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    • 4. 发明申请
    • STERILIZABLE BIOPHARMACEUTICAL PACKAGING
    • 无菌生物包装
    • US20130086871A1
    • 2013-04-11
    • US13642593
    • 2011-02-11
    • Isabelle GayGaelle NodinNicolas MendykStephanie Armau
    • Isabelle GayGaelle NodinNicolas MendykStephanie Armau
    • B65B17/00
    • B65B55/18A61L2/0094A61L2/20A61L2/204A61L2/206A61L2/208A61L2/26A61L2202/181B65B55/02B65D81/245
    • A sterilizable biopharmaceutical packaging includes an opening for inserting biopharmaceutical contents to be sterilized, the opening being separate from a sterilization gas conveyance channel so that the opening can be closed independently and before closing the sterilization gas conveyance channel. The opening is directly adjacent to an inner space for receiving the biopharmaceutical contents so that the contents to be sterilized are inserted directly into the inner space from outside the packaging. The elements for controlling the distribution of the sterilization gas open/close the sterilization gas conveyance channel independently of the opening or closing of the insertion opening. After sterilization, the outer wall, the sterilization gas conveyance channel, and the opening/closing element are capable of remaining rigidly connected therebetween so as to form a sterilized biopharmaceutical packaging that contains the sterilized biopharmaceutical contents and can be subjected to one or more integrity tests at any desired time after the sterilization.
    • 可灭菌的生物药物包装包括用于插入要灭菌的生物制药内容物的开口,所述开口与灭菌气体输送通道分开,使得开口可以独立地关闭并且在关闭灭菌气体输送通道之前。 开口直接邻近用于接收生物药物内容物的内部空间,使得待消毒的内容物从包装外部直接插入内部空间。 用于控制灭菌气体的分配的元件独立于插入开口的打开或关闭来打开/关闭灭菌气体输送通道。 灭菌后,外壁,灭菌气体输送通道和打开/关闭元件能够保持其间的刚性连接,从而形成包含灭菌的生物药物内容物并可进行一次或多次完整性测试的无菌生物药物包装 灭菌后任何所需时间。
    • 5. 发明申请
    • METHOD FOR RADIOCHEMICAL STERILIZATION
    • 放射化学灭菌方法
    • US20100196196A1
    • 2010-08-05
    • US12658956
    • 2010-02-18
    • Shalaby W. Shalaby
    • Shalaby W. Shalaby
    • A61L2/20A61L2/08A61L2/26
    • A61L2/204A61L2/08B65D75/14B65D2205/025
    • This invention deals with package components for radiochemical sterilization of medical or pharmaceutical products consisting of a hermetically sealed foil pack containing (1) a solid device, as in absorbable sutures and meshes, in a perforated holder or a liquid formulation in a sealed, flexible dispenser, as in absorbable cyanoacrylate-based tissue adhesive; (2) a microparticulate, unstabilized polyformaldehyde as a source of radiolytically generated formaldehyde encased in a sealed pouch comprising a porous, non-woven or woven fabric; and (3) a nitrogenous compound capable of reacting with residual formaldehyde, such as melamine or urea, that is encased in a sealed pouch comprising a porous, non-woven or woven fabric.
    • 本发明涉及医疗或药物产品的放射化学灭菌的包装组件,其由密封的箔包组成,其包含(1)在可吸收的缝合线和网眼中的固体装置,在穿孔保持器或密封的柔性分配器中的液体制剂中 ,如可吸收的氰基丙烯酸酯基组织粘合剂; (2)微囊化,未稳定的聚甲醛,作为包含在密封袋中的放射性产生的甲醛的源,其包含多孔,无纺布或机织织物; 和(3)能够与残留的甲醛反应的含氮化合物,例如三聚氰胺或尿素,其被封装在包含多孔,无纺布或机织织物的密封袋中。
    • 7. 发明授权
    • Package components for radiochemical sterilization
    • 用于放射化学灭菌的包装组件
    • US07694813B2
    • 2010-04-13
    • US11228719
    • 2005-09-16
    • Shalaby W. Shalaby
    • Shalaby W. Shalaby
    • A61L2/08
    • A61L2/204A61L2/08B65D75/14B65D2205/025
    • This invention deals with package components for radiochemical sterilization of medical or pharmaceutical products consisting of a hermetically sealed foil pack containing (1) a solid device, as in absorbable sutures and meshes, in a perforated holder or a liquid formulation in a sealed, flexible dispenser, as in absorbable cyanoacrylate-based tissue adhesive; (2) a microparticulate, unstabilized polyformaldehyde as a source of radiolytically generated formaldehyde encased in a sealed pouch comprising a porous, non-woven or woven fabric; and (3) a nitrogenous compound capable of reacting with residual formaldehyde, such as melamine or urea, that is encased in a sealed pouch comprising a porous, non-woven or woven fabric.
    • 本发明涉及医疗或药物产品的放射化学灭菌的包装组件,其由密封的箔包组成,其包含(1)在可吸收的缝合线和网眼中的固体装置,在穿孔保持器或密封的柔性分配器中的液体制剂中 ,如可吸收的氰基丙烯酸酯基组织粘合剂; (2)微囊化,未稳定的聚甲醛,作为包含在密封袋中的放射性产生的甲醛的源,其包含多孔,无纺布或机织织物; 和(3)能够与残留的甲醛反应的含氮化合物,例如三聚氰胺或尿素,其被封装在包含多孔,无纺布或机织织物的密封袋中。