Sartorius Stedim Fmt Sas

Nicolas Mendyk

Isabelle Gay

Gaelle Nodin

Stephanie Armau

Stéphanie Armau

Gaëlle Nodin

A sterile filling unit, of a basic container with contents that can be distributed in a fluid form and that is originally located in a source container in a sterile manner, includes a sterile chamber with at least one sterile entry port and/or outlet; a sterile fluid transfer and filling line with an intake and an outlet, such that for a filling stage the line passes through the wall of the sterile chamber in a sterile manner, with the intake located outside of the sterile chamber in sterile fluid communication with the source container, with the filling element at the outlet located inside the sterile chamber and positioned to be operating; and a unit that can introduce the disposable internal elements that, in a stage prior to the filling stage, were located outside of the sterile chamber, into the interior of the sterile chamber in a sterile manner.

Unit for the sterile filling of a final basic container with contents designed for the biopharmaceutical field

The invention relates to a biopharmaceutical container comprising: a connector to be secured to a chamber connector; a bag serving as a receptacle, one part of which is secured to the connector; and a flexible tube tucked inside the bag, which tube can extend out from the bag through the connector. The biopharmaceutical container, wherein: the tube forms part of the bag, the tube is a neck of reduced size extending from the body of the bag, and the aforementioned part of the bag that is secured to the connector is a fold in the wall of the bag, said wall of the bag forming the body of the bag on one side of the fold and the tube on the other side of the fold.

Biopharmaceutical container, biopharmaceutical container bag, and method for the production and use of said biopharmaceutical container

A method for the sterile filling of at least one final basic container, includes: providing at least one sterile chamber having at least one sterile entrance port and providing a source container containing the content, located outside the chamber; providing a communication element, a dispensing element and at least one filling member, to form when all are assembled, a sterile fluid filling and transfer line; inserting at least one final container into the chamber; structurally combining at least one final container with at least one filling member; providing inner members and elements in sterile condition for a single-use; inserting the inner element and members which were previously outside the chamber in the chamber in a sterile manner, such that after filling, a new filling process can be performed without sterilizing the inside of the chamber; transferring in a filling step content from the source container into the final container.

Method and unit for the sterile filling of a final basic container with content intended for the biopharmaceutical field

A fluid connection device () for connecting two fluid conduits (), includes a female plug (), a male plug (), intended to be inserted into the female plug into a final coupling position, a movable primary locking device (), having a locked position () in which it prevents the male and female plugs from being released from the final coupling position, and a movable secondary latch () having an active position () designed to prevent the primary locking device () from being moved out of the locked position of same, whereby the fluid connection device can establish a permanent connection of the first and second conduits.

Secure fluid connection

A sterile individual set for use in a process of manufacturing a biopharmaceutical product. To make it quicker and easier to grasp and use fluidic type functional members, the sterile individual set includes a sterile flexible bag having a peripheral wall defining a sterile internal space and a fluidic type functional member arranged at least partially inside the sterile internal space. The functional member includes one or more communication duct(s) arranged in the sterile internal space. The sterile individual set also includes structural association elements capable of holding together several portions of the communication duct or ducts that are to be bundled together into a bundle. The structural association elements have an external surface with lower static and dynamic friction coefficients so as to make the functional member easier to handle by slippage of the bundle of communication ducts with respect to the peripheral wall of the flexible bag.

Sterile individual set for producing biopharmaceutical products

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.

Growing community of inventors

Peypin, France

Nicolas Mendyk