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CN-122028941-A - Device and method for ensuring sterility

CN122028941ACN 122028941 ACN122028941 ACN 122028941ACN-122028941-A

Abstract

The invention relates to a device and a method for ensuring sterility of objects, products and/or components contacting the objects and/or the products in a clean room, wherein in the clean room an air flow is provided to the objects, the products and/or the components contacting the objects and/or the products via the components (20, 30) arranged in the clean room, wherein a cover (10) made of a sterilizable, in particular autoclavable material can be arranged at the components (20, 30) or upstream of the components (20, 30) in such a way that the air flow guided via the components (20, 30) is prevented from being contaminated at the components (20) by means of the cover (10). The invention also relates to the use of a cover (10) for ensuring sterility of objects in a clean room.

Inventors

  • M. HALL
  • F. Wei Peite

Assignees

  • 奥普蒂玛制药有限责任公司

Dates

Publication Date
20260512
Application Date
20240808
Priority Date
20231017

Claims (10)

  1. 1. Device for ensuring the sterility of objects, products and/or components contacting objects and/or products in a clean room, wherein in the clean room an air flow is provided via a component (20, 30) arranged in the clean room to the object, product and/or component contacting objects and/or product, the device comprising a cover (10) made of a sterilizable, in particular autoclavable material, wherein the cover (10) can be arranged at 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) at the component (20) is prevented by means of the cover (10).
  2. 2. The device according to claim 1, characterized in that the cover (10) is two-or multi-piece and surrounds at least one section of the member (20, 30).
  3. 3. The device according to claim 1 or 2, characterized in that the cover (10) can be fixed at the component (20, 30) by means of a form fit, by means of a force fit, by means of a snap-lock connection, by means of a magnetic connection and/or by means of a plug connection, wherein preferably the cover (10) has a fixing element for fixing the cover (10) at the component (20, 30) at one time without tools.
  4. 4. A device according to any one of claims 1, 2 or 3, characterized in that the cover (10) has an operating section, in particular an operating section protruding from the surface, such as for example a tongue, a hoop-like grip or a handgrip, and/or has an optically detectable marked area.
  5. 5. The device according to any one of claims 1 to 4, wherein the outer contour of the cover (10) is different from the outer contour of the member (20, 30).
  6. 6. Method for ensuring sterility of objects, products and/or components contacting objects and/or products in a clean room, wherein in the clean room an air flow is directed to the objects, products and/or components contacting objects and/or products via components (20, 30) arranged in the clean room, wherein a cover (10) made of a sterilizable, in particular autoclavable material is arranged at the components (20, 30) or upstream of the components (20, 30) in such a way that contamination of the air flow directed via the components (20, 30) at the components (20, 30) is prevented by means of the cover (10).
  7. 7. The method according to claim 6, characterized in that the cover (10) is two-part or multi-part and the components (20, 30) are surrounded at least in sections by means of the cover (10).
  8. 8. Method according to claim 6 or 7, characterized in that the cover (10) is fixed at the component (20, 30) by means of a form fit, by means of a force fit, by means of a snap-lock connection, by means of a magnetic connection and/or by means of a plug connection.
  9. 9. Method according to claim 6, 7 or 8, characterized in that after decontamination of the clean room, the cover (10) is introduced into the clean room and fixed at the component (20, 30) or upstream of the component (20, 30).
  10. 10. Use of a cover (10) made of a sterilizable, in particular autoclavable material for ensuring sterility of objects, products and/or components contacting objects and/or products in a clean room, wherein in the clean room an air flow is provided via a component (20, 30) arranged in the clean room to a component contacting objects, products and/or products, wherein the cover (10) is arranged at 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) at the component (20, 30) is prevented by means of the cover (10).

Description

Device and method for ensuring sterility Technical Field The present invention relates to a device and a method for ensuring sterility of objects in a clean room. The invention also relates to the use of a cover for ensuring sterility of a subject in a clean room. Background With respect to the present application, the decontaminated unit, which allows its interior to be isolated from the external environment, is referred to as an isolator. The separator is particularly useful in the manufacture, processing and handling of pharmaceutical products, biopharmaceutical products, biological products, toxic products and/or other highly sensitive products. A clean room is created in the interior of the isolator. Appliances and/or materials (which include packages (such as, for example, containers into which a product is filled), closure elements (such as plugs for closing containers), etc.) manufactured, processed, or otherwise manipulated in a clean room are referred to as objects in connection with the present application. In particular, high requirements are placed on sterility for handling (manufacturing, processing and/or manipulating) pharmaceutical and/or biopharmaceutical products. The requirements for clean rooms in the pharmaceutical industry are specified in particular in Annex 1 (EU-Annex 1) of the european union GMP guidelines concerning aseptic pharmaceutical manufacturing. Disclosure of Invention The object of the present invention is to create means for ensuring sterility of a product and/or object when it is handled in a clean room, in particular a clean room for manufacturing and/or filling sterile pharmaceutical products. This object is achieved by means of a device and a method with the features of claims 1 and 6 and by means of a use with the features of claim 10. Advantageous embodiments emerge from the dependent claims. According to a first aspect, a device for ensuring sterility of objects, products and/or components contacting objects and/or products in a clean room is created, wherein in the clean room an air flow is provided via the components arranged in the clean room to the objects, products and/or components contacting objects and/or products. The device comprises a cover made of a sterilizable, in particular autoclavable material, wherein the cover can be arranged at or upstream of the component in such a way that contamination of the component by the air flow guided through the component is prevented by means of the cover. The terms "a," "an," and the like, in connection with the present application, are used merely as indefinite articles, rather than numerical terms. In particular, in a design, the device may comprise more than one cover. The device enables to arrange a component that can only be sterilized in a limited way (e.g. a component that cannot or can only be autoclaved in a limited way due to its nature) in the air flow to the object, the product and/or the component that contacts the object and/or the product without the risk of the air flow reaching the surface of the component that cannot or can only be autoclaved and being contaminated by it. The components are, for example, components of a movement mechanism or an operating system, such as a lifting shaft, a cross beam, a joint or an arm, or other components, which are fixedly mounted in the isolator or the clean room and/or which are introduced into the isolator or the clean room before decontamination. By means of the cover it is possible to cover critical parts of the component with a layer of a second material, in particular autoclavable, and/or to divert the air flow so that it does not reach the surface of the component. Thus, in use, the air flow only contacts the pre-sterilizable cover, thereby preventing or at least reducing the risk of contamination to an acceptable level. In other words, the cover allows, in order to ensure sterility, an air guidance in the clean room in such a way that the filtered flow of air supplied to the clean room is diverted only at the sterilized, in particular autoclaved, face before it reaches the product, the object (in particular the face of the object contacting the product) and/or the component contacting the product or object (such as, for example, a filling needle or stopper face). The design of the cover can be appropriately selected by the person skilled in the art depending on the component to be covered. The cover is preferably designed and/or arranged in such a way that it does not have to take on a bearing function and therefore does not have to withstand forces. In a further embodiment, the cover can be thin-walled and lightweight. In this way, the cover can be removed from the isolator when needed (e.g., when disassembled) and reintroduced into the isolator and installed after decontamination of the isolator or replaced with an alternative component after sterilization (particularly after steam sterilization in an autoclave). In one embodiment, the cover is provid