| 摘要 |
A pre-filled, sterile delivery apparatus (20) and the process for making the apparatus. The apparatus is in the form of a syringe having a liquid filled container (22) with a sealed nozzle (24) at one end and an opposite end sealed by a piston (32). The piston has an elastic body portion with a solid film lubricant outer layer (36) to facilitate sliding engagement of the piston with the interior wall of the container. The sealed assembly is sterilized to provide a sterile syringe having sterile contents. The solid film lubricant provides the piston with the sliding property while avoiding the use of silicone oils or the like which can contaminate the liquid contents. The piston undergoes sterilization while within the container without adverse effect, e.g., delamination. The disclosed process involves filling the syringe container with a desired fluid material, e.g., a contrast medium, sealing the container with the piston, and sterilizing the sealed assembly. |
