nozzle 44 is arranged at the second outlet openings 40, whose profile has the shape of a trapezoid.
- 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.
- 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.
- a shut-off device 48 is arranged at the third container 46.
- 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.
- 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.
- Phase is operated only the first supply system 3, the second line system 4 is stationary.
- Container 34 is heated by the heater 6 until the hydrogen peroxide to 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
- Parameters of the corresponding intake phase e.g. their duration will be over one
- Control unit regulated.
- 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.
- Pulsation device 7 are controlled.
Landscapes
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102014202592.3A DE102014202592A1 (de) | 2014-02-13 | 2014-02-13 | Isolator zur Verarbeitung medizinischer Stoffe und Verfahren zum Dekontaminieren eines Isolators |
PCT/EP2014/079138 WO2015120943A1 (de) | 2014-02-13 | 2014-12-23 | Isolator zur verarbeitung medizinischer stoffe und verfahren zum dekontaminieren eines isolators |
Publications (1)
Publication Number | Publication Date |
---|---|
EP3104985A1 true EP3104985A1 (de) | 2016-12-21 |
Family
ID=52273154
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP14821186.5A Withdrawn EP3104985A1 (de) | 2014-02-13 | 2014-12-23 | Isolator zur verarbeitung medizinischer stoffe und verfahren zum dekontaminieren eines isolators |
Country Status (4)
Country | Link |
---|---|
EP (1) | EP3104985A1 (de) |
CN (1) | CN105980071B (de) |
DE (1) | DE102014202592A1 (de) |
WO (1) | WO2015120943A1 (de) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102021101402A1 (de) | 2021-01-22 | 2022-07-28 | Syntegon Technology Gmbh | Isolator zur Verarbeitung von medizinischen Stoffen und ein Verfahren zur Dekontamination eines Isolators |
Family Cites Families (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3542592A (en) * | 1968-05-02 | 1970-11-24 | Bell Tech Systems Inc | Method and apparatus for cleaning members with fluids |
GB2201344B (en) * | 1987-02-27 | 1991-07-17 | Senichi Masuda | Method for sterilising objects to be sterilised and sterilising apparatus |
GB2223678B (en) * | 1988-08-25 | 1991-10-23 | Cambridge Isolation Tech | Sterilizing systems |
AU634083B2 (en) * | 1990-08-14 | 1993-02-11 | Duphar International Research B.V. | Method of disinfecting the interior of an isolator and device suitable therefor |
US5525295A (en) * | 1992-05-06 | 1996-06-11 | Despatch Industries Limited Partnership | Barrier isolation system |
US5711705A (en) * | 1995-05-25 | 1998-01-27 | Flanders Filters, Inc. | Isolation work station |
CH689178A5 (de) * | 1996-11-18 | 1998-11-30 | Skan Ag | Vorrichtung zur gasfoermigen Dekontamination von Reinraeumen. |
CN2394710Y (zh) * | 1999-07-23 | 2000-09-06 | 黄斌 | 温控净化操作室 |
SE524496C2 (sv) * | 2002-12-13 | 2004-08-17 | Tetra Laval Holdings & Finance | Styrning av steriliseringsanordning |
EP1872874A1 (de) * | 2006-06-30 | 2008-01-02 | Ulrich Berens | Vorrichtung zum Reinigen von mit Öl oder Fett verschmutzten Maschinenteilen |
US8940245B2 (en) * | 2006-11-15 | 2015-01-27 | Micropyretics Heaters International, Inc. | Apparatus and method for sterilizing items |
JP5484681B2 (ja) * | 2007-03-28 | 2014-05-07 | パナソニックヘルスケア株式会社 | 無菌環境維持装置 |
US8658107B2 (en) * | 2008-08-20 | 2014-02-25 | Panasonic Healthcare Co., Ltd. | Isolator |
DE102008041521A1 (de) | 2008-08-25 | 2010-03-04 | Robert Bosch Gmbh | Vorrichtung mit abgeschlossenem Arbeitsraum mit verbesserter Reinigungsmöglichkeit |
DE102009012414B4 (de) | 2009-03-10 | 2012-01-19 | Ortner Reinraumtechnik Gmbh | Dekontamination eines Raumes mittels eines benutzerdefinierten Dekontaminationsprozesses |
JP5581018B2 (ja) * | 2009-07-30 | 2014-08-27 | パナソニックヘルスケア株式会社 | 滅菌庫 |
US8486332B1 (en) * | 2011-03-21 | 2013-07-16 | Jonathan J. Ricciardi | Methods and apparatuses for the disinfection of devices and other areas |
CN203075964U (zh) * | 2013-01-18 | 2013-07-24 | 杭州泰林生物技术设备有限公司 | 无菌层流隔离器 |
-
2014
- 2014-02-13 DE DE102014202592.3A patent/DE102014202592A1/de not_active Withdrawn
- 2014-12-23 EP EP14821186.5A patent/EP3104985A1/de not_active Withdrawn
- 2014-12-23 CN CN201480075422.3A patent/CN105980071B/zh not_active Expired - Fee Related
- 2014-12-23 WO PCT/EP2014/079138 patent/WO2015120943A1/de active Application Filing
Non-Patent Citations (2)
Title |
---|
None * |
See also references of WO2015120943A1 * |
Also Published As
Publication number | Publication date |
---|---|
WO2015120943A1 (de) | 2015-08-20 |
CN105980071B (zh) | 2020-02-18 |
DE102014202592A1 (de) | 2015-08-13 |
CN105980071A (zh) | 2016-09-28 |
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