STELMAH Mike,ARNOTT Rachel Paige,BURGESS Bart E.,CUPICHA Michael J.,GORALTCHOUK Alexei,GRYGUS Bryan
申请号:
IL25436717
公开号:
IL254367D0
申请日:
2017.09.07
申请国别(地区):
IL
年份:
2017
代理人:
摘要:
The present disclosure provides aseptic vial piercing and sterilization systems, and methods of assembling, using and sterilizing same. The systems and methods utilize a pre-sterilized primary container including a first end, a first cavity, a second end with an opening in communication with the first cavity, a septum at least partially sealing the opening, and a product within the first cavity. The systems and methods include an injection assembly including a first end portion of a hollow flowpath forming member. The injection assembly and the primary container may be assembled in a non-sterile environment to form a second cavity extending about the first end portion of the flowpath forming member and to the primary container. The second cavity may then be selectively sterilized in a non-deleterious manner to the product to allow the first end portion to aseptically pierce the septum to extend into the first cavity.