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METHOD AND UNIT FOR THE STERILE FILLING OF A FINAL BASIC CONTAINER WITH CONTENT INTENDED FOR THE BIOPHARMACEUTICAL FIELD
METHOD AND UNIT FOR THE STERILE FILLING OF A FINAL BASIC CONTAINER WITH CONTENT INTENDED FOR THE BIOPHARMACEUTICAL FIELD
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机译:一种用于生物制药领域内容的最终基本容器灭菌填充的方法和单元
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摘要
A method for the sterile filling of at least one final basic container, includes: providing at least one sterile chamber having at least one sterile entrance port and providing a source container containing the content, located outside the chamber; providing a communication element, a dispensing element and at least one filling member, to form when all are assembled, a sterile fluid filling and transfer line; inserting at least one final container into the chamber; structurally combining at least one final container with at least one filling member; providing inner members and elements in sterile condition for a single-use; inserting the inner element and members which were previously outside the chamber in the chamber in a sterile manner, such that after filling, a new filling process can be performed without sterilizing the inside of the chamber; transferring in a filling step content from the source container into the final container.
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