The invention relates to an insulator apparatus (10), in particular for pharmaceutical and/or biotechnological applications, having a manipulation chamber (12), at least one work glove (14) insertable into the manipulation chamber (12), and a sensor (16) for detecting an inserted state of the at least one work glove (14), the at least one work glove (14) being insertable into an access opening (18) of the manipulation chamber (12) in an exchangeable manner and sealing the insulator apparatus (10) when inserted. The sensor (16) is disposed at a distance to the access opening (18) in the manipulation chamber (12) and connected to a detection unit (20), a detection area (22) of the sensor (16) comprising at least one operating area of the at least one work glove (14) in the area of the access opening (18), in particular a cross section having a diameter (D) of the access opening (18), in order to detect and to evaluate, by means of the detection unit (20), at least a change and/or an operation of the at least one work glove (14) in the manipulation chamber (12).
B25J 21/02 - Boîtes à gants, c.-à-d. enceintes dans lesquelles les manipulations sont exécutées par des mains humaines dans des gants faisant partie de la paroi de l'enceinteGants de boîtes à gants
The invention relates to an isolator apparatus (10), in particular for pharmaceutical and/or biotechnical applications, having a manipulation chamber (12), at least one work glove (14) that can be inserted into the manipulation chamber (12), and sensor means (16) for detecting an inserted state of the at least one work glove (14), the at least one work glove (14) being insertable in an access opening (18) of the manipulation chamber (12) so as to be replaceable and, when inserted, sealing the isolator apparatus (10). The sensor means (16) are arranged in the manipulation chamber (12) at a distance from the access opening (18) and are connected to a detection unit (20), the detection range (22) of the sensor means (16) comprising at least one work area of the at least one work glove (14) in the region of the access opening (18), in particular a cross section having the diameter (D) of the access opening (18), in order to detect at least a replacement and/or use of the at least one work glove (14) in the manipulation chamber (12) and to evaluate same using the detection unit (20).
B25J 21/02 - Boîtes à gants, c.-à-d. enceintes dans lesquelles les manipulations sont exécutées par des mains humaines dans des gants faisant partie de la paroi de l'enceinteGants de boîtes à gants
G06F 3/01 - Dispositions d'entrée ou dispositions d'entrée et de sortie combinées pour l'interaction entre l'utilisateur et le calculateur
B23Q 17/00 - Agencements sur les machines-outils pour indiquer ou mesurer
The invention relates to a surface decontamination device (1) for decontaminating outer packagings (2) which contain pre-sterilised consumer goods, more particularly prefilled syringes, and have a circumferential collar (3) prior to transfer into an insulator, said surface decontamination device comprising conveying means for conveying the outer packagings (2) in a conveying direction (F) along a conveying path from an inlet side of the device to an outlet side of the device (1), wherein the conveying path passes through a decontamination chamber (5) which is arranged between the inlet side and outlet side and with which an irradiation source, (6) more particularly an electron beam source, is associated for irradiating the outer packagings (2) that can be conveyed through the decontamination chamber (5), and passes through at least one lock chamber (8) which is arranged between the inlet side and outlet side, is adjacent to the decontamination chamber (5) and which has an inlet and an outlet, said inlet and outlet being able to be opened and closed by means of closing means. The conveying means comprises a suspended transport unit (7) arranged in the decontamination chamber (5) for the suspended transport of the outer packagings (2) on the circumferential collar (3) thereof, wherein a lifting unit (11, 15) for the automatic, vertical adjustment of the outer packagings (2) relative to the suspended transport unit (7) is arranged in the lock chamber (8, 14) .
A61L 2/08 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet utilisant des phénomènes physiques des radiations
B65B 55/08 - Stérilisation des enveloppes d'emballage ou récipients avant ou pendant l'emballage par irradiation
5.
DECONTAMINATION DEVICE, ISOLATOR SYSTEM, AND OPERATING METHOD
The invention relates to a decontamination device (1) for decontaminating products in the form of consumer-products and/or consumer product packaging with consumer-products located therein prior to supplying the consumer-products into an isolator, in particular for pharmaceutical applications, comprising multiple decontamination chambers (3, 4, 5, 6), each of which has a closable inlet opening (9) and a closable outlet opening (10) and each of which comprises application means (7) for applying a decontamination agent (7), in particular a decontamination agent steam or aerosol, to the decontamination chambers (3, 4, 5, 6); a distributor chamber (11) which is arranged upstream of the decontamination chambers (3, 4, 5, 6), has a supply opening (24) for the products to be decontaminated, and comprises distributor means (15) for distributing the products to the different decontamination chambers (3, 4, 5, 6); and a discharge chamber (12) which is arranged downstream of the decontamination chambers (3, 4, 5, 6) and has a discharge opening (2) and which comprises transport means (16) for transporting the decontaminated products out of the decontamination chambers (3, 4, 5, 6), preferably in the direction of the discharge opening (2), wherein means (17) for reducing the decontamination agent concentration are paired with the distributor chamber (11) and/or the discharge chamber (12).
A61L 2/20 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet utilisant des substances chimiques des substances gazeuses, p. ex. des vapeurs
6.
DECONTAMINATION APPARATUS, ISOLATOR SYSTEM, AND OPERATING METHOD
The invention relates to a decontamination apparatus for decontaminating consumer good secondary packagings having pre-sterilised consumer goods, preferably in the form of primary packagings, disposed therein prior to the consumer goods being fed into an isolator, comprising a decontamination chamber (2), having application means (3) for applying a decontaminant, in particular a decontaminant vapour or aerosol, to the consumer good secondary packagings. The decontamination chamber (2) comprises transport means (6) for simultaneously transporting a plurality of consumer good secondary packagings, which are to be decontaminated at the same time during the decontamination, from an inlet (4) to an outlet (5) of the decontamination chamber (2). A loading port (7) is arranged upstream of the decontamination chamber (2) and can be loaded with consumer good secondary packagings that are to be decontaminated, and an unpacking port (14) is arranged downstream of the decontamination chamber (2), in which unpacking port the sterile consumer goods can be unpackaged, in particular in an automated manner, from the previously decontaminated consumer good secondary packagings prior to be being transported on into the isolator. The loading port (7) and the unpacking port (14) are associated with means for reducing the decontaminant concentration (8) in the loading port (7) and the unpacking port (14) respectively in an operating state decoupled from the decontamination chamber (2).
B65B 55/10 - Stérilisation des enveloppes d'emballage ou récipients avant ou pendant l'emballage par des liquides ou des gaz
A61L 2/20 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet utilisant des substances chimiques des substances gazeuses, p. ex. des vapeurs
7.
DECONTAMINATION ARRANGEMENT, SYSTEM AND DECONTAMINATION METHOD
The invention relates to a decontamination arrangement, in particular for pharmaceutical applications, comprising at least one chamber (4) to be decontaminated, in particular an isolation chamber, preferably a manipulation chamber and/or a plenum chamber separated from the manipulation chamber by means of a membrane, further comprising a decontamination liquid container (22) from which a number of atomizers (A, B, C) for producing a decontaminant aerosol that are arranged in the chamber (4) to be decontaminated and are preferably formed as two-substance nozzles can be supplied with decontamination liquid, preferably hydrogen peroxide, by means of at least one supply line (25, 26, 27), wherein the decontamination liquid container (22) is designed as a pressure vessel (16) which is connected to a compressed air source (8) and in which a delivery pressure can be produced by admitting compressed air, in particular sterile compressed air, from the compressed air source (8), and the delivery pressure can be used to deliver the decontamination liquid from the pressure vessel (16) through the at least one supply line (25, 26, 27) in the direction of the atomizers (A, B, C).
A61L 2/22 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet utilisant des substances chimiques des substances à phases, p. ex. des fumées, des aérosols
8.
RETURN AIR FILTER BOX, ISOLATOR AND ISOLATOR SYSTEM
The invention relates to a disposable return air filter device for an isolator, comprising a multi-part housing (2) that contains an air filter (7), in particular formed as a HEPA or ULPA filter, said housing having an inlet opening (3) for air to be filtered from an isolator chamber and an outlet opening (4) for filtered air, wherein the housing (2) comprises a first and a second half-shell (5, 6), which are connected, in particular glued, to each another in an air-tight manner, and the inlet opening (3) is associated with the first half-shell (5), said half-shell preferably forming a top housing part, and the outlet opening (4) is associated with the second half-shell (6), said half-shell preferably forming a bottom housing part. According to the invention, a receiving chamber (16) for cleaning material to be disposed of together with the return air filter device (1) is delimited by the first and/or second half-shell (5, 6) between the filter and the inlet opening (3) and/or between the filter and the outlet opening (4) respectively.
B01D 46/10 - Séparateurs de particules utilisant des plaques, des feuilles ou des tampons filtrants à surface plane, p. ex. appareils de précipitation de poussières
B08B 15/02 - Précautions prises pour empêcher les crasses ou les fumées de s'échapper de la zone où elles sont produitesRamassage ou enlèvement des crasses ou des fumées de cette zone par utilisation de chambres ou de hottes recouvrant cette zone
B25J 21/02 - Boîtes à gants, c.-à-d. enceintes dans lesquelles les manipulations sont exécutées par des mains humaines dans des gants faisant partie de la paroi de l'enceinteGants de boîtes à gants
9.
DECONTAMINATION ARRANGEMENT, SYSTEM AND DECONTAMINATION METHOD
The invention relates to a decontamination arrangement, in particular for pharmaceutical uses, comprising at least one space (4) to be decontaminated, in particular an isolator space, preferably a manipulator space and/or a plenum space separated from the manipulator space by a membrane, with a decontamination liquid reservoir (36) from which several atomizers (A, B, C, D), arranged in the space (4) to be decontaminated and preferably configured as two-substance nozzles, and serving to generate a decontamination aerosol, can be supplied with decontamination liquid, preferably hydrogen peroxide, via valve means (27) controllable by electronic control means, wherein the atomizers (A, B, C, D) are connected fluidically via the valve means (27) to a ring line (32) which has an inlet (33) and, separate therefrom, an outlet (34), into the inlet of which decontamination liquid from the decontamination liquid reservoir (36) can be delivered by means of a pump (35), and from the outlet of which decontamination liquid can flow back into the decontamination liquid reservoir (36), and wherein the ring line (32) is assigned pressure-adjusting means (37) for keeping the liquid pressure in the ring line (32) in a predefined liquid pressure range. According to the invention, measuring means (40) are provided for determining a total quantity of decontamination liquid delivered to the atomizers (A, B, C, D) during a decontamination cycle, in particular comprising weighing means (41) for determining a quantity of decontamination liquid in the decontamination liquid reservoir (36).
A61L 2/20 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet utilisant des substances chimiques des substances gazeuses, p. ex. des vapeurs
A61L 9/015 - Désinfection, stérilisation ou désodorisation de l'air utilisant des substances gazeuses ou à l'état de vapeur, p. ex. de l'ozone
A61L 2/22 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet utilisant des substances chimiques des substances à phases, p. ex. des fumées, des aérosols
The invention relates to a decontamination assembly (1), in particular for pharmaceutical applications, comprising an isolator (2) with a manipulator chamber (3) and a plenum chamber (4) which is arranged above the manipulator chamber (3) and which can be supplied with an air flow (9) via at least one circulating air fan (7) arranged in a circulating air generator chamber (6). A membrane (5), in particular a mesh, for producing a laminar air flow (11) in the manipulator chamber (3) during a working operational state is arranged between the plenum chamber (4) and the manipulator chamber (3), and the manipulator chamber (3) is connected to the circulating air generator chamber (6) so as to conduct air via a recirculation channel (12) which is preferably arranged between two transparent panels (13, 14). The decontamination assembly further comprises a fine distributing means (19), in particular an evaporator or atomizer, for generating a decontaminant/air mixture on the basis of a liquid decontaminant supply, preferably an H2O2 supply. The fine distributing means (19) is connected to the plenum chamber (4) via at least one plenum supply line (25) which opens into the plenum chamber (4) in order to supply the decontaminant/air mixture directly into the plenum chamber (4) in a decontamination operating state. According to the invention, the fine distributing means (19) is directly connected to the manipulator chamber (3) via at least one manipulator supply line (27) in order to supply the decontaminant/air mixture directly into the manipulator chamber (3) in the decontamination operating state.
A61L 2/22 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet utilisant des substances chimiques des substances à phases, p. ex. des fumées, des aérosols
The invention relates to an isolator (1), in particular for pharmaceutical and/or chemical applications, comprising an isolator space (5) having a double wall (2), wherein the double wall (2) comprises at least one transparent outer wall panel (8) and a transparent inner wall panel (7) at a distance to same, which delimit an intermediate space (9), in particular for conducting gas, and comprising at least one glove port (3) associated with the double wall (2), comprising means for detachably fixing a glove (4) for extending through the double wall (2) to manually engage in the isolator space (5), wherein the glove port (4) has a channel ring (10) which surrounds a reach-through channel (13), is preferably transparent, and which extends from the outer wall panel (8) in the direction of the inner wall panel (7). According to the invention, the means for the detachable fixing of the glove (4) is arranged in a region between the outer wall panel (8) and the inner wall panel (7) outside the reach-through channel (13).
B25J 21/02 - Boîtes à gants, c.-à-d. enceintes dans lesquelles les manipulations sont exécutées par des mains humaines dans des gants faisant partie de la paroi de l'enceinteGants de boîtes à gants
The invention relates to a device for generating a decontaminating agent vapor, in particular hydrogen peroxide vapor, comprising a single- or multipart evaporator body (1); a heating device for heating the evaporator body (1); at least one supply channel, preferably multiple supply channels, for supplying a liquid decontaminating agent to be evaporated, in particular hydrogen peroxide, to at least one of multiple blind holes (7, 8, 9, 10) arranged in the evaporator body (1); and a flow channel (2) which is arranged above the upper blind holes edges (11, 12, 13, 14) of the blind holes (7, 8, 9, 10) and which connects a carrier medium inlet (3) to an outlet (4) in a gas-conductive manner for a gaseous carrier medium, in particular air, in order to discharge the decontaminating agent vapor through the outlet (4) in a flow direction of the carrier medium. According to the invention, at least two of the blind holes (7, 8, 9, 10), preferably all of the blind holes (7, 8, 9, 10), are fluidically connected together at a distance from the respective upper blind hole edges (11, 12, 13, 14).
A61L 2/20 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet utilisant des substances chimiques des substances gazeuses, p. ex. des vapeurs
B01B 1/00 - ÉbullitionAppareils à ébullition en vue d'applications physiques ou chimiques
13.
ISOLATOR HAVING CATALYTIC DISINFECTANT DECOMPOSITION
The invention relates to a decontamination assembly (1), in particular for pharmaceutical applications, comprising a chamber (3) to be decontaminated, in particular an isolator chamber, and comprising at least one circulation-air generator chamber (4), which is arranged above the chamber (3) to be decontaminated and which has a fan arranged therein for producing a gas circulation-air volumetric flow between the circulation-air generator chamber (4) and the chamber (3) to be decontaminated, and comprising a decontamination device (13) for discharging decontaminating agent into the circulation-air generator chamber (4), which decontamination device is arranged inside the circulation-air generator chamber (4) and/or has an outlet for decontaminating agent into the circulation-air generator chamber (4) and preferably comprises a decontaminating agent vaporizer. According to the invention, a catalyst (16) for chemically cleaving the decontaminating agent is provided in the circulation-air generator chamber (4), wherein the decontaminating agent can be conveyed through the catalyst (16) by means of the fan, and gas-conducting means (18) are associated with the fan, which gas-conducting means can be switched between a first operating state, in which at least the majority of the gas circulation-air volumetric flow conveyed by means of the fan can be conveyed past the catalyst (16) in order to distribute the decontaminating agent discharged by the decontamination device (13), and a second operating state, in which at least the majority of the gas circulation-air volumetric flow conveyed by means of the fan can be conveyed through the catalyst (16) in order to cleave the decontaminating agent.
A61L 2/20 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet utilisant des substances chimiques des substances gazeuses, p. ex. des vapeurs
14.
Flash vapor generator and assembly comprising a flash vapor generator
A device is disclosed for generating a decontamination agent vapor, in particular hydrogen peroxide vapor. The device includes an evaporator body, a heating unit for heating the evaporator body, and a plurality of feed channels for feeding decontamination liquid to the evaporator body. The decontamination liquid is evaporated by the evaporator body. In one embodiment, the liquid contains hydrogen peroxide. In some embodiments, a plurality of blind holes are provided in a single- or multi-part evaporator body, and at least one of the feed channels is assigned to the blind holes.
A01G 13/06 - Dispositifs générateurs de chaleur, de fumée ou de brouillard pour les jardins, vergers ou forêts, p. ex. pour prévenir les dégâts provoqués par la gelée
The invention relates to a decontamination arrangement (1), in particular for pharmaceutical applications, comprising a space (3) to be decontaminated, in particular an isolation space, and a cleaning device (7) designed for extracting gaseous and/or vaporous decontaminants, in particular hydrogen peroxide, from the air in the space. According to the invention, it is provided that the cleaning device (7) is arranged in such a way that the air in the space can be made to circulate through it by means of at least one fan (5). Furthermore, the invention relates to a method for removing gaseous and/or vaporous decontaminants.
F24F 3/16 - Systèmes de conditionnement d'air dans lesquels l'air conditionné primaire est fourni par une ou plusieurs stations centrales aux blocs de distribution situés dans les pièces ou enceintes, blocs dans lesquels il peut subir un traitement secondaireAppareillage spécialement conçu pour de tels systèmes caractérisés par le traitement de l'air autrement que par chauffage et refroidissement par purification, p. ex. par filtrageSystèmes de conditionnement d'air dans lesquels l'air conditionné primaire est fourni par une ou plusieurs stations centrales aux blocs de distribution situés dans les pièces ou enceintes, blocs dans lesquels il peut subir un traitement secondaireAppareillage spécialement conçu pour de tels systèmes caractérisés par le traitement de l'air autrement que par chauffage et refroidissement par stérilisationSystèmes de conditionnement d'air dans lesquels l'air conditionné primaire est fourni par une ou plusieurs stations centrales aux blocs de distribution situés dans les pièces ou enceintes, blocs dans lesquels il peut subir un traitement secondaireAppareillage spécialement conçu pour de tels systèmes caractérisés par le traitement de l'air autrement que par chauffage et refroidissement par ozonisation
A61L 2/20 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet utilisant des substances chimiques des substances gazeuses, p. ex. des vapeurs
A61L 9/16 - Désinfection, stérilisation ou désodorisation de l'air utilisant des phénomènes physiques
B08B 15/02 - Précautions prises pour empêcher les crasses ou les fumées de s'échapper de la zone où elles sont produitesRamassage ou enlèvement des crasses ou des fumées de cette zone par utilisation de chambres ou de hottes recouvrant cette zone
B01D 46/00 - Filtres ou procédés spécialement modifiés pour la séparation de particules dispersées dans des gaz ou des vapeurs
16.
FLASH VAPOR GENERATOR AND ASSEMBLY COMPRISING A FLASH VAPOR GENERATOR
The invention relates to a device for generating decontamination agent vapor, in particular hydrogen peroxide vapor, comprising an evaporator body (9), a heating unit (22) for heating the evaporator body (9) and a plurality of feed channels (28) for feeding decontamination liquid to be evaporated, preferably a liquid containing hydrogen peroxide, to the evaporator body (9). According to the invention, a plurality of blind holes (16) are provided in the single- or multi-part evaporator body (9), and at least one of the feed channels (28) is assigned to the blind holes (16).
A61L 2/20 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet utilisant des substances chimiques des substances gazeuses, p. ex. des vapeurs
B01B 1/00 - ÉbullitionAppareils à ébullition en vue d'applications physiques ou chimiques
brevets
