Abstract: A method for sterilizing by X-rays an assembly containing a single-use device intended to receive a biopharmaceutical fluid, comprising: placing a plurality of dosimeters, repeatedly passing the assembly in front of the X-ray radiation window, according to a first face then according to a second face of the assembly, at several irradiation power-time pairs (PTi), followed by mapping the radiation dose; and —determining an optimum power-time pair (PTopt) for which the mapping reveals that all dosimeters have recorded a radiation dose above a minimum sterility dose (Dmin), and for which the dosimeter associated with a fragile element of the single-use device records a radiation dose below a maximum dose (Dmax) defined as being the dose from which the X-ray irradiation deteriorates the fragile element.

Abstract: A device (1; 2; 3; 4; 5) is provided for carrying out an integrity test on a sample of disposable components. The device has a medium chamber (10) with an inner chamber (11) that is bounded to the outside, for the purpose of receiving a culture medium. The device also has a sample holder (20) in which the sample (100) can be arranged in such a way that the sample (100) at least partially bounds the medium chamber (10) to the outside. The medium chamber (10) has a vent line (19) that is arranged on a side of the medium chamber (10) facing away from the sample holder (20).

Abstract: Disclosed is a bag including: a first envelope having at least one fill and/or discharge orifice for a biopharmaceutical fluid and a fill and/or discharge tube associated in a fluidtight manner with the fill and/or discharge orifice, a second envelope within which the first envelope is located, and a spacer element. The first envelope, the second envelope, and the spacer element form a coherent whole, in particular during use of the bag, and the fill and/or discharge tube traverses the second envelope by a fluidtight connection, the fill and/or discharge inlet being located outside the second envelope.

Abstract: A port is suitable for attachment to a container and suitable for being traversed by a needle used to transfer content between the inside of the container and the outside of the container, and includes a rigid annular body extending in a direction including a side wall surrounding a channel extending between an inner end and an outer end, the inner and outer ends being at opposite ends along the direction, the body being open at the ends, an overmolding member of thermoplastic elastomer including a sealing portion suitable for being traversed by the needle in a direction close to the direction, the needle passing through the inner and outer ends, the overmolding member sealing the channel in a fluidtight manner after withdrawal of a needle and further including an adhesion portion suitable for attaching the port to the container.

Abstract: A device (1; 2; 3; 4; 5) is provided for carrying out an integrity test on a sample of disposable components. The device has a medium chamber (10) with an inner chamber (11) that is bounded to the outside, for the purpose of receiving a culture medium. The device also has a sample holder (20) in which the sample (100) can be arranged in such a way that the sample (100) at least partially bounds the medium chamber (10) to the outside. The medium chamber (10) has a vent line (19) that is arranged on a side of the medium chamber (10) facing away from the sample holder (20).

Abstract: Disclosed is a bag including: a first envelope having at least one fill and/or discharge orifice for a biopharmaceutical fluid and a fill and/or discharge tube associated in a fluidtight manner with the fill and/or discharge orifice, a second envelope within which the first envelope is located, and a spacer element. The first envelope, the second envelope, and the spacer element form a coherent whole, in particular during use of the bag, and the fill and/or discharge tube traverses the second envelope by a fluidtight connection, the fill and/or discharge inlet being located outside the second envelope.