Sterilizable biopharmaceutical packaging and method of making a sterilizable biopharmeceutical packaging

US9242753B2 · kind B2 · utility

Assignee

• Sartorius Stedim FMT SAS · FR

Inventors

• Isabelle Gay · Allauch, FR
• Gaelle Nodin · Saint-Maximin-la-Sainte-Baume, FR
• Nicolas Mendyk · Le Terme, FR
• Stephanie Armau · Ossun, FR

Key dates

• Filing date: Feb 11, 2011
• Grant date: Jan 26, 2016
• Expiry date: Dec 7, 2032

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61L2202/181
• WIPO field: Medical technology
• WIPO sector: Instruments

Abstract

A sterilizable biopharmaceutical packaging includes an opening for inserting biopharmaceutical contents to be sterilized, the opening being separate from a sterilization gas conveyance channel so that the opening can be closed independently and before closing the sterilization gas conveyance channel. The opening is directly adjacent to an inner space for receiving the biopharmaceutical contents so that the contents to be sterilized are inserted directly into the inner space from outside the packaging. The elements for controlling the distribution of the sterilization gas open/close the sterilization gas conveyance channel independently of the opening or closing of the insertion opening. After sterilization, the outer wall, the sterilization gas conveyance channel, and the opening/closing element are capable of remaining rigidly connected therebetween so as to form a sterilized biopharmaceutical packaging that contains the sterilized biopharmaceutical contents and can be subjected to one or more integrity tests at any desired time after the sterilization.