Aseptic piercing system and method

US11406565B2 · kind B2 · utility

Assignee

• REGENERON PHARMACEUTICALS, INC. · US

Inventors

• Rachel Paige Arnott · San Francisco, US
• Bart E. Burgess · Glenmont, US
• Michael Cupicha · Tarrytown, US
• Alexei Goraltchouk · Rensselaer, US
• Bryan GRYGUS · Clifton Park, US
• Mike Stelmah · Tarrytown, US

Key dates

• Filing date: Dec 6, 2018
• Grant date: Aug 9, 2022
• Expiry date: Dec 8, 2040

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61M2005/31518
• WIPO field: Medical technology
• WIPO sector: Instruments

Abstract

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.