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摘要
The authors compare four well-established aseptic filling technologies, open vial, ampul, blow-fill-seal (BFS) and prefilled syringes, to the recently developed closed-vial technology with regards to the exposure risk from viable particles from the air supply. Containers (e.g., vial, syringe barrel, or ampul), container closures (e.g., stoppers, or plungers), and filling needles have all been taken into account and weighted by exposed surface and exposure time. The study assumes that all of these technologies are normally operated under controlled environmental conditions in accordance with worldwide GMP standards and with appropriate attention to generally accepted sterility assurance guidelines, including use of an ISO 5 environment during the filling operation. The analysis showed that two technologies, BFS and closed vial technology, significantly reduce the risk of contamination due to exposure to the environment. The reduction factor for this risk can exceed 100 compared with open containers.
- 出版日期2012-3
