| 摘要 |
Methods of producing prefilled, sterile delivery devices (10) without exterior or interior contamination which include preparing an assembled and sealed prefilled delivery device (10), sterilizing the assembled and sealed prefilled delivery device (10) and its contents (24), and aseptically placing the prefilled delivery device (10) in a secondary package (30) which provides a sterile barrier surrounding the delivery device (10). Optionally, the prefilled delivery device (10) can be non-aseptically placed in a secondary package (30) after sterilization and then the exterior surfaces of the delivery device (10) and the interior of the secondary package (30) can be sterilized while the delivery device (10) is in the secondary package (30). Further optionally, the prefilled delivery device (10) can be placed in a secondary package (30) prior to sterilization, thus permitting the sterilization of the exterior and interior of the delivery device (10) as well as the interior of the secondary package (30) during the initial autoclaving procedure, thereby eliminating the need for further sterilization. |
