EP2806222B1 - Clean room for producing objects and method for operating a clean room - Google Patents

Clean room for producing objects and method for operating a clean room Download PDF

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Publication number
EP2806222B1
EP2806222B1 EP14168712.9A EP14168712A EP2806222B1 EP 2806222 B1 EP2806222 B1 EP 2806222B1 EP 14168712 A EP14168712 A EP 14168712A EP 2806222 B1 EP2806222 B1 EP 2806222B1
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EP
European Patent Office
Prior art keywords
clean room
production
air
air flow
turbulence
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EP14168712.9A
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German (de)
French (fr)
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EP2806222A3 (en
EP2806222A2 (en
Inventor
Richard Bösl
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Gerresheimer Regensburg GmbH
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Gerresheimer Regensburg GmbH
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Publication of EP2806222A2 publication Critical patent/EP2806222A2/en
Publication of EP2806222A3 publication Critical patent/EP2806222A3/en
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    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24—HEATING; RANGES; VENTILATING
    • F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F13/00—Details common to, or for air-conditioning, air-humidification, ventilation or use of air currents for screening
    • F24F13/08—Air-flow control members, e.g. louvres, grilles, flaps or guide plates
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24—HEATING; RANGES; VENTILATING
    • F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F3/00—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems
    • F24F3/12—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems characterised by the treatment of the air otherwise than by heating and cooling
    • F24F3/16—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems characterised by the treatment of the air otherwise than by heating and cooling by purification, e.g. by filtering; by sterilisation; by ozonisation
    • F24F3/167—Clean rooms, i.e. enclosed spaces in which a uniform flow of filtered air is distributed

Definitions

  • the invention relates to a clean room for producing objects, in particular medical products, with production areas and production facilities and with air supply openings for supplying a low-turbulence air flow into the clean room and the air outlet openings for removing the possibly contaminated with dirt particles turbulence-poor air flow from the clean room addition.
  • the invention further relates to a method for operating a clean room for producing articles, in particular medical products, in which a turbulence-poor air flow directed from a ceiling region of the clean room passes through this clean room into a floor area of the clean room and from there out of the clean room is directed to thereby prevent as far as possible contamination of the articles to be produced or medical products with undesirable substances.
  • Generic clean rooms are widely known from the prior art, in particular to be able to keep a concentration of airborne particles, such as dirt particles or germs, as low as necessary or possibly also as low as possible. Areas of application of such clean rooms can be found, for example, in semiconductor manufacturing, in optics and laser technology, aerospace engineering and the like. Especially in the field of the production of medical articles or medical products, production under clean-room conditions is often necessary in order to be able to ensure in particular aseptic conditions on production areas and / or production facilities. So are also in assembly processes of medical Plastic articles or articles often required corresponding cleanrooms of the EU-GMP Class C class.
  • a clean room island for manufacturing objects, in particular semiconductors, storage disks, medicaments, pharmaceutical articles, foodstuffs or the like.
  • This clean room island comprises a local clean room area separated from an environment, in which a handling device for handling or treating objects introduced into the local clean room area is arranged.
  • the local clean room area is thereby flowed through by a laminar air flow from top to bottom, whereby the risk is reduced, on the one hand dirt particles or germs within the local clean room area are undesirably stirred up and on the other hand, as a result of a generated by the laminar air flow pressure within the local clean room area Such dirt particles or germs can not even get into this local clean room area or at least to a greatly reduced extent.
  • a disadvantage of this clean room island, but also in otherwise previously known clean rooms, is that the laminar air flow generated in the local clean room area directly on technical facilities, such as this handling device or other production facilities, and work surfaces of these production facilities impinges and thereby undesirable Verwirbelungs bine in the Clean room or local clean room area occur, so that the introduced into the local clean room area original laminar air flow causes at least partially and temporarily turbulent air flows.
  • the object of the invention is a clean room for producing objects, in particular medical products, with production areas and production facilities and with air supply openings for supplying a low-turbulence air flow into the clean room and with air outlet openings for removing the optionally contaminated with dirt particles low-turbulence air flow from the clean room addition in which in one or more air flow paths between the air supply openings and the air outlet openings an air guide with air guide elements is arranged such that the low-turbulence air flow, bypassing caused by the production areas and / or production facilities air flow deflection at least partially around these production areas and / or production facilities around is conductive.
  • the low-turbulence air flow on its flow path from the air supply openings to the air outlet openings no longer impacts directly on the production areas and / or on the production facilities.
  • an air volume entrained with the low-turbulence air flow can accordingly not bounce and interact at these production areas and / or production facilities in such a way that additional undesired turbulences arise within the clean room.
  • the low-turbulence air flow is now spaced from the production areas and / or the production facility passed around these production areas and / or this production facility around.
  • air guide elements By thus arranged and provided air guide elements is thus prevented in particular that meets the low-turbulence air flow at an obtuse angle to the production areas and / or on the production facilities and thereby critical air turbulence within the clean room, especially in the immediate vicinity of the production areas and / or production facilities, arise.
  • the low-turbulence air flow ideally meets at an acute angle to the air guide elements so that they do not rebound from these air guide elements and this but it is swirled and deflected at the surfaces of the spoiler almost turbulence free, and then completely turbulence-free or at least only slightly negligible swirling on the surfaces of the spoilers to be routed below the actual production areas and / or production facilities.
  • the surfaces of the air guide elements are designed to be particularly smooth in order to be able to further reduce the risk of turbulence formation.
  • air guiding device in the context of the invention describes a structure by means of which a production area and / or a production facility can be shielded from the low-turbulence air flow at least partially inaccessible.
  • the spoiler elements of the spoiler can be viewed with appropriate design as cladding elements of production areas and production facilities.
  • louver or its baffles made of a metal sheet, since this different geometric hollow body and larger dimensions can be relatively easily manufactured. It is understood that plastics, film materials or other materials for producing a suitable air guide can be used advantageously.
  • these hollow bodies can be arranged or placed at least partially over the production areas and production facilities.
  • the air guide elements has a surface roughness which does not or only negligibly contributes to an additional turbulence of the low-turbulence air flow when this low-turbulence air flow flows along the air guide elements.
  • low-turbulence air flow in the context of the invention describes a substantially not vortexed or only uncritically swirled air volume, which of the Air supply openings to the air outlet openings through the clean room without contact flows past the production areas and / or production facilities.
  • the low-turbulence air flow is ideally a laminar air flow.
  • the low-turbulence air flow is generated by means of an air flow device.
  • the air flow device comprises an air conveying device, such as a fan or the like, in order to be able to convey an air volume. Since such prior art air flow devices are well known in the clean room environment, this will not be discussed further.
  • the production areas are preferably an assembly station which is ideally provided with a rotary table, the air-guiding elements being arranged concentrically above this round table.
  • the undesired effect of air turbulence in the assembly area can be excellently prevented by the air guiding elements according to the invention since air guiding elements in this regard are placed in front of the relevant production areas and / or production facilities, that individual components, lines, cables or the like and of course also the products to be produced can be well shielded from the low-turbulence air flow.
  • the production facilities can be production units, assembly units, filling units, assembly or handling arm elements or the like.
  • the air guide elements are arranged centrically or concentrically above the production areas and / or the production facilities.
  • the air guide elements may also be arranged differently in the clean room, in order to keep the low-turbulence air flow in the context of the invention away from the production areas and / or production facilities. A particularly turbulence-free However, diverting the low-turbulence air flow can be achieved if the air guide elements are arranged concentrically or concentrically above the production areas and / or the production facilities.
  • the air guiding elements have air-flow directionally tapering housing elements, the low-turbulence air flow can be expanded particularly smoothly from top to bottom with respect to the main flow direction and can be guided around the production areas and / or the production facilities, thereby reducing the risk of additional turbulence on impact Air volume is significantly reduced to the air guide elements.
  • a preferred embodiment provides that the air guide elements are designed to taper at their air supply openings facing sides tapered, saddle-shaped or arcuate.
  • the low-turbulence air flow or an air volume relating thereto in the sense of the invention can be widened or redirected radially to the main direction of air flow, without critical air turbulences taking place due to the influence of the air guiding devices or respective housing elements.
  • such conical or saddle-shaped air guide elements taper in the direction of the air supply openings.
  • housing elements may also have other basic shapes than those mentioned above, provided that the clean room and the production areas and / or production facilities are designed accordingly.
  • the air guiding elements or housing elements relating to them are ideally lowered down to the surface of the actual production areas and / or production facilities, with the possible exception of those areas in which equipment or discharges are carried out by the objects to be produced.
  • the air guiding elements can also be arranged below the production areas and / or production facilities and possibly even into the floor area in order to be able to guide the low-turbulence air flow as far as possible down to the floor area.
  • the air guiding elements include housing elements whose body dimensions increase in the main air flow direction up to the maximum base area extent, the low-turbulence air flow can advantageously be conducted around the production areas and / or the production facilities without causing critical turbulences. In this respect, this can ensure that the low-turbulence air flow on its way between the air outlet openings to the air outlet openings remains substantially turbulence.
  • the present body expansion is a body extension which extends transversely to the low-turbulence air flow.
  • base area extent thus describes in the context of the invention a base area generated by an air guide element. It is understood that a base surface produced by the air guide element can have virtually any desired shape.
  • the air guide elements have a circular or oval base surface, the low-turbulence air flow in the main air flow direction can be guided around the production areas and / or production facilities with a particularly low turbulence.
  • the air guiding elements have openings on their sides facing the respective production areas and / or the production facilities, in which openings the production areas and / or the production facilities are at least partially projecting.
  • the air guiding elements form an envelope with respect to the production areas and / or the production facilities, which encloses an open volume in which the production areas and / or the production facilities can be arranged at least partially.
  • geometric bodies formed by the air guiding elements are open to the production areas and / or to the production facilities.
  • the air guiding elements are arranged at such a distance from the production areas and / or the production facilities that a suction effect is produced by means of the low-turbulence air flow in the region of the production areas and / or the production facilities or the like from the production areas and / or the production facilities are removable.
  • An advantageous embodiment variant therefore also envisages that the air-guiding elements at least partially surround the production areas and / or the production facilities in such a way that, during proper operation of the air-flow device between the air-guiding elements and the production areas and / or the production facilities, at least partially a negative pressure relative to the low-turbulence Air flow exists. If, due to the interaction between the arrangement of the air guide elements relative to the production areas and / or the production facilities and the low-turbulence air flow, a negative pressure between the air guide elements and the production areas and / or the production facilities can be generated by means of the low-turbulence air flow unwanted dirt particles or germs or the like of the Production areas and / or extracted from the production facilities and are immediately carried over the air vents out of the clean room.
  • the clean room according to the invention can be virtually any desired clean room. It is particularly advantageous if the clean room is a clean room of cleanroom class EU GMP Class C, in particular for particles larger than 5 microns.
  • the object of the invention is also achieved by a method for operating a clean room for producing objects, in particular medical products, in which a turbulence-poor air flow introduced from a ceiling area of the clean room passes through the clean room into a floor area of the clean room and from there is directed out of the clean room to prevent contamination of the articles or medical products to be produced as much as possible with undesirable substances, the method is characterized in that the low-turbulence air flow to arranged in the interior of the clean room production areas and / or production facilities such is passed that the low-turbulence air flow on its way from the ceiling area to the floor area, bypassing a direct operative contact with the production areas and / or production facilities to this production area and / or these production facilities are routed around.
  • the low-turbulence air flow can be guided past the present air guiding elements at a speed of, for example, 0.45 m per second, with a particularly low turbulence.
  • the Indian FIG. 1 shown clean room 1 according to the clean room class EU GMP Class C is part of a production facility 2 not shown here for the production of medical products 3 (here only exemplified) under aseptic conditions.
  • the clean room 1 comprises a manufacturing cell 4, which is spatially separated by a housing 5 from another working environment 6 of the production plant 2.
  • the housing 5 in this case consists essentially of a bottom part 7 and a frame 8 which is based thereon, in which glass elements 9 are held.
  • the manufacturing cell 4 is shown without ceiling plate, in which the air supply openings (not shown here) of an air flow device (not explicitly numbered here) for generating a low-turbulence air flow 10 (see Fig. 5 ) are arranged.
  • Air outlet openings 11 for drawing off the turbulence-poor air flow 10 possibly contaminated with dirt particles from the production cell 4 of the clean room 1 are placed directly above the floor part 7 in the floor area 12.
  • the low-turbulence air flow 10 runs inside the manufacturing cell 4 of the clean room 1 in an air flow main direction 13 from the ceiling part, not shown here from top to bottom to the bottom part 7 downwards; namely as laminar air flow.
  • the first production device 30 is a rotary table 40 with a centrally arranged and relatively large production area (not shown here) with a multiplicity of workpiece carriers 42 arranged concentrically around an axis of rotation 41 (numbered here only by way of example).
  • first production station 45 a first production station 45 and, secondly, different further identical or identical production stations 46, 47 and 48, by means of which the medical products 3 deposited on the workpiece carriers 42 are processed step by step or can be completed.
  • the production stations 46, 47 and 48 are distinguished in this embodiment by a respective manufacturing arm 49 from.
  • All of the production areas 26 and production facilities 30 to 34 associated air guide elements 20 to 24 are arranged above these production areas 26 and production facilities 30 to 34, so that the air guide elements 20 to 24 respectively between the individual air flow paths 14 of the above-flowing low-turbulence air flow 10 and the respective production areas 26 and production facilities 30 to 34 are located.
  • the air guiding elements 20 to 24 can shield these production areas 26 and production facilities 30 to 34 from the low-turbulence air flow 10 so that they can not come into operative contact with the production areas 26 and production facilities 30 to 34 critically.
  • the first air guiding element 20 is a conically extending housing element 50 whose tip 51 points in the direction of the air supply openings. insofar the conically extending housing element 50 is a conical housing element 53.
  • the conical housing element 50 completely shields the first production device 30, namely the rotary table 40, especially with respect to a central air flow path 14A, so that the low-turbulence air flow 10 in its entirety does not collide against the planar surface 55 of the rotary table 40 and thereby can swirl unfavorably.
  • the second air-guiding element 21 is designed as a saddle-shaped housing element 56, whereby the low-turbulence air flow 10 can also be directed around the second production device 31 or the first production station 45 in this respect with little turbulence.
  • the further air guide elements 22, 23, 24 of the production devices 32, 33 and 34 or the corresponding manufacturing stations 46, 47 and 48 are each designed as arcuate housing elements 60 (numbered here only as an example), so that the low-turbulence air flow 10 is also formed by these arcuate housing elements 60 only turbulence around the respective manufacturing station 46, 47 and 48 can be passed around.
  • the air flow paths 14B and 14C which flow laterally in the clean room 1, are guided by the arcuate housing elements 60 of the third air guide element 22 and the fifth air guide element 24, respectively, around the respective production arm element 49 of the second production station 46 and the fourth production station 48, respectively and is discharged into the air exhaust openings 11.
  • All air guide elements 20 to 24 have in common that they Einhausungsetti 50, 56 and 60 configure, which taper in flow direction 52 towards.
  • the housing elements 50, 56 and 60 are each a housing element 61 which tapers in the direction of air flow 52, albeit at least partially differently designed.
  • the production areas 26 and / or production facilities 30 to 34 side body horizontal extent 65 designed larger than the air supply opening side body horizontal extent, whereby a total of the flowing in the main air flow direction 13 low-turbulence air flow 10 without critical turbulence around these production areas 26 and production facilities 30 to 34 around become.
  • the air guiding elements 20 to 24 each have an opening 71 at their sides 70 facing the production surfaces 26 and the production devices 30 to 34 (here only exemplarily), in which the production devices 30 to 34 are at least partly in the Air guide elements 20 to 24 are introduced.
  • the air guiding elements 22, 23 and 24 are arranged at such a distance from the production areas 26 and production facilities 32, 33 and 34 that a suction effect is generated by means of the low-turbulence air flow 10 in the region of these production areas 26 and production facilities 32, 33 and 34 can, by means of which dirt particles from the production areas 26 and principlesss wornen 32, 33 and 34 are removable.
  • the quality of purity within the manufacturing cell 4 of the clean room 1 can be further improved advantageously.

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  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Combustion & Propulsion (AREA)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
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Description

Die Erfindung betrifft einen Reinraum zum Produzieren von Gegenständen, insbesondere von medizinischen Produkten, mit Produktionsflächen und Produktionseinrichtungen sowie mit Luftzufuhröffnungen zum Zuführen einer turbulenzarmen Luftströmung in den Reinraum hinein sowie die Luftabzugsöffnungen zum Abziehen der ggf. mit Schmutzpartikeln kontaminierten turbulenzarmen Luftströmung aus dem Reinraum hinaus.The invention relates to a clean room for producing objects, in particular medical products, with production areas and production facilities and with air supply openings for supplying a low-turbulence air flow into the clean room and the air outlet openings for removing the possibly contaminated with dirt particles turbulence-poor air flow from the clean room addition.

Die Erfindung betrifft darüber hinaus ein Verfahren zum Betreiben eines Reinraums zum Produzieren von Gegenständen, insbesondere von medizinischen Produkten, bei welchem eine aus einem Deckenbereich des Reinraums hinein geleitete turbulenzarme Luftströmung durch diesen Reinraum hindurch in einen Bodenbereich des Reinraums und von dort aus aus dem Reinraum hinaus geleitet wird, um hierdurch eine Kontamination der zu produzierenden Gegenstände oder medizinischen Produkte mit unerwünschten Stoffen möglichst umfänglich zu verhindern.The invention further relates to a method for operating a clean room for producing articles, in particular medical products, in which a turbulence-poor air flow directed from a ceiling region of the clean room passes through this clean room into a floor area of the clean room and from there out of the clean room is directed to thereby prevent as far as possible contamination of the articles to be produced or medical products with undesirable substances.

Gattungsgemäße Reinräume sind aus dem Stand der Technik vielfältig bekannt, um insbesondere eine Konzentration an luftgetragenen Partikeln, wie etwa Schmutzpartikeln oder Keimen, so gering wie nötig oder gegebenenfalls auch so gering wie möglich halten zu können. Einsatzbereiche derartiger Reinräume finden sich beispielsweise in der Halbleiterfertigung, in der Optik- und Lasertechnologie, der Luft- und Raumfahrttechnik und dergleichen. Speziell auch im Bereich der Produktion von medizinischen Gegenständen bzw. medizinischen Produkten ist eine Produktion unter Reinraumbedingungen oftmals erforderlich, um insbesondere aseptische Bedingungen an Produktionsflächen und/oder Produktionseinrichtungen gewährleisten zu können. So sind auch bei Montageprozessen von medizinischen Kunststoffartikeln oder Gegenständen oftmals entsprechende Reinräume der Klasse EU-GMP-Klasse C erforderlich. Beispielsweise beim Abfüllen von Spritzen oder Behältnissen mit einem Septum und/oder beim Verschließen bereits abgefüllter Behältnisse, die beispielsweise im Rahmen eines Bördelprozesses mithilfe eines Stempels versiegelt werden, ist auf eine kontaminationsfreie Produktionsumgebung zwingend zu achten.Generic clean rooms are widely known from the prior art, in particular to be able to keep a concentration of airborne particles, such as dirt particles or germs, as low as necessary or possibly also as low as possible. Areas of application of such clean rooms can be found, for example, in semiconductor manufacturing, in optics and laser technology, aerospace engineering and the like. Especially in the field of the production of medical articles or medical products, production under clean-room conditions is often necessary in order to be able to ensure in particular aseptic conditions on production areas and / or production facilities. So are also in assembly processes of medical Plastic articles or articles often required corresponding cleanrooms of the EU-GMP Class C class. For example, when filling syringes or containers with a septum and / or when closing already filled containers, which are sealed, for example in the context of a crimping process using a stamp, it is imperative to ensure a contamination-free production environment.

Beispielsweise ist aus der europäischen Patentschrift EP 0 587 845 B1 eine Reinrauminsel zum Fertigen von Gegenständen, insbesondere von Halbleitern, Speicherplatten, Medikamenten, pharmazeutischen Artikeln, Lebensmitteln oder dergleichen bekannt. Diese Reinrauminsel umfasst einen gegenüber einer Umgebung abgetrennten lokalen Reinraumbereich, in welchem ein Handhabungsgerät zum Handhaben bzw. Behandeln von in den lokalen Reinraumbereich eingebrachten Gegenständen angeordnet ist. Der lokale Reinraumbereich wird hierbei von einem laminaren Luftstrom von oben nach unten durchströmt, wodurch die Gefahr verringert wird, dass einerseits Schmutzpartikel oder Keime innerhalb des lokalen Reinraumbereichs unerwünschter Weise aufgewirbelt werden und dass andererseits in Folge eines durch den laminaren Luftstrom erzeugten Überdrucks innerhalb des lokalen Reinraumbereichs derartige Schmutzpartikel oder Keime erst gar nicht oder zumindest in einem stark verminderten Maße in diesen lokalen Reinraumbereich hinein gelangen können.For example, from the European patent specification EP 0 587 845 B1 a clean room island for manufacturing objects, in particular semiconductors, storage disks, medicaments, pharmaceutical articles, foodstuffs or the like. This clean room island comprises a local clean room area separated from an environment, in which a handling device for handling or treating objects introduced into the local clean room area is arranged. The local clean room area is thereby flowed through by a laminar air flow from top to bottom, whereby the risk is reduced, on the one hand dirt particles or germs within the local clean room area are undesirably stirred up and on the other hand, as a result of a generated by the laminar air flow pressure within the local clean room area Such dirt particles or germs can not even get into this local clean room area or at least to a greatly reduced extent.

Nachteilig bei dieser Reinrauminsel, aber auch bei ansonsten bisher bekannten Reinräumen, ist es, dass der in dem lokalen Reinraumbereich erzeugte laminare Luftstrom direkt auf technische Einrichtungen, wie eben dieses Handhabungsgerät oder sonstigen Produktionseinrichtungen, sowie Arbeitsflächen dieser Produktionseinrichtungen auftrifft und hierdurch bedingt unerwünschte Verwirbelungseffekte in dem Reinraum bzw. lokalen Reinraumbereich auftreten, so dass der in den lokalen Reinraumbereich eingeleitete ursprüngliche laminare Luftstrom zumindest bereichsweise und temporär turbulente Luftströmungen hervorruft.A disadvantage of this clean room island, but also in otherwise previously known clean rooms, is that the laminar air flow generated in the local clean room area directly on technical facilities, such as this handling device or other production facilities, and work surfaces of these production facilities impinges and thereby undesirable Verwirbelungseffekte in the Clean room or local clean room area occur, so that the introduced into the local clean room area original laminar air flow causes at least partially and temporarily turbulent air flows.

Nachteilig ist es, dass durch einen derartigen Aufprall des laminaren Luftstroms erzeugte turbulente Luftströmungen erst recht die Ursache begründen, dass Schmutzpartikel oder Keime vermehrt aufgewirbelt werden, wodurch die zwingend unter Reinraumbedingungen herzustellenden Produkte verstärkt kontaminiert werden können.It is disadvantageous that turbulent air flows generated by such an impact of the laminar air flow justify the reason that dirt particles or germs are increasingly being swirled up, as a result of which the products necessarily to be produced under clean room conditions can be contaminated more intensively.

Um diese Nachteile zu verhindern, wird bisher versucht, den laminaren Luftstrom derart einzustellen, dass die aufprallbedingten Verwirbelungseffekte möglichst gering gehalten werden können.In order to prevent these disadvantages, attempts have hitherto been made to adjust the laminar air flow in such a way that the impact-related turbulence effects can be kept as low as possible.

Es ist Aufgabe der Erfindung, gattungsgemäße Reinräume zum Produzieren von Gegenständen, aber auch Verfahren zum Betreiben derartiger Reinräume dahingehend weiterzuentwickeln, dass zumindest die vorstehend genannten Nachteile überwunden werden können.It is an object of the invention to develop generic clean rooms for producing objects, but also methods for operating such clean rooms to the effect that at least the above-mentioned disadvantages can be overcome.

Die Aufgabe der Erfindung wird von einem Reinraum zum Produzieren von Gegenständen, insbesondere von medizinischen Produkten, mit Produktionsflächen und Produktionseinrichtungen sowie mit Luftzufuhröffnungen zum Zuführen einer turbulenzarmen Luftströmung in den Reinraum hinein und mit Luftabzugsöffnungen zum Abziehen der gegebenenfalls mit Schmutzpartikeln kontaminierten turbulenzarmen Luftströmung aus dem Reinraum hinaus gelöst, bei welchem in einem oder mehreren Luftströmungspfaden zwischen den Luftzufuhröffnungen und den Luftabzugsöffnungen eine Luftleiteinrichtung mit Luftleitelementen derart angeordnet ist, dass die turbulenzarme Luftströmung unter Umgehung einer durch die Produktionsflächen und/oder die Produktionseinrichtungen verursachten Luftströmungsumlenkung zumindest teilweise um diese Produktionsflächen und/oder Produktionseinrichtungen herum leitbar ist.The object of the invention is a clean room for producing objects, in particular medical products, with production areas and production facilities and with air supply openings for supplying a low-turbulence air flow into the clean room and with air outlet openings for removing the optionally contaminated with dirt particles low-turbulence air flow from the clean room addition in which in one or more air flow paths between the air supply openings and the air outlet openings an air guide with air guide elements is arranged such that the low-turbulence air flow, bypassing caused by the production areas and / or production facilities air flow deflection at least partially around these production areas and / or production facilities around is conductive.

Erfindungsgemäß prallt die turbulenzarme Luftströmung auf ihrem Strömungsweg von den Luftzufuhröffnungen zu den Luftabzugsöffnungen nicht mehr unmittelbar auf die Produktionsflächen und/oder auf die Produktionseinrichtungen auf. Insofern kann ein mit der turbulenzarmen Luftströmung mitgeführtes Luftvolumen dementsprechend an diesen Produktionsflächen und/oder Produktionseinrichtungen auch nicht derartig aufprallen und wechselwirken, dass zusätzliche unerwünschte Turbulenzen innerhalb des Reinraums entstehen. Vielmehr wird die turbulenzarme Luftströmung nun beabstandet von den Produktionsflächen und/oder den Produktionseinrichtung um diese Produktionsflächen und/oder diese Produktionseinrichtung herum geleitet.According to the invention, the low-turbulence air flow on its flow path from the air supply openings to the air outlet openings no longer impacts directly on the production areas and / or on the production facilities. In this respect, an air volume entrained with the low-turbulence air flow can accordingly not bounce and interact at these production areas and / or production facilities in such a way that additional undesired turbulences arise within the clean room. Rather, the low-turbulence air flow is now spaced from the production areas and / or the production facility passed around these production areas and / or this production facility around.

Durch die derart angeordneten und vorgesehenen Luftleitelemente wird somit insbesondere verhindert, dass die turbulenzarme Luftströmung im stumpfen Winkel auf die Produktionsflächen und/oder auf die Produktionseinrichtungen trifft und hierdurch bedingt kritische Luftverwirbelungen innerhalb des Reinraums, insbesondere in unmittelbarer Nähe der Produktionsflächen und/oder der Produktionseinrichtungen, entstehen.By thus arranged and provided air guide elements is thus prevented in particular that meets the low-turbulence air flow at an obtuse angle to the production areas and / or on the production facilities and thereby critical air turbulence within the clean room, especially in the immediate vicinity of the production areas and / or production facilities, arise.

Vielmehr trifft die turbulenzarme Luftströmung idealerweise in einem spitzen Winkel derart auf die Luftleitelemente auf, dass sie von diesen Luftleitelementen nicht abprallt und hierbei kritisch verwirbelt, sondern sie wird an den Oberflächen der Luftleitelemente nahezu verwirbelungsfrei umgeleitet bzw. abgelenkt, um dann zur Gänze verwirbelungsfrei oder zumindest nur vernachlässigbar gering verwirbelt an den Oberflächen der Luftleitelemente bis unter die eigentlichen Produktionsflächen und/oder eine Produktionseinrichtungen geleitet zu werden.Rather, the low-turbulence air flow ideally meets at an acute angle to the air guide elements so that they do not rebound from these air guide elements and this but it is swirled and deflected at the surfaces of the spoiler almost turbulence free, and then completely turbulence-free or at least only slightly negligible swirling on the surfaces of the spoilers to be routed below the actual production areas and / or production facilities.

Vorteilhafterweise sind die Oberflächen der Luftleitelemente besonders glatt ausgebildet, um die Gefahr einer Turbulenzbildung weiter reduzieren zu können.Advantageously, the surfaces of the air guide elements are designed to be particularly smooth in order to be able to further reduce the risk of turbulence formation.

Der Begriff "Luftleiteinrichtung" beschreibt im Sinne der Erfindung ein Gebilde, mittels welchem eine Produktionsfläche und/oder eine Produktionseinrichtung gegenüber der turbulenzarmen Luftströmung zumindest teilweise unerreichbar abgeschirmt werden kann.The term "air guiding device" in the context of the invention describes a structure by means of which a production area and / or a production facility can be shielded from the low-turbulence air flow at least partially inaccessible.

Allein schon aufgrund dieser Abschirmfunktion können die Luftleitelemente der Luftleiteinrichtung bei entsprechender Ausgestaltung auch als Verkleidungselemente von Produktionsflächen und von Produktionseinrichtungen angesehen werden.Alone due to this shielding function, the spoiler elements of the spoiler can be viewed with appropriate design as cladding elements of production areas and production facilities.

Bevorzugt ist eine derartige Luftleiteinrichtung bzw. deren Luftleitbleche aus einem Metallblech hergestellt, da hiermit unterschiedliche geometrische Hohlkörper auch größerer Abmessung relativ einfach hergestellt werden können. Es versteht sich, dass auch Kunststoffe, Folienmaterialien oder andere Werkstoffe zum Erzeugen einer geeigneten Luftleiteinrichtung vorteilhaft eingesetzt werden können.Preferably, such a louver or its baffles made of a metal sheet, since this different geometric hollow body and larger dimensions can be relatively easily manufactured. It is understood that plastics, film materials or other materials for producing a suitable air guide can be used advantageously.

Wesentlich ist es vorliegend, dass mittels der Luftleitbleche Hohlkörper ausgestaltet werden können.It is essential here that can be configured by means of the air baffles hollow body.

Idealerweise können diese Hohlkörper zumindest teilweise über die Produktionsflächen und Produktionseinrichtungen angebracht bzw. gestülpt angeordnet werden.Ideally, these hollow bodies can be arranged or placed at least partially over the production areas and production facilities.

Darüber hinaus ist es vorteilhaft, wenn die Luftleitelemente eine Oberflächenrauigkeit aufweist, welche nicht oder nur vernachlässigbar gering zu einer zusätzlichen Verwirbelung der turbulenzarmen Luftströmung beiträgt, wenn diese turbulenzarme Luftströmung an den Luftleitelementen entlang strömt.Moreover, it is advantageous if the air guide elements has a surface roughness which does not or only negligibly contributes to an additional turbulence of the low-turbulence air flow when this low-turbulence air flow flows along the air guide elements.

Der Begriff "turbulenzarme Luftströmung" beschreibt im Sinne der Erfindung ein im Wesentlichen gar nicht verwirbeltes oder nur unkritisch verwirbeltes Luftvolumen, welches von den Luftzufuhröffnungen zu den Luftabzugsöffnungen durch den Reinraum kontaktlos an den Produktionsflächen und/oder Produktionseinrichtungen vorbei strömt.The term "low-turbulence air flow" in the context of the invention describes a substantially not vortexed or only uncritically swirled air volume, which of the Air supply openings to the air outlet openings through the clean room without contact flows past the production areas and / or production facilities.

Bei der turbulenzarmen Luftströmung handelt es sich im Sinne der Erfindung idealerweise um eine laminare Luftströmung.For the purposes of the invention, the low-turbulence air flow is ideally a laminar air flow.

Die turbulenzarme Luftströmung wird mittels einer Luftströmungseinrichtung erzeugt. Die Luftströmungseinrichtung umfasst hierzu eine Luftfördereinrichtung, wie etwa ein Gebläse oder dergleichen, um ein Luftvolumen fördern zu können. Da derartige Luftströmungseinrichtungen aus dem Stand der Technik im Zusammenhang mit Reinräumen gut bekannt sind, wird hierauf nicht weiter eingegangen.The low-turbulence air flow is generated by means of an air flow device. For this purpose, the air flow device comprises an air conveying device, such as a fan or the like, in order to be able to convey an air volume. Since such prior art air flow devices are well known in the clean room environment, this will not be discussed further.

Bei den Produktionsflächen handelt es sich vorzugsweise um eine idealerweise mit einem Rundtisch versehene Montagestation, wobei oberhalb dieses Rundtisches die Luftleitelemente entsprechend konzentrisch angeordnet sind.The production areas are preferably an assembly station which is ideally provided with a rotary table, the air-guiding elements being arranged concentrically above this round table.

Insbesondere hinsichtlich Rundtischmontageeinheiten kann durch die erfindungsgemäßen Luftleitelemente der unerwünschte Effekt von Luftverwirbelungen im Montagebereich ausgezeichnet verhindert werden, da diesbezügliche Luftleitelemente derart vor den relevanten Produktionsflächen und/oder Produktionseinrichtungen platziert werden, dass einzelne Bauteile, Leitungen, Kabel oder dergleichen und natürlich auch die zu produzierenden Produkte an sich vor der turbulenzarmen Luftströmung gut abgeschirmt werden können.In particular with regard to rotary table mounting units, the undesired effect of air turbulence in the assembly area can be excellently prevented by the air guiding elements according to the invention since air guiding elements in this regard are placed in front of the relevant production areas and / or production facilities, that individual components, lines, cables or the like and of course also the products to be produced can be well shielded from the low-turbulence air flow.

Bei den Produktionseinrichtungen kann es sich um Fertigungseinheiten, Bestückungseinheiten, Befülleinheiten, Montage- oder Handhabungsarmelemente oder dergleichen handeln.The production facilities can be production units, assembly units, filling units, assembly or handling arm elements or the like.

Da es zum Erzeugen und Aufrechterhalten einer turbulenzarmen Luftströmung besonders günstig ist, die Luftzufuhröffnungen in einem Deckenbereich des Reinraums und die Luftabzugsöffnungen in einem Bodenbereich des Reinraums anzuordnen, so dass die turbulenzarme Luftströmung Schwerkraft unterstützt von oben nach unten durch den Reinraum strömen kann, ist es vorteilhaft, wenn die Luftleitelemente zentrisch oder konzentrisch oberhalb der Produktionsflächen und/oder der Produktionseinrichtungen angeordnet sind.Since it is particularly favorable for generating and maintaining a low-turbulence air flow to arrange the air supply openings in a ceiling region of the clean room and the air outlet openings in a bottom portion of the clean room, so that the low-turbulence air flow gravity can flow from top to bottom through the clean room, it is advantageous if the air guide elements are arranged centrically or concentrically above the production areas and / or the production facilities.

Es versteht sich, dass die Luftleitelemente auch hiervon verschieden im Reinraum angeordnet sein können, um die turbulenzarme Luftströmung im Sinne der Erfindung von den Produktionsflächen und/oder den Produktionseinrichtungen fern zu halten. Ein besonders turbulenzfreies Herumleiten der turbulenzarmen Luftströmung kann jedoch erzielt werden, wenn die Luftleitelemente zentrisch oder konzentrisch oberhalb der Produktionsflächen und/oder der Produktionseinrichtungen angeordnet sind.It is understood that the air guide elements may also be arranged differently in the clean room, in order to keep the low-turbulence air flow in the context of the invention away from the production areas and / or production facilities. A particularly turbulence-free However, diverting the low-turbulence air flow can be achieved if the air guide elements are arranged concentrically or concentrically above the production areas and / or the production facilities.

Weisen die Luftleitelemente sich in Luftströmungsgegenrichtung verjüngende Einhausungselemente auf, kann die turbulenzarme Luftströmung in Bezug auf die Hauptströmungsrichtung von oben nach unten radial besonders ruhig aufgeweitet und hierbei um die Produktionsflächen und/oder die Produktionseinrichtungen herum geleitet werden, wodurch die Gefahr von zusätzlichen Turbulenzen beim Auftreffen des Luftvolumens auf die Luftleitelemente erheblich reduziert ist.If the air guiding elements have air-flow directionally tapering housing elements, the low-turbulence air flow can be expanded particularly smoothly from top to bottom with respect to the main flow direction and can be guided around the production areas and / or the production facilities, thereby reducing the risk of additional turbulence on impact Air volume is significantly reduced to the air guide elements.

Jedenfalls können mit solchen Einhausungselementen sehr gut Hohlkörper im Sinne der Erfindung zum Abschirmen der Produktionsflächen und/oder der Produktionseinrichtungen bereitgestellt werden.In any case, can be provided with such Einhausungselementen very well hollow body according to the invention for shielding the production areas and / or production facilities.

Insofern sieht eine bevorzugte Ausführungsvariante vor, dass die Luftleitelemente an ihren den Luftzufuhröffnungen zugewandten Seiten kegelförmig, sattelförmig oder bogenförmig zulaufend ausgestaltet sind. Hierdurch kann die turbulenzarme Luftströmung bzw. ein diesbezügliches Luftvolumen im Sinne der Erfindung radial zur Luftströmungshauptrichtung aufgeweitet bzw. umgeleitet werden, ohne dass hierbei kritische Luftverwirbelungen durch den Einfluss der Luftleiteinrichtungen bzw. diesbezüglichen Einhausungselementen erfolgt. Insbesondere derartig kegelförmig oder sattelförmig ausgeformte Luftleitelemente laufen in Richtung der Luftzufuhröffnungen spitz zu.In this respect, a preferred embodiment provides that the air guide elements are designed to taper at their air supply openings facing sides tapered, saddle-shaped or arcuate. In this way, the low-turbulence air flow or an air volume relating thereto in the sense of the invention can be widened or redirected radially to the main direction of air flow, without critical air turbulences taking place due to the influence of the air guiding devices or respective housing elements. In particular, such conical or saddle-shaped air guide elements taper in the direction of the air supply openings.

Es versteht sich, dass insbesondere die Einhausungselemente auch andere Grundformen als die zuvor genannten aufweisen können, sofern der Reinraum und die Produktionsflächen und/oder Produktionseinrichtungen entsprechend ausgestaltet sind.It is understood that in particular the housing elements may also have other basic shapes than those mentioned above, provided that the clean room and the production areas and / or production facilities are designed accordingly.

Die Luftleitelemente bzw. diesbezügliche Einhausungselemente gehen idealerweise bis auf die Oberfläche der eigentlichen Produktionsflächen und/oder Produktionseinrichtungen herunter mit gegebenenfalls der Ausnahme derjenigen Bereiche, in welchen Bestückungen bzw. Abführungen von den zu produzierenden Gegenständen erfolgen.The air guiding elements or housing elements relating to them are ideally lowered down to the surface of the actual production areas and / or production facilities, with the possible exception of those areas in which equipment or discharges are carried out by the objects to be produced.

Aber selbst diese Bereiche sind idealweise wiederum durch zusätzliche Luftleitelemente bzw. diesbezügliche Einhausungselemente abgeschirmt.But even these areas are ideally shielded in turn by additional air guide elements or related Einhausungselemente.

Je nach Ausgestaltung der Produktionsflächen und/oder Produktionseinrichtungen können die Luftleitelemente auch bis unterhalb der Produktionsflächen und/oder Produktionseinrichtungen und gegebenenfalls bis in den Bodenbereich hinein angeordnet sein, um die turbulenzarme Luftströmung möglichst weit hinunter bis in den Bodenbereich leiten zu können.Depending on the configuration of the production areas and / or production facilities, the air guiding elements can also be arranged below the production areas and / or production facilities and possibly even into the floor area in order to be able to guide the low-turbulence air flow as far as possible down to the floor area.

Umfassen die Luftleitelemente Einhausungselemente, deren Körperausdehnungen in Luftströmungshauptrichtung bis zur maximalen Grundflächenausdehnung ansteigen, kann die turbulenzarme Luftströmung vorteilhafter um die Produktionsflächen und/oder die Produktionseinrichtungen herum geleitet werden, ohne dass hierbei kritische Turbulenzen entstehen. Insofern kann hierdurch sichergestellt werden, dass die turbulenzarme Luftströmung auf ihrem Weg zwischen den Luftabzugsöffnungen bis zu den Luftabzugsöffnungen im Wesentlichen turbulenzarm bleibt.If the air guiding elements include housing elements whose body dimensions increase in the main air flow direction up to the maximum base area extent, the low-turbulence air flow can advantageously be conducted around the production areas and / or the production facilities without causing critical turbulences. In this respect, this can ensure that the low-turbulence air flow on its way between the air outlet openings to the air outlet openings remains substantially turbulence.

Bei der vorliegenden Körperausdehnung handelt es sich um eine Körperausdehnung, welche sich quer zur turbulenzarmen Luftströmung erstreckt. Insofern kann vorliegend auch von einer Körperhorizontalausdehnung gesprochen werden, wenn die turbulenzarme Luftströmung vom Deckenbereich des Reinraums zum Bodenbereich des Reinraums strömt.The present body expansion is a body extension which extends transversely to the low-turbulence air flow. In this respect, in the present case, it is also possible to speak of a body horizontal extent if the low-turbulence air flow flows from the ceiling area of the clean room to the floor area of the clean room.

Genauso verhält es sich hinsichtlich der Grundflächenausdehnung, so dass es sich hierbei um eine Grundflächenhorizontalausdehnung handelt.The same applies to the base area extent, so that this is a base area horizontal extent.

Steigt die Körperausdehnung in Luftströmungshauptrichtung bis zur maximalen Grundflächenausdehnung stetig an, kann die Gefahr, dass die turbulenzarme Luftströmung durch den Einfluss der Luftleitelemente ungünstig verwirbelt wird, besonders effektiv reduziert werden.If the body expansion in the direction of airflow increases steadily up to the maximum base area extent, the risk that the turbulence-poor air flow is unfavorably swirled by the influence of the air guide elements can be reduced particularly effectively.

Ein Ansteigen der Körperausdehnungen in Strömungshauptrichtung kann konstruktiv einfach dadurch erzielt werden, wenn die Luftleitelemente sich in Luftströmungsgegenrichtung verjüngende Einhausungselemente aufweisen.An increase in the body dimensions in the main direction of flow can be achieved structurally simply by virtue of the air-conducting elements having housing elements which taper in the direction of air flow.

Der Begriff "Grundflächenausdehnung" beschreibt im Sinne der Erfindung somit eine durch ein Luftleitelement erzeugte Grundfläche. Es versteht sich, dass eine durch das Luftleitelement erzeugte Grundfläche nahezu jede beliebige Form aufweisen kann.The term "base area extent" thus describes in the context of the invention a base area generated by an air guide element. It is understood that a base surface produced by the air guide element can have virtually any desired shape.

Weisen die Luftleitelemente eine kreisrunde oder ovale Grundfläche auf, lässt sich die turbulenzarme Luftströmung in Luftströmungshauptrichtung besonders turbulenzarm um die Produktionsflächen und/oder die Produktionseinrichtungen herum leiten.If the air guide elements have a circular or oval base surface, the low-turbulence air flow in the main air flow direction can be guided around the production areas and / or production facilities with a particularly low turbulence.

Jedenfalls können mittels der Einhausungselemente konstruktiv einfach Hohlkörper ausgestaltet werden.In any case, can be designed structurally simple hollow body by means of Einhausungselemente.

Nach einem weiteren wichtigen Aspekt der Erfindung ist es vorteilhaft, wenn die Luftleitelemente an ihren den jeweiligen Produktionsflächen und/oder den Produktionseinrichtungen zugewandten Seiten Öffnungen aufweisen, in welchen die Produktionsflächen und/oder die Produktionseinrichtungen zumindest teilweise hineinragend angeordnet sind.According to another important aspect of the invention, it is advantageous if the air guiding elements have openings on their sides facing the respective production areas and / or the production facilities, in which openings the production areas and / or the production facilities are at least partially projecting.

Durch diese Öffnungen können Produktionsflächen, aber auch insbesondere Produktionseinrichtungen, bis weit in die Luftleitelemente bzw. bis weit in sich entsprechenden verjüngenden Einhausungselemente bzw. bis weit in die durch diese erzeugten Hohlkörper hineinragend angeordnet werden, so dass diese Produktionsflächen und/oder Produktionseinrichtungen idealerweise zur Gänze von der turbulenzarmen Luftströmung abgeschirmt werden können.Through these openings production areas, but also in particular production facilities, far into the air guide elements or far into corresponding tapered housing elements or far into the hollow body produced by these protruding, so that these production areas and / or production facilities ideally in their entirety can be shielded from the low-turbulence air flow.

Insofern bilden die Luftleitelemente eine in Bezug auf die Produktionsflächen und/oder die Produktionseinrichtungen Einhüllende aus, welche ein geöffnetes Raumvolumen umschließt, in welches die Produktionsflächen und/oder die Produktionseinrichtungen zumindest teilweise angeordnet werden können.In this respect, the air guiding elements form an envelope with respect to the production areas and / or the production facilities, which encloses an open volume in which the production areas and / or the production facilities can be arranged at least partially.

Insofern ist es vorteilhaft, wenn durch die Luftleitelemente gebildete geometrische Körper zu den Produktionsflächen und/oder zu den Produktionseinrichtungen hin geöffnet sind.In this respect, it is advantageous if geometric bodies formed by the air guiding elements are open to the production areas and / or to the production facilities.

Darüber hinaus ist es nach einem weiteren wichtigen Aspekt der Erfindung vorteilhaft, wenn die Luftleitelemente von den Produktionsflächen und/oder den Produktionseinrichtungen derart beabstandet angeordnet sind, dass mittels der turbulenzarmen Luftströmung im Bereich der Produktionsflächen und/oder der Produktionseinrichtungen ein Sogeffekt entsteht, mittels welchem Schmutzpartikel oder dergleichen von den Produktionsflächen und/oder den Produktionseinrichtungen entfernbar sind.Moreover, according to a further important aspect of the invention, it is advantageous if the air guiding elements are arranged at such a distance from the production areas and / or the production facilities that a suction effect is produced by means of the low-turbulence air flow in the region of the production areas and / or the production facilities or the like from the production areas and / or the production facilities are removable.

Eine vorteilhafte Ausführungsvariante sieht deshalb auch vor, dass die Luftleitelemente die Produktionsflächen und/oder die Produktionseinrichtungen zumindest teilweise derart um-oder einhausen, dass im ordnungsgemäßen Betrieb der Luftströmungseinrichtung zwischen den Luftleitelementen und den Produktionsflächen und/oder den Produktionseinrichtungen zumindest teilweise ein Unterdruck gegenüber der turbulenzarmen Luftströmung besteht. Kann aufgrund des Zusammenspiels zwischen der Anordnung der Luftleitelemente gegenüber den Produktionsflächen und/oder den Produktionseinrichtungen und der turbulenzarmen Luftströmung ein Unterdruck zwischen den Luftleitelementen und den Produktionsflächen und/oder den Produktionseinrichtungen erzeugt werden, können mittels der turbulenzarmen Luftströmung unerwünschte Schmutzpartikel oder Keime oder dergleichen von den Produktionsflächen und/oder von den Produktionseinrichtungen abgesaugt und sogleich über die Luftabzugsöffnungen aus dem Reinraum heraus getragen werden.An advantageous embodiment variant therefore also envisages that the air-guiding elements at least partially surround the production areas and / or the production facilities in such a way that, during proper operation of the air-flow device between the air-guiding elements and the production areas and / or the production facilities, at least partially a negative pressure relative to the low-turbulence Air flow exists. If, due to the interaction between the arrangement of the air guide elements relative to the production areas and / or the production facilities and the low-turbulence air flow, a negative pressure between the air guide elements and the production areas and / or the production facilities can be generated by means of the low-turbulence air flow unwanted dirt particles or germs or the like of the Production areas and / or extracted from the production facilities and are immediately carried over the air vents out of the clean room.

In einem diesbezüglichen Fall ist es von Vorteil, wenn zwischen den Luftleitelementen und den Produktionsflächen und/oder den Produktionseinrichtungen ein Spalt besteht, an welchem die durch die Luftleiteinrichtungen abgelenkte turbulenzarme Luftströmung vorbei strömt, und hierbei nach dem Prinzip einer Strahlpumpe eventuell vorhandene Schmutzpartikel oder Keime oder dergleichen von den Produktionsflächen und/oder von den Produktionseinrichtungen absaugt und aus dem kritischen Produktionsbereich fortbewegt.In a related case, it is advantageous if there is a gap between the air guide elements and the production areas and / or the production facilities, at which the turbulence-poor air flow deflected by the louvers flows past, and any dirt particles or germs or dirt particles that may be present on the principle of a jet pump sucked from the production areas and / or from the production facilities and moved away from the critical production area.

Es versteht sich, dass es sich bei dem erfindungsgemäßen Reinraum um nahezu jeden beliebigen Reinraum handeln kann. Besonders vorteilhaft ist es, wenn der Reinraum ein Reinraum der Reinraumklasse EU-GMP-Klasse C ist, insbesondere für Partikel größer als 5 µm.It goes without saying that the clean room according to the invention can be virtually any desired clean room. It is particularly advantageous if the clean room is a clean room of cleanroom class EU GMP Class C, in particular for particles larger than 5 microns.

Darüber hinaus wird die Aufgabe der Erfindung auch von einem Verfahren zum Betreiben eines Reinraums zum Produzieren von Gegenständen, insbesondere von medizinischen Produkten, gelöst, bei welchem eine aus einem Deckenbereich des Reinraums eingeleitete turbulenzarme Luftströmung durch den Reinraum hindurch in einen Bodenbereich des Reinraums und von dort aus aus dem Reinraum hinaus geleitet wird, um hierdurch eine Kontamination der zu produzierenden Gegenstände oder medizinischen Produkte mit unerwünschten Stoffen möglichst umfänglich zu verhindern, wobei sich das Verfahren dadurch auszeichnet, dass die turbulenzarme Luftströmung an im Inneren des Reinraums angeordneten Produktionsflächen und/oder Produktionseinrichtungen derart vorbei geführt wird, dass die turbulenzarme Luftströmung auf ihrem Weg von dem Deckenbereich zu dem Bodenbereich unter Umgehung eines direkten Wirkkontaktes mit den Produktionsflächen und/oder den Produktionseinrichtungen um diese Produktionsflächen und/oder diese Produktionseinrichtungen herum geleitet wird.Moreover, the object of the invention is also achieved by a method for operating a clean room for producing objects, in particular medical products, in which a turbulence-poor air flow introduced from a ceiling area of the clean room passes through the clean room into a floor area of the clean room and from there is directed out of the clean room to prevent contamination of the articles or medical products to be produced as much as possible with undesirable substances, the method is characterized in that the low-turbulence air flow to arranged in the interior of the clean room production areas and / or production facilities such is passed that the low-turbulence air flow on its way from the ceiling area to the floor area, bypassing a direct operative contact with the production areas and / or production facilities to this production area and / or these production facilities are routed around.

Hierdurch können kritische Verwirbelungen insbesondere direkt an den Produktionsflächen und/oder den Produktionseinrichtungen erfolgreich verhindert werden, so dass der Reinraum insbesondere auch besonders gut unter aseptischen Bedingungen betrieben werden kann.As a result, critical turbulences can be successfully prevented, in particular directly at the production areas and / or the production facilities, so that the clean room can also be operated particularly well under aseptic conditions.

Es versteht sich, dass ein Umleiten der turbulenten Luftströmung im Sinne der Erfindung durch die unterschiedlichsten konstruktiven Maßnahmen erfolgen kann, beispielsweise mittels entsprechend ausgestalteter und ausgerichteter Luftzufuhröffnungen oder entsprechend ausgestalteten Luftvorhängen.It is understood that a diversion of the turbulent air flow in the context of the invention can be carried out by a variety of design measures, for example by means of appropriately designed and aligned air supply openings or appropriately designed air curtains.

Besonders vorteilhaft ist es jedoch, wenn die turbulenzarme Luftströmung zwischen dem Deckenbereich und dem Bodenbereich mittels der Luftleitelemente turbulenzarm beschleunigt wird. Hierdurch bedingt kann zusätzlich noch ein Sogeffekt zwischen den Luftleitelementen und den Produktionsflächen und/oder den Produktionseinrichtungen erzielt werden, um Schmutzpartikel oder dergleichen sogleich mitzureißen und aus dem Reinraum heraus zu befördern.However, it is particularly advantageous if the turbulence-poor air flow between the ceiling area and the floor area is accelerated by means of the air guide elements with little turbulence. As a result, additionally, a suction effect can be achieved between the air guiding elements and the production surfaces and / or the production equipment in order to immediately entrain dirt particles or the like and to convey them out of the clean room.

Es hat sich gezeigt, dass die turbulenzarme Luftströmung mit einer Geschwindigkeit von beispielsweise 0,45 m pro Sekunde besonders verwirbelungsarm an den vorliegenden Luftleitelementen vorbei geführt werden kann.It has been found that the low-turbulence air flow can be guided past the present air guiding elements at a speed of, for example, 0.45 m per second, with a particularly low turbulence.

Weitere Vorteile, Ziele und Eigenschaften vorliegender Erfindung werden anhand anliegender Zeichnung und nachfolgender Beschreibung erläutert, in welchen beispielhaft ein mit erfindungsgemäßen Luftleitelementen ausgerüsteter Reinraum dargestellt und beschrieben ist. In der Zeichnung zeigen:

Figur 1
schematisch eine perspektivische Ansicht eines Reinraums mit einer einen Rundarbeitstisch und vier Fertigungsstationen umfassenden Produktionseinrichtung;
Figur 2
schematisch eine detailliertere Ansicht der Produktionseinrichtung aus der Figur 1;
Figur 3
schematisch eine erste Schnittansicht des Reinraums aus den Figuren 1 und 2;
Figur 4
schematisch eine weitere Schnittansicht des Reinraums aus den Figuren 1 bis 3; und
Figur 5
schematisch eine andere Schnittansicht des Reinraums aus den Figuren 1 bis 4 mit einer laminaren Luftströmung aus Deckenrichtung.
Further advantages, objects and features of the present invention will be explained with reference to the appended drawings and the following description in which an example of a clean room equipped with air guide elements according to the invention is shown and described. In the drawing show:
FIG. 1
schematically a perspective view of a clean room with a round table and four production stations comprehensive production facility;
FIG. 2
schematically a more detailed view of the production facility of the FIG. 1 ;
FIG. 3
schematically a first sectional view of the clean room from the Figures 1 and 2 ;
FIG. 4
schematically another sectional view of the clean room from the FIGS. 1 to 3 ; and
FIG. 5
schematically another sectional view of the clean room from the FIGS. 1 to 4 with a laminar flow of air from the ceiling direction.

Der in der Figur 1 gezeigte Reinraum 1 nach der Reinraumklasse EU-GMP-Klasse C ist Bestandteil einer hier nicht näher gezeigten Produktionsanlage 2 zum Produzieren von medizinischen Produkten 3 (hier nur exemplarisch beziffert) unter aseptischen Bedingungen.The Indian FIG. 1 shown clean room 1 according to the clean room class EU GMP Class C is part of a production facility 2 not shown here for the production of medical products 3 (here only exemplified) under aseptic conditions.

Der Reinraum 1 umfasst eine Fertigungszelle 4, welche durch ein Gehäuse 5 von einer sonstigen Arbeitsumgebung 6 der Produktionsanlage 2 räumlich getrennt ist.The clean room 1 comprises a manufacturing cell 4, which is spatially separated by a housing 5 from another working environment 6 of the production plant 2.

Das Gehäuse 5 besteht hierbei im Wesentlichen aus einer Bodenteil 7 und aus einem darauf aufbauenden Rahmengestell 8, in welchem Glaselemente 9 gehaltert sind.The housing 5 in this case consists essentially of a bottom part 7 and a frame 8 which is based thereon, in which glass elements 9 are held.

Gemäß der Darstellung nach der Figur 1 ist die Fertigungszelle 4 ohne Deckenplatte dargestellt, in welchem sich die Luftzufuhröffnungen (hier nicht dargestellt) einer Luftströmungseinrichtung (hier nicht explizit beziffert) zum Erzeugen einer turbulenzarmen Luftströmung 10 (siehe Fig. 5) angeordnet befinden.As shown by the FIG. 1 the manufacturing cell 4 is shown without ceiling plate, in which the air supply openings (not shown here) of an air flow device (not explicitly numbered here) for generating a low-turbulence air flow 10 (see Fig. 5 ) are arranged.

Luftabzugsöffnungen 11 (nur exemplarisch beziffert) zum Abziehen der gegebenenfalls mit Schmutzpartikeln kontaminierten turbulenzarmen Luftströmung 10 aus der Fertigungszelle 4 des Reinraums 1 heraus sind im Bodenbereich 12 unmittelbar über dem Bodenteil 7 platziert.Air outlet openings 11 (numbered only by way of example) for drawing off the turbulence-poor air flow 10 possibly contaminated with dirt particles from the production cell 4 of the clean room 1 are placed directly above the floor part 7 in the floor area 12.

Insofern verläuft die turbulenzarme Luftströmung 10 innerhalb der Fertigungszelle 4 des Reinraums 1 in einer Luftströmungshauptrichtung 13 ausgehend vom hier nicht gezeigten Deckenteil von oben nach unten zu dem Bodenteil 7 runterwärts; und zwar als laminare Luftströmung.In this respect, the low-turbulence air flow 10 runs inside the manufacturing cell 4 of the clean room 1 in an air flow main direction 13 from the ceiling part, not shown here from top to bottom to the bottom part 7 downwards; namely as laminar air flow.

Wie insbesondere ab der Figur 2 besonders gut gezeigt ist, sind erfindungsgemäß in den Luftströmungspfaden 14 (siehe Figur 5) zwischen den nicht gezeigten Luftzufuhröffnungen und den Luftabzugsöffnungen 11 in diesem Ausführungsbeispiel insgesamt fünf Luftleitelemente 20, 21, 22, 23 und 24 einer Luftleiteinrichtung 25 derart angeordnet, dass die turbulenzarme Luftströmung 10 um Produktionsflächen 26 (hier nur exemplarisch beziffert) und Produktionseinrichtungen 30, 31, 32, 33 und 34 herum leitbar ist.As in particular from the FIG. 2 is particularly well, according to the invention in the air flow paths 14 (see FIG. 5 ) between the not shown air supply openings and the air outlet openings 11 in this embodiment, a total of five air guide elements 20, 21, 22, 23 and 24 of an air guide 25 arranged such that the low-turbulence air flow 10 to production areas 26 (here only exemplified) and production facilities 30, 31 , 32, 33 and 34 are conductive.

Mittels der hier verbauten Luftleitelemente 20 bis 24 gelingt es, die turbulenzarme Luftströmung 10 derart um die Produktionsflächen 26 bzw. die Produktionseinrichtungen 30 bis 34 herumzuleiten, dass die turbulenzarme Luftströmung 10 nicht direkt auf diese Produktionsflächen 26 und Produktionseinrichtungen 30 bis 34 prallt und hierbei unerwünschte Luftverwirbelungen innerhalb der Fertigungszelle 4 des Reinraums 1 verursacht.By means of the air guide elements 20 to 24 installed here, it is possible to bypass the low-turbulence air flow 10 around the production areas 26 and the production facilities 30 to 34 such that the low-turbulence air flow 10 does not impinge directly on these production areas 26 and production facilities 30 to 34 and unwanted air turbulence caused within the manufacturing cell 4 of the clean room 1.

Bei der ersten Produktionseinrichtung 30 handelt es sich um einen Rundtisch 40 mit einer zentral angeordneten und relativ großen Produktionsfläche (hier nicht gezeigt) mit einer Vielzahl an konzentrisch um eine Drehachse 41 angeordneten Werkstückträgern 42 (hier nur exemplarisch beziffert).The first production device 30 is a rotary table 40 with a centrally arranged and relatively large production area (not shown here) with a multiplicity of workpiece carriers 42 arranged concentrically around an axis of rotation 41 (numbered here only by way of example).

Hinsichtlich der weiteren Produktionseinrichtungen 31 bis 34 handelt es sich zum einen um eine erste Fertigungsstation 45 und zum anderen um hiervon verschiedene weitere gleiche oder gleich wirkende Fertigungsstationen 46, 47 und 48, mittels welchen die auf den Werkstückträgern 42 abgelegten medizinischen Produkte 3 schrittweise bearbeitet bzw. fertig gestellt werden können. Die Fertigungsstationen 46, 47 und 48 zeichnen sich in diesem Ausführungsbeispiel noch durch jeweils ein Fertigungsarmelement 49 aus.With regard to the further production devices 31 to 34, these are, firstly, a first production station 45 and, secondly, different further identical or identical production stations 46, 47 and 48, by means of which the medical products 3 deposited on the workpiece carriers 42 are processed step by step or can be completed. The production stations 46, 47 and 48 are distinguished in this embodiment by a respective manufacturing arm 49 from.

Alle den Produktionsflächen 26 und Produktionseinrichtungen 30 bis 34 zugeordneten Luftleitelemente 20 bis 24 sind oberhalb dieser Produktionsflächen 26 bzw. Produktionseinrichtungen 30 bis 34 angeordnet, so dass sich die Luftleitelemente 20 bis 24 jeweils zwischen den einzelnen Luftströmungspfaden 14 der von oben heran strömenden turbulenzarmen Luftströmung 10 und den jeweiligen Produktionsflächen 26 bzw. Produktionseinrichtungen 30 bis 34 befinden.All of the production areas 26 and production facilities 30 to 34 associated air guide elements 20 to 24 are arranged above these production areas 26 and production facilities 30 to 34, so that the air guide elements 20 to 24 respectively between the individual air flow paths 14 of the above-flowing low-turbulence air flow 10 and the respective production areas 26 and production facilities 30 to 34 are located.

Hierdurch können erfindungsgemäß die Luftleitelemente 20 bis 24 diese Produktionsflächen 26 bzw. Produktionseinrichtungen 30 bis 34 derart gegenüber der turbulenzarmen Luftströmung 10 abschirmen, dass diese erst gar nicht kritisch mit den Produktionsflächen 26 bzw. Produktionseinrichtungen 30 bis 34 in Wirkkontakt treten kann.In this way, according to the invention, the air guiding elements 20 to 24 can shield these production areas 26 and production facilities 30 to 34 from the low-turbulence air flow 10 so that they can not come into operative contact with the production areas 26 and production facilities 30 to 34 critically.

Demzufolge ist hierdurch auch die Gefahr drastisch reduziert, dass es durch einen Aufprall der turbulenzarmen Luftströmung 10 auf die Produktionsflächen 26 bzw. Produktionseinrichtungen 30 bis 34 zu unerwünschten Luftverwirbelungen kommt.Consequently, this also drastically reduces the risk that unwanted air turbulence may occur due to an impact of the low-turbulence air flow 10 on the production areas 26 or production facilities 30 to 34.

Bei dem ersten Luftleitelement 20 handelt es sich um ein konisch verlaufendes Einhausungselement 50, dessen Spitze 51 in Richtung der Luftzufuhröffnungen zeigt. Insofern ist das konisch verlaufende Einhausungselement 50 ein kegelförmiges Einhausungselement 53.The first air guiding element 20 is a conically extending housing element 50 whose tip 51 points in the direction of the air supply openings. insofar the conically extending housing element 50 is a conical housing element 53.

Insbesondere gemäß der Darstellung nach der Figur 5 ist gut zu erkennen, dass das kegelförmige Einhausungselement 50 die erste Produktionseinrichtung 30, nämlich den Rundtisch 40, speziell gegenüber einem mittigen Luftströmungspfad 14A vollständig abschirmt, so dass die turbulenzarme Luftströmung 10 in ihrer Gesamtheit nicht gegen die plane Oberfläche 55 des Rundtisches 40 prallen und hierbei ungünstig verwirbeln kann.In particular, according to the illustration of the FIG. 5 It can be clearly seen that the conical housing element 50 completely shields the first production device 30, namely the rotary table 40, especially with respect to a central air flow path 14A, so that the low-turbulence air flow 10 in its entirety does not collide against the planar surface 55 of the rotary table 40 and thereby can swirl unfavorably.

Das zweite Luftleitelement 21 ist als ein sattelförmiges Einhausungselement 56 ausgestaltet, wodurch die turbulenzarme Luftströmung 10 auch diesbezüglich turbulenzarm um die zweite Produktionseinrichtung 31 bzw. die erste Fertigungsstation 45 herum geleitet werden kann.The second air-guiding element 21 is designed as a saddle-shaped housing element 56, whereby the low-turbulence air flow 10 can also be directed around the second production device 31 or the first production station 45 in this respect with little turbulence.

Die weiteren Luftleitelemente 22, 23, 24 der Produktionseinrichtungen 32, 33 und 34 bzw. der dementsprechenden Fertigungsstationen 46, 47 und 48 sind jeweils als bogenförmige Einhausungselemente 60 (hier nur exemplarisch beziffert) ausgestaltet, so dass die turbulenzarme Luftströmung 10 auch durch diese bogenförmigen Einhausungselemente 60 lediglich turbulenzarm um die jeweilige Fertigungsstation 46, 47 bzw. 48 herum geleitet werden kann.The further air guide elements 22, 23, 24 of the production devices 32, 33 and 34 or the corresponding manufacturing stations 46, 47 and 48 are each designed as arcuate housing elements 60 (numbered here only as an example), so that the low-turbulence air flow 10 is also formed by these arcuate housing elements 60 only turbulence around the respective manufacturing station 46, 47 and 48 can be passed around.

Insbesondere gemäß der Darstellung nach der Figur 5 ist gut zu erkennen, dass die eher seitlich im Reinraum 1 strömenden Luftströmungspfade 14B und 14C durch die bogenförmigen Einhausungselemente 60 des dritten Luftleitelements 22 bzw. des fünften Luftleitelements 24 turbulenzarm um das jeweilige Fertigungsarmelement 49 der zweiten Fertigungsstation 46 bzw. der vierten Fertigungsstation 48 herum geleitet und in die Luftabzugsöffnungen 11 abgeleitet wird.In particular, according to the illustration of the FIG. 5 It can easily be seen that the air flow paths 14B and 14C, which flow laterally in the clean room 1, are guided by the arcuate housing elements 60 of the third air guide element 22 and the fifth air guide element 24, respectively, around the respective production arm element 49 of the second production station 46 and the fourth production station 48, respectively and is discharged into the air exhaust openings 11.

Ganz ähnlich verhält es sich bei dem durch das vierte Luftleitelement 23 eingehauste Fertigungsarmelement 49 der dritten Fertigungsstation 47, auch wenn ein diesbezüglicher seitlicher Luftströmungspfad explizit nicht eingezeichnet ist.The situation is quite similar in the case of the production arm element 49 of the third production station 47, which is enclosed by the fourth air-guiding element 23, even if a lateral airflow path of this kind is explicitly not shown.

Allen Luftleitelementen 20 bis 24 ist gemein, dass sie Einhausungselemente 50, 56 und 60 ausgestalten, welche sich in Strömungsgegenrichtung 52 hin verjüngen. Insofern handelt es sich bei den Einhausungselementen 50, 56 und 60 jeweils um ein sich in Luftströmungsgegenrichtung 52 verjüngendes Einhausungselement 61, wenn auch zumindest teilweise unterschiedlich ausgestaltet.All air guide elements 20 to 24 have in common that they Einhausungselemente 50, 56 and 60 configure, which taper in flow direction 52 towards. In this respect, the housing elements 50, 56 and 60 are each a housing element 61 which tapers in the direction of air flow 52, albeit at least partially differently designed.

Dies bedeutet, dass die Körperhorizontalausdehnungen 65 (hier nur schematisch eingezeichnet) aller Luftleitelemente 20 bis 24 in Luftströmungshauptrichtung 13 von einem oberen schmalen Körperbereich 66 jeweils bis zu einer maximalen Grundflächenhorizontalausdehnung 67 stetig zunehmen.This means that the body horizontal expansions 65 (shown here only schematically) of all the air guide elements 20 to 24 in the main air flow direction 13 increase steadily from an upper narrow body region 66 to a maximum base horizontal extent 67.

Hierdurch ist die den Produktionsflächen 26 und/oder Produktionseinrichtungen 30 bis 34 seitige Körperhorizontalausdehnung 65 größer ausgestaltet, als deren Luftzufuhröffnung seitige Körperhorizontalausdehnung, wodurch insgesamt die in Lufthauptströmungsrichtung 13 strömende turbulenzarme Luftströmung 10 ohne kritische Verwirbelungen um diese Produktionsflächen 26 bzw. Produktionseinrichtungen 30 bis 34 herum geleitet werden.As a result, the production areas 26 and / or production facilities 30 to 34 side body horizontal extent 65 designed larger than the air supply opening side body horizontal extent, whereby a total of the flowing in the main air flow direction 13 low-turbulence air flow 10 without critical turbulence around these production areas 26 and production facilities 30 to 34 around become.

Gemäß der Darstellungen nach den Figuren 3 und 4 ist besonders gut zu erkennen, dass die Luftleitelemente 20 bis 24 an ihrer den Produktionsflächen 26 bzw. den Produktionseinrichtungen 30 bis 34 zugewandten Seiten 70 (hier nur exemplarisch beziffert) jeweils eine Öffnung 71 aufweisen, in welchen die Produktionseinrichtungen 30 bis 34 zumindest teilweise in die Luftleitelemente 20 bis 24 eingebracht sind.According to the representations after the FIGS. 3 and 4 It can be seen particularly well that the air guiding elements 20 to 24 each have an opening 71 at their sides 70 facing the production surfaces 26 and the production devices 30 to 34 (here only exemplarily), in which the production devices 30 to 34 are at least partly in the Air guide elements 20 to 24 are introduced.

Vorteilhafterweise sind darüber hinaus die Luftleitelemente 22, 23 und 24 derart von den Produktionsflächen 26 bzw. Produktionseinrichtungen 32, 33 und 34 beabstandet angeordnet, dass mittels der turbulenzarmen Luftströmung 10 im Bereich dieser Produktionsflächen 26 bzw. Produktionseinrichtungen 32, 33 und 34 ein Sogeffekt erzeugt werden kann, mittels welchem Schmutzpartikel von den Produktionsflächen 26 bzw. Produktionseinrichtungen 32, 33 und 34 entfernbar sind. Hierdurch kann die Reinheitsqualität innerhalb der Fertigungszelle 4 des Reinraums 1 nochmals vorteilhaft verbessert werden.Advantageously, moreover, the air guiding elements 22, 23 and 24 are arranged at such a distance from the production areas 26 and production facilities 32, 33 and 34 that a suction effect is generated by means of the low-turbulence air flow 10 in the region of these production areas 26 and production facilities 32, 33 and 34 can, by means of which dirt particles from the production areas 26 and Produktionsseinrichtungen 32, 33 and 34 are removable. As a result, the quality of purity within the manufacturing cell 4 of the clean room 1 can be further improved advantageously.

Es versteht sich, dass es sich bei dem vorstehend erläuterten Ausführungsbeispiel lediglich um eine erste Ausgestaltung des erfindungsgemäßen Reinraums 1 handelt. Insofern beschränkt sich die Ausgestaltung der Erfindung nicht auf dieses eine Ausführungsbeispiel.It goes without saying that the exemplary embodiment explained above is only a first embodiment of the clean room 1 according to the invention. In this respect, the embodiment of the invention is not limited to this one embodiment.

Sämtliche in den Anmeldungsunterlagen offenbarten Merkmale werden als erfindungswesentlich beansprucht, sofern sie einzeln oder in Kombination gegenüber dem Stand der Technik neu sind.All disclosed in the application documents features are claimed as essential to the invention, provided they are new individually or in combination over the prior art.

BezugszeichenlisteLIST OF REFERENCE NUMBERS

11
Reinraumcleanroom
22
Produktionsanlageplant
33
medizinische Produktemedical products
44
Fertigungszellemanufacturing cell
55
Gehäusecasing
66
Arbeitsumgebungworking environment
77
Bodenteilthe bottom part
88th
Rahmengestellframe
99
Glaselementeglass elements
1010
turbulenzarme Luftströmunglow-turbulence airflow
1111
LuftabzugsöffnungenAir vents
1212
Bodenbereichfloor area
1313
LufthauptströmungsrichtungAir main flow direction
1414
LuftströmungspfadeAir flow paths
14A14A
mittiger Luftströmungspfadcentral air flow path
14B14B
erster seitlicher Luftströmungspfadfirst lateral air flow path
14C14C
zweiter seitlicher Luftströmungspfadsecond lateral airflow path
1515
laminare Luftströmunglaminar airflow
2020
erstes Luftleitelementfirst air guide
2121
zweites Luftleitelementsecond air guide
2222
drittes Luftleitelementthird air guide
2323
viertes Luftleitelementfourth air guide
2424
fünftes Luftleitelementfifth air guide
2525
LuftleiteinrichtungCowl
2626
Produktionsflächeproduction area
3030
erste Produktionseinrichtungfirst production facility
3131
zweite Produktionseinrichtungsecond production facility
3232
dritte Produktionseinrichtungthird production facility
3333
vierte Produktionseinrichtungfourth production facility
3434
fünfte Produktionseinrichtungfifth production facility
4040
Rundtischroundtable
4141
Drehachseaxis of rotation
4242
WerkstückträgerWorkpiece carrier
4545
erste Fertigungsstationfirst production station
4646
zweite Fertigungsstationsecond manufacturing station
4747
dritte Fertigungsstationthird manufacturing station
4848
vierte Fertigungsstationfourth manufacturing station
4949
FertigungsarmelementeFertigungsarmelemente
5050
konisch verlaufendes Einhausungselementconically extending housing element
5151
Kegelspitzeapex
5252
StrömungsgegenrichtungFlow the opposite direction
5353
kegelförmiges Einhausungselementconical housing element
5555
plane Oberflächenflat surfaces
5656
sattelförmiges Einhausungselementsaddle-shaped housing element
6060
bogenförmiges Einhausungselementarcuate housing element
6161
verjüngende Einhausungselementetapered housing elements
6565
KörpervertikalausdehnungenBody vertical extensions
6666
schmalere Körperbereichenarrower body areas
6767
maximale Grundflächenhorizontalausdehnungenmaximum base area horizontal expansions
7070
Seitenpages
7171
Öffnungenopenings

Claims (10)

  1. Clean room (1) for producing objects, in particular medical products (3), comprising production surfaces (26) and production devices (30, 31, 32, 33, 34) and comprising air supply openings for supplying a low-turbulence air flow (10, 15) into the clean room (1) and comprising air exhaust openings (11) through which the low-turbulence air flow (10, 15), which may be contaminated with dirt particles, can be withdrawn from the clean room (1), an air conduction device (25) having air conduction elements (20, 21, 22, 23, 24) being arranged in one or more air flow paths (14) between the air supply openings and the air exhaust openings (11) in such a way that the low-turbulence air flow (10, 15) can be conveyed at least in part around the production surfaces (26) and/or the production devices (30, 31, 32, 33, 34) so as to avoid an air flow deflection caused by the production surfaces (26) and/or the production devices (30, 31, 32, 33, 34),
    characterised in that
    the air conduction elements (20, 21, 22, 23, 24) are tapered in the opposite direction (52) to the air flow.
  2. Clean room (1) according to claim 1,
    characterised in that
    the air conduction elements (20, 21, 22, 23, 24) are centrically or concentrically arranged above the production surfaces (26) and/or the production devices (30, 31, 32, 33, 34).
  3. Clean room (1) according to any of claims 1 to 2,
    characterised in that
    the air conduction elements (20, 21, 22, 23, 24) are conical, saddle-shaped or arched on the sides thereof facing the air supply openings.
  4. Clean room (1) according to any of claims 1 to 3,
    characterised in that
    the air conduction elements (20, 21, 22, 23, 24) include housing elements (50, 53, 56, 60), the body dimensions (65) of which increase in the main air flow direction (13) as far as the maximum base surface extent (67).
  5. Clean room (1) according to any of claims 1 to 4,
    characterised in that
    the air conduction elements (20, 21, 22, 23, 24) have a circular or oval base surface.
  6. Clean room (1) according to any of claims 1 to 5,
    characterised in that
    the air conduction elements (20, 21, 22, 23, 24) comprise openings (71) on each of the sides (70) thereof facing the production surfaces (26) and/or production devices (30, 31, 32, 33, 34), in which openings the production surfaces (26) and/or the production devices (30, 31, 32, 33, 34) are arranged so as to inwardly protrude at least in part.
  7. Clean room (1) according to any of claims 1 to 6,
    characterised in that
    the air conduction elements (20, 21, 22, 23, 24) are arranged so as to be spaced apart from the production surfaces (26) and/or the production devices (30, 31, 32, 33, 34) such that a suction effect is produced by means of the low-turbulence air flow (10, 15) in the region of the production surfaces (26) and/or the production devices (30, 31, 32, 33, 34), by means of which suction effect dirt particles can be removed from the production surfaces (26) and/or the production devices (30, 31, 32, 33, 34).
  8. Clean room (1) according to any of claims 1 to 7,
    characterised in that
    the clean room (1) is a clean room (1) of EU GMP clean room class C.
  9. Method for operating a clean room (1) for producing objects, in particular medical products (3), in which a low-turbulence air flow (10, 15) fed in from a ceiling region of the clean room (1) is fed through the clean room (1) into a floor region (12) of the clean room (1) and from there out of the clean room (1) in order to prevent, as far as possible, contamination of the objects or medical products (3) to be produced with undesired substances, the low-turbulence air flow (10, 15) being guided past production surfaces (26) and/or production devices (30, 31, 32, 33, 34) arranged inside the clean room (1) in such a way that the low-turbulence air flow (10, 15) is conveyed around the production surfaces (26) and/or production devices (30, 31, 32, 33, 34) on its way from the ceiling region to the floor region (12) so as to avoid direct operative contact with these production surfaces (26) and/or the production devices (30, 31, 32, 33, 34),
    characterised in that
    the air conduction elements (20, 21, 22, 23, 24) are tapered in the opposite direction (52) to the air flow.
  10. Method according to claim 9,
    characterised in that
    the low-turbulence air flow (10, 15) is accelerated in a low-turbulence manner between the ceiling region and the floor region (12) by means of the air conduction elements (20, 21, 22, 23, 24).
EP14168712.9A 2013-05-23 2014-05-16 Clean room for producing objects and method for operating a clean room Active EP2806222B1 (en)

Applications Claiming Priority (1)

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DE102013105287.8A DE102013105287A1 (en) 2013-05-23 2013-05-23 Clean room for producing objects and method for operating a clean room

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EP2806222A2 EP2806222A2 (en) 2014-11-26
EP2806222A3 EP2806222A3 (en) 2014-12-24
EP2806222B1 true EP2806222B1 (en) 2017-04-05

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Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019035920A1 (en) * 2017-08-18 2019-02-21 Tel Fsi, Inc. Apparatus for spraying cryogenic fluids

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6475835A (en) * 1987-09-17 1989-03-22 Fujitsu Ltd Clean working booth
US4946484A (en) * 1988-02-05 1990-08-07 Donaldson Company, Inc. Support for clean room ceiling grid system
US5058491A (en) * 1990-08-27 1991-10-22 Taiwan Semiconductor Manufacturing Company, Ltd. Building and method for manufacture of integrated circuits
JPH0463122U (en) * 1990-10-04 1992-05-29
DE4121327C1 (en) * 1991-06-28 1992-09-17 Fraunhofer-Gesellschaft Zur Foerderung Der Angewandten Forschung Ev, 8000 Muenchen, De Local clean space module e.g. for exposure in semiconductor mfr. or packing sterile product - has inlets providing clean air of various qualities at predetermined areas of internal space limited by socket module with hood above
DE4210960C2 (en) 1992-04-02 1994-03-31 Ibm Clean room island and method for the clean room-appropriate handling of objects stored in containers
DE10351848A1 (en) * 2003-11-06 2005-06-09 Leica Microsystems Semiconductor Gmbh System for the detection of macro defects
SE532217C2 (en) * 2007-05-03 2009-11-17 Airsonett Ab Ventilation device for an operating room

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EP2806222A3 (en) 2014-12-24
DE102013105287A1 (en) 2014-11-27
EP2806222A2 (en) 2014-11-26

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