Means and method for aseptic particle-free production of articles
First Claim
1. A method of aseptic, particle-free production of interiors and exteriors of articles, to avoid the need for chemical or irradiation treatment of the articles, and to provide aseptic articles which are prepared for further processing, comprising the steps of:
- creating an aseptic environment within a clean room;
shrouding at least a portion of an article producing means of a production machine to substantially segregate the portion of the article producing means from the clean room but retaining some communication with the clean room;
substantially isolating the portion of the article producing means which is shrouded from any external environment and from the clean room;
sterilizing the interior of the clean room, the portion of the article producing means within the shroud, the interior of the shroud, and any surfaces of the shroud inside and communicating with the clean room;
filtering and sterilizing any air enclosed by the clean room and the shroud; and
imparting a flow of filtered, sterilized air through the clean room and into the shroud, over and around the articles being produced on the portion of the article producing means within the shroud, and out of the shroud, so that the articles produced will be aseptic interiorally and exteriorally and ready for further processing.
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Accused Products
Abstract
An apparatus and method for aseptic, particle-free production of articles. A shroud is placed around at least a portion of the device which produces the articles to substantially isolate that portion from the external environment. The device for producing the articles and the shroud are sterilized and the air inside the shroud is filtered and sterilized. A laminar or other type of flow of filtered, sterilized air is imparted through the shroud over the articles being produced. A secondary shroud encloses the corridor or work area adjacent the shroud and device which produces the articles. The corridor and secondary shroud are sterilized, and sterilized and filtered air is continually introduced therein. The articles therefore are particle-free and sterilized for further use. The apparatus and method can be used for any component production process employing high temperatures and/or pressures, including, but not limited to, blow molding, injection molding, and production of semiconductor electronic components. In the case of blow molding, sterilization of the interior of the article being blow molded is accomplished by blowing the article with filtered and sterilized air.
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Citations
23 Claims
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1. A method of aseptic, particle-free production of interiors and exteriors of articles, to avoid the need for chemical or irradiation treatment of the articles, and to provide aseptic articles which are prepared for further processing, comprising the steps of:
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creating an aseptic environment within a clean room; shrouding at least a portion of an article producing means of a production machine to substantially segregate the portion of the article producing means from the clean room but retaining some communication with the clean room; substantially isolating the portion of the article producing means which is shrouded from any external environment and from the clean room; sterilizing the interior of the clean room, the portion of the article producing means within the shroud, the interior of the shroud, and any surfaces of the shroud inside and communicating with the clean room; filtering and sterilizing any air enclosed by the clean room and the shroud; and imparting a flow of filtered, sterilized air through the clean room and into the shroud, over and around the articles being produced on the portion of the article producing means within the shroud, and out of the shroud, so that the articles produced will be aseptic interiorally and exteriorally and ready for further processing. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A method for aseptic, particle-free blow molding of interiorally and exteriorally sterile articles comprising the steps of:
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shrouding a portion of an article producing means of a production machine for blow molding sterile articles to substantially isolate the article producing portion of the blow molding machine from the remainder of the machine and from any external environment; sterilizing the portion of the article producing means of the blow molding machine and the machine shroud; filtering and sterilizing the air entered into the machine shroud; shrouding the work area adjacent to the shrouded portion of the article producing machine; sterilizing the work area and the shroud enclosing the work area; filtering and sterilizing the air entering the work area shroud; imparting a laminar flow of filtered, sterilized air over and around the articles being blow molded; and exhausting the laminar flow of filtered, sterilized air from the machine shroud; blowing filtered, sterilized air into the articles being blow molded.
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8. An apparatus for aseptic, particle-free production of interiors and exteriors of articles comprising:
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a clean room having an aseptic environment; a production machine including a means for producing the articles, at least a portion of said article producing means being sterilized, said article producing portion of the machine being adjacent said clean room; a shroud substantially isolating the article producing portion of the machine from the remainder of the machine and from any external wnvironment, the shroud being sterilized; an inlet opening in the shroud communicating between the clean room and the shroud; means for filtering and sterilizing air entering the clean room and the shroud; means for imparting a laminar flow of filtered, sterilized air over and around the articles being produced; at least one outlet opening in the shroud for exhausting the laminar flow of filtered, sterilized air from the shroud. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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Specification