Hoffmann-la Roche Inc.

Bionter Ag

F. Hoffmann-la Roche Ag

Viatris Asia Pacific Pte. Ltd.

Tobias Werk

Hanns-Christian Mahler

Markus Von Raumer

Jörg Lümkemann

Tom Kissling

Carmen Lema Martinez

Matthias Eppler

Gerhard Klokow

Simon Duerr

Joerg Luemkemann

Anke Dorn

Denis Luthringer

Imke Sonja Ludwig

René Rietmann

Roger Steiner

Sebastian Schneider

Daniel Kullmann

Jörg Völkle

Thomas Zumstein

Stephan Buchmann

Amandine Fraichard

Charlyse Herrmann

Céline Lienhart

Joerg Voelkle

The present invention provides for a single-use, disposable container and methods and apparatuses for testing liquid samples in a non-destructive fashion using the single-use, disposable container within a liquid sample analyzer. The single-use, disposable container reduces the overall sample volume contact within a flow path of the liquid sample analyzer, decreases the cleaning solution and drying time needed between sample analyses, and minimizes formation of particles during use of the container.

Single-use, disposable container

A method of manufacturing a flexible container housing a drug substance is disclosed that includes forming a first compartment from a flexible sheet-like material, filling a liquid into the first compartment, sealing the first compartment, forming a second compartment from the flexible sheet-like material, filling a dry drug formulation into the second compartment, and sealing the second compartment. The method further involves lyophilizing the drug formulation inside a tubular cartridge, filling the second compartment by introducing the tubular cartridge through an opening of the second compartment such that an open end of the tubular cartridge is positioned distant from the opening of the second compartment, providing the drug formulation from the open end of the tubular cartridge into the second compartment, and withdrawing the tubular cartridge from the second compartment. The first and second compartments are separated by a frangible seal which opens when the first compartment is compressed.

Manufacturing a flexible container

The invention provides for methods and apparatuses for testing liquid samples using small amounts of the liquid sample in a non-destructive fashion. The methods and apparatuses perform optical measurements of liquid samples, the method comprising: (a) obtaining a first container filled with the liquid sample to be analyzed; (b) flowing the liquid sample along a first flow direction through a flow path comprising an optical measuring device; (c) flowing the liquid sample along a second flow direction opposite the first flow direction through the flow path comprising the optical measuring device; (d) performing the optical measurement of the liquid sample in the second flow direction or in both the first and second flow directions; and (e) flowing the liquid sample through the flow path into a second container; wherein the first container and the second container may be the same or different containers; and wherein the liquid sample in the second container is substantially the same as the liquid sample in the first container.

Methods of testing liquid samples

A device for closing a chamber of a container having an opening for accessing the chamber comprises a plunger, a plunger seat, a container carrier and a spacer. The plunger seat releasably holds the plunger in a predefined alignment. The container carrier is arranged to be connected to the container in a predefined position and alignment in relation to the opening of the container. The spacer is arranged to position and align the plunger seat adjacent to and distant from the container carrier such that the opening of the container is open when the container is connected to the container carrier.

Closing a chamber of a container for a pharmaceutical product

A multi chamber syringe unit includes a body, a separating element and a bypass arrangement. The body has a distal end side, a proximal end side opposite to the distal end side, an interior limited by a side wall between the distal end side and the proximal end side and a longitudinal axis centrally extending from the distal end side to the proximal end side through the body. The separating element is arranged in the interior of the body forming a distal chamber between the distal end side and the separating element and a proximal chamber between the proximal end side and the separating element. The bypass arrangement is a section of the body in which the interior has a constant noncircular cross section orthogonal to the longitudinal axis. The multi camber syringe unit allows for being efficiently prepared and for efficiently providing or administering high quality of prefilled products.

Multi chamber syringe unit

An inspection device has a particle detector adapted to detect particles in a liquid, the particle detector preferably including a camera. The inspection device including a seat adapted to position a container housing the liquid in an area of operation of the particle detector and a vibration arrangement for vibrating the container. The vibration arrangement includes a frequency generator adapted to provide an electrical signal and a transducer adapted to transduce the electrical signal provided by the frequency generator into an acoustic wave. The seat is adapted to position the container adjacent to the transducer for inspecting a liquid inside a container with respect to the existence of particles. The inspection device allows for an accurate and gentle inspection of the liquid filled in the container and for detecting particles in the liquid.

Vibrating inspection device for detection of particles in a liquid

A method of preparing a double chamber container is disclosed that includes filling a substance into the container, freeze-drying the substance therein, inserting a middle plunger in the container to form distal and proximal chambers, wherein the middle plunger seals the distal chamber from the proximal chamber and the freeze-dried substance is inside the distal chamber. The method includes filling a reconstitution medium in the proximal chamber, and sealing distal and proximal openings of the container. The method includes providing a holder having a seat and arranging the container in the seat in an upright position wherein a distal end side of the container extends downwardly and a proximal end side of the container extends upwardly. The container is arranged in the seat while the substance is filled, the substance is freeze-dried, the middle plunger is inserted, the reconstitution medium is filled, and the proximal opening is sealed.

Preparing a double chamber container

A device () for closing a chamber of a container having an opening for accessing the chamber comprises a plunger, a plunger seat (), a container carrier () and a spacer (). The plunger seat () releasably holds the plunger in a predefined alignment. The container carrier () is arranged to be connected to the container in a predefined position and alignment in relation to the opening of the container. The spacer () is arranged to position and align the plunger seat () adjacent to and distant from the container carrier () such that the opening of the container is open when the container is connected to the container carrier ().

A method for providing a dried solid product containing an active pharmaceutical ingredient is disclosed and includes providing a primary packaging container, providing a drying cartridge different from the primary packaging container, the drying cartridge made of a material adapted to hold a liquid product to be dried, wherein the liquid product contains an active pharmaceutical ingredient and the drying cartridge is made of a material having a thermal conductivity higher than the thermal conductivity of glass. The method also includes filling the liquid product into the drying cartridge, drying the liquid product in the drying cartridge to form a dried solid product containing the active pharmaceutical ingredient, transferring the dried solid product into the primary packaging container.

Method for providing in a primary packaging container a dried solid product containing an active pharmaceutical ingredient

A method for determining whether reconstitution of a solution in a container is completed comprises the steps of:

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Riehen, Switzerland

Tobias Werk