Device and method for ensuring sterility

Abstract

The invention relates to a device and a method for ensuring the sterility of objects, products, and / or object- and / or product-contacting components in a cleanroom, wherein an airflow is provided in the cleanroom over a component (20, 30) arranged in the cleanroom to an object, a product, and / or an object- and / or product-contacting component, wherein a cover (10) made of a sterilizable, in particular autoclavable, material can be arranged on the component (20, 30) or upstream of the component (20, 30) such that contamination of the airflow passing over the component (20, 30) is prevented by means of the cover (10). The invention further relates to the use of a cover (10) for ensuring the sterility of objects in a cleanroom.

Description

FIELD OF APPLICATION AND PRIOR ARTThe invention relates to a device and a method for ensuring the sterility of objects in a clean room. The invention further relates to a use of a cover for ensuring the sterility of objects in a clean room.In the context of the application, a decontaminated unit which allows its interior to be isolated from an external environment is referred to as an insulator. Insulators are used in particular in the production, processing and manipulation of pharmaceutical products, biopharmaceutical products, biological products, toxic products and / or other highly sensitive products. A clean room is created inside the insulator. Devices and / or materials which are produced, processed or handled in some other way in the clean room, comprising packaging means, such as containers into which the products are filled, closure elements, such as plugs, for closing the containers, or the like, are referred to in connection with the application as objects.Particularly for the handling (production, processing and / or manipulation) of pharmaceutical and / or biopharmaceutical products, high sterility requirements are placed. Requirements for a clean room in the pharmaceutical industry are defined, inter alia, in Appendix 1 of the EU-GMP Guide concerning the preparation of sterile medicaments (EU-Annex 1).OBJECT AND SOLUTIONIt is the object of the invention to provide measures for ensuring the sterility of products and / or objects when they are handled in a clean room, in particular in a clean room for producing and / or filling sterile pharmaceutical preparations.This object is achieved by the device and the method having the features of claims 1 and 6 and the use having the features of claim 10.According to a first aspect, a device for ensuring the sterility of objects, products and / or components contacting the objects and / or products in a clean room is provided, wherein an air flow via a component arranged in the clean room to an object, a product and / or a component contacting the objects and / or products is provided in the clean room. The device comprises a cover made of a sterilizable, in particular autoclavable material, wherein the cover can be arranged on the component or upstream of the component in such a way that contamination of the air flow guided over the component on the component is prevented by means of the cover.The terms "a", "an", etc. are used in connection with the application merely as indefinite articles and not as count words. In particular, in embodiments, the device can comprise more than one cover.The device makes it possible to arrange components which can be sterilized only to a limited extent, for example components which cannot be autoclaved or can be autoclaved only to a limited extent because of their nature, in an air stream to objects, products and / or components which are in contact with the object and / or product, without there being the risk that the air stream reaches a surface of the components which cannot be autoclaved or can be autoclaved only to a limited extent and is contaminated by these components.The components are, for example, components of kinematics or handling systems, such as lifting shafts, beams, joints or arms, or other components which are fixedly installed in an insulator or clean room and / or which are introduced in the insulator or clean room before decontamination.By means of the cover, it is possible to cover critical points of the components with a second, in particular autoclavable, material layer and / or to deflect an air flow, so that an air flow does not reach a surface of the components.During use, an air flow thus only touches the covering which can be sterilized in advance, so that a risk of contamination is prevented or at least reduced to a tolerable extent.In other words, the cover makes it possible to realize an air guidance in a clean room in order to ensure sterility in such a way that a flow of the filtered air supplied to the clean room is deflected exclusively on sterilized, in particular autoclaved, surfaces before it reaches the product, the objects, in particular surfaces of the objects in contact with the product, and / or components which contact the product or the objects, such as for example filling needles or stopper webs.The design of the cover can be suitably selected by the skilled person depending on the component to be covered. The covers are preferably designed and / or arranged in such a way that they do not assume a load-bearing function and therefore do not have to withstand forces. The cover can therefore be configured with thin walls in embodiments and has a low weight. The cover can thus be removed from the insulator if necessary, for example during a desert, and, after sterilization, in particular after steam sterilization in an autoclave, can be introduced again into the insulator after its decontamination and installed or replaced by an alternative element.In one embodiment, it is provided that the cover is two- or multi-part and encloses at least one section of the component. The cover can be adapted to the shape of a component in such a way that it encloses the component in an airtight manner in its critical region.Depending on the application, in embodiments the cover can be fastened to the component by means of a form fit, by means of a force fit, by means of a latching connection, by means of a magnetic connection and / or by means of a plug connection. In one embodiment, the fastening to the component is indirect, wherein parts of the cover are brought into engagement with one another and the cover is thus fastened to a component arranged between the parts of the cover. In other embodiments, the cover is fastened directly to the component, for example, locked to it and / or fastened to it by means of a magnetic connection. In embodiments, the cover has fastening elements for a one-time fastening of the cover to the component without tools. The fastening elements are, for example, hooks for a latching connection or magnets for a magnetic connection. A "toolless fastening" is a fastening that allows the cover to be fastened to the component without a tool. In embodiments, the cover can be gripped or handled by means of a tool. In embodiments, dismantling the cover from the component is not possible without tools.In embodiments, a configuration is selected such that it is possible to attach the cover to the component by means of kinematic mechanism located in the insulator without the need for glove engagement. This prevents the cover from being contaminated by gloves that allow manual access to the clean room.Alternatively or additionally, it is provided in embodiments that the cover has a handling section, in particular a handling section protruding from a surface, such as a tab, a handle or a handle, and / or an optically detectable marked region, for handling it. The handling section is designed and / or positioned in such a way that, on the basis of the handling section, handling for manual mounting of the cover in the insulator is possible directly, by means of a tool and / or by means of a shielding device without any contamination of the surfaces lying in the air stream.In one configuration, an outer contour of the cover is equal to an outer contour of a component on which the cover is arranged. In other embodiments, it is provided that an outer contour of the cover deviates from an outer contour of the component. The cover can thus be used in a targeted manner in order to carry out local aerodynamic adaptations in the clean room without changing the associated component in a structural-mechanical manner, in particular without changing a design of the component.The cover can be adapted to the properties necessary for the respective application. In embodiments, it is provided that the cover is made of an autoclavable material, in particular of metal and / or plastic.According to a second aspect, a method for ensuring the sterility of objects, products and / or components which are in object and / or product contact is provided in a clean room, wherein an air flow is guided in the clean room via a component which is arranged in the clean room to an object, a product and / or a component which is in object and / or product contact, wherein a cover made of a sterilisable, in particular autoclavable, material is arranged on the component or upstream of the component in such a way that contamination of the air flow guided via the component on the component is prevented by means of the cover.Depending on the application, the cover can be brought into position manually by a person, for example by means of a tool via glove intervention, or completely or partially automatically by means of kinematics arranged in the clean room.In one embodiment, it is provided that the cover is two- or multi-part and the component is housed at least in sections by means of the cover. In embodiments, the cover is placed around the component, so that it is enclosed in a sleeve-like manner.Depending on the application, the cover is fastened to the component in embodiments by means of form-fit, by means of force-fit, by means of latching connection, by means of magnetic connection and / or by means of plug connection. A type of connection can be suitably selected depending on the application. In embodiments, the type of connection is selected such that repeated non-destructive attachment of the cover can be carried out completely or partially automatically by means of kinematics. In other embodiments, disassembly is possible only with destruction of the cover.In typical applications, the cover is introduced into the clean room after decontamination of the clean room and fastened to the component or upstream of the component. In embodiments, the cover is introduced into the clean room via a port provided on the clean room. In embodiments, the cover is designed such that it can be introduced into an autoclavable bag and can be provided by means of the latter at a port for transfer into the clean room.By means of the cover, it is possible to also re-fit an already existing clean room, for example in order to better adapt the clean room to increased requirements for sterility.According to a third aspect, the use of a cover made of a sterilisable, in particular autoclavable, material for ensuring the sterility of objects, products and / or object- and / or product-contacting components in a clean room is provided, wherein the cover is arranged on a component arranged in the clean room or upstream of the component in such a way that contamination of an air flow guided via the component to an object by means of the cover is prevented.As described above, the use of a cover makes it possible to realize air guidance in a clean room in order to ensure sterility in such a way that a flow of the filtered air supplied to the clean room is deflected exclusively on sterilized, in particular autoclaved, surfaces before it reaches the product and product-contacting surfaces of objects.Depending on the application, the cover can be suitably designed by the skilled person.BRIEF DESCRIPTION OF THE DRAWINGSFurther advantages and aspects of the invention are evident from the claims and from the description of exemplary embodiments of the invention, which are explained below with reference to the figures. The following are shown: FIG. 1 shows a first exemplary embodiment of a device for ensuring sterility, comprising a cover arranged on a solid arm of a kinematic mechanism; FIG. 2 shows the device according to FIG. 1 with the arm in an exploded illustration of the cover; FIG. 3 shows the arm according to FIG. 1 without the device; FIG. 4 shows a second exemplary embodiment of a device for ensuring sterility, comprising a cover arranged on an arm of a closing station; FIG. 5 shows the cover according to FIG. 4 in an exploded view; FIG. 6 shows an alternative exemplary embodiment of a cover in a cross-sectional view; and FIG. 7 shows a cross-sectional view of a further exemplary embodiment of a cover.DETAILED DESCRIPTION OF THE EMBODIMENTSIn the figures, uniform reference numerals are used for identical or similar elements.FIGS. 1 and 2 show a first exemplary embodiment of a device 1 for ensuring the sterility of objects and / or products, not shown in the figures, in a clean room.The device 1 comprises a cover 10 made of a sterilizable material, in particular of metal or plastic. The cover 10 shown in FIGS. 1 and 2 can be attached to a component 20 in such a way that contamination of an air flow guided over the component 20 on the component 20 is prevented by means of the cover 10.The component 20 according to FIGS. 1 and 2 is a solid arm of a kinematic mechanism 2. the cover 10 can be configured in such a way that a functionality of the kinematic mechanism 2 is not changed or at most is not changed insignificantly for the application by means of the cover 10.As can be seen in FIG. 2, the cover 10 illustrated is in two parts, comprising a first U-shaped part 11 and a second part 12 which can be connected to the first part 11, so that a closed enclosure for the component designed as an arm 20 is created.FIG. 1 shows very schematically by means of arrows a primary air supplied from above, which is deflected at the arm 20. The deflected air is not contaminated because of the cover 10 before the air reaches an object schematically shown as container 4 in FIG. 1.FIG. 3 shows the arm 20 of the kinematic mechanism 2 without the cover 10, wherein a primary air supplied from above, which is deflected at the arm 20, is likewise shown very schematically by means of arrows. The deflected air can be contaminated due to the contact with the arm 20, so that the air guided to the object schematically represented as container 4 in FIG. 3 can no longer be referred to as primary air.FIGS. 4 and 5 show a second exemplary embodiment of a device 1 for ensuring sterility, comprising a cover 10.The cover 10 shown in FIGS. 4 and 5 can also be attached to a component 30 in such a way that contamination of an air flow guided over the component 30 on the component 30 is prevented by means of the cover 10.The component 30 according to FIGS. 4 and 5 is an arm of a closing station in the form of a plug setter 3. The cover 10 for the component 30 has an analogous design in the exemplary embodiment shown and likewise has an aperture 13. The illustrated plug setter 3 has a second arm 32, wherein in the illustrated exemplary embodiment no cover is provided on the second arm 32. In other embodiments, a cover is also provided on the second arm 32.As can be seen in FIG. 5, the cover 10 illustrated in FIGS. 4 and 5 is also two-part, comprising a first part 11 and a second part 12 which can be connected to the first part 11, so that a closed enclosure for the component 30 designed as an arm, including a wall delimiting the aperture 33, is created. For this purpose, in the exemplary embodiment shown, the first part 11 shown has an outer wall 110 which is substantially U-shaped and an inner wall 113 which is designed in a manner corresponding to the wall delimiting the aperture 33.In the exemplary embodiments illustrated in FIGS. 1, 2 and 4 and 5, outer contours of the covers 10 correspond at least substantially to outer contours of the components 20, 30, on which the covers 10 are each arranged.FIGS. 6 and 7 each show, in a cross-sectional view, embodiments of a cover 10 similar to the cover 10 according to FIGS. 1 and 2 Like the cover according to FIG. 1, the covers 10 according to FIGS. 6 and 7 each have a first, U-shaped part 11 and a second part 12 connectable thereto, which together form a closed sleeve.In contrast to the configuration according to FIGS. 1 and 2, in the configuration according to FIG. 6, corners 101 of the first part 11 are beveled.In the configuration according to FIG. 7, a projection 102 is provided on an upwardly oriented side of the first part 11.The merely schematically illustrated configurations according to FIGS. 5 and 6 allow local aerodynamic adaptations in the clean room to be carried out by changing the outer contour of the covers 10 without changing the associated component to which the covers 10 are respectively attached.The illustrated embodiments are merely exemplary and numerous modifications are conceivable.

Claims

Device for ensuring the sterility of objects, products and / or components in contact with the object and / or product in a clean room, wherein an air flow via a component (20, 30) arranged in the clean room to an object, a product and / or a component in contact with the object and / or product is provided in the clean room, comprising a cover (10) made of a sterilizable, in particular autoclavable, material, wherein the cover (10) can be arranged on the component (20, 30) or upstream of the component (20, 30) in such a way that contamination of the air flow guided via the component (20, 30) on the component (20) is prevented by means of the cover (10).Device according to claim 1, characterised in that the cover (10) is two or more parts and encloses at least one section of the component (20, 30).Device according to claim 1 or 2, characterised in that the cover (10) can be fastened to the component (20, 30) by means of positive locking, by means of frictional locking, by means of latching connection, by means of magnetic connection and / or by means of plug connection, wherein the cover (10) preferably has fastening elements for a one-time fastening of the cover (10) to the component (20, 30) without tools.Device according to one of claims 1, 2 or 3, characterised in that the cover (10) has a handling section, in particular a handling section protruding from a surface, such as a tab, a handle or a handle, and / or a region which marks it optically detectable.Device according to one of Claims 1 to 4, characterized in that an outer contour of the cover (10) deviates from an outer contour of the component (20, 30).Method for ensuring the sterility of objects, products and / or components in contact with the object and / or product in a clean room, wherein an air flow is guided in the clean room via a component (20, 30) arranged in the clean room to an object, a product and / or a component in contact with the object and / or product, wherein a cover (10) made of a sterilisable, in particular autoclavable, material is arranged on the component (20, 30) or upstream of the component (20, 30) in such a way that contamination of the air flow guided via the component (20, 30) on the component (20, 30) is prevented by means of the cover (10).Method according to Claim 6, characterized in that the cover (10) is two-part or multi-part and the component (20, 30) is housed at least in sections by means of the cover (10).Method according to Claim 6 or 7, characterized in that the cover (10) is fastened to the component (20, 30) by means of form closure, by means of force closure, by means of latching connection, by means of magnetic connection and / or by means of plug connection.Method according to claim 6, 7 or 8, characterised in that the cover (10) is introduced into the clean room after decontamination of the clean room and is fastened to the component (20, 30) or upstream of the component (20, 30).Use of a cover (10) made of a sterilisable, in particular autoclavable, material for ensuring the sterility of objects, products and / or object- and / or product-contacting components in a clean room, wherein an air flow via a component (20, 30) arranged in the clean room to an object, a product and / or an object- and / or product-contacting component is provided in the clean room, wherein the cover (10) is arranged on the component (20, 30) or upstream of the component (20, 30) in such a way that contamination of the air flow guided via the component (20, 30) on the component (20, 30) is prevented by means of the cover (10).

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