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    • 10. 发明授权
    • Manufacture of prefilled syringes
    • 制造预充式注射器
    • US06189195B1
    • 2001-02-20
    • US08517645
    • 1995-08-22
    • David M. ReillyEdward J. RhinehartEugene A. GelblumMark W. HitchinsMichelle Robinson
    • David M. ReillyEdward J. RhinehartEugene A. GelblumMark W. HitchinsMichelle Robinson
    • B23P1500
    • B65B3/003Y10T29/49808Y10T29/4984
    • This invention relates to a process for manufacturing prefilled syringes where at least one of the syringe components is manufactured in at least a class 100 environment. The process includes the steps of manufacturing syringe components, such as the barrel and plunger substrate, within at least a class 100 and MCB-3 environment; manufacturing syringe components, such as the plunger cover and tip seal in an environment less clean than a class 100 environment; decontaminating the plunger cover and tip seal; lubricating at least one of the barrel, plunger substrate, plunger cover and tip seal; assembling the barrel and tip seal to form a barrel/tip seal combination; assembling the plunger cover and plunger substrate to form a plunger; filling the barrel/tip seal combination with a predetermined amount of fluid; and final assembling of the prefilled syringe by inserting the plunger into the barrel/tip seal combination. When the syringe components are manufactured at different locations, each component is tripled-bagged to maintain the component substantially free from contaminants, and transported to an assembly site where the components are unpackaged and assembled into the barrel/tip seal combination and plunger. When filling and final assembly of the barrel/tip seal combination takes place at a location separate from its assembly site, the barrel/tip seal combination is tripled-bagged to maintain it substantially free from contaminants, and transported to a filling and final assembling site for filling and final assembling into a prefilled syringe.
    • 本发明涉及一种用于制造预充式注射器的方法,其中至少一个注射器组件在至少100级环境中制造。 该方法包括在至少100级和MCB-3环境中制造注射器部件(例如筒体和柱塞基底)的步骤; 在比100级环境更干净的环境中制造注射器部件,例如柱塞盖和末端密封; 净化柱塞盖和顶端密封; 润滑桶,柱塞基板,柱塞盖和端盖密封件中的至少一个; 组装筒和尖端密封以形成筒/尖端密封组合; 组装柱塞盖和柱塞基板以形成柱塞; 用预定量的流体填充桶/尖端密封组合; 以及通过将柱塞插入筒/尖端密封组合中来预填充注射器的最终组装。 当注射器组件在不同位置制造时,每个组件被三倍重装,以保持组件基本上没有污染物,并被运输到组件的未被包装并组装到筒/尖端密封组合和柱塞中的组装位置。 当筒/尖端密封组合的填充和最终组装在与其组装位置分离的位置处发生时,筒/尖端密封组合被三倍重装,以使其基本上不含污染物,并被运送到填充和最终组装位置 用于填充和最终组装成预充式注射器。