Sartorius Stedim Fmt Sas

Sartorius Stedim Aseptics

Gaelle Nodin

Isabelle Gay

Stephanie Armau

Jeremy Gibelin

Nicolas Mendyk

Mathieu Labedan

A container for ensuring the transport and the aseptic transfer of a biopharmaceutical product from or to a closed chamber provided with a leaktight joining device, includes: an annular flange delimiting an opening, a removable cover, built-in elements for locking/unlocking the removable cover and a peripheral envelope. The built-in locking/unlocking elements include a built-in functional locking/unlocking arrangement formed by a through-housing formed in the annular flange and a blind housing formed in the removable cover, and by a pin at an inner radial position and a pin at an outer radial position. The container is capable of being in an initial locking position, in an intermediate unlocking position and in a final locking position owing to the displacements of the pin at an inner radial position and the pin at an outer radial position in the blind hole of the removable cover and in the through-housing of the annular flange.

Container for the aseptic transfer of a biopharmaceutical product

A leaktight joining device for ensuring the aseptic transfer of a biopharmaceutical product between a chamber equipped with a removable door and a container equipped with a removable cover, includes: stationary temporary flanging elements, stationary unlocking elements capable of changing the container from an initial locking position to an intermediate unlocking position so as to ensure an aseptic communication between the container and the chamber, stationary locking element capable of changing the container from the intermediate locking position to a final locking position, an annular functional ring gear capable of actuating the stationary unlocking elements and the stationary locking elements of the container. The stationary temporary flanging elements, the stationary unlocking elements, and the stationary locking elements are mechanically linked to the annular functional ring gear and arranged so that the unidirectional rotation of the annular functional ring gear about the geometric axis of rotation successively drives the actuation thereof.

Leaktight joining device for the aseptic transfer of a biopharmaceutical product between a chamber and a container

A device for a tight connection between a first housing () having a wall (), an opening (), a flange () and a door (), and a second housing () having a wall (), an opening (), a flange () and a door (). The flanges are complementary, and elements are used to displace the door (). Elements are used to hold the two doors against each other, and the housings communicate between each other via a communication space (). There is an inner annular critical line on the door () and an outer annular critical line of risk of contamination on the flange (). The device includes elements (and/or) that are structurally integrated into the door () and/or the flange () and can form a separation between the communication space and the inner annular critical line and/or the outer annular critical line, when the doors are open.

Tight connection and tight transfer between two housings in view of an aseptic transfer therebetween

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.

Sterilizable biopharmaceutical packaging and method of making a sterilizable biopharmeceutical packaging

The invention relates to a housing () that is especially designed to be associated with a device for a tight connection to a second housing (), said first housing comprising a structure including a wall () defining a space (), an opening () defined by a flange () that can be hermetically applied to a second flange () of the second housing (), holding means that can keep the first flange and the second flange () applied to each other, a door () supported by carrying means (), the door leaf () being mobile in such a way as to be closed or open and having an outer face () that can ensure the hermetic application of a second door () of the second housing (), fixing means for holding the leaves (Ov) against each other, displacement manoeuvring means (), and means for controlling the displacement manoeuvring means (), and, when the leaf () is open, an inlet/outlet space () in/of the inner space () forming part of a communication space () between the two housings (), wherein the carrying means () and the displacement manoeuvring means () for the door () are arranged in such a way that, when the leaf () is open, it extends essentially past the limit () of the inlet/outlet space (), a distancing space () being thus created between the inlet/outlet space () and the leaf () in the open state.

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Saint Maximin la Sainte Baume, France

Gaelle Nodin